EXHIBIT 10.8
EXECUTION COPY
SUBSCRIPTION, JOINT DEVELOPMENT AND OPERATING AGREEMENT
ELAN CORPORATION, PLC
ELAN INTERNATIONAL SERVICES, LTD.
AND
CELTRIX PHARMACEUTICALS INC.
AND
CELTRIX NEWCO LTD.
INDEX
CLAUSE 1 DEFINITIONS
CLAUSE 2 NEWCO'S BUSINESS
CLAUSE 3 REPRESENTATIONS AND WARRANTIES
CLAUSE 4 AUTHORIZATION AND CLOSING
CLAUSE 5 DEVELOPMENT FUNDING
CLAUSE 6 SUBLICENSE AND ASSIGNMENT RIGHTS
CLAUSE 7 OWNERSHIP OF INTELLECTUAL PROPERTY RIGHTS/NONCOMPETITION
CLAUSE 8 TRADEMARKS
CLAUSE 9 DIRECTORS; MANAGEMENT AND R&D COMMITTEES
CLAUSE 10 THE BUSINESS PLAN AND REVIEWS
CLAUSE 11 RESEARCH AND DEVELOPMENT
CLAUSE 12 INTELLECTUAL PROPERTY RIGHTS
CLAUSE 13 COMMERCIALIZATION
CLAUSE 14 MANUFACTURING
CLAUSE 15 TECHNICAL SERVICES AND ASSISTANCE
CLAUSE 16 AUDITORS, BANKERS, REGISTERED OFFICE,
ACCOUNTING REFERENCE DATE; SECRETARY; COUNSEL
CLAUSE 17 REGULATORY
CLAUSE 18 TRANSFER OF SHARES; RIGHTS OF FIRST OFFER; TAG ALONG RIGHTS
CLAUSE 19 MATTERS REQUIRING PARTICIPANTS' APPROVAL
CLAUSE 20 DISPUTES
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CLAUSE 21 TERMINATION
CLAUSE 22 INTENTIONALLY OMITTED
CLAUSE 23 CONFIDENTIALITY
CLAUSE 24 COSTS
CLAUSE 25 GENERAL
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EXCHANGE COMMISSION
THIS SUBSCRIPTION, JOINT DEVELOPMENT AND OPERATING AGREEMENT made this 21st day
of April, 1999
among:
(1) ELAN CORPORATION, PLC, a public limited company incorporated under the laws
of Ireland, and having its registered office at Xxxxxxx Xxxxx, Xxxxxxx
Xxxxx, Xxxxxx 0, Xxxxxxx ("ELAN");
(2) ELAN INTERNATIONAL SERVICES, LTD., an exempted company incorporated under
the laws of Bermuda, and having its registered office at Xxxxxxxxx Xxxxx, 0
Xxxxxx Xx., Xxxxxxxx, Xxxxxxx ("XXX");
(3) CELTRIX PHARMACEUTICALS INC. a corporation duly incorporated and validly
existing under the laws of Delaware, and having its principal place of
business at 0000 Xxxxxxx Xxxxx, Xxxxx 000, Xxx Xxxx, Xxxxxxxxxx 00000,
Xxxxxx Xxxxxx of America ("CELTRIX"); and
(4) CELTRIX NEWCO LTD. an exempted company incorporated under the laws of
Bermuda, and having its registered office at Xxxxxxxxx Xxxxx, 0 Xxxxxx Xx.,
Xxxxxxxx, Xxxxxxx ("XXXXX").
RECITALS:
A. Newco desires to issue and sell to the Participants (as defined below), and
the Participants desire to purchase from Newco, for aggregate consideration
of [*****], apportioned between them as set forth herein, [*****] ordinary
shares (the "SHARES") of Newco's common stock, par value $1.00 per share
(the "COMMON STOCK"), allocated [*****] shares to Celtrix and [*****]
shares to EIS.
B. Elan owns all right, title and interest in and to certain patents which
have been granted or are pending in relation to the MEDIPAD(R) Drug
Delivery System.
C. Celtrix owns all right, title and interest in and to certain patents that
have been granted or are pending in relation to SomatoKine(R).
D. As of the date hereof, Elan has entered into a license agreement with
Newco, and Celtrix has entered into a license agreement with Newco, in
connection with the license to Newco of the Elan Intellectual Property and
the Celtrix Intellectual Property, respectively (each as defined below).
E. Elan and Celtrix have agreed to co-operate in the establishment and
management of a business for the research, development and
commercialization of the Products (as defined below) based on the Licensed
Technologies (as defined below).
F. Elan and Celtrix have agreed to enter into this Agreement for the purpose
of recording the terms and conditions of the joint venture and of
regulating their relationship with each other and certain aspects of the
affairs of and their dealings with Newco.
NOW IT IS HEREBY AGREED AS FOLLOWS:
CLAUSE 1
DEFINITIONS
1.1 In this Agreement, the following terms shall, where not inconsistent with
the context, have the following meanings respectively.
"AFFILIATE" of any Person (in the case of a legal entity) shall mean any
other Person controlling, controlled by or under the common control with
such first Person, as the case may be. For the purposes of this definition,
"control" shall mean direct or indirect ownership of 50% or more of the
stock or shares entitled to vote for the election of directors or capital
interests representing at least 50% of the equity thereof and "controlling"
and "controlled" shall be construed accordingly. Notwithstanding the
foregoing, Newco shall not be construed to be an Affiliate, as defined
herein, of Elan or EIS.
"AGREEMENT" means this agreement (which expression shall be deemed to
include the Recitals and the Schedules hereto).
"BUSINESS" means the business of Newco as described in Clause 2 and as more
particularly specified in the Business Plan and such other business as the
Participants may agree from time to time in writing (each in its sole
discretion) should be carried on by Newco.
"BUSINESS PLAN" shall mean the business plan and program of development to
be agreed to by Elan and Celtrix within 60 days of the Closing Date, with
respect to the research, development, and commercialization of the
Products, which shall be reviewed and updated by Elan and Celtrix on an
annual basis, upon mutual written agreement.
"CELTRIX DIRECTORS" has the meaning set forth in Clause 7.
"CELTRIX IMPROVEMENTS" has the meaning assigned thereto in the Celtrix
License Agreement.
"CELTRIX INTELLECTUAL PROPERTY" has the meaning assigned thereto in the
Celtrix License Agreement.
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"CELTRIX KNOW-HOW" shall mean any and all rights owned or licensed by
Celtrix with respect to any knowledge, information, discovery, invention,
trade secret, technique, process, system, formulation, design, data and
expertise relating to SomatoKine(R) whether or not covered by any patent,
copyright, design, trademark, trade secret or other industrial or
intellectual property right.
"CELTRIX LICENSE AGREEMENT" means the license agreement between Celtrix and
Newco, of even date herewith, attached hereto in Schedule 2.
"CELTRIX PATENT RIGHTS" shall mean the patents and patent applications
(including provisional applications) relating to SomatoKine(R) that are
forth in Schedule 1 of the Celtrix License Agreement, that are owned or
licensed by or on behalf of Celtrix. Celtrix Patent Rights shall also
include all extensions, continuations, continuations-in-part, divisionals,
patents-of-addition, re-examinations, re-issues, supplementary protection
certificates and foreign counterparts of such patents and patent
applications and any patents issuing thereon and extensions of any patents
licensed under the Celtrix License Agreement.
"CELTRIX SECURITIES PURCHASE AGREEMENT" means that certain securities
purchase agreement, of even date herewith, by and between Celtrix and EIS.
"CLOSING DATE" shall mean the date upon which the Transaction Documents are
executed and delivered by the Parties and the transactions effected thereby
are closed.
"COMMON STOCK EQUIVALENTS" means any options, warrants, rights or any other
securities convertible, exercisable or exchangeable, in whole or in part,
for or into Common Stock.
"DIRECTORS" means, at any time, the directors of Newco.
"EIS DIRECTOR" has the meaning set forth in Clause 9.
"ELAN IMPROVEMENTS" has the meaning assigned thereto in the Elan License
Agreement.
"ELAN INTELLECTUAL PROPERTY" has the meaning assigned thereto in the Elan
License Agreement.
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"ELAN KNOW-HOW" shall mean any and all rights owned or licensed by Elan
relating to any knowledge, information, discovery, invention, trade
secret, technique, process, system, formulation, design, data and
expertise with respect to the MEDIPAD(R) Drug Delivery System whether
or not covered by any patent, copyright, design, trademark, trade
secret or other industrial or intellectual property right.
"ELAN LICENSE AGREEMENT" means the license agreement between Elan and
Newco, of even date herewith, attached hereto in Schedule 1.
"ELAN PATENT RIGHTS" shall mean the patents and patent applications
(including provisional applications) relating to the MEDIPAD(R) Drug
Delivery System as set forth in Schedule 1 of the Elan License
Agreement, and that are owned or licensed by or on behalf of Elan. Elan
Patent Rights shall also include all extensions, continuations,
continuations-in-part, divisionals, patents-of-addition,
re-examinations, re-issues, supplementary protection certificates and
foreign counterparts of such patents and patent applications and any
patents issuing thereon and extensions of any patents licensed under
the Elan License Agreement.
"ENCUMBRANCE" means any liens, charges, encumbrances, equities, claims,
options, proxies, pledges, security interests, or other similar rights
of any nature.
"EPT" shall mean Elan Pharmaceutical Technologies, a division of Elan.
"EXCHANGE RIGHT" has the meaning assigned to such term in the Amended
and Restated Certificate of Incorporation of Celtrix in effect on the
date hereof.
"EXCHANGE ACT" means the Securities Exchange Act of 1934, as amended.
"EXCHANGE RIGHT TERM" shall mean the period commencing on the Effective
Date and ending on the exercise by Elan of the Exchange Right.
"FIELD" shall mean [*****]
"FINANCIAL YEAR" means each year commencing on January 1 (or in the
case of the first Financial Year, the date hereof) and expiring on
December 31 of each year.
"FULLY DILUTED COMMON STOCK" means all of the issued and outstanding Common
Stock, assuming the conversion, exercise or exchange of all outstanding
Common Stock Equivalents.
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SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION
"FUNDING AGREEMENT" shall mean the Funding Agreement, dated as of the
date hereof, between EIS and Celtrix.
"LICENSE AGREEMENTS" means the Elan License Agreement and the Celtrix
License Agreement.
"LICENSED TECHNOLOGIES" means, collectively, the Elan Intellectual
Property and the Celtrix Intellectual Property.
"MEDIPAD(R) DRUG DELIVERY SYSTEM" shall mean the [*****] as disclosed
in the Elan Patent Rights set forth in Schedule 1 of the Elan License
Agreement.
"NEWCO INTELLECTUAL PROPERTY" shall mean all rights to technology,
patents and know-how belonging to Newco, other than the Elan
Intellectual Property and the Celtrix Intellectual Property, including
any technology acquired by or licensed to Newco from or by a third
party and any newly developed technology that is not Elan Intellectual
Property or Celtrix Intellectual Property.
"NEWCO MEMORANDUM OF ASSOCIATION AND BYE-LAWS" shall mean the
Memorandum of Association and Bye-Laws of Newco.
"OSTEOPOROSIS" shall mean a skeletal condition characterized by
decreased density of normal mineralized bone, which bone density, as
measured by dual-energy x-ray absorptiometry (DXA), is more than 2.5
standard deviations below the mean for the young adult reference range.
"PARTICIPANT" means Celtrix or Elan, as the case may be, and
"PARTICIPANTS" means both Celtrix and Elan together;
"PARTY" means Elan, Celtrix, or Newco, as the case may be, and
"PARTIES" means all three together;
"PERSON" means an individual, partnership, corporation, limited
liability company, business trust, joint stock company, trust,
unincorporated association, joint venture, governmental entity or
authority or other entity of whatever nature.
"PERMITTED TRANSFEREE" means any Affiliate or subsidiary of Elan, EIS
or Celtrix, to whom this Agreement may be assigned, in whole or in
part, pursuant to
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the terms hereof or, in the case of Elan/EIS, an off-balance sheet
special purpose entity created by Elan or EIS.
"PRODUCTS" shall mean the MEDIPAD(R) Drug Delivery System incorporating
SomatoKine(R) as its primary active ingredient.
"PROJECT" shall mean all activity as undertaken by or on behalf of
Newco in order to develop the Products in accordance with the Business
Plan.
"REGISTRATION RIGHTS AGREEMENTS" means the Registration Rights
Agreements of even date herewith relating to Newco and Celtrix,
respectively.
"REGULATORY APPLICATION" means any regulatory application or any other
application for marketing approval for a Product, which Newco will file
in any country of the Territory, including any supplements or
amendments thereto.
"REGULATORY APPROVAL" means the final regulatory approval to market a
Product in any country of the Territory, and any other approval which
is required to launch the Product in the normal course of business.
"RHA" means any relevant government health authority (or successor
agency thereof) in any country of the Territory whose approval is
necessary to market a Product in the relevant country of the Territory.
"SECURITIES ACT" means the Securities Act of 1933, as amended.
"SHARES" means the shares of Common Stock of Newco.
"SOMATOKINE"(R) shall mean [*****]
"STOCKHOLDER" means any of EIS, Celtrix, any Permitted Transferee or
any other Person who subsequently becomes bound by this Agreement as a
holder of the Shares, and "STOCKHOLDERS" means all of the Stockholders
together.
"SUBSIDIARY" means any company that is a subsidiary of Newco within the
meaning of applicable laws.
"TECHNOLOGICAL COMPETITOR OF ELAN" shall mean [*****]
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EXCHANGE COMMISSION
"TECHNOLOGICAL COMPETITOR OF CELTRIX" shall mean [*****]
"TERM" means the term of this Agreement.
"TERRITORY" means [*****]
"TRANSACTION DOCUMENTS" means this Agreement, the Funding Agreement,
the Elan License Agreement, the Celtrix License Agreement, the Celtrix
Securities Purchase Agreement, the Registration Rights Agreements and
associated documentation of even date herewith, by and between Celtrix,
Elan, EIS and Newco, as applicable.
"UNITED STATES DOLLAR" and "US$" and "$" means the lawful currency of
the United States of America.
1.2 In addition, the following definitions have the meanings in the Clauses
corresponding thereto, as set forth below.
DEFINITION CLAUSE
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"Buyout Option" 21.4
"Closing" 4.2
"Common Stock" Recital
"Confidential Information" 23.1
"Co-sale Notice" 18.3
"Elan/Newco Option" 13.2
"Expert" 20.3
"Management Committee" 9.2.1
"Notice of Exercise" 18.2
"Notice of Intention" 18.2
"Offered Shares" 18.2
"Offering Price" 18.2
"Presiding Justice" 20.3
"Proposing Participant" 21.4
"Proposing Participant Price" 21.6
"Purchase Price" 21.6
"R&D Committee" 9.2.2
"Recipient Participant" 21.4
"Recipient Participant Price" 21.6
"Remaining Stockholders" 18.3
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DEFINITION CLAUSE
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"Relevant Event" 21.2
"Selling Stockholder" 18.2
"Tag-Along Right" 18.3
"Transaction Proposal" 18.2
"Transfer" 18.1
"Transferee Terms" 18.3
"Transferring Stockholders" 18.3
1.3 Words importing the singular shall include the plural and vice versa.
1.4 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.
1.5 Reference to a statute or statutory provision includes a reference to it as
from time to time amended, extended or re-enacted.
1.6 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 Capitalized terms used but not defined herein shall have the meanings
ascribed in the Transaction Documents, if defined therein.
CLAUSE 2
NEWCO'S BUSINESS
2.1 The primary objective of Newco and any Subsidiaries is to carry on the
business of the development, testing, registration, manufacture,
commercialization and licensing of Products in the Territory and to achieve
the objectives set out in this Agreement. The focus of the collaborative
venture will be to develop the Products using the Elan Intellectual
Property, the Celtrix Intellectual Property and the Newco Intellectual
Property in accordance with agreed-upon specifications and timelines.
2.2 Except as the Participants otherwise agree in writing and except as may be
provided in this Agreement, the Business Plan or the License Agreements,
the Participants shall exercise their respective powers in relation to
Newco so as to ensure that the Business is carried on in a proper and
prudent manner.
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2.3 Each Participant shall use all commercially reasonable and proper means at
its disposal and within its power to maintain, extend and improve the
Business of Newco, within the limits of this Agreement, and to further the
reputation and interests of Newco.
2.4 The central management and control of Newco shall be exercised in Bermuda
and shall be vested in the Directors and such Persons as such Directors may
delegate the exercise of their powers in accordance with the Newco
Memorandum of Association and Bye-Laws. The Participants shall use their
best efforts to ensure that to the extent required pursuant to the laws of
Bermuda, and to ensure the sole residence of Newco in Bermuda, all meetings
of the Directors are held in Bermuda or other jurisdictions outside the
United States and generally to ensure that Newco is treated as resident for
taxation purposes in Bermuda.
CLAUSE 3
REPRESENTATIONS AND WARRANTIES
3.1 REPRESENTATIONS AND WARRANTIES OF NEWCO: Newco hereby represents and
warrants to each of the Stockholders as follows, as of the date hereof:
3.1.1 ORGANIZATION: Newco is an exempted company duly organized,
validly existing and in good standing under the laws of Bermuda,
and has all the requisite corporate power and authority to own
and lease its properties, to carry on its business as presently
conducted and as proposed to be conducted, to execute this
Agreement, which has been duly authorized and is enforceable
against Newco in accordance with its terms, and to carry out the
transactions contemplated hereby.
3.1.2 CAPITALIZATION: As of the date hereof, the authorized capital
stock of Newco consists of [*****] shares of Common Stock. Prior
to the date hereof, no shares of capital stock of Newco have been
issued.
3.1.3 AUTHORIZATION: The execution, delivery and performance by Newco
of this Agreement, including the issuance of the Shares, have
been duly authorized by all requisite corporate actions; this
Agreement has been duly executed and delivered by Newco and is
the valid and binding obligation of Newco, enforceable against it
in accordance with its terms except as limited by applicable
bankruptcy, insolvency, reorganization, moratorium and other laws
of general application affecting the enforcement of creditors'
rights generally, and except as enforcement of rights to
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indemnity and contribution hereunder may be limited by United
States federal or state securities laws or principles of public
policy. The Shares, when issued as contemplated hereby, will be
validly issued and outstanding, fully paid and non-assessable and
not subject to preemptive or any other similar rights of the
Stockholders or others.
3.1.4 NO CONFLICTS: The execution, delivery and performance by Newco of
this Agreement, the issuance, sale and delivery of the Shares,
and compliance with the provisions hereof by Newco, will not:
(i) violate any provision of applicable law, statute, rule or
regulation applicable to Newco or any ruling, writ,
injunction, order, judgment or decree of any court,
arbitrator, administrative agency or other governmental
body applicable to Newco or any of its properties or
assets;
(ii) conflict with or result in any breach of any of the terms,
conditions or provisions of, or constitute (with notice or
lapse of time or both) a default (or give rise to any right
of termination, cancellation or acceleration) under its
charter or organizational documents or any material
contract to which Newco is a party, except where such
violation, conflict or breach would not, individually or in
the aggregate, have a material adverse effect on Newco; or
(iii) result in the creation of, any Encumbrance upon any of the
properties or assets of Newco.
3.1.5 APPROVALS: As of the date hereof, no permit, authorization,
consent or approval of or by, or any notification of or filing
with, any Person is required in connection with the execution,
delivery or performance of this Agreement by Newco. Newco has
full authority to conduct its business as contemplated in the
Business Plan and the Transaction Documents.
3.1.6 DISCLOSURE: This Agreement does not contain any untrue statement
of a material fact or omit to state any material fact necessary
to make the statements contained herein not misleading. Newco is
not aware of any material contingency, event or circumstance
relating to its business or prospects, which could have a
material adverse effect thereon, in order for the disclosure
herein relating to Newco not to be misleading in any material
respect.
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3.1.7 NO BUSINESS; NO LIABILITIES: Newco has not conducted any business
or incurred any liabilities or obligations prior to the date
hereof, except solely in connection with its organization and
formation.
3.2 REPRESENTATIONS AND WARRANTIES OF THE STOCKHOLDERS: Each of the
Stockholders hereby severally represents and warrants to Newco as follows
as of the date hereof:
3.2.1 ORGANIZATION: Such Stockholder is a corporation duly organized
and validly existing under the laws of its jurisdiction of
organization and has all the requisite corporate power and
authority to own and lease its respective properties, to carry on
its respective business as presently conducted and as proposed to
be conducted and to carry out the transactions contemplated
hereby.
3.2.2 AUTHORITY: Such Stockholder has full legal right, power and
authority to enter into this Agreement and to perform its
obligations hereunder, which have been duly authorized by all
requisite corporate action. This Agreement is the valid and
binding obligation of such Stockholder, enforceable against it in
accordance with its terms except as limited by applicable
bankruptcy, insolvency, reorganization, moratorium and other laws
of general application affecting the enforcement of creditors'
rights generally, and except as enforcement of rights to
indemnity and contribution hereunder may be limited by United
States federal or state securities laws or principles of public
policy.
3.2.3 NO CONFLICTS: The execution, delivery and performance by such
Stockholder of this Agreement, purchase of the Shares, and
compliance with the provisions hereof by such Stockholder will
not:
(i) violate any provision of applicable law, statute, rule or
regulation known by and applicable to such Stockholder or
any ruling, writ, injunction, order, judgment or decree of
any court, arbitrator, administrative agency or other
governmental body applicable to such Stockholder or any of
its properties or assets;
(ii) conflict with or result in any breach of any of the terms,
conditions or provisions of, or constitute (with notice or
lapse of time or both) a default (or give rise to any right
of termination, cancellation or acceleration) under the
charter or organizational documents of such Stockholder or
any material contract to which such Stockholder is a party,
except where such violation, conflict or breach would not,
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EXCHANGE COMMISSION
individually or in the aggregate, have a material adverse
effect on such Stockholder; or
(iii) result in the creation of, any Encumbrance upon any of the
properties or assets of such Stockholder.
3.2.4 APPROVALS: As of the date hereof, no permit, authorization,
consent or approval of or by, or any notification of or filing
with, any Person is required in connection with the execution,
delivery or performance of this Agreement by such Stockholder.
3.2.5 INVESTMENT REPRESENTATIONS: Such Stockholder is capable of
evaluating the merits and risks of its investment in Newco. Such
Stockholder has not been formed solely for the purpose of making
this investment and such Stockholder is acquiring the Common
Stock and Preferred Stock for investment for its own account, not
as a nominee or agent, and not with the view to, or for resale in
connection with, any distribution of any part thereof. Such
Stockholder understands that the Shares have not been registered
under the Securities Act or applicable state and foreign
securities laws by reason of a specific exemption from the
registration provisions of the Securities Act and applicable
state and foreign securities laws, the availability of which
depends upon, among other things, the bona fide nature of the
investment intent and the accuracy of such Stockholders'
representations as expressed herein. Such Stockholder understands
that no public market now exists for any of the Shares and that
there is no assurance that a public market will ever exist for
such Shares.
CLAUSE 4
AUTHORIZATION AND CLOSING
4.1 Newco has authorized the issuance to (i) EIS of [*****] shares of Common
Stock and (ii) Celtrix of [*****] shares of Common Stock, issuable as
provided in Clause 4.3 hereof.
4.2 The closing (the "CLOSING") shall take place at the offices of Xxxxx
Xxxxxxxxxxx LLC at 000 Xxxx 00xx Xxxxxx, Xxx Xxxx, Xxx Xxxx 00000 on the
date hereof or such other places if any, as the Parties may agree and shall
occur contemporaneously with the closing under the Celtrix Securities
Purchase Agreement.
4.3 At the Closing:
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4.3.1 Newco shall issue and sell to EIS, and EIS shall purchase from
Newco, upon the terms and subject to the conditions set forth
herein, [*****] shares of Common Stock for an aggregate purchase
price of [*****] Newco shall issue and sell to Celtrix, and
Celtrix shall purchase from Newco, upon the terms and conditions
set forth herein, [*****] shares of Common Stock for an aggregate
purchase price of [*****]
4.3.2 The Parties shall execute and deliver to each other, as
applicable, certificates in respect of the Common Stock described
above and any other certificates, resolutions or documents which
the Parties shall reasonably require.
4.4 EXEMPTION FROM REGISTRATION:
The Shares will be issued under an exemption or exemptions from
registration under the Securities Act. Accordingly, the certificates
evidencing the Shares shall, upon issuance, contain the following legend:
THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER THE
SECURITIES ACT OF 1933, AS AMENDED, OR ANY SECURITIES LAWS OF A STATE OR
OTHER JURISDICTION AND MAY NOT UNDER ANY CIRCUMSTANCES BE SOLD,
TRANSFERRED, OR OTHERWISE DISPOSED OF (OTHER THAN TO AN AFFILIATE OF THE
ORIGINAL HOLDER OR AS OTHERWISE PERMITTED IN THE AGREEMENT PURSUANT TO
WHICH THEY WERE ISSUED) EXCEPT PURSUANT TO (i) AN EFFECTIVE REGISTRATION
STATEMENT UNDER THE SECURITIES ACT AND ANY APPLICABLE STATE SECURITIES OR
BLUE SKY LAWS, OR (ii) TO THE EXTENT APPLICABLE, RULE 144 UNDER THE
SECURITIES ACT (OR ANY SIMILAR RULE UNDER THE SECURITIES ACT RELATING TO
THE DISPOSITION OF SECURITIES) TOGETHER WITH AN OPINION OF COUNSEL
REASONABLY SATISFACTORY TO THE CORPORATION THAT REGISTRATION IS NOT
REQUIRED UNDER SUCH ACT OR APPLICABLE STATE SECURITIES LAWS.
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CLAUSE 5
DEVELOPMENT FUNDING
It is estimated that Newco will require approximately an additional [*****] (the
"DEVELOPMENT FUNDING") within the first [*****] of the date hereof, to commence
development of the first Product or Products based upon the Elan Technology, the
Celtrix Technology and/or Newco Technology. The funds necessary for such
development shall be provided in accordance with the Participants' respective
ownership in Newco at such time or times as shall be reasonably determined in
good faith by decision of Newco's board of directors with the affirmative vote
of at least the EIS Director and one Celtrix Director, pursuant to the terms and
conditions of the Funding Agreement.
CLAUSE 6
SUBLICENSE AND ASSIGNMENT RIGHTS
6.1 Newco shall not assign or, except as set forth in Section 6.2 below,
otherwise transfer any of its rights under the Licenses for the Licensed
Technologies and/or the Newco Intellectual Property without the prior
written consent of Elan and Celtrix.
6.2 Newco shall not sublicense any of its rights under the Licenses for the
Licensed Technologies and/or the Newco Intellectual Property without the
prior written consent of Elan and Celtrix, which consent shall not be
unreasonably withheld or delayed; provided, that the consent of Elan and/or
Celtrix may be withheld in Elan's or Celtrix's sole discretion in the case
of a proposed sublicense of such rights to a Technological Competitor of
Elan or a Technological Competitor of Celtrix, as the case may be.
6.3 Newco shall not enter into any agreement with any third party for
development or exploitation of the Elan Intellectual Property and/or the
Celtrix Intellectual Property without the prior written consent of Elan or
Celtrix, respectively, which consent may be withheld in Elan's or Celtrix's
sole discretion, as the case may be. Any agreement between Newco and any
permitted third party for the development or exploitation of the Elan
Intellectual Property and/or the Celtrix Intellectual Property shall
require such third party to maintain the confidentiality of all information
concerning the Elan Intellectual Property and/or the Celtrix Intellectual
Property, as applicable, provided that such obligation of confidentiality
shall be no less stringent than that set forth in Clause 23 and shall
provide that all right, title and interest in and to any [*****] shall be
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owned by [*****] and all right, title and interest in and to any [*****]
shall be owned by [*****]
6.4 Newco shall not enter into any agreement with any third party for
development of Newco Intellectual Property without the approval of the
Management Committee.
6.5 Upon 30 days' prior notice in writing from Elan to Newco and Celtrix, Newco
shall assign the Newco Intellectual Property including without limitation,
all rights and obligations related thereto, from Newco to a wholly-owned
subsidiary of Newco to be incorporated in Ireland, which company shall be
newly incorporated by Elan and Celtrix to facilitate such assignment.
CLAUSE 7
OWNERSHIP OF INTELLECTUAL PROPERTY RIGHTS/NON-COMPETITION
The Parties acknowledge and agree to be bound by:
7.1 the provisions of Clause 2 of the Elan License Agreement (as supplemented
by the provision of relevant definitions in the Elan License Agreement) and
Clause 2 of the Celtrix License Agreement (as supplemented by the provision
of relevant definitions in the Celtrix License Agreement) which set forth
the agreement between the parties thereto in relation to the ownership of
intellectual property rights; and
7.2 the provisions of Clause 5 of the Elan License Agreement and the provisions
of Clause 5 of the Celtrix License Agreement which set forth the agreement
between the parties thereto in relation to the non-competition obligations
of Elan and Celtrix, respectively.
CLAUSE 8
TRADEMARKS
8.1 Elan shall grant to Newco [*****] in accordance with the terms and
conditions of the Elan License Agreement. Elan shall at all times be and
remain the owner of such trademark licensed to Newco.
8.2 Celtrix shall grant to Newco [*****]
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in accordance with the terms and conditions of the Celtrix License
Agreement. Celtrix shall at all times be and remain the owner of such
trademark licensed to Newco.
CLAUSE 9
DIRECTORS; MANAGEMENT AND R&D COMMITTEES
9.1. DIRECTORS:
The Board of Directors of Newco shall be composed of [*****] Directors.
Celtrix shall have the right to nominate [*****] directors of Newco
("CELTRIX DIRECTORS") and EIS shall have the right to nominate [*****]
Director of Newco ("EIS DIRECTOR"). Celtrix may appoint [*****] of the
Celtrix Directors to be the chairman of Newco.
9.1.1. If the chairman is unable to attend any meeting of the Board,
[*****] shall be entitled to appoint another Director to act as
chairman in his place at the meeting.
9.1.2. If EIS removes the [*****], or Celtrix removes [*****] EIS or
Celtrix, as the case may be, shall indemnify the other
Stockholder against any claim by such removed Director arising
from such removal.
9.1.3. The Directors shall meet not less than [*****] in each Financial
Year and all Directors' meetings shall be held in [*****] to the
extent required pursuant to the laws of [*****]
9.1.4. At any such meeting, the presence [*****] shall be required to
constitute a quorum and, subject to Clause 19 hereof, the
affirmative vote of a majority of the Directors present at a
meeting at which such a quorum is present shall constitute an
action of the Directors. In the event of any meeting being
inquorate, the meeting shall be adjourned for a period of seven
days. A notice shall be sent to the EIS Director and the Celtrix
Directors specifying the date, time and place where such
adjourned meeting is to be held and reconvened.
9.1.5. The chairman of Newco, or his duly appointed successor, shall
hold office until the first meeting of the Directors after the
[*****] by [*****] of [*****]
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In the event that [*****] is exercised at any time by [*****],
each of [*****] and [*****] shall cause the board of directors of
Newco to be reconfigured so that an [*****] of Directors are
designated by [*****] and [*****.] Thereafter, (a) a quorum shall
require an [*****] and (b) each of [*****] and [*****] beginning
with EIS, shall have the right, exercisable [*****] to be [*****]
of Newco for a term of [*****] If the chairman of Newco is unable
to attend any meeting of the Directors, the Directors shall be
entitled to appoint another Director to act as chairman of Newco
in his place at the meeting.
9.1.6. In case of an equality of votes at a meeting of the board of
directors of Newco, the chairman of Newco shall not be entitled
to a second or casting vote. In the event of continued deadlock,
the board of directors shall resolve the deadlock pursuant to the
provisions set forth in Clause 20,
9.2. MANAGEMENT AND R&D COMMITTEES:
9.2.1. 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 Newco Memorandum of Association
of Bye-Laws. The Management Committee shall initially consist of
[*****] members, [*****] of whom will be nominated by EIS and
[*****] of whom will be nominated by Celtrix, and each of whom
shall be entitled to [*****] vote, whether or not present at any
Management Committee meeting during which such operational
functions are discussed. Decisions of the Management Committee
shall require approval by at least [*****] and [*****] Each of
EIS and Celtrix 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 a majority of the
directors of Newco; provided that, each of Elan and Celtrix shall
be entitled to appoint [*****] number of members to the
Management Committee.
9.2.2. The Management Committee shall appoint a research and development
committee (the "R&D COMMITTEE") which shall initially be
comprised of [*****] members, [*****] of whom will be nominated
by Elan and [*****] of whom will be nominated by Celtrix, and
each of whom shall have [*****] vote, whether or not present at
an R&D Committee meeting during which research and development
issues are discussed. Decisions of the R&D
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Committee shall require approval by at least [*****] and
[*****] Each of Elan and Celtrix 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 a
majority of the Directors; provided that, each of Elan and
Celtrix shall be entitled to appoint an [*****] of members to
the R&D Committee. The R & D Committee shall meet at least
[*****] each calendar quarter alternately at the offices of
Elan and Celtrix (except where otherwise agreed) to monitor the
progress of that portion of the Business Plan that relates to
the Project and to report on their progress to the Management
Committee.
9.2.3 The Management Committee shall be responsible for, inter alia,
devising, implementing and reviewing strategy for the business
of Newco, and the operation of Newco, and in particular,
devising Newco's strategy for research and development and to
monitor and supervise the implementation of Newco's strategy
for research and development. 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 in accordance with Clause 10.2 of
this Agreement.
9.2.4. The R&D Committee shall be responsible for:
9.2.4.1. designing that portion of the Business Plan that
relates to the Project for consideration by the
Management Committee;
9.2.4.2. establishing a joint Project team consisting of an
[*****] of team members from Elan and Celtrix,
including [*****] from each of Elan and Celtrix; and
9.2.4.3. implementing such portion of the Business Plan that
relates to the Project, as approved by the Management
Committee.
9.2.4 In the event of any dispute amongst the R&D Committee, the R&D
Committee shall refer such dispute to the Management Committee
whose decision on the dispute shall be binding on the R&D
Committee.
If the Management Committee cannot resolve such matter or any
other matter under consideration by the Management Committee,
then the dispute will be referred to the [*****] and the
[*****]
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and thereafter, in the event of continued deadlock, pursuant to
the deadlock provisions to be set forth in Clause 20, involving
inter alia, the referral of the dispute to an expert, whose
decision, however, will ultimately be non-binding on the
Participants.
9.2.6. [*****] Elan and Celtrix shall permit Newco 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 Elan or Celtrix
and any other book, record, voucher, receipt or invoice
relating to the calculation or the cost of the Project and to
the accuracy of the reports which accompanied them. Any such
inspection of Elan's or Celtrix's records, as the case may be,
shall be at the expense of Newco, except that if such
inspection reveals an overpayment in the amount paid to Elan or
Celtrix, as the case may be, for the Project hereunder in any
Financial Year of [*****] or more of the amount due to Elan or
Celtrix, as the case may be, then the expense of such
inspection shall be borne solely by Elan or Celtrix, as the
case may be, instead of by Newco. Any surplus over the sum
properly payable by Newco to Elan or Celtrix, as the case may
be, shall be paid promptly by Elan or Celtrix, as the case may
be, to Newco. If such inspection reveals a deficit in the
amount of the sum properly payable to Elan or Celtrix, as the
case may be, by Newco, Newco shall pay the deficit to Elan or
Celtrix, as the case may be.
CLAUSE 10
THE BUSINESS PLAN AND REVIEWS
10.1 The Directors shall meet together as soon as reasonably practicable
after the Closing Date hereof and shall agree upon and approve the
Business Plan for the current Financial Year within 60 days of the date
hereof. In subsequent Financial Years, the Directors shall meet
together prior to the accounting reference date specified in Clause 16
and agree upon and approve the Business Plan for the following
Financial Year, or any amendment or modification to the Business Plan.
10.2 The Participants agree that the Management Committee shall submit to
the Directors on [*****] or as soon as reasonably practicable
thereafter in each Financial Year a report on the performance of the
Business and research and development activities of Newco, and the
Directors shall hold such meeting as may be necessary to review the
performance of Newco against the Business Plan for the relevant year.
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CLAUSE 11
RESEARCH AND DEVELOPMENT WORK
11.1 Research and development work related to the Products and the Newco
Intellectual Property may include but shall not be limited to,
screening, in-vitro pharmacology, toxicology, stability, prototype
dosage form development, formulation, optimization, clinical and
regulatory activities. Such work shall be agreed to and jointly
conducted by Elan and Celtrix as provided in the Business Plan.
11.2 Elan (or an Affiliate of Elan nominated by Elan, including, without
limitation, Elan Pharmaceutical International, Ltd., an Irish company)
and Celtrix shall undertake for a period of thirty (30) months from the
Effective Date, pursuant to the Business Plan and in accordance with
the terms of the Funding Agreement, certain research and development
work (a) with respect to the development and commercialization of the
Products, and (b) in furtherance of the development of patent rights
and know-how related to the Elan Intellectual Property, Celtrix
Intellectual Property and Newco Intellectual Property. Newco shall pay
Celtrix and Elan or Elan's Affiliate nominated by Elan hereunder for
any research and development work carried out by them on behalf of
Newco at the end of each month during the Project, subject to the
proper vouching of research and development work and expenses. An
invoice shall be issued to Newco by Celtrix or Elan or Elan's Affiliate
nominated by Elan hereunder, as applicable, by the [*****] of the month
following the month in which work was performed. The payments by Newco
to Celtrix or Elan or Elan's Affiliate nominated by Elan hereunder
shall be calculated by reference to [*****] in carrying out such
research and development work, [*****] Research and development
activities that are [*****] shall be charged to Newco at [*****]
CLAUSE 12
INTELLECTUAL PROPERTY RIGHTS
12.1 Newco shall permanently xxxx or otherwise use reasonable efforts to
cause any third party to permanently xxxx all Products and/or the
packaging therefor with such license or patent notices to comply with
the laws of the country of sale or otherwise to generally communicate
the existence of any Elan Patents Rights or Celtrix Patent Rights for
the countries of the Territory and in such manner as Elan
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or Celtrix, as the case may be, may reasonably request in writing prior
to the sale or commercial use thereof.
12.2 The Participants shall discuss in good faith all material issues
relating to filing, prosecution and maintenance of Elan Patent Rights
and Celtrix Patent Rights insofar as such patent rights are of
relevance to the License Agreements and any patentable inventions and
discoveries within the Elan Intellectual Property, Celtrix Intellectual
Property and Newco Intellectual Property that relate to the License
Agreements and any patentable improvements thereto. Subject to mutual
agreement to the contrary by Celtrix and Elan the following provisions
shall apply:
12.2.1 Elan, [*****], shall make a good faith effort (a) to secure the
grant of any patent applications within the Elan Patent Rights
that relate to the Field; (b) to file and prosecute patent
applications covering the Elan Improvements that relate to the
Field; (c) to defend all such applications against third party
oppositions; and (d) to maintain in force any issued patent or
letters patent within the Elan Patent Rights that relate to the
Field (including any such patents that may issue covering any
such Elan Improvements that relate to the Field). Elan shall
have the sole right in its reasonable business discretion to
control such filing, prosecution, defense and maintenance;
provided, however, that Newco, at its request, shall be
provided with copies of all documents relating to such filing,
prosecution, defense, and maintenance in sufficient time to
review such documents and comment thereon prior to filing.
12.2.2 Celtrix, [*****], shall make a good faith effort (a) to secure
the grant of any patent applications within the Celtrix Patent
Rights that relate to the Field; (b) to file and prosecute
patent applications covering the Celtrix Improvements that
relate to the Field; (c) to defend all such applications
against third party oppositions; and (d) to maintain in force
any issued patent or letters patent within the Celtrix Patent
Rights that relate to the Field (including any such patents
that may issue covering any such Celtrix Improvements that
relate to the Field). Celtrix shall have the sole right in its
reasonable business discretion to control such filing,
prosecution, defense and maintenance; provided, however, that
Newco shall have the right to inspect copies of all documents
relating to such filing, prosecution, defense, and maintenance,
and to make copies thereof, upon reasonable prior notice to
Celtrix.
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12.2.3 In the event that a Participant informs Newco that it does not
intend to file patent applications on patentable inventions and
discoveries within its respective Intellectual Property that
relate to the Field or patentable Improvements that relate to
the Field in one or more countries in the Territory or fails to
file such an application within a reasonable period of time,
Newco shall have the right, but not the obligation, at Newco's
[*****] to file and prosecute such patent application(s) in the
joint names of Newco and the relevant Participant. Upon written
request from Newco, the relevant Participant shall execute all
documents, forms and declarations and do all things as shall be
reasonably necessary to enable Newco to exercise such option
and right.
12.2.4 Newco shall have responsibility and shall bear [*****]
necessary (a) to file and prosecute patent applications on
patentable inventions and discoveries within the Newco
Intellectual Property (b) to defend all such applications
against third party oppositions; and (c) to maintain in force
any issued patent, letters patent within the Newco Intellectual
Property (including any patents that issue on patentable
inventions and discoveries within the Newco Intellectual
Property).
12.3 The Participants and Newco shall promptly inform each other in writing
of any infringement or alleged infringement of any patents within the
Elan Patent Rights, Celtrix Patent Rights or Newco Intellectual
Property or any misappropriation or alleged misappropriation of trade
secrets within the Elan Intellectual Property, Celtrix Intellectual
Property or the Newco Intellectual Property by a third party of which
it becomes aware and provide the other with any available evidence of
such infringement or misappropriation.
12.3.1
12.3.1.1 Subject to Clauses 12.3.1.2 and 12.3.1.3 below and
during the term of the License Agreements, Newco shall
have the right to pursue legal action at [*****] to
protect against any such alleged infringements of the
Elan Patent Rights and Celtrix Patent Rights or
misappropriation of the Elan Intellectual Property and
Celtrix Intellectual Property; provided, however, that
such infringements or misappropriation must relate
solely to the Field. In the event that Newco takes
such action, Newco shall do so at [*****] At Newco's
request, the relevant Participant will co-operate with
such
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action insofar as the said action relates to the
Field at Newco's [*****] [*****]
12.3.1.2 In the event that (i) Newco decides, by unanimous vote
of the Management Committee, not to pursue such
infringers, within a reasonable period but in any
event within [*****] after receiving written notice of
such alleged infringement or misappropriation, or (ii)
if such alleged infringement or misappropriation does
not relate [*****] then either Elan, where the
infringement or misappropriation relates [*****] to
the [*****] or Celtrix, where the infringement or
misappropriate relates [*****] to the [*****] (in
either case, the [*****]), may in its discretion
initiate such proceedings in its own name, at [*****]
At the Affected Participant's request, Newco will
cooperate with such action at the [*****] At the
option and in the sole discretion of such Affected
Participant, the Affected Participant may request the
cooperation of the other Participant in such action;
in such case, the Participants may agree to institute
such proceedings in [*****] and shall reach agreement
[*****] to the third party.
12.2.1.3 In the event that the infringement of either the Elan
Patent Rights or Celtrix Patent Rights affects both
the Field as well as other products being developed or
commercialized by the Affected Participant or its
commercial partners outside the Field, then the
[*****] may in its discretion initiate such
proceedings in [*****] At the Affected Participant's
request, Newco will cooperate with such action at the
[*****] [*****]
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the [*****] may request the cooperation of the other
Participant in such action; in such case, the
Participants may agree to institute such proceedings
in [*****] and shall reach agreement [*****] to the
third party.
12.3.2 During the term of the License Agreements, Newco shall have the
first right but not the obligation to bring suit or otherwise
take action against any alleged infringement of the Newco
Intellectual Property or alleged misappropriation of the Newco
Intellectual Property. If any such alleged infringement or
misappropriation occurs which gives rise to a cause of action
both [*****] Newco shall negotiate, together with Elan and
Celtrix, in good faith to determine the cause of action to be
taken. In the event that Newco takes such action, Newco shall
do so solely [*****] and all damages and monetary awards
recovered in or with respect to such action shall be the
property of Newco. At Newco's request, Elan and Celtrix will
cooperate with any such action at Newco's [*****]
12.3.3 In the event that Newco does not bring suit or otherwise take
action against any alleged infringement of the Newco
Intellectual Property or alleged misappropriation of the Newco
Intellectual Property and so notifies the Participants in
writing within [*****] of receiving notice of such
infringement, (i) if only [*****] desires to and does pursue
such suit or take such action [*****], it shall be entitled
[*****] recovered in or with respect to such action, and (ii)
if both Participants want to pursue such suit or action outside
of Newco, they will negotiate in good faith an appropriate
allocation of costs, expenses and recovery amounts.
12.4 In the event that a claim is or proceedings are brought against Newco
by a third party alleging that the sale, distribution or use of a
Product in the Territory solely because of Newco's use of either the
Elan Intellectual Property or the Celtrix Intellectual Property, as the
case may be, infringes the intellectual property rights of such party,
Newco shall promptly advise either Elan or Celtrix, as the case may be,
of such threat or suit.
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12.5 Newco shall indemnify, defend and hold Elan or Celtrix, as the case may
be, harmless against all actions, losses, claims, demands, damages,
costs and liabilities (including reasonable attorneys fees) relating
directly or indirectly to all such claims or proceedings referred to in
Clause 12.3 provided that Elan or Celtrix, as the case may be, shall
not acknowledge to the third party or to any other person the validity
of any claims of such a third party, and shall not compromise or settle
any claim or proceedings relating thereto without the prior written
consent of Newco, not to be unreasonably withheld or delayed. At its
option, Elan or Celtrix, as the case may be, may elect to take over the
conduct of such proceedings from Newco; provided that Newco's
indemnification obligations shall continue; the costs of defending such
claim shall be borne by Elan or Celtrix, as the case may be; and such
Participant shall not compromise or settle any such claim or proceeding
without the prior written consent of Newco, such consent not to be
unreasonably withheld or delayed.
CLAUSE 13
COMMERCIALIZATION
13.1 Newco will diligently pursue the research, development, prosecution and
commercialization of the Products in accordance with the Business Plan.
The Participants shall reasonably assist and cooperate with Newco in
such research, development, prosecution and commercialization of the
Products.
13.2 Notwithstanding anything contained in this Agreement to the contrary,
[*****] shall have the right [*****] to enter into any agreement with
Newco [*****] Such right of [*****] shall be exercised as follows:
13.2.1 If Newco intends to commercialize or enter into an agreement
with a third party to commercialize the Products, then Newco
immediately shall notify [*****] in writing that [*****] may
elect to enter into negotiations referred to in this Clause
13.2. [*****] shall indicate its desire to enter into such
negotiations pursuant to this Clause 13.2 by delivering
written notice to Newco within [*****] of Elan's receipt of
the written notification from Newco to Elan (the "ELAN/NEWCO
OPTION"). If [*****] elects to enter into such negotiations,
the Parties shall negotiate in good faith the terms of an
applicable agreement.
13.2.2 If, despite such good faith negotiations, [*****] and Newco do
not reach agreement on the terms of such an agreement within
[*****]
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from [*****] exercise of the [*****] then Newco shall be free
to offer a third party[*****] terms to commercialize in the
Territory the Product that is subject to [*****]
CLAUSE 14
MANUFACTURING
14.1 If Newco elects to finance, develop and/or exploit the commercial
production of a Product, it is the expectation of the Participants that
Newco shall enter into a supply agreement with Elan or Celtrix, as the
case may be, to allow for the commercial production of such Product on
behalf of Newco, subject to the following: (a) Celtrix shall
manufacture and supply, and/or subcontract the manufacture and supply,
of SomatoKine(R) with respect to the Products, (b) Elan shall
manufacture and supply, and/or subcontract the manufacture and supply,
of the MEDIPAD(R) Drug Delivery System with respect to the Products,
and (c) Elan shall have the [*****] The supply agreements shall be
negotiated and agreed to by the Parties not later than the date of
completion of Phase III (as such term is commonly used in connection
with FDA applications) of the Project. The terms of the said supply
agreements shall be on normal commercial terms, and shall be negotiated
in good faith by the Parties thereto; provided that the Management
Committee shall have the authority to approve the cost to Newco of such
manufacture and supply of SomatoKine(R) and MEDIPAD(R) Drug Delivery
System to Newco.
CLAUSE 15
TECHNICAL SERVICES AND ASSISTANCE
15.1 Whenever commercially and technically feasible, Newco shall contract
with Celtrix or Elan, as the case may be, to perform such other
services as Newco may require, other than those specifically dealt with
hereunder or in the License Agreements. In determining which Party
should provide such services, the Management Committee shall take into
account the respective infrastructure, capabilities and experience of
Elan and Celtrix.
15.2 Newco shall, if appropriate, conclude an administrative support
agreement with Elan and/or Celtrix on such terms as the Parties thereto
shall in good faith negotiate. The administrative services shall
include one or more of the following administrative services as
requested by Newco:
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15.2.1 accounting, financial and other services;
15.2.2 tax services;
15.2.3 insurance services;
15.2.4 human resources services;
15.2.5 legal and company secretarial services;
15.2.6 patent and related intellectual property services; and
15.2.7 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.
The foregoing list of services shall not be deemed exhaustive and may
be changed from time to time upon written request by Newco.
15.3. The Parties agree that each Party shall effect and maintain [*****]
insurance in respect of all clinical trials and other activities
performed by them on behalf of Newco. The Stockholders and Newco shall
ensure that the industry standard insurance policies shall be in place
for all activities to be carried out by Newco.
15.4 If Elan or Celtrix so requires, Celtrix 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 Intellectual Property or the
Celtrix Intellectual Property, as the case may be, as necessary to
further the Project.
15.5 The employees received by Elan or Celtrix, as the case may be, shall be
subject to obligations of confidentiality no less stringent than those
set out in Clause 23 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 16
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AUDITORS, BANKERS, REGISTERED OFFICE,
ACCOUNTING REFERENCE DATE; SECRETARY; COUNSEL
Unless otherwise agreed by the Stockholders and save as may be provided to the
contrary herein:
16.1 the auditors of Newco shall be [*****]
16.2 the bankers of Newco shall be [*****] or such other bank as may be
mutually agreed from time to time;
16.3 the accounting reference date of Newco shall be December 31st in each
Financial Year; and
16.4 the secretary of Newco shall be [*****] or such other Person as may be
appointed by the Directors from time to time.
CLAUSE 17
REGULATORY
17.1 Newco shall keep the other Parties promptly and fully advised of
Newco's regulatory activities, progress and procedures. Newco 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
relating to the Products. The Parties shall collaborate to obtain any
required regulatory approval of the RHA to market the Products.
17.2 Newco shall, at its own cost, file, prosecute and maintain any and all
Regulatory Applications for the Products in the Territory in accordance
with the Business Plan.
17.3 Any and all Regulatory Approvals obtained hereunder for any Product
shall remain the property of Newco, provided that Newco shall allow
Elan and Celtrix access thereto to enable Elan and Celtrix to fulfill
their respective obligations and exercise their respective rights under
this Agreement. Newco shall maintain such Regulatory Approvals at its
own cost.
17.4 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
28
involved in undertaking the form of commercial collaboration as set
forth in this Agreement. Therefore, except for liabilities resulting
from failure to use reasonable efforts, none of Elan, EIS or Celtrix
shall have any liability to Newco solely as a result of any failure of
a Product to achieve the approval of any RHA.
CLAUSE 18
TRANSFERS OF SHARES;
RIGHT OF FIRST OFFER; TAG ALONG RIGHTS
18.1 GENERAL:
No Stockholder shall, directly or indirectly, sell or otherwise
transfer (each, a "TRANSFER") any Shares held by it except in
accordance with this Agreement. Newco shall not, and shall not permit
any transfer agent or registrar for any Shares to, transfer upon the
books of Newco any Shares from any Stockholder to any transferee, in
any manner, except in accordance with this Agreement, and any purported
transfer not in compliance with this Agreement shall be void.
18.2 RIGHTS OF FIRST OFFER:
If at any time after the end of the Term, a Stockholder shall desire to
Transfer any Shares owned by it (a "SELLING STOCKHOLDER"), in any
transaction or series of related transactions other than a Transfer to
an Affiliate or subsidiary or to an off-balance sheet special purpose
entity established by EIS or Celtrix, as the case may be, then such
Selling Stockholder shall deliver prior written notice of its desire to
Transfer (a "NOTICE OF INTENTION") (i) to Newco and (ii) to the
Stockholders who are not the Selling Stockholder (and any transferee
thereof permitted hereunder, if any), as applicable, setting forth such
Selling Stockholder's desire to make such Transfer, the number of
Shares proposed to be transferred (the "OFFERED SHARES") and the
proposed form of transaction (the "TRANSACTION PROPOSAL"), together
with any available documentation relating thereto and the price at
which such Selling Stockholder proposes to Transfer the Offered Shares
(the "OFFER PRICE"). The "Right of First Offer" provided for in this
Clause 18 shall be subject to any "Tag Along Right" benefiting a
Stockholder which may be provided for by Clause 18.3, subject to the
exceptions set forth therein.
Upon receipt of the Notice of Intention, the Stockholders who are not
the Selling Stockholder shall have the right to purchase at the Offer
Price the Offered Shares, exercisable by the delivery of notice to the
Selling Stockholder (the "NOTICE OF EXERCISE"), with a copy to Newco,
within 10 business days from the date of receipt of the Notice of
Intention. If no such Notice of Exercise has been delivered by the
Stockholders who are not the Selling Stockholder within such 10-
business day period, or such Notice of Exercise does not relate to all
of the
29
Offered Shares covered by the Notice of Intention, then the Selling
Stockholder shall be entitled to Transfer all of the Offered Shares to
the intended transferee. In the event that all of the Offered Shares
are not purchased by the non-selling Stockholders, the Selling
Stockholder shall sell the available Offered Shares within 30 days
after the delivery of such Notice of Intention on terms no more
favorable to a third party than those presented to the non-selling
Stockholders. If such sale does not occur, the Offered Shares shall
again be subject to the Right of First Refusal set forth in Clause
18.2.
In the event that any of the Stockholders who are not the Selling
Stockholder exercises their right to purchase all of the Offered
Shares (in accordance with this Clause 18.2), then the Selling
Stockholder shall sell all of the Offered Shares to such
Stockholder(s), in the amounts set forth in the Notice of Intention,
after not less than 10 business days and not more than 25 business
days from the date of the delivery of the Notice of Exercise. In the
event that more than one of the Stockholders who are not the Selling
Stockholders wish to purchase the Offered Shares, the Offered Shares
shall be allocated to such Stockholders on the basis of their pro rata
equity interests in Newco.
The rights and obligations of each of the Stockholders pursuant to the
Right of First Offer provided herein shall terminate upon the date
that the Common Stock is registered under Section 12(b) or 12(g) of
the Exchange Act.
At the closing of the purchase of all of the Offered Shares by the
Stockholders who are not the Selling Stockholder (scheduled in
accordance with Clause 18.2), the Selling Stockholder shall deliver
certificates evidencing the Offered Shares being sold, duly endorsed,
or accompanied by written instruments of transfer in form reasonably
satisfactory to the Stockholders who are not the Selling Stockholder,
duly executed by the Selling Stockholder, free and clear of any
adverse claims, against payment of the purchase price therefor in
cash, and such other customary documents as shall be necessary in
connection therewith.
18.3 TAG ALONG RIGHTS:
Subject to Clause 18.2, a Stockholder (the "TRANSFERRING STOCKHOLDER")
shall not Transfer (either directly or indirectly), in any one
transaction or series of related transactions, to any Person or group
of Persons, any Shares, unless the terms and conditions of such
Transfer shall include an offer to the other Stockholders who have not
exercised the Right of First Offer set forth above in Clause 18.2 (the
"REMAINING STOCKHOLDERS"), to sell Shares at the same price and on the
same terms and conditions as the Transferring Stockholder has agreed
to sell its Shares (the "TAG ALONG RIGHT").
30
In the event a Transferring Stockholder proposes to Transfer any
Shares in a transaction subject to this Clause 18.3, it shall notify,
or cause to be notified, the Remaining Stockholders in writing of each
such proposed Transfer. Such notice shall set forth: (i) the name of
the transferee and the amount of Shares proposed to be transferred,
(ii) the proposed amount and form of consideration and terms and
conditions of payment offered by the transferee (the "TRANSFEREE
TERMS") and (iii) that the transferee has been informed of the Tag
Along Right provided for in this Clause 18.3, if such right is
applicable, and the total number of Shares the transferee has agreed
to purchase from the Stockholders in accordance with the terms hereof.
The Tag Along Right may be exercised by each of the Remaining
Stockholders by delivery of a written notice to the Transferring
Stockholder (the "CO-SALE NOTICE") within 10 business days following
receipt of the notice specified in the preceding subsection. The Co-
sale Notice shall state the number of Shares owned by such Remaining
Stockholder which the Remaining Stockholder wishes to include in such
Transfer; provided, however, that without the written consent of the
Transferring Stockholder, the amount of such securities belonging to
the Remaining Stockholder included in such Transfer may not be greater
than such Remaining Stockholder's percentage beneficial ownership of
Fully Diluted Common Stock multiplied by the total number of shares of
Fully Diluted Common Stock to be sold by both the Transferring
Stockholder and all Remaining Stockholders. Upon receipt of a Co-sale
Notice, the Transferring Stockholder shall be obligated to transfer at
least the entire number of Shares set forth in the Co-sale Notice to
the transferee on the Transferee Terms; provided, however, that the
Transferring Stockholder shall not consummate the purchase and sale of
any Shares hereunder if the transferee does not agree to purchase all
such Shares specified in all Co-sale Notices. If no Co-sale Notice has
been delivered to the Transferring Stockholder prior to the expiration
of the 10 business day period referred to above and if the provisions
of this Section have been complied with in all respects, the
Transferring Stockholder shall have the right for a 45 day calendar
day period to Transfer Shares to the transferee on the Transferee
Terms without further notice to any other party, but after such 45-day
period, no such Transfer may be made without again giving notice to
the Remaining Stockholders of the proposed Transfer and complying with
the requirements of this Clause 18.3.
At the closing of any Transfer of Shares subject to this Clause 18.3,
the Transferring Stockholder, and the Remaining Stockholder, in the
event such Tag
31
[*****] INDICATES THAT CONFIDENTIAL MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
Along Right is exercised, shall deliver certificates evidencing such
securities as have been transferred by each, duly endorsed, or
accompanied by written instruments of transfer in form reasonably
satisfactory to the transferee, free and clear of any adverse claim,
against payment of the purchase price therefor.
The rights and obligations of each of the Stockholders pursuant to the
Tag Along Rights provided herein shall terminate upon the date that
the Common Stock of Newco is registered under Section 12(b) or 12(g)
of the Exchange Act.
Notwithstanding the foregoing, this Clause 18 shall not apply to any
sale of Common Stock pursuant to an effective registration statement
under the Securities Act in a bona fide public offering.
CLAUSE 19
MATTERS REQUIRING PARTICIPANTS' APPROVAL
19.1 Subject to the provisions of Clause 19.2, in consideration of Celtrix
and Elan agreeing to enter into the License Agreements, the Parties
hereby agree that Newco shall not without the prior approval of all of
the EIS Directors and all of the Celtrix Directors:
19.1.1. engage in any activity other than the Business;
19.1.2. acquire or dispose of assets of a value in excess of [*****]
or sell the principal assets, undertaking or Business of
Newco;
19.1.2. create any fixed or floating charge, lien (other than a lien
arising by operation of law) or other encumbrance over the
whole or any part of the undertaking, property or assets of
Newco or of any Subsidiary;
19.1.4. borrow any sum in excess of a maximum aggregate sum
outstanding at any time of [*****];
19.1.5. make any loan or advance or give any credit (other than
normal trade credit) in excess of [*****] to any Person;
19.1.6. 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;
32
[*****] INDICATES THAT CONFIDENTIAL MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
19.1.7. 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 realization by Newco 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;
19.1.8. issue any unissued Shares or create or issue any new shares
(including a split of the Shares), except as expressly permitted
by the Newco Memorandum of Association and Bye-Laws;
19.1.9. alter any rights attaching to any class of share in the capital of
Newco or alter the Newco Memorandum of Association and Bye-Laws;
19.1.10. consolidate, sub-divide or convert any of Newco's share capital or
in any way alter the rights attaching thereto;
19.1.11. dispose of Newco or of any shares in Newco;
19.1.12. 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;
19.1.13. do or permit or suffer to be done any act or thing whereby Newco
may be wound up (whether voluntarily or compulsorily), save as
otherwise expressly provided for in this Agreement;
19.1.14. issue any debentures or other securities convertible into shares
or debentures or any share warrants or any options in respect of
shares in Newco;
19.1.15. enter into any contract or transaction except in the ordinary and
proper course of the Business on arm's length terms;
19.1.16. acquire, purchase or subscribe for any shares, debentures,
mortgages or securities (or any interest therein) in any company,
trust or other Person;
19.1.17. adopt any employee benefit program or incentive schemes;
33
[*****] INDICATES THAT CONFIDENTIAL MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
19.1.18. engage any new employee at remuneration of greater than
[*****] per annum;
19.1.19. pay any remuneration to the Directors by virtue of holding such
office other than Directors who hold executive office;
19.1.20. licence or sub-licence any of the Elan Intellectual Property,
Celtrix Intellectual Property or Newco Intellectual Property;
19.1.21. amend or vary the terms of the Celtrix License Agreement or the
Elan License Agreement;
19.1.22. permit a person other than Newco to own a regulatory approval
relating to the Product(s);
19.1.23. change the authorized signatories on Newco bank accounts;
19.1.24. amend or vary the Business Plan;
19.1.25. alter the number of Directors;
19.1.26. pay dividends or distributions in respect of, or redeem or
repurchase, the equity of Newco;
19.1.27. enter into joint venture agreements or any similar arrangements
with any Person; or
19.1.28. create, acquire or dispose of any Subsidiary or of any shares in
any Subsidiary.
19.3 Notwithstanding any provision in this Agreement to the contrary, any
decision regarding U.S. tax elections to be made by Newco, such as whether
[*****], shall be made by unanimous vote of the Board of Directors.
CLAUSE 20
DISPUTES
20.1 Should any dispute or difference arise between Elan and Celtrix, or between
Elan or Celtrix and Newco, during the period that this Agreement is in
force, other than a dispute or difference relating to (i) the
interpretation of any provision of this
34
Agreement, (ii) the interpretation or application of law, or (iii) the
ownership of any intellectual property, then any Party may forthwith
give notice to the other Parties that it wishes such dispute or
difference to be referred to the chief executive officer of Celtrix
and the President of EPT.
20.2 In any event of a notice being served in accordance with Clause 20.1,
each of the Participants shall within 14 days of the service of such
notice prepare and circulate to the chief executive officer of Celtrix
and the President of EPT a memorandum or other form of statement
setting out its position on the matter in dispute and its reasons for
adopting that position. Each memorandum or statement shall be
considered by the chief executive officer of Celtrix and the President
of EPT who shall endeavor to resolve the dispute. If the chief
executive officer of Celtrix and the President of EPT agree upon a
resolution or disposition of the matter, they shall each sign a
statement which sets out the terms of their agreement. The
Participants agree that they shall exercise the voting rights and
other powers available to them in relation to Newco to assure that the
agreed terms are fully and promptly carried into effect.
20.3 The chief executive officer of Celtrix and the President of EPT shall,
if they are unable to resolve a dispute or difference when it is
referred to them under Clause 20.2, refer the matter to an independent
expert in pharmaceutical product development and marketing (including
clinical development and regulatory affairs) (the "EXPERT"). The
Expert shall be selected by the presiding justice of the Supreme Court
of the State of New York sitting in the County, City and State of New
York (the "PRESIDING JUSTICE") or, if the Expert should have a
conflict of interest, by such other Person as such justice shall
select, having assured himself as to such Person's independence. In
each case, the Expert shall be selected having regard to his
suitability to determine the particular dispute or difference on which
the Expert is being requested to determine. Unless otherwise agreed
between the chief executive officer of Celtrix and the President of
EPT, the following rules shall apply to the appointment of the Expert.
The fees of the Expert shall be shared equally between the Parties in
dispute. The Expert shall be entitled to inspect and examine all
documentation and any other material which the Expert may consider to
be relevant to the dispute. The Expert shall afford each Party a
reasonable opportunity (in writing or orally) of stating 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 four weeks
from the reference of the dispute or difference to him.
35
20.4 Any determination by the Expert of a dispute or difference shall not
be final and binding on the Parties; provided, however, that any
determination by the Expert of a dispute or difference referred by the
Parties pursuant to Clause 21.6. shall be final and binding on the
Parties.
CLAUSE 21
TERMINATION
21.1 This Agreement shall govern the operation and existence of Newco until
(i) terminated by written agreement of all Parties hereto or (ii)
otherwise terminated in accordance with this Clause 21.
21.2 For the purpose of this Clause 21, a "RELEVANT EVENT" is committed or
suffered by a Participant if:
21.2.1 it commits a material breach of its obligations under this
Agreement or the applicable License 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
period shall be extended by such period as is reasonably
necessary to permit the breach to be rectified;
21.2.2 a distress, execution, sequestration or other process is
levied or enforced upon or sued out against a material part
of its property which is not discharged or challenged within
30 days;
21.2.3 it is unable to pay its debts in the normal course of
business;
21.2.4 it ceases wholly or substantially to carry on its business,
otherwise than for the purpose of a reconstruction or
amalgamation, without the prior written consent of the other
Participant (such consent not to be unreasonably withheld);
21.2.5 the appointment of a liquidator, receiver, administrator,
examiner, trustee or similar officer of such Participant or
over all or substantially all of its assets under the law of
any applicable jurisdiction, including without limitation,
the United States of America, Bermuda or Ireland;
21.2.6 an application or petition for bankruptcy, corporate re-
organization, composition, administration, examination,
arrangement or any other procedure similar to any of the
foregoing under the law of any applicable jurisdiction,
including without limitation, the United States of America,
Bermuda or Ireland, is filed, and is not discharged within 60
days, or a Participant applies for or consents to the
appointment of a receiver, administrator, examiner or similar
officer of it or of all or a material part
36
of its assets, rights or revenues or the assets and/or the
business of a Participant are for any reason seized,
confiscated or condemned.
21.4 If either Participant commits or suffers a Relevant Event, the other
Participant shall be entitled, within three months of the occurrence
of the Relevant Event, to require the defaulting Participant (the
"RECIPIENT PARTICIPANT") to sell on reasonable terms of payment to the
non-defaulting Participant (the "PROPOSING PARTICIPANT") all (but not
some only) of the Shares, held or beneficially owned by the Recipient
Participant for an amount equal to the fair market value of the Shares
of the Recipient Participant (the "BUYOUT OPTION").
21.5 The Proposing Participant shall notify the Recipient Participant of
the exercise of the Buyout Option, no later than 30 business days
prior to the proposed exercise thereof, by delivering written notice
to the Recipient Participant stating that the Buyout Option is
exercised and the price at which the Proposing Participant is willing
to purchase the Shares of the Recipient Participant.
21.6 In the event that the Participants do not agree upon a purchase price
for the Shares within five Business Days following the receipt by the
Recipient Participant of written notice from the Proposing Participant
pursuant to Clause 21.5 above, the Proposing Participant may contact
the Presiding Justice and request that an independent US-based
arbitrator who is knowledgeable of the pharmaceutical/biotechnology
industry be appointed within 10 Business Days. The Presiding Justice
shall endeavor to select an arbitrator who is technically
knowledgeable in the pharmaceutical/biotechnology industry (and who
directly and through his affiliates, has no business relationship
with, or shareholding in, either the Proposing Participant or the
Recipient Participant). Promptly upon being notified of the
arbitrator's appointment, the Proposing Participant and the Recipient
Participant shall submit to the arbitrator details of their assessment
of the fair market value for the Shares of the Recipient Participant
together with such information as they think necessary to validate
their assessment. The arbitrator shall notify the Recipient
Participant of the fair market value assessed by the Proposing
Participant (the "PROPOSING PARTICIPANT PRICE") and shall notify the
Proposing Participant of the fair market value assessed by the
Recipient Participant (the "RECIPIENT PARTICIPANT PRICE"). The
Proposing Participant and the Recipient Participant shall then be
entitled to make further submissions to the arbitrator within five
Business Days explaining why the Recipient Participant
37
[*****] INDICATES THAT CONFIDENTIAL MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
Price or the Proposing Participant Price, as the case may be, is
unjustified. The arbitrator shall thereafter meet with the Proposing
Participant and the Recipient Participant and shall thereafter choose
either the Recipient Participant Price or the Proposing Participant
Price (but not any other price) as the purchase price for the Shares
(the "PURCHASE PRICE") on the basis of which price the Expert
determines to be closer to the fair market value for the Shares of the
Recipient Participant. The arbitrator shall use his best efforts to
determine the Purchase Price within 30 Business Days of his
appointment. The Proposing Participant and the Recipient Participant
shall bear the costs of the arbitrator equally provided that the
arbitrator may, in his discretion, allocate all or a portion of such
costs to one Party. Any decision of the arbitrator shall be final and
binding.
21.7 The Proposing Participant shall purchase the Shares of the Recipient
Participant by delivery of the Purchase Price in cash no later than
the 15th Business Day following determination of the Purchase Price by
the Expert.
21.8 The Shares of the Recipient Participant so transferred shall be sold
by the transferor as beneficial owner with effect from the date of
such transfer free from any lien, charge or encumbrance with all
rights and restrictions attaching thereto.
21.9 If the Proposing Participant exercises the Buyout Option, both parties
will negotiate in good faith to agree to additional reasonable
provisions and/or amendments to the License Agreements to protect the
intellectual property rights of the Recipient Party.
21.10 If either Participant commits a Relevant Event, the other Stockholder
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.
21.11 In the event of a termination of the Elan License Agreement and/or the
Celtrix License Agreement, both parties will negotiate in good faith
to determine whether this Agreement should be terminated and if so,
which provisions should survive termination.
21.12 The provisions of Clauses [*****] shall survive the termination of
this Agreement under this Clause 21 in accordance with their terms;
all other terms and provisions of this Agreement shall cease to have
effect and be null and void upon the termination of this Agreement
under this Clause 21.
38
CLAUSE 22
[INTENTIONALLY OMITTED]
CLAUSE 23
CONFIDENTIALITY
23.1 The Parties and/or Newco acknowledge and agree that it may be
necessary, from time to time, to disclose to each other confidential
and/or proprietary information, including without limitation,
inventions, works of authorship, trade secrets, specifications,
designs, data, know-how and other information, relating to the Field,
the Products, present or future products, the Newco Intellectual
Property, the Elan Intellectual Property or the Celtrix Intellectual
Property, as the case may be, methods, compounds, research projects,
work in process, services, sales suppliers, customers, employees
and/or business of the disclosing Party, whether in oral, written,
graphic or electronic form (collectively "CONFIDENTIAL INFORMATION").
23.2 Any Confidential Information revealed by a Party to another Party
shall be maintained as confidential and shall be used by the receiving
Party exclusively for the purposes of fulfilling the receiving Party's
rights and obligations under this Agreement, and for no other purpose.
Confidential Information shall not include:
23.2.1 information that is generally available to the public;
23.2.2 information that is made public by the disclosing Party;
23.2.3 information that is independently developed by the receiving
Party, as evidenced by such Party's records, without the aid,
application or use of the disclosing Party's Confidential
Information;
23.2.4 information that is published or otherwise becomes part of the
public domain without any disclosure by the receiving Party,
or on the part of the receiving Party's directors, officers,
agents, representatives or employees;
23.2.5 information that becomes available to the receiving Party on a
non-confidential basis, whether directly or indirectly, from a
source other than the disclosing Party, which source did not
acquire this information on a confidential basis; or
39
23.2.6 information which the receiving Party is required to disclose
pursuant to:
(i) a valid order of a court or other governmental body or
any political subdivision thereof or as otherwise
required by law, rule or regulation; or
(ii) other requirement of law; provided, however, 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
confidential treatment 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; or
23.2.7 information which was already in the possession of the
receiving Party at the time of receiving such information, as
evidenced by its records, provided such information was not
previously provided to the receiving party from a source which
was under an obligation to keep such information confidential;
or
23.2.8 information that is the subject of a written permission to
disclose, without restriction or limitation, by the disclosing
Party.
23.3 Each Party agrees to disclose Confidential Information of another
Party only to those employees, representatives and agents requiring
knowledge thereof in connection with their duties directly related to
the fulfilling of the Party's obligations under this Agreement, so
long as such persons are under an obligation of confidentiality no
less stringent than as set forth herein. Each Party further agrees to
inform all such employees, representatives and agents of the terms and
provisions of this Agreement and their duties hereunder and to obtain
their written consent hereto as a condition of receiving Confidential
Information. Each Party agrees that it will exercise the same degree
of care and protection to preserve the proprietary and confidential
nature of the Confidential Information disclosed by a Party, as the
receiving Party would exercise to preserve its own Confidential
Information. Each Party agrees that it will, upon request of another
Party, return all documents and any copies thereof containing
Confidential Information belonging to or disclosed by such other
Party. Each Party shall promptly notify
40
[*****] INDICATES THAT CONFIDENTIAL MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
the other Parties upon discovery of any unauthorized use or disclosure
of the other Parties' Confidential Information.
23.4 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
granting a permitted sub-license or otherwise exercising its rights
hereunder; provided, that if a Party is required to make any such
disclosure of the other Party's Confidential Information, other than
pursuant to a confidentiality agreement, such Party shall inform the
third party recipient of the terms and provisions of this Agreement and
their duties hereunder and shall obtain their consent hereto as a
condition of releasing to the third party recipient the Confidential
Information.
23.5 Any breach of this Clause 23 by any employee, representative or agent of
a Party is considered a breach by the Party itself.
23.6 The provisions relating to confidentiality in this Clause 23 shall
remain in effect during the Term and for a period of [*****] following
the termination of this Agreement.
23.7 The Parties agree that the obligations of this Clause 23 are necessary
and reasonable in order to protect the Parties' respective businesses,
and each Party expressly agrees that monetary damages would be
inadequate to compensate a Party for any breach by the other Party of
its covenants and agreements set forth herein. Accordingly, the Parties
agree and acknowledge that any such violation or threatened violation
will cause irreparable injury to a Party and that, in addition to any
other remedies that may be available, in law or in equity or otherwise,
any Party shall be entitled to obtain injunctive relief against the
threatened breach of the provisions of this Clause 23, or a continuation
of any such breach by the other Party, specific performance and other
equitable relief to redress such breach together with its damages and
reasonable counsel fees and expenses to enforce its rights hereunder,
without the necessity of proving actual or express damages.
23.8 If it is necessary for Celtrix to file a copy of this Agreement with the
Securities and Exchange Commission pursuant to applicable law, then (a)
Celtrix shall consult with Elan, and keep Elan fully informed, with
respect thereto, and (b) Celtrix shall use its best efforts to obtain
confidential treatment to the maximum extent possible with respect to
such filing of this Agreement.
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CLAUSE 24
COSTS
24.1 Each Stockholder shall bear its own legal and other costs incurred in
relation to preparing and concluding this Agreement and the Transaction
Documents.
24.2 All other costs, legal fees, registration fees and other expenses
relating to the transactions contemplated hereby, including the costs
and expenses incurred in relation to the incorporation of Newco, shall
be borne by Newco.
CLAUSE 25
GENERAL
25.1 GOOD FAITH:
Each of the Parties hereto undertakes with the others to do all things
reasonably within its power that are necessary or desirable to give
effect to the spirit and intent of this Agreement.
25.2 FURTHER ASSURANCE:
At the request of any of the Parties, the other Party or Parties shall
(and shall use reasonable efforts to procure that any other necessary
parties shall) execute and perform all such documents, acts and things
as may reasonably be required subsequent to the signing of this
Agreement for assuring to or vesting in the requesting Party the full
benefit of the terms hereof.
25.3 NO REPRESENTATION:
Each of the Parties hereto hereby acknowledges that in entering into
this Agreement it has not relied on any representation or warranty
except as expressly set forth herein or in any document referred to
herein.
25.4 FORCE MAJEURE:
Neither Party to this Agreement shall be liable for delay in the
performance of any of its obligations hereunder if such delay is caused
by or results from causes beyond its reasonable control, including
without limitation, acts of God, fires, strikes, acts of war (whether
war be declared or not), insurrections, riots, civil commotions,
strikes, lockouts or other labor disturbances or intervention of any
relevant government authority, but any such delay or failure shall be
remedied by such Party as soon as practicable.
42
25.5 RELATIONSHIP OF THE PARTIES:
Nothing contained in this Agreement is intended or is to be construed to
constitute Elan/EIS and Celtrix as partners, or Elan/EIS as an employee
or agent of Celtrix, or Celtrix as an employee or agent of Elan/EIS.
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.
25.6 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.
25.7 NOTICES:
Any notice to be given under this Agreement shall be sent in writing by
registered or recorded delivery post or reputable overnight courier such
as Federal Express or telecopied to:
Elan/EIS at:
Xxxxxxx Xxxxx, Xxxxxxx Xxxxx, Xxxxxx 0, Xxxxxxx
Attention: Vice President & General Counsel
Elan Pharmaceutical Technologies,
a division of Elan Corporation, plc
Telephone: 000-0-000-0000
Fax: 000-0-000-0000
and
Elan International Services, Ltd.
000 Xx. Xxxxx Xxxxx
Xxxxxx, Xxxxxx XX00
Bermuda
Attention: President
Telephone: 000-000-0000
Fax: 000-000-0000
43
with a copy to:
Xxxxx Xxxxxxxxxxx LLC
Xxx Xxxxxxxx Xxxxxx, 00xx Xxxxx
Xxx Xxxx, XX 00000 Xxxxxx Xxxxxx of America
Attention: Xxxxx Xxxxxxx, Esq.
Telephone 000-000-0000
Fax: 000-000-0000
Celtrix at:
0000 Xxxxxxx Xxxxx, Xxxxx 000
Xxx Xxxx, XX 00000 Xxxxxx Xxxxxx of America
Attention: President
Telephone: 000-000-0000
Fax: 000-000-0000
with a copy to:
Venture Law Group
0000 Xxxx Xxxx Xxxx
Xxxxx Xxxx, XX 00000 Xxxxxx Xxxxxx of America
Attention: Xxx Xxxxxx
Telephone: 000-000-0000
Fax: 000-000-0000
Newco at:
000 Xx. Xxxxx Xxxxx
Xxxxxx, Xxxxxx XX00
Bermuda
Attention: Secretary
Telephone: 000-000-0000
Fax: 000-000-0000
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
three Business Days after dispatch or delivery to the relevant courier
and any notice sent by telecopy shall be deemed to have been delivered
upon confirmation of receipt. Notices of change of address shall be
effective upon receipt. Notices by telecopy shall also be sent by
another method permitted hereunder.
44
25.8 GOVERNING LAW;
This Agreement shall be governed by and construed in accordance with
the laws of the State of New York without giving effect to any choice
or conflict or law provision or rule. For the purpose of this Agreement
the Parties submit to the personal jurisdiction of the United States
District Court for the State of New York. The Parties each further
irrevocably consent to the service of any complaint, summons, notice or
other process by delivery thereof to it by any manner in which notices
may be given pursuant to this Agreement.
25.9.1 SEVERABILITY.
If any provision in this Agreement is agreed in writing by the
Parties to be, or is deemed to be, or becomes invalid,
illegal, void or unenforceable under any law that is
applicable hereto, (i) such provision will be deemed amended
to conform to applicable laws so as to be valid and
enforceable without materially altering the intention of the
Parties, and (ii) the validity, legality and enforceability of
the remaining provisions of this Agreement shall not be
impaired or affected in any way.
25.10 AMENDMENTS:
No amendment, modification or addition hereto shall be effective or
binding on any Party unless set forth in writing and executed by a duly
authorized representative of all Parties.
25.11 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.
45
25.12 ASSIGNMENT:
None of the Parties shall be permitted to assign its rights or
obligations hereunder without the prior written consent of the other
Parties except as follows:
25.12.1 Elan, EIS and/or Celtrix shall have the right to assign their
rights and obligations hereunder to their Affiliates provided,
however, that such assignment does not result in adverse tax
consequences for any other Parties.
25.12.2 Elan, EIS and/or Celtrix shall have the right to assign their
rights and obligations hereunder to an off-balance sheet
special purpose entity established by Elan, EIS and/or
Celtrix.
25.13 WHOLE AGREEMENT/NO EFFECT ON OTHER AGREEMENTS:
This Agreement (including the Schedules attached hereto) and the
Transaction Documents set forth all of the agreements and
understandings between the Parties with respect to the subject matter
hereof, and supersedes and terminates all prior agreements and
understandings between the Parties with respect to the subject matter
hereof. There are no agreements or understandings with respect to the
subject matter hereof, either oral or written, between the Parties
other than as set forth in this Agreement and the Transaction
Documents.
In the event of any ambiguity or conflict arising between the terms of
this Agreement and those of the Newco Memorandum of Association and
Bye-Laws, the terms of this Agreement shall prevail.
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 herein. In the event of a conflict between the
provisions of this Agreement and the provisions of the License
Agreements, the terms of this Agreement shall prevail unless this
Agreement specifically provide otherwise.
25.14 SUCCESSORS:
This Agreement shall be binding upon and inure to the benefit of the
Parties hereto, their successors and permitted assigns.
46
IN WITNESS WHEREOF, the Parties hereto have executed this
Agreement on the day first set forth above.
SIGNED
BY: /s/ Xxxxx Xxxxxx
-------------------------
for and on behalf of
ELAN CORPORATION, PLC
in the presence of: /s/ [Illegible]
------------------
SIGNED
BY: /s/ Xxxxx Xxxxxx
----------------------------
for and on behalf of
ELAN INTERNATIONAL SERVICES, LTD.
in the presence of: /s/ [Illegible]
------------------
SIGNED
BY: /s/ Xxxxxxx Xxxxxx
----------------------------
for and on behalf of
CELTRIX PHARMACEUTICALS INC.
in the presence of: /s/ Kia P. Royal-Xxxxxxx SIGNED
-------------------------
BY: /s/ Xxxxxxx Xxxxxx
----------------------------
for and on behalf of
CELTRIX NEWCO LTD.
in the presence of:/s/ Kia P. Royal-Xxxxxxx
-------------------------
47
SCHEDULE 1
ELAN LICENSE AGREEMENT
SCHEDULE 2
CELTRIX LICENSE AGREEMENT
