EXHIBIT 10.24
CONFIDENTIAL TREATMENT HAS BEEN SOUGHT FOR
PORTIONS OF THIS EXHIBIT PURSUANT TO RULE 24B-2
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
JOINT DEVELOPMENT AND OPERATING AGREEMENT
ELAN CORPORATION, PLC,
ELAN INTERNATIONAL SERVICES, LTD.,
ENDOREX CORPORATION,
AND
ENDOREX NEWCO, LTD.
JOINT DEVELOPMENT AND OPERATING AGREEMENT, made as of October 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 CORPORATION, a Delaware corporation ("Endorex"),
and ENDOREX NEWCO, LTD., a Bermuda corporation (the "Company").
RECITALS
A. Endorex has proprietary know-how and expertise relating to, inter alia, the
research, development and commercialization of pharmaceutical formulations
capable of delivering drugs.
B. Elan is knowledgeable in the discovery, research, development, manufacture
and marketing of pharmaceutical formulations and devices capable of
delivering drugs, including the Medipad System. Elan owns or has licensed
the Elan Technology either itself or through EMT (defined below). Elan
also owns and uses certain trademarks in connection with the manufacture,
marketing and sale of the Medipad System, including the Elan Trademarks.
Elan Medical Technologies Limited is a wholly owned subsidiary of Elan
("EMT").
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 Elan Royalty
Products incorporating the technologies developed and/or to be developed by
Elan and Endorex and to distribute and sell such Elan Royalty Products
throughout the world.
D. Elan, EIS, Endorex and the Company 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.
AGREEMENT
The parties hereto agree as follows:
CLAUSE 1
DEFINITIONS
1.1 In this Agreement, the following expressions shall, where not inconsistent
with the context, have the following meanings respectively.
"AFFILIATE" means 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, "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 Plan and such other business as the
Parties may agree from time to time in writing should be carried on by the
Company;
"COMPANY COMPOUND(S)" means the [****] compounds made, invented, acquired,
developed or licensed by the Company and, if applicable, any Substitute
Compound;
"COMPANY SUBSCRIPTION AGREEMENT" means the Subscription and Stockholders
Agreement of the Company, made by and between EIS, Endorex and the Company
as of the date hereof;
"COMPANY TECHNOLOGY" shall have the meaning as such term is defined in the
License Agreement;
"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, [****] and will exclude
[****].
In the case of [****] Cost will comprise the amount [****] including
[****].
"DIRECTORS" means the members of the Company's board of directors, as more
fully described in Clause 12;
"DISPUTE" means, collectively, a Committee Dispute and a Management
Dispute, each as defined in Clause 15;
"EFFECTIVE DATE" means the date hereof;
"ELAN DIRECTOR" means a director or directors of the Company to be
appointed by EIS pursuant to Clause 12;
"ELAN ROYALTY PRODUCT" means a Medipad(TM) System based on, using and/or
incorporating the Elan Technology and containing a Company Compound, and,
if applicable, any Substitute Product;
"ELAN TECHNOLOGY" shall have the meaning as such term is defined in the
License Agreement;
_____________
[****] REPRESENTS MATERIAL WHICH HAS BEEN REDACTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.
3
"ELAN TRADEMARKS" shall have the meaning as such term is defined in the
License Agreement;
"EXCHANGE RIGHT" 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 the common stock of the Company to 50 %;.
"ENDOREX DIRECTOR" means any director or directors of the Company appointed
by Endorex, pursuant to Clause 12;
"EXPERT" shall have the meaning assigned to it in Clause 15.5;
"FIELD" means the research, development, and commercialization of
(i) [****] or
(ii) the Substitute Compound;
"FINANCIAL YEAR" means that time period commencing on January 1st and
expiring on December 31st of each calendar year;
"GLP" AND "GMP" means current Good Laboratory Practises and current Good
Manufacturing Practises, respectively;
"INDEPENDENT THIRD PARTY" means any Person other than Elan, Endorex, the
Company and/or any of their respective Affiliates;
"KNOW-HOW" means all trade secrets, confidential scientific, technical and
medical information and expertise, technical data and marketing
information, studies and data including, but not limited to, unpatented
inventions, discoveries, designs, theories, plans, ideas (whether or not
reduced to practice);
"LICENSE AGREEMENT" means the license agreement between Elan, Endorex, the
Company and EMT dated as of the date hereof;
"MANAGEMENT COMMITTEE" shall have the meaning as such term is defined in
Clause 3;
"MEDIPAD SYSTEM" means Elan's ambulatory, subcutaneous, micro-infusion pump
device and related technology;
_____________
[****] REPRESENTS MATERIAL WHICH HAS BEEN REDACTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.
4
"PANEL" shall have the meaning as such term is defined in Clause 15;
"PARTICIPANT" means Endorex or Elan, as the case may be, and "PARTICIPANTS"
means each of the Participants together;
"PARTY" means Elan, EIS, Endorex 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;
"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
Program, 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;
"PROVIDING PARTY" shall have the meaning assigned to such term in Clause
4.4;
"R&D COMMITTEE" means the committee established pursuant to Clause 3.2;
"REGULATORY APPLICATION" means any regulatory application or any other
application for marketing approval for an Elan Royalty Product but not the
Medipad System alone, which the Company will file in any country of the
Territory, including any supplements or amendments thereto;
"REGULATORY APPROVAL" means the final approval to market an Elan Royalty
Product but not the Medipad System alone, in any country of the Territory,
including pricing and reimbursement approval and any other approval which
is required to launch the Elan Royalty Product in the normal course of
business;
"RELEVANT EVENT" shall have the meaning as such term is defined in Clause
16;
"RESEARCH AND DEVELOPMENT PROGRAM" means the program of research and
development work being conducted or to be conducted for and on behalf of
the Company which have been devised by the R&D Committee and approved by
the Management Committee;
"RHA" means any relevant government health authority (or successor agency
thereof) in any country of the Territory whose approval is necessary to
market an Elan Royalty Product in the relevant country of the Territory;
5
"SHARES" means the common stock of the Company, par value $1.00 per share;
"SUBSIDIARY" of any Person means any other Person, (i) of which (or in
which) greater than 50% of (A) the outstanding capital stock having
ordinary voting power to elect a majority of the board of directors of such
second Person, if a corporation, (B) the interest in the capital or profits
of such second Person, if a partnership or other entity, or (C) the
beneficial interest of such trust or estate, if a trust or estate, is at
the time directly or indirectly owned by such first Person, by such first
Person and one or more other Subsidiaries of such first Person, or by one
or more other Subsidiaries of such first Person; (ii) which is otherwise
effectively controlled by such first Person or any other Subsidiary of such
first Person, pursuant to contract, arrangement, understanding or
otherwise; or (iii) or any other corporation, association or other business
entity that is required by GAAP to be combined or consolidated with such
Person.
"SUBSTITUTE PRODUCT" means a Medipad System based on, using and/or
incorporating the Elan Technology and/or the Company Technology a
Substitute Compound, including but not limited to patents and know-how that
may be acquired by or on behalf of the Company;
"SUBSTITUTE COMPOUND" means the substitute compound described in Clause 3
of the License Agreement;
"TECHNOLOGIES" means collectively, the Company Technology and the Elan
Technology;
"TERRITORY" means [****];
"TERM" shall have the meaning assigned to such word in Clause 16.1;
"TECHNOLOGICAL COMPETITOR" means a Type I Technological Competitor or a
Type II Technological Competitor;
"THIRD PARTY TECHNOLOGY" shall have the meaning assigned to it in Clause
3.1. of the License Agreement;
"TYPE I TECHNOLOGICAL COMPETITOR" means [****];
"TYPE II TECHNOLOGICAL COMPETITOR" shall mean [****];
_____________
[****] REPRESENTS MATERIAL WHICH HAS BEEN REDACTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.
6
"UNITED STATES DOLLAR" and "US$" means the lawful currency 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.
CLAUSE 2
REPRESENTATIONS AND WARRANTIES
2.1 Each of Elan, Endorex and the Company 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, Endorex and the Company 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 fulfillment 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.
7
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 or equivalent certificate or
document under applicable laws of the Company's country 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 referred by it to the
Directors.
3.5 The R&D Committee shall be responsible for the design of the Research and
Development Program for consideration by the Management Committee and the
implementation of the Research and Development Program as approved by the
8
Management Committee. The R&D Committee shall meet at regular intervals to
monitor the progress of the Research and Development Program and to report
on their progress to the Management Committee.
CLAUSE 4
CONDUCT OF RESEARCH AND DEVELOPMENT
4.1 For a period commencing on the date hereof and expiring on 31st December,
1999, as described in the Company Subscription Agreement, each of Elan and
Endorex shall undertake to perform research and development related to the
development and commercialization of the Elan Royalty Products in an amount
up to a maximum of [****] at the request of the Company and as articulated
in the Plan in furtherance of the development and commercialization of the
Elan Royalty Products and cultivation of Patent Rights and Know-How related
to the Elan Royalty Products, and the Company Technology. The cost of such
development work shall be the applicable Party's respective Cost plus
[****]. All subcontracted services by third parties shall be charged at
cost.
4.2 Research and development work related to Elan Royalty Products, the Third
Party Technology or the Company Technology, including, without limitation,
formulation, optimization, clinical and regulatory activities shall be
conducted by Elan and Endorex as provided in the Plan. Research and
development activities related primarily to the Elan Technology shall be
conducted by Elan. Nothing in this Clause 4.2. shall be deemed [****] in
the event that [****].
4.3 With reference to Clause 3 of the License Agreement, in the event that
notwithstanding its reasonable endeavours, the Company [****] Elan and
Endorex shall [****]. The selection of the Substitute Compound [****].
4.4 Each of Elan and Endorex (each, a "PROVIDING PARTY") shall use its
reasonable endeavours to conduct its portion of the Research and
Development Program in accordance with the timetable set out in the
Research and Development Program. 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, in
accordance with the terms and conditions set forth in this Agreement,
undertake reasonably diligent efforts, as would be 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.
_____________
[****] REPRESENTS MATERIAL WHICH HAS BEEN REDACTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.
9
4.5 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 and the Management Committee.
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 RHA's, including GMP and GLP standards.
4.6 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.
4.7 Elan, Endorex and the Company shall agree on a budget in connection with
the activities to be undertaken 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.
4.8 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.
4.9 [****] 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 Elan
Royalty Products and to the accuracy of the reports which accompanied them.
Any such inspection of the Providing Party's records shall be at the
expense of the Company, except that if any such inspection reveals an
overpayment in the amount of the Costs paid to the Providing Party for the
Research and Development Program in any calendar quarter of [****] or more
of the amount of the Costs actually due to the Providing Party hereunder,
then the expense of such inspection shall be borne solely by the Providing
Party instead of by the Company. Any surplus over the Costs properly
payable by the Company to the Providing Party shall be paid promptly to the
Company. If such inspection reveals a deficit in the amount of the Costs
properly payable to the Providing Party by the Company, the Company shall
pay the deficit to the Providing Party.
_____________
[****] REPRESENTS MATERIAL WHICH HAS BEEN REDACTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.
10
4.10 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 an RHA, and shall furnish the other Parties
with copies of all correspondence. The Parties shall collaborate in
relation to obtaining the approval of the RHA's for final approved
labelling.
5.2 The Company shall, at its own cost, file, prosecute and maintain any and
all Regulatory Applications specifically related to the Third Party
Technology, the Company Technology and the Elan Royalty Products but not
the Medipad System itself and all Regulatory Approvals specifically related
to the Third Party Technology, the Company Technology and the Elan Royalty
Products shall remain the property of the Company; provided, that the
Company shall allow the other Parties access thereto to enable those
Parties to fulfill their obligations and exercise their rights under this
Agreement, and the License Agreement. The Company shall diligently pursue
all regulatory activities described in this Clause 5.2.
5.3 The costs and expenses of any filings and proceedings made by the Company
to the RHA's, including post approval studies required by the RHA's in
respect of an Elan Royalty Product, and to maintain the RHA's 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 RHA's 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 an Elan Royalty Product to achieve the
approval of any RHA.
5.5 Elan shall, at its own cost, file, prosecute, maintain any and all
Regulatory Applications specifically related to the Medipad System and the
Elan Technology and all Regulatory Approvals specifically related to the
Elan Technology shall remain the property of Elan; provided, that Elan
shall allow the other Parties access thereto and the use thereof to enable
those Parties to fulfil their obligations and exercise their rights under
this Agreement, and the License Agreement.
11
CLAUSE 6
PROPERTY OWNERSHIP RIGHTS/COMPETITION
The Parties acknowledge and agree to be bound by:
6.1 the provisions of Clause 5 of the License Agreement outlining the agreement
between the parties thereto in relation to Intellectual Property Rights;
and
6.2 the provisions of Clause 5 of the License Agreement outlining the agreement
between the parties thereto in relation to competition.
CLAUSE 7
PATENT RIGHTS
7.1 The rights and obligations of the Elan and the Company in respect of any
Patents claiming the Technologies are governed by the provisions of the
License Agreement.
CLAUSE 8
EQUIPMENT
8.1 Any equipment or other assets purchased by Endorex 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 insurance and bailment provisions.
CLAUSE 9
EXPLOITATION OF PRODUCTS
9.1 The Company will have [****] any Elan Royalty Products subject to the 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.
_____________
[****] REPRESENTS MATERIAL WHICH HAS BEEN REDACTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.
12
9.2 The Management Committee shall review the Research and Development Program
on a regular basis to decide, inter alia, whether such Research and
Development Program should continue, be terminated, continue as modified or
whether the Parties should commence a new Research And Development Program.
Any Party may call upon the Management Committee of the Company to review
termination of the Research and Development Program for an Elan Royalty
Product.
9.3 The strategy for the registration and the commercialization of the Elan
Royalty Products shall be determined by the Management Committee.
CLAUSE 10
TECHNICAL SERVICES AND ASSISTANCE
10.1 Whenever commercially and technically feasible, the Company shall contract
with 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
Elan License Agreement and in Clause 4. In determining which Party should
provide such services, the Management Committee shall take into account the
respective infrastructure, experience and Cost of Elan, and Endorex.
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 Endorex 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.
_____________
[****] REPRESENTS MATERIAL WHICH HAS BEEN REDACTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.
13
10.3 If Elan or Endorex so requires, Endorex 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 Company Technology, as
the case may be, as is necessary to further the Research and Development
Programs.
10.4 The employees received by Elan or Endorex, as the case may be, shall be
subject to obligations of confidentiality no less stringent than those set
out in Clause 17 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 Elan shall supply, or procure the supply of, Elan Royalty Products to the
Company at [****]. In advance of the first launch of an Elan Royalty
Product, the Parties shall negotiate in good faith a supply agreement on
pharmaceutical industry standard terms, including provisions as to product
quality and supply.
CLAUSE 12
PROCEEDINGS OF DIRECTORS AND CHAIRMAN
12.1 As described in the Company Subscription Agreement, the board of directors
of the Company shall consist of five members as follows: one Elan Director
and four Endorex Directors. In the event that Elan shall exercise the
Exchange Right, the board of directors shall be altered so that the number
of shall consist of four members as follows: two Elan Directors and two
Endorex Directors.
12.2 As of the date hereof and until Elan exercises its Exchange Right, an
Endorex Director shall be the chairman of the Company's board of directors.
12.3 The Chairman appointed under Clause 12.2 shall retire once Elan exercises
its Exchange Right. Thereafter:
(i) 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;
_____________
[****] REPRESENTS MATERIAL WHICH HAS BEEN REDACTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.
14
(ii) the Chairman shall hold office until the termination of the next
Annual Meeting following his appointment;
(iii) if the Chairman is unable to attend any meeting of the board, the
Director of the same designation shall act as Chairman in his place
at the meeting.
CLAUSE 13
MATTERS REQUIRING PARTICIPANTS' APPROVAL
13.1 In consideration of Elan agreeing to enter into the License Agreement, 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) acquire or dispose of assets of a value in excess of [****] or 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;
_____________
[****] REPRESENTS MATERIAL WHICH HAS BEEN REDACTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.
15
(viii) create, acquire or dispose of any Subsidiary or of any shares in
any Subsidiary;
(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 or the Company
Technology;
(xvi) amend or vary the terms of the Licence Agreement;
(xvii) undertake a Research and Development Program;
(xviii) file an amendment to the Company's certificate of incorporation or
alter the by-laws or equivalent certificate or documents under
applicable laws of the Company's country of incorporation;
(xix) alter the number of the Company's directors;
(xx) any actions of the Company in relation to the acquisition of the
Third Party Technology or the nomination of the Substitute Compound
under Clause 3 of the License Agreement;
(xxi) pay dividends or distributions in respect of, or redeem or
repurchase, the equity of the Company; or
(xxii) amend or vary the terms of the Plan.
_____________
[****] REPRESENTS MATERIAL WHICH HAS BEEN REDACTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.
16
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 90 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 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 Plan for the relevant year of
trading.
CLAUSE 15
DISPUTES
15.1 Disputes among the members of the R&D Committee in connection with the
Licence Agreement (each such event, a "COMMITTEE 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.
15.2 In the event that the members of the Management Committee, after
reasonable consideration, cannot resolve a Committee Dispute within 10
days of receipt of a notice as described in Clause 15.1, such Committee
Dispute shall be forwarded to a designated senior officer of each of Elan
and Endorex and thereafter 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.
15.3 Disputes under this Agreement among members of the Management Committee
(each such event a "MANAGEMENT DISPUTE"; together with a Committee
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.
15.4 In the event of submission of a letter accordance with Clause 15.2 or
15.3, 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.
17
15.5 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 15.9 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 soon as practicable, but in any
event within three weeks from the reference of the Committee Dispute to
him.
15.6 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.
15.7 Any determination by the Expert shall not be final and binding on the
Parties.
15.8 In no event shall the referral of a Dispute to the Expert supercede the
provisions of Clause 13 of this Agreement, that both the Elan Director(s)
and Endorex Directors, and where applicable the Participants, approve
certain business decisions.
15.9 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.
Each of 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.
15.10 Notwithstanding Clause 15.9, 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 16
TERMINATION
16.1 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
18
such operation and existence until this Agreement shall be terminated in
accordance with this Clause 16 (the "TERM").
16.2 For the purpose of this Clause 16, a "RELEVANT EVENT" is committed by Elan
or Endorex if:
(i) it commits a material breach of one of its material obligations
under this Agreement and fails to remedy such breach 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 and with due diligence 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 Elan in the case of Company, or Company in the case of
Elan (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 its 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 its
state or country of incorporation, is filed, and is not discharged
within 90 days.
16.2 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.
16.3 In the event that a [****] shall, directly or indirectly, [****]or
otherwise [****] shall be entitled to forthwith [****] to [****].
16.4 If, at any time, the Participants agree that the Company should be wound
up or liquidated, 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 in accordance with the Participants' ownership
interest in the Company and/or as the Parties further agree to negotiate
in good faith, the terms for other arrangements, including cross licences,
as may be necessary to enable Endorex and Elan to exploit the Company
Technology for the Field.
_____________
[****] REPRESENTS MATERIAL WHICH HAS BEEN REDACTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.
19
CLAUSE 17
CONFIDENTIALITY
17.1 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, improvements
and the patents relating thereto, works of authorship, trade secrets,
specifications, designs, data, know-how and other information, relating to
the Field, the terms of the various agreements between the Parties, the
Elan Royalty 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 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 applicable law or judicial or administrative process;
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.
20
17.2 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.
17.3 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.
17.4 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 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.
17.5 The provisions relating to confidentiality in this Clause 17 shall remain
in effect during the Term, and for a period of [****] following the
expiration or earlier termination of this Agreement.
_____________
[****] REPRESENTS MATERIAL WHICH HAS BEEN REDACTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.
21
17.6 The Parties agree that the obligations of this Clause 17 are necessary and
reasonable in order to protect the Parties' respective businesses, and
each Party expressly agrees that monetary damages may 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 may 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 seek injunctive relief against the threatened breach of the
provisions of this Clause 17, 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 18
PARTICIPANTS' CONSENT
18.1 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 19
PARTIES AND COMPANY BOUND
19.1 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.
19.2 Each Party undertakes with the others to exercise its part in relation to
the Company so as to ensure that the Company fully and promptly observes,
performs and complies with its obligations under this Agreement.
CLAUSE 20
COSTS
20.1 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.
20.2 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.
22
CLAUSE 21
GENERAL
21.1 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.
21.2 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, throughout
the Territory.
21.3 NO REPRESENTATION
Each of the Parties hereto 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.
21.4 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.
21.5 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
21.6 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.
21.7 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.
21.8 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 to:
if to Elan: Elan Corporation, plc
Lincoln House
Lincoln Place
Dublin 2,
Ireland
Attention: Vice President & General Counsel
Elan Pharmaceutical Technologies
Fax; 353 1 662 4960
with a copy to: Brock Silverstein McAuliffe LLC
153 East 53rd Street
56th Floor
New York, New York 10022
Attention: David Robbins
Fax 1 212 371 5500
IF TO ENDOREX: Endorex Corp.
900 North Shore Drive
Lake Buff, Illinois 60044
Attention: President
Fax 1 847 604 8570
24
with a copy to:
Brobeck, Phleger & Harrison LLP
1633 Broadway
47th Floor
New York, New York 10019
Attention: Nigel Howard
Fax 1 212 586 7878
- -IF TO THE COMPANY: Clarendon House
2 Church Street
Hamilton
Bermuda
Attention: President and Chairman
Fax 1 441 292 4720
with a copy to:
Brobeck, Phleger & Harrison LLP
1633 Broadway
47th Floor
New York, New York 10019
Attention: Nigel Howard
Fax 1 212 586 7878
with a copy to counsel to each of Elan and Endorex at the respective
addresses listed above, 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 and any notice sent by reputable courier
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.
21.9 GOVERNING LAW AND DISPUTES
This Agreement shall be governed by and construed in accordance with the
laws of the State of New York, without giving effect to the principles
thereof relating to conflict of laws. 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.
21.10 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)
25
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.
21.11 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.
21.12 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.
21.13 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.
21.14 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.
21.15 SUCCESSORS
This Agreement shall be binding upon and enure to the benefit of the
Parties hereto, their successors and permitted assigns.
26
IN WITNESS THEREOF the Parties hereto have executed this Joint Development and
Operating Agreement in quadruplicate.
SIGNED BY
For and on behalf of
ELAN CORPORATION, PLC
/s/ Liam Daniel
SIGNED BY
FOR AND ON BEHALF OF
ELAN INTERNATIONAL SERVICES, LTD.
/s/ Liam Daniel
SIGNED BY
For and on behalf of
ENDOREX CORPORATION
/s/ Michael S. Rosen
President and Chief Executive Officer
SIGNED BY
For and on behalf of
ENDOREX NEWCO, LTD.
/s/ Michael S. Rosen
Chairman
27
SCHEDULE 1
TYPE II TECHNOLOGICAL COMPETITOR
[****]
_____________
[****] REPRESENTS MATERIAL WHICH HAS BEEN REDACTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.
28