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CONFIDENTIAL TREATMENT REQUESTED
FOR PORTIONS OF THIS DOCUMENT
EXHIBIT 10.13
EXCLUSIVE LICENSE AND DISTIBUTION AGREEMENT
This Exclusive License and Distribution Agreement ("Agreement") is made and
entered into this 4th day of February, 1999, by and among Global Medical
Enterprises Ltd., a British Virgin Islands corporation ("GMEL/BVI"), Global
Medical Enterprises Ltd., LLC, a California limited liability company having a
principal place of business at 00000 Xxxxxxx Xxxxxxxxx, Xxxxx 000, Xxxxxx,
Xxxxxxxxxx 00000 (hereinafter referred to as "GMEL/LLC") and United Therapeutics
Corporation, a corporation organized and existing under the laws of the State of
Delaware having a principal place of business at 0000 Xxxxxx Xxxxxx, Xxxxxx
Xxxxxx, Xxxxxxxx 00000 (hereinafter referred to as "UT").
RECITALS
WHEREAS, GMEL/BVI has obtained an exclusive license from Pacific
Pharmaceutical Co., Ltd. (hereinafter referred to as "Pacific"), attached at
Appendix A and incorporated herein, to commercialize Ketotop, an advanced
medicinal patch with analgesic efficacy, described in Appendix B attached hereto
and incorporated herein, in certain parts of the world, including the Territory
(as defined hereinafter); and
WHEREAS, GMEL/BVI has assigned the United States rights under the Pacific
Agreement to GMEL/LLC under the Assignment and Assumption Agreement dated July
24, 1998, described in Appendix A and incorporated herein; and
WHEREAS, UT desires to obtain an exclusive license under both GMEL, BVI's
rights to Ketotop and GMEL/LLC's rights to Ketotop in order to obtain regulatory
approvals, market and distribute Ketotop in the Territory for all indications.
NOW, THEREFORE, in consideration of the foregoing promises and the mutual
covenants herein contained, and for other good and valuable consideration, the
receipt of which is hereby acknowledged, the parties agree as follows:
ARTICLE 1
DEFINITIONS
For purposes of this Agreement, the terms defined in this Article 1 shall
have the respective meanings set forth below:
1.1 "Affiliate" shall mean, with respect to any Person, any other Person
which controls, is controlled by, or is under common control with, such Person.
A Person shall be regarded as in control of another Person if it owns, or
controls, at least fifty percent (50%) of the voting stock or other ownership
interest of the other Person, or if it posesses the power to direct or cause the
direction of the management and policies of the other Person by any means
whatsoever.
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1.2 "cGMP" means the United Stated Food and Drug Administration "current
Good Manufacturing Practices" as defined in 21 C.F.R parts 210-211.
1.3 "Dollars" or "$" means United States dollars.
1.4 "Effective Date" means the date appearing at the beginning of this
Agreement.
1.5 "FDA" means the United States Food and Drug Administration or any
successor entity.
1.6 "Field" shall mean the treatment of all indications for which the
Product (as defined hereinafter) offers therapeutic effectiveness.
1.7 "First Commercial Sale" shall mean, with respect to any Product, the
first sale for use or consumption by the general public of such Product. A
transfer of the Product by UT or its permitted sublicensees solely for the
purpose of directly enabling UT and its permitted sublicensees to obtain
approval of an NDA by the FDA (or similar approvals from the governing health
authority of any other country within the Territory) shall not be considered a
First Commercial Sale.
1.8 "GMEL" shall mean both GMEL/BVI and GMEL/LLC, to the extent of their
respective interests in the subject matter hereof, unless otherwise indicated
herein.
1.9 "IND" means an Investigational New Drug application or its equivalent
successor application.
1.10 "NDA" means a New Drug Application or any equivalent successor
application.
1.11 "Person" shall mean an individual, corporation, partnership, trust,
business trust, association, joint stock company, joint venture, pool,
syndicate, sole proprietorship, unincorporated organization, governmental
authority, or any other form of entity not specifically listed herein.
1.12 "Product" shall mean "Ketotop", an advanced medicinal patch with
analgesic efficacy as described in the attached Appendix B incorporated herein,
and any derivatives, successors, improvements, modifications, variations,
revisions thereof to which GMEL has the right to distribute pursuant to its
agreement with Pacific.
1.13 "Registration" shall mean, in relation to any Product, such approvals
by government authorities as may be legally required before such Product may be
commercialized.
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1.14 "Territory" unless otherwise indicated herein shall mean (i) the
United States of America, its territories and possessions under the grant from
GMEL, LLC, together with (ii) Canada, Mexico, Central America (Belize, Costa
Rica, El Salvador, Guatemala, Honduras, Nicaragua and Panama) and the Caribbean
nations under the grant from GMEL, BVI.
1.15 "Third Party" shall mean any Person other than GMEL and its Affiliates
and UT and its Affiliates and permitted sublicensees.
ARTICLE 2
REPRESENTATIONS AND WARRANTIES
2.1 By Both Parties. Each party represents and warrants to the other that
it has the full right to enter into this Agreement, this Agreement constitutes
its legal, valid and binding obligation, and that, to the best of its knowledge,
there are no agreements, commitments or obstacles, technical or legal, including
patent rights of others, which could prevent it from carrying out all of its
obligations hereunder, including, in the case of GMEL, its grant to UT of the
license described in Section 3.1 below.
2.2 By GMEL. GMEL represents and warrants to UT that:
2.2.1 GMEL has the sole and exclusive right to distribute the Product
within the Territory.
2.2.2 As of the Effective Date, to the best of GMEL's knowledge, there
are no (i) pending or threatened claims or litigation brought by a Third Party
under any Third Party patent, trade secret or other Third Party proprietary
right in respect of GMEL's distribution of the Product or as a result of
Pacific's manufacture or distribution of the Product, (ii) basis upon which sale
of the Product under this Agreement would infringe on the rights of Third
Parties; or (iii) licenses or other restrictions on the ability to usesell or
otherwise distribute the Product.
2.2.3 GMEL has made or will make available to UT all material technical
information in its possession or of which it is aware that is pertinent to
development, regulatory approval and commercialization of the Product and GMEL
shall use its best efforts to ensure that Pacific will assist GMEL in achieving
GMEL's obligations hereunder.
2.2.4 The price that GMEL pays to Pacific for Products under Article V
of this Agreement shall be the true and accurate price reflecting all refunds,
rebates, discounts, offsets and any other consideration of any kind paid or
transferred by or on behalf of Pacific to GMEL or at GMEL's direction. In the
event that any such compensation has been paid or transferred to or at GMEL's
direction, GMEL shall promptly notify UT in order to adjust payments UT has made
or will make pursuant to Article V of this Agreement.
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2.3 By UT. UT warrants to GMEL that it will use its best efforts to
develop, seek regulatory approval, commercialize and market Products within the
Territory for one or more indications within the Field and that UT is adequately
capitalized to undertake the obligations under this Agreement.
ARTICLE 3
GRANT
3.1 Grant. GMEL hereby grants to UT and its Affiliates an exclusive license
and exclusive distributorship (with the right to grant sublicenses and
subdistributorships as set forth in Section 3.2 below) to use, import, offer for
sale and sell Products in the Territory for use in the Field. Notwithstanding
anything to the contrary herein, UT shall not have the right to manufacture or
have others manufacture the Product.
3.2 Sublicenses and Subdistributorships. Subject to GMEL's prior written
consent, which consent shall not be unreasonably withheld or delayed, UT may
grant sublicenses and subdistributorships under the grant in Section 3.1 above
to any Third Party or Affiliate. UT shall deliver a copy of each sublicense and
subdistributorship under this Agreement to GMEL promptly after execution of the
same. Each sublicensee and subdistributor shall be subject to the terms and
conditions of this Agreement.
ARTICLE 4
DEVELOPMENT AND COMMERCIALIZATION PROGRAM
4.1 Development and Commercialization by UT.
4.1.1 Development Program. Subject to the satisfactory performance of
GMEL's obligations under Section 4.3 below, UT shall, at its sole expense, use
its best efforts to conduct research, development and clinical trials to obtain
the necessary regulatory approvals to import, market and commercialize such
Products as UT determines are commercially feasible for at least one indication,
and diligently obtain necessary approvals to commence marketing and market one
or more Products in the United States and Canada and such other countries of the
Territory as UT determines are commercially feasible (hereinafter the
"Development Program").
4.1.2 Development Milestones. The Development Program shall achieve the
following key milestones in the United States:
IND Submission by [ ]
NDA Submission by [ ]
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NDA Approval by [ ]
In the event that UT is unable to meet any of the above key milestones, GMEL
may, in its sole discretion, terminate this Agreement; provided, however, that
UT's inability to meet any key milestone is not the result of (i) the imposition
by a governmental regulatory agency of a material restriction on UT's Product
regulatory approval activities under this Agreement, which restriction has
delayed or prevented the Development Program, (ii) the requirement of a
governmental regulatory agency that UT materially change the Development Program
and timeline, (iii) negative or equivocal study results which necessitate a
material and significant change in the Development Program and timeline, which
change has delayed the Development Program, or (iv) delays in the performance of
GMEL's obligations under Section 4.3 below. In the event that UT's inability to
meet any key milestone is the result of (i) - (iii) above, then in such event,
GMEL and UT shall reasonably extend the key milestones accordingly. In the event
that UT's inability to meet any key milestone is the result of (iv) above, then
in such event, the above milestone dates shall be extended by a day for each day
of delay.
4.1.3 Regulatory Efforts. UT shall have the final authority to make all
clinical and regulatory decisions in its sole and reasonable discretion and UT
shall solely and exclusively own all regulatory applications, approvals and
clinical data obtained by UT with respect to Products. Notwithstanding the
foregoing, UT shall closely consult with GMEL with regard to its participation
in important clinical development meetings.
4.1.4 Marketing and Distribution. Subject to GMEL's prior written
consent, which consent shall not be unreasonably withheld or delayed, UT may
contract with a drug marketing organization that has demonstrated competence and
ability, based on sales in excess of $25 million annually for similar products,
to market and distribute Products throughout the Territory.
4.1.5 Records. UT shall maintain records, in sufficient detail and in
good scientific manner, which shall reflect all work done and results achieved
in the performance of its research and development regarding the Products
(including all data in the form required under all applicable laws and
regulations.)
4.1.6 Reports. So long as UT is engaged in the Development Program, UT
will provide semi-annual reports to GMEL within sixty (60) days following the
end of every two calendar quarters, summarizing in reasonable detail UT's
activities related to the development of a Product and securing of the requisite
marketing approvals during the period covered by such report. In addition, UT
shall provide GMEL with written notice of all regulatory filings and submissions
prior to the date of such submissions, and written notice of all approvals
obtained promptly after obtaining such approvals. UT shall keep GMEL reasonably
apprised of all written information or feedback provided by regulatory
authorities to UT during the term of this Agreement.
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4.1.7 Compliance with Laws. UT shall comply with all applicable
international, national, state, regional and local laws and regulations in
performing its duties hereunder and in any of its dealings with respect to the
Product.
4.1.8 Costs. Any and all costs associated with the clinical
development, regulatory approval, and commercialization of the Product shall be
borne solely by UT.
4.2 Advisory Committee.
4.2.1 Composition of the Advisory Committee. The Advisory Committee
shall be comprised of two representatives of GMEL and two representatives of UT.
The initial representatives for GMEL shall be Xxx Xxx and Xx. Xxxxxx Xxxxxxx.
The initial representatives for UT shall be Xxxxxxx Xxxxxxxxx and Xx. Xxxxxx
Xxxxxxxx. Each party may substitute one or more of its representatives, in its
sole dicretion, effective upon agreement of the other party of such change, such
agreement not to be unreasonably withheld or delayed.
4.2.2 Meetings. The Advisory Committee shall meet not less than twice
each year during the term of this Agreement on such dates and at such time and
places as agreed to by the parties, alternating between GMEL's principal offices
and UT's principal offices, or such other locations as the parties shall agree,
unless both parties mutually determine that a meeting should not take place. At
such meetings, the Advisory Committee shall discuss UT's research and
prospective development and commercialization efforts under this Agreement, UT's
requirements from GMEL and Pacific, any actual regulatory filings regarding
Products together with any anticipated regulatory filings with respect to
possible products, pricing of Product both to UT and to patients, UT's fiscal
status, patent filings, and, in general, shall coordinate the development and
marketing of Products. The Advisory Committee shall also review on an ongoing
basis the viability and economic expectations of the commercialization effort in
countries within the Territory. Each party shall bear its own expenses in
connection with travel and attendance at such meetings.
4.3 GMEL Obligations.
4.3.1 Clinical Supplies. GMEL, at its sole expense, shall be
responsible for providing UT with an adequate and timely supply of the Products
for use during clinical trials.
4.3.2 Information. GMEL, at its sole expense, shall be responsible for
the timely delivery to UT of all pre-clinical information available to GMEL and
reasonably necessary to support UT's preparation and filing of an IND with the
FDA including, but not limited to, information relating to acute toxicity and
repeat-dose toxicity, and the translation into English of summaries of all
foreign language reports. In addition, GMEL shall provide UT on a timely basis
and without charge all information concerning the Product which is available to
GMEL and which is reasonably required by UT to fulfill its obligations under
this Agreement, including but not limited to, information, compilations,
analyses, reports,
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studies, data, copies of regulatory filings and proceedings which GMEL and
Pacific have developed or acquired which may be related to the licensed rights
and which concerns or relates to preclinical and clinical research, safety, use,
efficacy, and copies of findings or reports which are required by the FDA or
similar regulatory agencies.
4.3.3 Cooperation. GMEL shall, upon the request by UT, provide UT with
reasonable assistance and consultation regarding the Product, including
reasonable access to sample materials and data. GMEL shall ensure the
cooperation of Pacific with the FDA's normal and customary requirements for the
approval of drugs such as Ketotop.
4.3.4 cGMP Requirements. GMEL shall exercise its best efforts to ensure
that Pacific provides a manufacturing process and facility for the Licensed
Products that complies with United States cGMP requirements during the term of
this Agreement.
4.4 Registration of License. UT may, at its expense, register the exclusive
license granted under this Agreement in any country, or community or association
of countries, where the use, sale or manufacture of a Product in such country
would be covered by a Valid Patent Claim. Upon request of UT, GMEL agrees
promptly to execute any "short form" licenses in a form submitted to it by UT
from time to time in order to effect the foregoing registration in such country.
ARTICLE 5
PAYMENTS TO GMEL
5.1 Purchase of Product.
5.1.1 Exclusive Source. In partial consideration for the exclusive
license granted to UT herein, UT shall purchase U.S. cGMP commercial Product
solely from GMEL during the term of this Agreement following the First
Commercial Sale of Product by UT, its Affiliates or permitted sublicensees. UT
shall neither manufacture Product nor purchase Product from a Third Party
without the prior written consent of GMEL. GMEL shall be responsible for the
timely delivery to UT of the amount of U.S. cGMP Product that UT reasonably
requires from time to time during the term of this Agreement. UT shall notify
GMEL in writing promptly upon the First Commercial Sale of a Product by UT, its
Affiliates or its sublicensees in each country of the Territory.
5.1.2 Purchase by UT.
5.1.2.1 Purchase. In further consideration of the exclusive
license granted herein and the performance of GMEL's obligations under Section
4.3 above, and following the First Commercial Sale of Product by UT, its
Affiliates or permitted sublicensees, GMEL shall timely deliver to UT such
amounts of cGMP commercial Product ordered by UT which GMEL will obtain from
Pacific pursuant to the pricing schedule
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issued by Pacific to GMEL attached at Appendix C to this Agreement and
incorporated herein (the "Pacific Price").
5.1.2.2 Pricing.
5.1.2.2.1 United States. UT shall purchase from GMEL/ LLC
Products for distribution within the United States of America, its territories
and possessions, at a [ ] xxxx-up over the Pacific Price for all prescription
sales and at a [ ] xxxx-up over the Pacific Price for all Over the Counter (OTC)
sales.
5.1.2.2.2 Canada. UT shall purchase from GMEL/BVI Products for
distribution within Canada at a [ ] xxxx-up over the Pacific Price for all
prescription sales and at a [ ] xxxx-up over the Pacific PRICE for all Over the
Counter (OTC) sales.
5.1.2.2.3 Other Countries. For all countries in the Territory
other than the United States, its territories and possessions, and Canada, the
Advisory Committee shall determine the terms upon which UT and GMEL/BVI shall
form a joint venture to commercialize Products in each country of the Territory,
recognizing that the spirit is to consider the parties as equal venturers. In
determining the terms of each such joint venture, including without limitation
provisions relating to the payment of expenses of the venture (including the
cost of Products purchased from Pacific) and the calculation and division of
profits, the Advisory Committee shall take into account relevant market and
financial information relating to the commercialization of comparable products
in each country.
5.1.2.3 Pricing Stability. The Pacific Price in Appendix C shall
be the base price upon which the above escalating cost of Products purchased by
UT will be calculated. Notwithstanding the foregoing, the Pacific Price shall be
adjusted on each anniversary of the NDA Approval based upon an actual, direct
and verifiable increase or decrease in Pacific's cost of goods sold for Products
sold to GMEL in the preceding annual period. GMEL shall exercise its best
efforts to negotiate with Pacific such annual price adjustments so that the
maximum increase or decrease in the adjusted Pacific Cost in any annual
adjustment shall not exceed (i) [ ] above or below the Pacific Price set for the
preceding annual period (the "Annual Cap") and (ii) the total of all annual
adjustments to the Pacific Price shall not exceed a [ ] increase over the term
of this Agreement (the "Term Cap"). The parties shall closely consult with each
other and Pacific and review relevant documentation to ensure that each annual
adjustment of the Pacific Price is fair and reasonable given the underlying
costs of goods, currency fluctuations, and other variables in pricing imported
pharmaceuticals.
5.1.3 Shipping. All Products shall be shipped by GMEL F.O.B. GMEL's
point of shipment. UT shall be responsible for and shall pay any sales, use,
excise or other taxes directly relating to the importation and transfer of
Products (excluding income taxes
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and similar for which GMEL shall be solely responsible) imposed by the laws of
any jurisdiction on GMEL's sale of Products to UT.
5.2 Pricing Adjustment. Notwithstanding any other provision of this
Agreement to the contrary, in the event that UT determines, after discussion
with GMEL, that
(i) it or they are required to pay royalties to any Third Party because
the development, use or sale of the Product infringes any patent or other
intellectual property rights of such Third Party in the Territory; or
(ii) the development, use or sale of the Products in any country in the
Territory no longer infringes a valid patent claim or any period of orphan drug
or other exclusivity granted by the FDA or other government agency with respect
to any Product; or
(iii) a compulsory license to manufacture and/or distribute Products
has been granted to a Third Party under the applicable laws of any country in
the Territory; or
(iv) the price for Product under Section 5.1.2 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 GMEL shall meet and in good faith endeavor to
agree on an appropriate and reasonable reduction in the pricing of the Product
under Section 5.1.2.2 in order to place UT in a position to market competitively
the Product in such country.
5.3 Payment.
5.3.1 United States and Canada. Payment for Products to GMEL/ LLC under
Section 5.1.2.2.1 above and payment for Products to GMEL/BVI under Section
5.1.2.2.2 above shall be made in Dollars by irrevocable 30-day sight letter of
credit confirmed by a first class international bank following the date of
delivery of Products to UT or at UT's request. All such payments shall be free
of set-off, counter-claims or any taxes imposed by the laws of any jurisdiction
and shall be made in accordance with written instructions from GMEL.
5.3.2 Other Countries. Payment for Products to GMEL/BVI under Section
5.1.2.2.3 above shall be made in such manner as determined by the Advisory
Committee.
5.4 Exchange Control. If at any time legal restrictions prevent the prompt
remittance of part or all royalties with respect to any country where the
Product is sold, payment shall be made through such lawful means or methods as
UT reasonably shall determine.
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ARTICLE 6
PROHIBITED SALES AND ADDITIONAL RIGHTS
6.1 Prohibited Sales. UT shall not sell, directly or indirectly, any of the
Products outside the Territory or sell any of the Products to any Person whom UT
knows, or reasonably should know, will resell the Products outside the Territory
or who will ship the Products from the Territory.
6.2 Third Party Distribution. To the extent that GMEL has the right to
distribute Products in any countries outside of the Territory as of the date
hereof, UT may present to GMEL potential Third Parties which are qualified to
distribute Products in any such country. Upon the presentation by UT of a
detailed proposal identifying a qualified Third Party distributor, reasonably
acceptable to GMEL, with whom UT desires to partner to distribute Products in
countries outside of the Territory, GMEL and UT shall negotiate in good faith to
extend the Territory to include such countries and Third Party distributors.
6.3 Right of First Refusal. Notwithstanding anything in this Agreement to
the contrary, in the event that, subsequent to the date hereof, GMEL shall
acquire from Pacific the right to distribute the Product in any countries
outside of the Territory and shall decide to license any aspect of the
commercialization of the Product in any such country to a Third Party, GMEL
shall give UT an exclusive option and right of first refusal to negotiate a
license agreement covering such matters with UT; provided, however, that such
option and right shall not be granted in cases where Pacific requires GMEL to
license to a particular Third Party other than UT or its Affiliates. UT shall
have sixty (60) days from receipt of written notice from GMEL of its intent to
enter into a license agreement, which notice shall describe in reasonable detail
the material terms of any proposed license to a Third Party, to deliver its
decision as to whether it shall exercise such option and right. Upon GMEL's
receipt of written notice from UT of its desire to enter into negotiations, the
parties shall have one hundred twenty (120) days, or such longer period as the
parties shall mutually agree (the "Negotiation Period"), to negotiate in good
faith and enter into a definitive license agreement. The terms of such agreement
shall be commercially reasonable under the circumstances then in existence. In
the event that UT shall decline to exercise its option or right hereunder or the
parties fail in good faith to enter into a license agreement prior to the
expiration of the Negotiation Period, GMEL shall be free to enter into a license
agreement covering the same matters with a Third Party, provided, however that
the material terms of any such agreement shall be no more favorable than the
terms offered to UT.
6.4 Medicinal Patch. To the extent that GMEL has rights in and to the use
of the medical patch other than in connection with the delivery of ketoprofen,
UT shall have the right to present to GMEL proposals it develops for the use of
such patch for the delivery of other drugs and for other indications. Upon the
presentation by UT of a detailed proposal identifying a proposed drug and
indication(s), GMEL and UT shall negotiate in good faith to exclusively license
the medicinal patch for such other drugs and indications.
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ARTICLE 7
CONFIDENTIALITY
7.1 Confidential Information. During the term of this Agreement, and for a
period of five (5) years following the expiration or earlier termination hereof,
each party shall maintain in confidence all information of the other party
(including samples) disclosed by the other party and identified as, or
acknowledged to be, confidential (the "Confidential Information"), and shall not
use, disclose or grant the use of the Confidential Information except on a
need-to-know basis to those directors, officers, affiliates, employees,
permitted licensees, permitted assignees and agents, consultants, lawyers,
bankers, clinical investigators or contractors, to the extent such disclosure is
reasonably necessary in connection with such party's activities as expressly
authorized by this Agreement. To the extent that disclosure is authorized by
this Agreement, prior to disclosure, each party hereto shall obtain agreement of
any such Person to hold in confidence and not make use of the Confidential
Information for any purpose other than those permitted by this Agreement. Each
party shall notify the other promptly upon discovery of any unauthorized use or
disclosure of the other party's Confidential Information.
7.2 Permitted Disclosures. The confidentiality obligations contained in
Section 7.1 shall not apply to the extent that (i) any receiving party (the
"Recipient") is required (a) to disclose information by law, order, or
regulation of a government agency or a court of competent jurisdiction, or (b)
to disclose information to any governmental agency for purposes of obtaining
approval to test or market a product, provided in either case that the Recipient
shall provide written notice thereof to the other party and sufficient
opportunity to object to any such disclosure or to request confidential
treatment thereof; or (ii) the Recipient can demonstrate that (a) the disclosed
information was public knowledge at the time of such disclosure to the
Recipient, or thereafter became public knowledge, other than as a result of
action of the Recipient in violation hereof; (b) the disclosed information was
rightfully known by the Recipient (as shown by its written records) prior to the
date of disclosure to the Recipient by the other party hereunder; (c) the
disclosed information was disclosed to the Recipient on an unrestricted basis
from a source unrelated to any party to this Agreement and not under a duty of
confidentiality to the other party; or (d) the disclosed information was
independently developed by the Recipient without use of Confidential Information
disclosed by the other party.
7.3 Terms of this Agreement. Except as otherwise provided in Section 7.2
above and subject to either party's reporting obligations under applicable state
and federal laws, GMEL and UT shall not disclose any terms or conditions of this
Agreement (or GMEL's agreement with Pacific) to any Third Party without the
prior written consent of the other party. Notwithstanding the foregoing, GMEL
and UT shall agree upon the substance of information that can be used to
describe the terms of this transaction in a press release or other similar
publication, and UT and GMEL may disclose such information, as modified by
mutual agreement from time to time, without the other party's consent.
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7.4 Publication. From time to time it may be to the mutual interest of the
parties to publish articles relating to data generated or analyzed as a part of
this Agreement. Neither party shall submit for written or oral publication or
presentation any manuscript, abstract, writing, printed material or the like
which includes data or any other information generated and provided solely by
the other party without first obtaining the prior written consent of the other
party, which consent shall not be unreasonably withheld or delayed, provided
however, that valid commercial reasons may exist for withholding such consent.
Nothing contained herein shall be construed as precluding either party from
making, in its discretion, any disclosures of information of any type which
relate to the safety, efficacy, toxicology, or pharmacokinetic characteristics
of the Products to the extent that either party may be required by law to make
disclosures of such information.
ARTICLE 8
INTELLECTUAL PROPERTY RIGHTS
8.1 Trademarks.
8.1.1 Ownership. UT acknowledges that Pacific owns the "Ketotop"
trademarks and all goodwill associated with or symbolized by the trademarks and
that GMEL has been granted the right to use Pacific's trademarks solely in
connection with the distribution, sale and promotion of the Product in the
Territory. GMEL hereby grants to UT a royalty-free license to use the trademarks
free of charge in connection with the regulatory approval process, distribution,
sale and promotion of the Products in the Territory during the terms of this
Agreement. Upon expiration or earlier termination of this Agreement, UT shall
cease using the trademarks and shall remove all references to said xxxx from its
stationary, advertising and all other property in its possession or control and
shall cease using said xxxx in any other manner, other than in connection with
the disposition of outstanding inventory under Section 10.5 below.
8.1.2 Registration. Unless otherwise agreed to by the parties, UT shall
be responsible for taking all necessary action to register and maintain
trademark protection for Ketotop trademarks in Pacific's name within all
countries in the Territory at UT's sole expense. UT shall use its best efforts
to provide GMEL with written notice of (i) all trademark filings and submissions
in countries within the Territory prior to the date of such submissions, and
(ii) all approvals obtained promptly after obtaining such approvals. UT shall
keep GMEL reasonably apprised of all written information or feedback provided by
trademark authorities to GMEL during the term of this Agreement.
8.2 Patents. GMEL and/or Pacific will be responsible for taking all
necessary action to maintain and/or extend patent registrations relating to
Products in the Territory. UT will render reasonable assistance to GMEL in this
effort. GMEL shall use its best eforts to provide UT with written notice of (i)
all patent filings and submissions in countries within the Territory prior to
the date of such submissions, and (ii) all approvals obtained promptly after
obtaining such approvals. GMEL shall keep UT reasonably apprised of all written
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information or feedback provided by patent authorities to GMEL during the term
of this Agreement.
ARTICLE 9
INDEMNIFICATION
9.1 Indemnity.
9.1.1 By GMEL. GMEL shall indemnify and hold UT and its directors,
officers, employees and agents harmless, and hereby forever releases and
discharges UT, from and against all losses, liabilities, damages and expenses
(including reasonable attorney's fees and costs) resulting from all claims,
demands, actions and other proceedings by any Third Party to the extent arising
from (i) the breach of any representation, warranty or covenant of GMEL under
this Agreement or (ii) the gross negligence or willful misconduct of GMEL in the
performance of its obligations and its permitted activities under this
Agreement.
9.1.2 By UT. UT shall indemnify and hold GMEL and its trustees,
directors, officers, employees and agents harmless, and hereby forever releases
and discharges GMEL, from and against all losses, liabilities, damages and
expenses (including reasonable attorney's fees and costs) resulting from all
claims, demands, actions and other proceedings by any Third Party to the extent
arising from (i) the breach of any representation, warranty or covenant of UT
under this Agreement, (ii) the research, development, commercialization or
marketing of Products (without regard to culpable conduct), or (iii) the gross
negligence or willful misconduct of UT or its Affiliates or permitted
sublicensees in the performance of its or their obligations and its or their
permitted activities under this Agreement.
9.2 Procedure. A party (the "Indemnitee") that intends to claim
indemnification under this Article 9 shall promptly notify the other party (the
"Indemnitor") in writing of any claim, demand, action or other proceeding for
which the Indemnitee intends to claim such indemnification. The Indemnitor shall
have the right to participate in, and to the extent the Indemnitor so desires
jointly with any other Indemnitor similarly noticed, to assume the defense
thereof with counsel selected by the Indemnitor; provided, however, that the
Indemnitee shall have the right to retain its own counsel, with the fees and
expenses to be paid by the Indemnitor, if representation of the Indemnitee by
the counsel retained by the Indemnitor would be inappropriate due to actual or
potential differing interests between the Indemnitee and any other party
represented by such counsel in such proceedings. The indemnity obligations under
this Article 9 shall not apply to amounts paid in settlement of any claim,
demand, action or other proceeding if such settlement is effected without the
prior express written consent of the Indemnitor, which consent shall not be
unreasonably withheld or delayed. The failure to deliver notice to the
Indemnitor within a reasonable time after notice of any such claim or demand, or
the commencement of any such action or other proceeding, if prejudicial to its
ability to defend such claim, demand, action, or other
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proceeding, shall relieve such Indemnitor of any liability to the Indemnitee
under this Article 9 with respect thereto, but the omission to so deliver notice
to the Indemnitor shall not relieve it of any liability that it may have to the
Indemnitee otherwise than under this Article 9. The Indemnitor may not settle or
otherwise consent to an adverse judgment in any such claim, demand, action or
other proceeding, that diminishes the rights or interests of the Indemnitee
without the prior express written consent of the Indemnitee, which consent shall
not be unreasonably withheld or delayed. The Indemnitee, its employees and
agents, shall reasonably cooperate with the Indemnitor and its legal
representatives in the investigation of any claim, demand, action or proceeding
covered by this Article 9.
9.3 Insurance. UT, at its own expense, shall maintain comprehensive general
liability insurance, including product liability insurance, against claims
regarding the research, development, commercialization or marketing of the
Products under this Agreement. UT shall maintain such insurance for so long as
it continues to research, develop, commercialize, and market Products, and
thereafter for so long as it customarily maintains insurance for itself covering
similar activities with its other similar products. During the clinical
development of Products, such coverage shall be at least $2,000,000 per
occurrence. Promptly upon commercial introduction of the Product, the parties
shall negotiate in good faith the level to which UT shall increase such
insurance coverage.
ARTICLE 10
TERMINATION
10.1 Term and Expiration. Subject to the provisions of Sections 10.2, 10.3,
10.4 and Article 11 below, this Agreement shall become effective as of the
Effective Date and shall expire on July 23, 2008, unless earlier terminated
pursuant to the terms of this Agreement and to the terms of the Pacific
Agreement. In the event that GMEL is able to extend the term of its agreement
with Pacific which it will endeavor to do with its best efforts, GMEL shall
renew this Agreement on the same terms and conditions herein for such additional
period of time as Pacific grants to GMEL under its agreement with GMEL.
10.2 Termination for Cause.
10.2.1 Breach. Except as provided elsewhere in this Agreement, either
party may terminate this Agreement upon or after the breach of any material
provision of this Agreement by the other party if the other party has not cured
such breach within sixty (60) days after notice thereof by the non-breaching
party. In the event that this Agreement is terminated as the result of a
material breach by GMEL/BVI, then in such event, GMEL/BVI grants to UT the
exclusive right to all of GMEL/BVI's rights under the Pacific Agreement so that
UT may continue its commercialization efforts hereunder, provided however, that
UT shall be obligated to perform all corresponding obligations GMEL/BVI has
under the Pacific Agreement. In the event that this Agreement is terminated as
the result of a material breach by GMEL/LLC, then in such event, GMEL/LLC grants
to UT the exclusive right to all of GMEL/LLC's rights under its Assignment and
Assumption Agreement with
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GMEL/BVI so that UT may continue its commercialization efforts hereunder,
provided however, that UT shall be obligated to perform all corresponding
obligations GMEL/LLC has under its Assignment and Assumption Agreement with
GMEL/BVI.
10.2.2 Regulatory and Material Adverse Change. UT may terminate this
Agreement at its sole option upon thirty (30) days written notice to GMEL in the
event that in UT's commercially reasonable discretion either (i) the Product is
unlikely to achieve contemplated regulatory approval within the development
milestones provided under Section 4.1.2 above through no fault of UT, or (ii) a
material adverse change has occured in UT's financial expectations for its
return on investment in commericalizing the Product hereunder through no fault
of UT.
10.3 Bankruptcy. In the event of the institution by or against either party
of insolvency, receivership, 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.
10.4 Effect of Expiration or Termination. Expiration or termination of this
Agreement shall not relieve the parties of any obligation accruing prior to such
expiration or termination, and the provisions of Articles 7, 8, and 9 shall
survive the expiration or termination of this Agreement.
10.5 Outstanding Inventory. Upon any termination of this Agreement, 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 GMEL as required under this Agreement.
ARTICLE 11
FORCE MAJEURE
Neither party shall be held liable or responsible to the other 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 to the extent, and for so
long as, such failure or delay is caused by or results from causes beyond the
reasonable control of the affected party including but not limited to fire,
floods, embargoes, war, acts of war (whether war is declared or not),
insurrections, riots, civil commotions, strikes lockouts or other labor
disturbances, acts of God or acts, omissions or delays in acting by any
governmental authority or other party. When such circumstances arise, the
parties shall discuss what, if any modification of the terms of this Agreement
may be required to arrive at an equitable solution.
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ARTICLE 12
MISCELLANEOUS
12.1 Notices. Any consent, notice or report required or permitted to be
given under this Agreement by one of the parties hereto to the other party shall
be in writing, delivered personally or by facsimile (and promptly confirmed by
personal delivery, first class mail, or courier, postage prepaid where
applicable), addressed to such other party at its address indicated below, or to
such other address as the addressee shall have last furnished in writing to the
addressor and, except as otherwise provided in this Agreement, shall be
effective upon receipt by the addressee.
If to GMEL/BVI: Global Medical Enterprises, Ltd.
c/o Global Medical Enterprises, Ltd., LLC
00000 Xxxxxxx Xxxxxxxxx
Xxxxx 000
Xxxxxx, Xxxxxxxxxx 00000
Attention: Xxxxxx X. Xxxxxxx, M.D.
Phone Number: (000) 000-0000
Fax Number: (000) 000-0000
If to GMEL/LLC: Global Medical Enterprises, Ltd., LLC
00000 Xxxxxxx Xxxxxxxxx
Xxxxx 000
Xxxxxx, Xxxxxxxxxx 00000
Attention: Xxxxxx X. Xxxxxxx, M.D.
Phone Number: (000) 000-0000
Fax Number: (000) 000-0000
If to UT: United Therapeutics Corporation
0000 Xxxxxx Xxxxxx
Xxxxxx Xxxxxx, Xxxxxxxx 00000
Attention: Xxxxxx Xxxxxxxx, Ph.D.
Phone Number: (000) 000-0000
Fax Number: (000) 000-0000
12.2 Governing Law. This Agreement shall be governed by and construed in
accordance with the laws of the State of California, without regard to conflicts
of laws principles thereof, 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.
12.3 Assignment. Neither party may assign its rights and obligations under
this Agreement, in whole or in part, by operation of law or otherwise, without
the prior written consent of the other party, provided however, that either
party may, without such consent, assign this Agreement to a wholly-owned
subsidiary. Any purported assignment in violation of this Section 12.3 shall be
void. No assignment shall relieve either party of
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responsibility for the performance of any accrued obligation which the such
party then has hereunder.
12.4 Waivers and Amendments. No change, modification, extension,
termination or waiver of this Agreement, or any of the provisions herein
contained, shall be valid unless made in writing and signed by duly authorized
representatives of the parties.
12.5 Entire Agreement. This Agreement constitutes the entire understanding
between the parties and supersedes any prior understanding and agreements
between them respecting the subject matter hereof, including the Letter of
Agreement dated September 8, 1998 with respect North American Marketing Rights
in Ketotop, which is hereby terminated. There are no representations,
agreements, arrangements or understandings, oral or written, between the parties
relating to the subject matter of this Agreement which are not fully expressed
in this Agreement. This Agreement shall be binding upon, and inure to the
benefit of, the legal successors to the parties hereto.
12.6 Severability. If any provision of this Agreement is found to be
invalid or unenforceable in any jurisdiction, it shall be ineffective to the
extent of such invalidity or unenforeceability in such jurisdiction, without
rendering invalid or unenforceable the remaining provisions hereof and without
affecting the validity or unenforceability of any of the terms of this Agreement
in any other jurisdiction. The parties agree to renegotiate in good faith any
term held invalid and be bound by the mutually agreed substitute provision.
12.7 Waiver. The waiver by either party of any right hereunder or the
failure to perform or of a breach by the other party shall not be deemed a
waiver of any other right under this Agreement or of any other breach or failure
by said party whether of a similar nature or otherwise.
12.8 Construction. The parties have participated jointly in the negotiation
and drafting of this Agreement. In the event of an ambiguity or question of
intent or interpretation arises, this Agreement shall be construed as if drafted
jointly by the parties and no presumption or buden of proof shall arise favoring
or disfavoring any party by virtue of the authorship of any of the provisions of
this Agreement.
12.9 Settlement of Disputes.
12.9.1 All disputes arising between the parties in connection with this
Agreement shall be resolved exclusively by arbitration in Los Angeles,
California in accordance with the rules of the American Arbitration Association,
and judgment upon the award entered by the arbitrator(s) may be enetered in any
court having jurisdiction thereof.
12.9.2 If any arbital or judicial proceedings shall be commenced to
enforce this Agreement or any abitral award issued pursuant to this Section
12.9, the prevailing party in such proceedings shall be entitled to recover the
reasonable attorneys'
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fees, costs and expenses incurred by the prevailing party in connection with
such proceedings.
12.10 Independent Contractors. The relationship between GMEL 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.
Neither party shall control, or have any right to control, the manner, method,
an means by which the other party makes, has made, uses, sells, leases or
otherwise provides or markets its products and services.
12.11 LIMITATION OF LIABILITY. EXCEPT AS MAY BE ELSEWHERE HEREIN
SPECIFICALLY PROVIDED FOR, NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR
INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES, OR FOR ANY
LOST PROFITS OF THE OTHER PARTY, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY,
ARISING OUT OF THE PERFORMANCE OR FAILURE TO PERFORM ANY OBLIGATIONS SET FORTH
HEREIN.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date
first above written.
Global Medical Enterprises, Ltd.
/s/ Xxx Xxx
--------------------------------
Xxx Xxx
Chairman
Date: February 5, 1999
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Global Medical Enterprises, Ltd., LLC
/s/ Xxxxxx X. Xxxxxxx
--------------------------------
Xxxxxx X. Xxxxxxx, M.D.
President and CEO
Date: February 5, 1999
UNITED THERAPEUTICS CORPORATION
/s/ Xxxxxx Xxxxxxxx
--------------------------------
Xxxxxx Xxxxxxxx, Ph.D.
Executive Vice President and COO
Date: February 4, 1999
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