EXHIBIT 10.60
Execution copy
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LICENSE AGREEMENT
BETWEEN
ELAN CORPORATION, PLC
ELAN PHARMA INTERNATIONAL LTD.
AND
INCARA DEVELOPMENT, LTD.
Portions of this exhibit marked [*] have been omitted pursuant to a request for
confidential treatment.
1
TABLE OF CONTENTS
1 DEFINITIONS
2 ELAN LICENSE TO NEWCO
3 INTELLECTUAL PROPERTY
4 [*] AFTER ACQUIRED TECHNOLOGY
5 FINANCIAL PROVISIONS
6 RIGHT OF INSPECTION AND AUDIT
7 REPRESENTATIONS AND WARRANTIES
8 TERM AND TERMINATION
9 CONFIDENTIAL INFORMATION
10 GOVERNING LAW AND JURISDICTION
11 IMPOSSIBILITY OF PERFORMANCE - FORCE MAJEURE
12 ASSIGNMENT
13 NOTICES
14 MISCELLANEOUS
[*] Confidential Treatment Requested; Certain Information Omitted and Filed
Separately with the SEC.
2
THIS AGREEMENT made this 19 January 2001
between:
(1) Elan Corporation, plc., a public limited company incorporated under the
laws of Ireland, and having its registered office at Xxxxxxx Xxxxx, Xxxxxxx
Xxxxx, Xxxxxx 0, Xxxxxxx;
(2) Elan Pharma International Ltd. incorporated under the laws of Ireland, and
having its registered office at XXX Xxxxx, Xxxxxxx Xxxxxxxx Xxxx, Xxxxxxx,
Xxxxxx Xxxxx, Xxxxxxx;
(3) Incara Development, Ltd., an exempted limited liability company
incorporated under the laws of Bermuda and having its registered office at
Xxxxxxxxx Xxxxx, 0 Xxxxxx Xx., Xxxxxxxx, Xxxxxxx ("Xxxxx"); and
(4) Incara Pharmaceuticals Corporation (formerly Intercardia, Inc.), a
corporation duly incorporated and validly existing under the laws of
Delaware and having its principal place of business at 0000 Xxxx Xxxxxxx
54, Cape Fear Building, Suite 300, Research Xxxxxxxx Xxxx, Xxxxx Xxxxxxxx
00000, Xxxxxx Xxxxxx of America.
RECITALS:
---------
A. Simultaneously herewith, Incara, Elan, EIS, and Newco are entering into the
JDOA for the purpose of recording the terms and conditions of the joint
venture and of regulating their relationship with each other and certain
aspects of the affairs of, and their dealings with Newco.
B. Newco desires to enter into this Agreement with Elan so as to permit Newco
to utilize the Elan Intellectual Property in making, having made,
importing, using, offering for sale and selling the Products in the Field
in the Territory.
C. Simultaneously herewith Newco and Incara are entering into the Incara
License Agreement relating to Newco's use of the Incara Intellectual
Property.
1 DEFINITIONS
1.1 In this Agreement unless the context otherwise requires:
"Affiliate" shall mean any corporation or entity controlling, controlled or
under the common control of Elan or Incara or any third party, as the case
may be, excluding, in
3
the case of Elan, an Elan JV. For the purpose of this definition,
(i)"control" shall mean direct or indirect ownership of fifty percent (50%)
or more of the stock or shares entitled to vote for the election of
directors and (ii) Newco shall not be an Affiliate of Elan or EIS or
Incara.
"After Acquired Technology" shall have the meaning as such term is defined
in Clause 4.
"Agreement" shall mean this license agreement (which expression shall be
deemed to include the Recitals and Schedules hereto).
"Bolus System" shall mean the ambulatory drug delivery system for direct
attachment to the body of a patient, which is capable of delivering drug
upon activation, either manually or automatically, as the foregoing are
disclosed and described in the Elan Patents, and in respect of which, Elan,
from time to time uses the trademark "MEDIPAD(R)" for descriptive purposes.
"Business Plan" shall have the meaning, as such term is defined in the
JDOA.
"Change of Control of Incara/Newco" shall mean circumstances where a
Technological Competitor of Elan shall:
(i) acquire [*]% or more of the voting stock of Incara or Newco, or
otherwise directly control or influence [*] respect their management
or business; or
(ii) otherwise have entered into any joint venture, collaborative, license
or other arrangement with Incara or Newco, as the case may be, to such
an extent that such a Technological Competitor of Elan controls or
influences [*] the business or management of Incara or Newco, as the
case may be.
"Compound" shall mean the compound identified by Incara as OP2000, an ultra
low molecular weight heparin, the structure of which is described in
Schedule 1, and in the Incara Patents.
"Confidential Information" shall have the meaning, as such term is defined
in Clause 9.
"Continuous System" shall mean the ambulatory drug delivery system for
direct attachment to the body of a patient having a flexible diaphragm drug
reservoir, which is capable of delivering factory pre-programmed continuous
amounts of drug upon activation, as the foregoing are disclosed and
described in the Elan Patents, and in respect of which, Elan, from time to
time uses the trademark "MEDIPAD(R)" for descriptive purposes.
"Definitive Documents" shall mean the definitive agreements relating to the
transaction including finance, stock purchase, research and license
agreements.
[*] Confidential Treatment Requested; Certain Information Omitted and Filed
Separately with the SEC.
4
"Effective Date" shall mean the date of this Agreement.
"EIS" shall mean Elan International Services, Ltd., a Bermudan exempted
limited liability company having its registered office at Xxxxxxxxx Xxxxx,
0 Xxxxxx Xx., Xxxxxxxx, Xxxxxxx.
"Elan" shall mean EPIL and Affiliates and subsidiaries of Elan Corp within
the division of Elan Corp carrying on business as Elan Pharmaceutical
Technologies. For the avoidance of doubt, "Elan" shall exclude the
Excluded Entities.
"Elan Corp" shall mean Elan Corporation, plc., a public limited company
incorporated under the laws of Ireland.
"Elan Improvements" shall mean improvements to the Elan Patents and/or the
Elan Know-How, developed (i) by Elan outside the Project, (ii) by Elan,
Incara or Newco or by a third party (under contract with Newco) pursuant to
the Project, and/or (iii) jointly by any combination of Elan, Incara, Newco
or a third party (under contract with Newco) pursuant to the Project,
except as limited by agreements with third parties.
Subject to third party agreements, Elan Improvements shall constitute part
of Elan Intellectual Property and be included in the license of the Elan
Intellectual Property pursuant to Clause 2.1 solely for the purposes set
forth therein. If the inclusion of a Elan Improvement in the license of
Elan Intellectual Property is restricted or limited by a third party
agreement, Elan shall use reasonable commercial efforts to minimize any
such restriction or limitation.
"Elan Intellectual Property" shall mean the Elan Know-How, the Elan Patents
and the Elan Improvements.
For the avoidance of doubt, Elan Intellectual Property shall exclude
inventions, patents and know-how owned, licensed or controlled by the
Excluded Entities.
"Elan JV" shall mean an entity that Elan and a third party (i) establish or
have established, (ii) take shareholdings in or have a right to take
shareholdings in, and (iii) grant certain licenses in and to certain
intellectual property rights for the purpose of implementing a strategic
alliance.
"Elan Know-How" shall mean, subject to Clause 4.3, any and all rights
owned, licensed or controlled by Elan to any scientific, pharmaceutical or
technical information, data discovery, invention (whether patentable or
not), know-how, substances, techniques, processes, systems, formulations,
designs and expertise relating to the System which is not generally known
to the public.
"Elan License" shall have the meaning set forth in Clause 2.1.
"Elan Patents" shall mean, subject to Clause 4.3, any and all rights under
any and all patent applications and/or patents, now existing, currently
pending or hereafter filed
5
or obtained or licensed by Elan relating to the System as set forth in
Schedule 2, and any foreign counterparts thereof and all divisionals,
continuations, continuations-in-part and all patents issuing on any of the
foregoing and any foreign counterparts thereof, together with all
registrations, reissues, re-examinations, supplemental protection
certificates, or extensions thereof and any foreign counterparts thereof.
"Elan Trademark(s)" shall mean one or more trademarks, trade names, or
service marks that are owned or licensed by or on behalf of Elan which Elan
may nominate and approve in writing from time to time for use in connection
with the sale or promotion of the Products by Newco.
"EPIL" or "Elan Pharma International Limited" shall mean Elan Pharma
International Limited, a private limited company incorporated under the
laws of Ireland.
"Excluded Entities" shall mean The Liposome Company, Inc. and its
subsidiaries; Axogen Limited; Neuralab Limited; Dura Pharmaceuticals, Inc.
and its subsidiaries; and Affiliates (present or future) of Elan Corp
within the division of Elan Corp carrying on business as Elan
Pharmaceuticals which incorporates, inter alia, EPIL (only to the extent
that it is the owner of patents, know-how or other intellectual property or
technology invented and/or developed within the division of Elan Corp
carrying on business as Elan Pharmaceuticals), Athena Neurosciences, Inc.,
Elan Pharmaceuticals, Inc. and Elan Europe Limited
"Field" shall mean the treatment and/or amelioration of any gastro-
intestinal disease by the administration of the Product. For the avoidance
of doubt, gastro-intestinal disease includes inflammatory bowel disease
(including ulcerative colitis and Crohn's Disease).
"Financial Year" shall mean each year commencing on 1 January (or in the
case of the first Financial Year, the Effective Date) and expiring on 31
December of each year.
"Incara" shall mean Incara Pharmaceuticals Corporation (formerly
Intercardia, Inc.), a Delaware corporation and its Affiliates.
"Incara Improvements" shall have the meaning as such term is defined in the
Incara License Agreement.
"Incara Intellectual Property" shall mean the Incara Know-How, the Incara
Patents and the Incara Improvements.
"Incara License Agreement" shall mean that certain license agreement, of
even date herewith, entered into between Incara and Newco.
"Incara Know-How" shall have the meaning as such term is defined in the
Incara License Agreement.
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"Incara Patents" shall have the meaning as such term is defined in the
Incara License Agreement.
"Incara Sublicense" shall have the meaning set forth in Clause 2.1 of the
Incara License Agreement.
"JDOA" shall mean that certain subscription, joint development and
operating agreement, of even date herewith, by and between Elan, Incara,
EIS and Newco.
"Licensed Technologies" shall mean the Elan Intellectual Property and the
Incara Intellectual Property.
"Licenses" shall mean the Elan License and the Incara Sublicense.
"License Agreements" shall mean this Agreement and the Incara License
Agreement.
"Management Committee" shall have the meaning, as such term is defined in
the JDOA.
"Merck Agreement" shall mean the Development, License and Supply Agreement
dated 26 July 1999 between Elan Pharma International Limited and Merck
Corporation.
"Minimed Agreement" shall mean the Manufacturing Agreement dated 11 June,
1999 among Elan Corp, EPIL and MiniMed Inc.
"Newco Intellectual Property" shall mean all rights to patents, know-how
and other intellectual property arising out of the conduct of the Project
by any person, including any technology acquired by Newco from a third
party, that does not constitute Elan Intellectual Property or Incara
Intellectual Property.
For the avoidance of doubt, any preclinical and clinical data and/or
toxicity, stability and pharmacological data generated pursuant to the
Project relating to the Compound shall constitute Newco Intellectual
Property.
For the further avoidance of doubt, any patent application filed by Newco,
or by Elan or Incara on behalf of Newco, and any patent issued pursuant
thereto, covering a Product shall constitute Newco Intellectual Property.
"Party" shall mean Elan Corp, EPIL or Newco, as the case may be, and
"Parties" means all such parties together.
"Product(s)" shall mean:
(i) the System containing or packaged with the Compound developed pursuant
to the Project; and/or
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(ii) an injectable (including, for the avoidance of doubt, by intramuscular
injection, intravenous injection, or subcutaneous injection)
formulation of the Compound developed pursuant to the Project.
For the avoidance of doubt, "Product" shall exclude any oral formulation of
heparin or any heparinoid.
"Project" shall mean all activities as undertaken by Elan, Incara and Newco
in order to develop the Products.
"R&D Committee" shall have the meaning, as such term is defined in the
JDOA.
"R&D Program(s)" shall mean any research and development program(s)
commenced by Newco pursuant to the Project.
"System" shall mean the Continuous System and/or the Bolus System.
"Technological Competitor of Elan" shall mean a person or entity listed in
Schedule 3 and divisions, subsidiaries and successors thereof or any
additional broad-based technological competitor of Elan added to such
Schedule from time to time upon mutual agreement of Incara and Elan.
"Term" shall have the meaning set forth in Clause 8.
"Territory" shall mean all the countries of the world, except Japan and
Korea.
"United States Dollar" and "US$" shall mean the lawful currency for the
time being of the United States of America.
1.2 In this Agreement:
1.2.1 The singular includes the plural and vice versa, and the masculine
includes the feminine and vice versa and the neuter includes the
masculine and the feminine.
1.2.2 Any reference to a Clause or Schedule shall, unless otherwise
specifically provided, be to a Clause or Schedule of this Agreement.
1.2.3 The headings of this Agreement are for ease of reference only and
shall not affect its construction or interpretation.
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2 ELAN LICENSE TO NEWCO
2.1 Elan hereby grants to Newco for the Term [*] license (the "Elan License")
to the Elan Intellectual Property to make, have made, import, use, offer
for sale and sell the Products in the Field in the Territory, subject to
any contractual obligations that Elan has as of the Effective Date,
including but not limited to the Minimed Agreement and the Merck Agreement.
2.2 [*] shall be responsible for payments related to the financial provisions
and obligations of any third party agreement with respect to the Elan
Intellectual Property to which it is a party on the Effective Date
(including amendments thereto) (the "[*] Effective Date Agreements"),
including without limitation, any royalty or other compensation obligations
triggered thereunder on the Effective Date, or triggered thereunder after
the Effective Date.
For the avoidance of doubt, royalties, milestones or other payments which
arise from the process of the commercialization or exploitation of products
under the [*] Effective Date Agreements (for example, a milestone payment
payable upon successful completion of Phase II clinical trials, the filing
of an NDA application, obtaining NDA approval, or first commercial sale)
shall be payments for which [*] will be responsible under this Clause 2.2.
2.3 Incara shall be a third party beneficiary under this Agreement and shall
have the right to cause Newco to enforce Newco's rights under this
Agreement against Elan.
2.4 Notwithstanding anything contained in this Agreement to the contrary, Elan
shall have the right outside the Field and subject to the [*] provisions of
Clause 4 to exploit and grant licenses and sublicenses of the Elan
Intellectual Property.
For the avoidance of doubt, Newco shall have no right to use the Elan
Intellectual Property outside the Field.
2.5 Except as provided in Clause 11 of the JDOA, Newco shall not be permitted
to assign, license or sublicense any of its rights under the Elan
Intellectual Property without the prior consent in writing of Elan.
2.6 Any agreement between Newco and any permitted third party for the
development or exploitation of the Elan Intellectual Property shall require
such third party to maintain the confidentiality of all information
concerning the Elan Intellectual Property.
Insofar as the obligations owed by Newco to Elan are concerned, Newco shall
remain responsible for all acts and omissions of any permitted sub-
licensee, including Incara, as if they were acts and omissions by Newco.
[*] Confidential Treatment Requested; Certain Information Omitted and Filed
Separately with the SEC.
9
2.7 At such time as the Management Committee is evaluating formulations for
formulating the Product(s), [*]
If the Parties should agree to in-license to Newco [*] will negotiate in
good faith such amendments as are required to this Agreement, such as
amending the provisions regulating non-competition.
2.8 For the avoidance of doubt,[*].
2.9 In the event that the Management Committee, by unanimous agreement,
terminates any R&D Program in respect of any Compound ("Abandoned
Compound") pursuant to Clause 2.3 of the JDOA:
2.9.1 Newco and Incara shall confirm to Elan in writing that the Elan
License has terminated insofar as it previously related to the
Abandoned Compound; and
2.9.2 Elan will cease to be bound by the [*] obligations set forth in
Clause 4 in respect of the Abandoned Compound, and the Parties shall
discuss in good faith what additional amendments are required to
this Agreement.
3 INTELLECTUAL PROPERTY
3.1 Ownership of Intellectual Property:
-----------------------------------
3.1.1 Newco shall own the Newco Intellectual Property.
3.1.2 Elan shall own the Elan Intellectual Property.
3.2 Trademarks:
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3.2.1 Elan hereby grants to Newco for the Term [*] license to use the Elan
Trademarks solely to research, develop, make, have made, import,
use, offer for sale and sell the Products in the Field in the
Territory and the following provisions shall apply as regards the
license of the Elan Trademarks by Elan to Newco hereunder:
(1) Newco shall ensure that each reference to and use of an Elan
Trademark by Newco is in a manner approved by Elan and
accompanied by an acknowledgement, in a form approved by Elan,
that the same is a trademark (or registered trademark) of Elan.
[*] Confidential Treatment Requested; Certain Information Omitted and Filed
Separately with the SEC.
10
From time to time, upon the reasonable request of Elan, Newco
shall submit samples of the Product to Elan or its duly appointed
agent to ensure compliance with quality standards and
specifications. Elan, or its duly appointed agent, shall have the
right to inspect the premises of Newco where the Product is
manufactured, held or stored, and Newco shall permit such
inspection, upon advance notice at any reasonable time, of the
methods and procedures used in the manufacture, storage and sale
of the Product. Newco shall not sell or otherwise dispose of any
Product under the Elan Trademarks that fails to comply with the
quality standards and specifications referred to in this Clause
3.2, as determined by Elan.
(2) Newco shall not use an Elan Trademark in any way which might
materially prejudice its distinctiveness or validity or the
goodwill of Elan therein.
(3) The parties recognize that the Elan Trademarks have considerable
goodwill associated therewith. Newco shall not use in relation to
the Products any trademarks other than the Elan Trademarks
(except the Incara Trademarks (as defined in the Incara License
Agreement) licensed to Newco under the Incara License Agreement)
without obtaining the prior consent in writing of Elan, which
consent may not be unreasonably withheld. However, such use must
not conflict with the use and display of the Elan Trademark and
such use and display must be approved by Elan.
(4) Newco shall not use in the Territory any trademarks or trade
names so resembling the Elan Trademark as to be likely to cause
confusion or deception.
(5) Newco shall promptly notify Elan in writing of any alleged
infringement or unauthorized use of which it becomes aware by a
third party of the Elan Trademarks and provide Elan with any
applicable evidence of infringement or unauthorized use.
(6) Newco shall favorably consider promoting and using the Elan
Trademarks in each country of the Territory and provide proof of
such use upon request by Elan.
(7) Newco shall not be permitted to assign or sublicense any of its
rights under the Elan Trademarks without the prior written
consents of Elan.
3.2.2 Elan may, at [*] expense, file and prosecute applications to
register and maintain registrations of the Elan Trademarks in the
Territory. Newco shall reasonably co-operate with Elan in such
efforts.
[*] Confidential Treatment Requested; Certain Information Omitted and Filed
Separately with the SEC.
11
3.2.3 Elan will be entitled to conduct all enforcement proceedings
relating to the Elan Trademarks and shall at its sole discretion
decide what action, if any, to take in respect to any enforcement
proceedings of the Elan Trademarks or any other claim or counter-
claim brought in respect to the use or registration of the Elan
Trademarks. Any such proceedings shall be conducted at [*] expense
and for its own benefit. Newco and Incara shall reasonably cooperate
with Elan in such efforts.
3.2.4 Newco shall promptly notify Elan in writing in the event that any
Elan Trademark has been challenged by a third party in a judicial or
administrative proceeding in a country in the Territory as
infringing on the rights of a third party and Elan shall have the
first right to decide whether or not to defend such allegations, or
to adopt an alternative xxxx. If Elan decides not defend the Elan
Trademark, then Newco may request Elan to defend the Elan Trademark,
at [*] expense, unless such requested defense is believed by Elan to
be unsubstantiated and without merit. In such a case, Elan may elect
not to initiate defense proceedings.
3.2.5 Newco will have no ownership rights in respect of the Elan
Trademarks or of the goodwill associated therewith, and Newco hereby
acknowledges that, except as expressly provided in this Agreement,
it shall not acquire any rights in respect thereof and that all such
rights and goodwill are, and will remain, vested in Elan.
3.2.6 Nothing in this Agreement shall be construed as a warranty on the
part of Elan regarding the Elan Trademarks, including without
limitation, that use of the Elan Trademarks in the Territory will
not infringe the rights of any third parties. Accordingly, Newco
acknowledges and agrees that Elan makes no such warranty.
3.2.7 Elan assumes [*] to Newco or to any third parties with respect to
the quality, performance or characteristics of any of the goods
manufactured or sold by Newco under the Elan Trademarks pursuant to
this Agreement.
4 [*] AFTER ACQUIRED TECHNOLOGY
4.1 [*]
4.2 [*]
[*] Confidential Treatment Requested; Certain Information Omitted and Filed
Separately with the SEC.
12
4.3 If, after the Effective Date, Elan:
4.3.1 licenses or otherwise acquires from a third party know-how or patent
rights relating to the Elan Intellectual Property in the Field in
the Territory; or
4.3.2 acquires or merges with a third party entity that has know-how or
patent rights relating to the Elan Intellectual Property in the
Field in the Territory;
("After Acquired Technology")
Elan shall offer to license the After Acquired Technology to Newco (subject
to existing contractual obligations) solely to make, have made, import,
use, offer for sale and sell the Products in the Field in the Territory, on
commercially reasonable terms, as would be offered to an independent third
party negotiating in good faith on an arm's length basis, for a reasonable
period under the prevailing circumstances.
If Newco, by unanimous decision of the Management Committee, determines
that Newco should not acquire such license, Elan shall be free to fully
exploit the After Acquired Technology, whether inside or outside the Field,
and to grant to third parties licenses and sublicenses with respect
thereto.
5 FINANCIAL PROVISIONS
5.1 License Fees:
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In consideration of the license to Newco of the Elan Patents under Clause
2, Newco shall pay to Elan Corp a [*] license fee of $12,750,000 in cash,
and Newco shall pay to EPIL a [*] license fee of $2,250,000 in cash (the
"License Fees"), the receipt of which is hereby acknowledged by Elan Corp
and EPIL.
The License Fees shall not be subject to future performance obligations of
Elan to Newco or Incara and shall not be applicable against future services
provided by Elan to Newco or Incara.
The terms of this Clause 5.1 relating to the License Fees are independent
and distinct from the other terms of this Agreement.
5.2 Royalties:
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Prior to the commercialization of the Products, the Management Committee
shall consider and if appropriate, determine reasonable royalties on Net
Sales with respect to the commercialization of the Products by Newco that
shall be payable by Newco to Elan Corp and EPIL and Incara, and [*] by Elan
Corp and EPIL and Incara [*] with EIS' and Incara's [*].
[*] Confidential Treatment Requested; Certain Information Omitted and Filed
Separately with the SEC.
13
At such time, the Management Committee will agree an appropriate definition
of "Net Sales" as such term is used in this Agreement.
The provisions set forth in Clauses 5.3 to 5.8 and 6 relate to the payment
of any royalties which the Management Committee may determine to be payable
by Newco to Elan under this Agreement.
5.3 Apportionment:
--------------
Any license fees, royalties and other payments due under the terms of this
Agreement to Elan Corp and EPIL shall be apportioned [*]% in favor of Elan
Corp and [*]% in favor of EPIL.
5.4 Payment of royalties pursuant to Clause 5.3 shall be made quarterly in
arrears during each Financial Year within 30 days after the expiry of the
calendar quarter. The method of payment shall be by wire transfer to an
account specified by Elan. Each payment made to Elan shall be accompanied
by a true accounting of all Products sold by Newco's permitted
sublicensees, if any, during such quarter.
Such accounting shall show, on a country-by-country and Product-by-Product
basis, Net Sales (and the calculation thereof) and each calculation of
royalties with respect thereto, including the calculation of all
adjustments and currency conversions.
5.5 Newco shall maintain and keep clear, detailed, complete, accurate and
separate records for a period of [*] years:
5.5.1 to enable any royalties on Net Sales that shall have accrued
hereunder to be determined; and
5.5.2 to enable any deductions made in the Net Sales calculation to be
determined.
5.6 All payments due hereunder shall be made in United States Dollars.
Payments due on Net Sales of any Product for each calendar quarter made in
a currency other than United States Dollars shall first be calculated in
the foreign currency and then converted to United States Dollars on the
basis of the exchange rate in effect on the last working day for such
quarter for the purchase of United States Dollars with such foreign
currency quoted in the Wall Street Journal (or comparable publication if
not quoted in the Wall Street Journal) with respect to the currency of the
country of origin of such payment, determined by averaging the rates so
quoted on each business day of such quarter.
5.7 If, at any time, legal restrictions in the Territory prevent the prompt
payment when due of royalties or any portion thereof, the Parties shall
meet to discuss suitable and reasonable alternative methods of paying Elan
the amount of such royalties. In the
[*] Confidential Treatment Requested; Certain Information Omitted and Filed
Separately with the SEC.
14
5.8 event that Newco is prevented from making any payment under this Agreement
by virtue of the statutes, laws, codes or government regulations of the
country from which the payment is to be made, then such payments may be
paid by depositing them in the currency in which they accrue to Elan's
account in a bank acceptable to Elan in the country the currency of which
is involved or as otherwise agreed by the Parties.
5.8 Elan and Newco agree to co-operate in all respects necessary to take
advantage of any double taxation agreements or similar agreements as may,
from time to time, be available.
5.9 Any taxes payable by Elan on any payment made to Elan pursuant to this
Agreement shall be for the account of Elan. If so required by applicable
law, any payment made pursuant to this Agreement shall be made by Newco
after deduction of the appropriate withholding tax, in which event the
Parties shall co-operate to obtain the appropriate tax clearance as soon as
is practicable. On receipt of such clearance, Newco shall forthwith arrange
payment to Elan of the amount so withheld.
6 RIGHT OF INSPECTION AND AUDIT
6.1 [*] during each Financial Year, or more often not to exceed [*] as
reasonably requested by Elan, Newco shall permit Elan or its duly
authorized representatives, upon reasonable notice and at any reasonable
time during normal business hours, to have access to inspect and audit the
accounts and records of Newco and any other book, record, voucher, receipt
or invoice relating to the calculation of the royalty payments on Net
Sales.
Any such inspection of Newco's records shall be at the expense of [*],
except that if any such inspection reveals a deficiency in the amount of
the royalty actually paid to Elan hereunder in any Financial Year quarter
of [*]% or more of the amount of any royalty actually due to Elan
hereunder, then the expense of such inspection shall be borne solely by
[*]. [*] shall promptly pay to Elan any amount of deficiency.
If such inspection reveals a surplus in the amount of royalties actually
paid to Elan by Newco, Elan shall reimburse Newco the surplus within 15
days after determination.
6.2 In the event of any unresolved dispute regarding any alleged deficiency or
overpayment of royalty payments hereunder, the matter will be referred to
an independent firm of chartered accountants chosen by agreement of Incara
and Elan for a resolution of such dispute. Any decision by the said firm
of chartered accountants shall be binding on the Parties.
[*] Confidential Treatment Requested; Certain Information Omitted and Filed
Separately with the SEC.
15
7 REPRESENTATIONS AND WARRANTIES
7.1 Elan represents and warrants to Newco and Incara, as of the Effective Date,
as follows:
7.1.1 Elan has the right to grant the Elan License;
7.1.2 there are no agreements between Elan and any third party that
conflict with the Elan License;
7.1.3 there are no proceedings pending against Elan in connection with the
Elan Intellectual Property in relation to the Field.
7.2 In addition to any other indemnities provided for herein, Elan shall
indemnify and hold harmless Newco and its Affiliates and their respective
employees, agents, officers and directors from and against any claims,
losses, liabilities or damages (including reasonable attorney's fees and
expenses) incurred or sustained by Newco arising out of or in connection
with any:
7.2.1 breach of any representation, covenant, warranty or obligation by
Elan hereunder; or
7.2.2 negligent act or omission on the part of Elan or any of its
respective employees, agents, officers and directors in the
performance of this Agreement.
7.3 In addition to any other indemnities provided for herein, Newco shall
indemnify and hold harmless Elan and its Affiliates and their respective
employees, agents, officers and directors from and against any claims,
losses, liabilities or damages (including reasonable attorney's fees and
expenses) incurred or sustained by Elan arising out of or in connection
with any:
7.3.1 breach of any representation, covenant, warranty or obligation by
Newco hereunder; or
7.3.2 negligent act or omission on the part of Newco or any of its agents
or employees in the performance of this Agreement.
7.4 The Party seeking an indemnity shall:
7.4.1 fully and promptly notify the other Party of any claim or
proceeding, or threatened claim or proceeding;
7.4.2 permit the indemnifying Party to take full care and control of such
claim or proceeding;
7.4.3 co-operate in the investigation and defense of such claim or
proceeding;
16
7.4.4 not compromise or otherwise settle any such claim or proceeding
without the prior written consent of the other Party, which consent
shall not be unreasonably withheld conditioned or delayed; and
7.4.5 take all reasonable steps to mitigate any loss or liability in
respect of any such claim or proceeding.
7.5 EXCEPT AS SET FORTH IN THIS CLAUSE 7, ELAN IS GRANTING THE LICENSE
HEREUNDER ON AN "AS IS" BASIS WITHOUT REPRESENTATION OR WARRANTY WHETHER
EXPRESS OR IMPLIED INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE, OR INFRINGEMENT OF THIRD PARTY RIGHTS, AND ALL SUCH
WARRANTIES ARE EXPRESSLY DISCLAIMED.
7.6 NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, ELAN AND NEWCO
SHALL NOT BE LIABLE TO THE OTHER BY REASON OF ANY REPRESENTATION OR
WARRANTY, CONDITION OR OTHER TERM OR ANY DUTY OF COMMON LAW, OR UNDER THE
EXPRESS TERMS OF THIS AGREEMENT, FOR ANY CONSEQUENTIAL, SPECIAL OR
INCIDENTAL OR PUNITIVE LOSS OR DAMAGE (WHETHER FOR LOSS OF CURRENT OR
FUTURE PROFITS, LOSS OF ENTERPRISE VALUE OR OTHERWISE) AND WHETHER
OCCASIONED BY THE NEGLIGENCE OF THE RESPECTIVE PARTIES, THEIR EMPLOYEES OR
AGENTS OR OTHERWISE.
8. TERM AND TERMINATION
8.1 The term of this Agreement shall commence as of the Effective Date and
shall, subject to the rights of termination outlined in this Clause 8 and
to the provisions of applicable laws, expire on the last to occur of:
8.1.1 the date [*] within the Elan Intellectual Property and the Incara
Intellectual Property in the Territory; or
8.1.2 the date which is [*] years following the date of the first
commercial sale of a Product in the Territory
(the "Term").
8.2 If either Party commits a Relevant Event, the other Party shall have, in
addition to all other legal and equitable rights and remedies hereunder,
the right to terminate this Agreement upon 30 days' prior written notice to
the defaulting Party.
[*] Confidential Treatment Requested; Certain Information Omitted and Filed
Separately with the SEC.
17
8.3 For the purpose of this Clause 8, a "Relevant Event" is committed by a
Party if:
8.3.1 such Party commits a material breach of its representations,
warranties or obligations under this Agreement or the JDOA and fails
to cure it within [*] days of being specifically required in writing
to do so by the other Party; provided, that if the breaching Party
has proposed a course of action to cure the breach and is acting in
good faith to cure same but has not cured the breach by the [*] day,
such period shall be extended by such period as is reasonably
necessary to permit the breach to be cured, provided that such
period shall not be extended by more than [*] days, unless otherwise
agreed in writing by the Parties;
8.3.2 a distress, execution, sequestration or other process is levied or
enforced upon or sued out against a material part of its property
which is not discharged or challenged within [*] days;
8.3.3 it is unable to pay its debts in the normal course of business;
8.3.4 it ceases wholly or substantially to carry on its business,
otherwise than for the purpose of a reconstruction or amalgamation,
without the prior written consent of the other Party (such consent
not to be unreasonably withheld) ;
8.3.5 the appointment of a liquidator, receiver, administrator, examiner,
trustee or similar officer of such Party or over all or
substantially all of its assets under the law of any applicable
jurisdiction, including without limitation, the United States of
America, Bermuda or Ireland;
8.3.6 an application or petition for bankruptcy, corporate re-
organisation, composition, administration, examination, arrangement
or any other procedure similar to any of the foregoing under the law
of any applicable jurisdiction, including without limitation, the
United States of America, Bermuda or Ireland, is filed, and is not
discharged within [*] days, or a Party applies for or consents to
the appointment of a receiver, administrator, examiner or similar
officer of it or of all or a material part of its assets, rights or
revenues or the assets and/or the business of a Party are for any
reason seized, confiscated or condemned.
8.4 Elan shall be entitled to forthwith terminate this Agreement by notice in
writing to Incara in the event of a Change of Control of Incara/Newco
provided that the foregoing right shall not be triggered by the exercise by
Elan of any options granted by the Definitive Documents.
Incara and Newco shall promptly notify Elan in writing of the occurrence of
a Change of Control of Incara/Newco.
[*] Confidential Treatment Requested; Certain Information Omitted and Filed
Separately with the SEC.
18
8.5 Upon expiration or termination of the Agreement:
8.5.1. any sums that were due from Newco to Elan on Net Sales in the
Territory or in such particular country or countries in the
Territory (as the case may be) prior to the expiration or
termination of this Agreement as set forth herein shall be paid in
full within 60 days after the expiration or termination of this
Agreement for the Territory or for such particular country or
countries in the Territory (as the case may be);
8.5.2 any provisions that expressly survive termination or expiration of
this Agreement, including without limitation this Clause 8, shall
remain in full force and effect;
8.5.3 all representations, warranties and indemnities shall insofar as are
appropriate remain in full force and effect;
8.5.4 the rights of inspection and audit set out in Clause 6 shall
continue in force for a period of [*];
8.5.5 subject to Clause 8.5.7, all rights and licenses granted to Newco
pursuant to this Agreement and to the Elan Intellectual Property
pursuant to the JDOA (including the rights of Newco pursuant to
Clause 10 of the JDOA) shall cease for the Territory or for such
particular country or countries in the Territory (as the case may
be) and shall revert to or be transferred to Elan, and Newco shall
not thereafter use in the Territory or in such particular country or
countries in the Territory (as the case may be) any rights covered
by this Agreement;
8.5.6 all rights to Newco Intellectual Property shall be assigned to and
jointly owned by Incara and Elan and may be exploited by both Elan
and Incara separately provided that Elan and Incara shall co-operate
reasonably in the prosecution and maintenance of patents claiming
such technology and rights and provided further that nothing
hereunder shall grant, or be construed to grant, a license to the
other party under the Elan Intellectual Property or the Incara
Intellectual Property; and
8.5.7 the rights of permitted third party sub-licensees in and to the Elan
Intellectual Property shall survive the termination of the license
and sublicense agreements granting said intellectual property rights
to Newco; and Newco, Elan and Incara shall in good faith agree upon
the form most advantageous to Elan and Incara in which the rights of
Newco under any such licenses and sublicenses are to be held (which
form may include continuation of Newco solely as the holder of such
licenses or assignment of such rights to a third party or parties,
including an assignment to both Elan and Incara).
[*] Confidential Treatment Requested; Certain Information Omitted and Filed
Separately with the SEC.
19
Any sublicense agreement between Newco and such permitted sublicensee
shall, inter alia, permit such an assignment of rights by Newco to
Elan and shall contain appropriate confidentiality provisions.
9 CONFIDENTIAL INFORMATION
9.1 The Parties agree that it will be necessary, from time to time, to disclose
to each other confidential and proprietary information, including without
limitation, inventions, works of authorship, trade secrets, specifications,
designs, data, know-how and other proprietary information relating to the
Field, the Products, processes, services and business of the disclosing
Party.
The foregoing shall be referred to collectively as "Confidential
Information".
9.2 Any Confidential Information disclosed by one Party to another Party shall
be used by the receiving Party exclusively for the purposes of fulfilling
the receiving Party's obligations under this Agreement and the JDOA and for
no other purpose.
9.3 Save as otherwise specifically provided herein, each Party shall disclose
Confidential Information of the other Party only to those employees,
representatives and agents requiring knowledge thereof in connection with
fulfilling the Party's obligations under this Agreement. Each Party
further agrees to inform all such employees, representatives and agents of
the terms and provisions of this Agreement relating to Confidential
Information and their duties hereunder and to obtain their agreement hereto
as a condition of receiving Confidential Information. Each Party shall
exercise the same standard of care as it would itself exercise in relation
to its own confidential information (but in no event less than a reasonable
standard of care) to protect and preserve the proprietary and confidential
nature of the Confidential Information disclosed to it by the other Party.
Each Party shall, upon request of the other Party, return all documents and
any copies thereof containing Confidential Information belonging to, or
disclosed by, such other Party.
9.4 Any breach of this Clause 9 by any person informed by one of the Parties is
considered a breach by the Party itself.
9.5 Confidential Information shall be deemed not to include:
9.5.1 information that is in the public domain;
9.5.2 information which is made public through no breach of this
Agreement;
9.5.3 information which is independently developed by a Party as evidenced
by such Party's records;
9.5.4 information that becomes available to a Party on a non-confidential
basis, whether directly or indirectly, from a source other than a
Party, which source did not acquire this information on a
confidential basis; or
20
9.6 The receiving Party will be entitled to disclose Confidential Information
which the receiving Party is required to disclose pursuant to:
9.6.1 a valid order of a court or other governmental body; or
9.6.2 any other requirement of law;
provided that if the receiving Party becomes legally required to disclose
any Confidential Information, the receiving Party shall give the disclosing
Party prompt notice of such fact so that the disclosing Party may obtain a
protective order or other appropriate remedy concerning any such
disclosure. The receiving Party shall fully co-operate with the disclosing
Party in connection with the disclosing Party's efforts to obtain any such
order or other remedy. If any such order or other remedy does not fully
preclude disclosure, the receiving Party shall make such disclosure only to
the extent that such disclosure is legally required.
9.7 The provisions relating to confidentiality in this Clause 9 shall remain in
effect during the term of this Agreement, and for a period of [*] years
following the expiration or earlier termination of this Agreement.
9.8 The Parties agree that the obligations of this Clause 9 are necessary and
reasonable in order to protect the Parties' respective businesses, and each
Party agrees that monetary damages would be inadequate to compensate a
Party for any breach by the other Party of its covenants and agreements set
forth herein.
Accordingly, the Parties agree that any such violation or threatened
violation shall cause irreparable injury to a Party and that, in addition
to any other remedies that may be available, in law and equity or
otherwise, each Party shall be entitled to obtain injunctive relief against
the threatened breach of the provisions of this Clause 9, or a continuation
of any such breach by the other Party, specific performance and other
equitable relief to redress such breach together with its damages and
reasonable counsel fees and expenses to enforce its rights hereunder,
without the necessity of proving actual or express damages.
10 GOVERNING LAW AND JURISDICTION
10.1 This Agreement shall be governed by and construed in accordance with the
laws of the State of New York.
10.2 The Parties will attempt in good faith to resolve any dispute arising out
of or relating to this Agreement promptly by negotiation between executives
of the Parties. In the event that such negotiations do not result in a
mutually acceptable resolution within 60 days of the commencement of such
negotiations, the Parties agree to consider other dispute resolution
mechanisms including mediation.
[*] Confidential Treatment Requested; Certain Information Omitted and Filed
Separately with the SEC.
21
In the event that the Parties fail to agree on a mutually acceptable
dispute resolution mechanism within 10 days of either Party's demand for
such alternative dispute resolution, or in the event that the dispute is
not resolved pursuant to any dispute resolution mechanism agreed by the
Parties within 6 months, save as otherwise agreed by the Parties, any such
dispute shall be finally settled by the courts of competent jurisdiction.
For the purposes of this Agreement the parties submit to the non-exclusive
jurisdiction of the courts of the State and Federal Courts located in the
State, City and County of New York.
11 IMPOSSIBILITY OF PERFORMANCE - FORCE MAJEURE
Neither Elan nor Newco shall be liable for delay in the performance of any
of its obligations hereunder if such delay results from causes beyond its
reasonable control, including, without limitation, acts of God, fires,
strikes, acts of war, intervention of a government authority, but any such
delay or failure shall be remedied by such Party as soon as practicable.
12 ASSIGNMENT
This Agreement may not be assigned by either Party without the prior
written consent of the other, save that either Party may assign this
Agreement to its Affiliates or subsidiaries without such prior written
consent; provided that such assignment does not have any adverse tax
consequences on the other Party.
13 NOTICES
13.1 Any notice to be given under this Agreement shall be sent in writing in
English by registered or recorded delivery post or reputable overnight
courier or telefaxed to the following addresses:
If to Newco at:
Xxxxxxxxx Xxxxx,
0 Xxxxxx Xx,
Xxxxxxxx,
Xxxxxxx.
Attention: Secretary
Telephone: 000 000 0000
Fax: 000 000 0000
with a copy to Incara at:
0000 Xxxx Xxxxxxx 00,
Xxxx: Chief Executive Officer
Xxxxx 000,
00
X.X.Xxx 00000,
Xxxxxxxx Xxxxxxxx Xxxx,
Xxxxx Xxxxxxxx 00000
XXX.
Attn: Chief Executive Officer
Telephone 000 000 000 0000
Fax: 000 000 000 0000
with a copy to:
Xxxxxx Xxxxxxx Xxxxx Xxxxxx LLP,
0000 Xxxx Xxxxx Xxxxx,
Xxxxx 000,
Xxxxxxx,
XX 00000.0000, XXX.
Attention: Xxxxx X. Xxxxxxx
Telephone 000 000 000 0000
Fax: 000 000 000 0000
If to Elan at:
c/o Elan International Services, Ltd.,
000 Xx. Xxxxx Xxxxx,
Xxxxxx, Xxxxxx XX00,
Bermuda.
Attention: President
Telephone: 000-000-0000
Fax: 000-000-0000
or to such other address(es) and telefax numbers as may from time to time
be notified by either Party to the other hereunder.
13.2 Any notice sent by mail shall be deemed to have been delivered within 7
working days after dispatch or delivery to the relevant courier and any
notice sent by telefax shall be deemed to have been delivered upon
confirmation of receipt. Notice of change of address shall be effective
upon receipt. Notices by telefax shall also be sent by another method
permitted hereunder.
14 MISCELLANEOUS
14.1 Waiver:
-------
No waiver of any right under this Agreement shall be deemed effective
unless
23
contained in a written document signed by the Party charged with
such waiver, and no waiver of any breach or failure to perform shall be
deemed to be a waiver of any other breach or failure to perform or of any
other right arising under this Agreement.
14.2 Severability:
-------------
If any provision in this Agreement is agreed by the Parties to be, or is
deemed to be, or becomes invalid, illegal, void or unenforceable under any
law that is applicable hereto:
14.2.1 such provision will be deemed amended to conform to applicable laws
so as to be valid and enforceable; or
14.2.2 if it cannot be so amended without materially altering the
intention of the Parties, it will be deleted, with effect from the
date of such agreement or such earlier date as the Parties may
agree, and the validity, legality and enforceability of the
remaining provisions of this Agreement shall not be impaired or
affected in any way.
14.3 Further Assurances:
-------------------
At the request of any of the Parties, the other Party or Parties shall (and
shall use reasonable efforts to procure that any other necessary parties
shall) execute and perform all such documents, acts and things as may
reasonably be required subsequent to the signing of this Agreement for
assuring to or vesting in the requesting Party the full benefit of the
terms hereof.
14.4 Successors:
-----------
This Agreement shall be binding upon and enure to the benefit of the
Parties hereto, their successors and permitted assigns.
14.5 No Effect on Other Agreements/Conflict:
---------------------------------------
No provision of this Agreement shall be construed so as to negate, modify
or affect in any way the provisions of any other agreement between the
Parties unless specifically referred to, and solely to the extent provided
herein.
In the event of a conflict between the provisions of this Agreement and the
provisions of the JDOA, the terms of the JDOA shall prevail unless this
Agreement specifically provides otherwise.
14.6 Amendments:
-----------
No amendment, modification or addition hereto shall be effective or binding
on any Party unless set forth in writing and executed by a duly authorized
representative of each Party.
24
14.7 Counterparts:
-------------
This Agreement may be executed in any number of counterparts, each of
which when so executed shall be deemed to be an original and all of which
when taken together shall constitute this Agreement.
14.8 Good Faith:
-----------
Each Party undertakes to act reasonably in giving effect to the provisions
of this Agreement.
14.9 No Reliance:
------------
Each Party hereby acknowledges that in entering into this Agreement it has
not relied on any representation or warranty save as expressly set out
herein or in any document referred to herein.
14.10 Relationship of the Parties:
----------------------------
Nothing contained in this Agreement is intended or is to be construed to
constitute Elan and Newco as partners, or Elan as an employee of Newco, or
Newco as an employee of Elan.
Neither Party hereto shall have any express or implied right or authority
to assume or create any obligations on behalf of or in the name of the
other Party or to bind the other Party to any contract, agreement or
undertaking with any third party.
14.11 Whole Agreement:
----------------
This Agreement (including the Schedules attached hereto) and the
Definitive Documents set forth all of the agreements and understandings
between the Parties with respect to the subject matter hereof, and
supersede and terminate all prior agreements and understandings between
the Parties with respect to the subject matter hereof. There are no
agreements or understandings with respect to the subject matter hereof,
either oral or written, between the Parties other than as set forth in
this Agreement and the Definitive Documents.
25
Schedule 1
----------
The Compound
------------
OP2000 STRUCTURE
[*]
[*] Confidential Treatment Requested; Certain Information Omitted and Filed
Separately with the SEC.
26
Schedule 2
----------
Elan Patents
------------
CONTINUOUS SYSTEM
[*]
BOLUS SYSTEM
[*]
updated as of 11/29/00
[*] Confidential Treatment Requested; Certain Information Omitted and Filed
Separately with the SEC.
27
Schedule 3
----------
Technological Competitors of Elan
---------------------------------
[*]
Including any and all divisions or subsidiaries of such entities and
successor entities.
[*] Confidential Treatment Requested; Certain Information Omitted and Filed
Separately with the SEC.
28
IN WITNESS WHEREOF the Parties hereto have executed this Agreement.
/s/ Xxxxx Xxxxxx
----------------
SIGNED BY
for and on behalf of
ELAN CORPORATION, PLC
/s/ Xxxxx Xxxxxx
----------------
SIGNED BY
for and on behalf of
ELAN PHARMA INTERNATIONAL LTD.
/s/ Xxxxxxx X. Xxxxxxxx
-----------------------
SIGNED BY
For and on behalf of
INCARA DEVELOPMENT, LTD.
/s/ Xxxxxxx X. Xxxxxx
---------------------
AGREED TO AND ACCEPTED BY
INCARA PHARMACEUTICALS CORPORATION
29
