EXHIBIT 10.2
This copy of the Amended and Restated License Agreement has been redacted to
omit trade secrets and confidential commercial and financial information
("Confidential Information"). Text omissions are indicated by asterisks (i.e.,
"***") in the place of omitted text. Pagination of this version of the Amended
and Restated License Agreement differs from the non-redacted version due to the
textual omissions. Section and paragraph designations, however, have been
maintained.
Amended Elan License Agreement
Execution
January 15, 2002
AMENDED AND RESTATED LICENSE AGREEMENT
BETWEEN
ELAN CORPORATION, PLC
AND
GENEREX (BERMUDA) LTD.
TABLE OF CONTENTS
1 DEFINITIONS
2 ELAN LICENSE TO NEWCO
3 INTELLECTUAL PROPERTY
4 NON-COMPETITION/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
THIS AMENDED AND RESTATED LICENSE AGREEMENT made this __ day of January 2002
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; and
(2) Generex (Bermuda) 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.
RECITALS:
---------
A. Elan and Newco are parties to that certain Original Elan License
Agreement pursuant to which Elan licensed certain intellectual property
to Newco.
B. Newco and Elan desire to amend and restate the Original Elan License
Agreement in its entirety (i) so that Newco may utilize the Elan
Know-How, the Elan Patents, and Elan Improvements, as of the Effective
Date, in connection with the research, development, manufacture,
distribution and sale of Morphine in Field 1 in the Territory, and (ii)
to provide that the Elan License granted to Newco shall be [***], and
(iii) such other amendments to the Original Elan License Agreement as
to which the parties have agreed, subject to the terms and conditions
set forth herein.
C. Simultaneously herewith, Generex, Elan, EIS, and Newco are entering
into the Amended JDOA for the purpose of recording the amended 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.
D. Simultaneously herewith Newco and Generex are entering into the Amended
Generex License Agreement relating to Newco's use of the Generex
Intellectual Property.
1 DEFINITIONS
1.1 In this Amended Elan License Agreement unless the context otherwise
requires:
"Additional Compound" shall mean any Additional Compound that is
approved in writing by the Management Committee in accordance with
Clause 2.3 of the Amended JDOA.
"Affiliate" shall mean any corporation or entity controlling,
controlled or under the common control of Elan or Generex 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 [***] 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.
1
"After Acquired Technology" shall have the meaning as such term is
defined in Clause 4.
"Alternative Compound" shall mean the meaning as such term is defined
in Clause 2.4 of the Amended JDOA.
"Amended Elan License Agreement" shall mean this Amended and Restated
License Agreement (which expression shall be deemed to include the
Recitals and Schedules hereto).
"Amended Generex License Agreement" shall mean that certain Amended and
Restated License Agreement, of even date herewith, entered into between
Generex and Newco.
"Amended JDOA" shall mean that certain Amended And Restated
Subscription, Joint Development and Operating Agreement, of even date
herewith, by and between Elan, Generex, EIS and Newco.
"Amended License Agreements" shall mean this Amended Elan License
Agreement and the Amended Generex License Agreement.
"Buccal Delivery" shall mean the delivery of the majority of a dose of
a pharmaceutical agent to and through the tissues of the mouth and/or
throat.
"Business Plan" shall have the meaning, as such term is defined in the
Amended JDOA.
"Change of Control of Generex/Newco" shall mean circumstances where:
(a) a Technological Competitor of Elan shall, directly or
indirectly, (i) acquire [***] or more of the voting stock of
Generex or Newco, or otherwise control or influence in any
material respect their management or business; or (ii)
otherwise have entered into any joint venture, collaborative,
license or other arrangement with Generex or Newco, as the
case may be, to such an extent that such a Technological
Competitor of Elan controls or influences in any material
respect the business or management of Generex or Newco, as the
case may be; or
(b) a Strategic Investor shall, directly or indirectly, acquire
[***]% or more of the voting stock of Generex or Newco, or
otherwise control or influence in any material respect their
management or business; or
(c) any person or entity other than a Strategic Investor shall,
after [***], directly or indirectly, acquire [***] or more of
the then voting stock of Generex or Newco, or otherwise merge,
consolidate or enter into any similar transaction (or binding
agreement in respect thereof) with Generex or Newco.
2
"Closing Date" shall mean January 17, 2001.
"Compound" shall mean Morphine and/or any Additional Compound that is
approved in writing by the Management Committee in accordance with
Clause 2 of the Amended JDOA.
"Confidential Information" shall have the meaning, as such term is
defined in Clause 9.
"Definitive Documents" shall mean the definitive agreements relating to
the Project including finance and stock purchase agreements dated as of
January 16, 2001, the Amended JDOA and the Amended License Agreements.
"Effective Date" shall mean the date of this Amended Elan License
Agreement, as set forth above.
"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 Elan Corporation, plc. and the Affiliates of Elan
Corporation, plc. within the [***] Business Unit of the Elan Group.
[***]
"Elan Corp. Patents" shall mean the Elan Patents owned by Elan
Corporation, plc.
"Elan Group" shall mean all the Affiliates of Elan Corporation, plc.
"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, Generex or Newco or by a third party (under contract with Newco)
pursuant to the Project, and/or (iii) jointly by any combination of
Elan, Generex, 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.
[***]
3
"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 [***] 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 or obtained or licensed by Elan
relating to [***] as set forth in Schedule 1 (representing all existing
patents relating to the Project), 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" shall mean Elan Pharma International Ltd, a private limited
company incorporated under the laws of Ireland.
[***]
"Fields" shall mean Field 1 and Field 2.
"Field 1" shall mean the Buccal Delivery of Morphine for the treatment
of all types of pain.
"Field 2" shall mean the Buccal Delivery of any Additional Compound for
the treatment of prostate cancer and endometriosis and/or the
suppression of testosterone and estrogen.
"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.
"Generex" shall mean Generex Biotechnology Corporation, a Delaware
corporation, and its Affiliates.
4
"Generex Improvements" shall have the meaning as such term is defined
in the Amended Generex License Agreement.
"Generex Intellectual Property" shall have the meaning as such term is
defined in the Amended Generex License Agreement.
"Generex Know-How" shall have the meaning as such term is defined in
the Amended Generex License Agreement.
"Generex License" shall have the meaning set forth in Clause 2.1 of the
Amended Generex License Agreement.
"Generex Patents" shall have the meaning as such term is defined in the
Amended Generex License Agreement.
"In Market" shall mean the sale of the Product(s) in the Territory by
Newco or its Affiliates, or where applicable by a permitted
sub-licensee, to an unaffiliated third party such as: (i) the end-user
consumer of the Product(s); or (ii) a wholesaler, managed care
organization, hospital or pharmacy or other third party who effects the
final commercial sale to the end-user consumer of the Product(s), and
shall exclude the transfer pricing of the Product(s) by Newco to an
Affiliate or a sub-licensee.
"Licenses" shall mean the Elan License and the Generex License.
"Management Committee" shall have the meaning, as such term is defined
in the Amended JDOA.
[***]
"Morphelan(TM)" shall mean Elan's proprietary ingestible [***] form of
Morphine.
"Morphine" shall mean all forms of morphine, including, without
limitation, morphine sulfate; provided, however, that Morphelan(TM)
shall not be included.
[***]
"Net Sales" shall mean that sum determined by deducting the following
deductions from the aggregate gross In Market sales proceeds billed for
the Products by Newco or, its Affiliate or a permitted sub-licensee, as
the case may be:
[***]
"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 Generex Intellectual Property.
5
For the avoidance of doubt, (a) any preclinical and clinical data
and/or toxicity, stability and pharmacological data generated pursuant
to the Project (and that does not constitute Elan Intellectual Property
or Generex Intellectual Property) shall constitute Newco Intellectual
Property, and (b) any patent application filed by Newco, or by Elan or
Generex on behalf of Newco, and any patent issued thereon, to the
extent that it covers a Product shall constitute Newco Intellectual
Property.
"Original Elan License Agreement" shall mean the license agreement
between Elan and Newco, dated January 16, 2001.
"Original Generex License Agreement" shall mean the license agreement
between Generex and Newco, dated January 16, 2001
"Original License Agreements" shall mean the Original Elan License
Agreement and the Original Generex License Agreement.
"Party" shall mean Elan or Newco, as the case may be, and "Parties"
shall mean Elan and Newco.
[***]
"Product" shall mean an appropriate pharmaceutical formulation of the
Compound.
"Project" shall mean all activities as undertaken by Elan, Generex and
Newco in order to develop the Products pursuant to the Business Plan,
the R&D Plan and otherwise pursuant to the Amended JDOA.
"R&D Plan" shall have the meaning, as such term is defined in the
Amended JDOA.
"Strategic Investor" shall mean a person or entity investing in Generex
or Newco for strategic purposes as evidenced by, inter alia, being
engaged in one or more pharmaceutical businesses.
"Technological Competitor of Elan" shall mean a person or entity listed
in Schedule 2 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 Generex and Elan.
"Term" shall have the meaning set forth in Clause 8.
"Territory" shall mean all the countries of the world.
"United States Dollar" and "US$" shall mean the lawful currency for the
time being of the United States of America.
1.2 In this Amended Elan License 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.
6
1.2.2 Any reference to a Clause or Schedule shall, unless otherwise
specifically provided, be to a Clause or Schedule of this
Amended Elan License Agreement.
1.2.3 The headings of this Amended Elan License Agreement are for
ease of reference only and shall not affect its construction
or interpretation.
2 ELAN LICENSE TO NEWCO
2.1 Elan hereby grants to Newco for the Term, subject to Clause 2.5 of the
Amended JDOA, (i) [***] license to the Elan Intellectual Property to
make, have made, import, use, offer for sale and sell Products in Field
1 in the Territory, and (ii) [***] license to the Elan Intellectual
Property to make, have made, import, use, offer for sale and sell
Products in the Field 2, in the Territory, subject to any contractual
obligations that Elan has as of the Effective Date, including but not
limited to [***] (the "Elan License").
[***]
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 "Elan 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 Elan 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 Generex shall be a third party beneficiary under this Amended Elan
License Agreement and shall have the right to cause Newco to enforce
Newco's rights under this Amended Elan License Agreement against Elan.
2.4 Notwithstanding anything contained in this Amended Elan License
Agreement to the contrary, Elan shall have the right outside the Fields
[***] 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 Fields.
7
2.5 Except as provided in Clause 11 of the Amended 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 Generex, as if they were acts and omissions by
Newco.
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:
3.2.1 Elan hereby grants to Newco for the Term a [***] license to
use the Elan Trademarks solely in connection with the
distribution, sale and marketing of the Products in the Fields
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.
Prior to initial use and from time to time
thereafter, 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.
8
(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
Generex Trademarks (as defined in the Amended Generex
License Agreement) licensed to Newco under the
Amended Generex 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) In each country of the Territory in which Newco or
any third party on behalf of Newco intends to
commercialize a Product, Newco shall favorably
consider promoting and using the Elan Trademarks in
connection with such Product and, upon the request of
Newco, and provide proof of such promoting and/or
use.
(7) Newco shall not be permitted to assign or sublicense
any of its rights under the Elan Trademarks without
the prior written consent of Elan.
3.2.2 Elan may, at its sole discretion [***], 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.
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 [***] and for its own benefit. Newco and
Generex 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, [***], 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.
9
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
Amended Elan License 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 Amended Elan License 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 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 Elan
Trademarks pursuant to this Amended Elan License Agreement.
4 NON-COMPETITION/AFTER ACQUIRED TECHNOLOGY
4.1 Subject to Clause 4.2 and Clause 4.3 of this Amended Elan License
Agreement and Clause 2.5 of Amended JDOA, during the Term [***] shall
not, alone or in conjunction with a third party, [***].
For the avoidance of doubt, the non-compete obligation set forth in
this Clause 4 shall not prevent or restrict [***] from entering into
any agreement with any third party to [***].
4.2 The provisions of Clause 4.1:
4.2.1 shall not apply to After Acquired Technology;
4.2.2 shall not apply to patents and know-how that are licensed or
acquired by Elan or Generex from a third party after the
Effective Date (by merger or otherwise) but which do not
constitute After Acquired Technology; and
4.2.3 [***]
4.3 If, after the Effective Date, [***]:
4.3.1 licenses or otherwise acquires from a third party know-how or
patent rights relating to [***]; or
4.3.2 acquires or merges with a third party entity that has know-how
or patent rights relating to [***]
10
(collectively, "After Acquired Technology")
[***] shall offer to license the After Acquired Technology to Newco (if
permitted by and subject to existing contractual obligations, including
the terms of the acquisition agreement) solely to make, have made,
import, use, offer for sale and sell Products for use in the Fields, 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 determines that Newco should not acquire such license, [***]
shall be free to fully exploit the After Acquired Technology, whether
inside or outside the Fields, and to grant to third parties licenses
and sublicenses with respect thereto.
5 FINANCIAL PROVISIONS
5.1 License Fee:
In consideration of the license to Newco of the Elan Corp. Patents
under Clause 2, Newco paid to Elan Corporation, plc, upon execution of
the Original Elan License Agreement, a non-refundable license fee of
$[***](the "License Fee"), the receipt of which is hereby acknowledged
by Elan Corporation, plc.
The License Fee shall not be subject to future performance obligations
of Elan to Newco or Generex and shall not be applicable against future
services provided by Elan to Newco or Generex.
The terms of this Clause 5.1 relating to the License Fee are
independent and distinct from the other terms of this Amended Elan
License Agreement.
5.2 Royalties:
Prior to the commercialization of the Products, the Management
Committee shall consider and if appropriate, determine reasonable
royalties with respect to the commercialization of the Products by
Newco that shall be payable by Newco to Elan Corporation, plc and
Generex [***].
5.3 Payment of royalties pursuant to Clause 5.2 shall be made [***] in
arrears during each Financial Year within [***] 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 [***].
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.
11
5.4 Newco shall maintain and keep clear, detailed, complete, accurate and
separate records for a period of [***]:
5.4.1 to enable any royalties on Net Sales that shall have accrued
hereunder to be determined; and
5.4.2 to enable any deductions made in the Net Sales calculation to
be determined.
5.5 All payments due hereunder shall be made in United States Dollars.
Payments due on Net Sales of any Product for each [***] 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
[***] 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 [***].
5.6 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 event that Newco is prevented
from making any payment under this Amended Elan License 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
Amended Elan License Agreement shall be for the account of Elan. If so
required by applicable law, any payment made pursuant to this Amended
Elan License 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 Once during each Financial Year, or more often not to exceed quarterly
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 submitted to Elan.
12
Any such inspection of Newco's records shall be at the expense of Elan,
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 Newco. Newco 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 [***] 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 Generex and Elan 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 Elan represents and warrants to Newco and Generex, as of the Effective
Date with respect to the Elan Intellectual Property as it relates to
Morphine in Field 1 and shall be deemed to have represented and
warranted to Newco and Generex upon the date of approval of any
Compound by the Management Committee in accordance with Clause 2 of the
Amended JDOA with respect to the Elan Intellectual Property as it
relates to such Additional Compound, 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 [***]
7.1.4 [***]
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 Amended Elan License Agreement.
13
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 Amended Elan
License 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;
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 AMENDED ELAN LICENSE
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 AMENDED ELAN LICENSE
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.
14
8. TERM AND TERMINATION
8.1 The term of this Amended Elan License 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 of expiration or lapse of the last to expire or lapse
of patent rights or abandonment of the last patent
application, on a country by country basis, within the Elan
Intellectual Property and the Generex Intellectual Property;
or
8.1.2 the date which is [***] 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 Amended Elan License Agreement
upon [***] 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 Amended Elan License
Agreement or the Amended JDOA and fails to cure it within
[***] 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
[***], 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
[***];
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;
15
8.3.6 an application or petition for bankruptcy, corporate
re-organization, 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 60
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 Amended Elan License
Agreement by notice in writing to Generex in the event of a Change of
Control of Generex/Newco, provided that the foregoing right shall not
be triggered by the exercise by Elan of any options granted by the
Definitive Documents.
Generex and Newco shall promptly notify Elan in writing of the
occurrence of a Change of Control of Generex/Newco.
8.5 Upon expiration or termination of this Amended Elan License 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 Amended Elan License Agreement as set
forth herein shall be paid in full within [***] after the
expiration or termination of this Amended Elan License
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 Amended Elan License 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 Amended Elan License Agreement and to
the Elan Intellectual Property pursuant to the Amended JDOA
(including the rights of Newco pursuant to Clause 10 of the
Amended JDOA entitled "Intellectual Property Rights") 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 Amended Elan License Agreement;
16
8.5.6 subject to such license, if any, granted by Newco to Elan and,
if any, granted by Newco to Generex pursuant to the provisions
of Clause 11 of the Amended JDOA (entitled "Cross
Licensing/Exploitation of Products Outside the Fields"), all
rights to Newco Intellectual Property shall be assigned to and
jointly owned by Generex and Elan and may be exploited by both
Elan and Generex separately provided that Elan and Generex
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 Generex 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
Generex shall in good faith agree upon the form most
advantageous to Elan and Generex 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 Generex).
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 Fields, the Products, processes, services
and business ("Confidential Information") of the disclosing Party
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 Amended Elan
License Agreement and the Amended 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 Amended
Elan License Agreement. Each Party further agrees to inform all such
employees, representatives and agents of the terms and provisions of
this Amended Elan License 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
17
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 known to the public;
9.5.2 information that is made public through no breach of this
Amended Elan License Agreement;
9.5.3 information that is independently developed by a Party as
evidenced by such Party's records; or
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.
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 Amended Elan License
Agreement, and for a period of [***] following the expiration or
earlier termination of this Amended Elan License 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.
18
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.
9.9 For the avoidance of doubt, all Confidential Information of Newco
received by any Party hereunder (other than Newco) shall not be
disclosed by such Party to an Elan JV [***]; provided, however, that
Elan shall not be deemed to have breached this Clause 9.9 for
disclosure of such Confidential Information to senior personnel of Elan
who are bound by confidentiality provisions, but such personnel shall
have no right to further disclose such Confidential Information.
10 GOVERNING LAW AND JURISDICTION
10.1 This Amended Elan License Agreement shall be governed by and construed
in accordance with the laws of the State of New York, without regard to
principles of conflicts of law.
10.2 The Parties will attempt in good faith to resolve any dispute arising
out of or relating to this Amended Elan License Agreement promptly by
negotiation between executives of the Parties. In the event that such
negotiations do not result in a mutually acceptable resolution within
[***]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 [***]of either Party's demand for
such alternative dispute resolution, any such dispute shall be finally
settled by the courts of competent jurisdiction. For the purposes of
this Amended Elan License Agreement the parties submit to the [***]
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.
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12 ASSIGNMENT
This Amended Elan License Agreement may not be assigned by either Party
without the prior written consent of the other, save that either Party
may assign this Amended Elan License 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 Amended Elan License 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: [***]
Fax: [***]
with a copy to Generex at:
Generex Biotechnology Corporation
00 Xxxxxxx Xxxxxx, Xxxxx 000,
Xxxxxxx, Xxxxxxx
Xxxxxx X0X 0X0
Attn: Chief Executive Officer
Telephone [***]
Fax: [***]
with a copy to:
Xxxxxx Xxxxxxx Xxxxxx & Xxxxxxx. LLC
0000 Xxxxxx Xxxxxx
0xx Xxxxx
Xxxxxxxxxxxx, XX 00000
Attention: Xxxx X. Xxxx, Esq.
Telephone 000-000-0000
Fax: 000-000-0000
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If to Elan at:
c/o Elan International Services, Ltd.,
000 Xx. Xxxxx Xxxxx,
Xxxxxx, Xxxxxx XX00,
Bermuda.
Attention: President
Telephone: [***]
Fax: [***]
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 Amended Elan License 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 Amended
Elan License Agreement.
14.2 Severability:
If any provision in this Amended Elan License 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 Amended Elan License
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 Amended
Elan License Agreement for assuring to or vesting in the requesting
Party the full benefit of the terms hereof.
21
14.4 Successors:
This Amended Elan License 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 Amended Elan License 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 Amended Elan
License Agreement and the provisions of the Amended JDOA, the terms of
the Amended JDOA shall prevail unless this Amended Elan License
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 Amended Elan License 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
Amended Elan License Agreement.
14.8 Good Faith:
Each Party undertakes to act reasonably in giving effect to the
provisions of this Amended Elan License Agreement.
14.9 No Reliance:
Each Party hereby acknowledges that in entering into this Amended Elan
License 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 Amended Elan License 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.
22
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 Amended Elan License 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 Amended Elan License Agreement and the
Definitive Documents.
Nothing contained herein shall be deemed to negate any rights or
obligations of any of the Parties which have accrued between the
Closing Date and the Effective Date, save to the extent expressly
provided herein.
23
IN WITNESS WHEREOF the Parties hereto have executed this Amended Elan License
Agreement.
SIGNED
BY ______________________
for and on behalf of
Elan Corporation, plc
DATED: __ day of January 2002
SIGNED
BY ___________________
For and on behalf of
Generex Newco Limited
DATED: __ day of January 2002
AGREED TO AND ACCEPTED:
SIGNED
BY ___________________
For and on behalf of
Generex Biotechnology Corporation
DATED: __ day of January 2002
24
SCHEDULE 1
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ELAN PATENTS
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US Patent No. Title
=========================== ====================================================================================
[***] [***]
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[***] [***]
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[***] [***]
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[Total redaction for Schedule 1 is 1 page]
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SCHEDULE 2
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[****] [Total redaction for Schedule 2 is 1 page]
26
