EXHIBIT 10.9
Execution Copy
LICENSE AGREEMENT
BY AND BETWEEN
CELTRIX NEWCO LTD.
A BERMUDA COMPANY
AND
CELTRIX PHARMACEUTICALS, INC.
A DELAWARE COMPANY
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............................ 18
10. TERM AND TERMINATION OF AGREEMENT................................. 18
11. IMPOSSIBILITY OF PERFORMANCE - FORCE MAJEURE...................... 20
12. SETTLEMENT OF DISPUTES; PROPER LAW................................ 20
13. ASSIGNMENT........................................................ 21
14. NOTICES........................................................... 21
15. MISCELLANEOUS CLAUSES............................................. 22
LICENSE AGREEMENT dated April 21, 1999 between CELTRIX NEWCO LTD., a Bermuda
limited company, and CELTRIX PHARMACEUTICALS, INC., a Delaware corporation.
WHEREAS
A. Contemporaneously herewith, Celtrix, Elan, 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. Celtrix owns all right, title and interest in and to certain patents that
have been granted or are pending in relation to SomatoKine(R).
C. Newco desires to obtain from Celtrix, and Celtrix desires to grant to
Newco, an exclusive license under the Celtrix 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 Schedules 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.
[*****] INDICATES THAT CONFIDENTIAL MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
"Celtrix" shall mean Celtrix Pharmaceuticals, Inc., a Delaware
corporation, its successors and permitted assigns.
"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
hereunder. 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
hereunder 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 hereunder 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
hereof.
"Celtrix Patent Rights" shall mean the patents and patent applications
(including provisional applications) relating to SomatoKine(R) that are set
forth in Schedule 1 attached hereto, and that are owned or licensed by or on
behalf of Celtrix. Celtrix Patent Rights shall also include all extensions,
continuations, continuations-in-part, divisionals, patents-of-addition, re-
examinations, re-issues, supplementary protection certificates and foreign
counterparts of such patents and patent applications and any patents issuing
thereon and extensions of any patents licensed hereunder.
"Celtrix Securities Purchase Agreement" shall mean that certain
securities purchase agreement, of even date herewith, by and between Celtrix and
EIS.
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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 Trademark(s)" shall mean one or more trademarks, trade
names, or service marks that are owned or licensed by or on behalf of Celtrix
that Celtrix may nominate and approve in writing from time to time for use in
connection with the sale or promotion of the Product by Newco. For the purposes
of this Agreement, the trademark "SomatoKine(R)" is deemed to be a Celtrix
Trademark hereunder.
"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 Elan 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 Celtrix, Elan, 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, 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 under the Elan License
Agreement. The Elan License specifically excludes
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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.
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
under the Elan License Agreement 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 under the
Elan License Agreement 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 of the
Elan License Agreement.
"Elan License Agreement" shall mean that certain license agreement, of
even date herewith, entered into between Elan and Newco.
"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 of the Elan License Agreement, and that
are owned or licensed by or on behalf of Elan. Elan Patent Rights shall also
include all extensions, continuations, continuations-in-part, divisionals,
patents-of-addition, re-examinations, re-issues, supplementary protection
certificates and foreign counterparts of such patents and patent applications
and any patents issuing thereon and extensions of any patents licensed under the
Elan License Agreement.
"Elan Trademark(s)" shall have the meaning given to such term in the
Elan License Agreement.
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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.
"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 [*****]
"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 [*****]
"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.
"MEDIPAD(R) Drug Delivery System" shall mean the [*****]
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SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
as disclosed in the Elan Patent Rights set forth in Schedule 1 of the Elan
License Agreement.
"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 Celtrix 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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[*****] INDICATES THAT CONFIDENTIAL MATERIAL HAS BEEN OMITTED AND FILED
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 Celtrix" 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. Celtrix hereby grants to Newco an exclusive license for the Term in
the Territory under the Celtrix Intellectual Property to develop, import, use,
offer for sale, sell and otherwise distribute Products, and [*****] practice any
process or method covered by the Celtrix Patent Rights, in the Field, subject to
any contractual obligations of Celtrix to third parties as of the Effective Date
and, unless prohibited by Clause 5 hereof ("Non-Competition"), contractual
obligations that Celtrix may enter into after the Effective Date (the "Celtrix
License"). Except as expressly provided herein, [*****] with respect to the
[*****] shall at all times remain solely with [*****]
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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.
2.2. To the extent royalty or other compensation obligations to third
parties that are payable with respect to Celtrix Intellectual Property would be
triggered by a proposed use of such Celtrix Intellectual Property in connection
with the Project, Celtrix will inform Newco and Elan of such royalty or
compensation obligation promptly upon Celtrix becoming aware that such proposed
use may trigger such royalty or compensation obligation. [*****]
2.3. If [*****]. If the Elan representatives on the Management Committee
determine that Newco should not [*****] shall be free to fully exploit [*****]
with respect thereto.
2.4. Elan shall be a third party beneficiary to this Agreement and shall
have the right to cause Newco to enforce Newco's rights against Celtrix
hereunder.
2.5. Notwithstanding anything contained in this Agreement to the
contrary and except as otherwise provided in Section 5.1 hereof, Celtrix shall
have the right, outside of the Field, to fully exploit and grant licenses and
sublicenses with respect to the Celtrix Intellectual Property.
3. SUBLICENSE AND ASSIGNMENT RIGHTS
3.1. Newco shall not assign any of its rights under the Celtrix
License and/or the Newco Intellectual Property without the prior written consent
of Celtrix.
3.2. Newco shall not sublicense any of its rights under the Celtrix
License and/or the Newco Intellectual Property without the prior written consent
of Celtrix, which consent shall not be unreasonably withheld or delayed;
provided, however, that the consent of Celtrix may be withheld in Celtrix's sole
discretion in the case of a proposed sublicense of such rights to a
Technological Competitor of Celtrix.
3.3. Newco shall not enter into any agreement with any third party
for development or exploitation of the Celtrix Intellectual Property without the
prior written consent of Celtrix, which consent may be withheld in Celtrix's
sole discretion. Any agreement between Newco and any permitted third party for
the development or exploitation of the Celtrix Intellectual Property shall
require: (i) such third party to maintain the confidentiality of all information
concerning the Celtrix 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
Celtrix Improvements shall be owned by Celtrix, and (iii) shall
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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.
permit an assignment of rights by Newco to Celtrix in accordance with the terms
of Clause 3.1 hereof.
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 Elan, as if such acts and omissions were those of Newco.
3.7. Rights of permitted third party sublicensees in and to the Celtrix
Intellectual Property granted by Newco in accordance with Clause 3.2 above shall
survive the termination of the Celtrix License granting said intellectual
property rights to Newco; and Newco and Celtrix shall in good faith agree upon
the form most advantageous to Celtrix 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 Celtrix). 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. Celtrix hereby grants to Newco for the Term a [*****] in the
Territory to use the Celtrix 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 a
Celtrix Trademark by Newco is in a manner approved by Celtrix and accompanied by
an acknowledgement, in a form approved by Celtrix, that the same is a trademark
of Celtrix.
4.1.2 From time to time, upon the reasonable request of Celtrix,
Newco shall submit samples of the Product to Celtrix or its duly appointed agent
to ensure compliance with quality standards and specifications. Celtrix, 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 Celtrix Trademarks that fails to comply with
the quality standards and specifications referred to in this Clause 4, as
determined by Celtrix.
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SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
4.1.3 Newco shall not use any Celtrix Trademark in any way that
might materially prejudice its distinctiveness or validity or the goodwill of
Celtrix therein.
4.1.4 The Parties recognize that the Celtrix Trademarks have
considerable goodwill associated therewith. Newco shall not use in relation to
the Products any trademarks other than the Celtrix Trademarks (except for the
Elan Trademarks) without obtaining the prior consent in writing of Celtrix 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 Celtrix
must not conflict with the use and display of any Celtrix Trademark.
4.1.5 Newco shall not use in the Territory any trademarks or trade
names so resembling any Celtrix Trademark as to be likely to cause confusion,
dilution or deception.
4.1.6 Newco shall promptly notify Celtrix in writing of any alleged
infringement or unauthorized use of which it becomes aware by a third party of
the Celtrix Trademarks and provide Celtrix with any applicable evidence of
infringement or unauthorized use.
4.1.7 Newco shall favorably consider promoting and using the Celtrix
Trademarks in each country of the Territory and provide proof of such use upon
request by Celtrix.
4.2. Newco shall not be permitted to assign or sublicense any of its rights
under the Celtrix Trademarks without the prior written consent of Celtrix, which
consent shall not be unreasonably withheld or delayed.
4.3. Celtrix shall, [*****] file and prosecute applications to register and
maintain registrations of the Celtrix Trademarks in the Territory. Newco shall
reasonably co-operate with Celtrix in such efforts.
4.4. Celtrix will be entitled to conduct all enforcement proceedings
relating to the Celtrix Trademarks and shall at its sole discretion decide what
action, if any, to take in respect to any enforcement proceedings related to the
Celtrix Trademarks or any other claim or counter-claim brought in respect to the
use or registration of the Celtrix Trademarks. Any such proceedings shall be
conducted [*****] and for its own benefit. Newco and Celtrix shall reasonably
cooperate with Celtrix in such efforts, [*****].
4.5. Newco shall promptly notify Celtrix in writing in the event that Newco
becomes aware that any Celtrix 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 Celtrix shall have the first right
to decide whether or not to defend against such allegations, or to adopt an
alternative xxxx. If Celtrix decides not to defend the Celtrix Trademark, then
Newco may request Celtrix to defend the Celtrix Trademark, [*****]
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SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
provided, however, that if Celtrix believes that such requested defense is
unsubstantiated and without merit, then Celtrix may elect not to initiate
defense proceedings.
4.6. Newco will have no ownership rights in or to the Celtrix
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 Celtrix.
4.7. Nothing in this Agreement shall be construed as a warranty on
the part of Celtrix regarding the Celtrix Trademarks, including without
limitation, that use of the Celtrix Trademarks in the Territory will not
infringe the rights of any third parties. Accordingly, Newco acknowledges and
agrees that Celtrix makes no warranty regarding the Celtrix Trademarks.
4.8. Celtrix 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 Celtrix Trademarks pursuant to this
Agreement.
5. NON-COMPETITION
5.1. [*****]
6. FINANCIAL PROVISIONS.
6.1. In consideration of the license to the Celtrix Patent Rights,
Newco shall pay to Celtrix the following amounts:
(i) [*****]
Notwithstanding anything contained herein to the contrary,
payments to Newco by Independent Third Parties with respect to development work
performed on
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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(i), 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 Celtrix and shall be
nonrefundable to Newco. Each payment made to Celtrix 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 Celtrix 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 Celtrix, the
Parties shall meet to discuss suitable and reasonable alternative methods of
reimbursing Celtrix the amount of such royalties. In the event that Newco is
prevented from making any payment under this Agreement to Celtrix 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 in which they accrue to Celtrix's account in a bank acceptable to
Celtrix in the country the currency of which is involved or as otherwise agreed
by the Parties.
6.6. Celtrix 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 Celtrix on any payment made to Celtrix pursuant
to this Agreement shall be paid by Celtrix 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
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EXCHANGE COMMISSION.
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 Celtrix.
6.8. Newco shall, [*****], permit Celtrix 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 Celtrix
hereunder. Any such inspection of Newco's records shall be at the expense of
Celtrix, except that if any such inspection reveals a deficiency in the amount
of the royalty actually paid to Celtrix hereunder in any calendar quarter of
[*****] or more of the amount of any royalty actually due to Celtrix hereunder,
then the expense of such inspection shall be borne solely by Newco. Any amount
of deficiency shall be paid promptly to Celtrix by Newco. If such inspection
reveals a surplus in the amount of royalties actually paid to Celtrix by Newco,
Celtrix 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 Celtrix Intellectual Property, the Newco Intellectual
Property or this Agreement, as the case may be, whether in oral, 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
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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;
(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
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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.
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.
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
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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.
hereunder, without the necessity of proving actual or express damages.
8. WARRANTIES/INDEMNITIES
8.1. Celtrix represents and warrants to Elan and Newco that, as of
the Effective Date, except for the European Opposition Proceedings between
Genentech Inc. and Celtrix relating to their IGFBP-3 patents (EP 0 451 194 and
EP 0 406 272):
8.1.1 to Celtrix's best knowledge, Celtrix has the right to grant
the Celtrix License and any other rights granted herein;
8.1.2 Schedule 1 contains the Celtrix Patent Rights existing as
of the Effective Date;
8.1.3 to Celtrix's best knowledge, [*****]
8.1.4 Celtrix is the owner or exclusive licensee of all rights,
title and interest in the Celtrix Intellectual Property
free and clear of all Liens, and Celtrix has the right to
use the Celtrix Intellectual Property, in the Territory;
8.1.5 to Celtrix's best knowledge, there is no infringement by
third parties of any Celtrix Intellectual Property;
8.1.6 there is not pending, or to Celtrix's best knowledge,
threatened action, suit, proceeding or claim by others
challenging Celtrix' rights in or to such Celtrix
Intellectual Property, or the validity or scope of such
Celtrix Intellectual Property;
8.1.7 there is not pending, or to Celtrix's best knowledge,
threatened action, suit, proceeding or claim by others that
Celtrix Intellectual Property, infringe or otherwise
violate any patent, or intellectual property rights of
others; and
8.1.8 to Celtrix's best knowledge, there is no patent or patent
application of others which contains claims that dominate
Celtrix Intellectual Property.
8.2. During the Term, Celtrix shall not grant, or suffer to exist, a
Lien in or to the Celtrix Intellectual Property that would have a material
adverse effect, individually or in the aggregate, on the financial condition,
results of operation, business, and/or assets (including the Licensed
Technologies and/or the Newco Intellectual Property) of Newco.
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8.3. Newco represents and warrants to Celtrix 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.
8.4. Newco represents and warrants to Celtrix 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.
8.5. In addition to any other indemnifications provided for herein,
Celtrix 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 Celtrix hereunder, or
(b) any act or omission on the part of Celtrix or any of its agents or employees
in the performance of this Agreement.
8.6. In addition to any other indemnifications provided for herein,
Newco shall indemnify and hold harmless Celtrix 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 Celtrix 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.
8.7. The Party seeking an indemnity shall:
8.7.1 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;
8.7.2 permit the indemnifying Party to take sole control of the
defense and/or settlement of such claim or proceeding;
8.7.3 cooperate in the investigation, defense and/or settlement
of such claim or proceeding;
8.7.4 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
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SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
8.7.5 take all reasonable steps to mitigate any loss or liability
in respect of any such claim or proceeding.
8.8. NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, IN NO
EVENT SHALL CELTRIX 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.
8.9. [*****] CELTRIX 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 [*****]
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 Celtrix a [*****] license, with the right to
sublicense, to the [*****] the Field on an as-is basis to make, use, offer for
sale and sell [*****]
9.4. Newco represents and warrants that it has the sole, exclusive and
unencumbered right to grant the licenses and rights herein granted to Celtrix
and that it has not granted any option, license, right or interest in or to the
Celtrix 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:
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10.1.1 fifteen (15) 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 Celtrix 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.
10.3. 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.
10.4. Upon exercise of those rights of termination as specified in
Clause 10.1 to Clause 10.3 inclusive or elsewhere within this Agreement, or the
wind-up of Newco's business, this Agreement shall, subject to the other
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.
10.5. Upon expiration or termination of the Agreement:
10.5.1 any sums that were due from Newco to Celtrix 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
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SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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);
10.5.2 Clauses [*****] shall survive termination or expiration
of this Agreement and shall remain in full force and effect;
10.5.3 all representations, warranties and indemnities shall
insofar as are appropriate remain in full force and effect;
10.5.4 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;
10.5.5 except as provided in Clause 3.7, the Celtrix Intellectual
Property and all rights and licenses granted in and pursuant to this Agreement
shall cease for the Territory or for such particular country or countries in the
Territory (as the case may be) and shall immediately revert to Celtrix.
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 Celtrix Patent Rights, (b) any Celtrix
Intellectual Property and/or (c) any Celtrix Trademarks;
10.5.6 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
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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
Change of Control Event. Celtrix 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
000 Xx. Xxxxx Xxxxx
Xxxxxx, Xxxxxx XX00
Bermuda
Attention: Secretary
Telephone: 000-000-0000
Telefax: 000-000-0000
with a copy to: Elan Corporation plc
Xxxxxxx Xxxxx, Xxxxxxx Xxxxx, Xxxxxx 0, Xxxxxxx
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Attention: Vice President, General Counsel,
Elan Pharmaceutical Technologies,
a division of Elan Corporation, plc
Telephone: + 000 0 000 0000
Telefax: + 353 1 662 4960
If to Celtrix at: Celtrix Pharmaceuticals, Inc.
0000 Xxxxxxx Xxxxx, Xxxxx 000
Xxx Xxxx, XX 00000
Attention: Xxxxxxx Xxxxxx, Ph.D.
Telephone: (000) 000-0000
Telefax: (000) 000-0000
with a copy to: Venture Law Group
0000 Xxxx Xxxx Xxxx
Xxxxx Xxxx, XX 00000
Attention: Xxx Xxxxxx, Esq.
Telephone: (000) 000-0000
Telefax: (000) 000-0000
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,
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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 Party. Amendments hereto shall be subject to
the prior written approval of Elan, 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.
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15.10. Nothing contained in this Agreement is intended or is to be
construed to constitute Celtrix, Elan, and Newco as partners, or Celtrix as an
employee or agent of Newco or Elan, or Newco and Elan as an employee or agent of
Celtrix. 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.
IN WITNESS WHEREOF the Parties hereto have executed this Agreement in duplicate.
CELTRIX PHARMACEUTICALS, INC.
By: /s/ Xxxxxxx Xxxxxx
-----------------------------------------
Name: Xxxxxxx Xxxxxx
---------------------------------------
Title: President and Chief Executive Officer
--------------------------------------
CELTRIX NEWCO LTD.
By: /s/ Xxxxxxx Xxxxxx
-----------------------------------------
Name: Xxxxxxx Xxxxxx
---------------------------------------
Title: President
--------------------------------------
AGREED TO:
ELAN PHARMACEUTICAL TECHNOLOGIES,
A DIVISION OF ELAN CORPORATION, PLC
By: /s/ Xxxxx Xxxxxx
-----------------------------------------
Name: Xxxxx Xxxxxx
---------------------------------------
Title: Authorized Signatory
--------------------------------------
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SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
SCHEDULE 1
CELTRIX PATENT RIGHTS
IGF-I/IGFBP-3 ISSUED/ALLOWED PATENTS US STATUS: FOREIGN #
-----------------------------------------------------------------------------------------------------------
1. An Insulin-like growth factor-binding protein-3 composition 5,200,509 EP 308500
JP 2648951
AU 627423
CA 1340295
2. IGF-I/IGFBP-3 for systemic treatment of tissue injury 5,407,913 Foreign filed in
WO 94/04030
3. IGF-I/IGFBP-3 for the treatment of anemia 5,527,776 AU 688793
Foreign filed in
WO 95/08567
4. A method for use of IGFBP-3 antibodies 5,624,805 Foreign filed in
WO 90/06950
5. IGF/IGFBP-3 for the treatment of catabolic conditions 5,643,867 Foreign filed in
WO 94/04030
6. A method for recombinant production of IGFBP-3 5,670,341 Foreign filed in
WO 90/06950
7. Therapeutic uses of IGF/IGFBP-3 and IGFBP-3 5,681,818 Foreign filed in
(including osteoporosis) WO 90/06950
8. IGFBP-3 composition and methods for production; therapeutic uses see # 4,6,7 EP 0 451 194*
of IGF/IGFBP-3 and IGFBP-3 (including osteoporosis) HK 1000826
9. IGF/IGFBP-3 for the treatment of renal disorders 5,723,441 AU 690941
10. Methods for predicting drug response 5,824,467 Foreign filed in
WO 98/37423
[*****] [*****] [*****] [*****]
[*****] [*****] [*****] [*****]
[*****] [*****] [*****] [*****]
[*****]
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SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
IGF-I/IGFBP-3 PATENT APPLICATIONS FOREIGN #/STATUS
------------------------------------------------------------------------------------------------------------------
1. Therapeutic uses of IGFBP-3 and IGF-I/IGFBP-3 (including WO 90/06950
osteoporosis) Granted in EP*
[*****]
[*****] [*****] [*****]
[*****] [*****] [*****]
4. IGF-I/IGFBP-3 for wasting diseases and tissue repair WO 94/04030
[*****]
5. IGF-I/IGFBP-3 for the treatment of renal diseases WO 95/13824
[*****]
6. IGF-I/IGFBP-3 for the treatment of reproductive diseases WO 95/03817
[*****]
7. IGF-I/IGFBP-3 for the treatment of neurological disorders WO 95/13823
[*****]
8. IGF-I/IGFBP-3 for the treatment of immunologic and hematologic disorders WO 95/08567
[*****]
9. IGF-1/IGFBP-3 for promoting bone formation and for regulating bone WO 96/02565
remodeling [*****]
10. IGF or IGF/IGFBP-3 for the treatment of psychological and metabolic WO 98/36764
disorders
[*****] [*****] [*****]
[*****] [*****] [*****]
[*****] [*****] [*****]
[*****] [*****] [*****]
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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.
EXPRESSION TECHNOLOGY ISSUED/ALLOWED PATENTS U.S. STATUS FOREIGN #
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1. Methods and DNA expression systems for over-expression of proteins 5,459,051 AU 674741
in host cells
2. Chromosomal expression of heterologous genes in bacterial cells 5,470,727 AU 695886
WO 95/17499
3. Fusion polypeptides and proteins 5,563,046 AU 688363
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4. Expression of fusion polypeptides transported out of the cytoplasm 5,629,172 WO 95/04076
without leader sequences
5. Chromosomal expression of heterologous genes in bacterial cells 5,861,273 WO 96/40722
(CIP of 5,470,727 )
6. Method of producing IGF-I and IGF-BP3 with correct folding and 5,789,547 WO 96/40736
disulfide bonding
7. Polypeptide fusions to polypeptides of the beta trefoil fold 5,830,706 WO 95/04076
structural family (continuation of 5,563,046)
[*****] [*****] [*****] [*****]
9. Method for increasing yields of recombinant proteins ALLOWED Filed via PCT
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