1
EXHIBIT 10.60
EXECUTION COPY
LICENSE AGREEMENT
BY AND BETWEEN
CELTRIX NEWCO LTD.
A BERMUDA COMPANY
AND
ELAN PHARMACEUTICAL TECHNOLOGIES,
A DIVISION OF ELAN CORPORATION, PLC
AN IRISH COMPANY
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TABLE OF CONTENTS
SECTION PAGE
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1. DEFINITIONS........................................................1
2. GRANT OF RIGHTS....................................................7
3. SUBLICENSE AND ASSIGNMENT RIGHTS...................................8
4. TRADEMARKS.........................................................9
5. NON-COMPETITION...................................................11
6. FINANCIAL PROVISIONS..............................................11
7. CONFIDENTIAL INFORMATION..........................................13
8. WARRANTIES/INDEMNITIES............................................16
9. INTELLECTUAL PROPERTY OWNERSHIP RIGHTS............................17
10. TERM AND TERMINATION OF AGREEMENT.................................18
11. IMPOSSIBILITY OF PERFORMANCE - FORCE MAJEURE......................20
12. SETTLEMENT OF DISPUTES; PROPER LAW................................20
13. ASSIGNMENT........................................................20
14. NOTICES...........................................................21
15. MISCELLANEOUS CLAUSES.............................................22
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LICENSE AGREEMENT dated April 21, 1999 between Celtrix Newco Ltd., a Bermuda
limited company, and Elan Pharmaceutical Technologies, a division of Elan
Corporation, plc, an Irish limited company.
WHEREAS
A. Contemporaneously herewith, Elan, Celtrix, EIS and Newco
(capitalized terms used herein are defined below) are entering into the
Development Agreement for the purpose of recording the terms and conditions of a
joint venture and of regulating their relationship with each other and certain
aspects of the affairs of and their dealings with Newco.
B. Elan owns all right, title and interest in and to certain
patents that have been granted or are pending in relation to the development and
production of various drug delivery technologies.
C. Newco desires to obtain from Elan, and Elan desires to grant to
Newco, an exclusive license under the Elan Intellectual Property to develop,
use, import, sell, offer for sale and otherwise distribute Products in the Field
and in the Territory on the terms and subject to the conditions set forth
herein.
D. The Parties entered into a letter agreement dated March 31,
1999, pursuant to which the Parties agreed to enter into the Definitive
Documents.
NOW THEREFORE IT IS HEREBY AGREED AS FOLLOWS:
1. DEFINITIONS.
1.1 In this Agreement, the following definitions shall apply:
"Affiliate" shall mean any corporation or entity other than
Newco controlling, controlled by or under the common control with Elan or
Celtrix, as the case may be. For the purposes of this definition, "control"
shall mean direct or indirect ownership of fifty percent (50%) or more of the
outstanding stock or shares of a corporation entitled to vote for the election
of directors or comparable equity interest in any other type of entity and
"controlling" and "controlled" shall be construed accordingly.
"Agreement" shall mean this agreement (which expression shall be
deemed to include the Recitals and the Schedule hereto).
"Business Plan" shall mean the business plan and program of
development to be agreed to by Elan and Celtrix within sixty (60) days of the
Effective Date with respect to the research, development, prosecution and
commercialization of the Products, which Business Plan shall be reviewed and
mutually agreed to in writing by Elan and Celtrix on an annual basis.
"Celtrix" shall mean Celtrix Pharmaceuticals, Inc. a Delaware
corporation, its successors and permitted assigns.
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[*****] INDICATES THAT CONFIDENTIAL MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
"Celtrix Improvements" shall mean any improvements to the
Celtrix Patent Rights and/or Celtrix Know-How developed (a) [*****] whether or
not pursuant to the Project, (b) [*****] pursuant to the Project, [*****]
pursuant to the Project, except as limited by agreements with third parties.
Celtrix Improvements shall be deemed, immediately upon development, to be
included in the license of the Celtrix Intellectual Property granted to Newco
under the Celtrix License Agreement. The Celtrix License shall specifically
exclude any right to use Celtrix Improvements outside of the Field. If the
inclusion of a Celtrix Improvement in the license of Celtrix Intellectual
Property granted to Newco under the Celtrix License Agreement is restricted or
limited by a third party agreement, then Celtrix shall use reasonable commercial
efforts to exclude or where applicable to minimize any such restriction or
limitation. All rights, title, and interest to any Celtrix Improvements [*****]
Newco, Elan and any such third party shall execute and deliver documents, and
take such other actions as Celtrix may reasonably request, to effect or evidence
such ownership.
"Celtrix Intellectual Property" shall mean the Celtrix Know-How,
the Celtrix Patent Rights and/or the Celtrix Improvements. Notwithstanding
anything contained in this Agreement to the contrary, Celtrix Intellectual
Property shall exclude (a) inventions, patents and know-how [*****], and (b)
inventions, patents and know-how that are subject to contractual obligations of
Celtrix to Independent Third Parties as of the Effective Date; provided,
however, that if the inclusion of inventions, patent rights and know-how in the
license of Celtrix Intellectual Property granted to Newco under the Celtrix
License Agreement is restricted or limited by such contractual obligations of
Celtrix to Independent Third Parties, then Celtrix shall use reasonable
commercial efforts to exclude or, where applicable, to minimize any such
restriction or limitation.
"Celtrix Know-How" shall mean any and all rights owned or
licensed by Celtrix with respect to any knowledge, information, discovery,
invention, trade secret, technique, process, system, formulation, design, data
and expertise relating to SomatoKine whether or not covered by any patent,
copyright, design, trademark, trade secret or other industrial or intellectual
property right.
"Celtrix License" shall have the meaning set forth in Clause 2.1
of the Celtrix License Agreement.
"Celtrix License Agreement" shall mean that certain license
agreement, of even date herewith, entered into between Celtrix and Newco.
"Celtrix Patent Rights" shall mean the patents and patent
applications (including provisional applications) relating to SomatoKine(R) that
are set forth in Schedule 1 of the Celtrix License Agreement, and that are owned
or licensed by or on behalf of Celtrix. Celtrix Patent Rights shall also include
all extensions, continuations, continuations-in-part,
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[*****] INDICATES THAT CONFIDENTIAL MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
divisionals, patents-of-addition, re-examinations, re-issues, supplementary
protection certificates and foreign counterparts of such patents and patent
applications and any patents issuing thereon and extensions of any patents
licensed under the Celtrix License Agreement.
"Celtrix Securities Purchase Agreement" shall mean that certain
securities purchase agreement, of even date herewith, by and between Celtrix and
EIS.
"Celtrix Trademark" shall have the meaning ascribed to such term
in the Celtrix License Agreement.
"cGCP", "cGLP" and "cGMP" shall mean current Good Clinical
Practices, current Good Laboratory Practices and current Good Manufacturing
Practices respectively.
"Change of Control Event" shall mean the occurrence of the
following: a Technological Competitor of Elan shall, directly or indirectly, (a)
acquire [*****] or more of the capital stock of Celtrix or Newco, or (b)
otherwise control or influence in any material respect their management or
business, or (c) otherwise merge, consolidate or enter into any similar
transaction (or binding agreement in respect thereof) with either of such
entities, or (d) otherwise have entered into any joint venture, collaboration,
license or other arrangement with Celtrix or Newco to such an extent that such
Technological Competitor of Elan is materially engaged or involved with the
business or development of Celtrix or Newco.
"Definitive Documents" shall mean this Agreement, the Celtrix
License Agreement, the Development Agreement, the Celtrix Securities Purchase
Agreement, the Funding Agreement, the Registration Rights Agreements and
associated documentation of even date herewith, by and among Newco, Elan,
Celtrix and EIS, as applicable.
"Development Agreement" shall mean the Subscription, Joint
Development and Operating Agreement of even date herewith entered into among
Celtrix, Elan, EIS and Newco.
"Effective Date" shall mean the date upon which the Definitive
Documents are executed and delivered by Elan, Celtrix and Newco and the
transactions effected thereby are closed.
"EIS" shall mean Elan International Services, Ltd., a Bermuda
company.
"Elan" shall mean Elan Pharmaceutical Technologies, a division
of Elan Corporation, plc, a public limited company incorporated under the laws
of Ireland, its successors and permitted assigns.
"Elan Improvements" shall mean any improvements to the Elan
Patent Rights and Elan Know-How developed (a) [*****] whether or not pursuant to
the Project, (b) [*****] pursuant to the Project, and/or (c) [*****] pursuant to
the Project,
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SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
except as limited by agreements with third parties. Elan Improvements shall be
deemed, immediately upon development, to be included in the license of the Elan
Intellectual Property granted to Newco hereunder. The Elan License specifically
excludes any right to use Elan Improvements outside of the Field. If the
inclusion of an Elan Improvement in the license of Elan Intellectual Property
granted to Newco hereunder is restricted or limited by a third party agreement,
then Elan shall use reasonable commercial efforts to exclude or where applicable
to minimize any such restriction or limitation. All rights, title, and interest
to any Elan Improvements [*****] Newco, Celtrix and any such third party shall
execute and deliver documents, and take such other actions as Elan may
reasonably request, to effect or evidence such ownership.
"Elan Intellectual Property" shall mean the Elan Know-How, the
Elan Patent Rights and/or the Elan Improvements. Notwithstanding anything
contained in this Agreement to the contrary, Elan Intellectual Property shall
consist of Elan Know-How, Elan Patent Rights and/or Elan Improvements controlled
by Elan Corporation plc doing business as Elan Pharmaceutical Technologies, and
shall exclude (a) inventions, patents and know-how [*****] and [*****]
including, without limitation, [*****] and (b) inventions, patents and know-how
that are subject to contractual obligations of Elan to third parties as of the
Effective Date; provided, however, that if the inclusion of inventions, patent
rights and know-how in the license of Elan Intellectual Property granted to
Newco hereunder is restricted or limited by such contractual obligations of Elan
to third parties, then Elan shall use reasonable commercial efforts to exclude
or, where applicable, to minimize any such restriction or limitation.
"Elan Know-How" shall mean any and all rights owned or licensed
by Elan with respect to any knowledge, information, discovery, invention, trade
secret, technique, process, system, formulation, design, data and expertise
relating to the MEDIPAD(R) Drug Delivery System whether or not covered by any
patent, copyright, design, trademark, trade secret or other industrial or
intellectual property right.
"Elan License" shall have the meaning set forth in Clause 2.1
hereof.
"Elan Patent Rights" shall mean the patents and patent
applications (including provisional applications) relating to the MEDIPAD(R)
Drug Delivery System that are set forth in Schedule 1 attached hereto, and that
are owned or licensed by or on behalf of Elan. Elan Patent Rights shall also
include all extensions, continuations, continuations-in-part, divisionals,
patents-of-addition, re-examinations, re-issues, supplementary protection
certificates and foreign counterparts of such patents and patent applications
and any patents issuing thereon and extensions of any patents licensed
hereunder.
"Elan Trademark(s)" shall mean one or more trademarks, trade
names, or service marks that are owned or licensed by or on behalf of Elan that
Elan may nominate and approve in writing from time to time for use in connection
with the sale or promotion of the
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SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
Product by Newco. For the purposes of this Agreement, the trademark [*****] is
deemed to be an Elan Trademark hereunder.
"Exchange Right" shall have the meaning set forth in the Amended
and Restated Certificate of Incorporation of Celtrix in effect on the date
hereof.
"Exchange Right Term" shall mean the period commencing on the
Effective Date and ending on the exercise by Elan of the Exchange Right.
"FDA" shall mean the United States Food and Drug Administration
or any successors or agency the approval of which is necessary to commercially
market a product in the United States of America.
"Field" shall mean the [*****]
"First Commercial Sale" shall mean the first commercial sale for
use or consumption of a Product. A sale to an Affiliate or sublicensee shall not
constitute a "First Commercial Sale," unless the Affiliate or sublicensee is the
end user of the Product.
"Funding Agreement" shall mean the Funding Agreement, dated as
of the date hereof, between EIS and Celtrix.
"Independent Third Party" shall mean any person other than
Newco, Elan, Celtrix or any of their respective Affiliates.
"In Market" shall mean [*****] or where applicable by a
sublicensee or a distributor, [*****] such as a [*****].
"Licensed Technologies" shall mean the Elan Intellectual
Property and the Celtrix Intellectual Property.
"Licenses" shall mean the Elan License and the Celtrix License.
"Lien" shall mean any and all liens, security interests,
restrictions, claims, encumbrances or rights of third parties of every kind and
nature.
"Management Committee" shall have the meaning set forth in the
Development Agreement.
"Marketing Authorization" shall mean the procurement of
registrations and permits required by applicable government authorities in a
country in the Territory for the marketing, sale, and distribution of a Product
in such country.
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SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
"MEDIPAD(R) Drug Delivery System" shall mean the [*****] as
disclosed in the Elan Patent Rights set forth in Schedule 1 attached hereto.
"Net Sales" shall mean [*****]
"Newco" shall mean Celtrix Newco Ltd., a Bermuda limited
company.
"Newco Intellectual Property" shall mean all rights to
technology, patents and know-how belonging to Newco, other than the Elan
Intellectual Property and the Celtrix Intellectual Property, including any
technology acquired by or licensed to Newco from or by a third party and any
newly developed technology that is not Elan Intellectual Property or Celtrix
Intellectual Property.
"Osteoporosis" shall mean a skeletal condition characterized by
decreased density of normally mineralized bone, which bone density, as measured
by dual-energy x-ray absorptiometry (DXA), is more than 2.5 standard deviations
below the mean for the young adult reference range.
"Parties" shall mean Elan and Newco.
"Person" shall mean an individual, partnership, corporation,
limited liability company, business trust, joint stock company, trust,
unincorporated association, joint venture, or other entity of whatever nature.
"Project" shall mean all activity as undertaken by Elan, Celtrix
and Newco in order to develop the Products in accordance with the Business Plan.
"Products" shall mean the MEDIPAD(R) Drug Delivery System
incorporating SomatoKine(R) as its primary active ingredient.
"Registration Rights Agreements" shall mean the Registration
Rights Agreements of even date herewith relating to Newco and Celtrix
respectively.
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SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
"Regulatory Authority" shall mean any regulatory authority
outside the United States of America, the approval of which is necessary to
market a Product.
"SomatoKine(R)" shall mean [*****]
"Technological Competitor of Elan" shall mean [*****]
"Term" shall have the meaning set forth in Section 10 hereof.
"Territory" shall mean [*****] and
"United States Dollar" and "US$" shall mean the lawful currency
for the time being of the United States of America.
1.2. Interpretation. In this Agreement the following shall apply:
1.2.1 The singular includes the plural and vice versa, the
masculine includes the feminine and vice versa.
1.2.2. Any reference to a Clause or Schedule shall, unless
otherwise specifically provided, be to a Clause or Schedule of this Agreement.
1.2.3. The headings of this Agreement are for ease of reference
only and shall not affect its construction or interpretation.
2. GRANT OF RIGHTS.
2.1. Elan hereby grants to Newco an exclusive license for the Term in
the Territory under the Elan Intellectual Property to develop, import, use,
offer for sale, sell and otherwise distribute Products, and [*****] practice any
process or method covered by the Elan Patent Rights, in the Field, subject to
any contractual obligations of Elan to third parties as of the Effective Date
and, unless prohibited by Clause 5 hereof ("Non-Competition"), contractual
obligations that Elan may enter into after the Effective Date (the "Elan
License"). Except as expressly provided herein, [*****] with respect to [*****]
shall at all times remain solely with [*****]
2.2. To the extent royalty or other compensation obligations to third
parties that are payable with respect to Elan Intellectual Property would be
triggered by a proposed use of such Elan Intellectual Property in connection
with the Project, Elan will inform Newco and Celtrix of such royalty or
compensation obligation promptly upon Elan becoming aware that
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SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
such proposed use may trigger such royalty or compensation obligation. [*****]
2.3. If [*****] on such terms [*****] If the Celtrix representatives
on the Management Committee determine that Newco should not [*****] shall be
free to fully exploit [*****] with respect thereto.
2.4. Celtrix shall be a third party beneficiary to this Agreement and
shall have the right to cause Newco to enforce Newco's rights against Elan
hereunder.
2.5. Notwithstanding anything contained in this Agreement to the
contrary, Elan shall have the right and except as otherwise provided in Section
5.1 hereof, outside of the Field, to fully exploit and grant licenses and
sublicenses with respect to the Elan Intellectual Property.
3. SUBLICENSE AND ASSIGNMENT RIGHTS
3.1. Newco shall not assign any of its rights under the Elan License
and/or the Newco Intellectual Property without the prior written consent of
Elan.
3.2. Newco shall not sublicense any of its rights under the Elan
License and/or the Newco Intellectual Property without the prior written consent
of Elan, which consent shall not be unreasonably withheld or delayed; provided,
however, that the consent of Elan may be withheld in Elan's sole discretion in
the case of a proposed sublicense of such rights to a Technological Competitor
of Elan.
3.3. Newco shall not enter into any agreement with any third party
for development or exploitation of the Elan Intellectual Property without the
prior written consent of Elan, which consent may be withheld in Elan's sole
discretion. Any agreement between Newco and any permitted third party for the
development or exploitation of the Elan Intellectual Property shall require: (i)
such third party to maintain the confidentiality of all information concerning
the Elan Intellectual Property provided that such obligation of confidentiality
shall be no less stringent than that set forth in Clause 7 herein, (ii) shall
provide that all right, title and interest in and to any Elan Improvements shall
be owned by Elan, and (iii) shall permit an assignment of rights by Newco to
Elan in accordance with the terms of Clause 3.7 hereof.
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SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
3.4. Newco shall not enter into any agreement with any third party
for development of the Newco Intellectual Property without the prior approval of
the Management Committee.
3.5. Notwithstanding anything to the contrary herein, upon thirty
(30) days prior notice in writing from Elan to Newco and Celtrix, Newco shall
assign the Newco Intellectual Property, including, without limitation, all
rights and obligations related thereto, from Newco to a wholly-owned subsidiary
of Newco to be incorporated in Ireland, which company shall be newly
incorporated by Elan and Celtrix to facilitate such assignment.
3.6. Newco shall remain responsible for all acts and omissions of any
sublicensee, including Celtrix, as if such acts and omissions were those of
Newco.
3.7. Rights of permitted third party sublicensees in and to the Elan
Intellectual Property granted by Newco in accordance with Clause 3.2 above shall
survive the termination of the Elan License granting said intellectual property
rights to Newco; and Newco and Elan shall in good faith agree upon the form most
advantageous to Elan in which the rights of the sublicensor under any such
sublicenses are to be held (which form may include continuation of Newco solely
as the holder of such licenses or assignment of such rights to a third party or
parties, including an assignment to Elan). Upon any such assignment, Elan and
Celtrix shall enter into good faith negotiations with respect to additional
reasonable confidentiality protections which Elan or Celtrix shall reasonably
require.
4. TRADEMARKS
4.1. Elan hereby grants to Newco for the Term a [*****] in the
Territory to use the Elan Trademarks solely to research, develop, import, use,
offer for sale and sell the Products in the Field in the Territory, in
accordance with the terms and conditions of this Agreement including, without
limitation, the following:
4.1.1 Newco shall ensure that each reference to and use of an
Elan Trademark by Newco is in a manner approved by Elan and accompanied by an
acknowledgement, in a form approved by Elan, that the same is a trademark of
Elan.
4.1.2 From time to time, upon the reasonable request of Elan,
Newco shall submit samples of the Product to Elan or its duly appointed agent to
ensure compliance with quality standards and specifications. Elan, or its duly
appointed agent, shall have the right to inspect the premises of Newco where the
Product is held or stored, and Newco shall permit such inspection, upon advance
notice at any reasonable time, of the methods and procedures used in the storage
and sale of the Product. Newco shall not sell or otherwise dispose of any
Product under the Elan Trademarks that fails to comply with the quality
standards and specifications referred to in this Clause 4, as determined by
Elan.
4.1.3 Newco shall not use any Elan Trademark in any way that
might materially prejudice its distinctiveness or validity or the goodwill of
Elan therein.
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SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
4.1.4 The Parties recognize that the Elan Trademarks have
considerable goodwill associated therewith. Newco shall not use in relation to
the Products any trademarks other than the Elan Trademarks (except for the
Celtrix Trademarks) without obtaining the prior consent in writing of Elan with
respect to such use and display, which consent may not be unreasonably withheld
or delayed. However, such use and display that has been so approved by Elan must
not conflict with the use and display of any Elan Trademark.
4.1.5 Newco shall not use in the Territory any trademarks or
trade names so resembling any Elan Trademark as to be likely to cause confusion,
dilution or deception.
4.1.6 Newco shall promptly notify Elan in writing of any
alleged infringement or unauthorized use of which it becomes aware by a third
party of the Elan Trademarks and provide Elan with any applicable evidence of
infringement or unauthorized use.
4.1.7 Newco shall favorably consider promoting and using the
Elan Trademarks in each country of the Territory and provide proof of such use
upon request by Elan.
4.2. Newco shall not be permitted to assign or sublicense any of its
rights under the Elan Trademarks without the prior written consent of Elan,
which consent shall not be unreasonably withheld or delayed.
4.3. Elan shall, [*****], file and prosecute applications to register
and maintain registrations of the Elan Trademarks in the Territory. Newco shall
reasonably co-operate with Elan in such efforts.
4.4. Elan will be entitled to conduct all enforcement proceedings
relating to the Elan Trademarks and shall at its sole discretion decide what
action, if any, to take in respect to any enforcement proceedings related to the
Elan Trademarks or any other claim or counter-claim brought in respect to the
use or registration of the Elan Trademarks. Any such proceedings shall be
conducted [*****] and for its own benefit. Newco and Celtrix shall reasonably
cooperate with Elan in such efforts, [*****].
4.5. Newco shall promptly notify Elan in writing in the event that
Newco becomes aware that any Elan Trademark has been challenged by a third party
in a judicial or administrative proceeding in a country in the Territory as
infringing on the rights of a third party and Elan shall have the first right to
decide whether or not to defend against such allegations, or to adopt an
alternative mark. If Elan decides not to defend the Elan Trademark, then Newco
may request Elan to defend the Elan Trademark[*****]; provided, however, that if
Elan believes that such requested defense is unsubstantiated and without merit,
then Elan may elect not to initiate defense proceedings.
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SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
4.6. Newco will have no ownership rights in or to the Elan Trademarks
or of the goodwill associated therewith, and Newco hereby acknowledges that,
except as expressly provided in this Agreement, it shall not acquire any rights
in respect thereof and that all such rights and goodwill are, and will remain,
vested in Elan.
4.7. Nothing in this Agreement shall be construed as a warranty on
the part of Elan regarding the Elan Trademarks, including without limitation,
that use of the Elan Trademarks in the Territory will not infringe the rights of
any third parties. Accordingly, Newco acknowledges and agrees that Elan makes no
warranty regarding the Elan Trademarks.
4.8. Elan assumes no liability to Newco or to any third parties with
respect to the quality, performance or characteristics of any of the goods
manufactured or sold by Newco under the Elan Trademarks pursuant to this
Agreement.
5. NON-COMPETITION
5.1. [*****]
5.2. [*****]
6. FINANCIAL PROVISIONS.
6.1. In consideration of the license to the Elan Patent Rights, Newco
shall pay to Elan the following amounts:
(i) [*****]
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[*****]
Notwithstanding anything contained herein to the
contrary, payments to Newco by Independent Third Parties with respect to
development work performed on behalf of Newco by Elan or Celtrix, as the case
may be, shall be paid to the party that performed such development work.
6.2. Payment of royalties pursuant to Clause 6.1(ii), if any, shall
be made quarterly within thirty (30) days after the end of the calendar quarter
in which payments from Net Sales are received by Newco. The method of payment
shall be by wire transfer to an account specified by Elan and shall be
nonrefundable to Newco. Each payment made to Elan shall be accompanied by a
written report showing a true accounting of all Products sold by Newco, its
Affiliates and its sublicensees, if any, during such quarter. Such accounting
shall include, on a country-by-country and Product-by-Product basis, Net Sales
(and the calculation thereof) and each calculation of royalties with respect
thereto, including the calculation of all adjustments and currency conversions.
6.3. Newco shall maintain and keep clear, detailed, complete,
accurate and separate records for a period of three (3) years after a calendar
quarter in sufficient detail to permit Elan to confirm the accuracy of any
royalties on Net Sales due hereunder, including, without limitation, any
deductions made in determining Net Sales.
6.4. All payments due hereunder shall be made in United States
Dollars. Payments due on Net Sales of any Product for each calendar quarter made
in a currency other than United States Dollars shall first be calculated in the
foreign currency for the country of origin of such payment and then converted to
United States Dollars on the basis of the average exchange rate in effect for
such quarter for the purchase of United States Dollars with such foreign
currency quoted in The Wall Street Journal (or comparable publication if not
quoted in The Wall Street Journal) with respect to the currency of the country
of origin of such payment, determined by averaging the rates so quoted on each
business day of such quarter.
6.5. If, at any time, legal restrictions in the Territory prevent the
prompt payment when due of royalties or any portion thereof to Elan, the Parties
shall meet to discuss suitable and reasonable alternative methods of reimbursing
Elan the amount of such royalties. In the event that Newco is prevented from
making any payment under this Agreement to Elan by virtue of the statutes, laws,
codes or government regulations of the country from which the payment is to be
made, then such payments may be paid by depositing them in the currency
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in which they accrue to Elan's account in a bank acceptable to Elan in the
country the currency of which is involved or as otherwise agreed by the Parties.
6.6. Elan and Newco agree to cooperate in all respects necessary to
take advantage of any double taxation agreements or similar agreements as may,
from time to time, be available.
6.7. Any taxes payable by Elan on any payment made to Elan pursuant
to this Agreement shall be paid by Elan for its own account. If so required by
applicable law, any payment made pursuant to this Agreement shall be made by
Newco after deduction of the appropriate withholding tax, in which event the
Parties shall cooperate to obtain the appropriate tax clearance as soon as is
practicable. On receipt of such clearance and a refund of any such amount, Newco
shall ensure that the amount so withheld is promptly paid to Elan.
6.8. Newco shall [*****], permit Elan or its duly authorized
representatives upon reasonable notice and at any reasonable time during normal
business hours to inspect and audit the accounts and records of Newco and any
other book, record, voucher, receipt or invoice relating to the calculation of
the royalty payments on Net Sales or any other payments made by Newco to Elan
hereunder. Any such inspection of Newco's records shall be at the expense of
Elan, except that if any such inspection reveals a deficiency in the amount of
the royalty actually paid to Elan hereunder in any calendar quarter of [*****]
or more of the amount of any royalty actually due to Elan hereunder, then the
expense of such inspection shall be borne solely by Newco. Any amount of
deficiency shall be paid promptly to Elan by Newco. If such inspection reveals a
surplus in the amount of royalties actually paid to Elan by Newco, Elan shall
reimburse Newco the surplus within fifteen (15) days after determination.
6.9. In the event of any unresolved dispute regarding any alleged
deficiency or overpayment of royalty payments hereunder, the matter will be
referred to mutually agreeable independent firm of accountants for a resolution
of such dispute. Any decision by the said independent firm of accountants shall
be binding on the Parties.
6.10. The parties acknowledge and agree that the methods for
calculating the royalties and fees hereunder are for the purposes of the
convenience of the parties, are freely chosen and not coerced.
7. CONFIDENTIAL INFORMATION.
7.1. The Parties acknowledge that it may be necessary, from time to
time, to disclose to each other confidential and/or proprietary information,
including, without limitation, inventions, works of authorship, trade secrets,
specifications, designs, data, know-how and other information relating to the
Field, the Products, the Elan Intellectual Property, the Newco Intellectual
Property or this Agreement, as the case may be, whether in oral,
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16
written, graphic or electronic form (collectively, "Confidential Information").
Any Confidential Information revealed by either Party to the other Party shall
be maintained confidential in accordance with this Clause 7 and shall be used by
the receiving Party exclusively for the purposes of fulfilling the receiving
Party's obligations under this Agreement and the Development Agreement and for
no other purpose.
7.2. Each Party agrees to disclose Confidential Information of the
other 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 parties to appropriate written agreements that contain an obligation
of confidentiality no less stringent than as set forth herein. Each Party
further agrees to inform all such employees, representatives and agents of the
terms and provisions of this Agreement and their duties hereunder and to obtain
their consent hereto as a condition of receiving Confidential Information. Each
Party agrees that it will exercise the same degree of care, but in no event less
than a reasonable degree of care to preserve the proprietary and confidential
nature of the Confidential Information disclosed by the other Party, as the
receiving Party would exercise to preserve its own Confidential Information.
Each Party agrees that it will, upon request of the other Party, return all
documents and any copies thereof containing Confidential Information belonging
to or disclosed by such Party. Each Party shall promptly notify the other Party
upon discovery of any unauthorized use or disclosure of the other Party's
Confidential Information.
7.3. Notwithstanding the foregoing, each Party may use or disclose
Confidential Information disclosed to it by the other 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, complying with applicable governmental regulations or otherwise
submitting information to tax or other governmental authorities, conducting
clinical trials, or granting a permitted sublicense or otherwise exercising its
rights hereunder, provided that if a Party is required to make any such
disclosure of the other Party's Confidential Information, other than pursuant to
a confidentiality agreement, such Party shall inform the recipient of the terms
and provisions of this Agreement and such recipient's duties hereunder and
obtain such recipient's written consent hereto as a condition to receiving such
Confidential Information.
7.4. Any breach of this Clause 7 by any employee, representative or
agent of a Party is considered a breach by the Party itself.
7.5. Confidential Information shall not include:
(i) information that becomes publicly available, except
through a breach of this Agreement by the receiving
Party;
(ii) information which is made public by the disclosing Party
or with such Party's prior written consent;
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17
[*****] INDICATES THAT CONFIDENTIAL MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
(iii) information which is independently developed by the
receiving Party as evidenced by such Party's records,
without the aid, application, use of or reference to the
disclosing Party's Confidential Information;
(iv) 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;
(v) 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
(vi) information which the receiving Party is required to
disclose pursuant to:
(A) a valid order of a court or other governmental
body or any political subdivision thereof having
competent jurisdiction or otherwise as required
by law, rule or regulation; or
(B) any other requirement of law or the rules of any
applicable securities exchange;
(vii) 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
(viii) information that is the subject of a written permission
to disclose, without restriction or limitation, by the
disclosing Party;
7.6. 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 cooperate 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.
7.7. The provisions relating to confidentiality in this Clause 7
shall remain in effect during the Term, and for a period of [*****] following
the expiration or earlier termination of this Agreement.
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18
[*****] INDICATES THAT CONFIDENTIAL MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
7.8. The Parties agree that the obligations of this Clause 7 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 in this Clause 7. 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 7, 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.
8. WARRANTIES/INDEMNITIES
8.1. Elan represents and warrants to Newco and Celtrix that, as of
the Effective Date, to Elan's best knowledge (a) Elan has the right to grant the
Elan License and any other rights granted herein, (b) Schedule 1 contains the
Elan Patent Rights existing as of the Effective Date, and (c) [*****]
8.2. Newco represents and warrants to Elan that the execution of this
Agreement by Newco and the full performance and enjoyment of the rights of Newco
under this Agreement will not breach the terms and conditions of any license,
contract, understanding or agreement, whether express, implied, written or oral
between Newco and any third party.
8.3. Newco represents and warrants to Elan that the Products shall be
developed, transported, stored, handled, packaged, marketed, promoted,
distributed, offered for sale and sold in accordance with all regulations and
requirements of the FDA and Regulatory Authorities including, without
limitation, cGCP, cGLP, cGMP regulations. The Products shall not be adulterated
or misbranded as defined by the United States Federal Food, Drug and Cosmetic
Act (or applicable foreign law) and shall not violate any section of such Act if
introduced in interstate commerce.
8.4. In addition to any other indemnifications provided for herein,
Elan shall indemnify and hold harmless Newco and its Affiliates and their
respective employees, agents, partners, officers and directors from and against
any claims, losses, liabilities or damages (including reasonable attorney's fees
and expenses) incurred or sustained by Newco arising out of any (a) breach of
any representation, covenant, warranty or obligation by Elan hereunder, or (b)
any act or omission on the part of Elan or any of its agents or employees in the
performance of this Agreement.
8.5. In addition to any other indemnifications provided for herein,
Newco shall indemnify and hold harmless Elan and its Affiliates and their
respective employees, agents, partners, officers and directors from and against
any claims, losses, liabilities or damages
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19
[*****] INDICATES THAT CONFIDENTIAL MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
(including reasonable attorney's fees and expenses) incurred or sustained by
Elan arising out of or in connection with any (a) breach of any representation,
covenant, warranty or obligation by Newco hereunder, or (b) any act or omission
on the part of Newco or any of its agents or employees in the performance of
this Agreement .
8.6. The Party seeking an indemnity shall:
8.6.1 fully notify the other Party of any claim or proceeding,
or threatened claim or proceeding within thirty (30) days of becoming aware of
such claim or threatened claim;
8.6.2 permit the indemnifying Party to take sole control of
the defense and/or settlement of such claim or proceeding;
8.6.3 cooperate in the investigation, defense and/or
settlement of such claim or proceeding;
8.6.4 not compromise or otherwise settle any such claim or
proceeding without the prior written consent of the other Party, which consent
shall not be unreasonably withheld, conditioned or delayed; and
8.6.5 take all reasonable steps to mitigate any loss or
liability in respect of any such claim or proceeding.
8.7. NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, IN
NO EVENT SHALL ELAN OR NEWCO BE LIABLE TO THE OTHER BY REASON OF ANY
REPRESENTATION OR WARRANTY, CONDITION OR OTHER TERM OR ANY DUTY OF COMMON LAW,
OR UNDER THE EXPRESS TERMS OF THIS AGREEMENT, FOR ANY CONSEQUENTIAL, INCIDENTAL,
SPECIAL, PUNITIVE OR INDIRECT LOSS OR DAMAGE (WHETHER FOR LOSS OF PROFIT OR
OTHERWISE) AND WHETHER OCCASIONED BY THE NEGLIGENCE OF THE RESPECTIVE PARTIES,
THEIR EMPLOYEES OR AGENTS OR OTHERWISE.
8.8. [*****] ELAN IS GRANTING THE LICENSES HEREUNDER ON AN "AS IS"
BASIS WITHOUT RECOURSE, REPRESENTATION OR WARRANTY WHETHER EXPRESS OR IMPLIED,
INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR
INFRINGEMENT OF THIRD PARTY RIGHTS, AND ALL SUCH WARRANTIES ARE EXPRESSLY
DISCLAIMED.
9. INTELLECTUAL PROPERTY OWNERSHIP RIGHTS
9.1. Subject to the terms and conditions of this Agreement, [*****]
shall own all legal and equitable right, title and interest in and to the
[*****]
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[*****] INDICATES THAT CONFIDENTIAL MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
9.2. Subject to the terms and conditions of this Agreement, [*****]
shall own all legal and equitable right, title and interest in and to the
[*****]
9.3. Newco hereby grants to Elan a [*****] license, with the right to
sublicense, to the [*****] on an as-is basis to make, use, offer for sale and
sell the [*****]
9.4. Newco represents and warrants that it has the sole, exclusive
and unencumbered right to grant the licenses and rights herein granted to Elan
and that it has not granted any option, license, right or interest in or to the
Elan Intellectual Property, the Newco Intellectual Property, or other property
to any third party which would conflict with the rights granted by this
Agreement and the Definitive Documents.
10. TERM AND TERMINATION OF AGREEMENT.
10.1. The term of this Agreement (the "Term") shall commence as of the
Effective Date and expire on a Product-by-Product basis and on a
country-by-country basis on the last to occur of:
10.1.1 [*****] years from the date of the First Commercial Sale
of a Product in a particular country in the Territory; or
10.1.2 the last to expire of the patents covering the Product
in such particular country in the Territory or a method of making or using the
Product included in the Elan Patent Rights and/or patents resulting from the
Newco Intellectual Property in such particular country in the Territory.
10.2. If either party breaches any material provision of this
Agreement and if such breach not cured within sixty (60) days after the
non-breaching party gives written notice of the breach to the breaching party,
the non-breaching party may terminate this Agreement immediately by giving
notice of the termination, effective on the date of the notice, provided,
however, that if any such breach is not capable of being cured within such sixty
(60) day period, so long as the breaching party commences to cure the breach
promptly after receiving notice of the breach from the non-breaching party and
thereafter diligently prosecutes the cure to completion as soon as is
practicable, the non-breaching Party may not terminate this Agreement unless the
breaching party, notwithstanding such efforts, is unable to cure the breach
within ninety (90) days after the other party gives notice of the default, in
which case the non-breaching party may terminate this Agreement immediately by
giving notice of the termination, effective on the date of the notice.
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21
[*****] INDICATES THAT CONFIDENTIAL MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
10.3. In the event that a Change of Control Event shall occur, at the
sole option of Elan and upon written notice to Celtrix and Newco, Elan shall
have the right to terminate the Elan License immediately.
10.4. Either Party may terminate this Agreement prior to the
expiration of the Term in the event that (a) 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 or Bermuda (other than as part of a bona fide restructuring or
reorganization), is filed by or against the other Party and is not discharged
within forty-five (45) days, or (b) if the other Party applies for or consents
to the appointment of a liquidator, receiver, administrator, examiner, trustee
or similar officer over such Party or over all or a material part of its assets,
rights or revenues, or (c) the assets and/or the business of the other Party are
for any reason seized, confiscated or condemned.
10.5. Upon exercise of those rights of termination as specified in
Clause 10.1 to Clause 10.4 inclusive or elsewhere within this Agreement, or the
wind-up of Newco's business, this Agreement shall, subject to the provisions of
this Agreement that survive termination as set forth in this Agreement,
automatically terminate forthwith and be of no further legal force or effect.
10.6. Upon expiration or termination of the Agreement:
10.6.1 any sums that were due from Newco to Elan with respect
to the license granted hereunder, including without limitation royalties on Net
Sales, in the Territory or in such particular country or countries in the
Territory (as the case may be) prior to the expiration or termination of this
Agreement as set forth herein shall be paid in full within sixty (60) days after
the expiration or termination of this Agreement for the Territory or for such
particular country or countries in the Territory (as the case may be);
10.6.2 Clauses [*****] shall survive termination or expiration
of this Agreement and shall remain in full force and effect;
10.6.3 all representations, warranties and indemnities shall
insofar as are appropriate remain in full force and effect;
10.6.4 expiration or termination of this Agreement for any
reason shall not release any Party hereto from any liability which, at the time
of such termination, has already accrued to the other Party or which is
attributable to a period prior to such termination nor preclude either Party
from pursuing all rights and remedies it may have hereunder or at law or in
equity with respect to any breach of this Agreement;
10.6.5 except as provided in Clause 3.7, the Elan Intellectual
Property and all rights and licenses granted in and pursuant to this Agreement
shall cease for the Territory or
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22
for such particular country or countries in the Territory (as the case may be)
and shall immediately revert to Elan. Following such expiration or termination,
Newco may not thereafter use in the Territory or in such particular country or
countries in the Territory (as the case may be) (a) any valid and unexpired Elan
Patent Rights, (b) any Elan Intellectual Property and/or (c) any Elan
Trademarks;
10.6.6 all rights to Newco Intellectual Property shall be
transferred to and jointly owned by Elan and Celtrix and may be utilized by one
party with the consent of the other pursuant to a written agreement to be
negotiated in good faith.
11. IMPOSSIBILITY OF PERFORMANCE - FORCE MAJEURE.
11.1. Neither Party to this Agreement shall be liable for delay in the
performance of any of its obligations hereunder if such delay results from
causes beyond its reasonable control, including, without limitation, acts of
God, fires, strikes, acts of war, or intervention of a government authority,
non-availability of raw materials, provided that any such delay or failure shall
be remedied by such Party as soon as practicable.
12. SETTLEMENT OF DISPUTES; PROPER LAW.
12.1. The Parties will attempt in good faith to resolve any dispute
arising out of or relating to this Agreement promptly by negotiation between
executives of the Parties. In the event that such negotiations do not result in
a mutually acceptable resolution, the Parties agree to consider other dispute
resolution mechanisms including mediation. In the event that the Parties fail to
agree on a mutually acceptable dispute resolution mechanism, any such dispute
shall be finally settled by the courts of competent jurisdiction.
12.2. This Agreement is construed under and governed by the laws of
the State of New York without giving effect to any choice conflict of law
provision or rule. For the purpose of this Agreement the Parties submit to the
personal jurisdiction of the United States District Court for the State of New
York. The Parties each further irrevocably consent to the service of any
complaint, summons, notice or other process by delivery thereof to it by any
manner in which notices may be given pursuant to this Agreement.
13. ASSIGNMENT.
13.1. This Agreement may not be assigned by either Party without the
prior written consent of the other Party, which consent shall not be
unreasonably withheld, conditioned or delayed; subject to the following (a) that
either Party may, without such consent, assign this Agreement to its respective
Affiliates, provided that such assignment does not have any material adverse tax
consequence on the other Party; and (b) that either Party may, without such
consent, assign its rights and obligations hereunder in connection with a sale
of all or substantially all its assets to an Independent Third Party or merger,
combination or reorganization of either Party such that the stockholders of such
Party hold less than fifty percent (50%) of the capital stock of the successor
following completion of such transaction, unless such action shall constitute a
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23
Change of Control Event. Elan and Newco will discuss any assignment by either
Party to an Affiliate prior to its implementation in order to avoid or reduce
any additional tax liability to the other Party resulting solely from different
tax law provisions applying after such assignment to an Affiliate. For the
purpose hereof, an additional tax liability shall be deemed to have occurred if
either Party would be subject to a higher net tax on payments made hereunder
after taking into account any applicable tax treaty and available tax credits
than such Party was subject to before the proposed assignment. Notwithstanding
any assignment hereof, each Party will remain fully liable hereunder.
14. NOTICES.
14.1. Any notice to be given under this Agreement shall be sent in
writing in English by registered airmail or telefaxed to the following
addresses:
If to Newco at: Newco
102 St. James Court
Flatts, Smiths FL04
Bermuda
Attention: Secretary
Telephone: 441-292-9169
Telefax: 441-292-2224
with a copy to: Celtrix Pharmaceuticals, Inc.
2033 Gateway Place, Suite 600
San Jose, CA 95110
Attention: Andreas Sommer, Ph.D.
Telephone: (408) 573-6263
Telefax: (408) 573-6228
with a copy to: Venture Law Group
2800 Sand Hill Road
Menlo Park, CA 94025
Attention: Ned Ruffin, Esq.
Telephone: (650) 854-4488
Telefax: (650) 233-8386
If to Elan at: Elan Corporation plc
Lincoln House, Lincoln Place, Dublin 2, Ireland
Attention: Vice President, General Counsel,
Elan Pharmaceutical Technologies,
a division of Elan Corporation, plc
Telephone: + 353 1 709 4000
Telefax: + 353 1 662 4960
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or to such other address(es) and telefax numbers as may from time to
time be notified by either Party to the other hereunder.
14.2. Any notice sent by mail shall be deemed to have been delivered
within seven (7) working days after dispatch and any notice sent by telex or
telefax shall be deemed to have been delivered within twenty four (24) hours of
the time of the dispatch. Notice of change of address shall be effective upon
receipt.
15. MISCELLANEOUS CLAUSES.
15.1. No waiver of any right under this Agreement shall be deemed
effective unless contained in a written document signed by the Party charged
with such waiver, and no waiver of any breach or failure to perform shall be
deemed to be a waiver of any other breach or failure to perform or of any other
right arising under this Agreement.
15.2. If any provision in this Agreement is agreed in writing by the
Parties to be, or is deemed to be, or becomes invalid, illegal, void or
unenforceable under any law that is applicable hereto, (i) such provision will
be deemed amended to conform to applicable laws so as to be valid and
enforceable without materially altering the intention of the Parties, and (ii)
the validity, legality and enforceability of the remaining provisions of this
Agreement shall not be impaired or affected in any way.
15.3. The Parties shall use reasonable efforts to ensure that the
Parties and any necessary third party shall execute and perform all such further
deeds, documents, assurances, acts and things as any of the Parties hereto may
reasonably require by notice in writing to the other Party or such third party
to carry out the provisions of this Agreement.
15.4. This Agreement shall be binding upon and inure to the benefit of
the Parties hereto, their successors and permitted assigns and sub-licenses.
15.5. This Agreement (including the Schedules attached hereto), and
the other Definitive Documents set forth all of the agreements and
understandings between Parties hereto 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, either oral or written,
between the Parties other than as set forth in this Agreement and the other
Definitive Documents. No provision of this Agreement shall be construed so as to
negate, modify or affect in any way the provisions of any other agreement
between the Parties unless specifically referred to, and solely to the extent
provided, in any such other agreement. In the event of a conflict between the
provisions of this Agreement and the provisions of the Development Agreement,
the terms of the Development Agreement shall prevail unless this Agreement
specifically provides otherwise.
15.6. No amendment, modification or addition hereto shall be effective
or binding on either Party unless set forth in writing and executed by a duly
authorized representative of each
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25
Party. Amendments hereto shall be subject to the prior written approval of
Celtrix, which approval shall not be unreasonably withheld or delayed.
15.7. This Agreement may be executed in any number of counterparts,
each of which when so executed shall be deemed to be an original and all of
which when taken together shall constitute this Agreement.
15.8. Each of the Parties undertakes to do all things reasonably
within its power which are necessary or desirable to give effect to the spirit
and intent of this Agreement.
15.9. Each of the Parties hereby acknowledges that in entering into
this Agreement it has not relied on any representation or warranty except as
expressly set out herein or in any document referred to herein.
15.10. Nothing contained in this Agreement is intended or is to be
construed to constitute Elan, Celtrix and Newco as partners, or Elan as an
employee or agent of Newco or Celtrix, or Newco and Celtrix as an employee or
agent of Elan. Neither Party hereto shall have any express or implied right or
authority to assume or create any obligations on behalf of or in the name of the
other Party or to bind the other Party to any contract, agreement or undertaking
with any third party without the prior written consent of the other Party.
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IN WITNESS WHEREOF the Parties hereto have executed this Agreement in duplicate.
ELAN PHARMACEUTICAL TECHNOLOGIES,
A DIVISION OF ELAN CORPORATION, PLC
By: /s/ Kevin Insley
-----------------------------------------
Name: Kevin Insley
---------------------------------------
Title: Authorized Signatory
--------------------------------------
CELTRIX NEWCO LTD.
By: /s/ Andreas Sommer
-----------------------------------------
Name: Andreas Sommer
---------------------------------------
Title: President
--------------------------------------
AGREED TO:
CELTRIX PHARMACEUTICALS, INC.
By: /s/ Andreas Sommer
-----------------------------------------
Name: Andreas Sommer
---------------------------------------
Title: President and Chief Executive Officer
--------------------------------------
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[*****] INDICATES THAT CONFIDENTIAL MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
SCHEDULE 1
ELAN PATENT RIGHTS
- ----------------------------------------------------------------------------------------------------------
File Number Brief Description Country Status
- ----------------------------------------------------------------------------------------------------------
[*****] [*****] Medipad Australia Granted (693136)
[*****] [*****]
[*****] [*****]
[*****] [*****]
[*****] [*****]
New Zealand Granted (276485)
Taiwan Granted (079227)
United States 2 Granted (5,527,288;
5,848,991); [*****]
South Africa Granted (94/9185)
- ----------------------------------------------------------------------------------------------------------
[*****] Medipad-[*****] [*****] [*****]
[*****] [*****]
[*****] [*****]
Ireland Granted (77523)
[*****] [*****]
[*****] [*****]
[*****] [*****]
[*****] [*****]
[*****] [*****]
United States Granted (5,814,020)
[*****] [*****]
South Africa Granted (96/7502)
- ----------------------------------------------------------------------------------------------------------
[*****] [*****] Medipad [*****] [*****]
[*****] [*****]
[*****] [*****]
[*****] [*****]
Taiwan Granted (090339)
[*****] [*****]
South Africa Granted (96/10374)
- ----------------------------------------------------------------------------------------------------------
[*****] [*****] [*****] [*****]
[*****] [*****]
South Africa Granted (97/5065)
Taiwan Published
[*****] [*****]
- ----------------------------------------------------------------------------------------------------------
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[*****] INDICATES THAT CONFIDENTIAL MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
- ----------------------------------------------------------------------------------------------------------
File Number Brief Description Country Status
- ----------------------------------------------------------------------------------------------------------
- ----------------------------------------------------------------------------------------------------------
[*****] [*****] [*****] [*****]
[*****] [*****]
[*****] [*****]
[*****] [*****]
[*****] [*****]
- ----------------------------------------------------------------------------------------------------------
[*****] [*****] [*****] [*****]
[*****] [*****]
[*****] [*****]
[*****] [*****]
[*****] [*****]
- ----------------------------------------------------------------------------------------------------------
[*****] [*****] [*****] [*****]
[*****] [*****]
[*****] [*****]
[*****] [*****]
[*****] [*****]
- ----------------------------------------------------------------------------------------------------------
[*****] [*****] [*****] [*****]
- ----------------------------------------------------------------------------------------------------------
[*****] Design of Medipad Housing (3ml) United States Granted (D404482)
- ----------------------------------------------------------------------------------------------------------
[*****] Design of Bolus Medipad Housing United States Granted (D405524)
- ----------------------------------------------------------------------------------------------------------
[*****] [*****] [*****] [*****]
- ----------------------------------------------------------------------------------------------------------
All countries are initially designated when filing in the European Patent Office
or the Patent Cooperation Treaty, and are then selected during the regional or
national phase.
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