Exhibit 10.9
LICENSE AGREEMENT
LICENSE AGREEMENT (this "Agreement") dated as of the 18th day of
October, 2004 (the "Effective Date"), by and among ORCEL LLC ("Orcel") and ORTEC
INTERNATIONAL INC. ("Ortec"; Orcel and Ortec being herein individually called a
"Licensor" and collectively called the "Licensors") and CAMBREX BIO SCIENCE
WALKERSVILLE, INC. (the "Licensee").
W I T N E S S E T H:
WHEREAS, Ortec and the Licensee are parties to a Cell Therapy
Manufacturing Agreement, dated as of October 29, 2003, as amended by Amendment
No. 1 to Cell Therapy Manufacturing Agreement dated as of October 18, 2004 (as
so amended and as the same may be further amended from time to time, the
"Manufacturing Agreement"), pursuant to which the Licensee has agreed, among
other things, to produce a product containing human cells intended for
therapeutic use in humans;
WHEREAS, concurrently with the execution and delivery hereof, Ortec and
the Licensee are entering into a Sales Agency Agreement, dated as of October 18,
2004 (as the same may be amended from time to time, the "Sales Agreement"),
pursuant to which the Licensee has agreed to be Ortec's exclusive agent to
market and sell Orcel'r' on behalf of Ortec;
WHEREAS, concurrently with the execution and delivery hereof, Orcel,
Ortec and the Licensee are entering into a Security Agreement dated as of
October 18, 2004 (as the same may be amended from time to time, the "Security
Agreement"), pursuant to which Orcel and Ortec grant the Licensee a security
interest in the Collateral (as defined in the Security Agreement) to secure the
Licensors' obligations to the Licensee under the Manufacturing Agreement, the
Sales Agreement and this Agreement;
WHEREAS, Orcel and Ortec are parties to a Management and Licensing
Agreement dated as of August 29, 2001 (as the same may be amended from time to
time, the "Management and Licensing Agreement") pursuant to which, among other
things, Orcel has licensed certain intellectual property rights to Ortec; and
WHEREAS, in connection with the performance of its duties under the
Manufacturing Agreement and the execution of the Sales Agreement, the Licensee
desires to obtain from the Licensors, and the Licensors are willing to grant, an
exclusive license under the Licensed Intellectual Property (as defined below) in
the Territory (as defined below) upon the terms and conditions set forth below.
NOW, THEREFORE, in consideration of the premises and the mutual
covenants contained herein, the parties hereto agree as follows:
SECTION 1. DEFINITIONS, ETC.
1.1 Definitions. For the purpose of this Agreement, the following words
and phrases shall have the meanings set forth below:
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1.1.1 "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 and, in the case of
any natural Person, any other Person related by blood or marriage or the legal
representative of any 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 to 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 50% of the securities having ordinary voting
power for the election of directors or other governing body of a corporation or
more than 50% of the ownership interest of any other Person, such Person shall
be deemed to control such corporation or other Person.
1.1.2 "CCS Technology" means the proprietary technology set forth and
described on Exhibit A hereto.
1.1.3 "Confidential Information" has the meaning provided in Section
7.1 hereof.
1.1.4 "Consent and Agreement" means the Consent and Agreement dated as
of October 18, 2004 between PRF and the Licensee, as the same may be amended
from time to time.
1.1.5 "Control" means, with respect to any Licensed Intellectual
Property, the possession of the ability to grant a license or sublicense with
respect thereto as provided for herein without violating the terms of any
agreement with, or the rights of, any third Person.
1.1.6 "Know-How" means any and all non-patented proprietary technology
and information necessary for the practice of the Patents included in the
Licensed Intellectual Property, and owned or Controlled by one or both Licensors
or their Affiliates.
1.1.7 "Launch Date" shall have the meaning provided in the Sales
Agreement.
1.1.8 "Licensed Intellectual Property" means, relating to the Licensed
Products, the CCS Technology, all inventions (whether patentable or unpatentable
and whether or not reduced to practice), all improvements thereto, and all
patents, patent rights, patent applications and invention disclosures, together
with all reissuance, continuations, continuations-in-part, names, service names,
including all goodwill associated therewith, and copyrights and all applications
and registrations for any of the foregoing, and all Know-How.
1.1.9 "Licensed Products" means any and all "Products" as such term is
defined in the Sales Agreement.
1.1.10 "Licensee Improvements" means any and all improvements to the
Licensed Intellectual Property or any Licensed Product discovered or developed
by the Licensee during the Term (as defined in Section 12.1 hereof) of this
Agreement.
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1.1.11 "Licensor Improvements" means any and all improvements to the
Licensed Intellectual Property or any Licensed Product discovered or developed
by a Licensor or both Licensors during the Term of this Agreement.
1.1.12 "Ortec/Orcel License Agreement" means the Exclusive License
Agreement dated as of August 29, 2001 between Ortec and Orcel, as the same may
be amended from time to time.
1.1.13 "Patents" means, relating to the Licensed Products, all patents,
patent applications and patent disclosures, together with all reissuance,
continuations, continuations-in-part, revisions, extensions, and reexaminations
thereof relating to the Licensed Products, composition of matter, formulation,
or methods of manufacture or use thereof, including, without limitation, those
identified on Exhibit B hereto.
1.1.14 "Person" means any individual, estate, trust, partnership, joint
venture, association, firm, corporation or company, or governmental body, agency
or official, or any other entity.
1.1.15 "PRF" means ▇▇▇▇ Royalty Fund, L.P.
1.1.16 "PRF Security Agreement" means the Amended and Restated Security
Agreement dated as of October 18, 2004 among Ortec, Orcel and PRF, as the same
may be amended from time to time.
1.1.17 "Territory" means the United States of America (including the
Commonwealth of Puerto Rico and other U.S. territories and possessions).
1.1.18 "Trademarks" means each Licensor's registered and unregistered
tradenames and/or trademarks that relate to the Licensed Products, whichever is
appropriate.
1.1.19 "U.S. Dollars" and the sign "$" each means lawful currency of
the United States of America.
1.2 Manufacturing Agreement and Sales Agreement. Copies of the
Manufacturing Agreement and the Sales Agreement, as in effect on the date
hereof, are attached hereto as Exhibit C and Exhibit D, respectively. To the
extent applicable to this Agreement, all financial terms of Section 11 of the
Manufacturing Agreement, the terms of Section 15 of the Sales Agreement and all
financial terms of Sections 3(c) and 4 of the Sales Agreement, in each case as
amended from time to time, are hereby incorporated herein by reference and shall
apply to this Agreement, whether or not the Manufacturing Agreement or the Sales
Agreement shall be in effect at any particular time. However, this Agreement is
separate and distinct from the Manufacturing Agreement and the Sales Agreement
and, in the event of any termination or suspension of the Manufacturing
Agreement and/or the Sales Agreement, this Agreement shall continue in full
force and effect.
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SECTION 2. GRANT
2.1 Grant of License. Upon the terms and subject to the conditions
herein stated, each Licensor hereby grants the Licensee as of the Effective
Date:
(a) an exclusive license (and/or sublicense, as applicable) to
make (including the right to practice methods, processes and
procedures), have made, manufacture, package, use, distribute, market
and sell the Licensed Products in the Territory under the Licensed
Intellectual Property now or hereinafter owned or licensed by such
Licensor, including, without limitation, Patent applications and
Patents now or hereinafter acquired, covering the Licensed Products
and/or any process relating to the manufacture of the Licensed
Products; and
(b) an exclusive license (and/or sublicense, as applicable) to
use the Trademarks in the Territory.
2.2 Management and Licensing Agreement. The rights granted to the
Licensee pursuant to Section 2.1 above include, but are not limited to, a
license by Orcel and a sublicense by Ortec of certain "Intellectual Property"
and "Trademarks" (as such terms are defined in the Management and Licensing
Agreement) and other rights which previously have been licensed on an exclusive
basis by Orcel to Ortec under the Management and Licensing Agreement. To the
extent that the rights granted to the Licensee under Section 2.1 above are
included in such exclusive license to Ortec under the Management and Licensing
Agreement, (a) the exclusive license by Orcel to the Licensee under Section 2.1
hereof and the exclusive license by Orcel to Ortec under the Management and
Licensing Agreement shall be deemed to be co-exclusive and (b) all of the rights
so licensed to Ortec on a co-exclusive basis are included in the exclusive
sublicense by Ortec to the Licensee pursuant to Section 2.1 above. The parties
hereto agree that this Agreement is a permitted license or sublicense, as
applicable, under the terms of the Management and Licensing Agreement and does
not constitute a default by Orcel or Ortec under any of the provisions thereof.
Orcel and Ortec agree that they will not modify, amend or terminate the
Management and Licensing Agreement without the prior written consent of the
Licensee, which (for any modification, amendment or termination approved by PRF)
shall not be unreasonably withheld unless such modification, amendment or
termination could reasonably be expected to have an adverse effect on the
Licensee's rights hereunder or under the Manufacturing Agreement, the Sales
Agreement, the Security Agreement or the Consent and Agreement, in which case
the Licensee may withhold its consent without regard to whether such withholding
is reasonable. The provisions of this Section 2.2 clarify but do not expand the
license grant contained in Section 2.1 above.
2.3 Ortec/Orcel License Agreement. The rights granted to the Licensee
pursuant to Section 2.1 above include, but are not limited to, a license by
Ortec and a sublicense by Orcel of certain "Licensed Patent Rights" (as defined
in the Ortec/Orcel License Agreement) and other rights which previously have
been licensed on an exclusive basis by Ortec to Orcel under the Ortec/Orcel
License Agreement. To the extent that the rights granted to the Licensee under
Section 2.1 above are included in such exclusive license to Orcel under the
Ortec/Orcel License Agreement, (a) the exclusive license by Ortec to the
Licensee under Section 2.1 hereof and the exclusive license by Ortec to Orcel
under the Ortec/Orcel License Agreement shall be deemed to
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be co-exclusive and (b) all of the rights so licensed to Orcel on a co-exclusive
basis are included in the exclusive sublicense by Orcel to the Licensee pursuant
to Section 2.1 above. The parties hereto agree that this Agreement is a
permitted license or sublicense, as applicable, under the terms of the
Ortec/Orcel License Agreement and does not constitute a default by Orcel or
Ortec under any of the provisions thereof. Orcel and Ortec agree that they will
not modify, amend or terminate the Ortec/Orcel License Agreement without the
prior written consent of the Licensee, which (for any modification, amendment or
termination approved by PRF) shall not be unreasonably withheld unless such
modification, amendment or termination could reasonably be expected to have an
adverse effect on the Licensee's rights hereunder or under the Manufacturing
Agreement, the Sales Agreement, the Security Agreement or the Consent and
Agreement, in which case the Licensee may withhold its consent without regard to
whether such withholding is reasonable. The provisions of this Section 2.3
clarify but do not expand the license grant contained in Section 2.1 above.
SECTION 3. ROYALTIES
3.1 Royalty Obligations. The Licensee shall pay to the Licensors
royalties in an amount equal to the net amount payable to the Licensors pursuant
to Sections 3(c) and 4 of the Sales Agreement (or the net amount which would be
so payable to the Licensors, if all payments were then being made under the
Sales Agreement and the Manufacturing Agreement). For the avoidance of doubt, in
calculating such net amount, the Licensee shall be entitled to take into account
any payments then actually being made under the Manufacturing Agreement and /or
the Sales Agreement and shall also be entitled to deduct from such net amount
(a) all Commissions and Transaction Fees (as such terms are defined in the Sales
Agreement) and any other amounts which the Licensee would be permitted to deduct
under the Sales Agreement, whether or not the Sales Agreement is then in effect,
and (b) any amounts which would be due and payable by one or both Licensors to
the Licensee under the Manufacturing Agreement, whether or not the Manufacturing
Agreement is then in effect. Such net amount shall be payable at the times and
in the manner provided in the Sales Agreement. Upon any payment of such net
amount to the Licensors under the Sales Agreement, such payment shall be deemed
to have been made hereunder and no additional or duplicative payment shall be
due hereunder with respect thereto. To the extent that the Licensors receive
proceeds from the sale of Licensed Products which would otherwise be part of the
net amount payable to them hereunder, the Licensee shall be deemed to have paid
such net amount to the Licensors hereunder.
3.2 Acknowledgement. The Licensors and the Licensee acknowledge that,
pursuant to the PRF Security Agreement, PRF has been granted a security interest
in the Licensors' right, title and interest in and to this Agreement. All
amounts payable by the Licensee to the Licensors hereunder shall be paid into
the PRF/Cambrex Lockbox Account (as defined in the Consent and Agreement) and
disposition of those funds will be governed by the Consent and Agreement.
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SECTION 4. PATENT PROSECUTION
4.1 Prosecution Obligation. The Licensors shall apply for, seek prompt
issuance of and maintain during the Term of this Agreement any and all Patents
in the Territory which are included in the Licensed Intellectual Property. All
costs and expenses of the prosecution and maintenance of such Patents shall be
borne by the Licensors and not by the Licensee.
SECTION 5. THIRD PARTY INFRINGEMENT
5.1 Third Party Infringement.
5.1.1 Notice. In the event that any party becomes aware of any
potential infringement of the Licensed Intellectual Property or the
Patents, such party shall notify the other parties of the potential
infringement in writing and must provide a summary of the relevant
facts and circumstances known to such party relating to such
infringement. Neither party will notify a third Person of the potential
infringement of any of the Licensed Intellectual Property or the
Patents without first obtaining consent of the other parties, which
consent shall not be unreasonably withheld or delayed. The parties
agree to consult with each other, prior to the commencement of any
legal or patent office proceedings, as to the most effective way of
pursuing such matter.
5.1.2 Licensors' Options. During the Term of this Agreement,
the Licensors shall be entitled to prosecute, at their own expense, any
infringements of the Licensed Intellectual Property and the Patents, to
defend the Licensed Intellectual Property and Patents and to recover
any damages, awards or settlements resulting therefrom. The Licensee
hereby agrees that the Licensors may join the Licensee as a party
plaintiff in any such suit, without expense to the Licensee. The
Licensors shall hold harmless and indemnify the Licensee from and
against any order for costs arising without fault of the Licensee that
may be made against the Licensee by reason of being named a party
plaintiff in such proceedings. The Licensors shall have sole control of
any such suit and all negotiations for its settlement or compromise,
provided that the Licensors shall not settle or compromise any such
suit or enter into any consent order for the settlement or compromise
thereof that adversely affects the Licensed Intellectual Property or
the Patents or any of the licenses or rights of the Licensee hereunder,
without the prior written consent of the Licensee, which consent shall
not be unreasonably withheld or delayed. The total cost of any
infringement action commenced or defended solely by the Licensors shall
be borne by the Licensors.
5.1.3 Licensee's Options. If, within ninety (90) days after
having been notified of any potential infringement subject to the
provisions of Sections 5.1.2, the Licensors shall have been
unsuccessful in causing the alleged infringer to desist and shall not
have brought and shall not be diligently prosecuting an infringement
action, or if the Licensors notify the Licensee at any time prior
thereto of their intention not to bring suit against any alleged
infringer, then, in those events only, the Licensee shall have the
right, but shall not be obligated, to prosecute, at its own expense,
any infringements of the Licensed Intellectual Property and the
Patents, to defend the Licensed Intellectual Property and the Patents
and to recover any damages, awards or settlements resulting therefrom.
The Licensors hereby agree that the Licensee may join the Licensors as
party plaintiffs in any such suit, without expense to the Licensors.
The Licensee
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shall hold harmless and indemnify the Licensors from and against any order for
costs arising without fault of the Licensors that may be made against the
Licensors by reason of being named party plaintiffs in such proceedings. The
Licensee shall have sole control of any such suit and all negotiations for its
settlement or compromise, provided that the Licensors shall not settle or
compromise any such suit or enter into any consent order for the settlement or
compromise thereof that adversely affects the Licensed Intellectual Property and
the Patents, without the prior written consent of the Licensors. The total cost
of any infringement action commenced or defended solely by the Licensee shall be
borne by the Licensee.
5.1.4 Applications of Awards. Any damages, awards or
settlements collected pursuant to this Section 5.1 shall be allocated
first to the costs and expenses of the party bringing suit, then to the
costs and expenses of the other party. Any amounts remaining shall be
considered as proceeds of the sale of Licensed Products manufactured
under the Manufacturing Agreement and sold under the Sales Agreement
and such amounts shall, subject to the terms of the Consent and
Agreement, be distributed as provided in the Manufacturing Agreement
and Sales Agreement or, if applicable, Section 3.1 hereof.
5.2 Infringement Charges Against the Licensee. In the event that any
action, suit or proceeding is brought against, or written notice or threat
thereof is provided to, the Licensee alleging infringement of any patent or
unauthorized use or misappropriation of technology arising out of or in
connection with the Licensee's practice of the Licensed Intellectual Property
and the Patents, the Licensee shall have the right to defend at its own expense
such action, suit or proceeding and, in furtherance of such rights, the
Licensors hereby agree that the Licensee may join the Licensors as parties in
such suit, without expense to the Licensors. The Licensee shall hold harmless
and indemnify the Licensors from and against any order for costs arising without
fault of the Licensors that may be made against the Licensors in such
proceedings, unless such order arises out of or relates to facts and
circumstances involving a breach of any representation or warranty by the
Licensors. The Licensors agree to cooperate with the Licensee, at the Licensee's
expense, in connection with the Licensee's response to or defense of such
action, suit or proceeding, or notice or threat thereof.
5.3 Cooperation. In the event that a party shall undertake the
enforcement and/or defense of the Licensed Intellectual Property or the Patents
by legal or patent office proceedings pursuant to this Agreement, the other
party shall, at the request and expense of the party undertaking such
enforcement and/or defense, cooperate in all reasonable respects and, to the
extent possible, have its employees testify when requested and make available
relevant records, papers, information, samples and the like.
SECTION 6. INDEMNIFICATION
6.1 Indemnification by Licensors. Each Licensor hereby agrees that it
shall be responsible for, indemnify, hold harmless and defend the Licensee and
its Affiliates and their respective directors, officers, managing members,
shareholders, partners, attorneys, accountants, agents, employees and
consultants and their respective heirs, successors and assigns (collectively,
the "Licensee Indemnitees"), from and against any and all liability, loss,
claims, lawsuits, damages, injury, settlements, costs and expenses whatsoever
(as incurred), including but not limited to court costs and reasonable
attorneys' fees (collectively, "Losses") suffered or
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incurred by any Licensee Indemnitee arising out of, relating to, resulting from
or in connection with (a) any patent infringement claims or actions brought by
third parties related to the manufacture, use or sale of the Licensed Products,
and (b) any action, suit or other proceeding, or compromise, settlement or
judgment, relating to any of the foregoing matters described in subparagraph (a)
hereof with respect to which the Licensee Indemnitees are entitled to
indemnification hereunder. The foregoing shall not apply to the extent that such
Losses are due to the willful misconduct or gross negligence of any of the
Licensee Indemnitees.
6.2 Notice of Claims. In the event that a claim is made pursuant to
Section 6.1 above against any party which seeks indemnification hereunder (the
"Indemnitee"), the Indemnitee agrees to promptly notify the other party (the
"Indemnitor") of such claim or action and, in any such case the Indemnitor may,
at its option, elect to assume control of the defense of such claim or action;
provided, however, that (a) the Indemnitee shall be entitled to participate
therein through counsel of its own choosing at the Indemnitee's sole cost and
expense, (b) the Indemnitee shall fully cooperate with the Indemnitor in all
reasonable respects, and (c) the Indemnitor shall not settle or compromise any
such claim or action without the prior written consent of the Indemnitee unless
such settlement or compromise includes a general release of the Indemnitee from
any and all liability with respect thereto.
SECTION 7. CONFIDENTIALITY
7.1 Definition. "Confidential Information" means all technical,
scientific and other know-how and information, trade secrets, knowledge,
technology, means, methods, processes, practices, formulas, instructions,
skills, techniques, procedures, specifications, data, results and other
material, pre-clinical and clinical trial results, manufacturing procedures,
test procedures and purification and isolation techniques, and any tangible
embodiments of any of the foregoing, and any scientific, manufacturing,
marketing and business plans, any financial and personnel matters relating to
any party hereto or its present or future products, sales, suppliers, customers,
employees, investors or business, that has been disclosed by or on behalf of the
Licensee to one or both Licensors or by one or both Licensors to the Licensee
either in connection with the discussions and negotiations pertaining to this
Agreement or in the course of performing or otherwise in connection with this
Agreement. Without limiting the foregoing, the terms of this Agreement will be
deemed "Confidential Information" and will be subject to the terms and
conditions set forth in this Section 7.
7.2 Exclusions. Notwithstanding the foregoing Section 7.1, any
information disclosed by a party to the other party will not be deemed
"Confidential Information" to the extent that such information:
(a) at the time of disclosure is in the public domain;
(b) becomes part of the public domain, by publication or
otherwise, through no fault of the party receiving such information;
(c) at the time of disclosure is already in possession of the
party who received such information, as established by contemporaneous
written records;
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(d) is received by a party in good faith from any third party
independent of the disclosing party, where the receiving party has no
reason to believe that such third party has obtained such information
by any wrongful means;
(e) is independently developed by a party without use of or
reference to any other party's Confidential Information, as established
by contemporaneous written records; or
(f) is required to be disclosed under securities laws, rules
and regulations applicable to the Licensee, Ortec or Orcel, as the case
may be, or pursuant to the rules and regulations of the Nasdaq Stock
Market or any other stock exchange or stock market on which securities
of the Licensee, Ortec or Orcel may be listed for trading.
7.3 Disclosure and Use Restriction. Except as expressly provided
herein, the parties agree that, for the longer of (i) fifteen years from the
Effective Date, and (ii) the Term of this Agreement and the ten-year period
following any termination of this Agreement, each party and its Affiliates will
keep completely confidential and will not publish or otherwise disclose any
Confidential Information of the other parties, its Affiliates or sublicensees.
None of the parties will use Confidential Information of the other parties
except as necessary to perform its obligations or to exercise its rights under
this Agreement.
7.4 Permitted Disclosure. The obligations of Section 7.3 will not apply
to any disclosure of Confidential Information to the extent such disclosure is
required by operation of the law or the requirement of a court or governmental
agency; provided, however, that: (i) the party subject to such required
disclosure will have promptly notified the other party prior to such disclosure
and such other party will have been given the opportunity to oppose such
disclosure by the party subject to the required disclosure by seeking a
protective order or other appropriate remedy; (ii) the party subject to such
required disclosure will disclose only that portion of Confidential Information
legally required to be disclosed; and (iii) the party subject to such required
disclosure will exercise all reasonable efforts to maintain the confidential
treatment of Confidential Information.
SECTION 8. INTELLECTUAL PROPERTY; IMPROVEMENTS
8.1 Rights to Proprietary Technology. No party shall through this
Agreement obtain any rights to any other party's proprietary technology except
for such rights as are expressly granted or allocated under this Agreement.
8.2 Improvements and Filing, Prosecution and Maintenance of Patents.
8.2.1 As between the parties, the Licensee will own all right,
title and interest in and to the Licensee Improvements. Each Licensor
agrees to assign and hereby assigns to the Licensors all of such
Licensor's right, title, and interest in and to the Licensee
Improvements.
8.2.2 As between the parties, the Licensors will own all
right, title and interest in and to the Licensor Improvements. The
Licensee agrees to assign and hereby assigns to the Licensors all of
the Licensee's right, title and interest in and to the Licensor
Improvements.
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8.2.3 Each Licensor hereby grants to the Licensee a license in
the Territory to the Licensor Improvements upon the same terms (and for
no additional royalty or other consideration) as set forth in Section
2.1 hereof.
8.2.4 The Licensee hereby grants to each Licensor a
non-exclusive, royalty-free, paid-up license to use the Licensee
Improvements solely as needed by such Licensor to make or have made the
Licensed Products.
8.2.5 In the event that any Licensee Improvements or Licensor
Improvements owned by any party are deemed patentable, such party shall
be entitled to file and prosecute patent applications related thereto
and maintain patents issued thereon, in its own name and at its own
cost. The other parties shall render reasonable assistance to such
party in filing such applications whenever requested to do so, at such
filing party's sole cost and expense. The Licensee and the Licensors
agree to sign and execute such forms and documents as may be reasonably
requested by the other party as being necessary or desirable to vest or
confirm in such other party title to all such Licensee Improvements or
Licensor Improvements, as the case may be, owned by such other party.
SECTION 9. LIMITATIONS ON LIABILITY
9.1 No Warranties. Except as expressly set forth herein, none of the
parties makes any representations or warranties as to any matter whatsoever.
EACH PARTY HEREBY DISCLAIMS ANY AND ALL OTHER REPRESENTATIONS AND WARRANTIES,
EXPRESS OR IMPLIED, WITH RESPECT TO THE LICENSED INTELLECTUAL PROPERTY AND THE
LICENSED PRODUCTS, INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.
9.2 Limitation of Damages. IN NO EVENT SHALL ANY PARTY BE LIABLE FOR
SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING, WITHOUT
LIMITATION, LOSS OF PROFITS) SUFFERED BY ANY OTHER PARTY, EXCEPT TO THE EXTENT
OF ANY SUCH DAMAGES PAID TO A THIRD PARTY AS PART OF A THIRD-PARTY CLAIM.
9.3 Force Majeure. In the event of strikes, lock-outs or other
industrial disturbances, rebellions, mutinies, epidemics, landslides, lightning,
earthquakes, fires, hurricanes or other storms, floods, sinking, drought, civil
disturbances, explosions, acts or decisions of duly constituted municipal, state
or national governmental authorities or of courts of law, as well as
impossibility to obtain equipment, supplies, fuel or other required materials,
in spite of having acted with reasonable diligence, or by reason of any other
causes which are not under the control of the party requesting the abatement of
performance, or causes due to unexpected circumstances which are not possible to
eliminate or overcome with due diligence by such party ("Force Majeure"), the
party or parties agree that, if either the Licensee or the Licensors finds
themselves wholly or partially unable to fulfill their respective obligations
under this Agreement by reasons of Force Majeure, the party or parties affected
shall advise such other parties in writing of its or their inability to perform,
giving a detailed explanation of the occurrence of the event which excuses
performance as soon as possible after the cause or event has occurred. If such
notice is
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given, the performance of the party or parties giving the notification shall be
abated, and any time deadlines shall be extended for so long as performance may
be prevented by Force Majeure; provided, however, that in the event the
suspension of performance continues for more than ninety (90) days after the
date of the occurrence of such Force Majeure, and such failure to perform would
constitute a material breach of this Agreement in the absence of such Force
Majeure, the non-affected party may terminate this Agreement immediately by
written notice to the other party.
SECTION 10. NON-USE OF NAMES
Except to the extent permitted under the license of Trademarks in
Section 2.1 (b) above, the Licensee shall not use the name of the Licensors, and
the Licensors shall not use the name of the Licensee, nor in either case the
name of any of the Affiliates or employees of such other party or parties, nor
any adaptation thereof, in any advertising, promotional or sales literature
without prior written consent obtained from such other party in each case (which
consent shall not be unreasonably withheld or delayed).
SECTION 11. PATENT MARKING
The Licensee shall ▇▇▇▇ all Licensed Products made, used, offered for
sale, sold or imported under this Agreement, or their containers, in accordance
with the applicable patent marking laws.
SECTION 12. TERM AND TERMINATION
12.1 Term. The term of this Agreement shall commence on the Effective
Date and shall continue until the date that is six (6) years after the Launch
Date (the "Initial Expiration Date"), unless sooner terminated in accordance
with the provisions of this Section 12 (the "Term"). The Term shall be
automatically extended beyond the Initial Expiration Date for each successive
one (1) year period for which the term of the Sales Agreement is extended
pursuant to Section 5 of the Sales Agreement.
12.2 Termination for Default.
12.2.1 The Licensee shall have the right to terminate this
Agreement upon the occurrence of any of the following events: (a) the
Licensee may terminate this Agreement immediately on written notice to
the Licensors in the event that the Manufacturing Agreement and/or the
Sales Agreement shall have terminated by reason of material breach of
one or both Licensors thereunder and (b) the Licensee may terminate
this Agreement if either Licensor shall commit a material breach of the
terms of this Agreement and the same shall not be remedied within
ninety (90) days after written notice thereof is given by the Licensee
to the Licensors.
12.2.2 The Licensors shall have the right to terminate this
Agreement upon the occurrence of any of the following events: (a) the
Licensors may terminate this Agreement immediately on written notice in
the event that the Manufacturing Agreement and/or the Sales Agreement
shall have terminated by reason of material breach of the Licensee
thereunder and (b) the Licensors may terminate this Agreement if the
Licensee shall commit a material breach of
11
the terms of this Agreement and the same shall not be remedied within ninety
(90) days after written notice thereof is given by the Licensors to the
Licensee.
12.3 Termination by Licensee. The Licensee may terminate this Agreement
or any license hereunder at any time by giving at least thirty (30) days' prior
written notice to the Licensors. The termination right contained in this Section
12.3 is independent of any termination right the Licensee or Licensors may have
under the Manufacturing Agreement or the Sales Agreement and any termination of
this Agreement by the Licensee pursuant to this Section 12.3 shall not be
interpreted or construed as any action with respect to or in furtherance of
termination of the Manufacturing Agreement or the Sales Agreement.
12.4 Termination by Licensors. In the event that Ortec at any time has
the right to terminate, and in fact properly terminates, the Sales Agreement
pursuant to Section 11(a)(2) thereof (or, if the Sales Agreement is not then in
effect, would have the right to terminate the Sales Agreement pursuant to said
Section 11(a)(2)), then the Licensors may terminate this Agreement upon the same
prior written notice and after the occurrence of the same events and subject to
the same terms and conditions as are provided in said Section 11(a)(2).
12.5 Termination for Change in Control. Upon the occurrence of a Change
in Control (as defined in the Sales Agreement) of Ortec, in the event that the
Licensee or Ortec has the right to terminate, and in fact properly terminates,
the Sales Agreement pursuant to Section 11(a)(7) thereof (or, if the Sales
Agreement is not then in effect, would have the right to terminate the Sales
Agreement pursuant to said Section 11(a)(7)), such party may terminate this
Agreement on the same terms and conditions (including the same prior written
notice) and subject to the same terms and conditions as are provided for in
Section 11 (a)(7) of the Sales Agreement; provided, however, that no such
termination of this Agreement by Ortec or the Licensors shall be effective
unless and until Ortec shall have indefeasibly paid the Termination Fee (as
defined in the Sales Agreement) in full to the Licensee.
12.6 Consequences of Termination. The termination of this Agreement for
any reason shall be without prejudice to (i) the right of the Licensors to
receive all amounts accrued under Section 3 hereof prior to the effective date
of such termination, (ii) the rights and obligations of the parties pursuant to
Sections 5, 6, 7, 8 and 9 hereof, and (iii) any other remedies as may now or
hereafter be available to any party, whether under this Agreement or otherwise.
After the effective date of the termination of this Agreement for any reason,
the Licensee may sell all Licensed Products in inventory and complete Licensed
Products in the process of manufacture at the time of such termination and sell
the same.
SECTION 13. MISCELLANEOUS
13.1 Notices. All notices, reports and/or other communications made in
accordance with this Agreement, shall be deemed to be duly made or given (i)
when delivered by hand, (ii) three days after being mailed by registered or
certified mail (air mail, if mailed overseas), return receipt requested, or
(iii) when received by the addressee, if sent by facsimile transmission or by
Express Mail, Federal Express or other express delivery service (receipt
requested), in each case addressed to such party at its address set forth below
(or to such other address as such party may hereafter designate as to itself by
notice to the other party hereto):
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In the case of the Licensee:
Cambrex Bio Science Walkersville, Inc.
▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Telecopier: (▇▇▇) ▇▇▇-▇▇▇▇
Attention: N. ▇▇▇▇▇ ▇▇▇▇▇▇,
President of BioProducts
Strategic Business Unit
with a copy to:
Cambrex Corporation
▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
Telecopier: (▇▇▇) ▇▇▇-▇▇▇▇
Attention: ▇▇▇▇▇ ▇. ▇▇▇▇▇▇, General Counsel
with a copy to:
▇▇▇▇ Royalty Fund, L.P.
Two Grand Central Tower
▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇ ▇▇▇▇▇
▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇
Attention: ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇
In the case of Orcel:
Orcel LLC
c/o Ortec International Inc.
▇▇▇▇ ▇▇▇▇▇▇▇▇
▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇
Telecopier: (▇▇▇) ▇▇▇-▇▇▇▇
Attention: ▇▇▇ ▇▇▇▇▇▇▇▇,
Vice Chairman
with a copy to:
▇▇▇▇▇ Kaszovitz ▇▇▇▇▇▇▇▇
▇▇▇▇▇ ▇▇▇▇▇ Bass & Rhine, LLP
▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇
▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇
Telecopier: (▇▇▇) ▇▇▇-▇▇▇▇
Attention: ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, Esq.
with a copy to:
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▇▇▇▇ Royalty Fund, L.P.
Two Grand Central Tower
▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇ ▇▇▇▇▇
▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇
Attention: ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇
In the case of Ortec:
Ortec International Inc.
▇▇▇▇ ▇▇▇▇▇▇▇▇
▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇
Telecopier: (▇▇▇) ▇▇▇-▇▇▇▇
Attention: ▇▇▇ ▇▇▇▇▇▇▇▇,
Vice Chairman
with a copy to:
▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
▇▇▇▇▇ ▇▇▇▇▇ Bass & Rhine, LLP
▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇
▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇
Telecopier: (▇▇▇) ▇▇▇-▇▇▇▇
Attention: ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, Esq.
with a copy to:
▇▇▇▇ Royalty Fund, L.P.
Two Grand Central Tower
▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇ ▇▇▇▇▇
▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇
Attention: ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇
13.2 Amendments, etc. This Agreement may not be amended or modified,
nor may any right or remedy of any party be waived, unless the same is in
writing and signed by such party or a duly authorized representative of such
party. The waiver by any party of the breach of any term or provision hereof by
any other party shall not be construed as a waiver of any other subsequent
breach.
13.3 No Waiver; Remedies. No failure or delay by any party in
exercising any of its rights or remedies hereunder shall operate as a waiver
thereof, nor shall any single or partial exercise of any such right or remedy
preclude any other or further exercise thereof or the exercise of any other
right or remedy. The rights and remedies of the parties provided in this
Agreement are cumulative and not exclusive of any rights or remedies provided by
law.
14
13.4 Successors and Assigns. This Agreement shall be binding upon and
inure to the benefit of the parties and their respective heirs, legal
representatives, successors and permitted assigns. This Agreement and the rights
and obligations hereunder shall not be assignable or transferable, directly or
indirectly, by the Licensee or either Licensor without the prior written consent
of the other parties (which may not be unreasonably withheld or delayed) except
(i) to an Affiliate of a party so long as such Affiliate agrees in writing to be
bound by the terms of this Agreement, (ii) in connection with a Change in
Control (as defined in the Sales Agreement) or (iii) in the case of any
foreclosure or other similar exercise of remedies by PRF under the PRF Security
Agreement, to PRF or its assignees in accordance with applicable law. The
assigning party shall remain primarily liable hereunder notwithstanding any such
assignment. Any attempted assignment in violation hereof shall be void.
13.5 Relationship of Parties. The Licensee and the Licensors are not
(and nothing in this Agreement shall be construed to constitute them) partners,
joint venturers, agents, representatives or employees of each other, nor to
create any relationships between them other than that of an independent
contractor. Neither the Licensee nor the Licensors shall have any responsibility
or liability for the actions of the other party except as specifically provided
herein. Neither the Licensee nor the Licensors shall have any right or authority
to bind or obligate the other in any manner or make any representation or
warranty on behalf of the other. The foregoing provisions of this Section 13.5
relate solely to the relationship between the Licensee, on the one hand, and the
Licensors, on the other hand.
13.6 Expenses. Unless otherwise provided herein, all costs and expenses
incurred in connection with this Agreement and the transactions contemplated
hereby shall be paid by the party which shall have incurred the same and the
other party shall have no liability relating thereto.
13.7 TRS Machines and TRS Trays. In the event that Ortec breaches its
obligations under Section 6(c) of the Sales Agreement or the Sales Agreement
terminates, Cambrex shall have the right to make arrangements directly with
Ortec's supplier(s) of TRS Machines and TRS Trays (as such terms are defined in
the Sales Agreement), or with an alternative supplier, to have TRS Machines
and/or TRS Trays made for and supplied to Cambrex in sufficient quantities to
satisfy customer demand and use of the Licensed Products in the Territory. Title
to all such TRS Machines and TRS Trays shall be in Cambrex. In calculating
royalties payable to the Licensors under Section 3.1 hereof, Cambrex shall be
entitled to deduct any and all amounts paid by Cambrex to obtain such TRS
Machines and/or TRS Trays. The Licensors will cooperate with and provide
reasonable assistance to the Licensee so that the Licensee can obtain sufficient
quantities of TRS Machines and TRS Trays in order to satisfy customer demand and
use of the Licensed Products in the Territory.
13.8 Entire Agreement. This Agreement constitutes the entire agreement
between the parties and supersedes all prior proposals, communications,
representations and agreements, whether oral or written, with respect to the
subject matter hereof.
13.9 Severability. Any term or provision of this Agreement which is
invalid or unenforceable in any jurisdiction shall, as to such jurisdiction, be
ineffective to the extent of such invalidity or unenforceability without
rendering invalid or unenforceable the remaining terms
15
and provisions of this Agreement or affecting the validity or enforceability of
any of the terms or provisions hereof in any other jurisdiction.
13.10 Counterparts. This Agreement may be signed in any number of
counterparts, each of which shall be deemed an original, with the same effect as
if the signatures thereto and hereto were upon the same instrument.
13.11 Headings. The headings used in this Agreement are for convenience
of reference only and shall not affect the meaning or construction of this
Agreement.
13.12 Governing Law. This Agreement, including the performance and
enforceability hereof, shall be governed by and construed in accordance with the
laws of the State of New York, without reference to choice of law doctrine. Each
party hereby submits itself for the sole purpose of this Agreement and any
controversy arising hereunder to the jurisdiction of the courts located in the
State of New York and any courts of appeal therefrom, and waives any objection
(on the grounds of lack of jurisdiction, or forum non conveniens or otherwise)
to the exercise of such jurisdiction over it by any such courts.
13.13 Arbitration. Except as expressly provided herein, any dispute,
controversy, or claim arising out of or relating to this Agreement, its
validity, construction or enforceability or the breach of any of the terms or
provisions hereof shall be settled by arbitration under the American Arbitration
Association by a panel of three arbitrators, one selected by each party and the
third selected by the other two arbitrators. Any arbitration proceeding
commenced by either party shall be held in the New York City, New York. The
decision of the arbitrators shall be final and binding upon the parties and
judgment upon the decision by the arbitrators may be entered in any court of
competent jurisdiction, and execution may be had thereon. The expense of such
arbitration, including attorneys' fees, shall be allocated between the parties
as the arbitrators may decide and as the claims and interests of each party may
prevail. Notwithstanding anything to the contrary contained in this Section
13.13, any dispute, controversy or claim relating to actual or threatened
unauthorized use or disclosure of any Confidential Information, or the validity,
applicability, enforceability or infringement of any Patents, shall not be
required to be submitted to arbitration hereunder and shall be resolved by a
court of competent jurisdiction.
13.14 Acknowledgement. The parties hereto acknowledge that this
Agreement is a license of intellectual property within the meaning of 11 U.S.C.
'SS'365(n).
[SIGNATURE PAGE FOLLOWS]
16
IN WITNESS WHEREOF, the parties have executed this Agreement as of the
date first written above.
ORCEL LLC
By: /s/ ▇▇▇ ▇▇▇▇▇▇▇▇
--------------------------------
Name: ▇▇▇ ▇▇▇▇▇▇▇▇
--------------------------------
Title: Chief Executive Officer
--------------------------------
ORTEC INTERNATIONAL INC.
By: /s/ ▇▇▇ ▇▇▇▇▇▇▇▇
--------------------------------
Name: ▇▇▇ ▇▇▇▇▇▇▇▇
--------------------------------
Title: Chief Executive Officer
--------------------------------
CAMBREX BIO SCIENCE WALKERSVILLE, INC.
By: /s/ ▇▇▇▇▇ ▇▇▇▇▇▇
--------------------------------
Name: N. ▇▇▇▇▇ ▇▇▇▇▇▇
--------------------------------
Title: President, BioProducts
--------------------------------
17
Exhibit A
CCS Technology
The method for making skin equivalents and the product obtained thereby as
described in the claims of:
1. U.S. Patent RE 35,399 (re-issue of U.S. Patent 5,282,859);
2. U.S. Patent 6,039,760;
3. U.S. Patent Application Serial No. 09/749,226, Filing Date - December 27,
2000, now abandoned;
4. U.S. Patent Application Serial No. 09/751,001, Filing Date - December 28,
2000, now U.S. Patent No. 6,500,464;
The cryopreservation method for the skin equivalents described above and the
product obtained thereby as described in:
5. U.S. Patent Application Serial No. 10/032,929, now U.S. Patent 6,638,709;
6. U.S. Patent Application No. 10/641,655. This is a Divisional Application
of No. 5 above directed to product claims.
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Exhibit B
Patents
U.S. Patent No. Expiration Date
-------------- ---------------
RE # 35,399 (re-issue of U.S. Patent 5,282,859) February 1, 2011
5,282,859 February 1, 2011
6,039,760 February 1, 2011
6,500,464 December 28, 2020
6,638,709 December 26, 2020
U.S. Patent Application No. 10/641,655. This is a divisional application of U.S.
Patent No. 6,638,709 listed above.
19
Exhibit C
Manufacturing Agreement
20
Exhibit D
Sales Agreement
21