EXHIBIT 10.59
Execution copy
- --------------
LICENSE AGREEMENT
BETWEEN
INCARA PHARMACEUTICALS CORPORATION
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 INCARA 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) 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 3200 East Highway
54, Cape Fear Building, Suite 300, Research Triangle Park, North Carolina
27709, United States of America;
(2) Incara Development, Ltd., an exempted limited liability company
incorporated under the laws of Bermuda and having its registered office at
Clarendon House, 2 Church St., Hamilton, Bermuda ("Newco"); and
(3) Elan Corporation, plc., a public limited company incorporated under the
laws of Ireland, and having its registered office at Lincoln House, Lincoln
Place, Dublin 2.
RECITALS:
- ---------
A. Simultaneously herewith, Elan, Incara, EIS, EPIL 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 Incara so as to permit
Newco to utilize the Incara 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 Elan are entering into the Elan License
Agreement relating to Newco's use of the Elan 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 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).
3
"Business Plan" shall have the meaning, as such term is defined in the
JDOA.
"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.
"Definitive Documents" shall mean the definitive agreements relating to the
transaction including finance, stock purchase, research and license
agreements.
"Effective Date" shall mean the date of this Agreement.
"EIS" shall mean Elan International Services, Ltd., a Bermuda exempted
limited liability company having its registered office at Clarendon House,
2 Church St., Hamilton, Bermuda.
"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 have the meaning as such term is defined in the
Elan License Agreement.
"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 have the meaning as such term is defined in the Elan
License Agreement.
"Elan License" shall have the meaning set forth in Clause 2.1 of the Elan
License Agreement.
"Elan License Agreement" shall mean that certain license agreement, of even
date herewith, entered into between Elan and Newco.
4
"Elan Patents" shall have the meaning as such term is defined in the Elan
License Agreement.
"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 Exhibit A 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 or obtained or licensed by Incara
relating to the Compound as set forth in Schedule 2, and any foreign
counterparts thereof and all divisionals, continuations, continuations-in-
part, any foreign counterparts thereof 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.
"Incara Exhibit B 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 or obtained or licensed by Incara
relating to the Compound as set forth in Schedule 3, and any foreign
counterparts thereof and all divisionals, continuations, continuations-in-
part, any foreign counterparts thereof 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.
"Incara Improvements" shall mean improvements to the Incara Exhibit A
Patents,
5
the Incara Exhibit B Patents and/or the Incara Know-How, developed (i) by
Incara outside the Project, (ii) by Incara, Elan or Newco or by a third
party (under contract with Newco) pursuant to the Project, and/or (iii)
jointly by any combination of Incara, Elan, 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, Incara Improvements shall constitute
part of Incara Intellectual Property and be included in the sublicense of
the Incara Intellectual Property pursuant to Clause 2.1 solely for the
purposes set forth therein. If the inclusion of a Incara Improvement in
the license of Incara Intellectual Property is restricted or limited by a
third party agreement, Incara shall use reasonable commercial efforts to
minimize any such restriction or limitation.
"Incara Intellectual Property" shall mean the Incara Know-How, the Incara
Patents and the Incara Improvements.
"Incara Know-How" shall mean, subject to Clause 4.3, any and all rights
owned, licensed or controlled by Incara to any scientific, pharmaceutical
or technical information, data discovery, invention (whether patentable or
not), know-how, substances, techniques, processes, systems, formulations
and designs and expertise relating to the Compound which is not generally
known to the public.
"Incara License Agreement" shall mean the license agreement to be entered
into by Incara and Newco on the Effective Date.
"Incara Patents" shall mean the Incara Exhibit A Patents and the Incara
Exhibit B Patents.
"Incara Sublicense" shall have the meaning set forth in Clause 2.1.
"Incara Trademark(s)" shall mean one or more trademarks, trade names, or
service marks that are owned or licensed by or on behalf of Incara which
Incara may nominate and approve in writing from time to time for use in
connection with the sale or promotion of the Products by Newco.
"JDOA" shall mean that certain subscription, joint development and
operating agreement, of even date herewith, by and between Incara, Elan,
EIS and Newco.
"Licensed Technologies" shall mean the Incara Intellectual Property and the
Elan Intellectual Property.
"Licenses" shall mean the Incara License and the Elan License.
"License Agreements" shall mean this Agreement and the Elan License
Agreement.
"Management Committee" shall have the meaning, as such term is defined in
the JDOA.
6
"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.
"Opocrin" shall mean Opocrin S.p.A., a corporation organized under the laws
of Italy.
"Opocrin Agreement" shall mean the License, Development, Marketing and
Clinical Trials Supply Agreement dated 20 July 1998 between Opocrin and
Incara (as amended by amendment agreement dated 15 September 2000).
"Party" shall mean Incara or Newco, as the case may be, and "Parties" shall
mean Incara and Newco.
"Product(s)" shall mean:
(i) the System containing or packaged with the Compound developed pursuant
to the Project; and/or
(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 Incara, Elan 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 have the meaning as such term is defined in the Elan License
Agreement.
"Term" shall have the meaning set forth in Clause 8.
7
"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.
2 INCARA SUBLICENSE TO NEWCO
2.1 In consideration of the mutual covenants contained herein and the
provisions of Clause 5.1, Incara hereby grants the following sublicenses to
Newco for the Term subject to the Opocrin Agreement:
2.1.1 [*] sublicense to the Incara Exhibit A Patents, the Incara Know-How
and the Incara Improvements (except to the extent comprising
improvements to the Incara Exhibit B Patents) to make, have made,
import, use, offer for sale and sell the Products in the Field in
the Territory; and
2.1.2 [*] sublicense to the Incara Exhibit B Patents and the Incara
Improvements which comprise improvements to the Incara Exhibit B
Patents to make, have made, import, use, offer for sale and sell the
Products in the Field in the Territory
(together the "Incara Sublicense").
If Opocrin licenses or otherwise grants any additional rights relating to
the Compound to Incara pursuant to the Opocrin Agreement (including but not
limited to the additional rights described in Clause 3.2 and Clause 3.3(a)
of the Opocrin Agreement), Incara shall forthwith grant Newco an
appropriate sublicense of such additional rights to make, have made,
import, use, offer for sale and sell the Products in the Field in the
Territory.
2.2 [*] shall be responsible for payments related to the financial provisions
and obligations of any third party agreement with respect to the Incara
Intellectual
[*] Confidential Treatment Requested; Certain Information Omitted and Filed
Separately with the SEC.
8
Property to which it is a party on the Effective Date (including amendments
thereto) (the "[*] Effective Date Agreements"), including any royalty or
other compensation obligations triggered thereunder on the Effective Date,
or triggered thereunder after the Effective Date, subject to the
following:.
2.2.1 [*] shall be responsible for payments related to the financial
provisions and obligations set forth in Clauses 4.1(b) and Clause
4.1(e) of the Opocrin Agreement;
2.2.2 [*] shall be responsible for payments related to the financial
provisions and obligations set forth in Clauses 4.1(c), Clause
4.1(d), Clause 4.1(f), Clause 4.1(g) and Clause 5.1 of the Opocrin
Agreement.
2.3 Elan 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 Incara.
2.4 Notwithstanding anything contained in this Agreement to the contrary,
Incara shall have the right outside the Field and subject to the [*]
provisions of Clause 4 to exploit and grant licenses and sublicenses of the
Incara Intellectual Property.
For the avoidance of doubt, Newco shall have no right to use the Incara
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 Incara
Intellectual Property without the prior consent in writing of Incara.
2.6 Any agreement between Newco and any permitted third party for the
development or exploitation of the Incara Intellectual Property shall
require such third party to maintain the confidentiality of all information
concerning the Incara Intellectual Property.
Insofar as the obligations owed by Newco to Incara are concerned, Newco
shall remain responsible for all acts and omissions of any permitted sub-
licensee, including Elan, as if they were acts and omissions by Newco.
2.7 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:
2.7.1 Newco and Elan shall confirm to Incara in writing that the Incara
License has terminated insofar as it previously related to the
Abandoned Compound; and
2.7.2 Incara 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.
[*] Confidential Treatment Requested; Certain Information Omitted and Filed
Separately with the SEC.
9
3 INTELLECTUAL PROPERTY
3.1 Ownership of Intellectual Property:
-----------------------------------
3.1.1 Newco shall own the Newco Intellectual Property.
3.1.2 Incara shall own the Incara Intellectual Property.
3.2 Trademarks:
-----------
3.2.1 Incara hereby grants to Newco for the Term [*] license to use the
Incara 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 Incara Trademarks by Incara to Newco hereunder:
(1) Newco shall ensure that each reference to and use of an Incara
Trademark by Newco is in a manner approved by Incara and
accompanied by an acknowledgement, in a form approved by
Incara, that the same is a trademark (or registered trademark)
of Incara.
From time to time, upon the reasonable request of Incara, Newco
shall submit samples of the Product to Incara or its duly
appointed agent to ensure compliance with quality standards and
specifications. Incara, 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 Incara Trademarks that fails to comply
with the quality standards and specifications referred to in
this Clause 3.2, as determined by Incara.
(2) Newco shall not use an Incara Trademark in any way which might
materially prejudice its distinctiveness or validity or the
goodwill of Incara therein.
(3) The parties recognize that the Incara Trademarks have
considerable goodwill associated therewith. Newco shall not use
in relation to the Products any trademarks other than the
Incara Trademarks (except the Elan Trademarks (as defined in
the Elan License Agreement) licensed to Newco under the Elan
License Agreement) without obtaining the prior consent in
writing of Incara, which consent may not be unreasonably
withheld. However, such use must not conflict with the use and
display of the Incara Trademark and such use and display must
be approved by Incara.
[*] Confidential Treatment Requested; Certain Information Omitted and Filed
Separately with the SEC.
10
(4) Newco shall not use in the Territory any trademarks or trade
names so resembling the Incara Trademark as to be likely to
cause confusion or deception.
(5) Newco shall promptly notify Incara in writing of any alleged
infringement or unauthorized use of which it becomes aware by a
third party of the Incara Trademarks and provide Incara with
any applicable evidence of infringement or unauthorized use.
(6) Newco shall favorably consider promoting and using the Incara
Trademarks in each country of the Territory and provide proof
of such use upon request by Incara.
(7) Newco shall not be permitted to assign or sublicense any of its
rights under the Incara Trademarks without the prior written
consents of Incara.
3.2.2 Incara may, at its sole discretion and expense, file and prosecute
applications to register and maintain registrations of the Incara
Trademarks in the Territory. Newco shall reasonably co-operate with
Incara in such efforts.
3.2.3 Incara will be entitled to conduct all enforcement proceedings
relating to the Incara Trademarks and shall at its sole discretion
decide what action, if any, to take in respect to any enforcement
proceedings of the Incara Trademarks or any other claim or counter-
claim brought in respect to the use or registration of the Incara
Trademarks. Any such proceedings shall be conducted at Incara's
expense and for its own benefit. Newco and Elan shall reasonably
cooperate with Incara in such efforts.
3.2.4 Newco shall promptly notify Incara in writing in the event that any
Incara 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 Incara shall have the
first right to decide whether or not to defend such allegations, or
to adopt an alternative mark. If Incara decides not defend the
Incara Trademark, then Newco may request Incara to defend the Incara
Trademark, at Newco's expense, unless such requested defense is
believed by Incara to be unsubstantiated and without merit. In such
a case, Incara may elect not to initiate defense proceedings.
3.2.5 Newco will have no ownership rights in respect of the Incara
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 Incara.
3.2.6 Nothing in this Agreement shall be construed as a warranty on the
part of Incara regarding the Incara Trademarks, including without
limitation, that use
11
of the Incara Trademarks in the Territory will not infringe the
rights of any third parties. Accordingly, Newco acknowledges and
agrees that Incara makes no such warranty.
3.2.7 Incara assumes no liability 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 Incara Trademarks
pursuant to this Agreement.
4 [*] AFTER ACQUIRED TECHNOLOGY
4.1 [*]
4.2 [*]
4.3 If, after the Effective Date, Incara:
4.3.1 licenses or otherwise acquires from a third party know-how or patent
rights relating to the Incara 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 Incara Intellectual Property in the
Field in the Territory;
("After Acquired Technology")
Incara 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, Incara 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 Royalties:
----------
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 Incara and Elan Corp and EPIL, and [*] by
Incara and Elan Corp and EPIL [*] with Incara's and EIS' [*].
[*] Confidential Treatment Requested; Certain Information Omitted and Filed
Separately with the SEC.
12
At such time, the Management Committee will agree on an appropriate
definition of "Net Sales" as such term is used in this Agreement.
The provisions set forth in Clauses 5.2 to 5.7 and 6 relate to the payment
of any royalties which the Management Committee may determine to be payable
by Newco to Incara under this Agreement.
5.2 Payment of royalties pursuant to Clause 5.1 shall be made [*] in arrears
during each Financial Year within 30 days after the expiry of the [*]. The
method of payment shall be by wire transfer to an account specified by
Incara. Each payment made to Incara shall be accompanied by a true
accounting of all Products sold by Newco's permitted sublicensees, if any,
during such [*].
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.
5.3 Newco shall maintain and keep clear, detailed, complete, accurate and
separate records for a period of [*] years:
5.3.1 to enable any royalties on Net Sales that shall have accrued
hereunder to be determined; and
5.3.2 to enable any deductions made in the Net Sales calculation to be
determined.
5.4 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.
5.5 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
Incara the amount of such royalties. In the 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 Incara's account in a bank acceptable to
Incara in the country the currency of which is involved or as otherwise
agreed by the Parties.
[*] Confidential Treatment Requested; Certain Information Omitted and Filed
Separately with the SEC.
13
5.6 Incara 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.
5.7 Any taxes payable by Incara on any payment made to Incara pursuant to this
Agreement shall be for the account of Incara. 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 Incara 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 Incara, Newco shall permit Incara 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 Incara hereunder in any Financial Year quarter
of [*]% or more of the amount of any royalty actually due to Incara
hereunder, then the expense of such inspection shall be borne solely by
[*]. [*] shall promptly pay to Incara any amount of deficiency.
If such inspection reveals a surplus in the amount of royalties actually
paid to Incara by Newco, Incara 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 Elan
and Incara for a resolution of such dispute. Any decision by the said firm
of chartered accountants shall be binding on the Parties.
7 REPRESENTATIONS AND WARRANTIES
7.1 Incara represents and warrants to Newco and Elan, as of the Effective Date,
as follows:
7.1.1 Incara has the right to grant the Incara Sublicense and Incara has
obtained all necessary consents under the Opocrin Agreement;
[*] Confidential Treatment Requested; Certain Information Omitted and Filed
Separately with the SEC.
14
7.1.2 there are no agreements between Incara and any third party that
conflict with the Incara Sublicense;
7.1.3 there are no proceedings pending against Incara in connection with
the Incara Intellectual Property in relation to the Field;
7.1.4 the Compound falls within the claims of at least one claim of each
of the Incara Exhibit A Patents.
7.2 Incara further agrees and represents and warrants to Newco and Elan, as of
the Effective Date, as follows:
7.2.1 the Opocrin Agreement is valid and in full force and effect;
7.2.2 there are no existing or claimed defaults by Incara, and to Incara's
best knowledge by any other party, under any of the Opocrin
Agreement and no event, act or omission has occurred which (with or
without notice, lapse of time or the happening or occurrence of any
other event) would result in a default under the Opocrin Agreement
by Incara, or to Incara's best knowledge by any other party;
7.2.3 during the Term, Incara will fully comply with all of the terms and
conditions of the Opocrin Agreement. Incara will enforce its rights
under the Opocrin Agreement and Incara will not assign its rights
under the Opocrin Agreement (other than to Elan pursuant to the
Incara License Agreement); and
7.2.4 during the Term, Incara will keep Newco and Elan fully informed with
respect to Incara's transactions, arrangements and business under
the Opocrin Agreement that relate to Newco and/or the transactions
contemplated hereunder, and Incara shall provide Newco and Elan with
any written notices delivered by any party thereunder.
7.3 During the Term, Incara shall not amend, modify, or waive any of its rights
under the Opocrin Agreement in any manner that would have a material impact
on Newco without the prior written consent of the Management Committee (by
the unanimous vote of its members).
For the avoidance of doubt, Incara shall not terminate any of its rights
under the Opocrin Agreement without the prior written consent of the
Management Committee (by the unanimous vote of its members).
7.4 Subject to the provisions of Clause 2.2.2, Incara shall indemnify and hold
harmless Newco and Elan against all costs, claims and liabilities in
respect of any claims or proceedings which may be taken by Opocrin under
the Opocrin Agreement against Newco and/or Elan which arise from the
performance or non-performance by Incara of any of its obligations under
the Opocrin Agreement.
7.5 In addition to any other indemnities provided for herein, Incara shall
indemnify and hold harmless Newco and its Affiliates and their respective
employees, agents,
15
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:
7.5.1 breach of any representation, covenant, warranty or obligation by
Incara hereunder; or
7.5.2 negligent act or omission on the part of Incara or any of its
respective employees, agents, officers and directors in the
performance of this Agreement.
7.6 In addition to any other indemnities provided for herein, Newco shall
indemnify and hold harmless Incara 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 Incara arising out of or in connection
with any:
7.6.1 breach of any representation, covenant, warranty or obligation by
Newco hereunder; or
7.6.2 negligent act or omission on the part of Newco or any of its agents
or employees in the performance of this Agreement.
7.7 The Party seeking an indemnity shall:
7.7.1 fully and promptly notify the other Party of any claim or
proceeding, or threatened claim or proceeding;
7.7.2 permit the indemnifying Party to take full care and control of such
claim or proceeding;
7.7.3 co-operate in the investigation and defense of such claim or
proceeding;
7.7.4 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
7.7.5 take all reasonable steps to mitigate any loss or liability in
respect of any such claim or proceeding.
7.8 EXCEPT AS SET FORTH IN THIS CLAUSE 7, INCARA IS GRANTING THE INCARA
SUBLICENSE 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.
16
7.9 NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, INCARA 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
the provisions of applicable laws, expire on the last to occur of:
8.1.1 the date [*] within the Incara Intellectual Property and the Elan
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.
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;
[*] Confidential Treatment Requested; Certain Information Omitted and Filed
Separately with the SEC.
17
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 Upon expiration or termination of the Agreement:
8.4.1. any sums that were due from Newco to Incara 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);
8.4.2 any provisions that expressly survive termination or expiration of
this Agreement, including without limitation this Clause 8, shall
remain in full force and effect;
8.4.3 all representations, warranties and indemnities shall insofar as are
appropriate remain in full force and effect;
8.4.4 the rights of inspection and audit set out in Clause 6 shall
continue in force for a period of [*];
8.4.5 subject to Clause 8.4.7, all rights and licenses granted to Newco
pursuant to this Agreement and to the Incara 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 Incara, and Newco
[*] Confidential Treatment Requested; Certain Information Omitted and Filed
Separately with the SEC.
18
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;
8.4.6 all rights to Newco Intellectual Property shall be assigned to and
jointly owned by Elan and Incara and may be exploited by both Incara
and Elan 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 Incara Intellectual Property or the Elan
Intellectual Property; and
8.5.7 the rights of permitted third party sub-licensees in and to the
Incara Intellectual Property shall survive the termination of the
license and sublicense agreements granting said intellectual
property rights to Newco; and Newco, Incara and Elan shall in good
faith agree upon the form most advantageous to Incara and Elan 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 Incara and
Elan).
Any sublicense agreement between Newco and such permitted
sublicensee shall permit an assignment of rights by Newco 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
19
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
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.
[*] Confidential Treatment Requested; Certain Information Omitted and Filed
Separately with the SEC.
20
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.
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 State and Federal Courts located in the State, City
and County of New York.
11 IMPOSSIBILITY OF PERFORMANCE - FORCE MAJEURE
Neither Incara 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.
21
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:
Clarendon House,
2 Church St,
Hamilton,
Bermuda.
Attention: Secretary
Telephone: 441 292 9169
Fax: 441 292 2224
If to Incara at:
3200 East Highway 54,
Cape Fear Building,
Suite 300,
P.O. Box 14287,
Research Triangle Park,
North Carolina 27709
USA.
Attn: Chief Executive Officer
Telephone 001 919 558 8688
Fax: 001 919 544 1245
with a copy to:
Wyrick Robbins Yates Ponton LLP,
4101 Lake Boone Trail,
Suite 300,
Raleigh,
NC 27607.7506,
USA
Attention: Larry E. Robbins
Telephone 001 919 781 4000
Fax: 001 919 781 4865
with a copy to Elan at:
22
c/o Elan International Services, Ltd.
102 St. James Court,
Flatts, Smiths FL04,
Bermuda.
Attention: President
Telephone: 441-292-9169
Fax: 441-292-2224
or to such other address(es) and telefax numbers as may from time to time
be notified by either Party to the other hereunder in the manner set forth
in Clause 13.2.
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 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
23
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.
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 Incara and Newco as partners, or Incara as an employee of
Newco, or Newco as an employee of Incara.
24
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
------------
[*]
[*] Confidential Treatment Requested; Certain Information Omittted and Filed
Separately with the SEC.
26
Schedule 2
----------
Incara Exhibit A Patents
------------------------
Patents and Patent Applications
. US Patent [*], dated [*]
. European Patent [*], dated [*]
(Also International [*])
[*]
[*] Confidential Treatment Requested; Certain Information Omitted and Filed
Separately with the SEC.
27
Schedule 3
----------
Incara Exhibit B Patents
------------------------
Patents and Patent Applications
Nonexclusive Grants
. US Patent [*] dated [*]
[*]
. US Patent [*] dated [*]
[*]
. European Patent Specification [*], dated [*]
[*]
. European Patent Specification [*], dated [*]
[*]
[*] Confidential Treatment Requested; Certain Information Omitted and Filed
Separately with the SEC.
28
IN WITNESS WHEREOF the Parties hereto have executed this Agreement.
/s/ Clayton I. Duncan
- ------------------------------------
SIGNED BY
for and on behalf of
INCARA PHARMACEUTICALS CORPORATION
/s/ Stephen J. Rossiter
- ------------------------------------
SIGNED BY
For and on behalf of
INCARA DEVELOPMENT, LTD.
/s/ Kevin Insley
- ------------------------------------
AGREED TO AND ACCEPTED BY
ELAN CORPORATION, PLC.
29