LICENSE AGREEMENT
This LICENSE AGREEMENT (the "Agreement"), dated as of April 21, 1997, is
between Immuno International AG, Xxxxxxxxxxxxxxx 00, XX-0000 Xxxxxxxx,
Xxxxxxxxxxx, a Swiss corporation (together with its subsidiaries, the
"Licensor") and Haemacure Corporation, 00000 Xxxxxx Xxx.-Xxxxx, Xxxxxxxx,
(Xxxxxx) X0X 0X0, Xxxxxx, a Canadian corporation ("Licensee").
Licensor is endeavoring to develop a topical biological product
(consisting, among other things, of fibrinogen and thrombin which are combined),
in any form, including, but not limited to, freeze-dried and frozen ("Fibrin
Sealant").
The Fibrin Sealant product described in Licensor's Product License
Application No. 87-0509 ("Licensor's PLA") on file with the U.S. Food and Drug
Administration ("FDA") as of March 24, 1997 (the "Order Effective Date"), the
date of acceptance by the Federal Trade Commission ("FTC") of a Consent Order
(the "Order") entered into between Xxxxxx International Inc. ("Baxter") and the
FTC, File No. 971-0002, and as such product may be modified as of the time of
initial licensure by the FDA, is referred to herein as the "Product."
Licensor desires to grant to Licensee, and Licensee desires to receive from
Licensor, a royalty-free license, in perpetuity, to use Licensor's Assets (as
defined below) for the research, development, manufacture, use, importation
and/or sale in the United States and its territories and possessions (the
"Territory") of Fibrin Sealant products.
Licensor and Licensee are entering into a contract manufacturing agreement
of even date herewith (the "Manufacturing Agreement").
Now, therefore, in consideration of the premises and of the mutual
covenants, representations and warranties herein contained, the parties hereto
agree as follows.
1. GRANT
1.1 Grant of License to Use of Assets. Subject to the terms and conditions
of this Agreement, Licensor hereby grants to Licensee, and Licensee hereby
accepts, a royalty-free license in perpetuity, to the Assets of Licensor to
make, have made, use, sell, offer for sale, research, develop and/or import
Fibrin Sealant products in the Territory. The license hereunder extends to all
rights under the United States patents listed on Exhibit A hereto, including all
continuations, continuations-in-part, divisions, renewals, substitutions,
reissues, reexaminations and extensions thereof, to make, have made, use, sell,
offer for sale, research, develop and/or import Fibrin Sealant products in the
Territory (the "Patent Rights").
1.2 Limitations. Nothing in this Agreement shall be construed to provide
either party with any rights to assets of the other party or its Affiliates (as
defined below) other than as specifically provided in this Agreement. Licensor
specifically retains the right to do itself all things it is licensing
hereunder, except for restrictions on licensing or assigning in Section 2
hereof.
1.3 Assets. The term "Assets" means all of the Licensor's rights and other
assets relating to the research, development, manufacture, use and/or sale of
the Product and of Licensor's liquid formulation Fibrin Sealant product which is
manufactured and sold in a frozen state ("Frozen Formulation"), as of the Order
Effective Date, and includes, without limitation, all formulations, Patent
Rights, trade secrets, technology, know-how, specifications, designs, drawings,
processes, pre-clinical and clinical data, production information, manufacturing
information, testing and quality control data, research materials, technical
information, software, information stored on management information systems (and
specifications sufficient for the Licensee to use such information) and all
data, contractual rights, materials and information relating to FDA and other
governmental or regulatory approvals for the Territory, as they may exist on the
Order Effective Date. Assets shall not include any trademarks, trade names, or
sales or marketing information, or any assets relating to Licensor's plasma
quality, including, but not limited to, screening of plasma for genetic material
or infectious agents by polymerase chain reaction methodology (other than
information regarding types of viruses tested for and required acceptance
levels, as included in testing and quality control data above). All of the
foregoing Assets, except for Patent Rights, are "Technical Information." Assets
shall include the Technical Information required for Licensee to make, have
made, use or sell the Product as licensed by the FDA.
2. LICENSE, SUBLICENSE AND ASSIGNMENT
2.1 Licensee Sublicensing.
(a) Licensee may sublicense its rights under this Agreement without
the consent of Licensor to any entity controlling, controlled by or under
common control with Licensee (an "Affiliate"), for any reason and to third
party contract manufacturers which are Responsible Suppliers (as defined in
Section 10 below) solely for the manufacture of Fibrin Sealant products
using the Assets for Licensee's account. For purposes of this Agreement, a
party is "controlled" if the controlling party owns more than 50% of the
equity of such party.
(b) Licensee may also sublicense its rights hereunder to a third party
or parties without Licensor's consent (a "Third Party Sublicensee"),
(i) during the Manufacturing Period (as defined in Section 8.1
below), in whole and not in part, and
(ii) thereafter, in whole or in part, or both,
provided that in the event of such a sublicense, Licensor may assign,
license or otherwise transfer Assets without restriction.
(c) A sublicense which is the equivalent of an assignment or which
grants exclusive rights to the sublicensee of substantially all the rights
licensed hereunder or otherwise substantially limits or restricts the
Licensee's independent exercise of its rights hereunder shall be subject to
the provisions of Section 2.3 below.
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2.2 Licensor Licensing.
(a) Without the prior written consent of Licensee, prior to a Third
Party Sublicense pursuant to Section 2.1(b) hereof, Licensor shall not
license the Assets to a third party to make, use, sell or import Restricted
Products (as hereafter defined) for sale in the Territory (a "Restricted
License").
(b) "Restricted Products" for purposes of this Section shall mean the
Product, Frozen Formulation, and Volume Variations (as defined in the
Manufacturing Agreement), together with the Product and Frozen Formulation
as improved during the period ended on the fourth anniversary of the date
of initial FDA licensure of the Product as a result of changes to the
manufacturing process set forth in the first sentence of Section 8.1 hereof
or as a result of improvements developed by the Licensor and licensed by
the FDA during the Manufacturing Period.
(c) In the event that Licensor wishes to enter into a third-party
license to the Assets for any Fibrin Sealant product in the Territory other
than a Restricted License, Licensor shall notify Licensee and the payments
thereafter due under Section 3 hereof shall be reduced as follows: the
payment due from Licensee under subsection (b)(v) shall be reduced to
$4,000,000; the payment due from Licensee under subsection (b)(vi) shall be
reduced to $4,000,0000; and the payment due from Licensee under subsection
(c) shall be reduced to $4,000,000. If any payment set forth in Section 3
is due prior to the entry into of such a non-Restricted License, such
payment shall not be reduced. This reduction shall apply to the first such
non-Restricted License granted and not to any subsequent license.
(d) Licensor may license or otherwise transfer the Assets without the
consent of Licensee without restriction except as set forth in this Section
and to any of its Affiliates for any reason and to third party contract
manufacturers to make Fibrin Sealant products using the Assets for
Licensor's own account or to purchasers of the Licensor's products for use
or sale of such products.
2.3 Assignment.
(a) Each party may assign its rights hereunder as a part of a sale or
change of control of all or substantially all of its respective assets
without the consent of the other party, and Licensor may assign its rights
hereunder as a part of a sale of the division in which the Assets are held
with the consent of Licensee, which consent may not be unreasonably
withheld. Such consent of the Licensee shall not be required for a
financially viable assignee that agrees to be bound by Licensor' s
obligations to Licensee under this Agreement and the Manufacturing
Agreement, provided that (i) Licensor or an Affiliate of Licensor owns a
substantial equity interest in the assignee, (ii) during the Manufacturing
Period (as defined in Section 8.1 below), such assignee does not change the
manufacturing situs for the Product, and (iii) during the Manufacturing
Period, the assignment does not adversely affect Licensee's complete and
timely access to the Assets.
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(b) Licensee may assign its rights under this Agreement, in whole and
not in part, to a third party without Licensor's consent, provided that (i)
during the Manufacturing Period, the assignee and the assignment receive
prior approval of the FTC, (ii) the assignee assumes Licensee's obligations
under this Agreement, (iii) Licensee remains fully liable under this
Agreement and (iv) any such assignment by Licensee shall allow Licensor to
assign, license or otherwise transfer Assets without restriction.
2.4 Payment by Licensee for Sublicensing or Assigning.
(a) If Licensee sublicenses or assigns its rights (other than in
connection with a sale or change of control of all or substantially all of
its assets) hereunder within three years of the date of this Agreement, the
unpaid installments set forth in Sections 3(a) through (c) below shall
become immediately due and be paid to Licensor at the time of such
sublicense or assignment.
(b) If Licensee sublicenses or assigns its rights (other than in
connection with a sale or change of control of all or substantially all of
its assets) hereunder after three years from the date of this Agreement,
the payment specified in Section 3(c) below shall become immediately due
and be paid to Licensor at the time of such sublicense or assignment, and
the sublicense or assignment shall require the sublicensee or assignee to
assume the obligations for all unpaid installments; and, in the case of a
sublicense, Licensee shall remain primarily responsible for such
installments and the sales of the sublicensees shall be included in Gross
Sales for purposes of Section 3(b) below.
2.5 Notice, etc. Each party shall be obliged to notify the other not less
than 30 days prior to entering into any assignment, license or sublicense
hereunder. Any assignment or sublicense hereunder shall provide that it is
subject to the terms of this Agreement.
3. CONSIDERATION
Subject to the achievement of the milestones provided in Section 4(b)
below, the maximum aggregate consideration payable hereunder shall be U.S.
$22,500,000, payable as follows:
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(a) Upon FTC approval of this Agreement (in consideration of the
Patent Rights licensed hereunder) $1,500,000
(b) For all other rights licensed hereunder:
(i) Upon licensure of Covered Product by
the FDA 250,000
(ii) Upon delivery to Licensee of its first
order of Covered Product 1,000,000
(iii) Upon FDA licensure of Licensee to
manufacture Covered Product 1,500,000
(iv) Upon achievement of total Gross Sales
of $50,000,000 3,250,000
(v) Upon achievement of total Gross Sales
of $150,000,000 5,000,000
(vi) Upon achievement of total Gross Sales
of $250,000,000 5,000,000
(c) Upon sublicense or assignment by Licensee to a Third Party
Sublicensee or assignee (a one-time payment for the first such sublicense
or assignment) 5,000,000
Of the payment under (a) above, $500,000 shall be refunded by Licensor to
Licensee if the FDA has not licensed the Product by January 1, 1998, and an
additional $750,000 shall be refunded by Licensor to Licensee if the FDA has not
licensed the Product by July 1, 1998. Such refunds shall be paid within 30 days
of the missed date.
Gross Sales in the schedule of milestones in Section 3(b) means sales of
Covered Product. "Covered Product" means (a) Product and Frozen Formulation
contract manufactured by Licensor for Licensee or its transferees ("Contract
Manufactured Product"), (b) Product and Frozen Formulation made, used or sold by
or for Licensee or its transferees using any of the Assets, and (c) other Fibrin
Sealant products made, used or sold by or for Licensee or its transferees using,
or resulting from use of, any of the Assets. Gross Sales shall be determined in
accordance with generally accepted accounting principles consistently applied
and as included in the audited financial statements of Licensee or its
transferees. Any disputes regarding the amount of Gross Sales shall be resolved
by a nationally-recognized independent public accounting firm selected by
agreement of the parties, or, failing agreement, by lot, and the determination
of such firm shall be final and binding on the parties.
Sales between and among Licensee, its Affiliates and sublicensees shall not
be included in Gross Sales to the extent re-sold by the recipient, but sales by
Licensee, its Affiliates and sublicensees to independent third parties shall be
included in Gross Sales.
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4. COVENANTS
4.1 Right of Reference. Licensor grants to Licensee the right of continued
reference to the data contained in the Licensor PLA as of the date the Product
is first licensed by the FDA for sale in the United States. Licensor shall make
all necessary filings with the FDA authorizing the FDA to refer to the Licensor
PLA for the data in support of the Licensee Product Licensing Application
("Licensee PLA") for the Product and, if it becomes subject to the Licensee PLA,
the Frozen Formulation, including any supplemental or related Licensor PLAs,
provided that the right of reference granted in this Section 4.1 does not
constitute a general release of the data in the Licensor PLA, including any
supplemental or related Licensor PLAs, except as it may appear in labeling. Any
Improvements may be used by Licensee only pursuant to an Improvements License as
provided in Section 7 below.
4.2 FDA Approval Process. Licensor shall use commercially reasonable
efforts to obtain all necessary FDA approvals to manufacture and sell the
Product in the Territory. Licensor shall provide Licensee with reasonable notice
of Licensor's efforts to develop, file and obtain approval of PLA and ELA for
the Product and respond to Licensee's reasonable requests for information
regarding such efforts. Licensor shall supply Licensee with a full copy of the
PLA for the Product upon execution of this Agreement and a full copy of all
modified PLAs for the Product and the Frozen Formulation applied for up to the
time Licensee is licensed for a Covered Product by the FDA ("Licensee FDA
Licensure") promptly after submission thereof to the FDA, including full reports
of all summaries included in the PLA. Licensor shall promptly provide Licensee
with copies of all correspondence with the FDA, and of all reports summarizing
contacts or meetings with the FDA, regarding the Product or the Frozen
Formulation. Licensor shall provide Licensee with prompt notice of any meetings
with the FDA, consult with Licensee regarding such meetings and any proposed
Product changes prior to meeting with the FDA and fumish reports summarizing
such meetings to Licensee. Licensor shall retain ultimate responsibility for the
FDA regulatory process for the Product and the Frozen Formulation. If Licensor
attempts to abandon, withdraw or otherwise ceases to maintain the PLA, Licensor
shall make all necessary filings with the FDA to transfer the PLA to Licensee or
undertake such actions necessary to allow Licensee's continued ability to
reference the PLA.
4.3 Licensee FDA Approval. Licensee shall submit to the trustee appointed
under Paragraph VI of the Order (the "Trustee") the periodic verified written
reports setting forth in detail the efforts of the Licensee to sell the Product
in the United States and to obtain all FDA approvals necessary to manufacture
its own Product for sale in the United States. The first such report shall be
submitted 60 days from the date the FTC approves this Agreement (the "FTC
Approval Date") and every 90 days thereafter until all necessary FDA approvals
are obtained by Licensee to manufacture Product for sale in the United States.
Licensee shall report to the FTC and the Trustee within 10 days of its
voluntarily ceasing the sale of the Contract Manufactured Product in the United
States for any time period exceeding 60 days or abandoning its efforts to obtain
all necessary FDA approvals to manufacture its own Product for sale in the
United States. Licensee shall use all commercially reasonable efforts to obtain
in an expeditious manner all FDA approvals to manufacture its own Product for
sale in the United States, and, unless previously effected, as promptly as
practicable after the execution of
6
this Agreement, Licensee shall prepare and submit to the FTC a certification of
Licensee's good faith intention and its plan for doing so.
4.4 Maintenance of Assets. While the obligations imposed under the Consent
Order are in effect, Licensor shall take such actions as the FTC may require:
(a) to maintain the viability and marketability of the Assets as well as all
tangible assets, including manufacturing facilities, needed to contract
manufacture and sell the Product; and (b) to prevent the destruction, removal,
wasting, deterioration or impairment of any of the Assets or tangible assets,
including manufacturing facilities, needed to contract manufacture and sell the
Product, except ordinary wear and tear.
4.5 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 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. Licensor agrees to
petition the United States Patent and Trademark Office to restore the maximum
patent term for the lead patent for which Patent Rights are licensed hereunder
if such extension is available.
4.6 Supply Agreement. Licensor agrees to enter into a Supply Agreement
substantially in the form of Exhibit 4.6 attached hereto (the "Supply
Agreement") upon Licensee's request at the time Licensee begins manufacturing
the Product.
4.7 Additions to Exhibit A. In the event that the Product as initially
licensed by the FDA or the process for manufacturing the Product starting with
fractionated plasma as initially licensed by the FDA infringe any patent (except
for patents with respect to the process of manufacturing Feiba and thrombin)
owned by Licensor, not on Exhibit A, Licensee and Licensor shall amend Exhibit A
to include such patent(s).
5. TERMINATION
5.1 Termination by FTC. The FTC may terminate this Agreement if the
Licensee (a) voluntarily ceases for 60 days or more the sale of Contract
Manufactured Product in the United States prior to obtaining all FDA approvals
to manufacture the Product for sale in the United States; (b) abandons its
efforts to obtain all necessary FDA approvals to manufacture Product for sale in
the United States; or (c) fails to obtain all necessary FDA approvals of its own
to manufacture Product for sale in the United States within three years from the
FTC Approval Date, provided, however, that the time period may be extended by
the FTC in 12 month increments for a period not to exceed an additional 48
months if the Trustee certifies to the FTC that the Licensee made good faith
efforts to obtain all necessary FDA approvals for manufacturing Product for sale
in the United States and that such FDA approvals appear likely to be obtained
within such extended time period. If all necessary FDA approvals to manufacture
Product for sale in the United States are not obtained within the time frames
specified by this Section 5.1, the FTC may terminate this Agreement. Licensor
agrees to assist
7
Licensee in obtaining such extensions provided that the delay is caused by
factors outside the control of Licensee (e.g., regulatory delay) and Licensee
has been pursuing Licensee FDA Licensure in good faith. If this Agreement is so
terminated, the Trustee shall grant a new license to a new licensee pursuant to
the provisions of Paragraph VII of the Order. If this Agreement is terminated by
the FTC pursuant to part 8(a) or (b) of Paragraph V of the Order, or pursuant to
part 8(c) of Paragraph V of the Order on the basis that Licensee has not
endeavored in good faith to obtain FDA approvals, any amounts set forth in
Sections 3(b)(i) through (iii) hereof which have not been paid shall be paid by
Licensee to Licensor. If this Agreement is terminated by the FTC pursuant to
part 8(c) of Paragraph V of the Order resulting from Licensor's non-performance
or breach of its obligations hereunder, Licensor shall refund all payments made
by Licensee pursuant to Section 3 hereof.
5.2 Termination by Parties. Either party may terminate this Agreement in
the event of a material breach by the other, provided that the allegedly
breaching party (and the Trustee, if applicable) is given written notice of such
alleged breach and a reasonable time, not to exceed 30 days, in which to cure
such breach. Such period to cure may be extended for up to 30 days, upon written
request of the allegedly breaching party, if such additional time is reasonably
necessary to effect such cure.
6. REPRESENTATIONS AND WARRANTIES
6.1 By Licensor.
(a) Licensor warrants that (i) other than the patents listed on
Exhibit A, neither the Product as currently proposed to be manufactured by
Licensor nor the process for manufacturing the Product starting with
fractionated plasma infringe any patent owned by Licensor in the Territory
except for patents with respect to the process of manufacturing Feiba
(which is expressly not licensed hereunder) and thrombin (which is
expressly not licensed hereunder, but is covered in the Supply Agreement);
(ii) it is the owner of the Patent Rights and Technical Information; (iii)
it has the right to license said Patent Rights and Technical Information in
the Territory in the manner set forth in this Agreement; (iv) it has not
received and does not reasonably expect to receive any notice of litigation
from any third party that the Product, as currently proposed to be made by
Licensor, incorporates know-how or trade secrets wrongfully obtained
directly or indirectly from said third party; and (v) it has not received
any notice from any third party that the Patent Rights in the Territory
incorporate know-how or trade secrets wrongfully obtained directly or
indirectly from said third party.
(b) Licensor warrants that it does not have actual knowledge of any
patents of third parties which would be infringed in the Territory by the
manufacture, use or sale of the Product, as currently proposed to be made
by Licensor.
(c) Licensor warrants that it has not assigned or conveyed any
interest in the Patent Rights or Technical Information which is
inconsistent with the rights granted hereunder.
8
(d) Licensor has full legal right, power and authority to execute,
deliver and perform its obligations under this Agreement.
(e) The execution, delivery and performance by Licensor of this
Agreement do not contravene or constitute a default under any provision of
applicable law or any agreement, judgment, injunction, order, decree or
other instrument binding upon Licensor.
(f) 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 of affecting creditors' rights
generally and (ii) subject to general principles of equity (regardless of
whether such enforceability is considered in a preceding in equity or at
law).
6.2 By Licensee.
(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.
(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).
6.3 Negation of Representations and Warranties. Nothing in this Agreement
shall be construed as:
(a) 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 6.5; or
(b) 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; or
9
(c) 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
(d) granting any rights to Licensor in any patents or trade secrets
of Licensee developed independently of any Assets licensed hereunder and
without use of any trade secrets, patents or other intellectual property of
Licensor.
6.4 Survival of Representations and Warranties. 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.
6.5 Infringements. etc.
(a) The parties agree to promptly notify each other of any suspected
infringement by a third party of any Patent Rights or other rights licensed
hereunder. Licensee shall promptly provide Licensor with the available
evidence, if any, of such infringement. The parties agree to promptly
notify each other of any claim or assertion that Licensor's rights to any
of the Assets are limited or invalid. If infringement occurs, the parties
agree to consult regarding the appropriate course of action.
(b) 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.
(c) 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
assistance reasonably required, provided that the costs of any such
materials or assistance shall be paid for by the Licensor.
(d) In the event Licensor fails to take reasonable steps to prevent
further infringement of Patent Rights (other than the infringement of
Patent Nos. 4,640,834 and 4,816,251) 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 in the Territory, 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 pursue 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.
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(e) 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.
(f) The party taking enforcement action shall not settle any alleged
infringement of the Patent Rights or rights licensed hereunder that would
adversely affect the other party without such other party's prior written
consent, which will not be unreasonably withheld.
7. IMPROVEMENTS
7.1 Licensor may develop improvements applicable to (i) the Product, (ii)
the Frozen Formulation and (iii) Volume Variations, and their manufacture,
licensed by the FDA during the Manufacturing Period (the "Improvements"). No
such Improvements are included in the license granted hereunder.
7.2 Licensor shall negotiate with Licensee for a royalty-bearing or other
license agreement (the "Improvement License") for the right to use Improvements
which have been developed by Licensor and licensed by the FDA for sale in the
Territory during the Manufacturing Period. The field of use of such Improvement
License shall be to use such Improvements to make, have made, use, sell and
import Product and Frozen Formulation and Licensee's Volume Variations in the
Territory. The Improvement License may be royalty-bearing and shall be subject
to such other terms and conditions (including field of use limitations) as the
Licensor may request, provided that such terms shall be reasonable, commercial
terms for the license. The Improvement License may be either exclusive or
non-exclusive, as determined by Licensor.
7.3 Licensor shall, within 30 days of the end of the Manufacturing Period,
send the Licensee a letter notifying Licensee of any Improvements Licensor has
developed and offering the Licensee the opportunity to negotiate for an
Improvement License (the "Improvement Letter"). The Improvement Letter shall set
forth a name of person who the Licensor designates as its representative for the
purpose of negotiating a license and the terms and conditions which Licensor
proposes for the Improvement License. The Licensee shall within 45 days after
the date of the Improvement Letter notify Licensee: (a) that it accepts the
terms offered; (b) of its interest in negotiating the terms of the Improvement
License in which case the notice shall name Licensee's negotiator and the terms
Licensee desires to negotiate; or (c) that it waives its right to negotiate for
such Improvements (which right shall be deemed waived in the event the Licensee
does not respond to the Improvement Letter within the 45-day period.)
7.4 If Licensee shall elect to negotiate the terms of an Improvement
License pursuant to Section 7.3(b), the representatives shall arrange to meet
within 15 days after the date of Licensee's notice and thereafter at the
reasonable request of either party for a period of 45 days after the initial
meeting and endeavor in good faith to reach an agreement on the terms of an
Improvement License. If the parties are unable to reach agreement or an
Improvement
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License within such 45-day period, this Section 7 shall be deemed void as to
such Improvements and the Licensee shall have no further rights under this
Agreement in such Improvements.
8. MANUFACTURING SUPPORT AND TECHNICAL INFORMATION TRANSFER
8.1 Manufacturing Support. Licensor shall make available to Licensee at no
additional cost all assays, standard operating procedures, manufacturing changes
and quality control and testing procedures that constitute part of the
manufacturing process for the Product (and Volume Variations) and the Licensor
PLA for the Product during the manufacturing period under the Manufacturing
Agreement (the "Manufacturing Period"), and the foregoing shall not be deemed
Improvements covered by Section 7 hereof. Licensor agrees, once it begins
manufacturing the Product and Frozen Formulation, upon reasonable notice and
request from Licensee, to provide (a) such assistance and advice as is
reasonably necessary to enable Licensee to obtain all necessary FDA approvals to
manufacture the Product and Frozen Formulation for sale in the Territory, (b)
such assistance as is reasonably necessary to enable Licensee to manufacture the
Product and Frozen Formulation in substantially the same manner and quality
employed or achieved by Licensor and (c) consultation with knowledgeable
employees of Licensor and training at a facility of Licensee's choosing, for a
period from Licensee's payment under Section 3(a) hereof through Licensee's FDA
Licensure, sufficient to adequately train Licensee's personnel in the
manufacture of the Product and Frozen Formulation for sale in the Territory.
Such assistance shall include at least one on-site inspection of Licensor's
facility that is performing the manufacturing under the Manufacturing Agreement,
upon reasonable notice and request by the Licensee. The parties shall mutually
agree in writing concerning details of such visits, including the frequency,
subject matter involved, duration, respective representatives involved, and
timing of such visits. Licensee will pay all of the traveling, living and other
expenses of its own representatives and personnel incurred in connection with
this Section 8.1 and will pay Licensor all of its direct costs of providing
services (not including employees' salaries).
8.2 Initial Transfer of Technical Information. In accordance with the
License granted hereby, upon one month's notice to Licensor, Licensor shall
furnish Licensee one copy of each of the documents embodying the Technical
Information ("Initial Transfer Materials"), Licensor shall have no obligation to
furnish any Initial Transfer Materials to any assignee or sublicensee of
Licensee.
8.3 Access to Technical Information. In addition to the manufacturing
support described in Section 8.1 and in accordance with the License granted
hereby, upon reasonable notice to Licensor, Licensor shall use all reasonable
efforts to provide to Licensee Technical Information not part of Initial
Transfer Materials for the purpose of enabling Licensee to obtain Licensee FDA
Licensure, to manufacture the Product and the Frozen Formulation for sale in the
Territory, and to improve the Product, for a period of two years after initial
FDA licensure of the Product, and thereafter for the purposes of defending
product liability and regulatory claims. Such access shall include consultation
on reasonable notice with Licensor's employees knowledgeable about the Technical
Information. Licensor shall only be obliged to answer Licensee's inquiries to
the extent it is reasonably able to do so, and Licensor shall have
12
no responsibility for any actions of Licensee based on such answers. Licensor
shall not furnish, nor shall Licensee be deemed to have accepted, any
information not requested by Licensee related to the Technical Information.
8.4 Transfer Log. The parties shall mutually agree in writing on
procedures for the memorialization of each Technical Information transfer,
including keeping a transfer log of all documents provided to Licensee. The
parties shall detail in written memoranda each oral communication, visit and
inquiry. The party initiating the contact shall be responsible for drafting the
memorandum memorializing the event. The other party shall have 14 days to
respond to the memorandum.
8.5 Commencement. Licensor shall not be required to furnish Technical
Information or otherwise assist Licensee pursuant to this Section 8 prior to
receipt of the payment contemplated by Section 3(a) of this Agreement.
9. CONFIDENTIALITY
To implement this Agreement and the Manufacturing Agreement, the parties
have and will disclose confidential information to each other, including
information regarding the Product. Any information transferred pursuant to this
Agreement or the Manufacturing Agreement and deemed confidential by the
transferring party shall be so designated at the time it is transferred or
provided, whether provided in writing, visually or orally ("Confidential
Information"). Each party agrees that it will not disclose Confidential
Information to third parties, except, (i) after reasonable notice to the other
party, to the extent required by appropriate governmental regulatory agencies
(for filings, communication or other purposes) or pursuant to court order, (ii)
to Affiliates and permitted sublicensees and assignees, and to such parties as
may be necessary for the purposes of conducting research regarding Fibrin
Sealant, but only after such parties have entered into agreements requiring the
same terms of confidentiality as set forth herein, and (iii) as may be
reasonably necessary, to potential customers for sales of Fibrin Sealant, so
long as such disclosures do not diminish the value of the Assets. Where
Confidential Information is required by a governmental regulatory agency or
pursuant to a court order, the disclosing party shall cooperate fully with the
other party's efforts in attempting to obtain a protective order or similar
activity or protection with respect to such disclosures. Thirty days' notice
shall be considered reasonable under this Section unless through no fault of the
disclosing party a shorter period is required. The parties further agree to take
such precautions as they would normally take with their own confidential and
proprietary information to prevent disclosure of the Confidential Information to
third parties except as provided herein. The obligations of confidentiality
shall not, in any event, apply to any information, which, at the time of
disclosure is available to the public in published literature or otherwise
through no fault of the disclosing party or was already rightfully in the
disclosing party's possession prior to disclosure to it by the other party, as
demonstrated by documentary evidence preserved by the disclosing party.
13
10. FOREIGN LICENSE
At the request of Licensee, Licensor shall license Licensee or any
Responsible Supplier the Foreign Equivalent Patents and the Technical
Information owned by Licensor solely for the purpose of making and having made
product in a country outside of the United States exclusively for import and
sale by Licensee in the Territory. Such a license shall be granted only to a
specific facility and only in one country at any one time. Such a license shall
contain such terms and restrictions consistent with this Agreement as Licensor
may reasonably require in order to secure its patent, trade secret and other
intellectual property rights. For purposes of this Section, Foreign Equivalent
Patents shall be patents based upon the disclosures in the patents listed on
Exhibit A hereto and claiming identical or equivalent inventions. A Responsible
Supplier shall mean a financially responsible party with adequate technical
expertise willing to enter into appropriate agreements ensuring that the
Technical Information and patent rights licensed pursuant to such a license will
not be used or disclosed for any purpose other than manufacture of Product and
Frozen Formulation for sale by Licensee in the Territory.
11. INDEMNIFICATION
11.1 By Licensee. Licensee shall indemnify, defend and hold Licensor
harmless from and against all liability, demands, damages, expenses and losses,
of any kind or nature whatsoever, arising from (a) the inaccuracy or breach of
any representation or warranty of Licensee contained in this Agreement; (b) the
breach of any covenant or other agreement of Licensee in this Agreement; (c) the
death, personal injury, illness or property damage arising out of the
manufacture, use, sale or other disposition of any Product or Frozen Formulation
manufactured by or for Licensee or its sublicensees or assignees, excepting
Product or Frozen Formulation manufactured by Licensor under the Manufacturing
Agreement, the indemnification provisions of which shall be controlling;
provided, however, that such is not the result of Licensor's own negligence and
that Licensee shall not indemnify Licensor for any liability arising out of a
claim relating to Licensor's right to enter into this Agreement or its right to
license any of the Patent Rights to Licensee hereunder. As used in this Section,
Licensor and Licensee include their respective Affiliates, trustees, officers,
agents and employees.
11.2 By Licensor. Licensor shall indemnify, defend and hold Licensee
harmless from and against all liability, demands, damages, expenses and losses,
of any kind or nature whatsoever, arising from (a) the inaccuracy or breach of
any representation or warranty of Licensor contained in this Agreement; (b) the
breach of any covenant or other agreement of Licensor in this Agreement; (c)
Licensor' s misappropriation of the trade secrets or know-how of third parties
with respect to the Patent Rights or Technical Information, insofar as it is
incorporated in the Product as made by Licensor.
12. EXPORT OF TECHNICAL INFORMATION
Notwithstanding any other provisions of this Agreement, Licensee agrees to
make no disclosure or use of any Technical Information furnished or made known
to it by Licensor
14
pursuant to this Agreement except in compliance with the laws and regulations of
the United States of America relating to exports as they may exist from time to
time, including, without limitation, regulations promulgated by the Office of
Foreign Asset Control and the Export Control Regulations promulgated by the
Office of Export Control, Bureau of International Commerce, U.S. Department of
Commerce and in particular, Licensee agrees that it will not, directly or
indirectly, export any Technical Information or the "direct product" thereof to
any country or countries for which a validated license is required pursuant to
said Export Control Regulations without first obtaining such a validated
license.
13. GENERAL PROVISIONS
13.1 Expenses. Except as otherwise provided in this Agreement, the
Manufacturing Agreement or the Supply Agreement, each party shall bear its own
expenses incident to or incurred in connection with the transactions
contemplated in this Agreement, including but not limited to fees of attorneys,
accountants, brokers and finders.
13.2 Further Action. Each party hereto shall take such further action and
shall execute and deliver such further documents as may be reasonably requested
by the other party in order to carry out the provisions and purposes of this
Agreement and to obtain for Licensee the benefits of the Assets.
13.3 Notices. All notices which are permitted or required under this
Agreement shall be in writing and shall be deemed given when delivered
personally, by datafax, telex or telegram, or if sent, three business days after
being mailed by registered or certified mail, postage prepaid, or by such other
method (including air courier) which provides for a signed receipt upon
delivery, addressed as follows, or to such other person or address as may be
designated by notice to the other party:
If to Licensor: Immuno International AG
Xxxxxxxxxxxxxxx 00
XX-0000 Xxxxxxxx, Xxxxxxxxxxx
Attention: Chairman
Phone: 00.0.000.0000
Facsimile: 00.0.000.0000
with a copy to: Xxxxxx International Inc.
Xxx Xxxxxx Xxxxxxx
Xxxxxxxxx, Xxxxxxxx 00000
Attention: General Counsel
Phone: 000-000-0000
Facsimile: 000-000-0000
15
If to Licensee: Haemacure Corporation
0 Xxxxx Xxxxxxx Xxxxx, Xxxxx 000
Xxxxxxxx, Xxxxxxx 00000
Attention: Xxxx X. Xxxxxx
Phone: 000-000-0000
Facsimile: 000-000-0000
with a copy to: Haemacure Corporation
00000 Xxxxxx Xxx.-Xxxxx
Xxxxxxxx, (Xxxxxx) X0X 0X0
Xxxxxx
Attention: Xxx Xxxxxxxx
Phone 000-000-0000
Facsimile: 000-000-0000
with a copy to: Xxxxx & Lardner
000 Xxxx Xxxxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxxx 00000-0000
Attention: Xxxxx X. Xxxxx
Phone: 000-000-0000
Facsimile: 000-000-0000
13.4 Public Disclosure. Except to the extent otherwise required by law, any
public disclosure of the subject matter of this Agreement (including but not
limited to press releases) by any party shall be approved by all parties prior
to release, provided that such approval shall not be unreasonably withheld or
delayed; such consent shall not be required for later disclosures consistent
with previously-approved disclosures.
13.5 Severability. Any provision of this Agreement which is invalid or
unenforceable shall be ineffective to the extent of such invalidity or
unenforceability, without affecting in any way the remaining provisions hereof.
13.6 Entire Agreement. This Agreement, including all schedules and exhibits
hereto, and the Supply Agreement and the Manufacturing Agreement, constitute the
entire agreement of the parties, superseding and extinguishing all prior
agreements and understandings, representations and warranties, relating to the
subject matter hereof.
13.7 Modification and Amendment. This Agreement may not be modified,
amended or terminated except by written agreement specifically referring to this
Agreement signed by the parties hereto.
13.8 Waiver. No waiver of a breach or default hereunder shall be considered
valid unless in writing and signed by the party giving such waiver, and no such
waiver shall be deemed a waiver of any subsequent breach or default of the same
or similar nature.
16
13.9 Governing Law. This Agreement shall be governed by the substantive,
internal laws of the state of Illinois applicable to contracts made and to be
performed therein.
13.10 Counterparts. This Agreement may be executed simultaneously in
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
13.11 Relationship of Parties. Licensor and Licensee are not, and nothing
in this Agreement shall be construed to constitute them, partners, joint
venturers, agents, representatives or employees of the other, nor to create any
relationship between them other than that of an independent contractor. Neither
party shall have any responsibility or liability for the actions of the other
party except as specifically provided herein. Neither party shall have any right
or authority to bind or obligate the other party in any manner or make any
representation or warranty on behalf of the other party.
17
IN WITNESS WHEREOF, the parties, by their duly authorized officers, have
signed this Agreement on the date first written above.
IMMUNO INTERNATIONAL AG HAEMACURE CORPORATION
By: /s/ XXXXXXX X. XXXXXXXX By: /s/ XXX XXXXXXXX
---------------------------------- ---------------------------------
Name: Xxxxxxx X. Xxxxxxxx Name: Xxx Xxxxxxxx
Title: Director Title: Vice President, Operations
By: /s/ XXXXXX X. XXXXXXXXX
----------------------------------
Name: Xxxxxx X. Xxxxxxxxx
Title: Director
18
Exhibit A
UNITED STATES PATENTS
Number Subject Date
------ ------- ----
4,362,567 Tissue adhesive December 7, 1982
4,414,976 Tissue adhesive November 15, 1983
4,298,598 Tissue adhesive November 3, 1981
4,377,572 Tissue adhesive March 22, 1983
4,909,251 Tissue adhesive March 20, 1990
4,640,834 Method of inactivating reproducible February 3, 1987
filterable pathogens in blood products
as well as a method of producing blood
products
4,816,251 Method of inactivating reproductives March 28, 1989
filterable pathogen in fibrinogen and
factor XIII compositions
19
Exhibit 4.6
SUPPLY AGREEMENT
This SUPPLY AGREEMENT (the "Agreement") is made as of the ____ day of
_________, 20/19__ between Immuno International AG, Xxxxxxxxxxxxxxx 00, XX-0000
Xxxxxxxx, Xxxxxxxxxxx, a Swiss corporation ("Immuno") and Haemacure Corporation,
00000 Xxxxxx Xxx.-Xxxxx, Xxxxxxxx, (Xxxxxx), X0X 0X0, Xxxxxx, a Canadian
corporation ("Haemacure").
R E C I T A L S
Haemacure and Immuno have entered into a license agreement dated as of
April 21, 1997 (the "License Agreement") and a manufacturing agreement of even
date with the License Agreement (the "Manufacturing Agreement").
Pursuant to the License Agreement, Haemacure is to pursue licensure by the
United States Food and Drug Administration (the "FDA") to sell product of its
own manufacture ("FDA Licensed Product") under the Licensee PLA (as defined in
the License Agreement) based upon the equivalency of the FDA Licensed Product to
the Product (as defined in the License Agreement).
A component of the Product is thrombin, which can be derived from Immuno's
bulk activated prothrombin complex concentrate ("Bulk Feiba"), and Immuno and
Haemacure wish to make provision for supplying Haemacure with Bulk Feiba under
the terms of this Agreement at such time as Haemacure commences production of
its FDA Licensed Product.
C O V E N A N T S
Accordingly, the parties agree as follows:
1. SALE. During the term of this Agreement, Immuno will sell to Haemacure
all of Haemacure's requirements of Bulk Feiba in connection with the production
of thrombin for use solely in Haemacure's production of the FDA Licensed Product
and Product Extensions (as hereafter defined) for sale in the United States and
its possessions (the "Territory") pursuant to the License Agreement. The
quantities and delivery schedules shall be as specified in purchase orders
submitted by Haemacure. Haemacure shall pay all invoices for Bulk Feiba
delivered by Immuno in accordance with normal commercial terms. Immuno will
supply Bulk Feiba to Haemacure in the form in which Immuno stores it. All sales
of Bulk Feiba shall be subject to the terms and conditions of this Agreement
and, to the extent they specify quantities, destinations and delivery dates, to
Haemacure's purchase orders, and shall not otherwise be subject to the terms,
conditions or provisions of any confirmation or business form of either party.
For purposes of this Agreement, "Product Extensions" shall mean Covered Product
(as defined in the License Agreement) which (i) is substantially equivalent to
the FDA Licensed Product, (ii) results from FDA Licensed Product improvements,
new indications or changes in
viral inactivation or removal, or (iii) which is otherwise modified in a manner
which does not materially change the nature of the product, its formulation and
application. Subject to Section 9 below, "Product Extensions" shall also mean
Covered Product which constitutes an improvement, new indication, extension or
modification derived from Fibrin Sealant core technology embodied in the FDA
Licensed Product, including changes in manufacturing process, but only if
Haemacure demonstrates that no alternate source of thrombin is available to it
because of FDA non-approval, after the exercise of all commercially reasonably
efforts by Haemacure to obtain such approval.
2. PRICE. The price paid by Haemacure to Immuno for Bulk Feiba shall be
Immuno's actual cost of obtaining and processing Bulk Feiba, plus 20%.
3. QUALITY. Immuno warrants that all Bulk Feiba supplied by Immuno shall
at the time of shipment be of a quality as specified in Immuno's Product
Licensing Application for the Product as used by Immuno and approved by the FDA.
4. DELIVERY. Immuno shall ship all Bulk Feiba ordered by Haemacure F.O.B.
Immuno's place of manufacture, with Haemacure responsible for all shipping costs
and customs duties.
5. USE. The Bulk Feiba sold to Haemacure hereunder may not be used for any
purpose other than set forth in Section 1 hereof. Specifically, the Bulk Feiba
may not be offered for resale or used in humans without being constituted into
thrombin and used to produce a Fibrin Sealant product.
6. OTHER TERMS. Other terms and conditions of sale of Bulk Feiba to
Haemacure pursuant to this Agreement that are not expressly provided for herein
shall be in accordance with commercially reasonable standards and substantially
similar in all material respects to terms and conditions offered to any other
customer of Immuno for substances similar to Bulk Feiba.
7. TERM OF AGREEMENT. This Agreement shall commence at the end of the
Manufacturing Period set forth in the Manufacturing Agreement and continue for a
period of five years from the date Haemacure commences manufacturing of the FDA
Licensed Product. If at the expiration of the initial five year term, this
Agreement is still in force and Haemacure can demonstrate that, after exercising
all commercially reasonable efforts, it has been unable to obtain FDA approval
of thrombin of its own manufacture or manufactured by others for inclusion in
the FDA Licensed Product, Haemacure may upon written notice to Immuno, not more
than 180 days and not less than 90 days prior to the expiration, extend the term
of this Agreement for an additional period of two years. Haemacure may terminate
this Agreement upon 120 days' written notice to Immuno. Immuno may terminate
this Agreement upon 60 days' written notice to Haemacure if the second sentence
of Section 8 below is applicable.
8. AVAILABILITY OF THROMBIN. Haemacure acknowledges that it is capable of
manufacturing thrombin and may have access to thrombin from other manufacturers.
Immuno shall not be required to sell Bulk Freiba to Haemacure to the extent
thrombin is available to Haemacure on commercially reasonable terms and may be
included in the FDA
2
Licensed Product pursuant to FDA regulations. Haemacure shall take all
commercially reasonable steps to cause thrombin which is available from sources
other than Immuno on commercially reasonable terms to be approved by the FDA for
use in the FDA Licensed product. Immuno agrees that one-half of the
out-of-pocket expenses reasonably incurred by Haemacure in seeking such FDA
approval of an alternate source of thrombin for FDA Licensed Product and Product
Extensions, after such approval is received, will be deducted from the next
milestone payment due under Section 3(b) of the License Agreement, provided that
such deduction shall not exceed $250,000.
9. ARBITRATION. Any dispute between the parties concerning whether
Haemacure has exercised all commercially reasonable efforts to have an alternate
source of thrombin approved by the FDA for FDA Licensed Product and Product
Extensions, as such pertain to the last sentence of Section 1, and to Sections 7
and 8, of this Agreement shall be finally resolved by arbitration in Chicago,
Illinois in accordance with the commercial arbitration rules of the American
Arbitration Association.
10. PATENTS AND KNOW-HOW. Immuno shall make available to Haemacure all
Technical Information (as defined in the License Agreement) used by Immuno to
process Bulk Feiba to make thrombin ("Thrombin Technical Information"). The
Thrombin Technical Information shall be made available in the same manner as
Technical Information under the License Agreement but shall be used only as
provided in this Agreement. During the term of this Agreement, Haemacure may use
the Thrombin Technical Information for the purpose of making thrombin from Bulk
Feiba for use solely in Haemacure's production of the FDA Licensed Product and
Product Extensions for sale in the Territory. In addition, in the event that
there are any existing patents or any patents are issued to Immuno on this
process during the term of this Agreement, Immuno covenants not to xxx Haemacure
for any infringement by Haemacure of such patents that may occur by Haemacure's
use of Bulk Feiba supplied by Immuno to make thrombin for use in accordance with
Section 1 hereof.
11. CONFIDENTIALITY. The parties agree that the Thrombin Technical
Information constitutes Confidential Information as that term is defined in
Section 9 of the License Agreement. The provisions of such Section 9 shall apply
to Thrombin Technical Information except that Haemacure shall not disclose the
information to potential customers for sales of Fibrin Sealant as contemplated
by Section 9(iii) of the License Agreement. Upon expiration or other termination
of this Agreement, the right to use the Thrombin Technical Information and the
covenant not to xxx set forth in Section 9 of this Agreement shall terminate and
Haemacure shall: (i) cease any use of the Thrombin Technical Information; (ii)
destroy all copies of all documents containing Thrombin Technical Information;
and, thereafter, shall not use or disclose such information.
12. EXPORT OF TECHNICAL INFORMATION. Notwithstanding any other provisions
of this Agreement, Haemacure agrees to make no disclosure of use or any
Technical Information furnished or made known to it by Immuno pursuant to this
Agreement except in compliance with the laws and regulations of the United
States of America relating to exports as they may exist from time to time,
including, without limitation, regulations promulgated by the Office of Foreign
Asset Control and the Export Control Regulations
3
promulgated by the Office of Export Control, Bureau of International Commerce,
U.S. Department of Commerce and in particular, Haemacure agrees that it will
not, directly or indirectly, export any Technical Information or the "direct
product" thereof to any country or countries for which a validated license is
required pursuant to said Export Control Regulations without first obtaining
such a validated license.
13. PERMITTED BUYERS. In addition to supplying Bulk Feiba to Haemacure,
Immuno will, at the request of Haemacure, supply Bulk Feiba to not more than
three Permitted Buyers pursuant to the terms of this Agreement. For purposes of
this paragraph, "Permitted Buyers" shall mean the following persons so long as
and to the extent such person is so acting: a Responsible Supplier as defined in
the License Agreement which is making the FDA Licensed Product or Product
Extensions under agreement pursuant to Section 10 of the License Agreement; a
permitted sublicensee of Haemacure rights under the terms of the License
Agreement; a permitted Assignee of Haemacure's rights under the License
Agreement; provided that such person has entered into appropriate agreements to
assure (i) compliance with the terms of this Agreement, and the License
Agreement and (ii) Thrombin Technical Information and patents will not be used
or disclosed for any purpose other than that permitted pursuant to this
Agreement. Nothing hereunder shall require Immuno to supply Haemacure and
Permitted Buyers with Bulk Feiba in quantities greater than that would be
required for Haemacure alone. The right to use the Thrombin Technical
Information and the covenant not to xxx in Section 9 hereof shall be limited to
use permitted under this Agreement and shall terminate immediately upon the
termination of any applicable license, assignment or supply agreement. Haemacure
shall guarantee the full performance of any Permitted Buyer.
14. SEVERABILITY. If any provision of this Agreement is held to be illegal,
invalid, or unenforceable, such provision shall be fully severable and this
Agreement shall be construed and enforced as if such illegal, invalid, or
unenforceable provision never comprised a part of this Agreement. Furthermore,
in lieu of such illegal, invalid or unenforceable provision there shall be added
automatically as part of this Agreement a provision as similar in its terms to
such illegal, invalid, or unenforceable provision as may be possible and be
legal, valid, and enforceable.
15. AMENDMENT. This Agreement may only be amended by written instrument
signed by Haemacure and Xxxxxx.
00. COUNTERPARTS. This Agreement may be executed in one or more
counterparts, each of which shall be deemed to be an original but all of which
together will constitute one and the same instrument.
17. SUCCESSORS AND ASSIGNS: LIMITATION UPON ASSIGNMENT. This Agreement
shall inure to the benefit of, and shall be binding upon, the respective legal
representatives, successors, assigns and sublicensees of each of the parties.
Haemacure may assign its rights under this Agreement only in connection with a
sublicense or an assignment of its rights under the License Agreement.
4
18. INTEGRATION. This Agreement represents the entire agreement between the
parties with respect to the subject matter of this Agreement, and all other
written or oral agreements relating to the subject matter hereof are hereby
superseded.
19. NOTICES. All notices which are permitted or required under this
Agreement shall be in writing and shall be deemed given when delivered
personally, by datafax, telex or telegram, or if sent, three business days after
being mailed by registered or certified mail, postage prepaid, or by such other
method (including air courier) which provides for a signed receipt upon
delivery, addressed as follows, or to such other person or address as may be
designated by notice to the other party:
If to Immuno: Immuno International AG
Xxxxxxxxxxxxxxx 00
XX-0000 Xxxxxxxx, Xxxxxxxxxxx
Attention: Chairman
Phone 00.0.000.0000
Facsimile: 00.0.000.0000
with a copy to: Immuno AG
Xxxxxxxxxxxxxxxx 00
X-0000 Xxxxxx
Xxxxxxx
Attention: Chief Financial Officer
Phone: 00.0.00.000.0000
Facsimile: 00.0.000.0000
with a copy to: Xxxxxx Healthcare Corporation
Xxx Xxxxxx Xxxxxxx
Xxxxxxxxx, Xxxxxxxx 00000
Attention: General Counsel
Phone: 000-000-0000
Facsimile: 000-000-0000
If to Haemacure: Haemacure Corporation
0 Xxxxx Xxxxxxx Xxxxx, Xxxxx 000
Xxxxxxxx, Xxxxxxx 00000
Attention: Xxxx X. Xxxxxx
Phone: 000-000-0000
Facsimile: 000-000-0000
5
with a copy to: Haemacure Corporation
00000 Xxxxxx Xxx.-Xxxxx
Xxxxxxxx, (Xxxxxx) X0X 0X0
Xxxxxx
Attention: Xxx Xxxxxxxx
Phone: 000-000-0000
Facsimile: 000-000-0000
with a copy to: Xxxxx & Lardner
000 Xxxx Xxxxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxxx 00000-0000
Attention: Xxxxx X. Xxxxx
Phone: 000-000-0000
Facsimile: 000-000-0000
20. FORCE MAJEURE. Any failure by Haemacure to accept any Bulk Feiba, and
any failure on the part of Immuno to deliver any Bulk Feiba, ordered by
Haemacure pursuant to a purchase order in accordance with the terms of this
Agreement, which failure is caused by any act of God, labor strike, inability to
procure raw materials, or other cause beyond the control of Haemacure or Immuno
as applicable and without fault or negligence by Haemacure or Immuno as
applicable, shall not constitute a breach of this Agreement. In such event, the
party which has been so affected shall immediately give notice to the other
party and shall use all reasonable efforts to resume performance.
21. GOVERNING LAW. THE TERMS AND PROVISIONS OF THIS AGREEMENT SHALL BE
CONSTRUED IN ACCORDANCE WITH, AND GOVERNED BY, THE INTERNAL SUBSTANTIVE LAWS OF
THE STATE OF ILLINOIS APPLICABLE TO CONTRACTS MADE AND TO BE PERFORMED THEREIN.
6
IN WITNESS WHEREOF, the parties have executed this Agreement to be
effective as of the date first above-written.
IMMUNO INTERNATIONAL AG HAEMACURE CORPORATION
By: By:
--------------------------- ---------------------------
Name: Name:
Title: Title:
By:
---------------------------
Name:
Title:
7
