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EXHIBIT 10.21
Confidential Treatment requested
for information omitted and filed
separately with the SEC.
LICENSE AGREEMENT
THIS AGREEMENT is made on the 9th day of June, 1997, between Nitto Boseki Co.,
Ltd., a corporation organized under the laws of Japan, having its principal
place of business at 5-5, Nihombashi Tomizawacho, Chuo-ku, Tokyo 103, Japan
(hereinafter called "Nittobo"), and GelTex Pharmaceuticals, Inc., a corporation
organized under the laws of the State of Delaware, U.S.A., having its principal
place of business at 303 Bear Hill Road, Waltham, Massachusetts 02154, U.S.A.
(hereinafter called "GelTex").
WHEREAS:
A. Nittobo developed and possesses process Patents for *******
B. GelTex has developed certain medicines named RenaGel and CholestaGel
which are produced from ***** as starting material, and wishes to have
manufacturing license right from Nittobo for producing ***** for
pharmaceutical purposes.
C. Nittobo is willing to grant a license to GelTex in accordance with the
terms and conditions provided hereunder.
NOW, THEREFORE, in consideration for the mutual promises and obligations
expressed herein, the parties agree as follows.
Article 1 DEFINITIONS
1.1 ******** shall mean ********
1.2 ******** shall mean ********
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and known as Nittobo's ********* manufactured in accordance with the
Licensed Patents.
1.3 "RenaGel" shall mean ********** used for the treatment of
hyperphosphatemia.
1.4 "CholestaGel" shall mean ********* used for the treatment of
hypercholesterolemia.
1.5 "*****" shall mean ******** material to be
manufactured as an intermediate to the GelTex Product hereunder.
1.6 "GelTex Product" shall mean RenaGel and CholestaGel.
1.7 "Licensed Patents" shall mean ********* and their corresponding
patents registered in all countries as described in Annex I (List of
the Licensed Patents) attached hereto, together with any divisions,
continuations or continuations-in-part thereof.
1.8 "Know-How" shall mean trade secret and confidential information held by
Nittobo which are useful for manufacture of **** and are actually
employed by Nittobo for its commercial production. For the purpose of
this Agreement, GelTex shall have no objection to include those
confidential informations Nittobo has provided to GelTex during the
course of negotiation of the sale of **** to GelTex.
1.9 "Territory" shall mean all the countries other than Japan, South Korea,
Republic of China (Taiwan), People's Republic of China, Singapore,
Malaysia, India, Thailand, Vietnam, Indonesia, Philippines, New Zealand
and Australia. (such countries to be referred to as the "Chugai
Territory")
* Confidential Treatment requested for information omitted and filed
separately with the SEC.
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Article 2 GRANT OF LICENSE
2.1 Nittobo hereby grants to GelTex a non-exclusive license under the
Licensed Patents and the Know-How to manufacture and sell ******
in the Territory for the sole purpose of (i) using ****** as
the starting material of GelTex Products to be sold in the Territory,
and (ii) using ********** as the starting material for RenaGel to be
manufactured by Dow or Abbott and sold by Chugai in the Chugai
Territory, if Chugai requires ****** and if only Nittobo does not sell
such ****** to Chugai. Provided however that GelTex will use best
efforts to arrange for its contract manufacturers of RenaGel to
purchase ***** from Nittobo for the exclusive use of Chugai, if and
when Nittobo becomes ready and wants to provide ***** to said GelTex
contract manufacturers and if Chungai so desires.
2.2 The license hereunder shall be non transferable, and GelTex shall have
no right to sublicense any other party without having Nittobo's prior
written approval, provided, however, that such approval shall not be
unreasonably withheld, and that GelTex shall be allowed to sublicense to
The Dow Chemical Company, Chemie Linz and/or Salsbury Chemical for
manufacture of ***** to be used in the manufacture of GelTex Products.
2.3 GelTex shall guarantee that the sublicensees of GelTex hereunder shall
have the same obligations to Nittobo as GelTex shall owe to Nittobo
hereunder, and shall submit to Nittobo a written consent of said
sublicensee(s) that they shall agree to the terms and conditions of this
Agreement and shall have obligation to be bound by this Agreement.
2.4 GelTex shall expressly agree that GelTex and its approved sublicensees
shall have no right to make use of ***** for any other purposes than
manufacturing RenaGel and CholestaGel.
Article 3 TRANSFER OF TECHNOLOGY
3.1 Within three (3) months of receipt of the first Initial Payment under
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Article 4.1.1, Nittobo will provide the Know-How to GelTex in the form
of documents, drawings and explanations. Within one month from receipt
of the Know-How, GelTex shall specify those information to Nittobo,
which fall in Article 5.3 together with written evidence to support the
same.
3.2 GelTex employees or employees of GelTex's sublicensees who are
designated by GelTex and accepted by Nittobo, but not exceeding six
people, will be sent to Nittobo's plant in Japan up to seven (7) working
days to learn the process of making **** including the Know-How. The
specification of **** shall be as described in Annex II attached hereto.
If reasonably requested by GelTex, Nittobo will dispatch its personnel
to GelTex or to its sublicensee for up to thirty (30) man-days to assist
GelTex or such sublicensee in setting up and implementing the Know-How.
3.4 All reasonable costs and expenses associated with transfer of the
Know-How shall be paid by GelTex to Nittobo upon presentation by Nittobo
of invoices properly documenting any such costs and expenses, and GelTex
shall reimburse Nittobo for all Nittobo's assistance requested by GelTex
at a rate of US$ 800 per person per working day, plus round trip
business class air fare, traveling, accommodation, subsistence and
communication expenses while Nittobo's employee is assisting GelTex or
its sublicensee with respect to the Know-How. In addition, it is
GelTex's obligation to prepare a translator while GelTex's or its
sublicensee's employees are in Japan or Nittobo's employee is in USA, or
sublicensee's country.
Article 4 ROYALTIES
4.1 In consideration of the license granted hereunder, GelTex shall make the
following payments to Nittobo:
4.1.1 Upon execution of this Agreement, the first Initial Payment of
****
4.1.2 On the first and second anniversaries of the execution of this
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with the SEC.
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Agreement, a payment of *****, respectively.
4.1.3 During the period any of the Licensed Patents is in effect in
any area in the Territory;
(i) *****
(ii) *****
(iii) *****
4.1.4 After all the Licensed Patents expire in all areas in the
Territory in consideration of the Know-How license hereunder;
(i) *****
(ii) *****
4.2 GelTex and its approved sublicensees shall keep true records relating to
manufacture and sales of **** in sufficient detail to enable the
royalties payable to be determined, and shall twice per calendar year
during
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with the SEC.
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normal business hours permit accountants and personnel appointed by
Nittobo to inspect such records and make copies thereof.
4.3 The royalty report shall be sent to Nittobo within sixty (60) days for
the end of such semi-annual period. The running royalty shall be
calculated and paid semi-annually (January - June, July - December)
within sixty (60) days of the end of each semi-annual period. The
formality and items to be contained in the royalty reports shall be
agreed between Nittobo and GelTex.
4.4 Any withholding taxes imposed on Nittobo regarding payments from GelTex
or its approved sublicensees to Nittobo shall be born by Nittobo, and
GelTex or its approved sublicensees shall deduct such withholding tax
from royalty payments otherwise due Nittobo and pay such withholding
tax to the appropriate tax authorities and shall furnish Nittobo with
appropriate evidence in order to enable Nittobo to claim exemption
from or income credit for any tax so payable.
4.5 GelTex shall agree that any payments made hereunder shall be
non-refundable, and termination of this Agreement shall not terminate
GelTex's obligation to pay royalties on sales that may have accrued but
have not yet been paid to Nittobo.
Article 5 CONFIDENTIALITY
5.1 The Know-How is and shall remain the property of Nittobo and GelTex
shall maintain and shall have its approved sublicensees maintain in
confidence the Know-How and shall not disclose it to any third party
except to the party expressly permitted by Nittobo hereunder.
5.2 Notwithstanding the foregoing, GelTex may disclose the Know-How to
officers and employees of GelTex and the approved sublicensees, who
specifically need to know such Know-How in order to accomplish the
manufacture of ****, and GelTex shall bear all responsibility and
liability to have such officers and employees comply with the
confidentiality obligations hereunder, whether or not such officers and
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with the SEC.
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employees continue to be officers or employees of GelTex or the approved
sublicensees.
5.3 The obligation of confidence hereunder shall not extend to information
which:
(a) is already in GelTex's possession prior to receiving it from
Nittobo;
(b) is or subsequently becomes public domain through no fault of
GelTex;
(c) is acquired by GelTex from a third party owing no obligation of
confidence to the disclosing party; or
(d) is independently developed by GelTex without reliance upon the
confidential information disclosed by Nittobo.
5.4 The obligation of confidence hereunder shall not prohibit the disclosure
of any information that GelTex or its sublicensees are required to
disclose by law or regulation, or the disclosure of any information that
may be necessary in order for GelTex to satisfy its regulatory
obligations.
5.5 The obligation of GelTex and its approved sublicensees hereunder shall
survive termination of this Agreement.
Article 6 REPRESENTATIONS, ETC.
6.1 Nittobo does not warrant that the License Patents is valid and that ****
manufactured by the License Patents and/or the Know-How does not
infringe on the intellectual property rights owned by third parties.
6.2 Nittobo specifically invites GelTex's attention to the fact that since
Nittobo is selling *** only as industrial chemicals for use as a reagent
and flocculating agent, Nittobo cannot give any warranty as to ****
suitability for medical or pharmaceutical use.
6.3 GelTex shall ******
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with the SEC.
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************
Nittobo shall give GelTex prompt written notice of ********
6.4 In no event shall Nittobo be liable for any indirect, incidental, or
consequential damage arising out of or pertaining to **** or any use
thereof, including any alleged defect of ****, whether such claim for
damages is allegedly based on a breach of warranty, negligence, product
liability or otherwise.
6.5 GelTex shall, at its own expense, be responsible for (i) complying with
all applicable laws and regulations that affect when and where **** may
be used or imported, and (ii) obtaining all approvals, licenses, etc.
that may be required under such laws or regulations.
Article 7 TERM AND TERMINATION
7.1 This Agreement shall become effective upon signing the Agreement by the
duly authorized representatives of the parties and shall terminate
(i) when the Licensed Patents expire in all countries in the
Territory and all the Know-How loses its confidential status as
identified in Article 5.3, or
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(ii) when GelTex and all its approved sublicensees cease production
of **** for a period of twelve (12) consecutive months.
7.2 If either party fails to perform any material obligation and does not
remedy any such failure within one (1) month of written notification
of the default by the other party, the other party may forthwith
terminate this Agreement.
7.3 Either party may terminate this Agreement immediately by giving written
notice of termination in the event that the other party (a) becomes
insolvent, files for bankruptcy or company reorganization, composition
or any similar act; or (b) dissolves, ceases doing business, or
changes its business substantially.
7.4 In the event of termination of this Agreement, other than in accordance
with the provisions of Article 7.1(i), GelTex shall immediately cease
use of the Know-How, nor thereafter utilize the Licensed Patents.
7.5 The provisions of this Article shall not limit any other additional
remedies available to Nittobo or GelTex on termination of the Agreement.
Article 8 GENERAL PROVISIONS
8.1 A waiver by either party of any term or condition of this Agreement in
any instance shall not be deemed or construed to be a waiver of such
term or condition of the future, or of any subsequent breach thereof.
All rights, remedies, undertakings or obligations contained in this
Agreement shall be cumulative and none of them shall be in limitation of
any other right, remedy, undertaking or obligation of either party.
8.2 Neither this Agreement nor any of the rights or obligations provided
herein may be assigned by either party without the express written
consent of the other party. This Agreement and the rights and
obligations hereunder shall, however, be binding upon and inure to the
benefit of each party's successors and permitted assigns.
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separately with the SEC.
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8.3 If any part of this Agreement is found to be invalid or unenforceable,
the remainder of the Agreement shall continue in full force and effect
consistent with the intent of the parties.
8.4 This Agreement incorporates the parties' entire agreement and supersedes
all prior understandings or agreements between the parties as to the
subject matter hereof. This Agreement may only be modified, altered or
amended by a writing of subsequent date signed by all parties.
8.5 This Agreement is to be governed by and construed according to the laws
of Japan.
8.6 Any dispute between the parties concerning this Agreement or the
performance of any obligation arising hereunder shall be resolved by
binding arbitration in Tokyo, Japan, according to the rules of the Japan
Commercial Arbitration Association. The decision of the arbitrator(s)
shall be final, and the parties hereby waive any right to appeal or
review of such decision.
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement, or
caused their duly authorized representatives to
Nitto Boseki Co., Ltd.
By: /s/ Atsuhiko Sagara
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Atsuhiko Sagara
Title: President
GelTex Pharmaceuticals, Inc.
By: /s/ Joseph E. Tyler
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Joseph E. Tyler
Title: Vice President, Manufacturing
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Annex I
LIST OF LICENSED PATENTS
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Country Appln No. Reg. No.
Appln Date Reg. Date
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separately with the SEC.
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Annex II
SPECIFICATION OF *****
************
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separately with the SEC.