EXHIBIT 10.113
Confidential Treatment Requested. Confidential portions of this document have
been redacted and have been filed separately with the Commission.
LICENSE AGREEMENT
by and between
Xxxxxx XX
and
INTERNEURON PHARMACEUTICALS, INC.
LICENSE AGREEMENT
THIS AGREEMENT effective as of November 26, 1999 ("Effective Date"),
between Xxxxxx XX, a corporation organized and existing under the laws of
Germany and having its principal office at Xxxxxxxxxxxx Xxxx/Xxxx/x 000, X-00000
Xxxx, Xxxxxxx ("Xxxxxx") and Interneuron Pharmaceuticals, Inc., a corporation
organized and existing under the laws of the state of Delaware, United States,
and having its principal office at 00 Xxxxxx Xxxxxx, Xxxxx 000, Xxxxxxxxx, XX
00000 ("Interneuron").
W I T N E S S E T H:
WHEREAS, Xxxxxx is the owner of the Xxxxxx Know-How, as defined herein;
WHEREAS, Interneuron desires to obtain an exclusive license under the
Xxxxxx Know-How, upon the terms and conditions set forth herein;
NOW, THEREFORE, in consideration of the foregoing premises and the mutual
covenants herein contained, the Parties hereby agree as follows:
ARTICLE I
DEFINITIONS
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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
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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, the voting stock or, if applicable, the 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
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(50%) of the securities or other ownership interests representing the
equity, voting stock or general partnership interests.
1.2 "Business Day" means any day that is not a Saturday or a Sunday or a day on
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which the New York Stock Exchange is closed.
1.3 "Calendar Quarter" shall mean the respective periods of three (3)
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consecutive calendar months ending on March 31, June 30, September 30 and
December 31.
1.4 "Calendar Year" shall mean each successive period of twelve (12) months
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commencing on January 1 and ending on December 31.
1.5 "Compound" shall mean trospium chloride, the active ingredient in Spasmo-
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lyt(R).
1.6 "Distribution Period" shall mean the ten (10) year period commencing on the
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date of First Commercial Sale.
1.7 "Effective Date" shall mean the date first above written.
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1.8 "FDA" shall mean the United States Food and Drug Administration and any
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successor agency having substantially the same functions.
1.9 "First Commercial Sale" shall mean, with respect to any Licensed Product,
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the first sale for end use or consumption of such Licensed Product in the
Territory after all required approvals, including marketing and pricing
approvals, if any, have been granted by the FDA and any other applicable
regulatory authority, by Interneuron, its Affiliates or sublicensees.
1.10 "GAAP" means generally accepted accounting principles in the United States.
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1.11 "Generic Drug(s)" shall mean any drug in which Compound is at least one
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active ingredient, except Licensed Product and any generic drugs identical
to Licensed Product originating from Interneuron or its Affiliates.
1.12 "GLP" shall mean current applicable good laboratory practices regulations
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of the FDA.
1.13 "cGMP" shall mean current applicable good manufacturing practices
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regulations of the FDA.
1.14 "Improvement" shall mean any enhancement in the manufacture, formulation,
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ingredients, preparation, presentation, means of delivery, dosage or
packaging of Compound or Licensed Product.
1.15 "IND" shall mean an investigational new drug application and any
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supplements and additions thereto relating to the use of Compound or
Licensed Product.
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1.16 "Interneuron Know-How" shall mean anything, tangible or intangible, which
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relates to Compound or Licensed Product, that is generated, developed,
discovered, invented or made during the Term of this Agreement, which are
in Interneuron's possession or control and as to which Interneuron has the
right to license or sublicense.
1.17 "Licensed Product" shall mean any product in final form for commercial sale
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by prescription, over-the-counter, or by any other method, which contains
Compound as at least one active ingredient, which product, Compound, its
manufacture, use or sale uses Xxxxxx Know How.
1.18 "Xxxxxx Know-How" shall mean any information and materials, including but
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not limited to, discoveries, information, Improvements, processes,
formulas, data, inventions, patents and patent applications (listed in
Schedule 1.18), know-how and trade secrets, patentable or otherwise, which
relates to Compound or Licensed Product, which are in Xxxxxx'x possession
or control as of the Effective Date or at any time during the Term of this
Agreement, and as to which Xxxxxx has the right to license or sublicense,
or are necessary or useful in connection with the rights granted and
activities contemplated under this Agreement. Such know-how shall include,
without limitation, all chemical, pharmaceutical, toxicological,
preclinical, clinical, assay control, manufacturing, regulatory, and any
other information used or useful for the development and/or regulatory
approval of Compound and Licensed Product, including any regulatory filing
or any data included in or generated as a result of or under any regulatory
filing.
1.19 "NDA" shall mean a new drug application filed with the FDA for marketing
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authorization of a Licensed Product in the United States.
1.20 "Net Sales" shall mean the actual gross amount invoiced for the sale of
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Licensed Product commencing upon the date of First Commercial Sale by
Interneuron or its Affiliates to the first Third Party after deducting, if
not previously deducted from the amount invoiced using GAAP:
(a) trade, cash, promotional and quantity discounts;
(b) recalls, credits and allowances on account of returned or rejected
products including, but not limited to, allowance for breakage and
spoilage;
(c) rebates, chargebacks and amounts paid on sale or dispensing of
Licensed Product;
(d) retroactive price reductions;
(e) sales or excise taxes, VAT or other taxes, transportation and
insurance charges and
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additional special transportation, custom duties, and other
governmental charges;
(f) reserves for bad debts or allowances, credits or rebates not covered
by (a) through (e) above;
provided that the deductions shall total no more than four percent (4%) of
gross sales, subject to the Net Sales definition in a potential future
sublicensing agreement.
1.21 "Party" shall mean Xxxxxx or Interneuron.
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1.22 "Proprietary Information" shall mean any and all scientific, clinical,
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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.
1.23 "Royalty Year" shall mean each successive twelve (12) month period during
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the Distribution Period commencing with the first day of the first month in
which occurs the First Commercial Sale.
1.24 "SEC" means the United States Securities and Exchange Commission.
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1.25 "Territory" shall mean the United States of America, including the
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District of Columbia, and its territories and possessions.
1.26 "Third Party(ies)" shall mean a person or entity who or which is neither a
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Party nor an Affiliate of a Party.
ARTICLE II
LICENSE; SUBLICENSES
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2.1 License Granted by Xxxxxx. Xxxxxx hereby grants to Interneuron an
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exclusive, even as to Xxxxxx during the Distribution Period, license under
the Xxxxxx Know-How, including the right to grant sublicenses, to make,
have made, use, develop, import, offer for sale, sell, or have sold the
Licensed Product in the Territory.
2.2 Right to Use Granted by Interneuron. It is understood that title to
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Interneuron Know-How or any general technology or Improvement developed or
discovered by Interneuron while engaged in activities embraced by or
pursuant to the license granted under SECTION 2.1 above shall vest solely
in Interneuron. Interneuron hereby grants to Xxxxxx the right to use
Interneuron's clinical and preclinical data relating to Compound or
Licensed Product for
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Xxxxxx' own regulatory filings relating to the development and marketing of
Compound, Licensed Product or both outside the Territory. In addition, it
is agreed and understood that after the Distribution Period, Xxxxxx shall
have the right to make, have made, use, and sell the Compound and/or
Licensed Product in the Territory, by itself or through an Affiliate, using
Interneuron's clinical and preclinical data relating to the Compound or
Licensed Product in regard to Interneuron's regulatory filing.
2.3 Sublicenses.
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(a) Interneuron shall have the right to issue sublicenses to Third Parties
to make, have made, use, develop, import, offer for sale, sell or have
sold the Licensed Product in the Territory as long as Interneuron has
rights thereto under this Agreement, provided, however that Xxxxxx
shall have the right to consent to the sublicensee, which consent
shall not be unreasonably withheld or delayed.
(b) Upon termination of this Agreement by Interneuron, Xxxxxx shall accept
assignment of sublicenses, provided that:
(i) the sublicensee is not in breach of its sublicense agreement at
the time of termination of this Agreement; and
(ii) 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, including past
due obligations existing at the time of assumption of the
sublicense, as well as any additional payments required of the
sublicensee.
ARTICLE III
DEVELOPMENT AND COMMERCIALIZATION
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3.1 Exchange of Information. Upon execution of this Agreement, Xxxxxx shall
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promptly disclose to Interneuron in writing all Xxxxxx Know-How not
previously disclosed. During the term of this Agreement, Xxxxxx shall also
promptly disclose to Interneuron in writing on an ongoing basis all Xxxxxx
Know-How.
3.2 Diligence; Development and Commercialization. Interneuron will be
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responsible for all preclinical development, toxicology and clinical
development, including regulatory filings, which are required for
commercialization of Licensed Product in the Territory. The progress and
results of such development, as well as such other information reasonably
requested by
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Xxxxxx relating to the progress, goals or performance of such development,
will be reported to Xxxxxx at meetings of the Committee (as defined below).
Interneuron shall also notify Xxxxxx upon the receipt of regulatory
approvals and of the date of First Commercial Sale.
3.3 Steering Committee. The Parties agree to establish a steering committee
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(the "Committee") to facilitate the development of Licensed Product as
follows:
(a) Composition of the Committee. The Committee shall be comprised of
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three (3) named representatives of Interneuron and three (3) named
representatives of Xxxxxx and shall be chaired by a representative of
Interneuron. The initial representatives for each Party hereto shall
be set forth on SCHEDULE 3.3. Each Party shall appoint its respective
representatives to the Committee from time to time, and may substitute
one or more of its representatives, in its sole discretion, effective
upon notice to the other Party of such change. Additional
representatives or consultants may from time to time, by mutual
consent of the Parties, be invited to attend Committee meetings,
subject to compliance with SECTION 4.1. The Committee shall use its
reasonable efforts in good faith to resolve by consensus any issue
relevant to the development of the Licensed Product.
(b) Committee Resolution. If a majority of the Committee is unable to
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reach an agreement on any issue relating to the development of
Licensed Product in the Territory, notwithstanding the exercise of its
reasonable efforts as provided in SECTION 3.3, then such issue shall
be referred to the chief executive officer of Interneuron (the
"CEO"). Any final decision of the CEO shall be conclusive and binding
on the Parties hereto. All other issues, including interpretation of
this Agreement shall be determined in accordance with the provisions
of SECTION 8.6 hereunder.
(c) Meetings and Costs. The Committee shall meet if necessary once each
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Calendar Quarter, starting in the Calendar Quarter in which this
Agreement is executed, with the location for such meetings alternating
between Xxxxxx and Interneuron facilities (or such other locations as
is determined by the Committee). Alternatively, the Committee may
meet by means of conference call or other similar communications
equipment. Any costs incurred by either Party in connection with
meetings of the Committee shall be borne by the respective Party
incurring such cost.
(d) Committee Responsibilities. Except as specifically set forth in this
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Agreement, the Committee shall be responsible for overseeing the
development of Licensed Product, including but not limited to
generation, review and approval of all clinical protocols, budgets and
timetables for the development of the Licensed Product. The Committee
shall establish appropriate estimates of timeframes for development of
Licensed Product in the Territory prior to filing of the NDA.
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3.4 Regulatory Matters. Interneuron shall own, control and retain primary
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legal responsibility for the preparation, filing and prosecution of all
filings and regulatory applications required to obtain marketing
authorization to commercially sell and use Licensed Product in the
Territory. Interneuron shall have the right to cross reference any
regulatory filing owned by Xxxxxx or to which Xxxxxx has access and the
legal right to disclose, including but not limited to any drug master file
relating to the drug substance or drug product manufacturing or
manufacturing facilities.
3.5 Trademark. Interneuron shall select, own and maintain any trademarks for
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Licensed Product in the Territory.
3.6 Excused Performance. Interneuron's obligations under this Agreement are
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expressly conditioned on the absence, in Interneuron's reasonable judgment,
of any adverse condition or event relating to the safety or efficacy of
Compound and/or Licensed Product.
3.7 Manufacturing.
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(a) Interneuron accepts Xxxxxx as exclusive manufacturer of the Licensed
Product during the Distribution Period, provided that Xxxxxx'
manufacturing facility is in compliance with GMP and all other regulatory
requirements in the Territory including successful regulatory inspection
of any such facility.
(b) Interneuron reserves the right to appoint a second source supplier if
Xxxxxx fails to meet the regulatory requirements or is unable to deliver
the Licensed Product at quantities which satisfy Interneuron's commercial
requirements. If such a situation arises, Xxxxxx has the right to
receive an adequate royalty, not to exceed 1% of net sales for giving
such a manufacturing license relying on Xxxxxx Know-How. And
Interneuron agrees that it will rely in such an eventual situation only
on the supply of the Compound by Xxxxxx in order to ensure consistent
Compound identity, provided that regulatory requirements are satisfied,
and commercial quantities are provided at a mutually agreeable price.
(c) The supply price, calculated on today's costing and pricing, is [*] German
Deutschmarks per 1,000 marked tablets of Bulk, FOB German sea-/airport,
(as defined in Incoterms 1990).
(d) The supply price is based upon Xxxxxx current active ingredient purchase
price and manufacturing structure, Xxxxxx will perform best reasonable
efforts in order to keep both elements as stable as possible for the
whole term of this agreement.
Nevertheless, if proven increase occurs Interneuron is prepared to accept
a fair
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* Confidential treatment requested.
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modification of the supply prices with prior notice of not less that 6
(six) months time, provided that the Parties shall agree on a maximum
annual price increase. In exchange Xxxxxx is prepared to lower the supply
prices in case the purchase price of the active ingredient moves downwards.
(e) Prior to the first commercial sale, the Parties agree to negotiate in good
faith the terms of the delivery which are not yet covered by Art. 3.7.,
e.g. ordering procedure, shipment, schedule, inventories, Interneuron
inspection rights standard representation and warranties and appropriate
insurance coverage.
3.8 Adverse Events. Xxxxxx shall promptly (within 48 hours if the event is
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serious, as defined by regulatory agencies, and otherwise within 30 days)
furnish to Interneuron all information concerning safety or utility of
Compound or Licensed Product, such as adverse or unexpected side effects,
injury or other events associated with uses, studies, investigations or
tests of Compound or Licensed 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 Licensed Product.
ARTICLE IV
CONFIDENTIALITY AND PUBLICATION
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4.1 Non-Disclosure and Non-Use Obligations. All Proprietary Information
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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:
(a) 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;
(b) is properly in the public domain;
(c) 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
(d) is developed by the receiving Party independently of Proprietary
Information received
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from the other Party, as documented by research and development
records.
4.2 Permitted Disclosure of Proprietary Information. Notwithstanding SECTION
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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 subject to this Agreement, or to gain approval to conduct
clinical trials or to market Licensed Product, but such disclosure may
be only to the extent reasonably necessary to obtain such patents or
authorizations;
(b) by each of Interneuron or Xxxxxx to its respective permitted
sublicensees, agents, consultants, Affiliates and/or Third Parties for
the research and development, manufacturing and/or marketing of the
Compounds and/or Licensed Products (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
(c) 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,
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it is understood that Interneuron, including any Affiliate, may make
disclosure of this Agreement, and the terms hereof in a press release
and in any filings required by the 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.
Upon execution of this Agreement, the Parties may issue a press release in
the form attached as Appendix 4.2.
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4.3 Publication. If either Party, its employees or consultants wish to make a
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publication or to make an oral disclosure, it shall deliver to the other
Party a copy of the proposed written publication or an outline of an oral
disclosure at least seven (7) days prior to submission for publication or
presentation. If the other Party requests modifications to the publication
or oral disclosure, the disclosing Party shall edit such publication to
prevent disclosure of proprietary business information prior to submission
of the publication or prior to oral disclosure.
ARTICLE V
PAYMENTS; ROYALTIES AND REPORTS
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5.1 Milestone Payments. Subject to the terms and conditions contained in this
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Agreement, Interneuron shall pay Xxxxxx the following milestone payments
within ninety (90) days after
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the achievement of each of the following milestones, provided that each
milestone payment will be made no more than once with respect to the
achievement of each such milestone for the Licensed Product:
(a) US$2,000,000 upon the receipt of written approval by the FDA of an NDA
with respect to Licensed Product, 50% of which shall be creditable
against royalties payable under SECTION 5.2 hereof; and
(b) US$[*] after the first Calendar Quarter in which cumulative Net Sales
of Licensed Product in the Territory exceed US$[*].
5.2 Royalties.
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5.2.1 Royalties Payable By Interneuron.
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(a) Subject to the terms and conditions of this Agreement, during the
first five (5) years of the Distribution Period, Interneuron
shall pay to Xxxxxx royalties equal to the following percentages
of Net Sales in the Territory each Royalty Year of Licensed
Product:
Amount of Net Sales Royalty Rate
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Up to US$75 million [*]%
Over US$75 million to US$150 million [*]%
Over US$150 million [*]%
(b) Subject to the terms and conditions of this Agreement, during the
second five (5) years of the Distribution Period, Interneuron
shall pay to Xxxxxx royalties equal to 2.5% of Net Sales in the
Territory each Royalty Year of Licensed Product.
(c) Notwithstanding the provisions of Subsection (a) and (b) above,
no royalties shall be payable commencing on the first date in
which any or all Generic Drugs achieve a market share in one
Calendar Quarter of thirty three percent (33%) or greater of the
total prescriptions for Compound or Licensed Product in the
Territory (as so shown by the average of the monthly IMS (or IMS-
equivalent) data for such prescriptions in those two consecutive
Calendar Quarters of that Calendar Year).
(d) The payment of royalties set forth above shall be subject to the
following conditions:
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* Confidential treatment requested.
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(i) that only one royalty shall be due with respect to the
same unit of Licensed Product;
(ii) that in the event that Interneuron enters into a
sublicense in the Territory to a Third Party or Third
Parties, in lieu of royalty payments set forth in SECTION
5.2.1, Interneuron shall pay Xxxxxx twenty-five percent
(25%) of sublicensing royalty on net sales of Licensed
Product(s) that Interneuron receives in respect of such
sublicense(s), provided, however, that during the first
five years of the Distribution Period, in no event shall
such sublicense royalty payments to Xxxxxx be less than
four percent (4%) of the net sales of Licensed Product(s)
by a sublicensee or sublicensees in the sublicensed
territory; and
(iii) no royalties shall accrue on the disposition of Licensed
Product by Interneuron, Affiliates or sublicensees as
samples (promotion or otherwise) or as donations (for
example, to non-profit institutions or government agencies
for a non-commercial purpose).
(e) Royalties on Licensed Product at the rate set forth above shall
be effective as of the date of First Commercial Sale of Licensed
Product in the Territory and shall continue until expiration of
the applicable portion of the Distribution Period.
5.2.2 Third Party Licenses. If one or more patent licenses from a Third
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Party or Parties are required by Interneuron, its Affiliates or
sublicensees in order to develop, make, have made, use, sell or
import the Licensed Product in the Territory, any royalties or other
payments paid under such Third Party patent licenses by Interneuron
for manufacture, use, or sale of such Licensed Product for such
Calendar Quarter shall be creditable in full against the royalty
payments to be paid to Xxxxxx by Interneuron with respect to the
manufacture, use, or sale of such Licensed Product.
5.3 Reports; Payment of Royalty. Following the First Commercial Sale of a
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Licensed Product and 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 Licensed
Products subject to royalty payments sold by Interneuron, its Affiliates
and its sublicensees in the Territory during the reporting period (and a
reconciliation of gross sales to Net Sales) and the royalties payable under
this Agreement. Reports shall be due on the forty-fifth (45th) day
following the close of each Calendar Quarter, subject to an extension in
accordance with the terms of a potential future sublicensing agreement.
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 payable hereunder to be determined.
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5.4 Audits.
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(a) Upon the written request of Xxxxxx and not more than once in each
Calendar Year, Interneuron shall permit an independent certified
public accounting firm of nationally recognized standing selected by
Xxxxxx and reasonably acceptable to Interneuron, to have access during
normal business hours at times mutually convenient to the Parties and
upon reasonable 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.
(b) If such accounting firm concludes, and Interneuron agrees, 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 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 8.6 herein.
In the event such accounting firm concludes that amounts were overpaid
by Interneuron during such period, Xxxxxx shall reimburse Interneuron
the amount of such overpayment within thirty (30) days of receipt of
such accounting firm's written report. The fees charged by such
accounting firm shall be paid by Xxxxxx; provided, however, that if an
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error in favor of Xxxxxx in the payment of royalties of more than the
greater of (i) US$100,000 or (ii) ten percent (10%) of the royalties
due hereunder for the period being reviewed is discovered, then the
fees and expenses of the accounting firm shall be reimbursed by
Interneuron.
(c) 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.
(d) Xxxxxx 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. All royalty payments to Xxxxxx under this Agreement shall be made
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in United States dollars.
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5.6 Tax Withholding. If laws, rules or regulations require withholding of
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income taxes or other taxes imposed upon payments set forth in this Article
V, Xxxxxx shall provide Interneuron, 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 (including, but not limited to, Form 1001 and 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 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.
ARTICLE VI
REPRESENTATIONS AND WARRANTIES
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6.1 Xxxxxx Representations and Warranties. Xxxxxx represents and warrants to
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Interneuron that as of the Effective Date:
(a) this Agreement has been duly executed and delivered by it and
constitutes legal, valid, and binding obligations of it enforceable
against it in accordance with its terms;
(b) 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;
(c) it 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. 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;
(d) it has not previously assigned, transferred, conveyed or otherwise
encumbered its right, title and interest in the Xxxxxx Know-How or
entered into any agreement with any Third Party which is in conflict
with the rights granted to Interneuron pursuant to this Agreement;
(e) it is the sole and exclusive owner under the Xxxxxx Know-How, all of
which are free and clear of any liens, charges and encumbrances, and
to the best of Xxxxxx' knowledge, no other person, corporate or other
private entity, or governmental entity or subdivision thereof, has
any valid claim of ownership with respect to the Xxxxxx Know-How,
whatsoever;
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(f) patents contained in the Xxxxxx Know-How are valid or enforceable;
(g) the Xxxxxx Know-How practiced as contemplated herein and the
development, manufacture, use and sale of Compound and Licensed
Products do not and will not infringe any patent rights owned or
possessed by any Third Party;
(h) there are no claims, judgments or settlements against or owed by
Xxxxxx or pending or, threatened claims or litigation relating to the
Xxxxxx Know-How; and
(i) it has disclosed to Interneuron all relevant information known by it
regarding the Xxxxxx Know-How reasonably related to the activities
contemplated under this Agreement.
6.2 Interneuron Representations and Warranties. Interneuron represents and
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warrants to Xxxxxx that as of the Effective Date:
(a) it has full corporate power and authority to execute and deliver this
Agreement and the other agreements and instruments to be executed and
delivered by it pursuant hereto and to consummate the transactions
contemplated hereby and thereby; and
(b) 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
TERM AND TERMINATION
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7.1 Term and Expiration. This Agreement shall be effective as of the Effective
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Date and unless terminated earlier pursuant to SECTION 7.2 or 7.3 below,
the term of this Agreement shall continue in effect until the end of the
Distribution Period. Upon expiration of the royalty obligations with
respect to a Licensed Product hereunder, Interneuron's license to such
Licensed Product pursuant to SECTION 2.1 shall become a fully paid-up,
perpetual license.
7.2 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 in the
event of any event, condition, or regulatory
14
action that affects the safety or efficacy of the Compound or Licensed
Product in the Territory. In the event of such termination, (i) the rights
and obligations hereunder, including any payment obligations not due and
owing as of the termination date, shall terminate and (ii) Interneuron
shall have no further rights with respect to the Xxxxxx Know-How.
7.3 Termination for Cause
---------------------
Either Party may terminate this Agreement by notice to the other Party at
any time during the term of this Agreement:
(a) if the other Party is in breach of its material obligations
hereunder by causes and reasons within its control 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.
7.4 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. 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, including the obligation to pay royalties for Licensed
Product(s) or Compound sold prior to such termination. Except as otherwise
provided in this SECTION 7, in the event of termination by Xxxxxx pursuant
to SECTION 7.3, Interneuron shall promptly return any and all Xxxxxx Know-
How in its possession at the time of termination.
15
ARTICLE VIII
MISCELLANEOUS
-------------
8.1 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
(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.
8.2 Assignment. The Agreement may not be assigned or otherwise transferred,
-----------
nor, except as expressly provided hereunder, may any right or obligations
hereunder be assigned or transferred by a Party; provided, however, that
-------- -------
either Party may assign the Agreement and its rights and obligations
hereunder to an Affiliate or in connection with the transfer or sale of all
or substantially all of its assets related to Compound or Licensed Products
or its business or in the event of its merger or consolidation or change in
control or similar transaction. Except as otherwise set forth herein, any
permitted assignee shall assume all obligations of its assignor under this
Agreement.
8.3 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.
8.4 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
XXX
Attention: President
Fax No.: 000-000-0000
16
if to Xxxxxx to: Xxxxxx XX
Xxxxxxxxxxxx Xxxx/Xxxx/x 000
X-00000 Xxxx
Xxxxxxx
Attention: Xx. Xxxx Xxxxxxxxx
Fax No.: 000-00-000-0000-000
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, 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.
8.5 Applicable Law. The Agreement shall be governed by and construed in
---------------
accordance with the laws of the United States of America and State of
Delaware without reference to any rules of conflict of laws.
8.6 Dispute Resolution. The Parties agree to attempt initially to solve all
-------------------
claims, disputes, or controversies arising under, out of, or in connection
with this Agreement by conducting good faith negotiations. If the Parties
are unable to settle the matter between themselves, the matter shall
thereafter be resolved by alternative dispute resolution, starting with
mediation and including, if necessary, a final and binding arbitration.
Whenever a Party shall decide to institute arbitration proceedings, it
shall give written notice to that effect to the other Party. The Party
giving such notice shall refrain from instituting the arbitration
proceedings 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 arbitration. Any arbitration
hereunder shall be conducted under the rules of arbitration of the
International Chamber of Commerce ("ICC"). Each such arbitration shall be
conducted by a panel of three arbitrators: one arbitrator shall be
appointed by each of Interneuron and Xxxxxx and the third shall be
appointed by the ICC. Any such arbitration shall be held in London,
England. The arbitrators shall have the authority to grant specific
performance. Judgment upon the award so rendered may be entered in any
court having jurisdiction or application may be made to such court for
judicial acceptance of any award and an order of enforcement, as the case
may be. In no event shall a demand for arbitration 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 Party shall bear its own costs and expenses
incurred in connection with any arbitration proceeding and the Parties
shall equally share the cost of the arbitration levied by the ICC.
8.7 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,
17
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.
8.8 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.
8.9 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.
8.10 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.
8.11 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.
8.12 Euro Conversion. If the Euro becomes the only legal tender in Germany at
----------------
any time during the term of this Agreement, in the event that financial
payments are required to be made in German Deutschemarks pursuant to this
Agreement, these payments shall be made in Euros, converted from
Deutschemarks based upon the officially defined rate of exchange as of the
date upon which the Euro becomes the only legal tender in Germany. The
fact that the Euro becomes the only legal tender in Germany, or the
conversion from Deutschemarks to Euros as provided herein, shall not affect
the validity or effectiveness of this Agreement, and shall not form the
basis for termination of this Agreement by either Party.
IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date
first set forth above.
XXXXXX XX
By: s/s Xxxxxxx Niederheide s/s Xxxx X. Xxxxxxxxx, Ph.D.
----------------------------------------------------------------------
Name: Xxxxxxx Niederheide Xxxx X. Xxxxxxxxx, Ph.D.
Title: Board Member Corporate Projects
INTERNEURON PHARMACEUTICALS, INC.
18
By: /s/ Xxxxx X. Xxxxxx, M.D.
-------------------------
Name: Xxxxx X. Xxxxxx, M.D.
Title: President and Chief Executive Officer
19
SCHEDULE 1.18
-------------
Xxxxxx Patents and Patent Applications*
U.S. Patent Number 4,780,476 entitled, "Azoniaspironortropanol Esters as Asthma
Therapeutics and Broncholytics"
U.S. Patent Number 4,855,422 entitled, "Processes for the Preparation of
Azoniaspironortropanol Esters"
*Xxxxxx has advised Interneuron that the bulk to be supplied by Xxxxxx to
Interneuron is not protected by the patents listed herein.
20
SCHEDULE 3.3
------------
Steering Committee
Interneuron:
-----------
Xxxxx X. Xxxxxxx, Xx., Ph.D., Executive Vice President, Research & Development
and CSO
Xxxxxxx X. Xxxxxxx, Ph.D., Senior Vice President, Clinical Research
Xxxxx Xxxxxx Xxxx, Pharm.D., Vice President, Regulatory and Scientific Affairs
Xxxxxx:
------
Xxxx Xxxx-Xxxxxxxx, Ph.D., International Project Director
Xxx Xxxxxx, Ph.D., Director of Regulatory Affairs
Xxxxxxx Xxxxxxxx, M.D., Medical Director
21
