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EX. 10.16
CONFIDENTIAL TREATMENT HAS BEEN SOUGHT FOR
PORTIONS OF THIS EXHIBIT PURSUANT TO RULE 24B-2
UNDER THE SECURITIES EXCHANGE AC TO 1934, AS AMENDED.
JOINT DEVELOPMENT AND OPERATING AGREEMENT, made as of
January 21, 1998 by and among ELAN CORPORATION, PLC, a public limited
company incorporated under the laws of Ireland ("Elan"), ELAN
INTERNATIONAL SERVICES, LTD., a Bermuda corporation ("EIS"), ENDOREX
CORP., a Delaware corporation ("Endorex"), ORASOMAL TECHNOLOGIES, INC.
a Delaware corporation ("Orasomal"), and ENDOREX VACCINE DELIVERY
TECHNOLOGIES, INC., a Delaware corporation (the "Company").
RECITALS
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. EIS and Endorex have, as of the date hereof, subscribed for the initial
share capital of the Company and agreed to co-operate in the management
of its business, which will be to research and develop certain Products
incorporating the technologies developed and/or to be developed by Elan
and Orasomal and to distribute and sell such Products throughout the
world.
D. Elan, EIS, Endorex and Orasomal have agreed to enter into this
Agreement for the purpose of recording the terms and conditions of the
Joint Venture and regulating their relationship with each other and
certain aspects of the affairs of and their dealings with the Company.
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AGREEMENT
CLAUSE 1
DEFINITIONS
1.1 In this Agreement, the following expressions shall, where not
inconsistent with the context, have the following meanings
respectively.
"ACQUIRING PARTY" shall have the meaning assigned to it in Clause 9.5;
"ADDITIONAL CAPITAL" means, for each of EIS and Endorex, the amount of
funds, if any, contributed to the Company subsequent to the first
anniversary of the Closing Date;
"AFFILIATE" and "SUBSIDIARY" mean any corporation or entity, other than
the Company, controlling, controlled or under the common control of
Elan or Endorex, as the case may be. For the purposes of this
definition and Clause 17.3, "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;
"AGREED" means agreed by all Parties and confirmed in writing;
"AGREEMENT" means this agreement (which expression shall be deemed to
include the Recitals and the Schedules hereto);
"BUSINESS" means the business of the Company as described in Clause 2
and as more particularly specified in the Business Plan and such other
business as the Parties may agree from time to time in writing should
be carried on by the Company;
"BUSINESS PLAN" means the plans to be prepared and approved by the
Directors, including mutual agreement of the Elan Director and the
Endorex Director, pursuant to Clause 14, in conjunction with the
Research and Development Programs, for the conduct of the Business of
the Company for each Financial Year for the duration of this Agreement
which shall include, in particular, details of the planned budget for
research and development expenses to be incurred in that Financial
Year, for which each of the Participants shall be responsible, and how
such expenses shall be funded;
"CLOSING DATE" means January 21, 1998;
"COMPANY PROGRAM TECHNOLOGY" shall have the meaning assigned to it in
Clause 6.4;
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"COMPANY SUBSCRIPTION AGREEMENT" means the Subscription and
Stockholders' Agreement of Endorex Vaccine Delivery Technologies, Inc.,
made by and between EIS, Endorex and the Company as of the date hereof;
"COST" means, depending upon the context, one of the following:
In the case of the [****], Cost shall comprise, [****]
excluding [****].
In the case of [****], Cost will be calculated, [****],
in accordance with [****] and will exclude [****].
In the case of [****], Cost will comprise the amount
[****], including [****] and [****];
"DIRECTORS" means, collectively, the Elan Director, the Endorex
Director and where applicable, the Independent Director;
"DISPUTE" means, collectively, a Program Dispute and a Management
Dispute, each as defined in Clause 16;
"EFFECTIVE DATE" means December 31, 1997;
"ELAN DIRECTOR" means a director of the Company to be appointed by EIS,
pursuant to the terms of the Company Subscription Agreement;
"ELAN LICENSE AGREEMENT" means the license agreement between Elan and
the Company dated as of the date hereof;
"ELAN OPTION" means the right of Elan, as described in the Company
Subscription and Stockholders Agreement made by and among EIS, Endorex
and the Company, as of the date hereof, whereby Elan may increase its
ownership percentage of Company common stock to 50%;
"ELAN PROGRAM TECHNOLOGY" has the meaning assigned to it in Clause
6.3(i);
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FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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"ELAN TECHNOLOGY" has the meaning assigned to it in the Elan License
Agreement;
"ENDOREX DIRECTOR" means a director of the Company to be appointed by
Endorex, pursuant to the terms of the Company Subscription Agreement
"ENDOREX OPTION" means the right of Endorex, as described in the
Company Subscription and Stockholders Agreement made by and among EIS,
Endorex and the Company, as of the date hereof to increase its
percentage ownership of Company common stock to 100%;
"EXPERT" shall have the meaning assigned to it in Clause 16.5;
"FDA" means the United States Food and Drug Administration or any
successor agencies, 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 in the Territory;
"FACTOR" means an interest rate of [****] per annum, from and after the
Closing Date;
"FIELD" shall be defined as the research, development, and
commercialization of oral and mucosal delivery technologies for
therapeutic and prophylactic Vaccines for humans and animals;
"FINANCIAL YEAR" means that time period commencing on January 1st and
expiring on December 31st of each calendar year;
"FIRST RIGHT OF NEGOTIATION" shall have the meaning assigned to it in
section 9.5;
"GLP" AND "GMP" means current Good Laboratory Practises and current
Good Manufacturing Practises, respectively;
"INDEPENDENT THIRD PARTY" means any Person other than Elan, EIS,
Endorex, Orasomal or the Company and/or any of their respective
Affiliates and advisors;
"INITIAL FUNDING" means the purchase of Common Stock of the Company
made as of the date hereof, pursuant to the Company Subscription
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
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FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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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;
"LICENSE AGREEMENTS" means the Elan License Agreement and the Orasomal
License Agreement;
"LISTED COMPANY" means the companies set forth in Schedule 3 and their
respective controlled (as such term is used in the definition of
Affiliates above) subsidiaries;
"ORASOMAL LICENSE AGREEMENT" means the license agreement between
Orasomal and the Company dated as of the date hereof;
"ORASOMAL PROGRAM TECHNOLOGY" has the meaning assigned to it in Clause
6.3(ii);
"ORASOMAL TECHNOLOGY" has the meaning assigned to it in the Orasomal
License Agreement;
"PARTICIPANT" means Endorex or Elan, as the case may be, and
"Participants" means each of the Participants together;
"PARTY" means Elan, EIS, Endorex, Orasomal or the Company, as the case
may be, and "PARTIES" means all or some of them together, as
applicable;
"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" shall mean an individual, partnership, corporation, limited
liability company, business trust, joint stock company, trust,
unincorporated association, joint venture, or other entity of whatever
nature;
"PRODUCT(S)" means [****];
"PROGRAM KNOW-HOW" means all Know-How produced, created or acquired
pursuant to one or more of the Research and Development Programs;
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THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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"PROGRAM PATENTS" means the inventions and underlying Patents that
constitute the inventions or discoveries that have been or subsequently
may be conceived pursuant to one or more of the Research and
Development Program, or are acquired or licensed by the Company from an
Independent Third Party;
"PROGRAM TECHNOLOGY" means the Program Patents and/or the Program
Know-How;
"PROVIDING PARTY" shall have the meaning assigned to such term in
Clause 4.2;
"R&D COMMITTEE" means the committee established pursuant to
Clause 3.2;
"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 R&D Committee and approved by
the Management Committee;
"SHARES" means the common stock of the Company, par value $.01 per
share;
"TECHNOLOGIES" means collectively, the Orasomal Technology together
with the Elan Technology;
"TERRITORY" means the world;
"TERM" shall have the meaning assigned to such word in Clause 17.1;
"THIRD PARTY TECHNOLOGY" shall have the meaning assigned to it in
Clause 9.5;
"UNITED STATES DOLLAR" and "US$" means the lawful currency for the time
being of the United States of America; and
"VACCINES" means a [****] administered to [****] to a specific [****],
including a [****] that is either [****];
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
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FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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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.
1.7 Unless the context or subject otherwise requires, references to words
in one gender include references to the other genders.
1.8 References to "include" or "including" shall be construed as examples
only, and in no way be read as limiting.
CLAUSE 2
REPRESENTATIONS AND WARRANTIES
2.1 Each of Elan, EIS, Endorex and Orasomal hereby represents and warrants
to the other that the Shares acquired or to be acquired by it in the
Company will be acquired for its own absolute beneficial ownership and
not on behalf of any other Person.
2.2 Each of Elan, EIS, Endorex and Orasomal hereby represents and warrants
to the other that:
(i) it is duly incorporated under the laws of its place of
incorporation;
(ii) it has full authority and capacity to enter into and perform
its obligations under this Agreement (having obtained all
requisite corporate and governmental approvals);
(iii) it is not engaged in any litigation or arbitration, or in any
dispute or controversy reasonably likely to lead to
litigation, arbitration or any other proceeding, which would
materially affect the validity of this Agreement, the Party's
fulfilment of its respective obligations under this Agreement
or the business of the Company as contemplated herein; and
(iv) this Agreement has been fully authorised, executed and
delivered by it and it has full legal right, power and
authority to enter into and perform this Agreement, which
constitutes a valid and binding agreement between the Parties.
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CLAUSE 3
DIRECTION OF RESEARCH AND DEVELOPMENT
3.1 The Directors shall appoint a management committee (the "MANAGEMENT
COMMITTEE") to perform certain operational functions, such delegation
to be consistent with the Directors' right to delegate powers pursuant
to the Company's Certificate of Incorporation. The Management Committee
shall initially consist of four members, two of whom shall be nominated
by the Elan Director and two of whom shall be nominated by the Endorex
Director, and each of whom shall be entitled to one vote, whether or
not present at any Management Committee meeting during which such
operational functions are discussed. Each of the Elan Director and the
Endorex Director shall be entitled to remove any of their nominees to
the Management Committee and appoint a replacement in place of any
nominees so removed. The number of members of the Management Committee
may be altered if agreed to by the Directors; provided that at all
times during the term of this Agreement, each of the Elan Director and
the Endorex Director shall be entitled to appoint an equal number of
members to the Management Committee.
3.2 The Management Committee shall appoint a research and development
committee (the "R&D COMMITTEE"). The R&D Committee shall initially
consist of four members, with an equal number being nominated by the
nominees of the Elan Director on the Management Committee and by the
nominees of the Endorex Director on the Management Committee, and each
of whom shall have one vote, whether or not present at an R&D Committee
meeting during which research and development issues are discussed. The
nominees of the Elan Director or the nominees of the Endorex Director
shall be entitled to remove any of their nominees to the R&D Committee
and appoint a replacement in place of any nominees so removed. The
number of members of the R&D Committee may be altered if agreed to by
the Management Committee; provided, that at all times during the term
of this Agreement an equal number of members shall be nominated by the
nominees of the Elan Director and by the nominees of the Endorex
Director.
3.3 The Management Committee shall be responsible for, inter alia,
devising, implementing and reviewing strategy for the Business and, in
particular, devising the Company's strategy for research and
development in relation to the Field and to monitor and supervise the
implementation of the Company's strategy for research and development.
3.4 The Management Committee shall report all significant developments to
the Directors on the occurrence thereof and, in addition, shall report
at quarterly intervals to the Directors. Any dispute or deadlock among
the members of the Management Committee shall be
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referred by it to the Directors.
3.5 The R&D Committee shall be responsible for the design of the Research
and Development Programs for consideration by the Management Committee
and the implementation of the Research and Development Programs as
approved by the Management Committee. The R&D Committee shall meet at
regular intervals to monitor the progress of the Research and
Development Programs and to report on their progress to the Management
Committee.
CLAUSE 4
CONDUCT OF RESEARCH AND DEVELOPMENT
4.1. During the 12 month period commencing on the January 1, 1998, each of
Elan and Endorex shall undertake to perform research and development
related to the commercialisation of Products in an amount of
approximately $1.5 million each, as stated in the Business Plan, in
furtherance of the development and cultivation of the Program
Technology. Subsequent to December 31, 1998, Elan and Endorex shall
fund research and development work in accordance with their respective
ownership interest in the Company. The cost of such development work
shall be each Party's respective Cost plus 40%.
4.2. Whenever commercially and technically feasible, the Company shall
contract with Elan or Orasomal, as the case may be, to perform
research, development and experimentation activities for the purpose of
developing the Field and the Products (each, a "PROVIDING PARTY"). In
the event that the Company [****], the Company [****]; provided, that
the [****] is not a [****].
4.3 Subject to the provisions of Clause 4.1, each of Elan and Orasomal
shall, at its respective option, provide such research and development
services in the Field as may reasonably be required by the Company. The
research and development work conducted by the Providing Party for the
Company shall be in accordance with the Research and Development
Program devised by the R&D Committee as approved by the Management
Committee. The Providing Party shall use its reasonable endeavors to
conduct its portion of the Research and Development Program in
accordance with the timetable set out in the Research and Development
Program. The Providing Party shall, in accordance with the terms and
conditions set forth in this Agreement, undertake reasonably diligent
efforts, as would be
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FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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deemed commensurate with the achievement of its own business aims for
a similar product of its own, to conduct its part of the Research and
Development Program.
4.4 The Research and Development Program(s) shall be directed by the R&D
Committee, subject to the strategic direction of the Management
Committee. In conducting the Research and Development Program(s), the
Providing Party shall co-operate fully with the R&D Committee, the
Management Committee and Orasomal or Elan as the case may be. Each
Providing Party shall maintain the facilities used by it for the
performance of the Research and Development Program in compliance with
the applicable requirements of the FDA and other regulatory
authorities, including GMP and GLP standards.
4.5 The Company may evaluate the reports and other data furnished by the
Providing Party for the purpose, inter alia, of deciding whether or not
to proceed with all or part of the applicable Research and Development
Program.
4.6 Elan, Endorex and the Company shall agree on a budget in connection
with the activities to be undertaken by Elan and Orasomal during the
Research and Development Program, which budget shall form part of the
Research and Development Program. In the event that as a result of
additional activities to be undertaken by the Providing Party at the
request of the Company the budget needs to be revised, Elan, Endorex
and the Company will agree on such revision prior to the Providing
Party commencing any such additional development activities.
4.7 The Providing Party will keep accurate records consistent with its
normal business practices of the efforts expended by it under the
Research and Development Program for which it is charging the Company,
which will include the time spent by each person working on the
Research and Development Program.
4.8 [****], the Providing Party shall permit the Company or its duly
authorized representative on reasonable notice and at any reasonable
time during normal business hours to have access to inspect and audit
the accounts and records of the Providing Party and any other book,
record, voucher, receipt or invoice relating to the calculation or the
Cost of the Research and Development Program or, where applicable, for
the supply of the Products and to the accuracy of the reports which
accompanied them. Any such [****] shall be at the [***], except that if
any such [****] in the amount of [****] for the [****] in any calendar
quarter [****] hereunder, then the [****] shall be [****] instead of
[****]. Any [****] properly [****]
**** REPRESENTS MATERIAL REACTED 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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[****] to the [****] shall be [****]. If such [****] properly [****].
4.9 Subject to the provisions of Clause 4.1, the Company shall pay the
Providing Party for any research and development work carried out by
them on behalf of the Company at the termination of each stage of the
Research and Development Program, subject to the proper invoicing of
research and development work and expenses.
CLAUSE 5
REGULATORY APPROVALS
5.1 During the relevant regulatory procedure, the Company shall keep the
other Parties promptly and fully advised of the relevant regulatory
activities, progress and procedures. The Company shall inform the other
Parties of any dealings it shall have with the FDA, and shall furnish
the other Parties with copies of all correspondence. The Parties shall
collaborate in relation to obtaining the approval of the FDA for final
approved labelling.
5.2 Any and all regulatory applications or approvals filed hereunder for
the Product shall remain the property of the Company; provided, that
the Company shall allow the other Parties access thereto to enable
those Parties to fulfil their obligations and exercise their rights
under this Agreement, the Orasomal License and the Elan License. The
Company shall maintain such regulatory approvals at its own cost.
5.3 The costs and expenses of any filings and proceedings made by the
Company to the FDA, including post approval studies required by the FDA
in respect of the Product, and to maintain the FDA approval hereunder
shall be paid by the Company.
5.4 It is hereby acknowledged that there are inherent uncertainties
involved in the registration of pharmaceutical products with the FDA
insofar as obtaining approval is concerned and such uncertainties form
part of the business risk involved in undertaking the form of
commercial collaboration as set forth in this Agreement. Therefore,
except for using its reasonable efforts, neither Elan nor Endorex shall
have any liability to the Company solely as a result of any failure of
the Product to achieve the approval of the FDA, or any other regulatory
body in the Territory.
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FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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CLAUSE 6
PROPERTY OWNERSHIP RIGHTS
6.1 The Company [****], the [****] and the [****]. Elan and Orasomal hereby
[****], which they may respectively [****], to the Company. Elan and
Orasomal shall each [****] in the aforesaid [****].
6.2 [****] shall own or license the legal and equitable title to the
[****]. Such rights of [****] shall be subject to the [****]. [****]
shall own or license the legal and equitable title to the [****]. Such
rights of [****] shall be subject to the [****].
6.3 All Program Technology developed by or on behalf of the Company shall:
(i) if based upon, or significantly derived from, [****],
constitute [****] (the "[****]"); or
(ii) if based upon, or significantly derived from, [****]
constitute [****] (the "[****]");
In determining whether Program Technology is based upon or
significantly derived from Elan Technology or Orasomal Technology,
reference shall be made to the Participant's respective patents, patent
applications and other relevant evidence of the Participants'
intellectual property such as laboratory notebooks.
6.4 Any technology acquired or licensed by the Company from an Independent
Third Party and any Program Technology which does not constitute Elan
Program Technology or Orasomal Program Technology shall constitute
Company Program Technology (the "COMPANY PROGRAM TECHNOLOGY").
6.5 [****] shall be [****] (the term of which may survive this Agreement),
and [****] (the term
**** REPRESENTS MATERIAL REACTED 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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of which may survive this Agreement). As a guide only, the parties
anticipate that [****] (i.e. [****] including [****]). In connection
with such [****], the Company's rights of inspection and audit and
other applicable terms shall be negotiated at the time [****], such
provisions, where applicable, to be mutatis mutandis with those set out
in [****].
6.6. To the extent that the Company Program Technology shall have
application outside the Field, the Company shall grant a world-wide
license to Elan and/or Orasomal on terms to be negotiated in good
faith, including whether such a licence should be exclusive,
semi-exclusive or non-exclusive in nature, the extent of the Company
Program Technology to be licensed, and the financial terms which shall
be generally consistent with prevailing market terms. In the event that
the parties cannot agree on such terms, the parties shall submit their
dispute to an Expert to determine the terms of such licenses.
CLAUSE 7
PATENT RIGHTS
7.1 The rights and obligations of the Participants and the Company in
respect of any Patents claiming the Technologies or the Program
Technology are governed by the provisions of the License Agreements.
CLAUSE 8
EQUIPMENT
8.1 Any equipment or other assets purchased by Orasomal and/or Elan which
are funded by the Company shall belong to the Company. In the event
that such equipment or assets are purchased, the Parties shall conclude
the appropriate arrangements as regards marking of goods, insurance and
bailment provisions.
CLAUSE 9
EXPLOITATION OF PRODUCTS
9.1 The Company will have [****] and in any Products subject to the
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THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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other terms of this Agreement. [****]. It may be necessary to file a
regulatory application and perform clinical testing in more than one
country. The conduct of such clinical trials and the obtaining of
regulatory approvals shall be regulated in accordance with arrangements
agreed upon by the Management Committee.
9.2 The Management Committee shall review the research and development
programs on a regular basis to decide, inter alia, whether one or more
of such programs should continue, be terminated, or continue as
modified. Any Party may call upon the Management Committee of the
Company to review termination of the research and development program
for a Product.
9.3. In the event that (i) [****], and (ii) an [****] shall negotiate in
good faith whether or not [****] shall be entitled [****], as the case
may be, in relation to [****] and such [****], if any, [****], which
has been [****], and if so upon what terms. In determining whether
[****] shall be [****], the parties shall take into account whether or
not the said [****].
9.4 The strategy for the registration and the commercialization of the
Products shall be determined by the Management Committee.
9.5 Subject to contractual constraints, in the event that [****], as the
case may be, (the "[****]") proposes to [****], or has [****] pursuant
to [****], from a [****], and such [****] relating to [****] (a
"[****]"), the [****]shall, for so long as [****], or may at its
election, if the [****], disclose such details as are required to
[****]. Subject to contractual constraints, the Company shall [****]
(the "[****]") to [****] (as is appropriate) [****]
**** REPRESENTS MATERIAL REACTED 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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[****]from the [****] (or [****]from the [****]). The [****]shall on
[****]promptly and exclusively [****]for a period of [****]unless the
Company gives [****] that it [****] in question. The terms for the
[****] shall be upon terms to be [****] in good faith, including terms
covering the [****] by the Company for any payments [****]to an
[****]in respect of [****]
9.6. In the event that the Company [****] (or subsequently discontinues
[****]), the [****] shall thereafter be entitled [****]with [****]
and/or to [****].
9.7. In the event that one Participant determines not to fund any amounts
required (as approved by the Elan Director and the Endorex Director in
the Company Budget) to develop and commercialize the Elan Technology or
the Orasomal Technology, or products based thereon, [****], as provided
in the Company's approved budgets, the [****] (a) [****] or (b) [****].
Subsequent to such an event, [****] (the "Revised Interest"). The
[****]. In no event shall such [****], if any, cause [****].
9.8. In the event that (a) one Participant determines not to fund any
amounts required to develop and commercialize a particular product
based on the Elan Technology or Orasomal Technology or project based
thereon, as opposed to generally failing to fund as described under
Section 9.7, above, and (b) the other Participant desires to fund such
product or project, [****].
**** REPRESENTS MATERIAL REACTED 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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CLAUSE 10
TECHNICAL SERVICES AND ASSISTANCE
10.1 [****], the Company shall contract with Orasomal, Endorex or Elan, as
the case may be, to perform such other services as the Company may
require, other than those specifically dealt with in the Orasomal
License Agreement and the Elan License Agreement. In determining which
Party should provide such services, the Management Committee shall take
into account the respective infrastructure and experience of Elan,
Endorex and Orasomal. Nothing in this Clause 10.1 shall be deemed to
prohibit the Company from contracting such required services from an
Independent Third Party in the event that [****].
10.2 The Company shall, if appropriate, conclude an administrative support
agreement with Elan and Orasomal on such terms as the parties thereto
shall in good faith negotiate. The management services required
include, but are not limited to, one or more of the following
management services which shall be requested by the Company:
(i) accounting, financial and other services;
(ii) tax services;
(iii) insurance services;
(iv) human resources services;
(v) legal and company secretarial services;
(vi) patent and related intellectual property services; and
(vii) all such other services consistent with and of the same type as
those services to be provided pursuant to this Agreement, as may be
required.
10.3 If Elan or Orasomal so requires, Orasomal or Elan, as the case may be,
shall receive, at times and for periods mutually acceptable to the
parties, employees of the other party (such employees to be acceptable
to the receiving party in the matter of qualification and competence)
for instruction in respect of the Elan Technology or the Orasomal
Technology,
**** REPRESENTS MATERIAL REACTED 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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as the case may be, as is necessary to further the Research and
Development Programs.
10.4 The employees received by Elan or Orasomal, as the case may be, shall
be subject to obligations of confidentiality no less stringent than
those set out in Clause 19 and such employees shall observe the rules,
regulations and systems adopted by the Party receiving the said
employees for its own employees or visitors.
CLAUSE 11
SUPPLY ARRANGEMENTS
11.1 The Company shall provide to Elan a right of first offer to provide
manufacturing for Products; provided, that Elan's terms and conditions
are consistent with terms and conditions (including as to pricing) then
available to the Company and similarly-situated companies; provided,
further, that in the event that the Company shall obtain more favorable
terms from an Independent Third Party, and Elan is unwilling or unable
to match such other party's terms and conditions, the Company shall
have the right to engage such Independent Third Party for manufacturing
services, so long as such Independent Third Party is not a Listed
Company.
CLAUSE 12
PROCEEDINGS OF DIRECTORS AND CHAIRMAN
12.1 The board of directors of the Company shall consist of three members as
follows: the Elan Director, the Endorex Director and an independent
director, mutually satisfactory in fitness of character and business
and industry experience, to each of Elan and Endorex.
12.2 As of the date hereof, the Endorex Director shall be the chairman of
the Company's board of directors.
12.3 The Chairman appointed under Clause 12.2 shall retire as Chairman at
the first Annual Meeting of the Company to be held no later than June
30, 1999. Thereafter, each Participant, beginning with Elan, shall have
the right, exercisable alternatively, of nominating one of the
Directors to be Chairman of the Company for a period of one year. The
Chairman shall hold office until the termination of the next Annual
Meeting following his appointment. If the Chairman is unable to attend
any meeting of the board, the Director of the same designation shall be
entitled to appoint another director to act as
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Chairman in his place at the meeting.
CLAUSE 13
MATTERS REQUIRING PARTICIPANTS' APPROVAL
13.1 In consideration of Orasomal and Elan agreeing to enter into the
License Agreements, the Parties hereby agree that neither the Company
nor any Subsidiary of the Company shall, without the prior approval of
each of the Participants:
(i) engage in any activity other than the Business;
(ii) sell the principal assets, undertaking or Business of the
Company;
(iii) borrow any sum (except from the Company's bankers in the
ordinary and proper course of the Business) in excess of a
maximum aggregate sum outstanding at any time of [****];
(iv) make any loan or advance or give any credit (other than normal
trade credit) in excess of [****] to any Person;
(v) give any guarantee or indemnity to secure the liabilities or
obligations of any Party other than those which it is usual to
give in the ordinary course of a business similar to the
Business;
(vi) enter into any contract, arrangement or commitment involving
expenditure on capital account or the realization of capital
assets if the amount or the aggregate amount of such
expenditure or realisation by the Company and all of the
Subsidiaries of the Company would exceed [****] in any one
year or in relation to any one project, and for the purpose of
this paragraph the aggregate amount payable under any
agreement for hire, hire purchase or purchase on credit sale
or conditional sale terms shall be deemed to be capital
expenditure incurred in the year in which such agreement is
entered into;
(vii) issue any unissued Shares or create or issue any new shares,
or alter any rights attaching to the Company's capital stock;
(viii) create, acquire or dispose of any Subsidiary or of any shares
in any Subsidiary;
**** REPRESENTS MATERIAL REACTED 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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(ix) enter into any partnership or profit sharing agreement with
any Person other than arrangements with trade representatives
and similar Persons in the ordinary course of business;
(x) issue any debentures or other securities convertible into
shares or debentures or any share warrants or any options in
respect of Shares;
(xi) acquire, purchase or subscribe for any shares, debentures,
mortgages or securities (or any interest therein) in any
company, trust or other Person;
(xii) adopt any employee benefit program or incentive schemes;
(xiii) engage any new employee of the Company at remuneration which
could exceed the rate of [****] per annum;
(xiv) pay any remuneration to Directors by virtue of holding such
office;
(xv) licence or sub-licence any of the Elan Technology, Orasomal
Technology, Company Program Technology, Elan Program
Technology or Orasomal Program Technology;
(xvi) amend or vary the terms of the Orasomal Licence Agreement or
the Elan Licence Agreement; and
(xvii) to undertake a Research and Development Program;
(xviii) file an amendment to the Company's certificate of
incorporation or alter the by-laws;
(xix) alter the number of the Company's directors.
CLAUSE 14
THE BUSINESS PLAN AND REVIEWS
14.1 The Directors shall meet as soon as reasonably practicable after the
date hereof and in any event within 30 days of signing this Agreement,
to agree and approve the Business Plan and operating budget for the
initial Financial Year. Thereafter the Directors shall reach
**** REPRESENTS MATERIAL REACTED 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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agreement on each subsequent Financial Year operating budget at least
30 days prior to the commencement of each respective Financial Year.
14.2 The Participants agree that the Management Committee shall submit to
the Directors, on 15th February, 15th May, 15th August and 15th
November, or as soon as reasonably practicable thereafter in each
Financial Year, a report on the performance of the business activities
of the Company and the Directors shall hold such meeting as may be
necessary to review the performance of the Company against the Business
Plan for the relevant year of trading.
CLAUSE 15
TRANSFER OF OR PLEDGING OF SHARES
15.1 Neither EIS nor Endorex shall, directly or indirectly, sell, assign,
pledge, encumber, hypothecate or otherwise transfer (in each case, a
"Transfer") any Shares except in accordance with this Agreement. The
Company shall not, and shall not permit any transfer agent or registrar
for the Shares to, transfer upon the books of the Company any Shares
from any stockholder to any Transferee (as hereinafter defined), in any
manner, except in accordance with this Agreement, and any purported
transfer not in compliance with this Agreement shall be void.
15.2 In the event a stockholder shall Transfer any Shares (including any
such Shares acquired after the date hereof) to any Person (all Persons
acquiring Shares from a stockholder, as described in this Clause 15,
regardless of the method of transfer, shall be referred to collectively
as "Transferees" and individually as a "Transferee") in accordance with
this Agreement, such Shares shall nonetheless bear legends as provided
in the Company Subscription Agreement of; provided, however, that the
provisions of this Clause 15.2 shall not apply in respect of a sale of
Shares in a registered public offering under the Securities Act of
1933, as amended (the "SECURITIES ACT") or pursuant to Rule 144, or any
successor rule under the Securities Act.
15.3 Notwithstanding any other provision of this Agreement, no stockholder
shall, directly or indirectly, Transfer any Shares at any time if such
action would constitute a violation of any federal or state securities
or blue sky laws or a breach of the conditions to any exemption from
registration of Shares under any such laws or a breach of any
undertaking or agreement of such stockholder entered into pursuant to
such laws or in connection with obtaining an exemption thereunder.
14.4 No stockholder shall effect a Transfer of Shares unless such Transferee
shall agree to be
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bound by this Agreement, and shall further agree to permit EIS or Endorex, as
applicable, to act on their behalf in accordance with the provisions of
this Agreement.
CLAUSE 16
DISPUTES
16.1 Disputes among the members of the R&D Committee (each such event, a
"Program Dispute") which cannot be resolved by consensus shall be
forwarded to the Management Committee for discussion and resolution, by
filing of a notice of dispute from the R&D Committee to the Management
Committee.
16.2 In the event that the members of the Management Committee, after
reasonable consideration, cannot resolve a Program Dispute within 10
days of receipt of a notice as described in Clause 16.1, such Program
Dispute shall be forwarded to the board of directors for discussion and
resolution, by submission of a letter from the Management Committee to
the Chairman of the board of directors detailing the issue in dispute
and the position of each party in relation thereto.
16.3 Disputes under this Agreement among members of the Management Committee
(each such event a "Management Dispute"; together with a Program
Dispute, a "Dispute"), which cannot be resolved by consensus shall also
be forwarded to the board of directors for discussion and resolution,
by submission of a letter from the Management Committee to the Chairman
of the board of directors detailing the issue in dispute and the
position of each party in relation thereto.
16.4 In the event of submission of a letter accordance with Clause 16.2 or
16.3, the members of the board of directors shall convene in person or
via telephone conference within 10 days in order to discuss the
Dispute. After discussion and consideration, resolution of the Dispute
shall be decided by a majority vote of the board of directors.
16.5 In the event that the board is unable to resolve a Dispute, the
Chairman shall refer the matter to an expert (the "Expert"), mutually
acceptable to the Parties; or in the event that the Parties cannot so
agree, a Panel (as defined below) in accordance with the procedures for
such Panel as set forth below in Clause 16.9 below. In each case, the
Expert shall be selected having regard to his suitability to determine
the particular dispute or difference on which he is being requested to
determine. The Expert shall afford each Party a reasonable opportunity,
in writing or orally, to state its respective reasons in support of
such contentions as each Party may wish to make relative to the matters
under consideration. The Expert shall give notice in writing of his
determination to the Parties within such time as may be stipulated in
his terms of appointment, or in the absence of such stipulation as
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soon as practicable, but in any event within three weeks from the
reference of the Program Dispute to him.
16.6 The fees of each Expert shall be shared equally between the Parties.
The Expert shall be entitled to inspect and examine all documentation
and any other material which he may consider to be relevant to the
Dispute.
16.7 Any [****] shall [****] on [****]; provided, however, that any [****]
of a [****] based upon [****] shall be [****].
16.8 In no event shall the referral of a Dispute to the Expert supercede the
requirement, as described in Section 2.6 of the Company Subscription
Agreement or the provisions of Clause 12 of this Agreement, that both
the Elan Director and Endorex Director, and where applicable the
Participants, approve certain business decisions.
16.9 In the event that the board of directors is unable to agree upon an
Expert, a panel of experts (the "Panel") shall be appointed as follows.
The Elan Director and the Endorex Director shall each select one
Expert, each in their sole discretion, using good faith to select an
Expert with appropriate qualifications. Within 20 days of the
appointment of such Experts, the two Experts so selected shall appoint
a third Expert from a list of arbitrators provided by the American
Arbitration Association (the "AAA"); provided, that in the event that
the two selected Experts are unable to agree upon such third Expert
within 20 days, any director of the Company may request the AAA to
appoint such third Expert.
16.10 Notwithstanding Clause 16.9, each of the Elan Director and the Endorex
Director shall be prohibited from selecting as an Expert any person who
has or has had a material interest or relationship (i.e., through
employment, stock ownership, business affiliation or otherwise) with a
Party or any of its directors, officers or employees. Service as an
Expert hereunder shall not constitute such a material interest or
relationship in connection with the resolution of subsequent Disputes.
CLAUSE 17
TERMINATION
17.1 The Company shall continue to operate and exist for so long as its
stockholders shall determine, and this Agreement and the Company
Subscription Agreement shall govern such operation and existence until
this Agreement shall be terminated in accordance with this
**** REPRESENTS MATERIAL REACTED 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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Clause 17 (the "Term").
17.2 For the purpose of this Clause 17, a "Relevant Event" is committed by
Elan or Endorex if:
(i) it commits a material breach of its obligations under this
Agreement and fails to remedy it within 60 days of being
specifically required in writing to do so by the other
Participant; provided, however, that if the breaching
Participant 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 60th day, such rectifying period shall
be extended by an amount of time as is reasonably necessary to
permit the breach to be rectified;
(ii) 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);
(iii) 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;
(iv) 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 90 days.
17.2 If either Participant commits a Relevant Event, the other Participant
shall have in addition to all other legal and equitable rights and
remedies hereunder, the right to terminate this Agreement upon 30 days'
written notice; provided, that such written notice be given within
60 days following the date that the other Participant becomes aware of
the Relevant Event.
17.3 In the event that (a) a Listed Company shall acquire 15% or more of the
voting stock of Endorex, Orasomal or the Company, or otherwise control
their management or business, or (b) any other person or entity shall
acquire 50% or more of the voting stock of Endorex, Orasomal or the
Company, or otherwise merge, consolidate or enter into any similar
transaction (or binding agreement in respect thereof) with any of such
entities, this Agreement shall, at the option of Elan, terminate, so
long as Elan shall provide written notice of such election to terminate
within 90 days of the such event; provided, that the foregoing shall
not apply in relation to any exercise of the Elan Option or the Endorex
Option (each as described in the Company Subscription Agreement).
17.4 If, at any time, the Participants agree that the Company should be
wound up or liquidated,
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the Parties shall ensure that, after all of the debts of the Company
have been satisfied, the assets of the Company shall be distributed,
in specie, as follows:
(i) to Elan of the Elan Program Technology for the Field; and
(ii) to Orasomal of the Orasomal Program Technology for the Field;
and
(iii) to Elan and Endorex of the Company Program Technology pro rata,
based upon each party's ownership percentage of the Company;
and/or the Parties further agree to negotiate in good faith, the terms
for other arrangements, including cross licences, as may be necessary
to enable Orasomal and Elan to exploit the technology of the other
Party for the Field.
17.5 The Parties agree that in the event that Elan shall exercise its right
to acquire 100% of the outstanding Shares, pursuant to its rights under
the Elan Option:
(i) the Orasomal Licence Agreement shall continue in full force
and effect;
(ii) the licence, if any, granted by the Company to Orasomal to use
the Orasomal Program Technology outside the Field pursuant to
this Agreement shall continue; and
(iii) Orasomal shall remain entitled to a licence to the Company
Program Technology outside the Field on terms to be agreed. If
the Parties cannot agree such terms, the Parties shall refer
the dispute to an Expert for resolution, as provided in Clause
16 hereof.
CLAUSE 18
ADDITIONAL FINANCING
18.1 Each Participant shall use its reasonable efforts to procure that the
requirements of the Company for working capital to finance the Business
are provided proportionately to the shareholding held by the
Participants (in the case of Elan, by its Affiliate EIS) in a manner to
be agreed by the Participants. For the avoidance of doubt, the
Participants agree that, [****], there is no [****] to contribute
[****].
18.2 Each of the Participants agree that to the extent that the Company's
assets are insufficient to repay the financial assistance made
available by each of the Participants to the Company,
**** REPRESENTS MATERIAL REACTED 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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whether directly or indirectly, in the event that the Company is wound
up or goes into liquidation then any deficiency shall be borne by them
in equal proportions.
18.3 If it is not possible to obtain sufficient financial assistance from
the Participants, the Company can obtain borrowings or other funding
from financial institutions and other similar sources on the most
favourable terms reasonably obtainable as to interest, repayment and
security.
CLAUSE 19
CONFIDENTIALITY
19.1 Each of the Parties acknowledge that it may be necessary, from time to
time, to disclose to one another confidential and proprietary
information, including without limitation, inventions, the
Technologies, the Program Technologies, Improvements and the Patents
relating thereto, works of authorship, trade secrets, specifications,
designs, data, Know-How and other information, relating to the Field,
the Maynooth Agreement, the MIT Agreement (as each is defined in,
respectively, the Elan License Agreement and the Orasomal License
Agreement), the terms of the various agreements between the Parties,
the Products, processes, and services, of the disclosing Party
("CONFIDENTIAL INFORMATION").
Confidential Information shall not be deemed 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;
(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 Participant'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 another Party, which source, to the best of
the receiving Party's knowledge, did not acquire this
information on a
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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.
19.2 Any Confidential Information revealed by a Party to another Party shall
be used by the receiving Party exclusively for the purpose of
fulfilling the receiving Party's obligations under this Agreement and
for no other purpose.
19.3 Each of the Parties 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 of the Parties 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 of
the Parties 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 Participant, as the receiving Party would exercise to
preserve its own proprietary and confidential information. Each of the
Parties 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.
19.4 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 rights hereunder; provided, that if a Party is required to
make any such disclosure of another Party's confidential information,
other than pursuant to a confidentiality
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agreement, such disclosing Party shall inform the other Party thereof,
and allow such other Party to participate in the disclosure process for
the purpose of generally limiting, to the extent possible, such
disclosure.
19.5 The provisions relating to confidentiality in this Clause 19 shall
remain in effect during the Term, and for a period of [****] following
the expiration or earlier termination of this Agreement.
19.6. The Parties agree that the obligations of this Clause 19 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 another 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, a
Party shall be entitled to obtain injunctive relief against the
threatened breach of the provisions of this Clause 19, or a
continuation of any such breach by another 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.
CLAUSE 20
PARTICIPANTS' CONSENT
20.1 Where this Agreement provides that any particular transaction or matter
requires the consent, approval or agreement of any Participant, such
consent, approval or agreement may be given subject to such terms and
conditions as that Participant may impose and to which the other
Participant shall agree and any breach of such terms and conditions by
any Persons subject thereto shall ipso facto be deemed to be a breach
of the terms of this Agreement.
CLAUSE 21
PARTIES AND COMPANY BOUND
21.1 The Company undertakes with each of the Parties to be bound by and
comply with the terms and conditions of this Agreement insofar as the
same relate to the Company.
21.2 Each Party undertakes with the others to exercise its part in relation
to the Company so as to
**** REPRESENTS MATERIAL REACTED 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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ensure that the Company fully and promptly observes, performs and
complies with its obligations under this Agreement.
CLAUSE 22
COSTS
22.1 Each Party shall bear its own legal and other costs incurred in
relation to preparing and concluding this Agreement and the related
agreements and other documents.
22.2 All costs, legal fees, registration fees and other expenses, including
the costs and expenses incurred in relation to the incorporation of the
Company, shall be borne by the Company.
CLAUSE 23
GENERAL
23.1 GOOD FAITH
Each of the Parties hereto undertakes with the others to do all things
reasonably within its power which are necessary or desirable to give
effect to the spirit and intent of this Agreement.
23.2 FURTHER ASSURANCE
The Parties hereto shall use their respective reasonable efforts to
procure that any necessary 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 others to carry the provisions of this Agreement into full force
and effect; including, without limitation, the execution of any
documents required to ensure the assignment of the Technologies, as
described in Clause 6.1. In addition, each of Elan and Endorex shall
cooperate and make reasonably available to the Company (including its
authorized agents and representatives) all assistance reasonably
necessary or appropriate to enable the Company to prepare, file,
prosecute and maintain Patents or other Intellectual Property Rights
related to the Technologies or the Company Program Technology,
throughout the Territory.
23.3 NO REPRESENTATION
Each of the Parties hereto hereby acknowledges that in entering into
this Agreement it has
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not relied on any representation or warranty save as expressly set out
herein or in any document referred to herein.
23.4 EXERCISE OF POWERS
Where either Participant is required under this Agreement to exercise
its powers in relation to the Company to procure a particular matter or
thing, such obligation shall be deemed to include an obligation to
exercise its powers both as a Participant and as a Director (where
applicable) of the Company and to procure that any Director appointed
by it (whether alone or jointly with any other Person) shall procure
such matter or thing.
23.5 FORCE MAJEURE
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 any relevant government authority, but any such delay or failure
shall be remedied by such Party as soon as practicable.
23.6 RELATIONSHIP OF THE PARTICIPANTS
Nothing contained in this Agreement is intended or is to be construed
to constitute Elan and Endorex as partners, or Elan as an employee of
Endorex, or Endorex as an employee of Elan. No 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 another Party or to bind
another Party to any contract, agreement or undertaking with any third
party.
23.7 COUNTERPARTS
This Agreement may be executed in any number of counterparts, each of
which when so executed shall be deemed to be an original and all of
which when taken together shall constitute this Agreement.
23.8 NOTICES
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 ELAN: Elan Corporation, plc
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00
Xxxxxxx Xxxxx
Xxxxxxx Xxxxx
Xxxxxx 0, Xxxxxxx
Telecopier: 011-353-1-662-4960
Attention: Vice President & General Counsel
Elan Pharmaceutical Technologies
with a copy to: Xxxxx Xxxxxxxxxxxx Xxxxxxxxxxx & XxXxxxxxx LLC
000 Xxxx 00xx Xxxxxx
00xx Xxxxx
Xxx Xxxx, Xxx Xxxx 00000
Telecopier: (000) 000-0000
Attention: Xxxxx Xxxxxxx
- IF TO ENDOREX: Endorex Corp.
000 Xxxxx Xxxxx Xxxxx
Xxxx Xxxx, Xxxxxxxx 00000
Telecopier: 000-000-0000
Attention: President
- IF TO ORASOMAL: Orasomal Technologies, Inc.
000 Xxxxx Xxxxx Xxxxx
Xxxx Xxxx, Xxxxxxxx 00000
Telecopier: 000-000-0000
Attention: President
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in the case of Endorex and Orasomal, with a copy to:
Xxxxxxx Xxxxxxx & Xxxxxxxx LLP
0000 Xxxxxxxx
Xxx Xxxx, Xxx Xxxx 00000
Telecopier: (000) 000-0000
Attention: Xxxxxxx Xxxxxxxxx
- IF TO THE COMPANY: Endorex Vaccine Delivery Technologies, Inc.
000 Xxxxx Xxxxx Xxxxx
Xxxx Xxxx, Xxxxxxxx 00000
Telecopier: 000-000-0000
Attention: President
with a copy to the non-notifying Parties; or to such other address(es)
as may from time to time be notified by any Party to the others
hereunder.
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 working days after
dispatch and any notice sent by telecopy shall be deemed to have been
delivered within 24 hours of the time of the dispatch. Notices of
change of address shall be effective upon receipt.
23.9 GOVERNING LAW AND DISPUTES
This Agreement shall be governed by and construed in accordance with
the laws of New York and 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.
23.10 SEVERABILITY
If any provision in this Agreement is agreed by the Parties to be,
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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23.11 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
authorised representative of all Parties.
23.12 WAIVER
No waiver of any right under this Agreement shall be deemed effective
unless contained in a written document signed by the Party charged with
such waiver, and no waiver of any breach or failure to perform shall be
deemed to be a waiver of any future breach or failure to perform or of
any other right arising under this Agreement.
23.13 ASSIGNMENT
This Agreement may not be assigned by any Party without the prior
written consent of the other, which consent in relation to the
proposed assignment to an Affiliate of a Party shall not be
unreasonably withheld, conditioned or delayed.
23.14 NO EFFECT ON OTHER AGREEMENTS
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 any of 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 License Agreements or the Company Subscription Agreement, the terms
of this Agreement shall prevail
23.15 SUCCESSORS
This Agreement shall be binding upon and enure to the benefit of the
Parties hereto, their successors and permitted assigns.
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IN WITNESS whereof, the Parties have executed this Joint Development &
Operating Agreement on the date first set forth above.
ELAN CORPORATION, PLC
By: /s/ Xxxxxx X. Xxxxx
-------------------------------
Name: Xxxxxx X. Xxxxx
Title: Director
ELAN INTERNATIONAL SERVICES, LTD.
By: /s/ Xxxxx Xxxxxx
-------------------------------
Name: Xxxxx Xxxxxx
Title: President & CEO
ENDOREX CORP.
By: /s/ Xxxxxxx X. Xxxxx
-------------------------------
Name: Xxxxxxx X. Xxxxx
Title: President/CEO
ORASOMAL TECHNOLOGIES, INC.
By: /s/ Xxxxxxx X. Xxxxx
-------------------------------
Name: Xxxxxxx X. Xxxxx
Title: President/CEO
ENDOREX VACCINE DELIVERY TECHNOLGIES, INC.
By: /s/ Xxxxxxx X. Xxxxx
-------------------------------
Name: Xxxxxxx X. Xxxxx
Title: President/CEO
33
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SCHEDULE 1
ELAN LICENSE AGREEMENT
35
SCHEDULE 2
ORASOMAL LICENSE AGREEMENT
36
SCHEDULE 3
LISTED COMPANIES
[*****]
(AS MAY BE AMENDED WITH MUTUAL AGREEMENT OF ALL THE PARTIES IN WRITING FROM TIME
TO TIME)
**** REPRESENTS MATERIAL REACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
