Confidential Materials omitted and
filed separately with the
Securities and Exchange Commission. Asterisks denote
omissions.
TECHNOLOGY AND TRADEMARK LICENSE
AGREEMENT
THIS TECHNOLOGY
AND TRADEMARK LICENSE
AGREEMENT (the “ Agreement ”), dated
as of June 5, 2009 (the “ Effective Date
”), is made and entered into by and between NxStage Medical, Inc. , a
company organized and existing under the laws of Delaware, and
having offices at 439 S. Union Street, 5 th Floor, Lawrence, Massachusetts 01843, United
States of America, (hereafter referred to as “ NxStage
”) and Asahi Kasei
Kuraray Medical, Co., Ltd. , a corporation organized and
existing under the law of Japan, having its principal place of
business at 1-105, Kanda Jinbocho, Chiyoda-ku, Tokyo 101-8101,
Japan (hereafter referred to as “ Asahi ”).
NxStage and Asahi are sometimes referred to herein individually as
a “ Party ” and collectively as the “
Parties .”
WHEREAS ,
NxStage owns certain intellectual property rights including
manufacturing technology to make, use, sell, and distribute Simplex
Dialyzers (as defined below), Harmony Products (as defined below)
and Streamline Blood Tubing Set (as defined below) for use in
Extracorporeal Therapies (as defined below) ;
WHEREAS ,
Asahi is engaged in the manufacture and sale of hollow fiber
membranes for various applications, including without limitation
Asahi Membranes (as defined below);
WHEREAS,
the Parties entered into the “Letter of Intent” dated
September 19, 2008 (“ LOI ”) in order to
negotiate agreements between the Parties under which the Parties
intend to establish a strategic alliance in the field of
Extracorporeal Therapies to capitalize on Asahi’s membrane
technology and market presence and on NxStage’s market
presence and experience in renal failure technology;
WHEREAS ,
as a part of such strategic alliance, Asahi desires to obtain a
license under NxStage Dialyzer Manufacturing Technology (as defined
below), NxStage Harmony Technology (as defined below) and NxStage
Streamline Technology (as defined below) to make, use, sell, offer
for sale and distribute certain products, including without
limitation Simplex Dialyzers incorporating Asahi Membranes for
distribution in the Territory (as defined below) for use in
Extracorporeal Therapies; and
WHEREAS ,
NxStage is willing to grant to Asahi such license all on the terms
and conditions set forth in this Agreement.
NOW,
THEREFORE , for good and valuable consideration, the receipt
and sufficiency of which is hereby acknowledged, the Parties agree
as follows:
As used in this
Agreement, the following terms shall have the following meanings
respectively;
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1.1
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“ Affiliate ”
shall mean any person or entity directly or indirectly controlling,
controlled by, or under common control with, the Party in question
where “control” means direct or indirect beneficial
ownership of fifty percent (50%) or more of the voting stock or
equity, or fifty percent (50%) or more of the interest in the
income of such corporation or other business entity.
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1.2
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“ Asahi Membrane
” shall mean any synthetic hollow fiber membrane manufactured
by or for Asahi which are suitable for use in Extracorporeal
Therapies. For purposes of clarification, any membrane manufactured
by or for Asahi for use in any application other than
Extracorporeal Therapies, including without limitation plasma or
apheresis therapy, is not Asahi Membrane for purposes of this
Agreement.
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1.3
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“ Asia Territory
” shall mean Japan, China, South Korea, Taiwan, Bangladesh,
Nepal, Pakistan, Sri Lanka, Mongolia, Brunei, Cambodia, Indonesia,
Laos, Malaysia, the Philippines, Singapore, Thailand, and
Vietnam.
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1.4
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“ Collaboration
Agreement ” shall mean the NxStage & Asahi
Collaboration Agreement entered into by NxStage and Asahi,
effective as of the Effective Date.
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1.5
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“ Confidential
Information ” shall mean any non-public information
disclosed by one Party to the other Party in connection with this
Agreement, whether in electronic, written, graphic, machine
readable or other tangible form, that is marked or identified at
the time of disclosure as “Confidential” or
“Proprietary” or is disclosed in a form other than in
tangible form and is reasonably apparent on its face to be
confidential or proprietary. NxStage will use its best efforts to
reduce to written form marked as “Confidential” or
“Proprietary” all Confidential Information disclosed to
Asahi in a form other than in tangible form. Notwithstanding
anything to the contrary in this Agreement, any and all NxStage
Dialyzer Manufacturing Technology, NxStage Harmony Technology,
NxStage Streamline Technology and the Deliverables shall be deemed
Confidential Information of NxStage.
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1.6
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“ Control ” shall
mean, with respect to an item of information or an intellectual
property right, possession of the ability, whether arising by
ownership or license, to grant a license or sublicense as provided
in this Agreement under such item or right without violating the
terms of any written agreement with any Third Party.
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1.7
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“ Deliverables ”
shall mean the documents describing the technical aspects of
NxStage Dialyzer Manufacturing Technology, NxStage Harmony
Technology and NxStage Streamline Technology, including without
limitation the list of patents and pending patent applications
thereof (“ Documentary Deliverables ”), together
with any proprietary equipment included within the definition of
NxStage Dialyzer Manufacturing Know-How (“ Equipment
Deliverables ”).
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1.8
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“ Dialyzer ”
shall mean any filter containing hollow fiber membranes intended
for use in Extracorporeal Therapies.
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2
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1.9
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“ Extracorporeal
Therapies” shall mean hemodialysis, hemofiltration,
hemodiafiltration, and/or ultrafiltration therapies. For purpose of
clarification, plasma or apheresis therapies are not the
Extracorporeal Therapies for purposes of this Agreement.
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1.10
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“ Harmony Products
” shall mean a product for Extracorporeal Therapies developed
and manufactured by NxStage consisting of a Dialyzer that
incorporates Asahi Membranes with design and performance features
of the Simplex Dialyzer, pre-attached to a Streamline Blood Tubing
Set.
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1.11
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“ Intellectual Property
Rights ” shall mean rights in and to any and all
(a) U.S. and foreign patents and patent applications,
including without limitation all divisions, substitutions,
continuations, continuations-in-part, reissues, re-examinations,
and extensions thereof, (b) copyrights, whether registered or
unregistered, (c) rights in trade secrets, data, or materials,
and (d) any other intellectual or other proprietary rights of
any kind now known or hereafter recognized in any jurisdiction,
whether registered or unregistered, but excluding trademarks,
service marks, trade names, trade dress, domain names, and similar
rights.
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1.12
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“ Loan Agreement
” shall mean the Term Loan and Security Agreement entered
into by NxStage and Asahi Kasei Kuraray Medical, Co., Ltd.,
effective as of the Effective Date.
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1.13
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“ New Facility ”
shall have the meaning set forth in the Production
Agreement.
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1.14
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“ NxStage Dialyzer
Manufacturing Know-How ” shall mean any technology,
information, expertise, know-how, and/or trade secrets Controlled
by NxStage necessary for the manufacture of Simplex Dialyzer(s)
that is not within the NxStage Dialyzer Manufacturing Patent
Rights, including without limitation any proprietary
equipment.
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1.15
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“ NxStage Dialyzer
Manufacturing Patent Rights ” shall mean any and all
rights under patents and pending patent applications Controlled by
NxStage necessary for the manufacture of Simplex
Dialyzer(s).
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1.16
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“ NxStage Dialyzer
Manufacturing Technology ” shall mean the NxStage
Dialyzer Manufacturing Know-How and the NxStage Dialyzer
Manufacturing Patent Rights.
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1.17
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“ NxStage Harmony
Technology ” shall mean the patents, patent applications
and know-how Controlled by NxStage that are necessary for the
manufacture and assembly of Harmony Products for use in
Extracorporeal Therapies.
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1.18
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“ NxStage Streamline
Technology’ ’ shall mean the patents, patent
applications and know-how Controlled by NxStage that are necessary
for the manufacture and assembly of Streamline blood tubing sets
for use in Extracorporeal Therapies.
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1.19
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“ NxStage System One
” shall mean the NxStage System One cycler, warmer, one view
accessory and stand presently sold by NxStage for use in
Extracorporeal Therapies, and any successor equipment to NxStage
System One for use in Extracorporeal Therapies.
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1.20
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“ Production Agreement
” shall mean the Dialyzer Production Agreement entered into
by NxStage (including its Affiliates) and Asahi (including its
Subsidiary defined therein), effective as of the Effective
Date.
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1.21
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“ Simplex Dialyzers
” shall mean any Dialyzer, not pre-attached to any blood
tubing set or cartridge, with the same general performance and
design features (including without limitation, an extruded body) of
the Dialyzer pre-attached to the cartridge used with the NxStage
System One as of the Effective Date, and covered by NxStage’s
Intellectual Property Rights. For purposes of clarification, any
Dialyzer used with NxStage System One, or any successor equipment
to NxStage System One, is not a Simplex Dialyzer for purposes of
this Agreement.
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1.22
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“ Streamline Blood Tubing
Set ” shall mean the NxStage blood tubing set for use in
Extracorporeal Therapies that incorporates the general performance
and design features of the Streamline Blood Tubing Set marketed by
NxStage as of the Effective Date.
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1.23
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“ Streamline Components
” shall mean components manufactured by NxStage for assembly
into Streamline Blood Tubing Sets.
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1.24
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“ Term ” shall
have the meaning set forth in Section 6.1.
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1.25
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“ Territory ”
shall mean all countries in the world including Asia Territory, but
excluding the United States of America (“ USA ”)
and Canada.
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1.26
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“ Third Party ”
shall mean any party other than NxStage, Asahi, or an Affiliate of
either NxStage or Asahi.
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2.
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License; Intellectual
Property
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2.1
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Manufacturing
License.
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(a)
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Subject to the terms and conditions
of this Agreement, in consideration for entering into the Loan
Agreement, NxStage hereby grants to Asahi
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(i)
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a
license, including a right to grant sublicense rights (but only in
accordance with the terms and conditions set forth in
Section 2.1(b)), under the NxStage Dialyzer Manufacturing
Technology to make, use, sell, offer for sale and distribute
Simplex Dialyzers in the Territory for use in Extracorporeal
Therapies, such license to be exclusive in the Asia Territory and
non-exclusive elsewhere in the Territory excluding the Asia
Territory; provided that Asahi, and any sublicensee of Asahi, shall
have no right to make, use, offer for sale, or sell Simplex
Dialyzers anywhere in the European Union unless and until
(A) the New Facility has been constructed and (B) after
Asahi has purchased at least [**] Simplex Dialyzers in a year from
such New Facility, and then only so long as Asahi continues to
purchase at least [**] Simplex Dialyzers in each calendar [**] from
such New Facility thereafter throughout the term of the Production
Agreement, from NxStage, provided that NxStage is able to supply
such minimum quantities of
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4
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Simplex Dialyzers meeting the
Specifications as defined in the Production Agreement from the New
Facility; and
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(ii)
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a
license, including a right to grant sublicense rights (but only in
accordance with the terms and conditions set forth in
Section 2.1(b) or Section 2.1(c)), under the NxStage
Streamline Technology to assemble Streamline Blood Tubing Sets
using Streamline Components purchased from NxStage, such license to
be exclusive in the Asia Territory and non-exclusive elsewhere in
the Territory excluding the Asia Territory; and
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(iii)
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a
license including a right to grant sublicense rights (but only in
accordance with the terms and conditions set forth in
Section 2.1(b)), under the NxStage Streamline Technology to
use, sell, offer for sale, and distribute Streamline Blood Tubing
Sets assembled under the license granted under Section 2.1(a)(ii)
in the Territory for use in Extracorporeal Therapies, such license
to be exclusive in the Asia Territory, and non-exclusive elsewhere
in the Territory excluding the Asia Territory; provided that
NxStage exceptionally has right to sell Streamline Blood Tubing
Sets to B. Braun Melsungen AG to use, sell, offer for sale, and
distribute in the Asia Territory. Any agreement that NxStage enters
with BBraun Melsungen AG will in no way reduce Asahi’s rights
granted under this Agreement; and
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(iv)
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a
license, including a right to grant sublicense rights (but only in
accordance with the terms and conditions set forth in
Section 2.1(b) or Section 2.1(c)), under the NxStage
Streamline Technology and the NxStage Harmony Technology to use
Streamline Blood Tubing Sets assembled under the license granted
under Section 2.1(a)(ii) to make Harmony Products, such
license to be exclusive in the Asia Territory and non-exclusive
elsewhere in the Territory excluding the Asia Territory;
and
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(v)
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a
license including a right to grant sublicense rights (but only in
accordance with the terms and conditions set forth in
Section 2.1(b)), under the NxStage Streamline Technology and
the NxStage Harmony Technology to use, sell, offer for sale and
distribute Harmony Products made under the license granted under
Section 2.1(a)(iv) in the in the Territory for use in
Extracorporeal Therapies, such license to be exclusive in the Asia
Territory and non-exclusive elsewhere in the Territory excluding
the Asia Territory;
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provided that,
for purposes of clarification, such licenses shall not include any
right to make, use, sell, offer for sale, or distribute any
Dialyzer, Streamline Blood Tubing Set or Harmony Product for use
with NxStage System One.
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(b)
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Asahi shall have the right to grant
sublicenses under the license set forth in Sections 2.1(a)(i),
(ii), (iii), (iv) and (v) solely to Asahi Kasei
Corporation or Affiliates of Asahi Kasei Corporation; provided that
(i) each sublicensee has agreed to be bound by all applicable
terms and conditions set forth in this Agreement (including without
limitation Asahi’s confidentiality obligations),
(ii) the terms and conditions of each
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such sublicense
are consistent with, and no less restrictive than, the terms and
conditions of this Agreement, and (iii) NxStage is designated
as a Third Party beneficiary of such sublicense and, consistent
with the terms and conditions of this Agreement, entitled to
enforce the terms and conditions of such sublicense with respect to
such sublicensee in the event that Asahi elects not to enforce such
terms and conditions of this Agreement. Notwithstanding anything to
the contrary, any such sublicense shall not be
sublicenseable.
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(c)
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Asahi shall have the right to grant
sublicenses under the licenses set forth in Section 2.1(a)(ii)
and 2.1(a)(iv) to Third Parties; provided that (i) each
sublicensee has agreed to be bound by all applicable terms and
conditions set forth in this Agreement (including without
limitation Asahi’s confidentiality obligations),
(ii) the terms and conditions of each such sublicense are
consistent with, and no less restrictive than, the terms and
conditions of this Agreement, and (iii) NxStage is designated
as a Third Party beneficiary of such sublicense and, consistent
with the terms and conditions of this Agreement, entitled to
enforce the terms and conditions of such sublicense with respect to
such sublicensee in the event that Asahi elects not to enforce such
terms and conditions of this Agreement. Notwithstanding anything to
the contrary, any such sublicense shall not be
sublicenseable.
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(d)
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No
later than [**] after the Effective Date, NxStage shall at
Asahi’s request provide a tour of its filter production
facility and review key processes and technology.. Within [**]
after the date of such tour, NxStage, with input from Asahi, will
provide a written list of Deliverables and deliver all Documentary
Deliverables to Asahi. At a commercially reasonable schedule and
time to be mutually agreed upon by the Parties, NxStage will
deliver the Equipment Deliverables to Asahi. Any Equipment
Deliverables shall be provided by NxStage to Asahi at
NxStage’s cost plus [**] percent ([**]%) only after Asahi has
exercised the option to construct a New Facility and made the Phase
II Capital available under the Production Agreement. NxStage shall
provide reasonable assistance to enable Asahi to implement the
manufacture of Simplex Dialyzers, such assistance to be provided
via telephone conference and, to the extent deemed necessary by
Asahi, [**], visits to Asahi’s manufacturing facilities, and,
as requested by Asahi, [**], accommodating Asahi’s personnel
at NxStage’s manufacturing facilities. At any time during the
Term after a period of [**] after the Effective Date, Asahi may
request that NxStage provide additional, reasonable assistance with
respect to the manufacture of Simplex Dialyzers, such assistance to
be provided [**].
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(e)
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In
the event Asahi exercises its rights under Section 14.3.2 or
15.6.3 of the Production Agreement, NxStage shall, on such
exercise, grant to Asahi a royalty-free and non-exclusive license
under all NxStage intellectual property (including NxStage Dialyzer
Manufacturing Technology) necessary to manufacture Simplex
Dialyzers in the New Facility. Such license shall be added to and
included in the licenses set forth in (a) of this
Section 2.1. Within [**] after such event, NxStage shall
disclose to Asahi, if any, all such NxStage intellectual
property.
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(a)
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In
this Section 2.2, “ Improvement ” shall
mean any improvement or modification to the NxStage Dialyzer
Manufacturing Technology, NxStage Harmony Technology and NxStage
Streamline Technology, (including designs, utilities, manufacturing
or methods) which either NxStage (including its Affiliates) or
Asahi (including its Affiliates, Asahi Kasei Corporation, and
Affiliates of Asahi Kasei Corporation) develops or obtains in the
course of using the NxStage Dialyzer Manufacturing Technology,
NxStage Harmony Technology and NxStage Streamline Technology and
which excludes any ideas, discoveries, developments and inventions
that are conceived, reduced to practice, or otherwise developed
under the Collaboration Agreement.
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(b)
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If
NxStage (including its Affiliates) develops or obtains any
Improvement during [**] period after the Effective Date, NxStage
shall free of charge grant to Asahi a license thereunder subject to
the same conditions set forth herein. If Asahi (including its
Affiliates, Asahi Kasei Corporation and Affiliates of Asahi Kasei
Corporation) develops or obtains any Improvement during [**] period
after the Effective Date, Asahi shall free of charge grant to
NxStage a license thereunder exclusively in USA and Canada and
non-exclusively in the Territory excluding Asia
Territory.
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(c)
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If
either NxStage (including its Affiliates) or Asahi (including its
Affiliates, Asahi Kasei Corporation and Affiliates of Asahi Kasei
Corporation) develops or obtains any Improvement during the Term
after the five years period set forth in (b) of this
Section 2.2, such developing Party may at its discretion
disclose to the other Party such Improvement. If the other Party
requests such developing Party to obtain a license of such
Improvement, such developing Party may at its discretion negotiate
with the other Party to grant such license.
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2.3
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Manufacture of Streamline,
Streamline Components and Harmony Products. Notwithstanding anything to the
contrary, in connection with the exclusive license granted by
NxStage to Asahi under Section 2.1(a), NxStage will
manufacture Streamline Blood Tubing Sets and/or Streamline
Components, or Harmony Products for sale to Asahi for sale by Asahi
exclusively in the Asia Territory, and Asahi shall have no right to
manufacture any Streamline Components.
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(a)
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If
Asahi elects to have NxStage manufacture and supply Streamline
Blood Tubing Sets and/or Streamline Components or Harmony Products
for sale by Asahi exclusively in the Asia Territory, Asahi shall
provide written notice thereof to NxStage within [**] after the
Effective Date.
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(b)
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In
the event that Asahi provides written notice to NxStage in
accordance with (a) of this Section 2.3, the Parties
shall, within [**], meet to discuss in good faith the terms of a
supply agreement for providing such product(s) to Asahi. Product
transfer pricing and terms for each such product shall be
[**].
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(a)
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NxStage hereby grants to Asahi a
non-exclusive and non-transferable license to use the NxStage
trademarks, trade names and logos (hereinafter collectively
referred to as “ Trademarks ”) set forth in
Exhibit 2.4(a) solely in connection with the marketing,
promotion, and sale of Simplex Dialyzers (including Simplex
Dialyzers manufactured by NxStage for Asahi under the Production
Agreement). Streamline Blood Tubing Sets and Harmony Products
(hereinafter collectively referred to as “ Contract
Products ”) for use in Extracorporeal Therapies in
accordance with this Agreement. All ownership and goodwill arising
out of the use of the Trademarks by Asahi shall vest in and inure
solely to the benefit o
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