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EXHIBIT 10.9
CONFIDENTIAL TREATMENT REQUEST
Confidential Portions Of This Agreement Which Have Been Redacted Are
Marked With Brackets ("[***]"). The Omitted Material Has Been Filed Separately
With The Securities And Exchange Commission.
HORIZON PHARMACEUTICAL & INPHARMAKON
COLLABORATION AGREEMENT
THIS AGREEMENT made as of the 31st day of October, 1998 ("Effective Date")
between Horizon Pharmaceutical Corporation, a Delaware corporation of 000
Xxxxxxx Xxxxxxx, Xxxxx 000, Xxxxxxx, Xxxxxxx 00000 ("Horizon") and InpharmaKon
Corporation, a Delaware corporation of 000 Xxxxxxxx Xxxx, Xxxxx 000,
Xxxxxxxxxx, Xxxxxxxx 00000 ("Inpharmakon").
RECITALS:
A. Horizon is a pharmaceutical product development and marketing
company;
B. Inpharmakon is in the business of developing and assembling
literature based product registration packages for the purpose of enabling
marketing partners to file NDAs (defined below) with the FDA (defined below)
for marketing approval of off label indications for FDA approved pharmaceutical
products.
C. Horizon wishes to collaborate with Inpharmakon and Inpharmakon
wishes to collaborate with Horizon for the purpose of preparing a NDA for
submission by Horizon to the FDA requesting approval to market [***] for the
indicated use of migraine prophylaxis on the following terms and conditions.
NOW, THEREFORE, the parties agree as follows:
ARTICLE I
DEFINITIONS
In this Agreement the following expressions shall have the meaning set
forth in this Article.
1.01 ACCOUNTING PERIOD. The term "Accounting Period" means a calendar
quarter.
1.02 AFFILIATE. The term "Affiliate" means a corporation or business
entity which, directly or indirectly, is controlled by one of the parties or
controls one of the parties. For this purpose, the meaning of the word
"control" shall include, but not be limited to, ownership of fifty percent
(50%) or more of the voting shares or interest of such corporation or business
entity.
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1.03 ANDA. The term "ANDA" means an Abbreviated New Drug Application.
1.04 CLINICAL TRIALS. The term "Clinical Trials" refers to the
clinical trials which Horizon is required to perform under Section 3.01 (ii)
below.
1.05 CONFIDENTIAL INFORMATION. The term "Confidential Information" is
defined in Article VII below.
1.06 FDA. The term "FDA" means the United States Food and Drug
Administration.
1.07 FIRST COMMERCIAL SALE. The term "First Commercial Sale" means the
first sale of the Product to a third party purchaser after NDA approval of the
Product for the Indication.
1.08 FORMULATION. The term "Formulation" is defined in Section 3.01(i)
below.
1.09 HORIZON AFFILIATE. The term "Horizon Affiliate" means an
Affiliate of Horizon.
1.10 INDICATION. The term "Indication" means the indication for
migraine prophylaxis.
1.11 INPHARMAKON AFFILIATE. The term "Inpharmakon Affiliate" means an
Affiliate of Inpharmakon.
1.12 NDA. The term "NDA" means a New Drug Application submitted to the
FDA requesting approval to market the Product for the Indication.
1.13 NET SALES. The term "Net Sales" means the gross invoice price of
all Product using the Formulation actually billed by Horizon, Horizon
Affiliates or sublicensees and their Affiliates to unrelated third party
customers less (i) any direct or indirect credits and allowances or adjustments
granted to such customers, including, without limitation, credits and
allowances on account of price adjustments or on account of rejection or return
of Product previously sold, (ii) any trade and cash discounts, and rebates,
(iii) any sales, excise, turnover and similar taxes, and any duties and other
governmental charges imposed upon the production, use or sale of Product or
partly processed Product, and (iv) transportation, insurance and other handling
charges provided that such charges can be reasonably allocated to such xxxxxxxx
and are not separately invoiced.
1.14 OPPORTUNITY PACKAGE. The term "Opportunity Package" means the
existing opportunity package already delivered to Horizon, receipt of which is
hereby acknowledged, which describes the Product, the targeted indication, and
an overview of its off label usage and was based upon a review of the published
clinical data for the Product and a patent search to establish prima facie
feasibility.
1.15 PRODUCT. The term "Product" means [***].
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1.16 SUBLICENSE. The term "Sublicense" is defined in Section 4.02
below.
ARTICLE II
COLLABORATION
2.01 SCOPE. Horizon shall work to obtain NDA registration for and
commercialization of the Product indicated for the Indication. Horizon shall
develop a once a day proprietary formulation for the Product and have primary
responsibility for clinical, formulation, manufacturing, and regulatory issues,
and preparation of the NDA for the Product for the Indication.
2.02. OPPORTUNITY PACKAGE. Inpharmakon shall give Horizon the
exclusive right to use the Opportunity Package for the purposes of preparing
and filing a NDA for the Product with the FDA for the Indication. Subject to
Inpharmakon's rights upon termination under Article IX below, with effect from
the Effective Date, Inpharmakon shall assert against Horizon no claim to the
ownership of the following intellectual property related to the Product (i) the
Formulation developed by or for Horizon under Section 3.01(i) below, or (ii)
the data arising from the Clinical Trials, nor to the rights to sales,
marketing and distribution for the Product for the Indication. After Horizon
has contracted with a formulator to develop the Formulation, Horizon shall have
the right and power to sublicense its exclusive rights to use the Opportunity
Package.
2.03 SUBLICENSES. In the event Horizon enters into any Sublicenses,
Horizon shall provide Inpharmakon with a copy of each such Sublicense within 10
days of its execution.
ARTICLE III
RESPONSIBILITIES OF THE PARTIES
3.01. RESPONSIBILITIES OF HORIZON. Horizon's responsibilities are as
follows:
i) To develop or have developed for it a workable once a day
formulation (the "Formulation") for the Product or, with
Inpharmakon's consent which consent will not be unreasonably
withheld, substitute another formulation (also referred to as
the "Formulation") with strong marketable differences over
available generic formulations of the Product;
ii) To conduct such clinical trials ("Clinical Trials") as may be
necessary to prepare and file a NDA for the Product using the
Formulation and indicated for the Indication; and
iii) To prepare and file with the FDA a NDA registration package
for the Product using the Formulation indicated for migraine
prophylaxis, and exert all reasonable efforts to obtain
approval of the NDA and commercialize the Product in the
United States of America.
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3.02 LICENSE OF FORMULATION. In the event Horizon licenses the
Formulation from a third party, Horizon shall ensure that the license permits
Horizon to assign its interest in the Formulation to Inpharmakon should
Inpharmakon exercise its rights to assume Horizon's rights to the Formulation
under Sections 9.01 and 9.02 below.
3.03 RESPONSIBILITIES OF INPHARMAKON: Inpharmakon's
responsibilities are to provide Horizon with the following services:
i) To deliver the Opportunity Package to Horizon plus, at no
additional cost to Horizon, provide additional review of such
published clinical trials not found in the Opportunity
Package as the FDA may require after its initial review of
the NDA for the Indication;
ii) To cooperate with and assist Horizon to design, conduct, and
evaluate the Clinical Trials using the Formulation for the
purpose of establishing safety and efficacy for the Product
indicated for the Indication;
iii) To cooperate with and assist Horizon to assemble the NDA for
the Product indicated for the Indication, including assembly
of published clinical literature and summaries;
iv) To assist and advise Horizon concerning follow-up information
required by the FDA in support of the NDA, including
attendance at meetings with the FDA; and
v) Provide other reasonable services as may be agreed by the
parties in support of Horizon's efforts to obtain approval of
the NDA for the Product for the Indication.
3.04 FDA REGULATORY SUPPORT. In the event that Horizon requires
support with regard to its activities regulated by the FDA over and above
Inpharmakon's services under Section 3.03(ii) through iv) above, Inpharmakon or
an Inpharmakon Affiliate shall provide reasonable support requested by Horizon.
Such support shall be free of charge during the first 8 months of the term of
this Agreement. Thereafter Inpharmakon shall charge Horizon at the provider's
(Inpharmakon's or the Inpharmakon Affiliate's) regular rates presently $120 per
hour and Horizon shall pay such charges within 30 days of the invoice date.
3.05 INPHARMAKON EXPENSES. Horizon shall reimburse Inpharmakon for
Inpharmakon's documented out of pocket travel expenses related to the
performance of its responsibilities under Section 3.03(ii) through (v) above.
Horizon shall make such reimbursements within 30 days of the invoice date.
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ARTICLE IV
COMPENSATION
4.01 FEES AND ROYALTIES. Horizon shall pay to Inpharmakon as
compensation for its services:
i) $200,000.00 within 30 days after the Effective Date;
ii) $100,000.00 within 30 days after filing the NDA for the
Product for the Indication
iii) $400,000.00 within 30 days after approval of such NDA; and
iv) A royalty of 5% of the Net Sales by Horizon or Horizon
Affiliates payable 45 days after the end of each Accounting
Period on all sales of the Product using the Formulation for
so long as Horizon or a Horizon Affiliate sell the Product.
Under no circumstances shall payments received by Inpharmakon under paragraphs
(i) through (iii) of this Section be refundable in whole or in part.
4.02 SUBLICENSES. In the event that Horizon grants any third party
a sublicense or other rights (together referred to as a "Sublicense") to make,
have made, use, import, market or sell the Product for the Indication, Horizon
shall pay to Inpharmakon the following royalties:
i) If a Sublicense is granted after Horizon enters into a
contract for development of the Formulation, 50% of the
consideration (cash and in kind) other than royalties under
paragraph (v) of this Section received by Horizon less costs
incurred by Horizon on behalf of the sublicensee and
reimbursed by the sublicensee;
ii) If a Sublicense is granted after development of the
Formulation has been completed, 33% of the consideration
(cash and in kind) other than royalties under paragraph (v)
of this Section received by Horizon less costs incurred by
Horizon on behalf of the sublicensee and reimbursed by the
sublicensee;
iii) If a Sublicense is granted after completion of the Clinical
Trials, 25% of the consideration (cash and in kind) other
than royalties under paragraph (v) of this Section received
by Horizon less costs incurred by Horizon on behalf of the
sublicensee and reimbursed by the sublicensee; or
iv) If a Sublicense is granted after approval of the NDA for the
Product indicated for the Indication, 20% of the
consideration (cash and in kind) other than royalties under
paragraph (v) of this Section received by Horizon less costs
incurred by Horizon on behalf of the sublicensee and
reimbursed by the sublicensee; and
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v) With effect from the First Commercial Sale, 5% of Net Sales
by sublicencees and their Affiliates.
4.03 NO RELEASE OF SECTION 4.01 PAYMENTS. The grant of Sublicenses
by Horizon shall not release Horizon from its obligations to make the payments
required by Section 4.01(i) through (iii) above.
4.04 OTHER INDICATIONS. Provided that Horizon has paid all of the
payments required by Section 4.01(i) through (iii) above, Horizon shall have
the right to prepare and file ANDAs and NDAs for the Product for indications
other than the Indication. In that event the following provisions shall apply:
i) If Product sold by Horizon or Horizon Affiliates for such
indications use the Formulation, Horizon shall pay to
Inpharmakon the royalties as provided under Section 4.01(iv)
above.
ii) If Product sold by Horizon or Horizon Affiliates for such
indications does not use the Formulation (i.e. it uses
another formulation useful in the therapeutic range for
migraine prophylaxis which improves on generically available
formulations for the Product) but the Product is prescribed
for migraine prophylaxis, Horizon shall pay to Inpharmakon
the royalties as provided under Section 4.01(iv) above on all
such sales of the Product for such prescriptions.
iii) Horizon shall pay to Inpharmakon the royalties provided under
Section 4.02(v) on all sales of Product by sublicensees and
their Affiliates which, if made by Horizon, would be subject
to royalty payments under paragraphs (i) or ii) of this
Section.
iv) No royalties shall be due or payable on the Product for such
indications where the Product uses a formulation that is
neither useful in the therapeutic range of migraine
prophylaxis nor a formulation which improves on generically
available formulations for the Product, and the formulation
is not prescribed for migraine prophylaxis.
For the purposes of paragraphs (ii) and (iv) of this Section the term
"improves" refers to a technical or non-technical difference in the formulation
not found in generically available formulations for the Product which
difference differentiates the Product from other [***] products (using either
the Formulation or a generically available formulation) for marketing purposes.
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ARTICLE V
CLINICAL TRIALS
For the purposes of Section 3.01(ii) above, Horizon shall contract
with LAB Biosyn of Montreal, Canada or another clinical research organization
to perform clinical trials the same as or equivalent to (1) the program
prepared by LAB Biosyn, a copy of which Inpharmakon shall provide to Horizon
contemporaneously with the execution of this Agreement, or (2) that recommended
by the FDA.
ARTICLE VI
PAYMENT OF ROYALTIES; AUDIT
6.01 PAYMENT OF ROYALTIES. Horizon shall remit all royalty payments to
Inpharmakon no later than 45 days after the close of each Accounting Period.
Each royalty payment shall be accompanied by a report of the Net Sales subject
to royalty during the Accounting Period. Horizon will deduct withholding taxes
from payments to Inpharmakon only if required by applicable law.
6.02 AUDIT RIGHTS. The following provisions shall apply:
(i) Inpharmakon, at its own expense, shall have the right, upon
reasonable prior notice, but no more than once in any year,
to appoint independent auditors and have them during normal
business hours, inspect and copy the books and accounts of
Horizon, Horizon Affiliates and Horizon's sublicensees, if
any, related to the payment and calculation of royalties
arising under this Agreement. Horizon shall cooperate and
cause Horizon Affiliates and sublicensees, if any, to
cooperate with such auditors. The auditors performing the
audit shall disclose to Inpharmakon only information relating
to the accuracy of records kept and the payments made, and
shall be under a duty to keep confidential any other
information obtained from such records.
(ii) If any such audit establishes that Horizon has underpaid or
overpaid the amount due, Horizon shall promptly pay any
remaining amounts due as established by such audit or, in the
event of an overpayment, Inpharmakon shall promptly refund any
such over payment. If the underpayment is by 5% or more during
any Accounting Period, Horizon shall reimburse Inpharmakon for
its out of pocket expense of such audit, and shall pay to
Inpharmakon interest on the amount of the underpayment at a
rate of 3% above the official prime rate, as announced from
time to time by Citibank NA, New York, or at such lower rate
as shall then be the maximum rate permitted by law that may be
charged on any such overdue payment from the date due until
paid.
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ARTICLE VII
CONFIDENTIALITY
For a period of 5 years after first disclosure, the parties shall keep
completely confidential, shall not publish or otherwise disclose, and shall not
use for any purpose other than the purposes contemplated by this Agreement, any
Confidential Information without the consent of the disclosing party first had
and obtained. The term "Confidential Information" is that information furnished
by either party to the other in writing and marked "Confidential", or if first
disclosed orally, disclosed in writing and marked "Confidential" within 30 days
after first disclosure. Confidential Information shall not include information
that the receiving party can establish by competent proof:
(i) was already known to it prior to disclosure by the disclosing
party as evidenced by written record or other proof;
(ii) was or becomes public knowledge through no fault of the
receiving party;
(iii) has been received from a third party who did not acquire it
directly or indirectly from the disclosing party;
(iv) is independently developed by the receiving party without
reference to any Confidential Information received from the
disclosing party under this Agreement; or
(v) is compelled to be disclosed in the course of litigation with
a third party, provided that the compelled party provides the
disclosing party with notice of such compulsion sufficiently
in advance of disclosure so as to provide the disclosing
party with a reasonable time period to seek a protective
order.
Notwithstanding the above, the parties may disclose such Confidential
Information to their legal representatives and employees, and to consultants,
to the extent such disclosure is reasonably necessary to achieve the purposes
of this Agreement, obtaining an NDA for the Product for the Indication, and
provided such representatives, employees, and consultants are covered by
obligations of confidentiality with respect to such information no less
stringent than those set forth above.
ARTICLE VIII
TERM AND TERMINATION
8.01 TERM. The term of this Agreement shall commence on the Effective
Date and shall continue for a period of 10 years thereafter, with automatic
renewal for successive 5 year terms for so long as Inpharmakon, Horizon, and
their respective Affiliates are in substantial compliance with the terms of
this Agreement, unless otherwise terminated earlier pursuant to this Article
VIII.
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8.02 TERMINATION FOR MATERIAL BREACH. Either party may terminate
this Agreement in the event the other party materially breaches in the
performance of its obligations under this Agreement, and such breach continues
for 90 days after written notice specifying the breach was provided to the
breaching party by the non-breaching party. Any such termination shall become
effective at the end of such 90 day period unless the breaching party (or any
other party on its behalf) has cured any such breach prior to the expiration of
the 90 day period. A material breach is (i) the assertion of ownership rights
by Inpharmakon in violation of Section 2.02, (ii) the failure by either party
to perform in a timely manner the respective obligations and responsibilities
of the parties under Article III above, (iii) the failure by Horizon to pay the
compensation due under Article IV above, or (iv) the breach by either party of
the confidentiality provisions of Article VII above.
8.03 BANKRUPTCY. Either party may terminate this Agreement upon the
filing or institution of bankruptcy, reorganization, liquidation or
receivership proceedings, or upon an assignment of substantially all of the
assets for the benefit of creditors by the other party; provided, however, in
the case of an involuntary bankruptcy proceeding such right to terminate shall
only become effective if the party consents to the involuntary bankruptcy or
such proceeding is not dismissed within 90 days after the filing thereof.
8.04 TERMINATION BY INPHARMAKON. Inpharmakon shall have the right
to terminate this Agreement on notice to Horizon in the event of:
(i) The failure of Horizon, within 4 months after the Effective
Date to acquire or authorize a formulator to develop a
workable once a day formulation for the Product.
(ii) The failure of Horizon, within 12 months after the Effective
Date to complete, in connection with the development of the
Formulation, all necessary in-vitro clinical studies and
complete a clinical bioavailability study in a small group of
at least 8 patients, provided that in the event that
technical difficulties with such study are encountered, such
12 month period will be extended by 3 months to 15 months if
the bioavailability study was initiated within such 12 month
period.
(iii) The failure of Horizon, within 6 months after completing the
clinical bio-availability study on the Formulation under
paragraph (ii) above, to authorize or initiate the Clinical
Trials.
(iv) The failure of Horizon to file the NDA within 8 months after
completion of the Clinical Trials, including the full
statistical analyses.
(v) The failure of the FDA within 3 years of the filing date of
the NDA for the Product for the Indication, to approve the
NDA unless the FDA is holding up approval pending agreement
on labeling requirements for the Formulation, in which case
the period will be 4 years;
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(vi) The failure of Horizon to make the First Commercial Sale
within 6 months after receipt of the NDA approval for the
Product for the Indication, and to thereafter aggressively
market and sell the Product for the Indication.
Should Horizon have informed Inpharmakon in due time of serious
reasons for the delay in the achievement of the events under
paragraphs (iii), (iv) or (v) above, the parties shall negotiate in
good faith an extension or extensions of time for Horizon to complete
the event delayed without Inpharmakon exercising its termination
rights provided that such serious reasons do not delay the
commercialization of the Product beyond 5 years after the Effective
Date. Any waiver by Inpharmakon in one instance shall not obligate
Inpharmakon to grant any additional or other waivers of Horizon's
obligations.
ARTICLE IX
CONSEQUENCES OF TERMINATION
9.01 DEFAULT OF HORIZON. If this Agreement is terminated for failure
of Horizon to pay any of the Article IV payments, or is terminated under
Section 8.04(i) through (iv) and no default of Inpharmakon was the primary
cause of the default, Inpharmakon shall have the exclusive right to proceed
with a NDA for the Product for the Indication using the Formulation and the
data from the Clinical Trials as has been acquired or developed by Horizon at
the date of termination, and shall have the right to assume Horizon's rights to
the same and the NDA, if applicable, without cost to Inpharmakon or Inpharmakon
Affiliates. In that event Horizon shall release to Inpharmakon its rights to
the Opportunity Package, the Formulation, the related not publicly available
information provided by Inpharmakon or developed by or for Horizon, and
registration data related to the NDA for the Product for the Indication.
9.02 FAILURE TO COMMERCIALIZE. If this Agreement is terminated under
Section 8.04(vi) for failure to commercialize the Product for the Indication,
Inpharmakon shall have the exclusive option to purchase Horizon's rights to the
Formulation and the NDA for the Product for the Indication, if applicable, and
the exclusive right to use the data from the Clinical Trials, all for a price
equal to Horizon's booked costs incurred to obtain the same. In that event,
Inpharmakon shall have the right to proceed with a NDA for the Product for the
Indication by itself or through others.
9.03 NO FAULT TERMINATION. If this Agreement is terminated under
Section 8.04(v) Horizon shall have the right to proceed with an ANDA or NDA
with any formulation of [***] for any indication, including hypertension,
without further obligation to Inpharmakon, including but not limited to no
obligation to pay royalties on Net Sales of any and all formulations of the
Product. In that event Inpharmakon shall have an option to purchase Horizon's
rights to the Formulation and the data from the Clinical Trials at Horizon's
booked costs incurred to obtain the same, but only for the Indication.
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9.04 CONDITIONS TO INPHARMAKON RIGHTS. Inpharmakon's rights under
Sections 9.01 and 9.02 above are conditioned upon the termination not arising
primarily from problems with the Opportunity Package or Inpharmakon's
regulatory support under Section 3.03ii) or iv). If the termination is as a
result of such problems Inpharmakon shall have no rights to the Formulation or
the data from the Clinical Trials. However, should Inpharmakon so request and
have informed Horizon in due time the reasons for the problems, the parties
shall negotiate in good faith an extension or extensions of time for
Inpharmakon to repair or cure the problems without Horizon exercising its
termination rights hereunder. Any waiver by Horizon in one instance shall not
obligate Horizon to grant additional or other waivers of Inpharmakon's
obligations.
9.05 NO RELEASE OF PRIOR OBLIGATIONS. Termination of this Agreement
for any reason shall not release either party from any liability which, at the
time of such termination, has already accrued to the other party or which is
attributable to a period prior to such termination nor preclude either party
from pursuing all rights and remedies it may have under this Agreement or at
law or in equity with respect to any breach of the Agreement.
9.06 SURVIVAL OF TERMS. Articles IV, VI, VII, X, XI, XII and XIII, and
Sections 3.02 and 9.01 through 9.05 shall survive the expiration or termination
of this Agreement for any reason.
ARTICLE X
REPRESENTATIONS & WARRANTIES, DISCLAIMERS & INDEMNITIES
10.01 REPRESENTATIONS & WARRANTIES.
(a) Horizon warrants and represents to Inpharmakon that it has or
prior to commercialization will have the right to manufacture, market and sell
[***], and that such manufacturing, marketing and sale will not infringe the
rights of any third parties.
(b) Inpharmakon warrants and represents that it has evaluated
and, to the best of its knowledge and belief, accurately reported all clinical
information, including safety and efficacy data, ft has included in the
Opportunity Package.
10.02 INPHARMAKON DISCLAIMER. Inpharmakon specifically disclaims any
guarantee that the NDA for the Product for the Indication will be successful,
in whole or in part. Inpharmakon will evaluate and accurately report all
clinical information, including safety and efficacy data, it includes in the
literature package for the NDA, but expressly disclaims any responsibility to
independently verify such information for accuracy or completeness. Further,
Inpharmakon expressly disclaims any responsibility for independently verifying
that such clinical information pulled from publicly available or commercial
sources does not infringe third party proprietary rights. However, Inpharmakon
has and will exercise reasonable judgment in deciding whether or not such
information should be used in the NDA. Inpharmakon expressly disclaims
responsibility for the scientific methodologies, clinical protocols and results
obtained and reported in the published literature.
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10.03. INDEMNIFICATION. Horizon shall indemnify, defend and hold
Inpharmakon harmless from and against all product liability claims, actions,
suits and other proceedings, and related costs, including legal fees and
expenses, liabilities, damages and other expenses arising from (i) Horizon's
use of the scientific methodologies, clinical protocols and results referenced
in Section 10.02 above and (ii) the manufacture and sale of the Product. In
addition, in the event of any claims, actions, suits or other proceedings
alleging that Horizon's use, manufacture, marketing or sale of the Product
infringes the rights of third parties, Horizon shall indemnify, defend and hold
Inpharmakon harmless from and against all such claims, actions, suits or other
proceedings, and related costs, including legal fees and expenses, liabilities,
damages, and other expenses incurred by Inpharmakon arising therefrom. Horizon
shall not be obligated to indemnify Inpharmakon as aforesaid unless Inpharmakon
promptly notifies Horizon of the claim, action, suit, or other proceeding and
Inpharmakon thereafter cooperates with and assists Horizon, at Horizon's
expense, in the defense of such claim, action, suit or other proceeding.
ARTICLE XI
NOTICES
All information, reports, notices and other communications under this
Agreement will be in writing. Such information, reports, notices and other
communications, and payments will be deemed given to a party when sent to such
party by certified or registered mail, return receipt requested, postage
prepaid; by hand; by facsimile, receipt confirmed; or by overnight courier
which provides confirmation of delivery, at the appropriate address set forth
above. Either party may change its address for the giving of notice by written
notice to the other party as set forth above.
ARTICLE XII
ARBITRATION
Any dispute arising out of the interpretation or performance of this
Agreement or the breach thereof, shall be submitted to arbitration in Chicago,
Illinois in accordance with the Commercial Rules of the American Arbitration
Association. The arbitration award shall be final and binding on the parties.
The arbitrators' fees shall be borne by the losing party. If both parties are
found liable, the arbitrators' fees shall be borne in proportion to the extent
to which each party is found liable. In the event either party is forced to
take legal action in order to enforce an arbitral award hereunder, the
defending party shall pay the claimant party's costs and expenses, including
reasonable attorney fees and expenses, incurred to enforce such arbitral award.
ARTICLE XIII
MISCELLANEOUS
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13.01 INDEPENDENT CONTRACTORS. The relationship of the parties is that
of independent contractors. The parties are not deemed to be agents, partners
or joint venturers with the other for any purpose as a result of this Agreement
or the transactions contemplated thereby.
13.02 AMENDMENT. This Agreement may not be amended, supplemented, or
otherwise modified except by an instrument in writing signed by both parties.
13.03 ENTIRE AGREEMENT. This Agreement constitutes the entire
agreement and understanding of the parries relating to the subject matter of
this Agreement. It supersedes all previous communications, proposals,
representations and agreements (including the Confidential Disclosure Agreement
dated June 25, 1998 and the Term Sheet dated October 13, 1998 between the
parties), whether oral or written, relating to the subject matter of this
Agreement.
13.04 SEVERANCE. Should any provision of this Agreement be determined
by a court of competent jurisdiction to violate or contravene any applicable
law or policy, such provision shall be severed or modified to the extent
necessary to comply with the applicable law or policy, and such modified
provision and the remainder of the provisions hereof will continue in full
force and effect.
13.05 GOVERNING LAW. This Agreement shall be governed by, and
construed in accordance with, the laws of the State of Illinois, excluding any
choice of law rules which may direct the application of the law of any other
jurisdiction.
13.06 ASSIGNMENT. Neither party may assign its rights or obligations
under this Agreement without the prior written consent of the other.
13.07 SECTION HEADINGS. All section headings are for reference
purposes only and shall not in any way affect the meaning or interpretation of
this Agreement.
13.08 COUNTERPARTS. This Agreement may be executed in one or more
counterparts, each of which shall be an original, but all of which taken
together shall constitute one and the same agreement.
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IN WITNESS WHEREOF, the duly authorized officers of the parties have
executed this Agreement as of the Effective Date.
INPHARMAKON CORPORATION
By:
-------------------------------
Title:
----------------------------
HORIZON PHARMACEUTICAL
CORPORATION
By:
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Title:
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