LICENSE AGREEMENT
EXHIBIT
10.4
This License Agreement (“Agreement”) is entered into as of September 1, 2006, by and
between National Quality Care, Inc., a Delaware corporation (“Licensor”), and Xcorporeal,
Inc. (“Licensee”) (each, a “Party;” collectively, the “Parties”). The
Parties hereby agree as follows:
1. Defined Terms.
For purposes of this Agreement, the following definitions will apply:
“Affiliate” means, when applied to a Party, any entity that is controlled by,
controls, or is under common control with, such Party.
“Confidential Information” means and includes any non-public information relating to
or concerning a Party hereto (the “Disclosing Party”), or any of its Affiliates, that is
provided or made available to the other Party (the “Receiving Party”), either before or
after the Effective Date of this Agreement, directly or indirectly, in any form whatsoever,
including in writing, orally, and in electronic or other machine readable form, including, but not
be limited to, designs, know-how, inventions, technical data, ideas, uses, processes, methods,
formulae, research and development records and materials, work in process, scientific, engineering
and/or manufacturing records or materials, marketing plans, business plans, financial or personnel
records or materials, present or future products, sales, suppliers, customers, employees, investors
or business, information about this Agreement, and any other non-public business records and
information, the use or disclosure of which might reasonably be construed to be contrary to the
interests of the Disclosing Party or any of its Affiliates, including non-public information of
third parties that is possessed by the Disclosing Party is subject to confidentiality obligations
and that the Disclosing Party is lawfully allowed to disclose to the Receiving Party.
“Derivative Works” means (a) for Licensor material subject to copyright or mask work
right protection, any work that as a whole represents an original work of authorship, and is based
upon one or more pre-existing works, such as a revision, modification, translation, abridgment,
condensation, expansion, collection, compilation or any other form in which such pre-existing works
may be recast, transformed or adapted; (b) for Licensor patentable materials, any adaptation,
subset, addition, improvement or combination of such materials; (c) for Licensor material subject
to trade secret protection, any new material, information or data relating to and derived from such
material, including new material that may be protectable by copyright, patent or other proprietary
rights; and (d) with respect to each of the above, any material the preparation, use and/or
distribution of which, in the absence of this Agreement or other authorization from Licensor, would
constitute infringement or misappropriation under applicable law.
“Gross Sales” means the total amount actually received by Licensee as revenue from the
exploitation of the Technology (as defined below) by Licensee, its Affiliates and sub licensees,
collectively, less separately stated freight payable to third parties, commercially reasonable
special packaging, and duties, sales, use, excise, value added and other taxes, discounts, returns,
and allowances.
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“Intellectual Property Rights” means all of the following worldwide legal rights
owned, held or controlled by Licensor: (a) patents, patent applications, and patent rights; (b)
trademarks, trademark registrations and applications therefor, trade names, rights in trade dress
and packaging; (c) rights associated with works of authorship (including audiovisual works),
including copyrights, copyright applications, and copyright registrations; (d) rights relating to
the protection of trade secrets, confidential information, technical information, know-how, ideas,
concepts, processes, procedures, techniques, discoveries, and inventions; (e) Moral Rights (as
defined below); (f) design rights; (g) rights in name, likeness and other rights of commercial
publicity; (h) any rights analogous to those set forth in the preceding clauses and any other
proprietary rights relating to intangible property; and (i) divisions, continuations, renewals,
reissues, and extensions of the foregoing (as applicable) now existing or hereafter filed, issued,
or acquired.
“Know-How” means all (i) information and data possessed by Licensor, exclusive of any
of the independent claims contained in the Licensor Patents (but including all other information
and data contained in, or related to, any patent application filed by or on behalf of Licensor),
relating to the exploitation and/or use of the Licensed Products (as defined below), including
without limitation: (a) sources of materials; (b) methods, processes and procedures (and related
test results and design data) for the extraction, isolation, creation, purification, and/or
chemical modification of materials used in the production of the Licensed Products; (c) methods,
processes and procedures used in the design, development, creation, modification, manufacture,
production, processing, storage, packaging, testing and/or evaluation of the Licensed Products,
including without limitation all biological and toxicological tests (and results thereof) together
with all correspondence, notes, memoranda, and other information and/or data provided to, or
received from, all health regulatory authorities; and (ii) trade secrets, data, formulae,
compositions, processes, designs, sketches, photographs, graphs, drawings, samples, program
proposals, presentations, inventions and ideas, past, current, and planned research and
development, current and planned manufacturing or distribution methods and processes, market
studies, business plans, computer software and programs, systems, structures and architectures (and
related processes, formulae, composition, improvements, devices, inventions, discoveries, concepts,
ideas, designs, methods and information), and any other information, however documented, that is
not generally known to the public or that constitutes a trade secret under any applicable trade
secret law.
“Licensed Products” means all products based on or derived from the Technology (as
defined below), and any products sold in connection with the use of such products, including, but
not limited to the Wearable Kidney and all related devices, whether now-existing or hereafter
developed, that where sold, would infringe or misappropriate one or more of Licensor’s Intellectual
Property Rights or Know-How, including, without limitation, the Licensor Patents or Licensor Patent
Applications.
“Licensor Patents” means the patents (and all re-issues and extensions) listed on the
Schedule attached hereto and the patents, when issued, based upon the Licensor Patent
Applications and in all divisions, continuations and continuations in part relating thereto.
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“Licensor Patent Applications” means the patent applications listed on the
Schedule attached hereto and any substitutions and continuations together with any patent
applications based on, or related to, the Technology that may be filed by Licensor from the date
hereof.
“Moral Rights” means any rights of paternity or integrity, any right to claim
authorship, to object to or prevent any distortion, mutilation or modification of, or other
derogatory action in relation to the subject work, whether or not such would be prejudicial to the
author’s honor or reputation, to withdraw from circulation or control the publication or
distribution of the subject work, and any similar right, existing under judicial or statutory law
of any country in the world, or under any treaty, regardless of whether or not such right is
denominated or generally referred to as a “moral right.”
“Net Sales” means Gross Sales less the following: (a) all direct costs and expenses of
Licensee attributable to the research, development, production, marketing, sale and exploitation of
the Licensed Products, including, without limitation, costs of materials and direct labor costs;
and (b) all indirect costs of Licensee properly allocated under generally accepted accounting
principles to the research, development, production, marketing, sale and/or exploitation of the
Licensed Products, including, without limitation, overhead and selling, general and administrative
expenses.
“Technology” means and includes all existing and hereafter developed Intellectual
Property, Know-How, Licensor Patents, Licensor Patent Applications, Derivative Works, and any other
technology invented, improved or developed by Licensor, or as to which Licensor owns or holds any
rights, arising out of or relating to the research, development, design, manufacture or use of:
(a) any medical device, treatment or method as of the date of this Agreement, (b) any portable or
continuous dialysis methods or devices, specifically including any wearable artificial kidney, or
Wearable Kidney, and related devices, (c) any device, methods or treatments for congestive heart
failure, and (d) any artificial heart or coronary device.
“Territory” means anywhere in the universe.
2. Grant Of Exclusive License. Subject to Licensee’s continuing full compliance and complete and
timely performance of all of the material obligations, terms and conditions imposed on it by this
Agreement, Licensor hereby grants to Licensee, with right to grant sublicenses, the sole and
exclusive license, during the Term and throughout the Territory, to use, improve, expand and
otherwise exploit the Technology, to make (and have made), use, and sell the Licensed Products, and
otherwise to practice the inventions and the art that is embodied or described in the Licensor
Patents, the Licensor Patent Applications, and any improvements thereto made in whole or in part by
Licensor (whether or not patented) in connection with the Technology (the “License”),
provided, however, that the terms of any sublicense shall expressly conform and be made subject to
the terms and conditions of this Agreement.
(1) During the Term of this Agreement, Licensee shall pay to Licensor a license fee of seven
percent (7.0 %) of Net Sales (the “Royalty”); provided, however, that
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Licensee shall pay to Licensor a minimum aggregate annual Royalty of two hundred fifty
thousand dollars ($250,000.00) (the “Minimum Royalty”). Within ninety (90) days of each
anniversary of the date of this Agreement, Licensee shall pay Licensor the remaining difference, if
any, between the Minimum Royalty and the aggregate of all Royalty payments for the preceding year.
All payments due hereunder will be paid by wire transfer or check payable in United States
currency. Whenever conversion of payments from any foreign currency is required, such conversion
will be made at the rate of exchange reported in The Wall Street Journal on the last business day
of the applicable reporting period. Unless earlier terminated as provided hereinafter, the
obligation of Licensee to pay Royalties to Licensor shall expire upon the date that none of the
Licensed Products infringe any of the Licensor Patents.
(2) Notwithstanding the foregoing Section 3(A)(1), in the event that the Merger
Agreement of even date herewith among the Parties and NQCI Acquisition Corporation, a Delaware
corporation (the “Merger Agreement”) is terminated pursuant to Section 6(A) thereof, the
Royalty pursuant to this Agreement will thereafter be as follows:
(a) If notice of termination is given pursuant to Section 6(A)(3), six and one-half
percent (6.5%) of Gross Sales;
(b) If notice of termination is given pursuant to Section 6(A)(1), (5) or (6), seven
and one-half percent (7.5%) of Gross Sales; and
(c) If notice of termination is given pursuant to Section 6(A)(2) or (4), eight and
one-half percent (8.5%) of Gross Sales;
provided, however, that if it is later determined by an arbitrator or court of competent
jurisdiction that a notice of termination was improper, or that the Merger Agreement was terminated
on a different basis or pursuant to a different provision, the Royalty rate will be retroactively
adjusted to the correct rate pursuant to one of the foregoing subsections, and any difference
between the Royalty paid and the Royalty rate determined to be correct will be paid by the
appropriate Party to the other within ninety (90) days of any such final determination.
(a) Audits. Licensor may appoint an independent certified public accountant, who
shall have the right to examine the records required under this Section 3.C during normal
business hours on reasonable notice. Licensee shall, as a condition to the grant of any
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sublicense, obtain the agreement of the sublicensee to make such records available for
inspection by Licensor’ independent auditor.
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written notice to Licensor of Licensee’s intent to prosecute and/or maintain such patent
rights and Licensor shall thereupon promptly assign the entire right, title and interest, legal and
equitable, in and to that patent or application to Licensee. Licensee shall be under no obligation
to prosecute or maintain in force any Licensor Patents, Licensor Patent Applications or other
Intellectual Property Rights.
(1) If Licensor discovers that a third party is manufacturing or selling products in the
Territory that infringe the Licensor Patents or any other legally enforceable Intellectual Property
Rights pertaining to the Technology, it shall notify Licensee of such infringement and give such
Party all appropriate information in its possession relating to the infringement. This section
shall not impose any obligation on either Licensor or Licensee to maintain any ongoing
investigative program to detect any third party infringement.
(2) Licensee shall have the sole right and authority to take such steps as it deems reasonable
and appropriate in its sole discretion to determine whether actionable infringement is occurring
and, if it is, to stop the infringement in the Territory during the Term, including but not limited
to filing a legal action against the alleged infringer in its own name.
(3) Licensee shall have the sole right to direct and control the prosecution of such an
action, including selection of counsel and deciding to settle, dismiss or continue the prosecution
of the action on such terms and in the manner it deems reasonable and appropriate in its sole
discretion, and shall, subject to Section 5.C(4), bear all costs and expenses of such
action, and shall retain all damages and other remedies recovered in such action.
(4) Licensee shall have the right to offset all damages and losses awarded by any Court of
competent jurisdiction relating to any infringement of the Intellectual Property Rights or the sale
or use of the Licensed Products, including Licensee’s legal fees, costs and expenses, against any
Royalty otherwise payable to Licensor.
(1) Development. Licensee shall make commercially reasonable efforts to develop and
commercially exploit the Technology to generate revenues during the Term.
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(2) Requested Expenses. Upon Licensee’s request, Licensor shall make commercially
reasonable efforts to continue and advance the research and development program to prepare the
Technology for commercial exploitation, and Licensee shall pay all reasonable and necessary
research and development costs and expenses arising therefrom.
(3) Monthly Expenses. No later than the earlier of (i) thirty (30) days after the
date on which Licensee has obtained total debt or equity investment of at least three million five
hundred thousand dollars ($3,500,000.00) or (ii) ninety (90) days after the date hereof, Licensee
shall reimburse Licensor’s reasonable and necessary expenses incurred in the ordinary course of
business consistent with past practices (“Licensor Expenses”), during the period from the
date hereof to the Closing (as defined therein) or termination of the Merger Agreement. All such
Licensor Expenses shall: (a) be only for the specific persons, services and expenses listed in
reasonable detail on the Budget contained in the Company Disclosure Schedule to the Merger
Agreement, (b) be payable hereunder only to the extent not paid pursuant to the Merger Agreement,
(c) be mutually agreed upon in advance of being reimbursed with regard to all Professional Fees set
forth in the Budget, and (d) include, but not be limited to, expenses already paid or accrued
relating to human clinical trials carried out or to be carried out on behalf of Licensor in Italy
and the United Kingdom as set forth in the Budget.
6. Confidentiality.
A. Each Party agrees that during the performance of this Agreement, it may disclose to the
other Confidential Information of such Disclosing Party. Each Receiving Party shall not, at any
time or in any manner, disclose, copy, modify, distribute or otherwise transfer the Disclosing
Party’s Confidential Information, or any part thereof, to any other person, except as permitted by
this Agreement.
B. A Receiving Party may disclose Confidential Information (1) to professional advisors of the
Receiving Party in accordance with customary business practices in connection with the Agreement,
and (2) to the Disclosing Party’s employees who have a specific need to know in order to perform
that Party’s obligations hereunder, provided, however, that all such permitted disclosees shall be
required to maintain the confidentiality of the Confidential Information in accordance with this
Agreement, and each Receiving Party shall be responsible for all of its employees’ actions. Each
Party shall use the other Party’s Confidential Information only to properly fulfill its obligations
hereunder, and not for any other purpose. Upon request of a Party, and in any event promptly
following termination of this Agreement under Section 4.C above, each Receiving Party shall
immediately return the originals and all copies of any Confidential Information to the Disclosing
Party.
C. The obligations and restrictions set forth in this Section 6 shall not apply to any
Confidential Information that falls within any of the following exceptions:
(1) is or becomes part of the public domain without breach of this Agreement by a Receiving
Party;
(2) is lawfully in the possession of a Receiving Party prior to receiving it from the
Disclosing Party hereunder;
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(3) is independently developed by or for a Receiving Party completely apart from the
disclosures hereunder;
(4) is received from a third party who lawfully acquires such information without restriction,
and without breach of this Agreement by a Receiving Party; or
(5) is released to the public or to a third party without a duty of confidentiality, pursuant
to a binding court order or government regulation, provided that the Receiving Party delivers a
copy of such order or action to the Disclosing Party and cooperates with the Disclosing Party if it
elects to contest such disclosure.
Nothing provided for in this Section 6 shall be construed to preclude or inhibit Licensee’s
rights to exploit any of its rights under the License.
(1) Licensor has the right to enter into this Agreement and there are no outstanding
assignments, grants, licenses, encumbrances, obligations or agreements, whether written, oral or
implied, that are inconsistent with this Agreement;
(2) Licensor is the owner of the entire right, title and interest in and to invention and the
art claimed in the Licensor Patent Applications and the claims contained in any Licensor Patent
Rights that issues and that it has the sole right to grant the licenses granted to Licensee herein;
(3) The Licensor Patents will not have been fraudulently procured, and Licensor has no reason
to believe that the claims contained in the Licensor Patent Applications will not be issued in a
manner that will protect sales of the Licensed Products in the Territory from competitors utilizing
the invention or its equivalent;
(4) Licensor has no knowledge of any circumstances that would render the Licensor Patents,
when issued, invalid; and
(5) Licensor has not granted any license to or under the Technology to any other person or
entity for its use within the Territory.
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partners, managers, attorneys and agents, from and against any liability, claims, demands,
actions, costs, expenses, including reasonable attorneys’ fees, or causes of action whatsoever
(collectively, “Claims”) arising on account of:
(1) Any breach by Licensor of its representations and warranties contained herein;
(2) Licensee’s lawful and non-negligent use of any Intellectual Property Rights licensed by
Licensor hereunder;
(3) Any Claims that Licensee’s use of the Intellectual Property Rights in conformity of this
Agreement infringes upon or misappropriates the intellectual property rights of any third party; or
(4) Licensor’s operations or conduct prior to the date of this Agreement with regard to the
research, development, or production of the Technology and/or Licensed Products. Such Claims shall
include, without limitation, any product liability claims or Claims on account of any injury or
death of persons or damage to property based on alleged defects in the Technology existing as of
the effective date of this Agreement or based on actions or omissions of Licensor, regardless of
whether such Claims are made prior to or at any time after the date of this Agreement.
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explain, modify, limit, amplify or aid in the meaning, construction or interpretation of any
of the provisions of this Agreement.
G. Choice of Law. This Agreement and all matters or issues collateral hereto shall be
construed in accordance with, and governed by, the laws of the State of Delaware.
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If to Licensee:
Xcorporeal, Inc.
Attn: Xxxxxx X. Xxxxxx
c/x Xxxxxxxxx Xxxxxxx, LLP
0000 Xxxxxxxx Xxxxxx, Xxxxx 000X
Xxxxx Xxxxxx, Xxxxxxxxxx 00000
Attn: Xxxx X. Xxxxxxxx, Esq.
Fax: (000) 000-0000
Attn: Xxxxxx X. Xxxxxx
c/x Xxxxxxxxx Xxxxxxx, LLP
0000 Xxxxxxxx Xxxxxx, Xxxxx 000X
Xxxxx Xxxxxx, Xxxxxxxxxx 00000
Attn: Xxxx X. Xxxxxxxx, Esq.
Fax: (000) 000-0000
With a copy to:
Xxxxxxxxx Xxxxxxx, LLP
0000 Xxxxxxxx Xxxxxx, Xxxxx 000X
Xxxxx Xxxxxx, Xxxxxxxxxx 00000
Attn: Xxxx X. Xxxxxxxx, Esq.
Fax: (000) 000-0000
0000 Xxxxxxxx Xxxxxx, Xxxxx 000X
Xxxxx Xxxxxx, Xxxxxxxxxx 00000
Attn: Xxxx X. Xxxxxxxx, Esq.
Fax: (000) 000-0000
If to Licensor:
National Quality Care, Inc.
0000 Xxxxxxxx Xxxxxxxxx, Xxxxx 000
Xxxxxxx Xxxxx, Xxxxxxxxxx 00000
Attention: Xxxxxx X. Xxxxxx
Fax: (000) 000-0000
0000 Xxxxxxxx Xxxxxxxxx, Xxxxx 000
Xxxxxxx Xxxxx, Xxxxxxxxxx 00000
Attention: Xxxxxx X. Xxxxxx
Fax: (000) 000-0000
With a copy to:
Xxxxxxx & Xxxxxxxxx, LLP
00000 Xxxxxxxx Xxxxxxxxx, 00xx Xxxxx
Xxx Xxxxxxx, Xxxxxxxxxx 00000
Attn: Xxxxxxx X. Xxxx, Esq.
Fax: (000) 000-0000
00000 Xxxxxxxx Xxxxxxxxx, 00xx Xxxxx
Xxx Xxxxxxx, Xxxxxxxxxx 00000
Attn: Xxxxxxx X. Xxxx, Esq.
Fax: (000) 000-0000
All notices given by electronic means shall be confirmed by delivering to the Party entitled
thereto a copy of said notice by certified or registered mail, postage prepaid, return receipt
requested. All written notices shall be deemed delivered and properly received upon the earlier of
two (2) days after mailing the confirmation notice or upon actual receipt of the notice provided by
personal delivery or electronic means.
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LICENSOR:
NATIONAL QUALITY CARE, INC.
By:
|
/s/ Xxxxxx Xxxx | |||
Name:
|
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Title:
|
Chief Scientific Officer | |||
By:
|
/s/ Xxxxxx X. Xxxxxx | |||
Name:
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||||
Title:
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Chief Executive Officer |
LICENSEE: | ||||||
XCORPOREAL, INC. | ||||||
By: | /s/ Xxxxxx X. Xxxxxx | |||||
Name: | ||||||
Title: | Chairman of the Board |
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