EXHIBIT 10.22
[CONFIDENTIAL TREATMENT REQUESTED] /*/ INDICATES MATERIAL THAT HAS BEEN OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED
MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
EXECUTION COPY
SUBSCRIPTION, JOINT DEVELOPMENT AND OPERATING AGREEMENT
ELAN CORPORATION, PLC
(ACTING THROUGH ITS DIVISION ELAN PHARMACEUTICAL TECHNOLOGIES)
ELAN PHARMA INTERNATIONAL LIMITED
ELAN INTERNATIONAL SERVICES, LTD.
AND
ACUSPHERE, INC.
AND
ACUSPHERE NEWCO, LTD.
INDEX
CLAUSE 1 DEFINITIONS
CLAUSE 2 BUSINESS AND SELECTION OF COMPOUNDS
CLAUSE 3 REPRESENTATIONS AND WARRANTIES
CLAUSE 4 AUTHORIZATION AND CLOSING
CLAUSE 5 DIRECTORS; MANAGEMENT AND R&D COMMITTEES
CLAUSE 6 THE BUSINESS PLAN AND REVIEWS
CLAUSE 7 RESEARCH AND DEVELOPMENT
CLAUSE 8 COMMERCIALIZATION
CLAUSE 9 OWNERSHIP OF INTELLECTUAL PROPERTY RIGHTS/NONCOMPETITION
CLAUSE 10 INTELLECTUAL PROPERTY RIGHTS
CLAUSE 11 CROSS LICENSING/EXPLOITATION OF PRODUCTS OUTSIDE FIELD
CLAUSE 12 REGULATORY
CLAUSE 13 MANUFACTURING
CLAUSE 14 TECHNICAL SERVICES AND ASSISTANCE
CLAUSE 15 AUDITORS, BANKERS, ACCOUNTING REFERENCE DATE; SECRETARY
CLAUSE 16 TRANSFER OF SHARES; RIGHTS OF FIRST OFFER; TAG ALONG RIGHTS
CLAUSE 17 MATTERS REQUIRING SHAREHOLDERS' APPROVAL
CLAUSE 18 DISPUTES
CLAUSE 19 TERMINATION
CLAUSE 20 SHARE RIGHTS
CLAUSE 21 CONFIDENTIALITY
CLAUSE 22 COSTS
CLAUSE 23 GENERAL
THIS SUBSCRIPTION, JOINT DEVELOPMENT AND OPERATING AGREEMENT made this 30th day
of June, 2000
BETWEEN:
(1) ELAN CORPORATION, PLC, a public limited company incorporated under the
laws of Ireland, acting through its division ELAN PHARMACEUTICAL
TECHNOLOGIES, and having its registered office at ▇▇▇▇▇▇▇ ▇▇▇▇▇,
▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇ ▇, ▇▇▇▇▇▇▇ ("ELAN, PLC");
(2) ELAN INTERNATIONAL SERVICES, LTD., a Bermuda exempted limited liability
company incorporated under the laws of Bermuda, and having its
registered office at ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇ ▇▇▇▇▇▇ ▇▇., ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇
("▇▇▇");
(3) ELAN PHARMA INTERNATIONAL LIMITED a private limited company
incorporated under the laws of Ireland, and having its registered
office at ▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇,
▇▇▇▇▇▇▇ ("EPIL");
(4) ACUSPHERE, INC. a corporation duly incorporated and validly existing
under the laws of Delaware and having its principal place of business
at ▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇ of America
("ACUSPHERE"); and
(5) ACUSPHERE NEWCO LIMITED a Bermuda exempted limited liability company
incorporated under the laws of Bermuda, and having its registered
office at ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇ ▇▇▇▇▇▇ ▇▇., ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ("▇▇▇▇▇").
RECITALS:
A. Newco desires to issue and sell to the Shareholders (as defined below),
and the Shareholders desire to purchase from Newco, for aggregate
consideration of $15,000,000, apportioned between them as set forth
herein, (i) 6,000 shares of Newco's common shares, par value $1.00 per
share (the "COMMON SHARES") to Acusphere, and (ii) 6,000 shares of
Newco's preferred shares, par value $1.00 per share (the "PREFERRED
SHARES") allocated 3,612 shares to Acusphere and 2,388 shares to EIS.
B. As of the Closing Date, Elan, plc and EPIL, have entered into a license
agreement with Newco, and Acusphere has entered into a license
agreement with Newco, in connection with the license to Newco of the
Elan Intellectual Property and the Acusphere Intellectual Property,
respectively (each as defined below).
C. Elan, plc, EPIL and Acusphere have agreed to co-operate in the
research, development and commercialization of the Products (as defined
below) based on their respective technologies.
1
D. Elan, plc, EPIL and Acusphere have agreed to enter into this Agreement
for the purpose of recording the terms and conditions regulating their
relationship with each other, with respect to the Licensed Technologies
and 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.
"ACUSPHERE DIRECTORS" has the meaning set forth in Clause 5.
"ACUSPHERE IMPROVEMENTS" has the meaning assigned thereto in the
Acusphere License Agreement.
"ACUSPHERE INTELLECTUAL PROPERTY" has the meaning assigned thereto in
the Acusphere License Agreement.
"ACUSPHERE JV" shall mean an entity that Acusphere and a third party
(i) establish or has established, (ii) take shareholdings in or have a
right to take shareholdings in, and (iii) grant certain licenses in and
to certain intellectual property rights for the purpose of implementing
a strategic alliance.
"ACUSPHERE KNOW-HOW" has the meaning assigned thereto in the Acusphere
License Agreement.
"ACUSPHERE LICENSE" has the meaning assigned thereto in the Acusphere
License Agreement.
"ACUSPHERE LICENSE AGREEMENT" shall mean the license agreement between
Acusphere and Newco, of even date herewith, attached hereto in
Schedule 2.
"ACUSPHERE PATENTS" has the meaning assigned thereto in the Acusphere
License Agreement.
"ACUSPHERE SECURITIES PURCHASE AGREEMENT" shall mean that certain
securities purchase agreement, of even date herewith, by and between
Acusphere and EIS.
2
"AFFILIATE" of any Person (in the case of a legal entity) shall mean
any other Person controlling, controlled or under the common control of
such first Person, as the case may be, excluding an Elan JV and an
Acusphere JV. For the purposes of this definition, "control" shall mean
direct or indirect ownership of [CONFIDENTIAL TREATMENT REQUESTED] /*/
or more of the stock or shares entitled to vote for the election of
directors and "controlling" and "controlled" shall be construed
accordingly. For purposes of this Agreement, Newco is not an Affiliate
of Elan or EIS.
"AGREEMENT" shall mean this agreement (which expression shall be deemed
to include the Recitals and the Schedules hereto).
"BOARD" shall mean the board of directors of Newco.
"BUSINESS" shall mean the business operated by Newco, as described in
Clause 2.1 and as more fully specified in the Business Plan.
"BUSINESS PLAN" shall have the meaning set forth in Clause 6 below.
"CHARTER" shall mean the Amended and Restated Certificate of
Incorporation of Acusphere, in the form attached as an Exhibit to the
Securities Purchase Agreement.
"CLOSING DATE" shall mean the date upon which the Definitive Documents
are executed and delivered by the Parties and the transactions effected
thereby are closed.
"COMMERCIALIZATION" shall mean the manufacture, have manufactured,
promotion, distribution, import, use, market, offer for sale and sale
of the Products in accordance with the terms of this Agreement.
"COMMON SHARE EQUIVALENTS" shall mean any options, warrants, rights or
any other securities convertible, exercisable or exchangeable, in whole
or in part, for or into Common Shares.
"COMPOUNDS" shall mean [CONFIDENTIAL TREATMENT REQUESTED]/*/ and such
other active ingredients for the Products as may be nominated by the
Management Committee in accordance with Clause 2 below.
"CONVERTIBLE NOTE" shall mean that certain convertible promissory note,
of even date herewith, by and between Acusphere and EIS.
"DEFINITIVE DOCUMENTS" shall mean this Agreement, the Elan License
Agreement, the Acusphere License Agreement, the Convertible Note, the
Acusphere Securities Purchase Agreement, the Investors Rights
Agreements, the Charter and associated documentation of even date
herewith, by and between Acusphere, Elan, EIS and Newco, as applicable.
3
"DIRECTORS" shall mean, at any time, the directors of Newco.
"EIS DIRECTOR" has the meaning set forth in Clause 5.
"ELAN" shall mean Elan, plc and EPIL.
"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.
"ELAN JV" has the meaning assigned thereto in the Elan License
Agreement.
"ELAN KNOW-HOW" has the meaning assigned thereto in the Elan License
Agreement.
"ELAN LICENSE" has the meaning assigned thereto in the Elan License
Agreement.
"ELAN LICENSE AGREEMENT" shall mean the license agreement between Elan
and Newco, of even date herewith, attached hereto in Schedule 1.
"ELAN PATENTS" has the meaning assigned thereto in the Elan License
Agreement.
"ENCUMBRANCE" shall mean any liens, charges, encumbrances, equities,
claims, options, proxies, pledges, security interests, or other similar
rights of any nature.
"EXCHANGE ACT" shall mean the Securities Exchange Act of 1934, as
amended.
"EXCHANGE AGREEMENT" shall mean the Exchange Agreement of even date
herewith between EIS and Acusphere.
"EXCHANGE RIGHT" has the meaning assigned to such term in the Exchange
Agreement in effect on the Closing Date.
"FDA" shall mean the United States Food and Drug Administration or any
other successor agency in the USA.
"FIELD" shall mean delivery of a specified Compound by a specific Mode
of Administration in a specific device to treat a specific medical
condition, as set
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forth in Clause 2.3 below with respect to [CONFIDENTIAL TREATMENT
REQUESTED] /*/ and as further determined by the unanimous vote of the
Management Committee in accordance with Clause 2 hereof.
"FINANCIAL YEAR" shall mean each year commencing on January 1 (or in
the case of the first Financial Year, the Closing Date) and expiring on
December 31 of each year.
"FULLY DILUTED COMMON SHARES" shall mean all of the issued and
outstanding Common Shares, assuming the conversion, exercise or
exchange of all outstanding Common Share Equivalents.
"INVESTORS RIGHTS AGREEMENT" shall mean the Amended and Restated
Investors Rights Agreement, of even date herewith, among Acusphere, EIS
and other investors in Acusphere.
"LICENSE AGREEMENTS" shall mean the Elan License Agreement and the
Acusphere License Agreement.
"LICENSED TECHNOLOGIES" shall mean, collectively, the Elan Intellectual
Property and the Acusphere Intellectual Property.
"LICENSES" shall mean the Elan License and the Acusphere License.
"MANAGEMENT COMMITTEE" shall have the meaning set forth in Clause 5.2
hereof.
"MODE OF ADMINISTRATION" shall mean administration via the pulmonary
route (a) for local or systemic effect and (b) by immediate or
controlled release.
"NEWCO INTELLECTUAL PROPERTY" shall mean all rights to patents,
know-how and other intellectual property arising out of the conduct of
the Project by any person, including any technology acquired by Newco
from a third party, that relates to the Products and which is not (in
the case of the Compound) or which cannot be segregated into (nor does
it constitute) Elan Intellectual Property or Acusphere Intellectual
Property.
"NEWCO BYE-LAWS" shall mean the Memorandum of Association and Bye-Laws
of Newco Limited.
"PARTICIPANT" shall mean Acusphere or Elan, as the case may be, and
"PARTICIPANTS" shall mean both of the Participants together.
"PARTY" shall mean Elan, Acusphere, or Newco, as the case may be, and
"PARTIES" shall mean all such parties together.
5
"PERSON" shall mean 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" shall mean any Affiliate or subsidiary of Elan,
EIS or Acusphere, to whom this Agreement may be assigned, in whole or
in part, pursuant to the terms hereof or in the case of Elan and EIS, a
special purpose financing entity created by Elan or EIS or their
respective Affiliates.
"PRODUCTS" shall mean formulations of the Compound(s) for use as a
human therapeutic for a specified medical condition.
"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.
"R&D COMMITTEE" shall have the meaning set forth in Clause 5.2 hereof.
"REGISTRATION RIGHTS AGREEMENTS" shall mean the Registration Rights
Agreements of even date herewith relating to Newco and Acusphere,
respectively.
"REGULATORY APPLICATION" shall mean 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" shall mean the final 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" shall mean 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.
"RESEARCH AND DEVELOPMENT PROGRAM" has the meaning set forth in Clause
6.1.
"RESEARCH AND DEVELOPMENT TERM" shall mean the research and development
stage of the Business Plan, which stage shall be deemed terminated upon
the first commercial launch of a Product by Newco.
"SECURITIES ACT" shall mean the Securities Act of 1933, as amended.
"SHARES" shall mean the shares of Common Shares and shares of Preferred
Shares of Newco.
6
"SHAREHOLDER" shall mean any of EIS, Acusphere, any Permitted
Transferee or any other Person who subsequently becomes bound by this
Agreement as a holder of the Shares, and "SHAREHOLDERS" shall mean all
of the Shareholders together.
"TECHNOLOGICAL COMPETITOR OF ELAN" shall have the meaning assigned
thereto in the Elan License Agreement.
"TERM" shall mean the term of this Agreement.
"TERRITORY" shall mean all of the countries of the world.
"UNITED STATES DOLLAR" and "US$" and "$" shall mean 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
"AAA" 18.4
"Closing" 4.3
"Common Shares" Recital
"Confidential Information" 21.1
"Co-sale Notice" 16.4
"Expert" 18.4
"Management Committee" 5.2.1
"Notice of Exercise" 16.3
"Notice of Intention" 16.3
"Offered Shares" 16.3
"Offer Price" 16.3
"Preferred Shares" Recital
"R&D Committee" 5.2.2
"Remaining Shareholders" 16.4
"Relevant Event" 19.2
"Selling Shareholder" 16.3
"Tag-Along Right" 16.4
"Transaction Proposal" 16.3
"Transfer" 16.1
"Transferee Terms" 16.4
"Transferring Shareholder" 16.4
1.3 Words importing the singular shall include the plural and vice versa.
7
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 Definitive Documents, if defined therein.
CLAUSE 2
BUSINESS AND SELECTION OF COMPOUNDS
2.1 The primary objective of the Agreement is to regulate the business of
the development, testing, registration, manufacture, commercialization
and licensing of Products in the Field in the Territory and to achieve
the other objectives set out in this Agreement. The focus of the
Business will be to develop the Products using the Elan Intellectual
Property, the Acusphere Intellectual Property and the Newco
Intellectual Property to agreed-upon specifications and timelines.
2.2 The central management and control of Newco shall be exercised in
Bermuda and shall be vested in the Directors and such Persons as they
may delegate the exercise of their powers in accordance with the Newco
Bye-Laws. The Shareholders agree to conduct the Business in such a
manner as to ensure that Newco is liable to taxation in Bermuda and not
in any other jurisdiction. The Participants shall use their best
endeavors to ensure that to the extent required the sole residence of
Newco in Bermuda, that 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.
2.3 The Parties hereby nominate as a Compound [CONFIDENTIAL TREATMENT
REQUESTED] /*/ for local effect and controlled release using a Mode of
Administration (other than a [CONFIDENTIAL TREATMENT REQUESTED]/*/) to
treat asthma [CONFIDENTIAL TREATMENT REQUESTED]/*/. Subject to Clauses
2.4 and 2.5, the Management Committee shall, by unanimous agreement,
nominate two other Compounds, in addition to [CONFIDENTIAL TREATMENT
REQUESTED]/*/, for development as a
8
Product in a specific device by a specific Mode of Administration to
treat a specific medical condition having regard to the following
criteria:
2.3.1 development cost of each of the Compounds in such Field, as
estimated by the Management Committee;
2.3.2 market potential of each of the Compounds in such Field, as
estimated by the Management Committee;
2.3.3 results of regulatory and intellectual property due diligence
primarily focused on determining whether there are any
regulatory and third party intellectual property issues which
might impact the development and marketing of each of the
Compounds in such Field; and
2.3.4 whether the nominated Compound is subject to contractual
obligations, existing at the date of nomination, of Elan or
Acusphere which would prevent the conduct of the research and
development program or from granting Newco the right to
Commercialize the nominated Compound or which may adversely
affect the scope and/or nature of the rights which could be
granted to Newco and thereby the potential commercial
viability of the nominated Compound.
The Management Committee shall prioritize the research and development
programs with respect to such additional Compounds. If the Management
Committee unanimously determines that the research, development and
Commercialization of a Product would require additional technology
owned or licensed by Elan and/or Acusphere, as the case may be, then
the Parties shall discuss in good faith in-licensing such additional
technology, subject to among other things, third party contractual
obligations. In such case, the Parties shall negotiate in good faith
such amendments as are required to this Agreement.
2.4 The selection of the Compounds or any substitute Compounds shall be
subject to, inter alia, the then existing contractual arrangements of
Elan and Acusphere and such discussions as Elan or Acusphere are having
with one or more third parties at the time of such selection.
[CONFIDENTIAL TREATMENT REQUESTED]/*/ On the date of selection of a
Compound by the Management Committee,
(a) [CONFIDENTIAL TREATMENT REQUESTED]/*/; and
(b) Acusphere shall confirm that the Acusphere
Intellectual Property as it relates to the selected
Compound is not subject to contractual obligations of
Acusphere to an unaffiliated third party; and
provided, however, that if any such contractual obligation exists,
Acusphere and/or
9
Elan, as the case may be, shall prior to the date of selection of the
Compound inform the other of the scope and extent of any such
contractual obligation.
2.5 The Management Committee may determine, by unanimous agreement, that a
Compound should be abandoned by Newco and accordingly deleted from the
list of Compounds to be advanced in the Project where the results of
the regulatory and intellectual property due diligence described in
Clause 2.3.3 reveal regulatory or third party intellectual property
issues which might materially impact the development and
Commercialization of a Compound in the Field.
2.6 Should a Compound fail to meet agreed specifications, the Management
Committee shall terminate the portion of the Project that relates to
such Compound. The Parties shall review in good faith the possibility
of developing one substitute compound, or in-licensing or acquiring the
rights from one or more third parties to one substitute compound,
unless Phase II (as such term is commonly used in connection with FDA
applications) has been initiated with respect to the terminated
Compound; provided that no more than one substituted compound is
contemplated to be considered during the course of this Agreement.
Alternatively, [CONFIDENTIAL TREATMENT REQUESTED]/*/. In either case,
the Parties shall negotiate in good faith such amendments as are
required to this Agreement, such as amending the provisions regulating
non-competition.
CLAUSE 3
REPRESENTATIONS AND WARRANTIES
3.1 REPRESENTATIONS AND WARRANTIES OF NEWCO: Newco hereby represents and
warrants to each of the Shareholders as follows, as of the Closing
Date:
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.
3.1.2 CAPITALIZATION: As of the Closing Date, the authorized capital
stock of Newco consists of 6,000 shares of Common Shares and
6,000 shares of Preferred Shares. Prior to the Closing Date,
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
10
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
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 pre-emptive or any other
similar rights of the Shareholders 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 Closing Date, 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 Definitive 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.
11
3.1.7 NO BUSINESS; NO LIABILITIES: Newco has not conducted any
business or incurred any liabilities or obligations prior to
the Closing Date, except solely in connection with its
organization and formation.
3.2 REPRESENTATIONS AND WARRANTIES OF THE SHAREHOLDERS: Each of the
Shareholders hereby severally represents and warrants to Newco as
follows as of the Closing Date:
3.2.1 ORGANIZATION: Such Shareholder 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 Shareholder 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 Shareholder, 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
Shareholder of this Agreement, purchase of the Shares, and
compliance with the provisions hereof by such Shareholder will
not:
(i) violate any provision of applicable law, statute,
rule or regulation known by and applicable to such
Shareholder or any ruling, writ, injunction, order,
judgment or decree of any court, arbitrator,
administrative agency or other governmental body
applicable to such Shareholder 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 Shareholder or any material
contract to which such Shareholder is a
12
party, except where such violation, conflict or
breach would not, individually or in the aggregate,
have a material adverse effect on such Shareholder;
or
(iii) result in the creation of, any Encumbrance upon any
of the properties or assets of such Shareholder.
3.2.4 APPROVALS: As of the Closing Date, 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 Shareholder.
3.2.5 INVESTMENT REPRESENTATIONS: Such Shareholder is sophisticated
in transactions of this type and capable of evaluating the
merits and risks of its investment in Newco. Such Shareholder
has not been formed solely for the purpose of making this
investment and such Shareholder is acquiring the Common Shares
and Preferred Shares 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
Shareholder 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
Shareholders' representations as expressed herein. Such
Shareholder 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 2,388 shares of
Preferred Shares and (ii) Acusphere of 6,000 shares of Common Shares
and 3,612 shares of Preferred Shares, issuable as provided in Clause
4.3 hereof.
4.2 Acusphere and EIS hereby subscribe for the number of Shares set forth
in Clause 4.1 and shall pay to Newco in consideration therefor, by wire
transfer of immediately available funds (to a bank account established
by Newco in connection with Completion) the subscription amounts each
as provided in Clause 4.4.1.
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4.3 The closing (the "CLOSING") shall take place at the offices of ▇▇▇▇▇▇
▇▇▇▇▇▇ & ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇ on the
Closing Date or such other places if any, as the Parties may agree and
shall occur contemporaneously with the closing under the Acusphere
Securities Purchase Agreement.
4.4 At the Closing, each of the Shareholders shall take or (to the extent
within its powers) cause to be taken the following steps at directors
and shareholder meetings of Newco, or such other meetings or locations,
as appropriate:
4.4.1 Newco shall issue and sell to EIS, and EIS shall purchase from
Newco, upon the terms and subject to the conditions set forth
herein, 2,388 shares of Preferred Shares for an aggregate
purchase price of $2,985,000;
Newco shall issue and sell to Acusphere, and Acusphere shall
purchase from Newco, upon the terms and conditions set forth
herein, (i) 6,000 shares of Common Shares for an aggregate
purchase price of $4,515,000 and (ii) 3,612 shares of
Preferred Shares for an aggregate purchase price of
$7,500,000;
4.4.2 the Parties shall execute and deliver to each other, as
applicable, certificates in respect of the Common Shares and
Preferred Shares described above and any other certificates,
resolutions or documents which the Parties shall reasonably
require;
4.4.3. the adoption by Newco of Newco Bye-Laws;
4.4.4. the appointment of ▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇, and ▇▇▇▇
▇▇▇▇▇▇▇▇▇ as Directors of Newco;
4.4.5. the resignation of all directors and the secretary of Newco
holding office prior to the execution of this Agreement and
delivery of written confirmation under seal by each Person so
resigning that he has no claim or right of action against
Newco and that Newco is not in any way obligated or indebted
to him; and
4.4.6. the transfer to Newco of the share register.
4.5 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:
14
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.
4.6. Newco shall use reasonable efforts to file any documents that require
filing with the Registrar of Companies in Bermuda within the prescribed
time limits. EIS and Acusphere shall provide all reasonable
co-operation to Newco in relation to the matters set forth in this
Clause 4.6.
4.7. In the event that EIS exercises the Exchange Right, Newco shall,
immediately upon such exercise, take all necessary steps to ensure that
EIS is duly and validly issued and has full legal right, title and
interest in and to the shares of Preferred Shares covered thereby.
CLAUSE 5
DIRECTORS; MANAGEMENT AND R&D COMMITTEES
5.1. DIRECTORS:
5.1.1 Prior to the exercise of the Exchange Right, the Board shall
be composed of five Directors.
Acusphere shall have the right to nominate four directors of
Newco, ("ACUSPHERE DIRECTORS") and EIS shall have the right to
nominate one Director of Newco ("EIS DIRECTOR") which
Director, save as further provided herein, shall only be
entitled to 15% of the votes of the Board.
15
In the event that the Exchange Right is exercised by EIS
within (2) years following the Closing Date, the EIS Director
shall only be entitled to 15% of the votes of the Board until
the expiry of (2) years from the Closing Date.
In the event that the Exchange Right is exercised by EIS at
any time after years following the Closing Date or upon the
expiry of (2) years following the Closing Date where the
Exchange Right has been exercised by EIS within two (2) years
following the Closing Date, each of Acusphere, and EIS shall
cause the Board to be reconfigured so that an equal number of
Directors are designated by EIS and Acusphere and that each of
the Directors has equal voting power.
5.1.2 If EIS removes the EIS Director, or Acusphere removes any of
the Acusphere Directors, EIS or Acusphere, as the case may be,
shall indemnify the other Shareholder against any claim by
such removed Director arising from such removal.
5.1.3 The Directors shall meet not less than three times in each
Financial Year and all Board meetings shall be held in
Bermuda.
5.1.4 At any such meeting, the presence of the EIS Director and at
least three of the Acusphere Directors shall be required to
constitute a quorum and, subject to Clause 17 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
Acusphere Directors specifying the date, time and place where
such adjourned meeting is to be held and reconvened.
5.1.5 On the Closing Date, Acusphere may appoint one of the
Acusphere Directors to be the chairman of Newco. Such chairman
of Newco shall hold office until:
(i) the first meeting of the Board following the exercise
by EIS of the Exchange Right, where the Exchange
Right has been exercised by EIS after two years
following the Closing Date; or
(ii) the first meeting of the Board following the expiry
of (2) years following the Closing Date where the
Exchange Right has been exercised by EIS within 2
years following the Closing Date
(in each case the "CHAIRMAN STATUS BOARD MEETING").
16
After the Chairman Status Board Meeting, each of EIS and
Acusphere, beginning with EIS at the Chairman Status Board
Meeting, shall have the right, exercisable alternatively, of
nominating one Director to be chairman of Newco for a term of
one year.
If the chairman is unable to attend any meeting of the Board
held prior to the Chairman Status Board Meeting, the Acusphere
Directors shall be entitled to appoint another Acusphere
Director to act as chairman in his place at the meeting.
If the chairman of Newco is unable to attend any meeting of
the Board held after the Chairman Status Board Meeting, the
Directors shall be entitled to appoint another Director to act
as chairman of Newco in his place at the meeting.
5.1.6 In case of an equality of votes at a meeting of the Board, the
chairman of Newco shall not be entitled to a second or casting
vote. In the event of continued deadlock, the Board shall
resolve the deadlock pursuant to the provisions set forth in
Clause 18.
5.2 MANAGEMENT AND R&D COMMITTEES:
5.2.1 Newco's board of directors shall appoint a management
committee (the "MANAGEMENT COMMITTEE") to consist initially of
four members, two of whom shall be nominated by Elan and two
of whom shall be nominated by Acusphere, and each of whom
shall be entitled to one vote, whether or not present at any
Management Committee meeting. Decisions of the Management
Committee shall require approval of at least one Elan nominee
on the Management Committee and one Acusphere nominee on the
Management Committee.
Each of Elan and Acusphere 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 Acusphere shall be entitled to appoint an
equal number of members to the Management Committee. The
Management Committee shall be responsible for, inter alia,
devising, implementing and reviewing strategy for the Project.
5.2.2 The Management Committee shall appoint a research and
development committee (the "R&D COMMITTEE"), which
shall initially be comprised of four members, two of
whom shall be nominated by Elan and two of whom
17
shall be nominated by Acusphere, and each of whom
shall have one vote, whether or not present at an R&D
Committee meeting during which research and
development issues are discussed. Decisions of the
R&D Committee shall require approval of at least one
Elan nominee on the R&D Committee and one Acusphere
nominee on the R&D Committee.
Each of Elan and Acusphere 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 of Newco provided that each of Elan and
Acusphere shall be entitled to appoint an equal
number of members to the R&D Committee.
5.2.3 The R&D Committee shall be responsible for:
(a) designing the Research and Development
Program for consideration by the Management
Committee;
(b) if deemed advisable, establishing a joint
Project team consisting of an equal number
of team members from Elan and Acusphere,
including one Project leader from each of
Elan and Acusphere; and
(c) implementing the Research and Development
Program as approved by the Management
Committee.
5.2.4 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 the
matter, the dispute will be referred to a designated
senior officer of each of Elan and Acusphere, and
thereafter, in the event of continued deadlock,
pursuant to the deadlock provisions to be set forth
in Clause 18. This process shall also apply to any
dispute within the Management Committee.
CLAUSE 6
THE BUSINESS PLAN AND REVIEWS
6.1 The Directors shall meet together as soon as reasonably practicable
after the Closing Date and shall agree upon and approve the Business
Plan for the current Financial Year within 180 days of the Closing
Date. The Business Plan shall contain, among other things, a research
and development program (the "RESEARCH AND DEVELOPMENT PROGRAM") which
shall include to the extent practicable, the
18
research and development objectives, desired Product specifications,
clinical indications, preliminary clinical trial designs (Phase I/II),
development timelines, budgeted costs and the relative responsibilities
of Acusphere and Elan as it relates to the implementation of the
Research and Development Program.
6.2. The Business Plan shall be subject to ongoing review by the Directors
and the approval of the EIS Director and the Acusphere Directors on a
quarterly basis.
6.3. Neither Participant shall be obliged to provide subsequent funding to
Newco in the absence of quarterly approval of the Business Plan and a
determination by each Participant, in its sole discretion
(notwithstanding Clause 17.2 below), that Development Funding (as such
term is defined in the Securities Purchase Agreement) shall be provided
for the development of the Products in accordance with the terms of the
Securities Purchase Agreement.
CLAUSE 7
RESEARCH AND DEVELOPMENT WORK
7.1 Subject to the provisions of Clause 6.3, Acusphere and Elan shall
provide at their respective discretion such research and development
services as is requested by Newco and as articulated in the Business
Plan. Newco shall pay Acusphere and Elan for any research and
development work carried out by them on behalf of Newco [CONFIDENTIAL
TREATMENT REQUESTED]/*/ during the Research and Development Program
developed by the R&D Committee and approved by the Management
Committee, subject to the proper vouching of research and development
work and expenses. An invoice shall be issued to Newco by Acusphere or
Elan, as applicable, [CONFIDENTIAL TREATMENT REQUESTED]/*/ following
the [CONFIDENTIAL TREATMENT REQUESTED]/*/ in which work was performed.
The payments by Newco to Acusphere or Elan in carrying out such
research and development work shall be calculated by reference to the
fully allocated costs thereof incurred by Acusphere and Elan calculated
in accordance with generally accepted accounting principles
consistently applied plus [CONFIDENTIAL TREATMENT REQUESTED]/*/, or
[CONFIDENTIAL TREATMENT REQUESTED]/*/ FTE rate agreed to by the
unanimous vote of the Management Committee. Research and development
activities that are outsourced to third party providers shall be
charged to Newco at fully burdened actual costs.
7.2 Elan and Acusphere 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 Acusphere and any other book, record, voucher,
receipt or invoice relating to the calculation or the
19
cost of the Research and Development Program and to the accuracy of the
reports which accompanied them. Any such inspection of Elan's or
Acusphere'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 Acusphere, as the case may be, for the Research
and Development Program hereunder in any Financial Year of 5% or more
of the amount due to Elan or Acusphere, as the case may be, then the
expense of such inspection shall be borne solely by Elan or Acusphere,
as the case may be, instead of by Newco. Any surplus over the sum
properly payable by Newco to Elan or Acusphere, as the case may be,
shall be paid promptly by Elan or Acusphere, as the case may be, to
Newco. If such inspection reveals a deficit in the amount of the sum
properly payable to Elan or Acusphere, as the case may be, by Newco,
Newco shall pay the deficit to Elan or Acusphere, as the case may be.
CLAUSE 8
COMMERCIALIZATION
8.1 Newco shall diligently pursue the research, development, prosecution
and Commercialization of the Products as provided in the Business Plan.
At such time as Newco notifies Elan in writing that Newco in good faith
intends to Commercialize a Product (other than to manufacture or have
manufactured the Product which is the subject of Clause 13 below),
Elan, plc or any Affiliate of Elan shall have a first option to
negotiate the terms of any agreement for the Commercialization of such
Product (the "ELAN OPTION PRODUCT"), which option shall be exercised
within [CONFIDENTIAL TREATMENT REQUESTED/*/ of Elan's receipt of such
written notification from Newco (the "ELAN/NEWCO OPTION"). If Elan
elects to enter into such negotiations, the Participants shall
negotiate in good faith the terms of an applicable agreement that would
grant Elan such Commercialization rights.
If, despite good faith negotiations, Elan, plc or the relevant
Affiliate and Newco do not reach agreement within [CONFIDENTIAL
TREATMENT REQUESTED]/*/ from Elan's exercise of the Elan/Newco Option
(the "PERIOD OF NEGOTIATION"), then Newco shall be free to enter into
negotiations with a third party (other than a Technological Competitor
Of Elan) to agree terms upon which such third party would Commercialize
the relevant Product in the Territory, which terms when taken as a
whole, are not more favorable to the third party than the principal
terms of the last written proposal offered by Newco to Elan, plc or the
relevant Affiliate or by Elan, plc or the relevant Affiliate to Newco,
as the case may be. The definitive agreement between Newco and such
third party to Commercialize the relevant Product in the Territory
shall be subject to the written approval of the
20
Participants, which approval shall not to be unreasonably withheld or
delayed, and which approval shall be further subject to the last
paragraph of this Clause 8.1.
Acusphere, acting on behalf of Newco, shall have the right to initiate
negotiations with a third party (other than a Technological Competitor
Of Elan) during the Period of Negotiation but Newco may not enter into
an agreement for Commercialization until such Period of Negotiation has
terminated.
If (i) the Product that is the subject of such Elan/Newco Option
relates to a therapeutic area in which Elan, plc and/or its Affiliates
have a marketing or sales presence and (ii) Newco has not entered into
an agreement with a third party within [CONFIDENTIAL TREATMENT
REQUESTED]/*/ from the expiration of the Period of Negotiation, then
the Elan/Newco Option shall be deemed to have re-commenced upon the
same terms as set forth herein but with a [CONFIDENTIAL TREATMENT
REQUESTED]/*/ option period as opposed to the initial [CONFIDENTIAL
TREATMENT REQUESTED]/*/ Period of Negotiation.
Newco and the Acusphere Directors and EIS Director shall use their
respective good faith and reasonable business judgement in the best
interest of Newco when negotiating, agreeing and approving terms for
the Commercialization of the Products.
CLAUSE 9
OWNERSHIP OF INTELLECTUAL PROPERTY RIGHTS/NON-COMPETITION
9.1. The Parties acknowledge and agree to be bound by the provisions of
Clause 3 of the Elan License Agreement and Clause 3 of the Acusphere
License Agreement which set forth the agreement between the parties
thereto in relation to the ownership of the Elan Intellectual Property,
the Acusphere Intellectual Property and the Newco Intellectual property
respectively.
9.2 The Parties acknowledge and agree to be bound by the provisions of
Clause 4 of the Elan License Agreement and the provisions of Clause 4
of the Acusphere License Agreement which set forth the agreement
between the parties thereto in relation to the non-competition
obligations of Elan and Acusphere, respectively.
CLAUSE 10
INTELLECTUAL PROPERTY RIGHTS
10.1 Elan, [CONFIDENTIAL TREATMENT REQUESTED]/*/ sole discretion
[CONFIDENTIAL TREATMENT REQUESTED]/*/ (i) secure the grant of any
patent applications within the Elan Patents that relate to the Field;
(ii) file and
21
prosecute patent applications on patentable inventions and discoveries
within the Elan Improvements that relate to the Field; (iii) defend all
such applications against third party oppositions; and (iv) maintain in
force any issued letters patent within the Elan Patents that relate to
the Field (including any letters patent that may issue covering any
such Elan Improvements that relate to the Field). Elan shall have the
right in its sole discretion to control such filing, prosecution,
defense and maintenance provided that Newco and Acusphere at their
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.
10.2 Acusphere, [CONFIDENTIAL TREATMENT REQUESTED]/*/ and sole discretion,
[CONFIDENTIAL TREATMENT REQUESTED]/*/ (i) secure the grant of any
patent applications within the Acusphere Patents that relate to the
Field; (ii) file and prosecute patent applications on patentable
inventions and discoveries within the Acusphere Improvements that
relate to the Field; (iii) defend all such applications against third
party oppositions; and (iv) maintain in force any issued letters patent
within the Acusphere Patents that relate to the Field (including any
letters patent that may issue covering any such Acusphere Improvements
that relate to the Field). Acusphere shall have the right in its sole
discretion to control such filing, prosecution, defense and maintenance
provided that Elan and Newco at their 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.
10.3 In the event that Elan does not intend to file for patent protection on
patentable inventions or discoveries within the Elan Intellectual
Property that relates to the Field in one or more countries in the
Territory after providing written notice to Newco and Acusphere, Newco
shall have the option [CONFIDENTIAL TREATMENT REQUESTED]/*/, upon the
prior written approval of Elan which approval shall not be unreasonably
withheld, to request Elan to file and prosecute such patent
application(s) jointly on behalf of Newco and Acusphere. Upon such
written request from Newco, Elan shall be responsible for preparing and
prosecuting and otherwise seeking patent protection for such Elan
Intellectual Property described in this Clause 10.3. Any such Elan
Intellectual Property shall be owned by Elan but Elan shall grant to
Newco a royalty free exclusive license to such Elan Intellectual
Property in the Field. The Parties shall have the right to remove their
confidential information from any such patent application.
10.4 In the event that Acusphere does not intend to file for patent
protection on patentable inventions or discoveries within the Acusphere
Intellectual Property that relates to the Field in one or more
countries in the Territory after providing written notice to Newco and
Elan, Newco shall have the option [CONFIDENTIAL TREATMENT
REQUESTED]/*/, upon the prior written approval of Acusphere
22
which approval shall not be unreasonably withheld, to request Acusphere
to file and prosecute such patent application(s) jointly on behalf of
Newco and Elan. Upon such written request from Newco, Acusphere shall
be responsible for preparing and prosecuting and otherwise seeking
patent protection for such Acusphere Intellectual Property described in
this Clause 10.4. Any such Acusphere Intellectual Property shall be
owned by Acusphere but Acusphere shall grant a royalty free exclusive
license to Newco to such Acusphere Intellectual Property in the Field.
The Parties shall have the right to remove their confidential
information from any such patent application.
10.5 Newco [CONFIDENTIAL TREATMENT REQUESTED]/*/ shall have the right but
shall not be obligated (i) to file and prosecute patent applications on
patentable inventions and discoveries within the Newco Intellectual
Property; (ii) to defend all such applications against third party
oppositions; and (iii) to maintain in force any issued letters patent
within the Newco Patents (including any patents that issue on
patentable inventions and discoveries within the Newco Intellectual
Property). Newco shall have the right to control such filing,
prosecution, defense and maintenance provided that the other Parties
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. The Parties shall have
the right to remove their confidential information from any such patent
application.
10.6 In the event that Newco informs both Elan and Acusphere that it does
not intend to file an application on the Newco Intellectual Property in
or outside the Field, Elan shall have the right to file and prosecute
such patent applications on inventions that Elan invents solely or
which relate predominantly to the Elan Intellectual Property, and
Acusphere shall have the right to file and prosecute such patent
applications on inventions which Acusphere invents solely or which
relate predominantly to the Acusphere Intellectual Property, and Elan
and Acusphere agree to negotiate in good faith on the course of action
to be taken with respect to Newco inventions that relate to both the
Elan and Acusphere Intellectual Property. The Parties shall have the
right to remove their confidential information from any such patent
application.
10.7 The Parties shall promptly inform each other in writing of any actual
or alleged unauthorized use of any Elan Intellectual Property, the
Acusphere Intellectual Property or the Newco Intellectual Property by a
third party of which it becomes aware and provide the others with any
available evidence of such unauthorized use.
10.8 At its option, as the case may be, Elan or Acusphere shall have the
first option to enforce [CONFIDENTIAL TREATMENT REQUESTED]/*/ for its
own benefit any unauthorized use of its respective Intellectual
Property (the Elan Intellectual
23
Property or the Acusphere Intellectual Property as the case may be) in
the Field. At the enforcing party's request, the other Parties shall
cooperate with such action. Should Elan or Acusphere decide not to
enforce the Elan Intellectual Property or the Acusphere Intellectual
Property respectively, against such unauthorized use in the Field,
within a reasonable period but in any event within twenty (20) days
after receiving written notice of such actual or alleged unauthorized
use, Newco may in its discretion initiate such proceedings in its own
name, [CONFIDENTIAL TREATMENT REQUESTED]/*/ for its own benefit, and at
such Party's request, Elan and Acusphere shall cooperate with such
action. Any recovery remaining after the deduction by Newco
[CONFIDENTIAL TREATMENT REQUESTED]/*/ shall belong to Newco.
Alternatively, the Parties may agree to institute such proceedings in
their joint names and shall reach agreement as to the proportion in
which they shall share the proceeds of any such proceedings
[CONFIDENTIAL TREATMENT REQUESTED]/*/.
10.9 Newco shall have the first right but not the obligation to bring suit
or otherwise take action against any unauthorized use of the Newco
Intellectual Property. If any such alleged use occurs that gives rise
to a cause of action both inside and outside the Field, Newco, in
consultation with the other Parties, shall determine the course of
action to be taken. In the event that Newco takes such action, Newco
shall do so [CONFIDENTIAL TREATMENT REQUESTED]/*/ and all damages and
monetary award recovered in or with respect to such action shall be the
property of Newco. Newco shall keep Elan and Acusphere informed of any
action in a timely manner so as to enable Acusphere and Elan to provide
input in any such action and Newco shall reasonably take into
consideration any such input. At Newco's request, the Parties shall
cooperate with any such action [CONFIDENTIAL TREATMENT REQUESTED]/*/.
10.10 In the event that Newco does not bring suit or otherwise take action
against any unauthorized use of the Newco Intellectual Property (i) if
only one Participant determines to pursue such suit or take such action
[CONFIDENTIAL TREATMENT REQUESTED]/*/, it shall be entitled to all
damages and monetary award recovered in or with respect to such action
[CONFIDENTIAL TREATMENT REQUESTED]/*/. At the Participant's request,
Newco shall cooperate with any such action [CONFIDENTIAL TREATMENT
REQUESTED]/*/.
10.11 In the event that a claim or proceeding is brought against Newco by a
third party alleging that the sale, distribution or use of a Product in
the Territory constitutes the unauthorized use of the intellectual
property rights of such Party, Newco shall promptly advise the other
Parties of such threat or suit.
10.12 Save in respect of claims by Newco against either Party or by a third
party against Newco where there has been a breach of representation or
warranty under Clause 7
24
of either of the License Agreements by Elan or Acusphere, as the case
may be, Newco shall indemnify, defend and hold harmless Elan or
Acusphere, as the case may be, 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 10.11, provided that Elan or Acusphere, as the
case may be, shall not acknowledge to the third party or to any other
person or entity 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 to Newco, not to be
unreasonably withheld or delayed. [CONFIDENTIAL TREATMENT
REQUESTED]/*/.
CLAUSE 11
CROSS LICENSING/EXPLOITATION OF PRODUCTS OUTSIDE THE FIELD
11.1 Solely for the purpose of and insofar as is necessary, in each case,
for Elan to conduct research and development work on behalf of Newco,
Newco hereby grants to Elan a non-exclusive, worldwide, royalty-free,
fully paid-up license for the term of the Licenses:
11.1.1 to use the Newco Intellectual Property in the Field, and
11.1.2 subject to the terms and conditions of the Acusphere License,
a sublicense to use the Acusphere Intellectual Property in the
Field.
11.2 Solely for the purpose of and insofar as is necessary, in each case,
for Acusphere to conduct research and development work on behalf of
Newco, Newco hereby grants to Acusphere a non-exclusive, worldwide,
royalty-free, fully paid-up license for the term of the Licenses:
11.2.1 to use the Newco Intellectual Property in the Field, and
11.2.2 subject to the terms and conditions of the Elan License, a
sublicense to use the Elan Intellectual Property in the Field.
11.3 Elan and Acusphere, as the case may be, shall be entitled to exploit
the Newco Intellectual Property outside the Field subject to the
Parties negotiating a license agreement in good faith (including all
material provisions thereof, including as to whether the license should
be exclusive or non-exclusive), pursuant to which Newco will grant Elan
or Acusphere, as the case may be, a license under the Newco
Intellectual Property outside the Field. The financial terms of the
said license agreement shall have regard, inter alia, to:
25
11.3.1 the amount of monies expended by Newco in developing the Newco
Intellectual Property;
11.3.2 the materiality of the contribution of the Newco Intellectual
Property by comparison to the further research and development
work to be conducted, and of the Elan Intellectual Property
and the Acusphere Intellectual Property; and
11.3.3 the financial return likely to be earned by Elan or Acusphere,
as the case may be, from the proposed exploitation outside the
Field; and
11.3.4 the impact of the proposed exploitation of the Newco
Intellectual Property outside the Field on the exploitation of
the Newco Intellectual Property within the Field.
CLAUSE 12
REGULATORY
12.1 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.
12.2 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.
12.3 Subject to Clauses 12.5 and 12.6, any and all Regulatory Approvals
obtained hereunder for any Product shall remain the property of Newco,
provided that Newco shall allow Elan and Acusphere access thereto to
enable Elan and Acusphere to fulfill their respective obligations and
exercise their respective rights under this Agreement. Newco shall
maintain such Regulatory Approvals at its own cost.
12.4 It is hereby acknowledged that there are inherent uncertainties
involved in the registration of pharmaceutical products with the RHA's
insofar as obtaining approval is concerned and such uncertainties form
part of the business risk involved in undertaking the form of
commercial collaboration as set forth in this Agreement.
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12.5 All regulatory approvals and the DMF (Drug Master File) relating to
[CONFIDENTIAL TREATMENT REQUESTED]/*/ shall be processed by and be the
property of Elan and at all times held in Elan's sole name. Elan will
authorize Newco to reference Elan's DMF, as described herein, with the
FDA to the extent necessary for Newco's regulatory purposes.
12.6 All regulatory approvals and the DMF (Drug Master File) relating to
[CONFIDENTIAL TREATMENT REQUESTED]/*/ shall be processed by and be the
property of Acusphere and at all times held in Acusphere's sole name.
Acusphere will authorize Newco to reference Acusphere's DMF, as
described herein, with the FDA to the extent necessary for Newco's
regulatory purposes.
CLAUSE 13
MANUFACTURING
13.1 Subject to Clause 13.2, Newco shall be responsible for manufacturing,
or having manufactured, all quantities of Products required for the
development and Commercialization of Products for use in the Field.
13.2 Notwithstanding the provisions of Clause 13.1, it is the expectation of
the Parties that Newco shall enter into a supply agreement with Elan or
Acusphere or a third party (other than a Technological Competitor of
Elan), as the case may be, to allow for the commercial production of
the Products on behalf of Newco, provided however, that Elan shall have
the first right to manufacture and supply, and/or subcontract the
manufacture and supply, of [CONFIDENTIAL TREATMENT REQUESTED]/*/ which
are incorporated in the Products. In determining which of Elan or
Acusphere or a third party shall provide such services, the Management
Committee shall, in good faith, consider the respective infrastructure
and experience of Elan, Acusphere and the relevant third parties.
13.3 The terms of the said supply agreements shall be on normal commercial
terms, and shall be negotiated in good faith by the Parties thereto.
CLAUSE 14
TECHNICAL SERVICES AND ASSISTANCE
14.1 Whenever commercially and technically feasible, Newco shall contract
with Acusphere 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 Acusphere. There shall be no obligation upon either of
Acusphere or Elan to perform such services.
27
14.2 Newco shall, if the Participants so agree, conclude an administrative
support agreement with Elan and/or Acusphere on such terms as the
Parties thereto shall in good faith negotiate. Such service agreement
shall include, among other things, a right of 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 books and records of Elan or Acusphere, as applicable, relating to
such administrative services provided on behalf of Newco. Any such
inspection of Elan's or Acusphere's records, as the case may be, shall
be [CONFIDENTIAL TREATMENT REQUESTED]/*/. The administrative services
shall include one or more of the following administrative services as
requested by Newco:
14.2.1 accounting, financial and other services;
14.2.2 tax services;
14.2.3 insurance services;
14.2.4 human resources services;
14.2.5 legal and company secretarial services;
14.2.6 patent and related intellectual property services; and
14.2.7 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.
14.3. The Parties agree that each Party shall effect and maintain
comprehensive general liability insurance in respect of all clinical
trials and other activities performed by them on behalf of Newco. The
Participants and Newco shall ensure that the industry standard
insurance policies shall be in place for all activities to be carried
out by Newco.
14.4 If Elan or Acusphere so requires, Acusphere 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
Acusphere Intellectual Property, as the case may be, as necessary to
further the Project.
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14.5 The employees received by Elan or Acusphere, as the case may be, shall
be subject to obligations of confidentiality no less stringent than
those set out in Clause 21 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 15
AUDITORS, BANKERS, ACCOUNTING REFERENCE DATE; SECRETARY
15.1 Unless otherwise agreed by the Participants and save as may be provided
to the contrary herein:
15.1.1 the auditors of Newco shall be KMPG Peat Marwick of Vallis
Building, Hamilton, Bermuda;
15.1.2 the Participants shall have the right of access for each
Participant's authorized auditors (reasonably acceptable to
the other Participant and subject to the confidentiality
undertakings hereunder) to audit the books and records of
Newco during regular business hours and upon reasonable prior
written notice;
15.1.3 the bankers of Newco shall be Bank of Bermuda or such other
bank as may be mutually agreed from time to time;
15.1.4 the accounting reference date of Newco shall be December 31st
in each Financial Year; and
15.1.5 the secretary of Newco shall be I.S. ▇▇▇▇▇▇▇▇▇▇▇ or such other
Person as may be appointed by the Directors from time to time.
CLAUSE 16
TRANSFERS OF SHARES;
RIGHT OF FIRST OFFER; TAG ALONG RIGHTS
GENERAL:
16.1. Until such time as the Common Shares shall be registered pursuant to
the Exchange Act and be publicly traded in an established securities
market, no Shareholder shall, directly or indirectly, sell or otherwise
transfer (each, a "TRANSFER") any Shares held by it except in as
expressly permitted by and accordance with the terms of this Agreement.
Newco shall not, and shall not permit any transfer agent or registrar
for any Shares to, transfer upon the books of
29
Newco any Shares from any Shareholder 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.
During the Research and Development Term, no Shareholder shall,
directly or indirectly, sell or otherwise Transfer any of its legal
and/or beneficial interest in the Shares held by it to any other
Person. After completion of the Research and Development Term, a
Shareholder may Transfer Shares provided such Shareholder complies with
the provisions of Clauses 16.2, 16.3 and 16.4.
Notwithstanding anything contained herein to the contrary, at all
times, EIS and/or Acusphere shall have the right to Transfer any Shares
to a Permitted Transferee of such Party, provided, however, that such
Transfer does not result in adverse tax consequences for any other
Parties and that such Permitted Transferee to which such legal and/or
beneficial interest in the Shares have been transferred shall agree to
be expressly subject to and bound by all the limitations and provisions
which are embodied in this Agreement.
16.2 No Shareholder shall, except with the prior written consent of the
other Shareholder, create or permit to subsist any Encumbrance in all
or any of the Shares held by it (other than by a Transfer of such
Shares in accordance with the provisions of this Agreement).
16.3 RIGHTS OF FIRST OFFER:
If at any time after the end of the Research and Development Term a
Shareholder shall desire to Transfer any Shares owned by it (a "SELLING
SHAREHOLDER"), in any transaction or series of related transactions
other than a Transfer to a Permitted Transferee, then such Selling
Shareholder shall deliver prior written notice of its desire to
Transfer (a "NOTICE OF INTENTION") (i) to Newco and (ii) to the
Shareholders who are not the Selling Shareholder (and any transferee
thereof permitted hereunder, if any), as applicable, setting forth such
Selling Shareholder'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, if any, and the
price at which such Selling Shareholder proposes to Transfer the
Offered Shares (the "OFFER PRICE"). The "Right of First Offer" provided
for in this Clause 16 shall be subject to any "Tag Along Right"
benefiting a Shareholder which may be provided for by Clause 16.4,
subject to the exceptions set forth therein.
Upon receipt of the Notice of Intention, the Shareholders who are not
the Selling Shareholder shall have the right to purchase at the Offer
Price the Offered Shares, exercisable by the delivery of notice to the
Selling Shareholder (the "NOTICE OF EXERCISE"), with a copy to Newco,
within 10 business days from the date of receipt
30
of the Notice of Intention. If no such Notice of Exercise has been
delivered by the Shareholders who are not the Selling Shareholder
within such 10-business day period, or such Notice of Exercise does not
relate to all of the Offered Shares covered by the Notice of Intention,
then the Selling Shareholder 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 Shareholders, the
Selling Shareholder 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
Shareholders. If such sale does not occur, the Offered Shares shall
again be subject to the Right of First Offer set forth in Clause 16.3.
In the event that any of the Shareholders who are not the Selling
Shareholder exercises their right to purchase all of the Offered Shares
(in accordance with this Clause 16), then the Selling Shareholder shall
sell all of the Offered Shares to such Shareholder(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
Shareholders who are not the Selling Shareholders wish to purchase the
Offered Shares, the Offered Shares shall be allocated to such
Shareholders on the basis of their pro rata equity interests in Newco.
The rights and obligations of each of the Shareholders pursuant to the
Right of First Offer provided herein shall terminate upon the date that
the Common Shares 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
Shareholders who are not the Selling Shareholder (scheduled in
accordance with Clause 16), the Selling Shareholder shall deliver
certificates evidencing the Offered Shares being sold, duly endorsed,
or accompanied by written instruments of transfer in form reasonably
satisfactory to the Shareholders who are not the Selling Shareholder,
duly executed by the Selling Shareholder, 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.
16.4 TAG ALONG RIGHTS:
Subject to Clause 16.3, a Shareholder (the "TRANSFERRING SHAREHOLDER")
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 Shareholders (the
"REMAINING SHAREHOLDERS"), to sell Shares at the same price and on the
same terms and conditions as the Transferring Shareholder has agreed to
sell its Shares (the "TAG ALONG Right").
31
In the event a Transferring Shareholder proposes to Transfer any Shares
in a transaction subject to this Clause 16.4, it shall notify, or cause
to be notified, the Remaining Shareholders 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 16, if such right is applicable, and the total
number of Shares the transferee has agreed to purchase from the
Shareholders in accordance with the terms hereof.
The Tag Along Right may be exercised by each of the Remaining
Shareholders by delivery of a written notice to the Transferring
Shareholder (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
Shareholder which the Remaining Shareholder wishes to include in such
Transfer; provided, however, that without the written consent of the
Transferring Shareholder, the amount of such securities belonging to
the Remaining Shareholder included in such Transfer may not be greater
than such Remaining Shareholder's percentage beneficial ownership of
Common Share Equivalents multiplied by the total number of shares of
Common Share Equivalents to be sold by both the Transferring
Shareholder and all Remaining Shareholders. Upon receipt of a Co-sale
Notice, the Transferring Shareholder 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 Shareholder shall not consummate the purchase and sale of
any Shares hereunder if the transferee does not purchase all such
Shares specified in all Co-sale Notices. If no Co-sale Notice has been
delivered to the Transferring Shareholder 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
Shareholder 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
Shareholders of the proposed Transfer and complying with the
requirements of this Clause 16.
At the closing of any Transfer of Shares subject to this Clause 16, the
Transferring Shareholder, and the Remaining Shareholder, in the event
such Tag 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.
32
Notwithstanding the foregoing, this Clause 16 shall not apply to any
sale of Common Shares pursuant to an effective registration statement
under the Securities Act in a bona fide public offering.
CLAUSE 17
MATTERS REQUIRING SHAREHOLDERS' APPROVAL
17.1 In consideration of Acusphere and Elan agreeing to enter into the
License Agreements, the Parties hereby agree that Newco shall not
without the prior approval of the EIS Director and the Acusphere
Directors:
17.1.1. make a material Newco determination outside the ordinary
course of business, including, among other things,
acquisitions or dispositions of intellectual property and
licenses or sublicenses as they relate to the Licensed
Technologies, enter into joint ventures and similar
arrangements as they relate to the Licensed Technologies;
17.1.2. issue any unissued Shares or unissued Common Share
Equivalents, or create or issue any new shares (including a
split of the Shares) or Common Share Equivalents, except as
expressly permitted by the Newco Bye-Laws;
17.1.3. alter any rights attaching to any class of share in the
capital of Newco or alter the Newco Bye-Laws;
17.1.4. consolidate, sub-divide or convert any of Newco's share
capital or in any way alter the rights attaching thereto;
17.1.5. dispose of all or substantially all of the assets of Newco;
17.1.6. 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;
17.1.7. enter into any contract or transaction except in the ordinary
and proper course of the Business on arm's length terms;
17.1.8. subject to Clause 23.13, assign, license or sub-license any of
the Elan Intellectual Property, Acusphere Intellectual
Property, Newco Intellectual Property, except in connection
with a commercialization agreement or manufacturing agreement
adopted in accordance with the provisions of the Agreement;
33
17.1.9. amend or vary the terms of the Acusphere License Agreement or
the Elan License Agreement;
17.1.10 permit a person other than Newco to own a regulatory approval
relating to the Product(s);
17.1.11 amend or vary the Business Plan or the Newco budget as they
relate to the Licensed Technologies;
17.1.12 alter the number of Directors
17.1.13 change the domicile of Newco from, or discontinue Newco out
of, Bermuda;
17.1.14 register any Shares of Newco for public trading with any
governmental authority for public trading in any securities
market; and
17.1.15 declare or pay any dividend or make any distribution, directly
or indirectly, with respect to its capital stock; or issue,
sell, exchange, deliver, redeem, purchase or otherwise acquire
or dispose of any shares of its capital stock or other
securities.
17.2 [CONFIDENTIAL TREATMENT REQUESTED]/*/
CLAUSE 18
DISPUTES
18.1 Should any dispute or difference arise between Elan and Acusphere, or
between Elan or Acusphere and Newco or among the Newco Directors or
Management Committee such that a majority or (if required) unanimous
decision cannot be made, during the period that this Agreement is in
force, then any Party may forthwith give notice to the other Parties
that it wishes such dispute or difference to be referred to a
designated senior officer of each of Elan and Acusphere.
18.2 In any event of a notice being served in accordance with Clause 18.1,
each of the Participants shall within 14 days of the service of such
notice prepare and circulate to the designated senior officer of each
of Elan and Acusphere a memorandum or
34
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 designated senior officers of each
of Elan and Acusphere who shall endeavor to resolve the dispute using
good faith and diligent efforts. If designated senior officers of each
of Elan and Acusphere 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 procure that the agreed terms are fully and promptly carried into
effect.
18.3 In the event the designated senior officers of each of Elan and
Acusphere are unable to resolve a dispute or difference when it is
referred to them under Clause 18.1, within sixty (60) days, the
following procedures shall apply:
18.3.1 If the dispute relates to (i) the interpretation of this
Agreement or any other Definitive Document or the compliance
of the Parties with their legal obligations thereunder, (ii)
the interpretation or application of law, or (iii) the
ownership of any intellectual property, then the provisions of
Clause 23.8 shall govern.
18.3.2 If the dispute does not relate to the matters described in
Clause 18.3.1, then the provisions of Clause 18.4 shall
govern.
18.4 The designated senior officers of each of Elan and Acusphere shall, if
they are unable to resolve a dispute or difference when it is referred
to them under Clause 18.1, within sixty (60) days of such referral,
refer the matter to an independent expert in pharmaceutical product
development and marketing (including clinical development and
regulatory affairs) jointly selected by the designated senior officers
of each of Elan and Acusphere (the "EXPERT").
In the event the designated senior officers of each of Elan and
Acusphere cannot agree upon the designation of the Expert, the
Participants shall request the American Arbitration Association
("AAA"), sitting in the City of New York to select the Expert. 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
designated senior officers of each of Elan and Acusphere, the following
rules shall apply to the appointment of the Expert. The fees of the AAA
and the Expert shall be shared equally by the Participants. 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
35
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.
18.5 Any determination by the Expert of a dispute or difference shall not be
binding on the Parties.
CLAUSE 19
TERMINATION
19.1 This Agreement shall govern the operation and existence of Newco until
19.1.1 terminated by written agreement of all Parties hereto; or
19.1.2 otherwise terminated in accordance with this Clause 19.
19.2 For the purpose of this Clause 19, a "RELEVANT EVENT" is committed or
suffered by a Participant if:
19.2.1 it commits a breach of its material obligations under this
Agreement or the applicable License Agreement and fails to
cure 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 cure the breach and is acting in good faith to cure
same but has not cured the breach by the 60th day, such period
shall be extended by such period as is reasonably necessary to
permit the breach to be cured, provided that such period shall
not be extended by more than 90 days, unless otherwise agreed
in writing by the Participants; or
19.2.2 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; or
19.2.3 it is unable to pay its debts in the normal course of
business; or
19.2.4 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); or
19.2.5 the appointment of a liquidator, receiver, administrator,
examiner, trustee or similar officer of such Participant or
over all or substantially all of its
36
assets under the law of any applicable jurisdiction, including
without limitation, the United States of America, Bermuda or
Ireland; or
19.2.6 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 of its assets,
rights or revenues or the assets and/or the business of a
Participant are for any reason seized, confiscated or
condemned.
19.3 If either Participant commits or suffers a Relevant Event, the other
Participant shall have in addition to all other legal and equitable
rights and remedies hereunder, the right to terminate this Agreement
upon 30 days' written notice.
19.4 In the event of a termination of the Elan License Agreement and/or the
Acusphere 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.
19.5 The provisions of Clauses 1 (Definitions), 3 (Representations), 9
(Ownership of Intellectual Property), 10.11 and 10.12 (Intellectual
Property Rights), 11.3, 12.3, 12.5, 12.6 (Regulatory Approval), 16
(Transfer Restrictions), 17 (Shareholders' Veto Rights), 18 (Disputes),
19 (Termination), 20 (Share Rights), 21 (Confidentiality), 22.2 (Costs)
and 23 (General) shall survive the termination of this Agreement under
this Clause 19; all other terms and provisions of this Agreement shall
cease to have effect and be null and void upon the termination of this
Agreement.
CLAUSE 20
SHARE RIGHTS
The provisions regulating the rights and obligations attaching to the Common
Shares and the Preferred Shares are set out in the Newco Bye-laws.
CLAUSE 21
CONFIDENTIALITY
21.1 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,
37
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
Acusphere 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").
21.2 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:
21.2.1 information that is generally available to the public;
21.2.2 information that is made public by the disclosing Party;
21.2.3 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;
21.2.4 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;
21.2.5 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
21.2.6 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
21.2.7 information that is the subject of a written permission to
disclose, without restriction or limitation, by the disclosing
Party.
21.3 The receiving Party will be entitled to disclose Confidential
Information which the receiving Party is required to disclose pursuant
to:
38
21.3.1 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; or
21.3.2 any 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.
21.4 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 confidentiality
terms and provisions of this Agreement and their duties hereunder and
to obtain their consent hereto as a condition of receiving Confidential
Information. Each Party agrees that it will exercise the same degree of
care 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 (except to the extent
such Confidential Information is required to exercise a Party's rights
under this Agreement or License Agreements). Each Party shall promptly
notify the other Parties upon discovery of any unauthorized use or
disclosure of the other Parties' Confidential Information.
21.5 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
39
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.
21.6 Any breach of this Clause 21 by any employee, representative or agent
of a Party is considered a breach by the Party itself.
21.7 The provisions relating to confidentiality in this Clause 21 shall
remain in effect during the Term and for a period of seven years
following the termination of this Agreement.
21.8 The Parties agree that the obligations of this Clause 21 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 21, 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.
CLAUSE 22
COSTS
22.1 Each Shareholder shall bear its own legal and other costs incurred in
relation to preparing and concluding this Agreement and the Definitive
Documents.
22.2 All other costs, legal fees, registration fees and other expenses
relating to the incorporation of Newco, shall be borne by Newco.
CLAUSE 23
GENERAL
23.1 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.
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23.2 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.
23.3 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.
23.4 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.
23.5 RELATIONSHIP OF THE PARTIES:
Nothing contained in this Agreement is intended or is to be construed
to constitute Elan/EIS and Acusphere as partners, or Elan/EIS as an
employee or agent of Acusphere, or Acusphere 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.
23.6 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.
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23.7 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 at:
▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇ ▇, ▇▇▇▇▇▇▇
Attention: Vice President & General Counsel
Elan Pharmaceutical Technologies,
a division of Elan Corporation, plc
Telephone: ▇▇▇-▇-▇▇▇-▇▇▇▇
Fax: ▇▇▇-▇-▇▇▇-▇▇▇▇
and
Elan International Services, Ltd.
▇▇▇ ▇▇. ▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇
Bermuda
Attention: President
Telephone: ▇▇▇-▇▇▇-▇▇▇▇
Fax: ▇▇▇-▇▇▇-▇▇▇▇
Acusphere at:
▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
Attn: Chief Executive Officer
Telephone ▇▇▇-▇▇▇-▇▇▇▇
Fax: ▇▇▇-▇▇▇-▇▇▇▇
with a copy to:
▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇, ▇▇▇▇▇▇▇ & ▇▇▇▇▇▇▇▇▇, LLP
▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Telephone: ▇▇▇-▇▇▇-▇▇▇▇
Fax: ▇▇▇-▇▇▇-▇▇▇▇
42
Newco at:
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇,
▇ ▇▇▇▇▇▇ ▇▇.,
▇▇▇▇▇▇▇▇,
▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇: Secretary
Telephone: ▇▇▇ ▇▇▇ ▇▇▇▇
Fax: ▇▇▇ ▇▇▇ ▇▇▇▇
with a copy to EIS if the notice is served by Acusphere and a copy to
Acusphere if a notice is served by EIS or Elan,
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.
23.8 GOVERNING LAW; [CONFIDENTIAL TREATMENT REQUESTED]/*/
23.8.1. This Agreement shall be governed by and construed in
accordance with the laws of the State of New York.
23.8.2 In the event that a dispute regarding the matters described in
Clause 18.3.1 is not resolved pursuant to the provisions of
Clause 18.1, the Parties agree to consider other dispute
resolution mechanisms including mediation.
23.8.3 In the event that the Parties fail to agree on a mutually
acceptable dispute resolution mechanism under Clause 23.8.2,
or in the event that the dispute is not resolved pursuant to
any dispute resolution mechanism agreed by the Parties under
Clause 23.8.2 within 6 months, the dispute shall be finally
settled by the courts of competent jurisdiction. For the
purposes of this Agreement the parties submit to the
[CONFIDENTIAL TREATMENT REQUESTED]/*/ jurisdiction of the
courts of the State of New York.
23.9 SEVERABILITY:
If any provision in this Agreement is agreed by the Parties to be,
deemed to be or becomes invalid, illegal, void or unenforceable under
any law that is applicable
43
hereto, such provision will be deemed amended to conform to applicable
laws so as to be valid and enforceable or, if it cannot be so amended
without materially altering the intention of the Parties, it will be
deleted, with effect from the date of such agreement or such earlier
date as the Parties may agree, and the validity, legality and
enforceability of the remaining provisions of this Agreement shall not
be impaired or affected in any way.
23.10 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.
23.11 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.
23.12 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:
23.12.1 Elan, EIS and/or Acusphere 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.
23.12.2 Elan and EIS shall have the right to assign their rights and
obligations hereunder to a special purpose financing or
similar entity established by Elan or EIS.
23.13 ASSIGNMENT OF NEWCO INTELLECTUAL PROPERTY:
Upon one month's prior notice in writing from Elan to Newco and
Acusphere, Newco shall assign the Newco Intellectual Property from
Newco to a wholly-owned subsidiary of Newco to be incorporated in
Ireland, which company shall be newly incorporated by Elan to
facilitate such assignment.
44
23.14 WHOLE AGREEMENT/NO EFFECT ON OTHER AGREEMENTS:
This Agreement (including the Schedules attached hereto) and the
Definitive Documents set forth all of the agreements and understandings
between the Parties with respect to the subject matter hereof, and
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 Definitive Documents.
In the event of any ambiguity or conflict arising between the terms of
this Agreement and those of the Newco Bye-Laws the terms of this
Agreement shall prevail, except with respect to the rights and
obligations attaching to the Common Shares and the Preferred Shares in
which respect the Newco Bye-Laws shall prevail.
45
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.
23.15 SUCCESSORS:
This Agreement shall be binding upon and inure to the benefit of the
Parties hereto, their successors and permitted assigns.
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IN WITNESS WHEREOF, the Parties hereto have executed this Agreement on the day
first set forth above.
SIGNED
BY: /s/ illegible signature
---------------------------------------
for and on behalf of
ELAN CORPORATION, PLC
(acting through its division
Elan Pharmaceutical Technologies)
SIGNED
BY: /s/ illegible signature
---------------------------------------
for and on behalf of
ELAN PHARMA INTERNATIONAL LIMITED
SIGNED
BY: /s/ illegible signature
---------------------------------------
for and on behalf of
ELAN INTERNATIONAL SERVICES, LTD.
SIGNED
BY: /s/ ▇▇▇▇▇▇ ▇▇▇▇▇
---------------------------------------
for and on behalf of
ACUSPHERE, INC.
SIGNED
BY: /s/ illegible signature
---------------------------------------
for and on behalf of
ACUSPHERE NEWCO, LTD.
47
SCHEDULE 1
ELAN LICENSE AGREEMENT
48
SCHEDULE 2
ACUSPHERE LICENSE AGREEMENT
49