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CONFIDENTIAL TREATMENT REQUESTED
FOR PORTIONS OF THIS DOCUMENT
EXHIBIT 10.14
EXCLUSIVE LICENSE AGREEMENT
This Exclusive License Agreement ("Agreement") is effective as of March
15, 1999 (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, Toray granted UT an exclusive license of patent rights,
trademark and know-how in order to develop, use and sell the Product within the
Territory for use in treatment of Pulmonary Vascular Disease, including
Pulmonary Hypertension, under the Exclusive License Agreement dated September
16, 1998 ("PH Agreement").
WHEREAS, UT also 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 for use in treatment of the Indication (as herein defined);
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.
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c. "FDA" means the United States Food and Drug Administration or any
successor entity.
d. "Indication" means Peripheral Vascular Disease.
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 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 refereed 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
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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 1.k,
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.
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.
q. "IND" means Investigational New Drug.
r. "Other Product" means non-immediate release formulation
(including, but not limited to, oral and dermal) of TRK-100 (Beraprost Sodium).
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 infringed by reason of UT exercise of rights under the
license granted to UT hereunder.
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c. Other Formulation UT and Toray understand that the FDA orphan drug
exclusivity of the Product for the Indication has no effect for Toray and
Toray's licensee to develop, manufacture, use, import, offer for sale and sell
the Other Product in the Territory. UT and Toray understand that all orphan drug
exclusivity are only for the same molecule, the same delivery and the same
pharmokinetics (i.e.generic of the Product).
In the event that Toray and Toray's licensee have any difficulties from
the laws, the regulations or the guidelines in the Territory to develop,
manufacture, use, import, offer for sale and sell the Other Product because of
UT's orphan drug exclusivity of the Product, then UT shall cooperate with Toray
to make possible for Toray and Toray's licensee to develop, manufacture, use,
import, offer for sale and sell the Other Product in the Territory.
3. CONSIDERATION FOR THE GRANT.
a. License Fees. In consideration for the exclusive license granted
to UT under this Agreement, UT shall, on the day on which UT concludes that all
the information related to the Indication is provided by Toray to UT for IND
filing, or on thirty (30) days after the effective date of this Agreement,
whichever comes earlier:
1. pay to Toray a non-refundable license fee of $100,000; and
2. deliver to Toray a certificate representing [ ]
shares of UT common stock.
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.
3. UT shall pay to Toray a non-refundable milestone payment of
[ ] in cash and upon the date of first FDA approval of the Product.
c. Purchase of Product.
1. UT shall purchase commercial Product according to United
Statescurrent GMP solely from Toray during the term of this Agreement. UT shall
neither
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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 cGMP 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 "The Amount" per 120 micrograms determined by using the following formula
and (2) is [ ] per 120 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 converted 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 of over [ ] of the Net
Sales or 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.
In the event the Product for both Pulmonary Vascular Disease and
the Indication is approved, the price of the Product for Pulmonary Vascular
Disease is calculated according to the above formulation and Net Sales includes
Net Sales of the Product for Pulmonary Vascular Disease. In such case, the
provision of the Section 3. c. 2. of PH Agreement shall not be applied. 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.
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
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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.
4. Payment for Product shall be made in Dollars by UT in
accordance with the terms and conditions as designated by the mutual agreement
of UT and Toray.
d. Minimum Annual Product Net Sales. UT shall be reponsible 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 Sales 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 non-competition shall only extend for six months
after the date the failure was demonstrated.
4. DEVELOPMENT AND COMMERCIALIZATION PROGRAM.
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
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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
------ ----
Orphan-IND (US) [ ]
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 timethe 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 outside the Territory
free of charge. In the event that Toray grants the right to use such information
to a Third Party except Yamanouchi Parmaceutical Co.,LTD. and
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Kaken Parmaceutical Co.,LTD. outside the Territory or uses such information
itself and grants the right to use such Information to a Third Party 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 full sales year, then the Management Committee shall have the right, after
full 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 Indication 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
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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.
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 afforney'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 for a period
of seven (7) years thereafter:
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."
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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) 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 Party") 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.
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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.
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)."
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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 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 the 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 commotions,
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
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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
PO Box 14186
Research Xxxxxxxx Xxxx, XX 00000, XXX
Attention: Xx. Xxxxxx Xxxxxxxx, Ph.D.
Fax Number: 000-000-0000
For Toray: Toray Industries, Inc.
2-1, 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
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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.
i. 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.
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 Xxxxxxx Xxxxxxxxx
Managing Director of the Board Chief Executive Officer
Date: March 15, 1999 Date: March 15, 1999
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