Exhibit 10.3
Amended Generex License Agreement
Execution
Dated January 15, 2002
AMENDED AND RESTATED LICENSE AGREEMENT
BETWEEN
GENEREX BIOTECHNOLOGY CORPORATION
AND
GENEREX (BERMUDA), LTD.
TABLE OF CONTENTS
1 DEFINITIONS
2 GENEREX 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 as of this __ day of January
2002
between:
(1) Generex Biotechnology Corporation a corporation duly incorporated and
validly existing under the laws of Delaware; and
(2) Generex (Bermuda), Ltd. a Bermuda 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. Generex and Newco are parties to that certain Original Generex License
Agreement pursuant to which Generex licensed certain intellectual
property to Newco.
B. Newco and Generex desire to amend and restate the Original Generex
License Agreement in its entirety (i) so that Newco may utilize the
Generex Know-How, the Generex Patents, and Generex 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 Generex License granted to
Newco shall be exclusive, and (iii) such other amendments to the
Original Generex 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 Elan are entering into the Amended
Elan License Agreement relating to Newco's use of the Elan Intellectual
Property.
NOW THEREFORE, the Parties agree as follows:
1 DEFINITIONS
1.1 In this Amended Generex 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 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.
1
"After Acquired Technology" shall have the meaning as such term is
defined in Clause 4.
"Alternative Compound" shall have the meaning as such term is defined
in Clause 2.4 of the Amended JDOA.
"Amended Elan License Agreement" shall mean that certain Amended and
Restated License Agreement, of even date herewith, entered into between
Elan and Newco.
"Amended Generex License Agreement" shall mean this Amended and
Restated License Agreement (which expression shall be deemed to include
the Recitals and Schedules hereto).
"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 Generex License
Agreement and the Amended Elan 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 given to such term in the
Amended JDOA.
"Change of Control of Generex/Newco" shall have the meaning given to
such term in the Amended Elan License Agreement.
"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 given to such term 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 Generex 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.
2
"Elan" Elan Corporation, plc. and the Affiliates of Elan Corporation,
plc. within the Drug Delivery Business Unit of the Elan Group. For the
avoidance of doubt, "Elan" shall exclude the Excluded Entities.
"Elan Group" shall mean all the Affiliates of Elan Corporation, plc.
"Elan Improvements" shall have the meaning as such term is defined in
the Amended Elan License Agreement.
"Elan Intellectual Property" shall have the meaning as such term is
defined in the Amended Elan License Agreement.
"Elan Know-How" shall have the meaning as such term is defined in the
Amended Elan License Agreement.
"Elan License" shall have the meaning set forth in Clause 2.1 of the
Amended Elan License Agreement.
"Elan Patents" shall have the meaning as such term is defined in the
Amended Elan License Agreement.
"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.
"Xxx Xxxxx Agreement" shall mean the Development and License Agreement,
dated September 5, 2000, between Generex and Xxx Lilly and Company.
"EPIL" shall mean Elan Pharma International Limited, a private limited
company incorporated under the laws of Ireland.
"Excluded Entities" shall mean Neuralab Ltd.; and the Affiliates
(present and future) of Elan Corporation, plc. within the
Biopharmaceuticals Business Unit of Elan Corporation, plc, including,
without limitation, Elan Pharmaceuticals, Inc. and EPIL (only to the
extent that EPIL is the owner of patents, know-how or other
intellectual property or technology invented and/or developed within
the Biopharmaceutical Business Unit of the Elan Group).
"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.
3
"Field 2" shall mean the Buccal Delivery of an 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.
"Generex Improvements" shall mean improvements to the Generex Patents
and/or the Generex Know-How, developed (i) by Generex outside the
Project, (ii) by Generex, Elan or Newco or by a third party (under
contract with Newco) pursuant to the Project, and/or (iii) jointly by
any combination of Generex, 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, Generex Improvements shall
constitute part of Generex Intellectual Property and be included in the
license of the Generex Intellectual Property pursuant to Clause 2.1
solely for the purposes set forth therein. If the inclusion of a
Generex Improvement in the license of Generex Intellectual Property is
restricted or limited by a third party agreement, Generex shall use
reasonable commercial efforts to minimize any such restriction or
limitation.
"Generex Intellectual Property" shall mean the Generex Know-How, the
Generex Patents and the Generex Improvements.
"Generex Know-How" shall mean, subject to Clause 4.3, any and all
rights owned, licensed or controlled by Generex 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
all Compounds and/or the Buccal Delivery of Compounds and the
RapidMist(TM) Device which is not generally known to the public.
For the avoidance of doubt, Generex Know-How shall include any
pre-clinical and clinical data and/or toxicity, stability and
pharmacological data generated pursuant to proof of concept studies
conducted or initiated by Generex prior to the Effective Date of the
Buccal Delivery of pharmaceutical formulations of Morphine and animal
studies conducted or initiated by Generex prior to the Effective Date
of the Buccal Delivery of pharmaceutical formulations of Morphine,
including animal safety studies.
"Generex License" shall have the meaning set forth in Clause 2.1.
"Generex 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 Generex
relating to all Compounds and/or the Buccal Delivery of Compounds and
the RapidMist(TM) Device as set forth in Schedule 1, 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.
4
"Generex Trademark(s)" shall mean one or more trademarks, trade names,
or service marks that are owned or licensed by or on behalf of Generex
which Generex may nominate and approve in writing from time to time for
use in connection with the sale or promotion of the Products by Newco.
"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:
(i) transportation charges or allowances, if any, included in such
price;
(ii) trade, quantity or cash discounts, broker's or agent's
commissions, if any, allowed or paid;
(iii) credits or allowances, if any, given or made on account of
price adjustments, returns, promotional discounts, rebates and
any and all federal, state or local government rebates whether
in existence now or enacted at any time during the term of the
Licenses; and
(iv) any tax, excise or governmental charge upon or measured by the
sale, transportation, delivery or use of the Products.
5
"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.
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 Generex or Newco, as the case may be, and "Parties"
shall mean Generex and Newco.
"Product" shall mean an appropriate pharmaceutical formulation of a
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.
"RapidMist(TM) Device" shall mean a hand-held, propellant powered
aerosol spray device developed and supplied by Generex that is used to
deliver a pharmaceutical formulation to the buccal cavity.
"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 have the meaning as such term
is defined in the Amended Elan License Agreement.
"Term" shall have the meaning set forth in Clause 8.
"Territory" shall mean all the countries of the world.
6
"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 Generex 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.
1.2.2 Any reference to a Clause or Schedule shall, unless otherwise
specifically provided, be to a Clause or Schedule of this
Amended Generex License Agreement.
1.2.3 The headings of this Amended Generex License Agreement are for
ease of reference only and shall not affect its construction
or interpretation.
2 GENEREX LICENSE TO NEWCO
2.1 Generex hereby grants to Newco for the Term, subject to Clause 2.5 of
the Amended JDOA, (i) an exclusive license to the Generex Intellectual
Property to make, have made, import, use, offer for sale and sell
Products in Field 1 in the Territory, and (ii) a non-exclusive license
to the Generex Intellectual Property to make, have made, import, use,
offer for sale and sell Products in the Field 2, in the Territory (the
"Generex License").
2.2 Generex shall be responsible for payments related to the financial
provisions and obligations of any third party agreement with respect to
the Generex Intellectual Property to which Generex is a party on the
Effective Date (including amendments thereto) including any royalty or
other compensation obligations.
2.3 Elan shall be a third party beneficiary under this Amended Generex
License Agreement and shall have the right to cause Newco to enforce
Newco's rights under this Amended Generex License Agreement against
Generex.
2.4 Notwithstanding anything contained in this Amended Generex License
Agreement to the contrary, Generex shall have the right outside the
Fields and subject to the non-competition provisions of Clause 4 to
exploit and grant licenses and sublicenses of the Generex Intellectual
Property.
For the avoidance of doubt, Newco shall have no right to use the
Generex Intellectual Property outside the Fields.
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
Generex Intellectual Property without the prior consent in writing of
Generex.
7
2.6 Any agreement between Newco and any permitted third party for the
development or exploitation of the Generex Intellectual Property shall
require such third party to maintain the confidentiality of all
information concerning the Generex Intellectual Property.
Insofar as the obligations owed by Newco to Generex 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.
3 INTELLECTUAL PROPERTY
3.1 Ownership of Intellectual Property:
3.1.1 Newco shall own the Newco Intellectual Property.
3.1.2 Generex shall own the Generex Intellectual Property.
3.2 Trademarks:
3.2.1 Generex hereby grants to Newco for the Term a non-exclusive,
royalty free license to use the Generex 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 Generex
Trademarks by Generex to Newco hereunder:
(1) Newco shall ensure that each reference to and use of
a Generex Trademark by Newco is in a manner approved
by Generex and accompanied by an acknowledgement, in
a form approved by Generex, that the same is a
trademark (or registered trademark) of Generex.
Prior to initial use and from time to time
thereafter, upon the reasonable request of Generex,
Newco shall submit samples of the Product to Generex
or its duly appointed agent to ensure compliance with
quality standards and specifications. Generex, 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 Generex Trademarks that fails to
comply with the quality standards and specifications
referred to in this Clause 3.2, as determined by
Generex.
(2) Newco shall not use a Generex Trademark in any way
which might materially prejudice its distinctiveness
or validity or the goodwill of Generex therein.
8
(3) The parties recognize that the Generex Trademarks
have considerable goodwill associated therewith.
Newco shall not use in relation to the Products any
trademarks other than the Generex Trademarks (except
the Elan Trademarks (as defined in the Amended Elan
License Agreement) licensed to Newco under the
Amended Elan License Agreement) without obtaining the
prior consent in writing of Generex, which consent
may not be unreasonably withheld. However, such use
must not conflict with the use and display of the
Generex Trademark and such use and display must be
approved by Generex.
(4) Newco shall not use in the Territory any trademarks
or trade names so resembling the Generex Trademark as
to be likely to cause confusion or deception.
(5) Newco shall promptly notify Generex in writing of any
alleged infringement or unauthorized use of which it
becomes aware by a third party of the Generex
Trademarks and provide Generex 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 Generex 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 Generex Trademarks
without the prior written consent of Generex.
3.2.2 Generex may, at its sole discretion and expense, file and
prosecute applications to register and maintain registrations
of the Generex Trademarks in the Territory. Newco shall
reasonably co-operate with Generex in such efforts.
3.2.3 Generex will be entitled to conduct all enforcement
proceedings relating to the Generex Trademarks and shall at
its sole discretion decide what action, if any, to take in
respect to any enforcement proceedings of the Generex
Trademarks or any other claim or counter-claim brought in
respect to the use or registration of the Generex Trademarks.
Any such proceedings shall be conducted at [ * ] expense and
for its own benefit. Newco and Elan shall reasonably cooperate
with Generex in such efforts.
3.2.4 Newco shall promptly notify Generex in writing in the event
that any Generex 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 Generex shall have the first right to decide whether or
not to defend such allegations, or to adopt an alternative
xxxx. If Generex decides not defend the Generex Trademark,
then Newco may request Generex to defend the Generex
Trademark, at [ * ] expense, unless such requested defense is
believed by Generex to be unsubstantiated and without merit.
In such a case, Generex may elect not to initiate defense
proceedings.
9
3.2.5 Newco will have no ownership rights in respect of the Generex
Trademarks or of the goodwill associated therewith, and Newco
hereby acknowledges that, except as expressly provided in this
Amended Generex License Agreement, it shall not acquire any
rights in respect thereof and that all such rights and
goodwill are, and will remain, vested in Generex.
3.2.6 Nothing in this Amended Generex License Agreement shall be
construed as a warranty on the part of Generex regarding the
Generex Trademarks, including without limitation, that use of
the Generex Trademarks in the Territory will not infringe the
rights of any third parties. Accordingly, Newco acknowledges
and agrees that Generex makes no such warranty.
3.2.7 Generex 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
Generex Trademarks pursuant to this Amended Generex License
Agreement.
4 NON-COMPETITION/AFTER ACQUIRED TECHNOLOGY
4.1 Subject to Clause 4.2 and Clause 4.3 of this Amended Generex License
Agreement and Clause 2.5 of the Amended JDOA, during the Term Generex
shall not, alone or in conjunction with a third party, develop or
commercialize the Buccal Delivery of Morphine for the treatment of all
types of pain.
4.2 The provisions of Clause 4.1:
4.2.1 shall not apply to After Acquired Technology; and
4.2.2 shall not apply to patents and know-how that are licensed or
acquired by Generex or Elan from a third party after the
Effective Date (by merger or otherwise) but which do not
constitute After Acquired Technology.
4.3 If, after the Effective Date, Generex:
4.3.1 licenses or otherwise acquires from a third party know-how or
patent rights relating to the Generex Intellectual Property in
the Fields; or
4.3.2 acquires or merges with a third party entity that has know-how
or patent rights relating to the Generex Intellectual Property
in the Fields
10
(collectively, "After Acquired Technology")
Generex 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, Generex
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 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 Generex and Elan Corporation,
plc, and shared by Generex and Elan Corporation, plc pro rata with EIS'
and Generex's respective percentage ownership of the capital stock
(whether common stock and/or preferred stock) in Newco.
5.2 Payment of royalties pursuant to Clause 5.1 shall be made [ * ] in
arrears during each Financial Year within [ * ] after the expiry of the
[ * ]. The method of payment shall be by wire transfer to an account
specified by Generex. Each payment made to Generex 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 [ * ]:
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 [ * ] 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 [ * ].
11
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
Generex the amount of such royalties. In the event that Newco is
prevented from making any payment under this Amended Generex 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 Generex's account in a bank acceptable to Generex in the
country the currency of which is involved or as otherwise agreed by the
Parties.
5.6 Generex 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 Generex on any payment made to Generex pursuant to
this Amended Generex License Agreement shall be for the account of
Generex. If so required by applicable law, any payment made pursuant to
this Amended Generex 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 Generex 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 Generex, Newco shall permit Generex 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 Generex. Such inspection shall occur
at Newco's principal offices or at such other location as may be
mutually agreeable to the Parties.
Any such inspection of Newco's records shall be at the expense of
Generex, except that if any such inspection reveals a deficiency in the
amount of the royalty actually paid to Generex hereunder in any
Financial Year quarter of [ * ] or more of the amount of any royalty
actually due to Generex hereunder, then the expense of such inspection
shall be borne solely by Newco. Newco shall promptly pay to Generex any
amount of deficiency.
If such inspection reveals a surplus in the amount of royalties
actually paid to Generex by Newco, Generex shall reimburse Newco the
surplus within [ * ] after determination.
12
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 Generex 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 Generex represents and warrants to Newco and Elan as of Effective Date
with respect to the Generex Intellectual Property as it relates to
Morphine in Field 1 and 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 Generex Intellectual Property as it relates to
such Compound, as follows:
7.1.1 Generex has the right to grant the Generex License;
7.1.2 there are no agreements between Generex and any third party
that conflict with the Generex License;
7.1.3 the patents and patent applications included in the Generex
Patents are free and clear of encumbrances and liens;
7.1.4 there are no proceedings pending or to the best of Generex's
knowledge threatened against Generex in connection with the
Generex Intellectual Property in relation to the Fields; and
7.1.5 there are no agreements between Generex and any Affiliate or
unaffiliated third party that relate to or that could prevent
or restrict the research, development or commercialization of
Morphine for use in Field 1, or any Additional Compound for
use in the Field 2, including without limitation, the Xxx
Lilly Agreement, and Generex shall not enter into any such
agreement.
7.2 In addition to any other indemnities provided for herein, Generex 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 Generex hereunder; or
7.2.2 negligent act or omission on the part of Generex or any of its
respective employees, agents, officers and directors in the
performance of this Amended Generex License Agreement.
13
7.3 In addition to any other indemnities provided for herein, Newco shall
indemnify and hold harmless Generex 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 Generex 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 Generex
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, GENEREX IS GRANTING THE GENEREX
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 GENEREX
LICENSE AGREEMENT, GENEREX 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
GENEREX 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 Generex 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 Generex
Intellectual Property and the Elan Intellectual Property; or
8.1.2 the date which is 15 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 Amended Generex License
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 Amended Generex License
Agreement or the Amended JDOA and fails to cure it within 60
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
60th 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
90 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 30
days;
8.3.3 it is unable to pay its debts in the normal course of
business;
8.3.4 it ceases wholly or substantially to carry on its business,
otherwise than for the purpose of a reconstruction or
amalgamation, without the prior written consent of the other
Party (such consent not to be unreasonably withheld);
8.3.5 the appointment of a liquidator, receiver, administrator,
examiner, trustee or similar officer of such Party or over all
or substantially all of its assets under the law of any
applicable jurisdiction, including without limitation, the
United States of America, Bermuda or Ireland;
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 If Elan elects to terminate the Amended Elan License Agreement pursuant
to Clause 8.4 thereof due to a Change of Control of Generex/Newco, then
Generex, at Generex's option, shall be entitled to terminate this
Amended Generex License Agreement upon written notice to Elan and
Newco.
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 Generex License
Agreement:
8.5.1. any sums that were due from Newco to Generex 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 Generex License Agreement as set
forth herein shall be paid in full within 60 days after the
expiration or termination of this Amended Generex 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 Generex 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 one year;
8.5.5 subject to Clause 8.5.7, all rights and licenses granted to
Newco pursuant to this Amended Generex License Agreement and
to the Generex 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 Generex, 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 Generex License Agreement;
16
8.5.6 subject to such license, if any, granted by Newco to Generex
and, if any, granted by Newco to Elan 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 Elan and Generex and may be exploited by both
Generex and Elan separately provided that Generex and Elan
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 Generex
Intellectual Property or the Elan Intellectual Property; and
8.5.7 the rights of permitted third party sub-licensees in and to
the Generex Intellectual Property shall survive the
termination of the license and sublicense agreements granting
said intellectual property rights to Newco; and Newco, Generex
and Elan shall in good faith agree upon the form most
advantageous to Generex 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 Generex and Elan).
Any sublicense agreement between Newco and such permitted
sublicensee shall, inter alia, permit such an assignment of
rights by Newco to Generex 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 Generex
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
Generex License Agreement. Each Party further agrees to inform all such
employees, representatives and agents of the terms and provisions of
this Amended Generex 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
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.
17
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 Generex 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 Generex License
Agreement, and for a period of [ * ] following the expiration or
earlier termination of this Amended Generex License Agreement.
18
9.8 The Parties agree that the obligations of this Clause 9 are necessary
and reasonable in order to protect the Parties' respective businesses,
and each Party agrees that monetary damages would be inadequate to
compensate a Party for any breach by the other Party of its covenants
and agreements set forth herein.
Accordingly, the Parties agree that any such violation or threatened
violation shall cause irreparable injury to a Party and that, in
addition to any other remedies that may be available, in law and equity
or otherwise, each Party shall be entitled to obtain injunctive relief
against the threatened breach of the provisions of this Clause 9, or a
continuation of any such breach by the other Party, specific
performance and other equitable relief to redress such breach together
with its damages and reasonable counsel fees and expenses to enforce
its rights hereunder, without the necessity of proving actual or
express damages.
9.9 For the avoidance of doubt, Confidential Information of Newco received
by Elan hereunder shall not be disclosed by Generex to Affiliates of
Generex; provided that the disclosure of such Confidential Information
to an executive officer common to Generex and an Affiliate of Generex
shall not be deemed to be a violation of this Clause.
10 GOVERNING LAW AND JURISDICTION
10.1 This Amended Generex 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 Generex 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 Generex 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 Generex 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.
19
12 ASSIGNMENT
This Amended Generex 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 Generex 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 Generex 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: 000 000 0000
Fax: 000 000 0000
with a copy to Elan at:
c/o Elan International Services, Ltd.,
000 Xx. Xxxxx Xxxxx,
Xxxxxx, Xxxxxx XX00,
Bermuda.
Attention: President
Telephone: 000-000-0000
Fax: 000-000-0000
If to Generex at:
Generex Biotechnology Corporation
00 Xxxxxxx Xxxxxx, Xxxxx 000,
Xxxxxxx, Xxxxxxx
Xxxxxx X0X 0X0
20
Attn: Chief Executive Officer
Telephone 000- 000-0000
Fax: 000- 000-0000
with a copy to:
Xxxxxx Xxxxxxx Xxxxxx & Xxxxxxx. LLC
0000 Xxxxxx Xxxxxx
0xx Xxxxx
Xxxxxxxxxxxx, XX 00000
Attention: [ * ], Esq.
Telephone 000-000-0000
Fax: 000-000-0000
or to such other address(es) and telefax numbers as may from time to
time be notified by either Party to the other hereunder 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 Generex 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
Generex License Agreement.
14.2 Severability:
If any provision in this Amended Generex 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 Generex License
Agreement shall not be impaired or affected in any way.
21
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
Generex License Agreement for assuring to or vesting in the requesting
Party the full benefit of the terms hereof.
14.4 Successors:
This Amended Generex 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 Generex 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
Generex License Agreement and the provisions of the Amended JDOA, the
terms of the Amended JDOA shall prevail unless this Amended Generex
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 Generex 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 Generex License Agreement.
14.8 Good Faith:
Each Party undertakes to act reasonably in giving effect to the
provisions of this Amended Generex License Agreement.
22
14.9 No Reliance:
Each Party hereby acknowledges that in entering into this Amended
Generex 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 Generex License Agreement is intended
or is to be construed to constitute Generex and Newco as partners, or
Generex as an employee of Newco, or Newco as an employee of Generex.
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 Generex 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 Generex 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 Generex License
Agreement.
SIGNED
BY______________________
for and on behalf of
Generex Biotechnology Corporation
DATED: __ day of January 2002
SIGNED
BY___________________
For and on behalf of
Generex (Bermuda) Ltd.
DATED: __ day of January 2002
AGREED TO AND ACCEPTED:
SIGNED
BY___________________
For and on behalf of
Elan Corporation, plc
DATED: __ day of January 2002
24
SCHEDULE TO BE UPDATED IF NECESSARY
SCHEDULE 1
GENEREX PATENTS
--------------------------------------------------------------------------------------------------------------------------
SUMMARY - Generex Biotechnology Corporation patent portfolio(1)(2)(3)
January , 2002
--------------------------------------------------------------------------------------------------------------------------
Identification/Status Description
--------------------------------------------------------------------------------------------------------------------------
A. Large Molecule Drug Delivery
--------------------------------------------------------------------------------------------------------------------------
1.
US Patent 6,017,545 issued 01/25/00; Mixed micellar delivery system for the administration of large molecule
US Application 09/021,114 filed pharmaceuticals (i.e., peptidic drugs, vaccines, hormones) and method of
02/10/98 (public) preparation
--------------------------------------------------------------------------------------------------------------------------
2.
US Application 09/161,447 filed Proteinic drug delivery system using membrane mimetics.
09/27/98; Notice of Allowance issued
10/24/00 (public)
--------------------------------------------------------------------------------------------------------------------------
3.
US Application 09/216,733 filed Mixed micellar delivery system and method of preparation. A continuation
12/21/98; Notice of Allowance issued in part ("CIP") of 09/021,114.
10/13/00 (public)
--------------------------------------------------------------------------------------------------------------------------
4.
US Application 09/---,--- filed Aerosol formulations for buccal and pulmonary application.
--/--/99
--------------------------------------------------------------------------------------------------------------------------
5.
US Application 09/272,563 filed Pharmaceutical solubilized in aerosol propellant.
03/19/99; Notice of Allowance mailed
8/13/01 (public)
--------------------------------------------------------------------------------------------------------------------------
6.
US Patent 6,312,665, issued 11/6/02; Aerosol formulations for buccal and pulmonary application.
US Application 09/386,284 filed 8/31/99 CIP of 09/251,464.
--------------------------------------------------------------------------------------------------------------------------
25
--------------------------------------------------------------------------------------------------------------------------
7.
US Patent 6,221,378, issued 4/24/01; Mixed micellar delivery system and method of preparation. CIP of 09/216,733.
US Application 09/386,285 filed 8/31/99
--------------------------------------------------------------------------------------------------------------------------
8.
US Patent 6,315,984, issued 11/13/01; Pharmaceutical solubilized in aerosol propellant. CIP of 09/272,563.
US Application 09/388,344 filed
09/03/99
--------------------------------------------------------------------------------------------------------------------------
9.
US Patent 6,290,987, issued 9/18/01; Proteinic drug delivery system using membrane mimetics. CIP of 09/161,447.
US Application 09/391,664 filed
09/07/99
--------------------------------------------------------------------------------------------------------------------------
10.
US Patent 6,271,200, issued 8/7/01; US Proteinic drug delivery system using aerosolized membrane mimetic
application 09/397,701 filed 09/16/99 amphiphiles.
--------------------------------------------------------------------------------------------------------------------------
11.
US Patent 6,294,153, issued 9/25/01; Pulmonary drug delivery.
US Application 09/397,102 filed 09/16/99
--------------------------------------------------------------------------------------------------------------------------
12.
US Application 09/519,285 filed 3/6/00 Pharmaceutical compositions for buccal and pulmonary application.
(public) CIP of 09/386,284.
--------------------------------------------------------------------------------------------------------------------------
13.
US Application 09/538,829, filed Method of administering insulin to the buccal region. CIP of 09/216,733.
3/30/00 (public)
--------------------------------------------------------------------------------------------------------------------------
14.
US Application 09/---,--- filed --/--/00 Method for administering insulin.
--------------------------------------------------------------------------------------------------------------------------
15.
US Application 09/---,--- filed Method for administering insulin to the buccal region. CIP of
--/--/00 09/021,114.
--------------------------------------------------------------------------------------------------------------------------
16.
US Application 09/---,--- Pharmaceutical compositions for buccal and pulmonary applications
Filed --/--/00
--------------------------------------------------------------------------------------------------------------------------
26
--------------------------------------------------------------------------------------------------------------------------
B. Other Delivery Technology
--------------------------------------------------------------------------------------------------------------------------
1.
CDN Patent 2,181,391 issued 02/15/00 Controlled release tablet
(no US counterpart)
--------------------------------------------------------------------------------------------------------------------------
2.
CDN Application 2,181,390 Phospholipid formulations
Filed 7/17/96, Notice of Allowance
issued 11/20/00
--------------------------------------------------------------------------------------------------------------------------
3. [ * ] [ * ]
--------------------------------------------------------------------------------------------------------------------------
4. [ * ] [ * ]
--------------------------------------------------------------------------------------------------------------------------
5.
US Application 09/557,474 filed Controlled release medicine (capsules). CIP of an earlier case now
--/--/00 abandoned.
--------------------------------------------------------------------------------------------------------------------------
Notes to SUMMARY of Generex Biotechnology Corporation patent portfolio
(1) This Summary includes US patent and patent application information
only, except where indicated. In most cases, we have corresponding
patent filings in Canada, Japan, Europe and elsewhere for US patents
and patent applications.
(2) We cannot be sure that any of pending patent applications referred to
in the Summary or filed after the date of the Summary will be granted,
or that any patents that we own or obtain in the future will fully
protect our scientific or commercial positions. We believe that neither
our technology nor the patents which we have or have applied for
infringe third parties' patent rights, and that our patent portfolio
provides meaningful protection against others duplicating our
proprietary technologies. We cannot be sure of this, however, because
of the complexity of the legal and scientific issues that could arise
in any patent litigation. Furthermore, patent applications are
maintained in secrecy in the United States until the patents are
approved, and in most foreign countries for a period of time following
the date from which priority is claimed. Thus, we cannot be sure that
any technology that we currently are developing is not covered already
by third parties' pending patent applications.
(3) This Summary excludes our interests in the following US patents (and
related foreign patents) and patent applications owned by Centrum
Biotechnologies, Inc.:
27
--------------------------------------------------------------------------------------------------------------------------
Description of Technology Application Patent No.
--------------------------------------------------------------------------------------------------------------------------
1. Liquid Formulation for Proteinic Pharmaceuticals CDN 2,210,996 US 5,653,987
--------------------------------------------------------------------------------------------------------------------------
2. Biodegradable Polymer Microspheres Vaccine Delivery N/A US 5,569,468
CDN
2,180,424
--------------------------------------------------------------------------------------------------------------------------
3. Controlled Release of Drugs Regarding Hormones in Biodegradable N/A US 5,417,982
Polymer Microspheres
--------------------------------------------------------------------------------------------------------------------------
