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EXHIBIT 10.20
CONFIDENTIAL TREATMENT HAS BEEN SOUGHT FOR
PORTIONS OF THIS EXHIBIT PURSUANT TO RULE 24b-2
UNDER THE SECURITIES ACT OF 1934, AS AMENDED
THIS AGREEMENT is made the 22nd day of January 1998
BY AND BETWEEN
ORASOMAL TECHNOLOGIES, INC.
A Delaware corporation of 000 Xxxxx Xxxxx Xxxxx, Xxxx Xxxx, Xxxxxxxx 00000,
Xxxxxx Xxxxxx of America
AND
ENDOREX VACCINE DELIVERY TECHNOLOGIES, INC.
A Delaware company, of 000 Xxxxx Xxxxx Xxxxx, Xxxx Xxxx, Xxxxxxxx 00000,
Xxxxxx Xxxxxx of America
AND
ENDOREX CORP.
A Delaware company, of 000 Xxxxx Xxxxx Xxxxx, Xxxx Xxxx, Xxxxxxxx 00000,
Xxxxxx Xxxxxx of America
LICENSE AGREEMENT
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TABLE OF CONTENTS
Clause No. Clause Page No.
1. DEFINITIONS.....................................................1
2. GRANT OF RIGHTS.................................................7
3. IMPROVEMENTS....................................................9
4. INTELLECTUAL PROPERTY RIGHTS...................................10
5. EXPLOITATION OF LICENSED TECHNOLOGY............................10
6. FINANCIAL PROVISIONS...........................................11
7. RIGHT OF AUDIT AND INSPECTION..................................12
8. PATENTS........................................................13
9. CONFIDENTIAL INFORMATION.......................................17
10. TRADEMARKS.....................................................19
11. TERM AND TERMINATION...........................................21
12. WARRANTIES/INDEMNITIES.........................................22
13. INSURANCE......................................................24
14. IMPOSSIBILITY OF PERFORMANCE - FORCE MAJEURE...................25
15. SETTLEMENT OF DISPUTES; PROPER LAW.............................25
16. ASSIGNMENT.....................................................26
17. NOTICES........................................................26
18. MISCELLANEOUS CLAUSES..........................................27
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WHEREAS
A. Orasomal has proprietary know-how and expertise relating, inter alia,
to immunology and is knowledgeable in the discovery, research,
development, manufacture and marketing of pharmaceutical formulations
capable of delivering drugs, including oral or mucosal Vaccine
delivery. Orasomal owns or has licensed the Orasomal Technology.
Orasomal also owns and uses certain trademarks in connection with the
manufacture, marketing and sale of such compounds, including the
Orasomal Trademarks.
B. Elan is knowledgeable in the discovery, research, development,
manufacture and marketing of pharmaceutical formulations capable of
delivering drugs, including oral or mucosal Vaccine delivery. Elan owns
or has licensed the Elan Technology. Elan also owns and uses certain
trademarks in connection with the manufacture, marketing and sale of
such compounds, including the Elan Trademarks.
C. Elan and Endorex have agreed to co-operate in the establishment and
management of the Company, the business of which will be to research
and develop certain Products incorporating the technologies developed
and/or to be developed by Elan and Orasomal and to commercialize such
Products throughout the world.
D. Simultaneously herewith, Elan, Endorex and Orasomal are entering into
the Development Agreement for the purpose of recording the terms and
conditions of the joint venture and of regulating their relationship
with each other and certain aspects of the affairs of and their
dealings with the Company.
E. Under the Development Agreement, the Company shall own all rights in
technology developed pursuant to certain Research and Development
Programs being conducted or to be conducted by the Company or by
Orasomal, Elan or an Independent Third Party on behalf of the Company,
including the Company Program Technology, the Orasomal Program
Technology and the Elan Program Technology.
F. The Company desires to enter into this Agreement with Orasomal so as to
(a) permit the Company to utilise the Orasomal Patents, the Orasomal
Know-How and the Orasomal Trademarks in the research, development,
manufacture, distribution and sale of the Products in the Field and (b)
to permit Orasomal to utilize the Orasomal Program Technology, the Elan
Program Technology and the Company Program Technology in connection
with (i) Orasomal's research and development work on behalf of the
Company and (ii) Orasomal's manufacturing and supplying the Company or
its designee(s) with the Products and other components.
G. Simultaneously herewith, the Company and Elan are entering into a
similar license agreement relating to the Company's use of the Elan
Patents, the Elan Know-How and the Elan Trademarks and Orasomal's use
of the Orasomal Program Technology, the Elan Program Technology and the
Company Program Technology.
NOW IT IS HEREBY AGREED AS FOLLOWS:
1. DEFINITIONS
1.1. In this present Agreement, including the Recitals, Schedules and
Appendices, the following definitions shall prevail unless the context
otherwise requires:
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"ACQUIRED" means a transfer or license of a Patent, Know-How or
other forms of Intellectual Property Rights or
information from an Independent Third Party to Elan
or Orasomal, as the case may be, to the extent to
which there are no obligations or restrictions (such
as confidentiality) in respect of that information
which prohibit disclosure to or use by the Company;
"AFFILIATE" means any corporation or entity other than the
Company controlling, controlled or under the common
control of Elan, Orasomal or the Company as the case
may be. For the purpose of this definition "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;
"AGREEMENT" means this agreement (which expression shall be
deemed to include the Recitals, the Schedules and
Appendices hereto);
"BUSINESS PLAN" means a plan for the business of the Company to be
reasonably agreed to by Elan, Orasomal, Endorex and
the Company prior to signing this Agreement or as
soon thereafter as is practicable and in any event
within thirty (30) days of signing this Agreement;
"CLOSING DATE" means January 22, 1998;
"COMPANY" means Endorex Vaccine Delivery Technologies, Inc;
"COMPANY PROGRAM
PATENTS" means the inventions and underlying Patents that
constitute the Company Program Technology;
"COMPANY PROGRAM
TECHNOLOGY" shall have the meaning assigned to it in the
Development Agreement;
"DEVELOPMENT
AGREEMENT" means the Joint Development & Operating Agreement of
even date entered into between Orasomal, Elan, EIS,
Endorex and the Company;
"EFFECTIVE DATE" means December 31, 1997;
"ELAN" means Elan Corporation, plc (Elan will be acting
through its division Elan Pharmaceutical
Technologies);
"ELAN EXCLUDED
TECHNOLOGY" has the meaning set forth in Schedule 1;
"ELAN LICENSE
AGREEMENT" means the license agreement of even date herewith
entered into between the Company and Elan;
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"ELAN KNOW-HOW" means Elan's drug delivery Know-How (including oral
or mucosal Vaccine delivery Know-How) and Know-How
relating to oral or mucosal Vaccines, other than the
Elan Program Know-How and the Elan Excluded
Technology;
"ELAN PATENTS" means Elan's drug delivery inventions and underlying
Patents (including oral or mucosal Vaccine delivery
inventions) and inventions and underlying Patents
relating to oral or mucosal Vaccines, other than the
Elan Program Patents and the Elan Excluded
Technology;
"ELAN PROGRAM
PATENTS" means the inventions and underlying Patents that
constitute Elan Program Technology;
"ELAN PROGRAM
TECHNOLOGY" will have the meaning assigned to it in the
Development Agreement;
"ELAN TECHNOLOGY" means the Elan Patents and/or the Elan Know-How
(which exclude the Elan Excluded Technology). The
primary examples of the Elan Technology existing as
of the Effective Date are set forth on Schedule 1 to
the Elan License Agreement; for the avoidance of
doubt the Parties confirm that the said list is not
necessarily exhaustive. The Elan Technology also
includes the inventions and know how that are the
subject of the Maynooth Agreement or any agreement
with Maynooth University Enterprise Development
Limited envisaged by the Maynooth Agreement. For the
avoidance of doubt, Elan Technology shall exclude
Patents and Know How [****] or [****] including, but
not limited to, [****];
"ELAN TRADEMARKS" means, depending on the context, one or more of the
trademarks owned by, Acquired by, assigned or
licensed to Elan which are relevant to the Elan
Technology or the Products;
"ENDOREX" means Endorex Corp.;
"ESTABLISHMENT LICENSE
APPLICATION" shall have the meaning given to such term in Title 21
CFR Section 600 et seq.;
"FDA" means the United States Food and Drug Administration
or any successors or agency the approval of which is
necessary to market a product in the United States of
America or any other relevant regulatory authority
the approval of which is necessary to market a
product in any other country of the Territory;
"FIELD" shall mean the [****];
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TREATMENT PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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"FIRST RIGHT OF
NEGOTIATION" shall have the meaning assigned to such term in
Clause 9.5. of the Development Agreement;
"IMPROVEMENTS" means inventions, discoveries, developments and
indications relating to (A) the Orasomal Technology
that can usefully be applied to the Field, and (B)
which were first reduced to practice during the Term
by Orasomal but shall for the avoidance of doubt
exclude Program Technology;
"INDEPENDENT THIRD
PARTY" means any person other than the Company, Elan,
Endorex, Orasomal or any of their respective
Affiliates;
"IN-MARKET" means [****] (or where applicable by [****]) to an
[****] such as a [****] and shall exclude [****];
"INTELLECTUAL PROPERTY
RIGHTS" means proprietary rights in Patents, Know-How,
registered and unregistered designs, copyrights,
trademarks, trade dress, and other like legal rights
for the protection of intellectual property;
"INVESTIGATIONAL NEW
DRUG APPLICATION" shall have the same meaning as understood in the MIT
Agreement;
"KNOW-HOW" means all trade secrets, confidential scientific,
technical and medical information and expertise,
technical data and marketing information, studies and
data from time to time developed, produced by or on
behalf of Elan, Orasomal or the Company, as the case
may be, whether before the Effective Date or during
the Term including, but not limited to, unpatented
inventions, discoveries, theories, plans, ideas
(whether or not reduced to practice) relating to the
research and development, manufacture, registration
for marketing, use or sale of the Product,
toxicological, pharmacological, analytical and
clinical data, bioavailability studies, product forms
and formulations, control assays and specifications,
methods of preparation and stability data;
"MAJOR COUNTRY" means those countries of the Territory set forth in
Schedule 2;
"MANAGEMENT
COMMITTEE" means the management committee appointed by the
directors of the Company pursuant to the Development
Agreement;
"MAYNOOTH
AGREEMENT" means that certain Proposal Concerning the
Exploitation of Intellectual Property Rights by and
between Elan and Maynooth University
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**** REPRESENTS MATERIAL REDACTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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Enterprise Development Limited dated March 25, 1996
attached as Schedule 4 to the Elan License Agreement;
"MIT" means the Massachusetts Institute of Technology;
"MIT AGREEMENT" means that certain Patent License Agreement by and
between Orasomal and the Massachusetts Institute of
Technology dated December 16, 1996 attached as
Schedule 3;
"MIT PATENTS" means the Patents licensed by the Massachusetts
Institute of Technology pursuant to the MIT
Agreement;
"MIT PATENTED
PRODUCT" means any product or part thereof which: (a) is
covered in whole or in part by an issued, unexpired
claim in the MIT Patents in the country in which any
such product or part thereof is made, used or sold;
or (b) is manufactured by using a process or is
employed to practice a process which is covered in
whole or in part by an issued, unexpired claim in the
MIT Patents in the country in which any MIT Patented
Process is used or in which such product or part
thereof is used or sold;
"MIT PATENTED
PROCESS" means any process which is covered in whole or in
part by an issued, unexpired claim or a pending claim
contained in the MIT Patents;
"NET SALES" means [****];
"ORASOMAL" means Orasomal Technologies Inc.;
"ORASOMAL KNOW-
HOW" means Orasomal's drug delivery Know-How (including
oral or mucosal Vaccine delivery Know-How) and
Know-How relating to oral or mucosal Vaccines, other
than Orasomal Program Know-How;
"ORASOMAL PATENTS" means Orasomal's drug delivery inventions and
underlying Patents (including oral or mucosal Vaccine
delivery inventions) and inventions and underlying
Patents relating to oral or mucosal Vaccines, other
than Orasomal Program Technology. The Orasomal
Patents include the MIT Patents and those listed on
Schedule 1;
"ORASOMAL PROGRAM
PATENTS" means the inventions and underlying Patents that
constitute Orasomal Program Technology;
"ORASOMAL PROGRAM
TECHNOLOGY" shall have the meaning assigned to it in the
Development Agreement;
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**** REPRESENTS MATERIAL REDACTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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"ORASOMAL
TECHNOLOGY" means the [****] and/or the [****]. The Orasomal
Technology also includes [****]. For the avoidance of
doubt, Orasomal Technology shall exclude [****],
including [****];
"ORASOMAL
TRADEMARKS" means, depending on the context, one or more of the
trademarks and any other relevant trademark owned by,
Acquired by, assigned or licensed to Orasomal which
are relevant to the Orasomal Technology or the
Products;
"PARTIES" means Orasomal, the Company and Endorex for the
purposes of Clause 2.9. and Clause 12 only;
"PATENTS" means all and any patents and any applications
therefor in the Territory (including any and all
divisions, continuations, continuations-in-part,
extensions, additions or reissues thereto or
thereof);
"PERSON" means an individual, partnership, corporation,
limited liability company, business trust, joint
stock company, trust, unincorporated association,
joint venture, or other entity of whatever nature;
"PLA" means the Product License Approval ,or its
equivalent, as such term is understood by the FDA;
"PRODUCT" means any [****];
"PRODUCT LICENSE
APPLICATION" shall have the same meaning as understood in the MIT
Agreement;
"PROGRAM
TECHNOLOGY" has the meaning assigned to it in the Development
Agreement;
"RELEVANT EVENT" has the meaning set forth in Clause 11.3.1;
"RESEARCH AND DEVELOPMENT
PROGRAM" means depending on the context, one or more programs
of research and development work being conducted or
to be conducted by, inter alia, Orasomal and Elan for
and on behalf of the Company which have been devised
by the Research Committee and approved by the
Management Committee;
"TECHNOLOGIES" means collectively, the Orasomal Technology together
with the Elan Technology;
"TERM" has the meaning set forth in Clause 11.1;
"TERRITORY" means the world;
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**** REPRESENTS MATERIAL REDACTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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"THIRD PARTY
TECHNOLOGY" has the meaning set forth in Clause 9.5. of the
Development Agreement;
"VACCINES" means a biologically or synthetically derived
substance administered to [****]; and
"UNITED STATES DOLLAR"
AND "US$" means the lawful currency for the time being of the
United States of America.
1.2. Words importing the singular shall include the plural and vice versa.
1.3. Unless the context otherwise requires, reference to a recital, article,
paragraph, provision, clause or schedule is to a recital, article,
paragraph, provision, clause or schedule of or to this Agreement.
1.4. Reference to a statute or statutory provision includes a reference to
it as from time to time amended, extended or re-enacted.
1.5. The headings in this Agreement are inserted for convenience only and do
not affect its construction.
1.6. Unless the context or subject otherwise requires, references to words
in one gender include references to the other genders.
1.7. References to "include" or "including" shall be construed as examples
only, and in no way be read as limiting.
2. GRANT OF RIGHTS
2.1. Subject to the terms of this Agreement, under all of Orasomal's
existing and future Patents and other Intellectual Property Rights
covering the Orasomal Technology, Orasomal hereby grants to the Company
for the Term an exclusive licence to the Orasomal Technology in the
Field for all research, development, and commercial purposes in the
Field. All proprietary rights and rights of ownership with respect to
the Orasomal Technology shall at all times remain solely with Orasomal,
or where applicable with Orasomal's licensor. The Company shall not
have any rights to use the Orasomal Technology other than insofar as
they relate directly to the Field and are expressly granted herein. The
Company agrees that the MIT Patented Products leased or sold in the
United States of America shall be manufactured substantially in the
United States of America. The Company hereby acknowledges that MIT
reserves the right to practice under the MIT Patents for non-commercial
research purposes.
2.2. Subject to any restriction in any licenses or other agreements pursuant
to which Orasomal licenses any of the Orasomal Trademarks, Orasomal
hereby grants the Company for the Term of this Agreement a
non-exclusive, royalty-free, fully paid-up license (or, if applicable,
sublicense) to use the Orasomal Trademarks which relate to the Orasomal
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**** REPRESENTS MATERIAL REDACTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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Technology applicable to the Product, such as an acronym for the
applicable technology applied to the Product, on the terms set forth in
Clause 10 upon or in relation to the promotion, marketing, advertising,
sale or offering for sale of the Products. The Company shall not be
obliged to use the Orasomal Trademark to identify the Product but at
Orasomal's request shall be obliged to use the Orasomal Trademark to
identify the applicable Orasomal Technology embodied in the Product.
For the avoidance of doubt, the Parties hereby confirm that the Company
shall not be entitled to a licence to use any trademark owned or
controlled by Orasomal which identifies a pharmaceutical product.
2.3. [Intentionally Deleted]
2.4. Orasomal shall be [****].
2.5. In addition Orasomal has entered into a preliminary development
agreement, an evaluation agreement and two material transfer
arrangements with third parties in relation to the Field, the terms of
which are subject to confidentiality restrictions. If one or more of
such preliminary development and evaluation programs are successful,
Orasomal shall seek the consent of the applicable third party to
disclose the results of such program to the Company and such results
shall be deemed Third Party Technology and governed by the provisions
of Clause 2.9. of this Agreement and Clause 9.5. of the Development
Agreement.
2.6. Subject to the terms of this Agreement, the Company hereby grants to
Orasomal for the Term a [****] license to use the Elan Program
Technology, Orasomal Program Technology and the Company Program
Technology, and, subject to the terms and conditions of the Elan
License Agreement, a [*****] to use the Elan Technology
insofar as is necessary, in each case, solely to permit Orasomal to
perform its obligations pursuant to this Agreement and the Development
Agreement for the benefit of the Company, including, without
limitation, (a) conducting research and development pursuant to the
Research and Development Programmes, and (b) developing, manufacturing
and supplying the Products and any other chemical or formulation
components. All rights of ownership with respect to the Elan Program
Technology, the Orasomal Program Technology and the Company Program
Technology shall at all times remain solely with the Company.
2.7. Orasomal is entitled to negotiate a license agreement to exploit the
Orasomal Program Technology outside the Field in accordance with the
provisions of Clause 9.3. and 9.8. of the Development Agreement
pursuant to which the Company may in the case of Clause 9.3. of the
Development Agreement, and shall in the case of Clause 9.8. of the
Development Agreement grant Orasomal a licence to use the Orasomal
Program Technology.
2.8. The Company shall not be permitted to sublicense any of the rights
granted to the Company by Orasomal pursuant to this Agreement without
the prior written consent of Orasomal, which consent will not be
unreasonably withheld or delayed. However, the Company shall have the
right to grant a royalty-free sublicense to the Orasomal Technology in
the Field to Elan to enable Elan to fulfil its obligations pursuant to
the
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**** REPRESENTS MATERIAL REDACTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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Elan License Agreement and the Development Agreement. Insofar as the
obligations owed by the Company to Orasomal are concerned, the Company
shall remain responsible for all acts and omissions of any sub-
licensee, including Elan, as if they were by the Company. In the event
of a termination of this Agreement due to a breach by the Company,
Orasomal shall have the right but not the obligation to assume any such
sub-license. Any sublicense granted by the Company to the MIT Patents
shall contain terms which comply with the provisions of Section 2.5. of
the MIT Agreement and cannot be for anything of value in lieu of cash
payments. Notwithstanding the provisions of Clause 9 of this Agreement
and Clause 19 of the Development Agreement, the Company notes and
agrees that Orasomal shall be entitled to furnish to MIT (I) a copy of
this Agreement and (II) a copy of all agreements in which the Company
grants a sublicense to the MIT Patents (for which purpose, inter alia,
the Company shall furnish a copy of such sublicense agreement to
Orasomal promptly after execution).
2.9. Subject to the other provisions of this Agreement and to the provisions
of [****] of the Development Agreement, [****] (a) for or on behalf of
the Company, (b) in relation to [****] for which the Company has
elected not to [****] or has been unable to [****] after the applicable
[****] has been exercised by the Company, or (c) with the Company's
prior written consent.
2.10. Orasomal shall also provide all reasonable assistance to the Company in
delivering and enabling the Company to utilize the Company's license to
the Orasomal Technology.
2.11. Insofar as the rights licensed to the MIT Patents by MIT to Orasomal
pursuant to the MIT Agreement are concerned, nothing in this Agreement
shall be construed to confer any rights upon the Company by
implication, estoppel or otherwise as to any technology or patent
rights of MIT or any other entity other than the MIT Patents,
regardless of whether such patent rights shall be dominant or
subordinate to any MIT Patents.
2.12. The Company acknowledges that it is subject to the laws and regulations
of the United States of America controlling the export of technical
data, computer software, laboratory prototypes and other commodities
(including the Arms Export Control Act, as amended and the United
States Department of Commerce Export Administration Regulations). The
transfer of such items may require a license from the cognizant agency
of the United States Government and/or written assurances by the
Company that the Company shall not export data or commodities to
certain foreign countries without prior approval of such agency. The
Company notes and agrees that pursuant to the MIT Agreement, MIT
neither represents that a license shall not be required nor that, if
required, it shall be issued.
3. IMPROVEMENTS
3.1. Except to the extent prohibited by any undertaking given to any
Independent Third Party (provided that after the Closing Date each
Party shall use all commercially reasonably efforts to exclude or
minimise the extent of any such limitations or restrictions), the
licenses to the Orasomal Technology granted by Orasomal pursuant to
Clause 2 of this Agreement shall include the Improvements. If Orasomal
shall develop any
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AMENDED.
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Improvements during the Term, Orasomal shall communicate to the Company
such Improvements and shall provide to the Company such rights,
licenses, information and explanations as the Company may reasonably
require to be able effectively to utilise the Improvements for the life
of this Agreement. Such disclosed Improvements shall automatically on
disclosure to the Company become part of the Orasomal Know-How or
Orasomal Patents (as the case may be) and shall be subject to the
provisions of this Agreement. The Company shall not have any right to
use such Improvements outside the Field.
4. INTELLECTUAL PROPERTY RIGHTS
4.1. The respective rights of Elan, the Company and Orasomal to exploit the
Elan Program Technology, Orasomal Program Technology and the Company
Program Technology shall be regulated by the provisions of Clause 6 of
the Development Agreement.
5. EXPLOITATION OF LICENSED TECHNOLOGY
5.1. Except as provided for in this Agreement, the Company's obligations to
exploit the Orasomal Technology shall be regulated by Clause 9 of the
Development Agreement.
5.2. The Company shall exert its reasonable efforts [****] consistent with
the [****] in each [****] determined in a commercially reasonable
manner and with a view to [****]. The Company will diligently pursue
the [****], as provided in the Business Plan.
5.3. The Company will be solely responsible for ensuring that the
manufacture, promotion, distribution, marketing and sale of the
Products within each country of the Territory is in strict accordance
with all the legal and regulatory requirements of each country of the
Territory.
5.4. All advertising, promotional materials and marketing costs needed to
exploit the Products are to be paid for by the Company. Any packaging
for the Products shall contain information to the effect that the
Product has been developed by Elan in conjunction with Orasomal and the
Company and is to be agreed upon by Orasomal in advance. Such
acknowledgement shall take into consideration regulatory requirements
and the Company's reasonable commercial requirements. The Company shall
submit copies of all forms of trade package cartons and labels and
other printed materials to Orasomal for approval before commercial sale
of the Product commences. If a change in such materials from that
initially approved which would require regulatory approval or filing or
any other material change is proposed, all such package cartons and
labels and printed materials shall be resubmitted for approval before
commercial use thereof. It shall be presumed that Orasomal approved of
such use unless Orasomal provides written notice of disapproval of such
use to the Company within ten (10) business days of delivery of such
materials to Orasomal, such approval not to be unreasonably withheld.
The further consent of Orasomal shall not be required where the format
and content of such materials is substantively similar as the materials
previously furnished to and approved by Orasomal.
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TREATMENT PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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6. FINANCIAL PROVISIONS
6.1. In consideration of the rights and licences granted to the Company
pursuant to this Agreement, the Company shall pay the following amounts
to Orasomal in the manner and on the dates set forth below [****]:
6.1.1. [****];
6.1.2. [****].
6.2. In consideration of the rights and licences granted to the Company
pursuant to this Agreement , the Company shall [****] of any and all
[****] received by the Company to Orasomal.
6.3. In the event that Orasomal shall cease to be a shareholder of the
Company, the Parties shall negotiate in good faith such amendments to
this Agreement as are equitable and applicable having regard to the
fact that Orasomal no longer has any representation on the Board of
Directors of the Company or the Management Committee (for example the
royalty provisions and such provisions of the Development Agreement as
are applicable), provided that such negotiations shall not apply to the
existence of the Agreement.
6.4. Payment of royalties shall be made quarterly within forty-five (45)
days after the expiry of the calendar quarter. The method of payment
shall be by way of wire transfer to an account specified by Orasomal.
Each payment made to Orasomal shall be accompanied by a written report,
prepared and signed by a senior financial officer of the Company. In
addition the report shall clearly show the Net Sales for the months of
the calendar quarter for which payment is being made on a country by
country basis. In the event that no royalty is due to Orasomal for any
calendar quarter, the senior financial officer shall so report. In
addition to the written reports accompanying each payment, the Company
shall notify Orasomal, within thirty (30) days of the end of each
calendar quarter, of the Net Sales of the Product(s) for that preceding
quarter on a country by country basis. The Company shall maintain and
keep clear, detailed, complete, accurate and separate records so:
6.4.1. as to enable any royalties on Net Sales of a Product which
shall have accrued hereunder to be determined; and
6.4.2. that any deductions made in arriving at the Net Sales of a
Product can be determined.
6.5. All payments due hereunder shall be made in United States Dollars.
Payments due on Net Sales of the Product 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 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
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AMENDED.
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such payment for the day prior to the date on which the payment by the
Company is being made.
6.6. Subject to the provisions of Clauses 6.8. and 6.10. of this Agreement,
the Company shall pay all royalties at the full rates specified in this
Clause 6.
6.7. If, at any time, legal restrictions in the Territory prevent the prompt
payment of royalties or any portion thereof, the Parties shall meet to
discuss suitable and reasonable alternative methods of reimbursing
Orasomal the amount of such running royalties. In the event that the
Company is prevented from making any payment under this Agreement by
virtue of the statutes, laws, codes or government regulations of the
country from which the payment is to be made, then such payments may be
paid by depositing them in the currency in which they accrue to
Orasomal's account in a bank acceptable to Orasomal in the country the
currency of which is involved or as otherwise agreed by the Parties.
6.8. Orasomal and the Company agree to co-operate in all respects reasonably
necessary to take advantage of any double taxation agreements or
similar agreements as may, from time to time, be available.
6.9. Any taxes payable by Orasomal on any payment made to Orasomal pursuant
to this Agreement shall be for the account of Orasomal. If so required
by applicable law any payment made pursuant to this Agreement shall be
made by the Company after deduction of the appropriate withholding tax
in which event the Parties shall co-operate to the extent reasonably
necessary to obtain the appropriate tax credits, as soon as is
practicable. In the event of a credit, the Company shall forthwith
forward copies of the credit documentation to Orasomal.
7. RIGHT OF AUDIT AND INSPECTION
7.1. On not more than two times in each calendar year, the Company shall
permit Orasomal or its duly authorised 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 the Company and
any other book, record, voucher, receipt or invoice relating to the
calculation of the royalty payments on Net Sales submitted to Orasomal
and to the accuracy of the reports which accompanied them. Any such
inspection of the Company's records shall be at the expense of
Orasomal, except that if any such inspection reveals a deficiency in
the amount of the running royalty actually paid to Orasomal hereunder
in any calendar quarter of [****] or more of the amount of any running
royalty actually due to Orasomal hereunder, then the expense of such
inspection shall be borne solely by the Company. Any amount of
deficiency shall be paid promptly to Orasomal. If such inspection
reveals a surplus in the amount of running royalty actually paid to
Orasomal by the Company, Orasomal shall promptly reimburse the Company
the surplus. The Company shall maintain the foregoing records for a
period of at least five (5) years following the end of the calendar
year to which they pertain.
7.2. 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
----------
**** REPRESENTS MATERIAL REDACTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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chartered accountants for a resolution of such dispute mutually
acceptable to both parties. Any decision by the said firm of chartered
accountants shall be binding on the Parties.
8. PATENTS
8.1. The Company shall permanently xxxx or otherwise cause Elan or any
Independent Third Party to permanently xxxx all Products and/or the
packaging therefor with such license or patent notices and in such
manner as Orasomal may reasonably request in writing prior to the sale
or commercial use thereof.
8.2. Orasomal shall be obliged to disclose promptly to the Company
inventions and discoveries made by or on behalf of Orasomal otherwise
than in connection with the performance of a Research and Development
Program (which inventions and discoveries shall be regulated by the
provisions of the Development Agreement), any patentable inventions and
discoveries within the Orasomal Know-How which relate to the Field as
well as any Improvements developed by or on behalf of Orasomal.
8.3. The Parties shall discuss in good faith all material issues relating to
filing, prosecution and maintenance of Orasomal Patents (insofar as the
Orasomal Patents are of relevance to the Field), the Orasomal Program
Patents, any patentable inventions and discoveries within the Orasomal
Know-How that relate to the Field and any Improvements developed by or
on behalf of Orasomal (other than pursuant to one or more of the
Research and Development Programmes). Subject to agreement to the
contrary the following provisions shall apply:
8.3.1. Orasomal [****] shall have the right but shall not be
obligated (a) to secure the grant of any patent from
applications within the Orasomal Patents that relate to the
Field; (b) to file and prosecute patent applications on
patentable inventions and discoveries within the Orasomal
Know-How that relate to the Field and patentable Improvements
developed by or on behalf of Orasomal (other than pursuant to
one or more of the Research and Development Programmes); (c)
to defend all such applications against Independent Third
Party oppositions; and/or (d) to maintain in force any issued
letters patent within the Orasomal Patents that relate to the
Field (including any letters patent that may issue covering
any Improvements). Orasomal shall have the sole right in its
reasonable business discretion to control such filing,
prosecution, defence and maintenance; provided however, that
the Company shall be provided with copies of all documents
relating to such filing, prosecution, defence, and maintenance
in sufficient time to review such documents and comment
thereon prior to filing of such documents.
8.3.2. In the event that Orasomal (i) elects that it does not intend
to file patent applications on patentable inventions and
discoveries within the Orasomal Know-How that relates to the
Field or patentable Improvements developed by or on behalf of
Orasomal (other than pursuant to one or more of the Research
and Development Programmes) in one or more countries in the
Territory, (ii) fails to file such an application within a
reasonable period of time, or (iii) elects or fails to
maintain or prosecute further any such pending application or
issued patent
----------
**** REPRESENTS MATERIAL REDACTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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then Orasomal shall so notify the Company in writing no less
than two (2) months prior to the expiration of any applicable
due date or time bar, and after receipt of such notice, the
Company shall have the right, but not the obligation, at the
Company's sole expense to file and prosecute such patent
application(s) in the joint names of the Company and Orasomal,
and Orasomal upon written request from the Company shall
execute all documents, forms and declarations and to do all
things as shall be reasonably necessary to enable the Company
to exercise such option and right.
8.3.3. In relation to the Orasomal Program Patents, the Company at
its expense shall have the right but shall not be obligated
(a) to secure the grant of any patent from applications within
the Orasomal Program Patents; (b) to file and prosecute patent
applications on patentable inventions and discoveries within
the Orasomal Program Know-How; (c) to defend all such
applications against Independent Third Party oppositions; and
(d) to maintain in force any issued letters patent within the
Orasomal Program Patents (including any patents that issue on
patentable inventions and discoveries within the Orasomal
Program Know-How). The Company shall have the right to control
such filing, prosecution, defence and maintenance; provided
however Elan and Orasomal shall be provided with copies of all
documents relating to such filing, prosecution, defence, and
maintenance in sufficient time to review such documents and
comment thereon prior to filing of such documents.
8.3.4. In the event that the Company (i) elects that it does not
intend to file patent applications on patentable inventions
and discoveries within the Orasomal Program Know-How, (ii)
fails to file such an application within a reasonable period
of time or, (iii) elects or fails to maintain or prosecute
further any such pending application or issued patent then the
Company shall so notify Orasomal in writing no less than two
(2) months prior to the expiration of any applicable due date
or time bar, and after receipt of such notice, Orasomal shall,
insofar as it is necessary to enable Orasomal to exploit the
Orasomal Program Know-How pursuant to Clauses 2.6. and 2.7. of
this Agreement or Clause 6.5. of the Development Agreement,
have the right, but not the obligation at Orasomal's sole
expense to file and prosecute such patent application(s) in
the Company's name and the Company upon written request from
Orasomal shall execute all documents, forms and declarations
and to do all things as shall be reasonably necessary to
enable Orasomal to exercise such option and right. In the
event that Orasomal and the Company negotiate a license to
enable Orasomal to exploit the Orasomal Program Technology
outside the Field pursuant to Clause 6.5. of the Development
Agreement, the Parties shall take the patent related
expenditures incurred by Orasomal as referred to above into
account to the extent they are incurred in relation to the
Patents being licensed to Orasomal in determining the royalty
payable by Orasomal to the Company. Notwithstanding anything
herein to the contrary, the Parties agree that the Company
shall own all right, title and interest in such patent
applications and any patents that may issue thereon (including
any and all divisions, continuations, continuations-in-part,
extensions, additions or reissues thereto or thereof). Insofar
as any patent filing has application within and outside the
Field, the Company and Orasomal will negotiate, in good faith,
on the course of action to be taken.
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8.3.5. Orasomal and the Company shall promptly inform the other in
writing of any alleged infringement of any Patents within the
Orasomal Patents that relate to the Field, the Orasomal
Program Patents, the Elan Program Patents or the Company
Program Patents or any alleged misappropriation of trade
secrets within the Orasomal Know-How that relate to the Field,
the Orasomal Program Know-How, the Elan Program Know-How or
the Company Program Technology by an Independent Third Party
of which it becomes aware and provide the other with any
available evidence of such infringement or misappropriation.
8.3.5.1. Subject to the provisions of Clause 8.4.1.2, during
the Term, the Company shall have the right to bring
suit or otherwise take action at its own expense and
for its own benefit any such alleged infringements of
the Orasomal Patents or misappropriation of the
Orasomal Know-How, insofar as such infringements or
misappropriation relate to the Field. In relation to
the MIT Patents, the Company notes and agrees that
MIT shall have the right at its own expense to be
represented in any action involving the MIT Patents
using counsel of its own choice. In the event that
the Company takes such action, the Company shall do
so at its own cost and expense. At the Company's
request, Orasomal will co-operate with such action
insofar as the said action relates to the Field at
the Company's sole cost and expense. Any recovery
remaining after the deduction by the Company of the
reasonable expenses (including attorney's fees and
expenses) incurred in relation to such an
infringement proceeding shall constitute Net Sales
for the purpose of this Agreement and the Elan
License Agreement and prior to commencing, or at an
early stage in the proceedings, the Company, Elan and
Orasomal shall agree upon the royalty that shall be
due to each of Elan and Orasomal in respect of such
deemed Net Sales. Should the Company decide not to
pursue such infringers, within a reasonable period
but in any event (i) within sixty (60) days after
receiving written notice of such alleged infringement
or misappropriation or (ii) ten (10) days before the
time limit, if any, set forth in the appropriate laws
and regulations for the filing of such actions,
whichever comes first, or if such alleged
infringement or misappropriation does not relate to
the Field, Orasomal may in its discretion initiate
such proceedings in its own name, at its expense and
for its own benefit, and at Orasomal's request, the
Company will co-operate with such action at
Orasomal's sole cost and expense. In the alternative,
the Parties may agree to institute such proceedings
in their joint names and shall reach agreement as to
the proportion in which they will share the proceeds
of any such proceedings, and the expense of any costs
not recovered, or the costs or damages payable to the
Independent Third Party. If the infringement of the
Orasomal Patents affects the Field as well as other
products being developed or commercialised by
Orasomal or its commercial partners outside the
Field, the Parties shall agree as to the manner in
which the proceedings should be instituted and shall
reach agreement as to the proportion in which they
will share the proceeds of any such proceedings, and
the expense of any costs not recovered, or the costs
or damages payable to the Independent Third Party.
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8.3.5.2. The provisions of this Clause 8.4.1.2. shall apply in
relation to any alleged infringements of the MIT
Patents by an Independent Third Party. In the event
that the Company brings, or in the event of failure
by the Company and Orasomal fails to bring, an
infringement action as referred to in Section 7.2 of
the MIT Agreement, the Company shall co-operate
fully, including if required to enable MIT to bring
such action, the furnishing of a power of attorney.
The Company will consult with Orasomal and MIT as to
any significant actions that the Company proposes to
take with respect to same. The Company shall give to
MIT all authority (including the right to exclusive
control of the defense of any such suit, action or
proceeding and the exclusive right to compromise,
litigate, settle or otherwise dispose of any such
suit, action or proceeding), information and
assistance necessary to defend or settle any such
suit, action or proceeding, and MIT shall have sole
discretion to determine actions to be taken or not
taken in connection therewith and the terms of any
settlement; provided, however, that MIT shall not
have the right to settle any patent infringement
litigation as referred to in the MIT Agreement
without the prior written consent of Orasomal (not to
be unreasonably withheld or delayed) (who shall not
furnish such consent without the prior written
consent of the Company not to be unreasonably
withheld or delayed) in a manner that diminishes the
scope or duration of the MIT Patents, which would
constitute an amendment of the MIT Agreement, which
would adversely affect the compensation or revenues
to be derived by the Company pursuant to the MIT
Agreement, or which would require a payment by the
Company, or would require an admission of wrongdoing
by the Company. Except as otherwise agreed to by the
parties to the MIT Agreement as part of a cost
sharing arrangement (in which case Orasamol shall not
enter into such an agreement without the consent of
the Company), any recovery realised as a result of
such litigation, shall be applied first toward
reimbursement of any litigation expenses of Orasomal,
the Company and MIT, and then Orasomal shall pay MIT
five percent (5%) of the remainder; provided that the
monies payable by the Company to Orasomal shall be at
least sufficient to enable Orasomal to discharge the
sums due to MIT.
8.3.6. During the Term, the Company shall have the first right but
not the obligation to bring suit or otherwise take action
against any alleged infringement of the Orasomal Program
Patents or the Company Program Patents (and as appears from
Clause 8.4.2. of the Elan License Agreement, the Elan Program
Patents) or alleged misappropriation of the Orasomal Program
Know-How (and as appears from Clause 8.4.2. of the Elan
License Agreement, the Elan Program Know-How) within the
Field. If any such alleged infringement or misappropriation
occurs which gives rise to a cause of action both inside and
outside the Field, the Parties shall negotiate, together with
Elan, in good faith to determine the cause of action to be
taken. In the event that the Company takes such action, the
Company shall do so solely at its own cost and expense. At the
Company's request, Orasomal will co-operate with any such
action at the Company's sole cost and expense. Any recovery
remaining after the deduction by the Company of the reasonable
expenses (including attorney's fees and expenses) incurred in
relation to such an infringement proceeding shall constitute
Net Sales for the purpose of this Agreement and the Elan
License Agreement and prior to
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commencing, or at an early stage in the proceedings, the
Company, Elan and Orasomal shall agree upon the royalty that
shall be due to each of Elan and Orasomal in respect of such
deemed Net Sales. In the event that the Company decides not to
take such action against such infringement or misappropriation
or fails to do so within a reasonable period but in any event
(i) within sixty (60) days after receiving written notice of
such alleged infringement or misappropriation or (ii) ten (10)
days before the time limit, if any, set forth in the
appropriate laws and regulations for the filing of such
actions, whichever comes first, Orasomal may in its discretion
initiate such proceedings in its own name regarding the
Orasomal Program Technology (or in the Company's name if
required by law; provided, however, that Orasomal identifies
itself as the real party in interest and does not take any
action that would expose the Company to liability of any
kind). In the event that Orasomal initiates such action, it
shall do so solely at its sole cost and expense and all
damages and monetary award recovered in or with respect to
such action shall be the property of Orasomal. At Orasomal's
request, the Company agrees to co-operate with Orasomal in any
such proceeding at Orasomal's sole cost and expense. In the
alternative, the Parties may agree to institute such
proceedings in their joint names and shall reach agreement as
to the proportion in which they will share the proceeds of any
such proceedings, and the expense of any costs not recovered,
or the costs or damages payable to the Independent Third
Party.
8.4. In the event that a claim or proceedings are brought against the
Company by an Independent Third Party alleging that the sale,
distribution or use of the Product in the Territory solely because of
the Company's use of the Orasomal Technology infringes the intellectual
property rights of such an Independent Third Party, the Company shall
promptly advise Orasomal of such threat or suit.
8.5. Orasomal shall have no liability to the Company whatsoever or howsoever
arising for any losses incurred by the Company as a result of having to
cease selling Product or having to defer the launch of selling Product
as a result of any infringement proceedings.
9. CONFIDENTIAL INFORMATION
9.1. The Parties acknowledge that it may be necessary, from time to time, to
disclose to each other confidential and/or proprietary information,
including without limitation, the Technologies, Program technologies,
Improvements and the Patents relating thereto, inventions, works of
authorship, trade secrets, specifications, designs, data, know-how and
other information relating to the Field, the MIT Agreement, the
Maynooth Agreement, the terms of the Definitive Documents, the
Products, processes and services, or the business of the disclosing
Party ("Confidential Information").
Confidential Information shall be deemed not to include:
(i) information that is in the public domain;
(ii) information which is made public by the
disclosing Party;
(iii) information which is independently developed by
a Party without the aid or application of the Confidential
Information;
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(iv) information that is published or otherwise
becomes part of the public domain without any disclosure by a
Party, or on the part of a Party's directors, officers,
agents, representatives or employees;
(v) 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, to the best of the
Party's knowledge, did not acquire this information on a
confidential basis; or
(vi) information which the receiving Party is
required to disclose pursuant to:
(A) a valid order of a court or other
governmental body or any political subdivision
thereof or otherwise required by law; or
(B) 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.
9.2. Any Confidential Information revealed by a Party to another Party shall
be used by the receiving Party exclusively for the purposes of
fulfilling the receiving Party's obligations under this Agreement and
the Development Agreement and for no other purpose.
9.3. Each Party agrees to disclose Confidential Information of another Party
only to those employees, representatives and agents requiring knowledge
thereof in connection with their duties directly related to the
fulfilling of the Party's obligations under this Agreement. Each Party
further agrees to inform all such employees, representatives and agents
of the terms and provisions of this Agreement and their duties
hereunder and to obtain their consent hereto as a condition of
receiving Confidential Information. Each Party agrees that it will
exercise the same degree of care, but in no event less than a
reasonable degree, and protection to preserve the proprietary and
confidential nature of the Confidential Information disclosed by a
Party, as the receiving Party would exercise to preserve its own
proprietary and confidential information. Each Party agrees that it
will, upon request of a Party, return all documents and any copies
thereof containing Confidential Information belonging to or disclosed
by, such Party.
9.4. Notwithstanding the above, each Party may use or disclose confidential
information disclosed to it by another Party to the extent such use or
disclosure is reasonably necessary in filing or prosecuting patent
applications, prosecuting or defending litigation, complying with
patent applications, prosecuting or defending litigation, complying
with applicable governmental regulations or otherwise submitting
information to tax or other governmental authorities, conducting
clinical trials, or making a permitted sub-license or otherwise
exercising its rights hereunder, provided that if a Party is required
to make any such disclosure of the other Party's confidential
information, other than pursuant to a
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confidentiality agreement, such Party shall inform the other Party,
allow the other Party to participate in the process and generally limit
disclosure to the greatest extent possible and seek confidential
treatment or a protective order.
9.5. The provisions relating to confidentiality in this Clause 9 shall
remain in effect during the Term, and for a period of [****] following
the expiration or earlier termination of this Agreement.
9.6. 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 expressly 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 and acknowledge that any such violation or threatened violation
will cause irreparable injury to a Party and that, in addition to any
other remedies that may be available, in law and equity or otherwise,
any Party shall be entitled to obtain injunctive relief against the
threatened breach of the provisions of this Clause 9, or a continuation
of any such breach by the other Party, specific performance and other
equitable relief to redress such breach together with its damages and
reasonable counsel fees and expenses to enforce its rights hereunder,
without the necessity of proving actual or express damages.
10. TRADEMARKS
10.1. The Company undertakes that all Products and all materials utilised in
connection with the provision, marketing, distribution, advertising
and/or marketing thereof that bear or incorporate the Orasomal
Trademarks shall be of a consistent and high standard of quality,
commensurate with the prestige of the Orasomal Trademarks and that its
use of the Orasomal Trademarks shall conform to such reasonable
standards as Orasomal shall from time to time specify. The Company
shall co-operate fully with the reasonable instructions of Orasomal
with respect to the maintenance of such standards.
10.2. The Company shall:
10.2.1. subject to the agreement of the Company's commercial partner
such as a sub-licensee, favourably consider promoting and
using the Orasomal Trademarks in each country of the Territory
and provide proof of use of the Orasomal Trademarks if
requested by Orasomal;
10.2.2. use the Orasomal Trademarks strictly in compliance with any
applicable trademark and other laws and regulations and to use
such legends, markings and notices in connection therewith as
are required by law or otherwise reasonably required by
Orasomal to protect Orasomal's rights therein;
10.2.3. do nothing to mislead the public as to the nature or quality
of any Product on which the Orasomal Trademarks are affixed
nor use it on advertising or display materials which are
unethical, immoral or offensive to good taste;
----------
**** REPRESENTS MATERIAL REDACTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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10.2.4. at Orasomal's reasonable request, supply samples of the
Products and any materials utilized in connection with the
distribution, advertising and/or marketing thereof that bear
or incorporate the Orasomal Trademarks for inspection by
Orasomal;
10.2.5. not adopt or seek to register any trademark, design or logo
confusingly similar to the Orasomal Trademarks without
Orasomal's prior written consent; and
10.2.6. promptly notify Orasomal in writing if any alleged
infringement or unauthorized use of the Orasomal Trademarks
comes to the Company's attention.
10.3. The Company undertakes to use the Orasomal Trademarks in relation only
to the Products (or materials for advertising and promotion thereof),
and in accordance with any reasonable specifications and directions
given by Orasomal from time to time. In particular, but without
limitation, the Company agrees to state on the Products or materials
for the advertising or promotion thereof that the Orasomal Trademarks
are used under license from Orasomal.
10.4. The Company shall take no action which could prejudice the validity,
re-registration or reputation of the Orasomal Trademarks or which could
impair the reputation, business standing or prestige of Orasomal.
10.5. Orasomal shall remain the owner of the Orasomal Trademarks and the
goodwill associated with the same and the Company agrees not to assert
any ownership interest in the Orasomal Trademarks or the goodwill
associated therewith. The Company shall own and retain all right,
title, and interest in and to any trademark or trademarks (other than
the Orasomal Trademarks and the Elan Trademarks) used in the Territory
in connection with the sale of the Products.
10.6. Orasomal shall have the exclusive right to take such action in respect
of the registration, defence, infringement and maintenance of the
Orasomal Trademarks as Orasomal in its reasonable business judgement
deems appropriate. The Company shall provide all such assistance and
co-operation, including the furnishing of documents and information and
the execution of registered user documentation or the like, as may be
required to give effect to any action as may be taken, or required to
be taken, by Orasomal. In taking any such action, Orasomal shall
consider the legitimate commercial interests of the Company.
10.7. New trademarks used in relation to the Elan Program Technology, the
Orasomal Program Technology, the Company Program Technology, or the
Products and all registrations thereof and applications therefor shall
be owned and registered by the Company. New trademarks used in relation
to the Orasomal Technology and all registrations thereof and
applications therefor shall be owned and registered by Orasomal and
shall constitute Orasomal Trademarks.
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11. TERM AND TERMINATION
11.1. This Agreement is concluded for a period commencing as of the Effective
Date and expiring on a Product by Product basis and on a country by
country basis on the later to occur of:
11.1.1. fifteen (15) years starting from the date of the launch of the
Product in the country concerned; and
11.1.2. the last to expire Patent included in the Orasomal Patents
and/or the Orasomal Program Patents and/or the Elan Program
Patents and/or the Company Program Patents (the "Term").
11.2. At the end of the Term, the Company shall have a paid-up non-exclusive
license to the Orasomal Technology for the Field.
11.3. For the purpose of this Clause 11.3, a "Relevant Event" is committed by
Orasomal or the Company if:
(i) it commits a material breach of its obligations
under this Agreement (and in the case of Orasomal if it or
Endorex breaches Clause 2.9. or Clause 12) and fails to remedy
it within sixty (60) days of being specifically required in
writing to do so by the other Party; provided, however, that
if the breaching Party has proposed a course of action to
rectify the breach and is acting in good faith to rectify same
but has not cured the breach by the sixtieth (60th) day, such
rectifying period shall be extended by an amount of time as is
reasonably necessary to permit the breach to be rectified; it
ceases, wholly or substantially, to carry on its business,
other than for the purpose of a reorganization, without the
prior written consent of the other Participant (such consent
not to be unreasonably withheld);
(ii) the voluntary appointment of a liquidator,
receiver, administrator, examiner, trustee or similar officer
over all or substantially all of its assets under the laws of
such Participant's state or country of incorporation; or
(iii) an application or petition for bankruptcy,
corporate reorganization, composition, administration,
examination, arrangement or any other procedure similar to any
of the foregoing under the laws of such Participant's state or
country of incorporation, is filed, and is not discharged
within ninety (90) days.
11.3.1. If either Party commits a Relevant Event, the other Party
shall have in addition to all other legal and equitable rights
and remedies hereunder, the right to terminate this Agreement
upon thirty (30) days' written notice; provided, that such
written notice be given within sixty (60) days following the
date that the other Party becomes aware of the Relevant Event.
11.4. In the event that the MIT Agreement is terminated, the sublicense to
the MIT Patents shall automatically terminate.
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11.5. Upon exercise of those rights of termination as specified in Clause
11.1. to Clause 11.3. inclusive or elsewhere within the Agreement, this
Agreement shall, subject to the other provisions of the Agreement,
automatically terminate forthwith and be of no further legal force or
effect.
11.6. Upon expiration or termination of the Agreement:
11.6.1. any sums that were due from the Company to Orasomal on Net
Sales in the Territory or in such particular country or
countries in the Territory (as the case may be) prior to the
expiration or termination of this Agreement as set forth
herein shall be paid in full within sixty (60) days of the
expiration or termination of this Agreement for the Territory
or for such particular country or countries in the Territory
(as the case may be);
11.6.2. all confidentiality provisions set out herein shall remain in
full force and effect;
11.6.3. the rights of inspection and audit set out in Clause 7 shall
continue in force for a period of one year;
11.6.4. except as expressly provided for under Clause 11.6.5. all
rights, licenses and sublicenses granted in and pursuant to
this Agreement shall cease for the Territory or for such
particular country or countries in the Territory (as the case
may be). Following such expiration or termination, the Company
may not thereafter, except as expressly provided for in Clause
11.6.5, use in the Territory or in such particular country or
countries in the Territory (as the case may be) (a) any valid
and unexpired Orasomal Patents, (b) any Orasomal Know-How that
remains confidential or otherwise proprietary to Orasomal,
and/or (c) any Orasomal Trademarks; and
11.6.5. the Company shall promptly make an accounting to Orasomal of
the inventory of the Product which it has in the Territory or
for such particular country or countries in the Territory (as
the case may be), if any, as of the date of such termination
and the Company shall thereafter have the right for a period
of six (6) months after said expiration or termination to sell
such inventory of the Product in the Territory or in such
particular country or countries in the Territory (as the case
may be) or, if appropriate and legally permissible, to
transport such inventory of Product for sale in another
country or countries in the Territory within such six month
period; provided that the Net Sales thereof shall be subject
to the royalty provisions of Clause 6 and so payable to
Orasomal. Thereafter, any remaining inventory of Product shall
be disposed of by mutual agreement of the Parties in
accordance with regulatory requirements.
12. WARRANTIES/INDEMNITIES
12.1. Orasomal and Endorex, severally and not jointly, represent and warrant
to the Company that to their respective best knowledge, after
reasonable investigations, (a) Orasomal and Endorex have the right to
grant the licenses and rights granted herein, (b) Schedule 1 contains a
summary of the Orasomal Technology existing as of the Effective Date,
(c) other than the MIT Agreement there are no agreements with any third
parties that relate to Orasomal Technology existing as of the Effective
Date, (d) that to the best of their respective knowledge and belief,
Orasomal is not in breach or threatened breach of the
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MIT Agreement and will in the future not procure a breach and (e) there
are no agreements with any Independent Third Parties that conflict with
the rights granted by Orasomal pursuant to this Agreement.
12.2. Orasomal and Endorex, severally and not jointly, represent and warrant
to the Company that Orasomal has the sole, exclusive and unencumbered
right to grant the licenses and rights herein granted to the Company,
and that Orasomal has not granted any option, license, right or
interest in or to the Orasomal Technology to any Independent Third
Party which would conflict with the rights granted by this Agreement.
12.3. The Company represents and warrants to Orasomal that it has the sole,
exclusive and unencumbered right to grant the licenses and rights
herein granted to Orasomal and that it has not granted any option,
license, right or interest in or to the Orasomal Program Technology,
the Elan Program Technology or the Company Program Technology to any
Independent Third Party which would conflict with the rights granted by
this Agreement.
12.4. Orasomal and Endorex, severally and not jointly, represent and warrant
to the Company that to the best of its knowledge, the true inventors of
the subject matter claimed are named in the Orasomal Patents and all
such inventors have irrevocably assigned all their rights and interests
therein to Orasomal.
12.5. Orasomal and Endorex, severally and not jointly, and the Company on
the other hand each represent and warrant to and for the benefit for
each other that the execution of this Agreement by them and the full
performance and enjoyment of the rights of them under this Agreement
will not breach the terms and conditions of any license, contract,
understanding or agreement, whether express, implied, written or oral
between them and any Independent Third Party.
12.6. In addition to any other indemnifications provided for herein, Orasomal
and Endorex, severally and not jointly, shall indemnify and hold
harmless the Company and its Affiliates and their respective employees,
agents, partners, officers and directors from and against any claims,
losses, liabilities or damages (including reasonable attorney's fees
and expenses) incurred or sustained by the Company arising out of or in
connection with any breach of any representation, covenant, warranty or
obligation by Orasomal hereunder.
12.7. In addition to any other indemnifications provided for herein, the
Company shall indemnify and hold harmless Orasomal and its Affiliates
and their respective employees, agents, partners, officers and
directors from and against any claims, losses, liabilities or damages
(including reasonable attorney's fees and expenses) incurred or
sustained by Orasomal arising out of or in connection with any breach
of any representation, covenant, warranty or obligation by the Company
hereunder.
12.7.1. The Company shall assume the sole and entire responsibility
and shall indemnify and save harmless Orasomal from any and
all claims, liabilities, expenses, including reasonable
attorney's fees, responsibilities and damages by reason of any
claim, proceedings, action, liability or injury arising out of
any faults of the Product resulting from the transport,
packaging, storage, handling, distribution, marketing or sale
of the Product by the Company, to the extent that it was
caused by the negligence or wrongful acts or omissions on the
part of the Company.
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12.7.2. Insofar as the MIT Patents are concerned, the Company shall at
all times during the term of the MIT Agreement and thereafter,
indemnity, defend and hold MIT, its trustees, directors,
officers, employees and affiliates (as such term is understood
in the MIT Agreement) and Orasomal, harmless against all
claims, proceedings, demands and liabilities of any kind
whatsoever, including legal expenses and reasonable attorneys'
fees, arising out of the death or injury to any person or
persons or out of any damage to property, resulting from the
production, manufacture, sale, use, lease, consumption or
advertisement of the MIT Patented Product(s) and/or MIT
Patented Process or arising from any obligation of the Company
as a sublicensee of Orasomal pursuant to the MIT Agreement.
12.8. As a condition of obtaining an indemnity in the circumstances set out
above, the Party seeking an indemnity shall:
12.8.1. fully and promptly notify the other Party of any claim or
proceeding, or threatened claim or proceeding;
12.8.2. permit the indemnifying Party to take full care and control of
such claim or proceeding;
12.8.3. co-operate in the investigation and defence of such claim or
proceeding;
12.8.4. 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
12.8.5. take all reasonable steps to mitigate any loss or liability in
respect of any such claim or proceeding.
12.9. NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, ORASOMAL,
NEWCO AND MIT (INCLUDING MIT's TRUSTEES, DIRECTORS, OFFICERS, EMPLOYEES
AND AFFILIATES (as such terms are understood in the MIT Agreement))
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 TERMS OF THIS AGREEMENT, FOR ANY CONSEQUENTIAL, INDIRECT OR
INCIDENTAL LOSS OR DAMAGE (WHETHER FOR LOSS OF PROFIT OR OTHERWISE) AND
WHETHER OCCASIONED BY THE NEGLIGENCE OF THE RESPECTIVE PARTIES, THEIR
EMPLOYEES OR AGENTS OR OTHERWISE.
13. INSURANCE
13.1. Orasomal shall maintain comprehensive general liability insurance,
including product liability insurance on the Products manufactured
and/or sold by Orasomal in such prudent amount as shall be determined
by the Management Committee. Orasomal shall provide the Company with a
certificate from the insurance company verifying the above and
undertakes to notify the Company directly at least thirty (30) days
prior to the expiration or termination of such coverage. Orasomal shall
also provide the Company with a vendor's certificate substantially in a
form to be agreed between the Parties.
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13.2. The Company shall maintain comprehensive general liability insurance,
including product liability insurance on Products manufactured and/or
sold by the Company that incorporate intellectual property licensed
hereunder by Orasomal in such prudent amount as shall be determined by
the Management Committee. The Company shall provide Orasomal with a
certificate from the insurance company verifying the above and
undertakes to notify Orasomal thirty (30) days prior to the expiration
or termination of such coverage. Insofar as the MIT Patented Products
are concerned, MIT shall be a named insured under the foregoing
insurance policy and the limits of liability shall be no less than set
forth in Section 8.2. of the MIT Agreement. The Company shall deliver
the appropriate certificates of insurance evidencing such insurance
policy to Orasomal.
14. IMPOSSIBILITY OF PERFORMANCE - FORCE MAJEURE
14.1. Neither Party to this Agreement 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, or intervention
of a government authority, non availability of raw materials, but any
such delay or failure shall be remedied by such Party as soon as
practicable.
15. SETTLEMENT OF DISPUTES; PROPER LAW
15.1. Subject to the provisions of Clause 15.3, the Parties will attempt in
good faith to resolve any dispute arising out of or relating to this
Agreement promptly by negotiation between executives of the Parties,
failing which the Parties shall invoke the dispute resolution
provisions set forth in Clause 16 of the Development Agreement.
15.2. Subject to the provisions of Clause 15.3, this Agreement shall be
governed by and construed in accordance with the laws of New York and
subject to the provisions of Clause 15.1, the Parties agree to submit
to the jurisdiction of the courts of New York for the resolution of
disputes hereunder, which the Parties have not otherwise agreed should
be subject to the binding determination of an Expert or Panel, pursuant
to the terms of this Agreement.
15.3. The provisions of this Clause 15.3. shall apply to the extent that a
dispute arises out of or is related to the MIT Agreement, or the
performance, enforcement, breach or termination thereof and any
remedies relating thereto:
15.3.1. Except for the right of either party to apply to a court of
competent jurisdiction for a temporary restraining order, a
preliminary injunction, or other equitable relief to preserve
the status quo or prevent irreparable harm, any and all
claims, disputes or controversies arising under, out of, or in
connection with the MIT Agreement, including any dispute
relating to patent validity or infringement, which the parties
shall be unable to resolve within one hundred twenty (120)
days shall be mediated in good faith. The party raising such
dispute shall promptly advise the other party of such claim,
dispute or controversy in a writing which describes in
reasonable detail the nature of such dispute. By not later
than five (5) business days after the recipient has received
such notice of dispute, each party shall have selected for
itself a representative who shall have the authority to bind
such party, and shall additionally have advised the other
party in writing of the name and title of such representative.
By not later than ten (10) business days after the date of
such notice of dispute, the party against whom the dispute
shall
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be raised shall select a mediation firm in the Boston area and
such representatives shall schedule a date with such firm for
a mediation hearing. The parties shall enter into good faith
mediation and shall share the costs equally. If the
representatives of the parties have not been able to resolve
the dispute within fifteen (15) business days after such
mediation hearing, then any and all claims, disputes or
controversies arising under, out of, or in connection with
the MIT Agreement, including any dispute relating to patent
validity or infringement, shall be resolved by final and
binding arbitration in Boston, Massachusetts under the rules
of the American Arbitration Association, or the Patent
Arbitration Rules if applicable, then obtaining. The
arbitrators shall have no power to add to, subtract from or
modify any of the terms or conditions of the MIT Agreement,
nor to award punitive damages. Any award rendered in such
arbitration may be enforced by either party in either the
courts of the Commonwealth of Massachusetts or in the United
States District Court for the District of Massachusetts, to
whose jurisdiction for such purposes the Company as a
sublicensee of Orasomal hereby irrevocably consents and
submits.
15.3.2. Notwithstanding the foregoing, nothing in this Clause 15.3.
shall be construed to waive any rights or timely performance
of any obligations existing under the MIT Agreement.
15.3.3. All disputes arising out of or related to the MIT Agreement,
or the performance, enforcement, breach or termination
thereof, and any remedies relating thereto, shall be
construed, governed, interpreted and applied in accordance
with the laws of the Commonwealth of Massachusetts, United
States of America, except that questions affecting the
construction and effect of any patent shall be determined by
the law of the country in which the patent shall have been
granted.
16. ASSIGNMENT
16.1. This Agreement may not be assigned by either Party without the prior
written consent of the other, which consent in relation to the proposed
assignment to an Affiliate of Orasomal or the Company, as the case may
be, shall not be unreasonably withheld, conditioned or delayed.
17. NOTICES
17.1. Any notice to be given under this Agreement shall be sent in writing in
English by registered mail, airmail, reputable courier or recorded
delivery post, or telecopied (with a confirmation copy promptly sent by
mail) to:
- if to the Company: Endorex Vaccine Delivery Technologies, Inc.
000 Xxxxx Xxxxx Xxxxx
Xxxx Xxxx, Xxxxxxxx 00000
Telecopier: 1 847 604 8570
Attention: President
with a copy to: Xxxxx Xxxxxxxxxxxx Xxxxxxxxxxx & XxXxxxxxx LLC
000 Xxxx 00xx Xxxxxx
00xx Xxxxx
00
00
Xxx Xxxx, Xxx Xxxx 00000
Telecopier: 1 212 371 5500
Attention: Xxxxx Xxxxxxx
- if to Orasomal: Orasomal Technologies, Inc.
000 Xxxxx Xxxxx Xxxxx
Xxxx Xxxx, Xxxxxxxx 00000
Telecopier: 1 847 604 8570
Attention: President
with a copy to: Xxxxxxx Xxxxxxx & Xxxxxxxx LLP
0000 Xxxxxxxx
Xxx Xxxx, Xxx Xxxx 00000
Telecopier: 1 212 586 7878
Attention: Xxxxxxx Xxxxxxxxx
- if to Endorex: Endorex Corp.
000 Xxxxx Xxxxx Xxxxx
Xxxx Xxxx, Xxxxxxxx 00000
Telecopier: 1 847 604 8570
Attention: President
with a copy to: Xxxxxxx Xxxxxxx & Xxxxxxxx LLP
0000 Xxxxxxxx
Xxx Xxxx, Xxx Xxxx 00000
Telecopier: 1 212 586 7878
Attention: Xxxxxxx Xxxxxxxxx
or to such other address(es) as may from time to time be notified by any Party
to the others hereunder.
17.2. Any notice sent by mail shall be deemed to have been delivered within
seven working days after dispatch, any notice sent by reputable courier
shall be deemed to have been delivered within two (2) working days
after dispatch and any notice sent by telecopy shall be deemed to have
been delivered within twenty four (24) hours of the time of the
dispatch. Notices of change of address shall be effective upon receipt.
18. MISCELLANEOUS CLAUSES
18.1. No waiver of any right under this Agreement shall be deemed effective
unless contained in a written document signed by the Party charged with
such waiver, and no waiver of any breach or failure to perform shall be
deemed to be a waiver of any other breach or failure to perform or of
any other right arising under this Agreement.
18.2. If any provision in this Agreement is agreed by the Parties to be, or
is deemed to be, or becomes invalid, illegal, void or unenforceable
under any law that is applicable hereto, (i) such provision will be
deemed amended to conform to applicable laws so as to be valid and
enforceable or, 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 (ii) the validity, legality and enforceability of the remaining
provisions of this Agreement shall not be impaired or affected in any
way.
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18.3. The Parties shall use their respective reasonable endeavours to ensure
that the Parties and any necessary Independent Third Party shall do,
execute and perform all such further deeds, documents, assurances, acts
and things as any of the Parties hereto may reasonably require by
notice in writing to the other Party or such Independent Third Party to
carry the provisions of this Agreement.
18.4. This Agreement shall be binding upon and enure to the benefit of the
Parties hereto, their successors and permitted assigns and
sub-licensees.
18.5. No provision of this Agreement shall be construed so as to negate,
modify or affect in any way the provisions of any other agreement
between the Parties unless specifically referred to, and solely to the
extent provided, in any such other agreement. In the event of a
conflict between the provisions of this Agreement and the provisions of
the Development Agreement, the terms of the Development Agreement shall
prevail unless this Agreement specifically provides otherwise.
18.6. No amendment, modification or addition hereto shall be effective or
binding on either Party unless set forth in writing and executed by a
duly authorised representative of each Party.
18.7. This Agreement may be executed in any number of counterparts, each of
which when so executed shall be deemed to be an original and all of
which when taken together shall constitute this Agreement.
18.8. Each of the Parties undertake to do all things reasonably within its
power which are necessary or desirable to give effect to the spirit and
intent of this Agreement.
18.9. Each of the Parties hereby acknowledges that in entering into this
Agreement it has not relied on any representation or warranty save as
expressly set out herein or in any document referred to herein.
18.10. Nothing contained in this Agreement is intended or is to be construed
to constitute Orasomal and the Company as partners, or Orasomal as an
employee of the Company, or the Company as an employee of Orasomal.
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 Independent Third Party.
18.11. The Company shall not use the names or trademarks of MIT or Lincoln
Laboratory, nor any adaptation thereof, nor the names of any of their
employees, in any advertising, promotional or sales literature without
prior written consent obtained from MIT or said employee, in each case,
except that Licensee may state that it is licensed by MIT under one or
more of the patents and/or applications comprising the MIT Patents.
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IN WITNESS THEREOF the Parties hereto have executed this License
Agreement in duplicate.
SIGNED BY /s/ Xxxxxxx X. Xxxxx
-------------------------
For and on behalf of
ORASOMAL TECHNOLOGIES, INC.
SIGNED BY /s/ Xxxxxxx X. Xxxxx
-------------------------
For and on behalf of
ENDOREX CORP. (for the purposes of Clause 2.9
and Clause 12 only)
SIGNED BY /s/ Xxxxxxx X. Xxxxx
-------------------------
For and on behalf of
ENDOREX VACCINE DELIVERY
TECHNOLOGIES, INC.
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SCHEDULE 1
[****]
----------
**** REPRESENTS MATERIAL REDACTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
33
SCHEDULE 2
[****]
----------
**** REPRESENTS MATERIAL REDACTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
34
SCHEDULE 3
MIT AGREEMENT*
----------------
* Incorporated by reference to the Company's Annual Report on Form 10-KSB, as
amended, for the transition period ended December 31, 1996.
