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CONFIDENTIAL TREATMENT REQUESTED
FOR PORTIONS OF THIS DOCUMENT
EXHIBIT 10.11
EXCLUSIVE LICENSE AGREEMENT
This Exclusive License Agreement ("Agreement") is effective as of September 16,
1998 (the "Effective Date"), by and between United Therapeutics Corporation, a
Delaware corporation, having an address at 68 X.X. Xxxxxxxxx Drive, Research
Xxxxxxxx Xxxx, Xxxxx Xxxxxxxx 00000, XXX ("UT"), and Toray Industries, Inc., a
Japanese corporation, having an address at 2-1, Xxxxxxxxxx-Xxxxxxxxx 0-xxxxx,
Xxxx-xx, Xxxxx 000-0000, Xxxxx ("Toray").
WHEREAS, Toray owns all right, title and interest in certain patent rights,
trademark and the right to use certain know-how relating to the Product (as
herein defined) in the Territory (as herein defined);
WHEREAS, UT desires to obtain an exclusive license of such patent rights,
trademark and know-how in order to develop, use and sell the Product within the
Territory; and
WHEREAS, Toray is willing to grant such an exclusive license to UT according to
the terms and conditions herein below.
NOW, THEREFORE, in consideration of the foregoing and the mutual promises and
covenants set forth in this Agreement, the parties to this Agreement mutually
agree as follows.
1. Definitions. As used in this Agreement, the following terms, whether used
in the singular or the plural, shall have the following meanings:
a. "Affiliate" means any corporation or non-corporate entity which
controls, is controlled by, or is under common control with a party to this
Agreement. A corporation or non-corporate entity shall be regarded as in
control of another corporation if it owns or directly or indirectly controls at
least fifty percent (50%) of the voting stock of the other corporation, or (i)
in the absence of the ownership of at least fifty percent (50%) of the voting
stock of a corporation or (ii) in the case of a non-corporate entity, if it
possesses, directly or indirectly, the power to direct or cause the direction
of the management and policies of such corporation or non-corporate entity, as
applicable
b. "Dollars" or "$" means United States dollars.
c. "FDA" means the United States Food and Drug Administration or any
successor entity.
d. "Indication" means Pulmonary Vascular Disease, including Pulmonary
Hypertension.
e. "Improvements" means modifications, variations and revisions of the
Know-How as well as all processes, machines, manufactures or compositions of
matter directly pertaining to the Patent Rights.
f. "Patent Rights" means all domestic and foreign patents and patent
applications listed
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in Appendix A attached hereto and made a part hereof, and any Improvements,
extensions, continuations, continuations-in-part, divisions, substitutions,
foreign equivalents, renewals, modifications, variations, new models, or
reissues thereof; as well as all processes, machines, manufactures or
compositions of matter directly pertaining to the patents which come into
existence during the term of this Agreement.
g. "Know-How" means all technical information and data, including but not
limited to ideas, concepts, methods, procedures, processes, compounds,
inventions, discoveries, whether or not patentable, which are owned by Toray,
or which Toray has the right to use and license as of the Effective Date and
which relates to the Product and its use as described in the claims of the
patents and patent applications listed in Appendix A attached hereto and made a
part hereof; or any other patents or patent applications comprising the Patent
Rights.
h. "Trademark" means the trademark selected by both parties and registered
by Toray for the Product in accordance with Section 6.b.
i. "Product" means immediate release (not sustained or controlled) oral
formulation of TRK-100 (Beraprost Sodium) which includes what has been
developed in the USA by HMR.
j. "Licensed Technology" means, collectively, the Product, the Patent
Rights, the Trademark, the Know-How and the Improvements.
k. "Net Sales", with respect to any Product, means the gross sales
(i.e., gross invoice prices) of such Product billed by UT or its distributor to
final wholesaler or, if and when UT or its distributor sells the Product
directly to hospital, clinic, HMO Hospital Management Organization) or other
end users (hereinafter collectively referred to as the "End Users", and final
wholesaler or the End Users, as the case may be, being hereinafter referred to
the "Third Party Customers"), the gross sales of such Product billed by UT or
its distributor to the End Users, less : (i)actual credited allowances to the
Third Party Customers for spoiled, damaged, out dated and returned Product and
for retroactive price reductions in lieu of returned Product; (ii)customary
trade and cash discount, to the extent such trade and cash discounts are not
deducted by UT at the time of invoice in order to arrive at the gross invoice
prices; (iii)all transportation, packaging, handling and insurance charges,
sales taxes, excise taxes, use taxes or import/export duties actually paid;
(iv)any tax or other government charge on the sale, transportation, or delivery
of Product; and (v)all other invoiced allowances and adjustments actually
credited the Third Party Customers including, but not limited to, rebates paid
to the Third Party Customers, whether during the specific royalty period or
not. All the deduction shall be reasonable, customary and certified with
evidence. In this Section 1k, final wholesaler means the firm, corporation or
individual which sells Product directly to the End Users.
l. "NDA" means a New Drug Application or any equivalent successor
application.
m. "Registration" means, in relation to any Product, such approvals by
government authorities as may be legally required before such Product may be
commercialized in the Territory.
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n. "Territory" means the United States of America and Canada.
o. "Third Party" means any party other than UT and Toray.
p. "Valid Claim" means a claim of an issued and unexpired patent included
within the Patent Rights which has not been held unenforceable, unpatentable or
invalid by a decision of a court or other governmental agency of competent
jurisdiction, unappealable or unappealed within the time allowed for appeal,
and which has not been admitted to be invalid or unenforceable through reissue,
disclaimer or otherwise.
2. Grant of Exclusive License.
x. Xxxxx. Toray hereby grants to UT an exclusive license, without a right
to sublicense, under the Licensed Technology to develop, use, import, offer for
sale and sell Products in the Territory for use in treatment of the Indication.
b. Covenant Not to Xxx. Toray agrees that it will not assert nor cause to
be asserted against UT any patent not included in the Patent Rights that is or
might be infrin8ed by reason of UT exercise of rights under the license granted
to UT hereunder.
3. Consideration for the Grant.
a. License Fees. In consideration for the exclusive license granted to UT
under this Agreement, UT shall on execution of this Agreement:
1. pay to Toray a non-refundable license fee of [ ];
2. deliver to Toray a certificate representing [ ] shares of UT
common stock; and
3. execute and deliver to Toray a Stock Option Grant issuing to Toray
options to acquire [ ] shares of UT common stock at a purchase price of [ ]
per share, exercisable by Toray upon the date of UT's first filing of an NDA in
the United States for the Product.
b. Milestone Payments. As further consideration for the exclusive license
granted to UT under this Agreement, UT shall make the following payments upon
completion of the following milestones:
1. UT shall pay to Toray a non-refundable milestone payment of
[ ] in cash upon UT's written notice to Toray that it is proceeding with
its first Phase III Studies.
2. UT shall pay to Toray a non-refundable milestone payment of
[ ] in cash upon UT's first filing of an NDA in the United States for the
Product.
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3. UT shall pay to Toray a non-refundable milestone payment of [ ] in
cash upon the date of first FDA approval of the Product.
c. Purchase of Product.
1. UT shall purchase commercial Product according to United States current
OMP solely from Toray during the term of this Agreement. UT shall neither
manufacture Product nor purchase Product from a Third Party. Toray will be
responsible for the manufacture and delivery to UT of the amount of United
States current OMP Product that UT reasonably requires from time to time during
the term of this Agreement.
2. Toray will supply commercial Product to UT at the prices which are
inclusive of all costs and revenues) including but not limited to) costs of
formulation, manufacture, bulk materials, as well as a royalty stream on Net
Sales. The price of the Product shall be the sum of(1) and (2), in which (1) is
"Tile Amount" per 120 micrograms determined by using the following formula and
(2) is $ 1.00 per 320 micrograms:
(a) If Net Sales within the Territory are below [ ], then The Amount
shall be the greater of either the amount per 120 micrograms converted from [
] of Net Sales or Japanese Yen [ ] per 120 micrograms.
(b) If Net Sales within the Territory are between [ ] and [ ], then The
Amount shall be (i) the amount determined according to (a) above for the
portion up to [ ], plus (ii) the greater of either the amount per 120
micrograms convened from [ ] of the portion of over [ ] of the Net Sales or
Japanese Yen [ ] per 120 micrograms.
(c) If Net Sales within the Territory are between [ ] and [ ], then The
Amount shall be (i) the amount determined according to (b) above for the portion
up to [ ], plus (ii) the greater of either the amount per 120 micrograms
converted from [ ] of the portion or over [ ] of the Net Sales- ~ Japanese Yen
[ ] per 120 micrograms.
(d) If Net Sales within the Territory are over [ ], then The Amount shall
be (i) the amount determined according to (c) above for the portion up to [ ],
plus (ii) the greater of either the amount per 120 micrograms converted from [ ]
of the portion of over [ ] of the Net Sales or Japanese Yen [ ] per 120
micrograms.
Toray and UT shall consult with each other and decide provisional sales
price of the Product sold to UT for the next sales year, and after the said
sales year) adjust the amount already paid by UT on the basis of provisional
sales price in the said sales year (hereinafter referred to as "Paid Price") by
defining and paying or paying back the difference between the Paid Amount and
the total amount calculated according to the above method for the Product sold
to UT in the said sales year.
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3. In the event that UT determines after discussion with Toray, that
(a) UT is required to pay royalties to any Third Party because the
development, manufacture, use or sale of the Product infringes any patent or
other intellectual property rights of such Third Party in the Territory; or
(b) the development, manufacture, use or sale of the Product in any
country in the Territory no longer infringes a Valid Claim with respect to any
Product and Third Party starts the sale of the same compound with Beraprost in
chemical structure in the Territory; or
(c) a compulsory license has been granted to a Third Party under the
applicable laws of any country in the Territory under the Licensed Technology
licensed to UT hereunder Third Party starts the sale of the same compound with
Beraprost in chemical structure in the Territory; or
(d) the price for Product under this Paragraph 3(c) causes or may cause UT
a significant reduction in its sales of Product in any country in the
Territory;
then, in any such event, UT and Toray shall meet and in good faith endeavor to
agree on how to deal with the situation in order to place UT in a position to
market competitively the Product in such country.
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the terms and conditions as designated by the mutual agreement of UT and Toray.
d. Minimum Annual Product Net Sales. UT shall be responsible for
achieving minimum annual Product Net Sales as determined in advance by mutual
agreement of Toray and UT for the duration of this Agreement . Toray and UT
agree that the minimum Net Sales amount for the first two commercial sales
years shall be [ ] and [ ] respectively. In the event that UT is
unable to meet any minimum annual Net Salts amount as designated by the parties
for a period of two consecutive years, then Toray may convert the exclusive
license granted under this Agreement to be non-exclusive, in which event UT
shall thereafter share the Product marketing rights approved by the FDA with
such Third Party designated by Toray.
e. Non-Competition. UT shall not engage in the development of an
immediate release (not sustained or controlled) orally available stable
prostacyclin analog compound including UT-15 for the duration of this Agreement
plus five years. Notwithstanding the foregoing, in the event that immediate
release TRK- 100 (Beraprost Sodium) failure has been demonstrated in clinical
trials) then the period of noncompetition shall only extend for six months
after the date the failure was demonstrated.
4. Development and Commercialization Program.
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a. UT shall be responsible for all costs and expenses for obtaining
regulatory approval and commercializing Products for treatment of the
Indication, including all costs of clinical trials. UT will solely and
exclusively own all regulatory applications and approvals obtained by UT with
respect to Products. UT will closely consult with Toray with regard to its
participation in important clinical development meetings.
b. UT and Toray shall establish a Management Committee, comprised of two
persons from UT and two persons from Toray, which will meet at least once a
year at each party's expense to coordinate the development and marketing of
Products under this Agreement, to determine the Product development schedule,
and to take such other actions as required under this Agreement.
1. The initial Product development schedule, subject to revision by the
Management Committee, is as follows:
Action Date
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Orphan-IND QIS) [ ]
Phase II start [ ]
Phase III start [ ]
NDA filing [ ]
FDA approval [ ]
In the event that the Product development schedule falls more than six months
behind the above initial development schedule, then Toray may at its discretion
terminate this Agreement without any additional penalty to UT.
2. The initial quantity of Product provided by Toray to UT free of charge
for use in clinical studies, subject to revision by the Management Committee,
is up to 100g. The Management Committee will decide from time to time the
appropriate product sample requirements and the price on quantities exceeding
100g, to support UT's development and commercialization approval of the
Product.
c. Toray shall provide UT on a timely basis and without charge all
information concerning the Product which is available to Toray and which is
reasonably required by UT to fulfill its obligations under this Agreement,
including but not limited to, information relating to preclinical and clinical
research, safety, use, pharmacokinetics and efficacy, access through Toray to
HMR European data and authority to use and submit such data to the FDA to the
extent legally required, etc. In the event that UT uses information from other
licensees of Toray, UT will be responsible for payment of reasonable
compensation to such licensee through Toray.
d. UT shall disclose to Toray on a timely basis and without charge all
Product information (including but not limited to, clinical studies, ADR, GCP,
preparation for registration, NDA filing, FDA approval, US market PMS, safety
issues) which UT acquires or will acquire during the term of this Agreement UT
agrees that Toray may use such information
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outside the Territory free of charge. In the event that Toray grants the right
to use such information to a Third Party except Yamanouchi Pharmaceutical Co.,
LTD. and Kaken Pharmaceutical Co., LTD. outside the Territory or uses such
information itself within the Territory, Toray will be responsible for payment
of reasonable compensation to UT
e. Neither UT nor Toray shall appoint a Third Party to promote or
distribute Product under UT's marketing rights approved by the FDA, without the
other's approval. Notwithstanding the foregoing, in the event that UT fails to
achieve at least [ ] annual Net Sales of Product in each year in and
after the third fill sales year, then the Management Committee shall have the
right, after frill discussion, to appoint a promoting company. In the event
that the Management Committee is unable to reach agreement on the identity of
such Third Party promoting company, Toray shall have the right to appoint such
company.
f. In the event that UT desires to market and/or advertise the Product
for off-label use, UT shall discuss with Toray such off-label use and get the
approval of it from Toray in advance.
5. Rights of First Refusal.
a. Toray agrees to enter into a separate negotiation with UT for the first
refusal right to co-promote the non-immediate release formulation of TRK-100
(Beraprost Sodium) for the Indication when it is developed or marketed in the
Territory.
b. Toray agrees to enter into a separate negotiation with UT for the first
refusal right to develop and sell the Product in other therapeutic areas than
the medication, including peripheral vascular disease in the Territory.
c. Toray agrees to enter into a separate negotiation with UT for the first
opportunity to develop and sell the Product in Mexico once Toray's other
licensee indicates that it does not want to commence development in Mexico.
d. UT agrees to enter into a separate negotiation with Toray for the first
refusal right to develop and sell in Japan up to two compounds which UT is
developing or will develop and which UT has the right to license or sublicense.
6. Intellectual Property.
a. Patents. Toray will be responsible for taking all necessary action
to maintain and/or extend the Patents Right in the Territory. UT will render
reasonable assistance to Toray in this effort.
b. Trademarks. UT will be responsible for selecting an enforceable
trademark(s) for the Product acceptable to Toray and Toray will be responsible
for registering and maintaining such registrations within all countries in the
Territory. UT will market the Product using such trademark(s) to identify the
Product within the Territory. Toray hereby grants to UT the exclusive right to
use the trademark within the Territory during the term of this Agreement.
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7. Warranties.
a. Toray represents and warrants to UT that: (i) Toray is the sole owner
of the Licensed Technology and has the exclusive right and authority to use the
Know-How and to license the Patent Rights and the Know-How; (ii) as of the
Effective Date, Toray is not aware of any action or threatened claim of
infringement brought by a Third Party under any Third Party intellectual
property right in respect of Toray's exploitation of the Licensed Technology;
and (iii) Toray will make available to UT all material technical information in
its possession or of which it is aware that is pertinent to development and
commercialization of the rights licensed under this Agreement.
b. Toray and UT each represents and warrants to the other that: (i) it is
free to enter into this Agreement and to carry out its obligations hereunder;
(ii) this Agreement constitutes its legal, valid and binding obligation; and
(iii) execution, delivery and performance of this Agreement will not constitute
a violation or breach of any agreement or contract to which it is a party or by
which it is bound or the terms of any judicial or administrative decree or
order to which it is subject.
8. Indemnification. UT agrees to indemnify and hold Toray, its Affiliates,
and its and their directors, officers, employees and agents harmless from and
against any liabilities or damages or expenses in connection therewith
(including reasonable attorney's fees and costs and other expenses of
litigation) resulting from Third Party claims arising out of UT's clinical
development of Products, defectiveness of Product PPI (information to doctors,
pharmacists and patients), and the use, storage or sales of the Product within
the Territory
9. Confidentiality
a. Treatment of Confidential Information. Except as otherwise provided in
this Section 9.a, during the term of this Agreement and thereafter: for a
period of seven (7) years
1. UT will retain in confidence and use only for purposes of this
Agreement any information and data supplied by or on behalf of Toray to UT
under this Agreement; and
2. Toray will retain in confidence and use only for purposes of this
Agreement any information and data supplied by or on behalf of UT to Toray
under this Agreement.
For purposes of this Agreement, all such information and data which a Party is
obligated to retain in confidence shall be called "Information."
b. Right to Disclose. To the extent it is reasonably necessary or
appropriate to fulfill its obligations or exercise its rights under this
Agreement or any rights which survive termination or expiration hereof, a party
may disclose Information to its Affiliates, licensees, consultants, outside
contractors and clinical investigators on condition that such entities or
persons agree (i)
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to keep the Information confidential for at least the same time periods and to
the same extent as each party is required to keep the Information confidential
and (ii) to use the Information only for such purposes as such party is
entitled to use the Information. Each party or its Affiliates may disclose
such Information to government or other regulatory authorities to the extent
that such disclosure (a) is reasonably necessary to obtain patents or
authorizations, to conduct clinical trials and to market commercially the
Product, provided such party is otherwise entitled to engage in such activities
under this Agreement, or (b) is otherwise required by applicable laws or
regulations.
c. Release from Restrictions. The obligation not to disclose Information
shall not apply to any part of such Information that (i) is or becomes
patented, published or otherwise part of the public domain other than by acts
of the party obligated not to disclose such Information (for purposes of this
Section 9, the "Receiving Parry"') or its Affiliates or licensees in
contravention of this Agreement, or (ii) is disclosed to the Receiving Party or
its Affiliates or licensees by a Third Party, provided such Information was not
obtained by such Third Party directly or indirectly from the other party under
this Agreement; or (iii) prior to disclosure under this Agreement, was already
in the possession of the Receiving Party or its Affiliates or licensees,
provided such Information was not obtained, directly or indirectly, from the
other party under this Agreement; or (iv) results from research and development
by the Receiving party or its Affiliates or licensees independent of
disclosures from the other party under this Agreement.
d. Publications. No announcement, news release, public statement,
publication or other public presentation relating to the existence of this
Agreement, the subject matter herein, or either party's performance hereunder
including any written or oral publication, any manuscript, abstract or the like
which includes data or any other information generated and provided by the
development effort hereunder, shall be made without the other party's prior
approval as to form and content. An acceptable joint press release announcing
the execution of this Agreement is required to be agreed by both Parties.
10. Term and Termination.
a. Term and Expiration. This Agreement shall become effective as of the
Effective Date and shall continue in full force and effect until that date ten
years after FDA approval of the Product. UT may extend the term of this
Agreement by successive one-year periods by giving written notice of each such
extension to Toray no later than two-hundred ten (210) days prior to the end of
the term set forth in the previous sentence or the end of each extension
one-year period with written consent of Toray, which shall not be withheld
without reasonable reason.
b. Termination.
1. Product Development Delay. In the event that the Product development
schedule falls six months or more behind the schedule initially determined
under Section 4.b.1 by the Management Committee without a reasonable
justification, then Toray may terminate this Agreement as provided in Section
4.b.1.
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2. Infringement. UT may terminate this Agreement if a court of competent
jurisdiction from which no further appeal can be taken has entered a final
order indicating that the Licensed Technology infringes the rights of a Third
Party.
3. Default. If a party materially defaults in its performance of any of
its material obligations under this Agreement, and such default is not cured
within sixty (60) days of written notice of such default by the other party,
this Agreement may be terminated at the end of such 60-day period by the party
not in default by written notice of termination to the defaulting party, such
written notice to be given not later than seventy-five (75) days after the
first written notice. Termination under this provision does not limit any
remedies for breach.
4. Bankruptcy. In the event of the institution by or against either party
of insolvency, receivership or bankruptcy proceedings or any other proceedings
for the settlement of a party's debts which are not dismissed within sixty (60)
days, or upon a party's making an assignment for the benefit of creditors, or
upon a party's dissolution or ceasing to do business, the other party may
terminate this Agreement upon written notice.
5. Mergers and Acquisitions ("M&A") If M&A is anticipated, in which UT
merges a Third Party company or is merged by a Third Party company, or acquires
more than 50% of the shares of a Third Party company or more than 50% of the
shares of UT is acquired by a Third Party ("M&A"), and if such M&A is
anticipated to affect badly the development and marketing of the Product, then
UT agrees that, in order to minimize the inconvenience of Toray caused by such
M&A, UT shall promptly inform Toray thereof and in good faith endeavor to agree
with Toray about how to continue the development and marketing of the Product.
If UT and Toray can not reach an agreement about how to continue the
development and marketing of the Product according to this Agreement, then
Toray has a right to terminate this Agreement. For the purposes of this Section
10.b.5, "to affect badly the development and marketing of the Product" means
"to result in UT actually missing a milestone date in this Agreement, or
failing to achieve a minimum Net Sales specified in this Agreement".
Furthermore, if the M&A is reasonably expected to result in access to any
information defined in Section 9 by a Third Party with very competitive
products or pipelines to the Product Beraprost), then, prior to the M&A, UT
shall reach agreement with Toray on how to prevent such access to any
Information. No such M&A shall be completed until reasonable measures are in
place to prevent access to Information as a result of any M&A by any Third
Party with very competitive products or pipelines to the Product (Beraprost).
c. Continuing Obligations. Upon expiration or termination of this
Agreement with respect to all countries within the Territory, the rights and
obligations of the parties shall cease, except as follows.
1 the rights and obligations of the Parties under Section 8 shall
survive termination or expiration,
2. upon expiration or termination for any reason, the obligations of
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confidentiality and use of Information under Section 9 shall survive for the
period provided therein; and
3. expiration or termination of this Agreement shall not relieve the
parties of any other obligation accruing prior to such termination.
d. Outstanding Inventory. Only upon termination of this Agreement caused
by the reason not attributable to UT, UT shall have the right and option to
sell any completed inventory of Product, as if licensed under this Agreement,
which remains on hand as of thc date of the termination, so long as UT pays to
Toray as required under this Agreement.
11. General.
a, Entire Agreement. This Agreement constitutes the entire agreement
and understanding relating to the subject matter of this Agreement and
supersedes all previous communications, proposals, representations and
agreements, whether oral or written relating to the subject matter of this
Agreement.
b. Assignment. This Agreement is personal to UT and neither this
Agreement nor any particular rights or obligations under this Agreement may be
assigned or otherwise transferred by UT without the prior written consent of
Toray. Any purported assignment in violation of the preceding sentence shall be
void and shall constitute a material default of this Agreement.
c. Force Majeure. A party shall not be held liable or responsible to
another party nor be deemed to have defaulted under or breached this Agreement
for failure or delay in fulfilling or performing any term of this Agreement
when such failure or delay is caused by or results from fires, floods,
embargoes, government regulations, prohibitions or interventions, wars, acts of
war (whether war be declared or not), insurrections, riots, civil commotion's,
strikes, lockouts, acts of God, or any other cause beyond the reasonable
control of the affected party.
d. Notices. Any notice required or permitted to be given under this
Agreement shall be in writing and shall be deemed to have been sufficiently
given for all purposes if personally delivered or mailed by first class
certified or registered mail, postage prepaid, hand delivered, or sent by
telecopy or by reputable overnight courier service which requires signature
upon delivery. Notices sent by U.S. mail shall be deemed delivered three days
after deposit with postal authorities or upon confirmed delivery if personally
delivered, sent by confirmed fax or courier service. Unless otherwise
specified in writing, the mailing addresses of the Parties shall be as
described below:
For UT: United Therapeutics Corporation
68 X.X. Xxxxxxxxx Drive
P0 Box 14186
Research Xxxxxxxx Xxxx, XX 00000, XXX
Attention; Xx. Xxxxxx Xxxxxxxx, Ph.D.
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Fax Number: 000-000-0000
For Toray: Toray Industries, Inc.
0-0,Xxxxxxxxxx-Xxxxxxxxx 0-xxxxx, Xxxx-xx, Xxxxx 000-0000, XXXXX
Attention: Dr. Masanobu Naruto, Ph.D.
Pharmaceuticals Planning Department.
Fax Number: 00-0-0000-0000
e. Amendment and Waiver. This Agreement may be modified, amended and
supplemented only by written agreement signed by the parties. The waiver by
any party to this Agreement of any breach or violation of any provision of this
Agreement by the other party shall not operate or be construed to be a waiver
of any subsequent breach or violation of the same or any other provision of
this Agreement,
f. Governing Law. This Agreement shall be governed by and construed in
accordance with the laws of the State of New York applicable to contracts
between residents of New York which are wholly executed and performed in New
York, except that questions affecting the validity, construction and effect of
any patent shall be determined by the laws of the country in which the patent
was granted.
g. Arbitration All claims, controversies, disputes or differences
arising between Toray and UT in connection with, arising from, or with respect
to this Agreement, which shall not be resolved within thirty (30) days after
either party notify the other in writing of such claim, controversy, dispute or
difference, shall be submitted for arbitration to the American Arbitration
Association on demand of Toray and shall be submitted for arbitration to the
Japan Commercial Arbitration Association on demand of UT. Such arbitration
proceedings shall be conducted in Washington D.C., USA in accordance with the
then current Commercial Arbitration Rules of the American Arbitration
Association if initiated by Toray and shall be conducted in Tokyo, Japan in
accordance with the then current Commercial Arbitration Rules of the Japan
Commercial Arbitration Association if initiated by UT. The award and decision
of the arbitrator(s) shall be conclusive and binding upon all parties hereto
and judgment upon the award may be entered into any court of general
jurisdiction. This Agreement to arbitrate shall continue in full force and
effect subsequent to and notwithstanding the expiration or termination of this
Agreement.
h. Partial Invalidity. If any provision of this Agreement is found to be
invalid, illegal, or otherwise unenforceable, then the remaining provisions
shall nevertheless remain in full force and effect and shall not be affected by
the modification of striking of the involved or unenforceable provision. The
parties agree to renegotiate in good faith any term held invalid and be bound
by the mutually agreed substitute provision.
j. Independent Contractors. The relationship between Toray and UT is that
of independent contractors. Neither party has any actual or apparent
authority, express or implied, to act on behalf of the other party or to bind
the other party to any obligations. Neither party shall be deemed to be an
agent or servant of the other party or a partner or venturer with the other
party.
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IN WITNESS WHEREOF, this Agreement is executed and effective as of the date
first above written.
TORAY INDUSTRIES, INC. UNITED THERAPEUTICS CORPORATION
/s/ Kiyoteru Wakasugi /s/ Xxxxxxx Xxxxxxxxx
----------------------- ----------------------
By: Kiyoteru Wakasugi By: Xxxxxxx Xxxxxxxxx
Managing Director of the Board Chief Executive Officer
Date: Sept. 16, 1998 Date: Sept. 24, 1998
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