Confidential Treatment Requested. Confidential portions of this document have
been redacted and have been filed separately with the Commission.
LICENSE AGREEMENT
by and between
XXXXXXX X. XXXXXX, M.D.
and
INTERNEURON PHARMACEUTICALS, INC
dated
December 26, 2000
THIS LICENSE AGREEMENT effective as of December 26, 2000 ("Effective
Date"), by and between Xxxxxxx X. Xxxxxx, M.D., an individual having his
principal office at 0 Xxxxxxxx Xxxxxx, Xxxxxxxxx Xxxxxx, Xxx Xxxxxx 00000
("XXXXXX") and Interneuron Pharmaceuticals, Inc., a corporation organized and
existing under the laws of the State of Delaware and having its principal office
at 00 Xxxxxx Xxxxxx, Xxxxx 000, Xxxxxxxxx, Xxxxxxxxxxxxx 00000 ("Interneuron").
W I T N E S S E T H:
WHEREAS, XXXXXX is the owner of the Patent Assets, as defined herein;
WHEREAS, pursuant to an Option Agreement dated as of March 9, 1997 (the
"Option Agreement"), XXXXXX granted Interneuron the exclusive option (the
"Option") to obtain a license under the Patent Assets, subject to certain terms
and conditions;
WHEREAS, Interneuron desires to exercise the Option and obtain license
rights, with a right to grant sublicenses, under the Patent Assets, and XXXXXX
desires to grant such license to Interneuron, upon the terms and conditions set
forth herein; and
NOW, THEREFORE, in consideration of the foregoing premises and the mutual
covenants herein contained, and for other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, the Parties hereby
agree as follows:
ARTICLE I
DEFINITIONS
Unless specifically set forth to the contrary herein, the following terms,
where used in the singular or plural, shall have the respective meanings set
forth below:
1.1. "Affiliate" shall mean (i) any corporation or business entity of which
---------
more than fifty percent (50%) of the securities or other ownership
interests representing the equity, the voting stock or general partnership
interest are owned, controlled or held, directly or indirectly, by a
Party; (ii) any corporation or business entity which, directly or
indirectly, owns, controls or holds more than fifty percent (50%) (or the
maximum ownership interest permitted by law) of the securities or other
ownership interests representing the equity, voting stock or general
partnership interest of a Party or (iii) any corporation or business
entity of which a Party has the right to acquire, directly or indirectly,
at least fifty percent (50%) of the securities or other ownership
interests representing the equity, voting stock or general partnership
interest thereof.
1.2. "Alcoholic Cirrhosis Study" shall mean the ongoing Phase 3 double-blind
-------------------------
placebo-controlled clinical studies evaluating the use of Compound to
treat and prevent alcoholic cirrhosis and fibrosis of the liver that are
being sponsored in part by the Veterans Administration.
2
1.3. "Business Day(s)" means any day that is not a Saturday or a Sunday or a
---------------
day on which the New York Stock Exchange is closed.
1.4. "Calendar Quarter" shall mean the respective periods of three (3)
----------------
consecutive calendar months ending on March 31, June 30, September 30 and
December 31.
1.5. "Calendar Year" shall mean each successive period of twelve (12) months
-------------
commencing on January 1 and ending on December 31.
1.6. "Compound" shall mean dilinoleoylphosphatidylcholine (DLPC), any
--------
derivative, homolog, or analog thereof, and any isomer, salt, hydrate,
solvate, amide, prodrug and esters thereof, and any pharmaceutical
composition containing any of the foregoing in any pharmaceutically
acceptable form.
1.7. "Data Delivery Date" shall mean the date on which the final results of the
------------------
Alcoholic Cirrhosis Study are available to Interneuron.
1.8. "Effective Date" shall mean the date first above written.
--------------
1.9. "Europe" shall mean all countries under the regulatory jurisdiction of the
------
European Medicines Evaluation Authority (or any successor agency having
substantially the same functions).
1.10. "Exclusive Territory" shall mean the United States of America, including
-------------------
the territories and possessions of the United States of America (including
the District of Columbia, Puerto Rico and U.S. Virgin Islands), Canada,
Japan and the Republic of Korea.
1.11. "FDA" shall mean the United States Food and Drug Administration and any
---
successor agency having substantially the same functions.
1.12. "First Commercial Sale" shall mean the first sale of Product by
---------------------
Interneuron, its Affiliate or its sublicensee(s), for end use or
consumption, after all required approvals have been granted by the
governing health authority of such country or where regulatory approval is
not required, the first sale in that country in connection with the
nationwide introduction of Product in such country.
1.13. "GAAP" means generally accepted accounting principles in the United
----
States.
1.14. "Hepatitis C Study" shall mean a clinical trial evaluating the use of
-----------------
Compound in patients with liver disease and hepatitis C that is to be
sponsored in part by the NIH.
1.15. "Improvement" shall mean any enhancement in the manufacture, formulation,
-----------
ingredients, means of delivery or administration, dosage, indication or
use of Compound or Product which could have application in the prevention
or treatment of fibrosis or cirrhosis of the liver.
1.16. "IND" shall mean an FDA investigational new drug application, and any
---
supplements and additions thereto, relating to the use of Product.
*Confidential Treatment Requested.
3
1.17. "NDA" shall mean a new drug application filed with the FDA for marketing
---
authorization of a Product in the United States.
1.18. "Net Sales" shall mean the actual gross amount invoiced for the sale of
---------
Product (except as provided in Section 5.2.3), commencing upon the date
of First Commercial Sale, after deducting, in accordance with GAAP, the
following :
(i) trade, cash and quantity discounts;
(ii) recalls and credits on account of returned or rejected
Product;
(iii) rebates and chargebacks;
(iv) retroactive price reductions;
(v) sales or excise taxes, VAT or other taxes, and
transportation and insurance charges and additional
special transportation, custom duties, and other
governmental charges; and
(vi) write-offs for bad debts or allowances.
1.19. "NIH" shall mean the United States National Institutes of Health, or any
---
successor agency having substantially the same functions.
1.20. "Party" shall mean XXXXXX or Interneuron.
-----
1.21. "Patent Assets" shall mean the patent and applications listed on Schedule
-------------
1.21 hereto, and further including (a) any divisions, continuations,
continuations-in-part, reissues, renewals, extensions, supplementary
protection certificates or the like relating to those patent and
applications on Schedule 1.21 and (b) any patents or patent applications
covering any Improvements made by XXXXXX which as of the Effective Date
or at any time during the term of this Agreement are owned or controlled
by XXXXXX or which XXXXXX through license or otherwise has or acquires
rights (and is not prohibited from sublicensing to third parties).
1.22. "Positive Results" shall mean the final results of the Alcoholic
----------------
Cirrhosis Study, delivered to Interneuron in the form of the SAS original
data listings that, in Interneuron's judgment, are supportive and
sufficient to submit an NDA to the FDA without any additional clinical
testing of Compound.
1.23. "Positive Interim Results" shall mean the interim data of the Hepatitis C
------------------------
Study, delivered to Interneuron, that result in a decision to continue
the study and are deemed by Interneuron to be positive.
*Confidential Treatment Requested.
4
1.24. "Product" shall mean any product in final form for commercial sale by
-------
prescription, over-the-counter, or by any other method, which contains
Compound in any dosage form as an active ingredient.
1.25. "Proprietary Information" shall mean any and all scientific, clinical,
-----------------------
regulatory, marketing, financial and commercial information or data,
whether communicated in writing, orally or by any other means, which is
provided by one Party to the other Party in connection with this
Agreement.
1.26. "Royalty Year" shall mean each successive twelve (12) month period
------------
commencing with the first day of the first month in which occurs the
First Commercial Sale.
1.27. "Semi-exclusive License" shall mean a non-exclusive license for the Semi-
----------------------
exclusive Territory, provided, however, that XXXXXX may xxxxx only one
other non-exclusive license within the Semi-exclusive Territory, and
subject to the provisions of Section 2.1 of this Agreement.
1.28. "Semi-exclusive Territory" shall mean all of the countries in the
------------------------
Territory except those in the Exclusive Territory and those in Europe
subject to the previously granted exclusive option from XXXXXX to Xx.
Xxxx Pharma GmbH, of Freiburg, Germany ("Xxxx").
1.29. "Territory" shall mean all of the countries in the world.
---------
1.30. "Third Party(ies)" shall mean a person or entity who or which is neither
----------------
a Party nor an Affiliate of a Party.
1.31. "Valid Claim" means a claim of an issued and unexpired patent included
-----------
within the Patent Assets, which has not been revoked or held
unenforceable or invalid by a decision of a court or other governmental
agency of competent jurisdiction, unappealable or for which an appeal has
not been filed within the time allowed for appeal, and which has not been
disclaimed, denied or admitted to be invalid or unenforceable through
reissue or disclaimer or otherwise.
ARTICLE II
LICENSE; SUBLICENSES
2.1. License Grant. XXXXXX hereby grants to Interneuron a license under the
-------------
Patent Assets, including the right to grant sublicenses, to develop, make,
have made, use, import, offer for sale, market and sell and otherwise
dispose of Product, including any Improvements made by XXXXXX. The
foregoing license shall be an exclusive (even as to XXXXXX) license in the
Exclusive Territory and a Semi-exclusive License in the Semi-exclusive
Territory, except that in the event Interneuron exercises its Exclusive
Option, as defined and under Section 2.2 hereof, the foregoing license
shall be an exclusive license in the Territory, effective as of the date
Interneuron elects to exercise such Exclusive Option. Notwithstanding the
foregoing, no provision in this Agreement shall be construed to prevent
XXXXXX from conducting research.
*Confidential Treatment Requested.
5
2.2. Option to License. In the event XXXXXX does not enter into a license
-----------------
agreement with Xxxx in Europe within six (6) months after the Data
Delivery Date, then Interneuron shall have an exclusive option (the
"Exclusive Option"), exercisable for a period of three (3) months
commencing upon the expiration of such six (6) month period, to obtain
from XXXXXX an exclusive license, identical to the license granted by
XXXXXX to Interneuron under the first sentence of Section 2.1 of this
Agreement, in Europe. Until expiration of Interneuron's Exclusive Option
period, XXXXXX shall not grant any rights to Third Parties that are
inconsistent with Interneuron's rights under this Section 2.2. In the
event Interneuron exercises the Exclusive Option:
(a) it shall provide written notice of such election to XXXXXX prior
to expiration of the three (3) month Exclusive Option period;
(b) the license granted by XXXXXX to Interneuron under this Agreement
shall automatically become an exclusive license in the Territory,
effective upon the date of such election; and
(c) subject to the terms and conditions contained in this Agreement
and in consideration of the rights granted by XXXXXX to
Interneuron under this Agreement, Interneuron shall make the
additional payments applicable to the Exclusive Option and the
license obtained upon exercise of the Exclusive Option.
2.3. Improvements by Interneuron. Title to any Improvement developed or
---------------------------
discovered by Interneuron in connection with the license granted under
Section 2.1 above shall be vested solely in Interneuron.
2.4. Sublicenses.
------------
(a) Interneuron shall have the right to grant sublicenses to
Affiliates or any Third Party to develop, make, have made, use,
import, market, sell, have sold, offer to sell and import
Product. Each such sublicense shall include a provision that the
sublicensee's obligations to Interneuron under the sublicense
shall become obligations to XXXXXX upon termination of this
Agreement and assignment of the sublicense to XXXXXX pursuant to
Section 2.4(b).
(b) Upon termination of this Agreement by Interneuron, XXXXXX shall
accept assignment of sublicenses, provided that:
(ii) the sublicensee is not in breach of its sublicense
agreement at the time of termination of this Agreement;
and
(iii) the sublicensee acquires no rights from or obligations on
the part of XXXXXX, other than those that are specifically
granted in this Agreement, and the sublicensee assumes all
obligations to XXXXXX required of Interneuron by this
Agreement.
*Confidential Treatment Requested.
6
ARTICLE III
DEVELOPMENT AND COMMERCIALIZATION
3.1. Exchange of Information. During the term of this Agreement, XXXXXX shall
-----------------------
promptly disclose to Interneuron in writing on an ongoing basis any
development regarding the Patent Assets, the Compound or the Product and
shall disclose to Interneuron in writing within 10 Business Days of his
receipt of any final data or interim results of each of the Alcoholic
Cirrhosis Study and the Hepatitis C Study, subject to the provisions of
Article IV hereunder. Assuming the sufficiency of the final data of the
Alcoholic Cirrhosis Study, Interneuron shall be responsible for compiling
such data into a format suitable for inclusion in a Good Clinical Practice
("GCP") statement of compliance to be completed by Interneuron at its
expense.
3.2. Diligence; Development and Commercialization. Interneuron shall use
--------------------------------------------
commercially reasonable efforts to develop and commercialize Product,
including the preparation and filing of regulatory submissions. As used
herein, "commercially reasonable efforts" shall mean efforts and resources
normally used by Interneuron for a product owned by it or to which it has
exclusive rights, which is of similar market potential at a similar stage
in its development or product life, taking into account issues of safety
and efficacy, product profile, the competitiveness of the marketplace, the
proprietary position of the compound or product, the regulatory and
reimbursement structure involved, the profitability of the applicable
products, and other relevant factors.
3.3. Regulatory Matters.
------------------
(a) Interneuron shall own, control and retain primary legal
responsibility for the preparation, filing and prosecution of all
filings and regulatory applications required to obtain
authorization to commercially develop, sell and use Product in
each country of the Exclusive Territory, the Semi-Exclusive
Territory and, if Interneuron exercises the Exclusive Option, the
Territory. Interneuron shall promptly notify XXXXXX upon the
receipt of regulatory approvals and of the date of First
Commercial Sale.
(b) XXXXXX shall transfer to Interneuron as soon as practicable after
the Effective Date any IND or other regulatory filings relating
to Compound or Product owned or controlled by XXXXXX, and XXXXXX
shall allow Interneuron to cross reference any other IND or Drug
Master File relating to Compound or Product to the extent (a)
XXXXXX is legally able to do so and (b) such transfer does not
impair XXXXXX'x ability to conduct ongoing research. Such
transfer will occur within 30 days of satisfaction of the
milestone payment of section 5.1(a) hereunder. XXXXXX shall add a
representative designated by Interneuron as a member of the
Executive Committee managing the Hepatitis C Study. Interneuron's
initial designee to such Executive Committee shall be Xxxxx X.
Xxxxxxx, Xx. Ph.D. Upon
*Confidential Treatment Requested.
7
Interneuron's request, XXXXXX shall consult and cooperate with
Interneuron in connection with obtaining regulatory approval of
Product.
3.4. Trademark. Interneuron shall select, own and maintain trademarks for
---------
Product.
3.5. Manufacturing. Interneuron shall be solely responsible for manufacture of
-------------
the Compound and Product in the Exclusive Territory and the Semi-exclusive
Territory and, if Interneuron exercises the Exclusive Option, the
Territory.
3.6. Adverse Events. XXXXXX shall promptly furnish to Interneuron all
--------------
information concerning safety or utility of Compound or Product, such as
adverse or unexpected side effects, injury or other events associated with
uses, studies, investigations or tests of Compound or Product, whether or
not XXXXXX is required to report such information to any regulatory
authority and whether or not such event is determined to be attributable
to Compound or Product.
3.7. Third Party Agreements and Study Payments. Interneuron shall not be
-----------------------------------------
responsible for any contractual obligations incurred prior to the
Effective Date in connection with either the Alcoholic Cirrhosis Study or
the Hepatitis C Study. Interneuron shall be responsible for contracting
with, and shall pay directly to, the supplier the following costs of
supply and distribution of Compound for the Hepatitis C Study:
(a) $[*], plus any transportation, customs, and incidental costs,
payable within ten Business Days of execution of this Agreement
to cover the cost of the Product for the Hepatitis C Study; and
(b) $[*], plus any transportation, customs, and incidental costs to
replace defective Product intended for use in the Hepatitis C
Study, payable within ten Business Days of notification by
XXXXXX.
In addition, provided that Interneuron has received Positive Interim
Results, Interneuron shall pay (i) up to $[*] three years from the
Effective Date; and (ii) up to $[*] four years from the Effective Date,
each payment in an amount necessary to defray costs of the Hepatitis C
Study and payable to the Kingsbridge Research Foundation or any successor
to it responsible for the Hepatitis C Study, provided that such costs are
set forth in a budget that Interneuron has had an opportunity to review
and approve.
ARTICLE IV
CONFIDENTIALITY AND PUBLICITY
4.1. Non-Disclosure and Non-Use Obligations. All Proprietary Information
--------------------------------------
disclosed by one Party to the other Party hereunder shall be maintained in
confidence and shall not be disclosed to any Third Party or used for any
purpose except as expressly permitted herein without the prior written
consent of the Party that disclosed the Proprietary Information to the
other Party. The foregoing non-disclosure and non-use obligations shall
not apply to the extent that such Proprietary Information:
*Confidential Treatment Requested
8
(c) is known by the receiving Party at the time of its receipt, and
not through a prior disclosure by the disclosing Party, as
documented by business records;
(d) is properly in the public domain or knowledge;
(e) is subsequently disclosed to a receiving Party by a Third Party
who may lawfully do so and is not under an obligation of
confidentiality to the disclosing Party; or
(f) is developed by the receiving Party independently of Proprietary
Information received from the other Party, as documented by
research and development records.
4.2. Permitted Disclosure of Proprietary Information. Notwithstanding Section
-----------------------------------------------
4.1, a Party receiving Proprietary Information of another Party may
disclose such Proprietary Information:
(a) to governmental or other regulatory agencies in order to obtain
patents pursuant to this Agreement, or to gain approval to
conduct clinical trials or to market Product, but such disclosure
may be only to the extent reasonably necessary to obtain such
patents or authorizations;
(a) by each of Interneuron or XXXXXX to its respective agents,
consultants, Affiliates, Interneuron's sublicensees and/or other
Third Parties for the research and development, manufacturing
and/or marketing of the Compound and/or Product (or for such
parties to determine their interests in performing such
activities) on the condition that such Third Parties agree to be
bound by the confidentiality obligations contained in this
Agreement; or
(b) if required to be disclosed by law or court order, provided that
notice is promptly delivered to the non-disclosing Party in order
to provide an opportunity to challenge or limit the disclosure
obligations; provided, however, without limiting any of the
foregoing, it is understood that Interneuron or its Affiliates
may make disclosure of this Agreement and the terms hereof in any
filings required by the Securities and Exchange Commission
("SEC"), may file this Agreement as an exhibit to any filing with
the SEC and may distribute any such filing in the ordinary course
of its business.
(c) Neither Party shall use the name of the other Party in any
publicity or advertising without the prior written approval of
the other Party. Upon execution of this Agreement, either Party
may issue a press release in the form to be attached as Appendix
4.2.
4.3 Publication Both Parties acknowledge the mutual interest in publishing
-----------
results relating to Product and obtaining valid patent protection.
Consequently, in the event XXXXXX or
9
Interneuron or any of their Affiliates wishes to make a publication
relating to Compound or Product, the party seeking to publish shall
deliver to the other a copy of the proposed publication or an outline of
the oral disclosure at least thirty (30) Business Days prior to submission
or presentation, such that any issue of patent protection can be resolved.
ARTICLE V
PAYMENTS; ROYALTIES AND REPORTS
5.1. Milestone Payments. Subject to the terms and conditions contained in this
------------------
Agreement, and in consideration of the rights granted by XXXXXX hereunder,
Interneuron shall pay XXXXXX the following milestone payments, contingent
upon occurrence of the specified event, with each milestone payment to be
made no more than once with respect to the achievement of such milestone
(but payable the first time such milestone is achieved) for Compound or
Product, as applicable:
(a) $[*] upon receipt by Interneuron of Positive Results of the
Alcoholic Cirrhosis Study;
(b) $[*] upon the earlier of obtaining regulatory approval for
marketing of Product in the United States or Japan;
(c) in the event Interneuron has exercised its Exclusive Option under
Section 2.2 hereof, $[*] upon obtaining regulatory approval in
Europe;
(d) $[*] upon the earlier of First Commercial Sale in the United
States or Japan; and
(e) in the event Interneuron has exercised its Exclusive Option under
Section 2.2 hereof, $[*] upon First Commercial Sale in Europe.
Interneuron shall notify XXXXXX in writing within thirty (30) days after
the achievement of each milestone, and such notice shall be accompanied by
payment of the appropriate milestone payment.
5.2. Royalties and Other Payments.
-----------------------------
5.2.1. Royalties Payable By Interneuron.
(i) Subject to the terms and conditions of this Agreement, and in
consideration of the rights granted by XXXXXX hereunder,
Interneuron shall pay to XXXXXX royalties in an amount equal
to the following percentages of Net Sales in each Royalty
Year by Interneuron or its Affiliates in each country in the
Exclusive Territory where the manufacture, use or sale of
such Product would, absent the license granted hereunder,
infringe one or more Valid Claims of the Patent Assets in
such country:
Amount of Net Sales Royalty Rate
------------------- ------------
*Confidential Treatment Requested.
10
Up to $[*] million [*]%
Over $[*] million and up to $[*] million [*]%
More than $[*] million [*]%
(ii) Subject to the terms and conditions of this Agreement, and in
consideration of the rights granted by XXXXXX hereunder, Interneuron
shall pay to XXXXXX royalties in an amount equal to the following
percentages of Net Sales in each Royalty Year by Interneuron or its
Affiliates in each country in the Semi-Exclusive Territory where the
manufacture, use or sale of such Product would, absent the license
granted hereunder, infringe one or more Valid Claims of the Patent
Assets in such country:
Amount of Net Sales Royalty Rate
------------------- ------------
Up to $[*] million [*]%
Over $[*] million and up to $[*] million [*]%
More than $[*] million [*]%
(iii) In the event Interneuron exercises its Exclusive Option under
Section 2.2 of this Agreement, then subject to the terms and
conditions of this Agreement, and in consideration of the rights
granted by XXXXXX hereunder, Interneuron shall pay to XXXXXX
royalties in an amount equal to the following percentages of Net
Sales in each Royalty Year by Interneuron or its Affiliates in each
country in Europe where the manufacture, use or sale of such Product
would, absent the license granted hereunder, infringe one or more
Valid Claims of the Patent Assets in such country:
Amount of Net Sales Royalty Rate
------------------- ------------
Up to $[*] million [*]%
Over $[*] million and up to $[*] million [*]%
More than $[*] million [*]%
*Confidential Treatment Requested.
11
(iv) Royalties on Net Sales at the rates set forth in (i), (ii) and, if
applicable, (iii) above shall accrue as of the date of First Commercial
Sale of Product in the applicable country and shall continue and accrue
on Net Sales on a country-by-country basis until (a) for Net Sales in the
United States, the expiration of U.S. Patent No. 5,284,835 and (b) for
Net Sales in any country outside the United States, the expiration in
such country of any foreign patent that is the counterpart to U.S. Patent
No. 5,284,835. Thereafter, Interneuron shall be relieved of any royalty
payment under this Section 5.2.
(v) The payment of royalties set forth above shall be subject to the
following conditions:
(A) only one payment shall be due with respect to the same unit of
Product;
(B) no royalties shall accrue on the disposition of Product by
Interneuron, Affiliates or sublicensees as samples (promotion
or otherwise) or as donations (for example, to non-profit
institutions or government agencies); and
(C) XXXXXX shall be responsible for payment of any royalties owed
by XXXXXX to any Third Party in connection with XXXXXX'x
research relating to Compound or Product.
5.2.2. Sublicenses. In the event that Interneuron enters into a sublicense with
-----------
a Third Party or Third Parties, any compensation received by Interneuron
from the Third Party or Third Parties shall belong to Interneuron except
that, with respect to sales of Product by the sublicensee(s), in lieu of
royalty payments set forth in Section 5.2.1, Interneuron shall pay XXXXXX
[*] percent ([*]%) of sublicensing royalties received by Interneuron from
such sublicensee(s) on net sales of Product(s) by such sublicensee(s).
5.2.3. Minimum Annual Payment. On the fifth Business Day of each Calendar Year
----------------------
(the "Payment Date") during the term of this Agreement, commencing in
2003, Interneuron shall make to XXXXXX an annual non-refundable payment,
as set forth below, for such Calendar Year (the "Minimum Annual
Payment"); provided, however, that, Interneuron may credit the Minimum
Annual Payment against any other payments payable to XXXXXX for that
Calendar Year. The Minimum Annual Payments shall be as follows:
(1) $[*] per Calendar Year until expiration of United States
Patent No. 5,284,835;
(2) an additional $[*] per Calendar Year if the Japanese patent
application included in the Patent Assets is pending (and has not been
abandoned), which amount shall increase to $[*] per Calendar Year if the
Japanese patent application under the Patent Assets has issued as a patent in
Japan; and
*Confidential Treatment Requested.
12
(3) in the event Interneuron exercises its Exclusive Option under
Section 2.2 hereof and a patent under the Patent Assets has issued in Europe, an
additional $[*] per Calendar Year.
For example, if:
(A) as of the 2003 Payment Date, Interneuron has exercised its Exclusive
Option and the patent under the Patent Assets has issued in Europe,
the patent application under the Patent Assets for Japan is pending
but has not issued as a patent in Japan, the Minimum Annual Payment
shall be $[*]; however, if Interneuron is obligated to make for the
Calendar Year ending on December 31, 2003 a payment or payments to
XXXXXX under this Agreement aggregating at least $[*], the Minimum
Annual Payment shall be credited against any such payments; and
(B) as of the 2004 Payment Date, Interneuron has exercised its Exclusive
Option and the patent under the Patent Assets has issued in Europe,
the patent application under the Patent Assets for Japan has issued
as a patent in Japan, the Minimum Annual Payment shall be $[*];
however, if Interneuron is obligated to make for the Calendar Year
ending on December 31, 2004 a payment or payments to XXXXXX under
this Agreement aggregating at least $[*], the Minimum Annual Payment
shall be credited against any such payments.
5.2.4. Royalties for Bulk Compound and Affiliate Sales. Interneuron may sell
-----------------------------------------------
bulk Compound to be incorporated into Product, rather than a Product. In
such event, if Interneuron is unable to determine Net Sales, royalties
shall be calculated as if the bulk Compound is deemed to be Product. In
the event that Interneuron transfers Compound (for conversion to Product)
or Product to one of its Affiliates, there shall be no royalty due at the
time of transfer. Subsequent sales of any Product by the Affiliate for
end use shall be reported as Net Sales hereunder by Interneuron.
5.2.5. Compulsory Licenses. If a compulsory license is granted to a Third Party
-------------------
with respect to Product in any country in the Territory with a royalty
rate lower than the royalty rate provided by Section 5.2.1, then the
royalty rate to be paid by Interneuron on Net Sales in that country under
Section 5.2.1 shall be reduced to the rate paid by the compulsory Third
Party licensee.
5.2.6. Third Party Licenses. If one or more licenses from a Third Party or Third
--------------------
Parties are obtained by Interneuron in order to develop, make, have made,
use, sell or import Compound or Product in a particular country, fifty
percent (50%) of any royalties or other payments paid under such Third
Party patent licenses by Interneuron in such country for such Calendar
Quarter shall be creditable against the royalty or other payments payable
to XXXXXX by Interneuron in such country.
5.3. Reports; Payment of Royalty. During the term of the Agreement for so long
---------------------------
as royalty payments are due, Interneuron shall furnish to XXXXXX a
quarterly written report for the Calendar Quarter showing the sales of all
Products subject to royalty payments sold by
*Confidential Treatment Requested. 13
Interneuron, its Affiliates and its sublicensees during the reporting
period and the royalties payable under this Agreement. Reports shall be due
on the ninetieth (90/th/) day following the close of each Calendar Quarter.
Royalties shown to have accrued by each royalty report, if any, shall be
due and payable on the date such royalty report is due. Interneuron shall
keep complete and accurate records in sufficient detail to enable the
royalties hereunder to be determined.
5.4. Audits. Upon the written request of XXXXXX and not more than once in each
------
Calendar Year, Interneuron shall permit an independent certified public
accounting firm selected by XXXXXX and reasonably acceptable to Interneuron
to have access during normal business hours, upon ten-day notice to
Interneuron, to such of the records of Interneuron as may be reasonably
necessary to verify the accuracy of the royalty reports hereunder for any
year ending not more than twenty-four (24) months prior to the date of such
request. The accounting firm shall disclose to XXXXXX only whether the
royalty reports are correct or incorrect and the specific details
concerning any discrepancies.
5.4.1. If such accounting firm concludes that additional royalties were
owed during such period, Interneuron shall pay the additional
royalties within sixty (60) days of the date XXXXXX delivers to
Interneuron such accounting firm's written report so concluding;
provided however, that, in the event that Interneuron shall not be
in agreement with the conclusion of such report (a) Interneuron
shall not be required to pay such additional royalties and (b)
such matter shall be resolved pursuant to the provisions of
Section 9.5 herein. In the event such accounting firm concludes
that amounts were overpaid by Interneuron during such period,
Interneuron shall have a credit against future royalties payable
to XXXXXX in the amount of such overpayment. The fees charged by
such accounting firm shall be paid by XXXXXX; provided, however,
-------- -------
that if an error in favor of XXXXXX of more than the lesser of (i)
$50,000 or (ii) seven percent (7%) of the royalties due hereunder
for the period being reviewed is discovered, then the fees and
expenses of the accounting firm shall be paid by Interneuron.
5.4.2. Upon the expiration of twenty-four (24) months following the end
of any Royalty Year the calculation of royalties payable with
respect to such year shall be binding and conclusive upon XXXXXX,
and Interneuron and its sublicensees shall be released from any
liability or accountability with respect to royalties for such
year.
5.4.3. XXXXXX and Interneuron shall treat all financial information
subject to review under this Section 5.4 or under any sublicense
agreement in accordance with the confidentiality provisions of
this Agreement.
5.5. Payment Exchange Rate. All payments to XXXXXX under this Agreement shall
---------------------
be made in United States dollars. In the case of sales outside the United
States, the rate of exchange to be used in computing the amount of currency
equivalent in United States dollars due XXXXXX shall be calculated monthly
in accordance with GAAP and based on the average of the conversion rates on
the first and last Business Day of each
14
month during each Calendar Quarter published in the Wall Street Journal,
Eastern edition.
5.6. Tax Withholding. If laws, rules or regulations require withholding of
---------------
income taxes or other taxes imposed upon payments set forth in this Article
V, XXXXXX shall provide Interneuron at Interneuron's expense, prior to any
such payment, annually or more frequently if required, with all forms or
documentation required by any applicable taxation laws, treaties or
agreements to such withholding or as necessary to claim a benefit
thereunder (including, but not limited to, Form 1001, Form W-8BEN or any
successor form) and Interneuron shall make such withholding payments as
required and subtract such withholding payments from the payments set forth
in this Article V. Interneuron shall submit appropriate proof to XXXXXX of
payment of the withholding taxes within a reasonable period of time.
Interneuron will use commercially reasonable efforts consistent with its
usual business practices to ensure that any withholding taxes imposed are
reduced as far as possible under the provisions of the current or any
future taxation treaties or agreements between foreign countries, and
XXXXXX shall cooperate with such efforts.
5.7. Exchange Controls. Notwithstanding any other provision of this Agreement,
-----------------
if at any time legal restrictions prevent the prompt remittance of part or
all of the royalties with respect to Net Sales in any country, payment
shall be made through such lawful means or methods as Interneuron may
determine. When in any country the law or regulations prohibit both the
transmittal and deposit of royalties on sales in such a country, royalty
payments shall be suspended for as long as such prohibition is in effect
(and such suspended payments shall not accrue interest), and promptly after
such prohibition ceases to be in effect, all royalties that Interneuron or
its Affiliates or sublicensees would have been obligated to transmit or
deposit, but for the prohibition, shall be deposited or transmitted, as the
case may be, to the extent allowable (with any interest earned on such
suspended royalties which were placed in an interest-bearing bank account
in that country, less any transactional costs). If the royalty rate
specified in this Agreement should exceed the permissible rate established
in any country, the royalty rate for sales in such country shall be
adjusted to the highest legally permissible or government-approved rate.
ARTICLE VI
REPRESENTATIONS AND WARRANTIES
6.1. XXXXXX Representations and Warranties. XXXXXX represents and warrants to
-------------------------------------
Interneuron that as of the Effective Date:
(a) To the best of his knowledge, XXXXXX is unaware of any reason
that the presumption of validity would not apply to the issued
patents included in the Patent Assets or that a court of
competent jurisdiction would, upon investigation, find such
patents invalid or unenforceable;
15
(b) this Agreement has been duly executed and delivered by him and
constitutes legal, valid, and binding obligations enforceable
against him in accordance with its terms;
(c) to the best of his knowledge, no approval, authorization,
consent, or other order or action of or filing with any court,
administrative agency or other governmental authority is required
for the execution and delivery by him of this Agreement or the
consummation by him of the transactions contemplated hereby;
(d) he has the full right, power and authority to enter into and
deliver this Agreement, to perform and to grant the licenses
granted under Article II hereof and to consummate the
transactions contemplated hereby;
(e) he has not previously assigned, transferred, conveyed or
otherwise encumbered his right, title and interest in the Patent
Assets or entered into any agreement with any Third Party which
is in conflict with the rights granted to Interneuron pursuant to
this Agreement;
(f) he is the sole and exclusive owner under the Patent Assets, all
of which are free and clear of any liens, charges and
encumbrances, and no other person, corporate or other private
entity, or governmental or university entity or subdivision
thereof (including, without limitation, the NIH, the Veterans
Administration, Bronx Veterans Affairs Medical Center or the
Mount Sinai School of Medicine) has any claim of ownership with
respect to the Patent Assets, whatsoever;
(g) to the best of XXXXXX'x knowledge, the development, manufacture,
use and sale of Compound and Products do not infringe any patent
rights owned or possessed by any Third Party;
(h) Schedule 1.21 is a complete and accurate list of all patents and
patent applications in the Territory relating to Compound or
Product owned by XXXXXX or to which XXXXXX has the right to
license;
(i) there are no claims, judgments or settlements against or owed by
XXXXXX or pending or, to the best of his knowledge, threatened
claims or litigation relating to the Patent Assets;
(j) to the best of XXXXXX'x knowledge, he has disclosed to
Interneuron all relevant information known by him regarding the
Patent Assets reasonably related to the activities contemplated
under this Agreement;
(k) to his knowledge, no contract research organization, corporation,
business entity or individual which have been involved in any
studies conducted for the purpose of obtaining regulatory
approvals have been debarred individuals or entities within the
meaning of 21 U.S.C. section 335(a) or (b); and
16
(l) to his knowledge, in connection with development of Product,
XXXXXX has complied in all material respects with applicable U.S.
laws and regulations.
6.2. Interneuron Representations and Warranties. Interneuron represents and
------------------------------------------
warrants to XXXXXX that as of the Effective Date:
(a) this Agreement has been duly executed and delivered by it and
constitutes legal, valid, and binding obligations enforceable
against it in accordance with its terms;
(b) it has full corporate power and authority to execute and deliver
this Agreement and to consummate the transactions contemplated
hereby. All corporate acts and other proceedings required to be
taken to authorize such execution, delivery, and consummation
have been duly and properly taken and obtained;
(c) no approval, authorization, consent, or other order or action of
or filing with any court, administrative agency or other
governmental authority is required for the execution and delivery
by it of this Agreement or the consummation by it of the
transactions contemplated hereby.
ARTICLE VII
PATENT MATTERS
7.1. Filing, Prosecution and Maintenance of Patent Applications or Patents.
---------------------------------------------------------------------
Interneuron shall file, prosecute, and maintain the Patent Assets in
XXXXXX'x name and, upon Interneuron's request, XXXXXX shall reasonably
cooperate in the filing, prosecution, or maintenance of such patent
application or patent. Interneuron shall be responsible for the payment of
all patent costs in the Exclusive Territory incurred after the date of the
Option Agreement and, in the event Interneuron exercises its Exclusive
Option, for the payment of all patent costs in the Territory incurred
after the date it exercises the Exclusive Option. XXXXXX shall be
responsible for the payment of all other patent costs. If Interneuron
elects not to file, prosecute or maintain a patent application or patent
included in the Patent Assets, it shall provide XXXXXX with written
advance notice sufficient to avoid any loss or forfeiture, and XXXXXX
shall have the right, at his sole expense, to file, prosecute, or maintain
such patent application or patent and, upon XXXXXX'x request, Interneuron
shall reasonably cooperate in the filing, prosecution, or maintenance of
such patent application or patent. Any such election by Interneuron shall,
at XXXXXX'x option, convert each and every exclusive license hereunder to
a non-exclusive license solely in the country in which the particular
patent or patent application relates.
7.2. Patent Office Proceedings. Each Party shall inform the other Party of any
-------------------------
request for, filing, or declaration of any proceeding before a patent
office seeking to protest, oppose,
17
cancel, reexamine, declare an interference proceeding, initiate a
conflicts proceeding, or analogous process involving a patent application
or patent included in the Patent Assets. Each Party thereafter shall
cooperate fully with the other with respect to any such patent office
proceeding. Each Party will provide the other with any information or
assistance that is reasonable.
7.3. Enforcement and Defense.
-----------------------
(a) Each Party shall promptly give the other Party notice of any
infringement in the Territory of any patent application or patent
included in the Patent Assets that comes to such Party's
attention. The Parties will thereafter consult and cooperate
fully to determine a course of action, including, without
limitation, the commencement of legal action by any Party.
However, Interneuron shall have the first right to initiate and
prosecute such legal action at its own expense and in the name of
XXXXXX and Interneuron, or to control the defense of any
declaratory judgment action relating to Patent Assets.
Interneuron shall promptly inform XXXXXX if Interneuron elects
not to exercise such first right, and XXXXXX thereafter shall
have the right either to initiate and prosecute such action or to
control the defense of such declaratory judgment action in the
name of XXXXXX and, if necessary, Interneuron. In no event shall
XXXXXX be obligated to enforce or defend any of the Patent
Assets.
(b) If Interneuron elects not to initiate and prosecute an
infringement or defend a declaratory judgment action in any
country in the Exclusive Territory as provided in Subsection
7.3(a), and XXXXXX elects to do so, the cost of any agreed-upon
course of action, including the costs of any legal action
commenced or any declaratory judgment action defended, shall be
borne solely by XXXXXX.
(c) For any such legal action or defense, in the event that any Party
is unable to initiate, prosecute, or defend such action solely in
its own name, the other Party will join such action voluntarily
and will execute all documents necessary for the Party to
prosecute, defend and maintain such action. In connection with
any such action, the Parties will cooperate fully and will
provide each other with any information or assistance that either
reasonably may request.
(d) Any recovery obtained by Interneuron or XXXXXX shall be shared as
follows:
(i) the Party that initiated and prosecuted, or maintained the
defense of, the action shall recoup all of its costs and
expenses (including reasonable attorneys' fees) incurred in
connection with the action, whether the recovery is by
settlement or otherwise;
18
(ii) the other Party then shall, to the extent possible,
recover its costs and expenses (including reasonable
attorneys' fees) incurred in connection with the action;
(iii) if XXXXXX initiated and prosecuted, or maintained the
defense of, the action, the amount of any recovery
remaining then shall be retained by XXXXXX; and
(iv) if Interneuron initiated and prosecuted, or maintained the
defense of, the action, the amount of any recovery
remaining shall be retained by Interneuron, except that
XXXXXX shall receive a portion equivalent to the royalties
or other payments he would have received in accordance
with the terms of this Agreement if the infringing sales
had been made by Interneuron or its sublicensee(s).
(e) XXXXXX shall inform Interneuron of any certification regarding
any Patent Assets it has received pursuant to either 21 U.S.C.
(S)(S) 355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) or under Canada's
Patented Medicines (Notice of Compliance) Regulations Article 5
and shall provide Interneuron with a copy of such certification
within five (5) days of receipt. XXXXXX`s and Interneuron's
rights with respect to the initiation and prosecution, or
defense, of any legal action as a result of such certification or
any recovery obtained as a result of such legal action shall be
allocated as defined in Subsections 7.3(a) through (d); provided,
---------
however, that Interneuron shall exercise the first right to
--------
initiate and prosecute, or defend, any action and shall inform
XXXXXX of such decision within fifteen (15) days of receipt of
the certification, after which time, if Interneuron has not
advised XXXXXX of its intention to initiate and prosecute, or
defend, such action, XXXXXX shall have the right to initiate and
prosecute, or defend, such action.
7.4. Patent Term Extensions and Supplemental Protection Certificates. The
---------------------------------------------------------------
Parties shall cooperate in obtaining patent term extensions or
supplemental protection certificates or their equivalents in any country
in the Territory where applicable and where desired by Interneuron. If
elections with respect to obtaining such extension or supplemental
protection certificates are to be made, Interneuron shall have the right
to make the election and XXXXXX shall abide by such election.
ARTICLE VIII
TERM AND TERMINATION
8.1. Term and Expiration. This Agreement shall be effective as of the Effective
-------------------
Date and unless terminated earlier pursuant to Section 8.2 and 8.3 below,
the term of this Agreement shall continue in effect until expiration of
all royalty obligations hereunder.
19
8.2. Termination by Notice. Notwithstanding anything contained herein to the
---------------------
contrary, Interneuron shall have the right to terminate this Agreement at
any time by giving thirty (30) days advance written notice to XXXXXX.
Except as set forth in this Agreement, in the event of such termination,
(i) the rights and obligations hereunder, excluding any payment obligation
that has accrued as of the termination date, shall terminate immediately,
(ii) Interneuron shall have no further rights with respect to the Patent
Assets, and (iii) the provisions of Section 8.4 shall be applicable.
8.3. Termination.
-----------
8.3.1 Termination for Cause. Either Party may terminate this Agreement by
---------------------
notice to the other Party at any time during the term of this
Agreement as follows:
(a) if the other Party is in breach of any material obligation
hereunder (including, without limitation, payments due under
Article V) by causes and reasons within its control, or has
breached, in any material respect, any representations or
warranties set forth in Article VI, and has not cured such
breach within ninety (90) days after notice requesting cure of
the breach, provided, however, that if the breach is not
capable of being cured within ninety (90) days of such written
notice, the Agreement may not be terminated so long as the
breaching Party commences and is taking commercially
reasonable actions to cure such breach as promptly as
practicable; or
(b) upon the filing or institution of bankruptcy, reorganization,
liquidation or receivership proceedings, or upon an assignment
of a substantial portion of the assets for the benefit of
creditors by the other Party; provided, however, in the case
------------------
of any involuntary bankruptcy, reorganization, liquidation,
receivership or assignment proceeding such right to terminate
shall only become effective if the Party consents to the
involuntary proceeding or such proceeding is not dismissed
within ninety (90) days after the filing thereof.
8.3.2 Licensee Rights Not Affected.
----------------------------
(a) In the event Interneuron terminates this Agreement under
Section 8.3.1(b), or this Agreement is otherwise terminated
under Section 8.3.1(b), or XXXXXX is a debtor in a bankruptcy
proceeding, whether voluntary or involuntary, all rights and
licenses granted pursuant to this Agreement are, and shall
otherwise be deemed to be, for purposes of Section 365(n) of
11 U.S.C. (S)101 et seq. (the "Bankruptcy Code"), licenses of
rights to "intellectual property" as defined under Section
101(35A) of the Bankruptcy Code. The Parties agree that
Interneuron and XXXXXX shall retain and may fully exercise all
of their respective rights, remedies and elections under the
Bankruptcy Code. The Parties further agree that, in the event
of the commencement of a bankruptcy proceeding by or against
XXXXXX under the Bankruptcy Code, Interneuron shall be
entitled to all
20
applicable rights under Section 365 of the Bankruptcy Code,
including but not limited to, entitled to a complete duplicate of
(or complete access to, as appropriate) any such intellectual
property and all embodiments of such intellectual property upon
written request therefor by Interneuron.
(b) In the event Interneuron is a debtor in a bankruptcy proceeding,
whether voluntary or involuntary, all rights and licenses granted
pursuant to this Agreement are, and shall otherwise be deemed to
be, for purposes of Section 365 of the Bankruptcy Code, executory
contracts. The Parties agree that applicable law does not excuse
XXXXXX from accepting performance by, or rendering performance
under this Agreement and all rights and licenses granted
hereunder to, a person or entity other than Interneuron.
8.4. Effect of Expiration or Termination.
-----------------------------------
(a) Expiration or termination of this Agreement shall not relieve the
Parties of any obligation accruing prior to such expiration or
termination. In addition to any other provisions of this
Agreement which by their terms continue after the expiration of
this Agreement, the provisions of Article IV shall survive the
expiration or termination of this Agreement and shall continue in
effect for five (5) years from the date of expiration or
termination. Any expiration or early termination of this
Agreement shall be without prejudice to the rights of any Party
against the other accrued or accruing under this Agreement prior
to termination.
(b) Except as otherwise provided in this Section 8, in the event of
termination by Interneuron pursuant to Section 8.2, and if
requested by XXXXXX, Interneuron and XXXXXX shall negotiate in
good faith the commercially reasonable terms of an exclusive
license from Interneuron to XXXXXX of all information, materials,
Improvements, processes, formulas, data, inventions, know-how,
trademarks, patent applications, patents, regulatory approvals
and intellectual property rights which relate to Compound or
Product and which are in Interneuron's possession or control and
as to which Interneuron has the right to license or sublicense to
XXXXXX without compensation to any third party.
ARTICLE IX
MISCELLANEOUS
9.1. Force Majeure. Neither Party shall be held liable or responsible to the
-------------
other Party nor be deemed to have defaulted under or breached the
Agreement for failure or delay in fulfilling or performing any term of the
Agreement during the period of time when 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, flood, embargo, war, acts of
war
21
(whether war be declared or not), insurrection, riot, civil commotion,
strike, lockout or other labor disturbance, act of God or act, omission or
delay in acting by any governmental authority or the other Party. The
affected Party shall notify the other Party of such force majeure
circumstances as soon as reasonably practicable.
9.2. Assignment. The Agreement may not be assigned or otherwise transferred;
----------
provided, however, that (i) Interneuron may assign this Agreement to an
Affiliate or in connection with the transfer or sale of all or
substantially all of its assets related to Compound or Product or its
business or in the event of its merger or consolidation and (ii) XXXXXX
may assign this Agreement in connection with the transfer or sale of the
Patent Assets with the prior consent of Interneuron. Any permitted
assignee/transferee shall assume, in writing and prior to any
assignment/transfer, all obligations of its assignor/transferor under this
Agreement.
9.3. Severability. In the event that any of the provisions contained in this
------------
Agreement are held invalid, illegal or unenforceable in any respect, the
validity, legality and enforceability of the remaining provisions
contained herein shall not in any way be affected or impaired thereby,
unless the absence of the invalidated provision(s) adversely affect the
substantive rights of the Parties. In such event, the Parties shall
replace the invalid, illegal or unenforceable provision(s) with valid,
legal and enforceable provision(s) which, insofar as practical, implement
the purposes of this Agreement.
9.4. Notices. All notices or other communications which are required or
-------
permitted hereunder shall be in writing and sufficient if delivered
personally, sent by facsimile (and promptly confirmed by personal
delivery, registered or certified mail or overnight courier), sent by
nationally-recognized overnight courier or sent by registered or certified
mail, postage prepaid, return receipt requested, addressed as follows:
if to Interneuron to:
Interneuron Pharmaceuticals, Inc.
00 Xxxxxx Xxxxxx, Xxxxx 000
Xxxxxxxxx, XX 00000
Attention: President
Fax No.: 000-000-0000
if to XXXXXX to:
Xxxxxxx X. XXXXXX, M.D.
0 Xxxxxxxx Xxxxxx
Xxxxxxxxx Xxxxxx, XX 00000
Fax No.: 000-000-0000
or to such other address as the Party to whom notice is to be given may have
furnished to the other Parties in writing in accordance herewith. Any such
communication shall be deemed to have been given when delivered if personally
delivered or sent by facsimile on a Business Day,
22
upon confirmed delivery by nationally-recognized overnight courier if so
delivered and on the third Business Day following the date of mailing if sent by
registered or certified mail.
9.5. Applicable Law and Dispute Resolution. The Agreement shall be governed by
-------------------------------------
and construed in accordance with the laws of the United States of America
and State of New York without reference to any rules of conflict of laws.
If the Parties are unable to settle the matter between themselves within
forty-five (45) days, either Party may initiate mediation upon written
notice to the other Party. If the Parties have not reached a settlement
within forty-five (45) days of the initiation of the mediation, then
either Party may initiate the dispute resolution process described in this
section 9.5, below. Whenever a Party shall decide to institute such
dispute resolution process, it shall give written notice to that effect to
the other Party. The Party giving such notice shall refrain from
instituting the dispute resolution process for a period of sixty (60) days
following such notice. During such period, the Parties shall continue to
make good faith efforts to amicably resolve the dispute without the
dispute resolution process. If the parties are still unable to resolve
their disputes by the end of the sixty (60) day period, the Parties
establish the following expedited dispute resolution process. In no event
shall a demand for dispute resolution be made after the date when
institution of a legal or equitable proceeding based on such claim,
dispute or other matter in question would be barred by the applicable
statute of limitations. Each resolution hereunder shall be final and
binding on the Parties and shall be enforceable in any court. Except as
otherwise provided herein:
(i) the dispute shall be set forth in writing by the asserting Party;
(ii) the Parties shall negotiate in good faith for an additional 20
Business Days to resolve the dispute;
(iii) the retained attorneys will select an independent individual
experienced in the subject matter relating to the dispute as the
decision maker, and the three will reach an agreed-upon fee to be
charged by the decision maker;
(iv) the respective positions will be presented to the decision maker by
the retained attorneys in written briefs within ten Business Days
of selection and in oral argument within twenty Business Days of
selection;
(v) based on the presentations, the decision maker will declare, in
writing and within seven Business Days of the oral argument, the
winning party, the losing party, the relief and the amount of
payment due the winning party from the losing party (if
appropriate);
(vi) the losing party will, within ten Business Days, abide by the
decision and pay the amount awarded by the decision maker and the
agreed-upon fee to the decision maker, with each party to be
responsible for their own costs, provided, however, that any
amounts required by this decision to be paid by XXXXXX to
Interneuron shall not exceed, in the aggregate, fifty percent (50%)
of all payments made to XXXXXX pursuant to this Agreement; and
(vii) the decision maker has the power and authority to grant injunctive
relief and to order a party to take certain affirmative action.
23
9.6. Entire Agreement. This Agreement contains the entire understanding of the
----------------
Parties with respect to the subject matter hereof. All express or implied
agreements and understandings, either oral or written, heretofore made are
expressly merged in and made a part of this Agreement. This Agreement may
be amended, or any term hereof modified, only by a written instrument duly
executed by all Parties hereto.
9.7. Independent Contractors. It is expressly agreed that the Parties shall be
-----------------------
independent contractors and that the relationship between the Parties
shall not constitute a partnership, joint venture or agency. Neither Party
shall have the authority to make any statements, representations or
commitments of any kind, or to take any action, which shall be binding on
the other Party, without the prior consent of such other Party.
9.8. Indemnification. Interneuron shall defend, indemnify and hold harmless
----------------
XXXXXX from any and all costs or damages resulting from claims or causes
of action relating in any way to, or arising in any way out of, any
activity of Interneuron under this Agreement, including without limitation
the development, making, having made, use, importation, offer for sale,
marketing, sale and/or other disposition of Product and/or Compound or
relate to the Patent Assets except to the extent such Losses are
determined to have resulted from the negligence or willful misconduct of
or a breach of this Agreement by XXXXXX or relate to the Patent Assets.
9.9. Waiver. The waiver by a Party hereto of any right hereunder or the failure
------
to perform or of a breach by another Party shall not be deemed a waiver of
any other right hereunder or of any other breach or failure by said other
Party whether of a similar nature or otherwise.
9.10. Headings. The captions to the several Articles and Sections hereof are not
--------
a part of the Agreement, but are merely guides or labels to assist in
locating and reading the several Articles and Sections hereof.
9.11. Counterparts. The Agreement may be executed in two or more counterparts,
------------
each of which shall be deemed an original, but all of which together shall
constitute one and the same instrument.
24
IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date
first set forth above.
/s/ Xxxxxxx X. Xxxxxx
-------------------------------
XXXXXXX X. XXXXXX, M.D.
INTERNEURON PHARMACEUTICALS, INC.
By: /s/ Xxxxx X. Xxxxxx
--------------------------
Name: Xxxxx X. Xxxxxx, M.D.
Title: President and Chief Executive Officer
25
SCHEDULE 1.21
-------------
PATENT ASSETS
1. U.S. Patent No. 5,284,835
2. Canadian Patent Application No. 2,141,432
3. Japanese Patent Application No. 6-505,480
4. European Patent Application No. 93918554.2
26
APPENDIX 4.2
------------
FORM OF PRESS RELEASE
FOR IMMEDIATE RELEASE
Contact, at (000) 000-0000:
Xxxxx X. Xxxxxx, M.D. Xxxxxxx X. Xxxxxx
President and CEO Exec. VP and Chief Financial Officer
INTERNEURON LICENSES PHASE 3 COMPOUND FOR THE
TREATMENT AND PREVENTION OF LIVER DISEASE
LEXINGTON, MA, January 10, 2001 - Interneuron Pharmaceuticals, Inc. (NASDAQ:
IPIC) today announced that it has exercised its option and entered into an
agreement to license IP 501, an orally-administered anti-fibrotic purified
phospholipid compound in Phase 3 development for the treatment and prevention of
liver diseases, including alcohol and Hepatitis C-induced cirrhosis. The license
agreement gives Interneuron rights to develop and commercialize the drug in
several major markets, including the United States and Japan. In addition, the
Company announced the initiation of a government-funded Phase 3 clinical trial
evaluating IP 501 in Hepatitis C.
IP 501 is the subject of a recently completed Phase 3 clinical trial funded by
the government to evaluate the compound in alcoholic cirrhosis. The primary
endpoint of the study is reduction in the progression of cirrhosis among drug-
treated pre-cirrhotic patients compared with placebo patients, as measured by
serial liver biopsies. The Company expects to receive a preliminary analysis of
the data in the first quarter of this year.
In addition to this trial, IP 501 is also being studied in another government-
funded, multi-center, Phase 3 clinical trial. This recently initiated, multi-
year trial is designed to evaluate the safety and effectiveness of IP 501 in
treating patients with Hepatitis C-associated cirrhosis.
Under the terms of the license agreement, the Company has acquired rights to
develop and commercialize IP 501 in the United States, Canada, Japan, Korea,
and, under certain circumstances, Europe and other markets. Interneuron is
responsible for all remaining clinical and regulatory development,
manufacturing, and marketing of the compound.
-MORE-
27
Interneuron Pharmaceuticals is a biopharmaceutical company engaged in the
development and commercialization of a diversified portfolio of product
candidates. Including multiple compounds in late-stage clinical development.
Except for the descriptions of historical facts contained herein, this press
release contains forward-looking statements that involve risks and uncertainties
that could cause the Company's actual results and financial condition to differ
materially from those anticipated by the forward looking statements. These risks
and uncertainties are set forth in the Company's filings under the Securities
Act of 1933 and the Securities Exchange Act of 1934 under "Risk Factors" and
elsewhere, and include, but are not limited to, risks relating to the Redux-
related litigation; uncertainties relating to clinical trials, regulatory
approval and commercialization of the Company's products; the early stage of
products under development; need for additional funds and corporate partners;
history of operating losses and expectation of future losses; product liability;
dependence on third parties for manufacturing and marketing; competition;
government regulation; risks associated with contractual arrangements; limited
patents and proprietary rights; dependence on key personnel; uncertainty
regarding pharmaceutical pricing and reimbursement and other risks.
28
