Exhibit 10.13
CONFIDENTIAL TREATMENT HAS BEEN SOUGHT FOR
PORTIONS OF THIS EXHIBIT PURSUANT TO RULE 24B-2
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
EXECUTION COPY
LICENSE AGREEMENT
BETWEEN
PHOTOGEN TECHNOLOGIES, INC.
AND
PHOTOGEN NEWCO LTD.
TABLE OF CONTENTS
1. DEFINITIONS
2. ELAN LICENSE TO NEWCO
3. INTELLECTUAL PROPERTY
4. [****]/AFTER ACQUIRED TECHNOLOGY
5. FINANCIAL PROVISIONS
6. RIGHT OF INSPECTION AND AUDIT
7. REPRESENTATIONS AND WARRANTIES
8. TERM AND TERMINATION
9. CONFIDENTIAL INFORMATION
10. GOVERNING LAW AND ARBITRATION
11. IMPOSSIBILITY OF PERFORMANCE - FORCE MAJEURE
12. ASSIGNMENT
13. NOTICES
14. MISCELLANEOUS
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[****] REPRESENTS MATERIAL WHICH HAS BEEN REDACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
THIS AGREEMENT made this 20th October 1999
BETWEEN:
(1) PHOTOGEN TECHNOLOGIES, INC., a corporation duly incorporated and
validly existing under the laws of Nevada and having its principal
place of business at 0000 Xxx Xxxxx, Xxxxxxxxx, XX. 00000, Xxxxxx
Xxxxxx of America; and
(2) PHOTOGEN NEWCO, LTD., an exempted limited liability company
incorporated under the laws of Bermuda and having its registered
office at Xxxxxxxxx Xxxxx, 0 Xxxxxx Xxxxxx, Xxxxxxxx, Xxxxxxx
("XXXXX"); and
(3) ELAN PHARMA INTERNATIONAL LIMITED incorporated under the laws of
Ireland, and having its registered office at XXX Xxxxx, Xxxxxxx
Xxxxxxxx Xxxx, Xxxxxxx, Xxxxxx Xxxxx, Xxxxxxx ("EPIL").
RECITALS:
A. Simultaneously herewith, Photogen, Elan, EIS, and Newco are entering
into the JDOA for the purpose of recording the terms and conditions of
the joint venture and of regulating their relationship with each other
and certain aspects of the affairs of, and their dealings with Newco.
B. Newco desires to enter into this Agreement with Photogen so as to
permit Newco to utilize the Photogen Intellectual Property in making,
having made, importing, using, offering for sale and selling the
Products in the Field in the Territory.
C. Simultaneously herewith Newco and Elan are entering into the Elan
License Agreement relating to Newco's use of the Elan Intellectual
Property.
1 DEFINITIONS
1.1 In this Agreement unless the context otherwise requires:
"AFFILIATE" shall mean any corporation or entity controlling,
controlled or under the common control of Elan or Photogen, as the case
may be. For the purpose of this definition, "control" shall mean direct
or indirect ownership of fifty percent (50%) or more of the stock or
shares entitled to vote for the election of directors. Newco is not an
Affiliate of Photogen, Elan or EIS.
"AGREEMENT" shall mean this license agreement (which expression shall
be deemed to include the Recitals and Schedules hereto).
"ALLIANCE" shall mean Alliance Pharmaceutical Corp., whose principal
place of business is at 0000 Xxxxxxx Xxxx Xxxx, Xxx Xxxxx, Xxxxxxxxxx.
"ALLIANCE AGREEMENT" shall mean the Agreement dated 9 August 1999,
between Alliance, Photogen and Xx. Xxxxxx Xxxx ("XX XXXX"), which
agreement, inter alia, assigned the Method Patents from Alliance and
Xx. Xxxx to Photogen.
"[****]"
"[****]"
"BUSINESS PLAN" shall have the meaning, as such term is defined in
the JDOA.
"COMPOUNDS" shall mean the [****].
"CONFIDENTIAL INFORMATION" shall have the meaning, as such term is
defined in Clause 9.
"CONTROL" shall mean the ability to grant a license or sublicense as
contemplated herein without violating the terms of any agreement with
any third party.
"DEFINITIVE DOCUMENTS" shall mean the definitive agreements relating to
the transaction between the Parties and Elan including finance, stock
purchase, research and license agreements.
"ELAN " shall mean EPIL (a wholly owned subsidiary of Elan Corporation,
Plc., which owns the Nanocrystal-TM- technology formerly Controlled by
NanoSystems LLC, formerly a subsidiary of the Xxxxxxx Kodak Company)
and Affiliates and subsidiaries of Elan Corporation, Plc. within the
division of Elan Corporation, Plc. carrying on business as Elan
Pharmaceutical Technologies but shall not include Affiliates and
subsidiaries (present or future) of Elan Corporation Plc within the
division of Elan Corporation, Plc carrying on business as Elan
Pharmaceuticals which incorporates, inter alia, Targon Corporation,
Athena Neurosciences, Inc., Elan Pharmaceuticals, Inc., Elan
Diagnostics, Carnrick Laboratories, and Elan Europe Limited.
"EIS" shall mean Elan International Services, Limited, an exempted
limited liability company incorporated under the laws of Bermuda and
having its registered office at Xxxxxxxxx Xxxxx, 0 Xxxxxx Xxxxxx,
Xxxxxxxx, Xxxxxxx and a subsidiary of Elan.
"EFFECTIVE DATE" shall mean the date of this Agreement.
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[****] REPRESENTS MATERIAL WHICH HAS BEEN REDACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
EXCHANGE ACT OF 1934, AS AMENDED.
"ELAN INTELLECTUAL PROPERTY" shall mean the Elan Know-How, the Elan
Patents and the Elan Improvements, as such terms are defined in the
Elan License Agreement.
"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 EPIL and Newco.
"ELAN PATENTS" shall have the meaning as such term is defined in the
Elan License Agreement.
"FIELD" shall mean the research, development, manufacture and
commercialization of nanoparticulate x-ray, CT, and/or MRI diagnostic
imaging agents using radio-opaque molecules containing Iodine that
passively target to lymphnodes involved in a disease state following
parenteral administration to a mammal to locate, diagnose and/or treat
cancer and/or other diseases.
For the avoidance of doubt, the Field does not include:
(iv) active targeting agents, including but not limited to
monoclonal antibodies, short-chain antibodies or any other
active targeting agents including protein, peptide or
peptidomimetic targeting agents; or
(ii) ultrasound diagnostic imaging agents.
"GENERAL NYCOMED AGREEMENT" shall mean the License Agreement dated 30
September, 1999 between The General Hospital Corporation (acting, inter
alia, as agent for Nycomed) and Photogen which agreement licenses,
inter alia, certain rights with respect to the Compounds [****] and
[****] to Photogen.
"GENERAL NYCOMED PATENTS" shall mean the patents included in the
GenNyc Intellectual Property.
"GENNYC INTELLECTUAL PROPERTY" shall mean all the rights to and under
the General Patent Rights, the Joint Patent Rights and the [****]
Patent Rights (as those terms are defined in the General Nycomed
Agreement) which were licensed to Photogen pursuant to the General
Nycomed Agreement.
The primary examples of GenNyc Intellectual Property existing as of the
Effective Date are set forth on Schedule 2, which listing is not
necessarily exhaustive.
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[****] REPRESENTS MATERIAL WHICH HAS BEEN REDACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
"IN-LICENSE AGREEMENTS" shall mean collectively the General Nycomed
Agreement and the Alliance Agreement.
"JDOA" shall mean that certain joint development and operating
agreement, of even date herewith, by and between Elan, Photogen, EIS
and Newco.
"KNOW-HOW" shall mean information and know-how, whether patentable or
not, including but not limited to any and all discoveries, inventions,
substances, data, techniques, processes, systems, formulations, designs
and commercial information relating to design, development,
manufacture, assembly, use or sale.
"LICENSED TECHNOLOGIES" shall mean the Elan Intellectual Property, the
Photogen Intellectual Property and the GenNyc Intellectual Property.
"LICENSES" shall mean the Elan License, the Photogen License and the
General Nycomed Sublicense.
"MANAGEMENT COMMITTEE" shall have the meaning, as such term is
defined in the JDOA.
"METHOD PATENTS" shall mean the patent family that contains the [****]
Patent, the [****] Patent, [****] and others as described in Exhibit B
of the Alliance Agreement.
"NEWCO INTELLECTUAL PROPERTY" shall mean all Patent Rights and Know-How
and other intellectual property arising pursuant to the Project by any
person, that does not constitute Elan Intellectual Property or Photogen
Intellectual Property and any technology licensed or acquired by Newco
from a third party.
For avoidance of doubt, Newco Intellectual Property includes that
portion of all improvements developed pursuant to the Project relating
solely and specifically to Product(s).
"NEWCO PATENTS" shall mean any and all Patent Rights now existing,
currently pending or hereafter filed or obtained relating to the Newco
Intellectual Property.
"NYCOMED" shall mean Nycomed Imaging AS doing business as Nycomed
Amersham, whose principal place of business is at 000 Xxxxxxxx Xxxxxx,
Xxxxxxxxx, XX 00000, XXX.
"PARTY" shall mean Photogen or Newco, as the case may be, and
"PARTIES" shall mean Photogen and Newco.
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[****] REPRESENTS MATERIAL WHICH HAS BEEN REDACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
"PATENT RIGHTS" shall mean any and all patents and patent applications,
including all divisonals, continuations, continuations-in-part,
extensions, patents-of-additions, re-examinations, re-issues,
supplementary protection certificates and foreign counterparts of such
patents and patent applications and any patents issuing thereon and
extensions thereon.
"PHOTOGEN" shall mean Photogen Technologies, Inc. and its
Affiliates, excluding Newco.
"PHOTOGEN INTELLECTUAL PROPERTY" shall mean the Photogen Know-How, the
Photogen Patents and the Photogen Improvements.
"PHOTOGEN KNOW-HOW" shall mean any and all rights owned, licensed or
Controlled by Photogen to Know-How other than Know-How included in the
GenNyc Intellectual Property, relating to medical diagnostic imaging
agents, methods of treatment using medical diagnostic imaging agents
and related compositions.
The primary examples of the Photogen Know-How existing as of the
Effective Date are set forth on Schedule 1 attached hereto, which
listing is not necessarily exhaustive, and includes Know-How owned,
licensed or Controlled by Photogen related to the Method Patents.
"PHOTOGEN LICENSE" shall have the meaning set forth in Clause 2.1.
"PHOTOGEN PATENTS" shall mean any and all Patent Rights owned or
Controlled by Photogen other than Patent Rights included in the GenNyc
Intellectual Property, now existing, currently pending or hereafter
filed by Photogen relating to nanoparticulate medical diagnostic
imaging agents including medical diagnostic imaging agents, methods of
treatment using medical diagnostic imaging agents and related
compositions.
The primary examples of Photogen Patents existing as of the Effective
Date are set forth on Schedule 1 attached hereto, which listing is not
necessarily exhaustive, and includes the Method Patents.
"PHOTOGEN IMPROVEMENTS" shall mean improvements relating to the
Photogen Patents and/or the Photogen Know-How, developed (i) by
Photogen not pursuant to the Project, (ii) by Photogen pursuant to the
Project except for that portion of improvements relating solely and
specifically to Product(s) (iii) by Newco or Elan or by a third party
(under contract with Newco) pursuant to the Project except for that
portion of improvements relating solely and specifically to Product(s),
and/or (iv) jointly by any combination of Photogen, Elan or Newco
pursuant to the Project except for that portion of improvements
relating solely and specifically to Product(s), except as limited by
agreements with unaffiliated third parties.
Subject to third party agreements with unaffiliated third parties,
Photogen Improvements
shall constitute part of Photogen Intellectual Property and be
included in the license of the Photogen Intellectual Property
pursuant to Clause 2.1 solely for the purposes set forth therein. If
the inclusion of a Photogen Improvement in the license of Photogen
Intellectual Property is restricted or limited by a third party
agreement, Photogen shall use reasonable commercial efforts to
minimize any such restriction or limitation.
"PRODUCT" shall mean a formulation containing one or more x-ray, CT,
and/or MRI Compounds in nanoparticulate form developed by or on behalf
of Newco pursuant to the Project.
"PHOTOGEN TRADEMARK(S)" shall mean one or more trademarks, trade names,
or service marks that are owned or licensed by or on behalf of Photogen
which Photogen may nominate and approve in writing from time to time
and Newco may accept for use in connection with the sale or promotion
of the Products by Newco
"PROJECT" shall mean all activities as undertaken by Elan, Photogen and
Newco in order to develop the Products.
"R&D COMMITTEE" shall have the meaning, as such term is defined in
the JDOA.
"R&D PLAN" shall have the meaning, as such term is defined in the
JDOA.
"R&D PROGRAM" shall mean any research and development program
commenced by Newco pursuant to the Project.
"TERM" shall have the meaning set forth in Clause 8.
"TERRITORY" shall mean all the countries of the world.
"UNITED STATES DOLLAR" and "US$" shall mean the lawful currency for the
time being of the United States of America.
1.2 In this Agreement:
1.2.1 The singular includes the plural and vice versa, and the
masculine includes the feminine and vice versa and the neuter
includes the masculine and the feminine.
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. PHOTOGEN LICENSE TO NEWCO
2.1 Photogen hereby grants to Newco for the Term an [****] license
(including the right to grant sublicenses under Clause 2.7) (the
"PHOTOGEN LICENSE") of the Photogen Intellectual Property solely in the
Field to make, have made, import, use, offer for sale and sell the
Products in the Field in the Territory.
2.2 Photogen hereby grants to Newco for the Term an [****] sublicense
(including the right to grant sublicenses under Clause 2.7) (the
"GENERAL NYCOMED SUBLICENSE") of all Photogen's rights to the GenNyc
Intellectual Property solely in the Field solely to make, have made,
import, use, offer for sale and sell the Products in the Field in the
Territory.
2.3 Save only the specific royalty obligations of Photogen to Nycomed under
Clause 5.1(c) and Clause 5.1(d) of the General Nycomed Agreement in
respect of Newco's sales of Products as a "SUB-LICENSEE" as defined in
the General Nycomed Agreement for which Newco will be responsible,
Photogen shall be responsible for payments related to the financial
provisions and obligations of any third party agreement with respect to
the Photogen Intellectual Property to which it is a party on the
Effective Date (including amendments thereto) (the "PHOTOGEN EFFECTIVE
DATE AGREEMENTS"), including without limitation, any royalty or other
compensation obligations triggered thereunder on the Effective Date, or
triggered thereunder after the Effective Date.
For the avoidance of doubt, royalties, milestones or other payments
which arise from the process of the commercialization or exploitation
of products under the Photogen Effective Date Agreements (for example,
a milestone payment payable upon successful completion of Phase II
clinical trials, the filing of an NDA application, obtaining NDA
approval, or first commercial sale) shall be payments for which
Photogen will be responsible under this Clause 2.3.
2.4 To the extent royalty or other compensation obligations that are
payable to third parties with respect to the Photogen Intellectual
Property would be triggered after the Effective Date under any third
party agreement entered into by Photogen after the Effective Date (the
"PHOTOGEN POST-EFFECTIVE DATE AGREEMENTS"), by a proposed use of such
Photogen Intellectual Property in connection with the Project, Photogen
will inform Newco of such royalty or compensation obligations. [****]
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[****] REPRESENTS MATERIAL WHICH HAS BEEN REDACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
For the avoidance of doubt, royalties, milestones or other payments
which arise from the process of the commercialization or exploitation
of products under the Photogen Post-Effective Date Agreements (for
example, a milestone payment payable upon successful completion of
Phase II clinical trials, the filing of an NDA application, obtaining
NDA approval, or first commercial sale) shall be payments for which
Newco will be responsible under this Clause 2.4.
2.5 Elan shall be a third party beneficiary under this Agreement and shall
have the right to cause Newco to enforce Newco's rights under this
Agreement against Photogen.
2.6 Notwithstanding anything contained in this Agreement to the contrary,
Photogen shall have the right outside the Field and subject to the
non-competition provisions of Clause 4 to exploit and grant licenses
and sublicenses of the Photogen Intellectual Property. For the
avoidance of doubt, Newco shall have no right to use the Photogen
Intellectual Property outside the Field.
2.7 Newco shall not be permitted to assign or sublicense any of its rights
under the Photogen Intellectual Property without the prior written
consents of Photogen and Elan, which consents shall not be unreasonably
withheld or delayed.
2.8 Any agreement between Newco and any permitted third party for the
development or exploitation of the Photogen Intellectual Property shall
require such third party to maintain the confidentiality of all
information concerning the Photogen Intellectual Property.
Insofar as the obligations owed by Newco to Photogen are concerned, Newco
shall remain responsible for all acts and omissions of any permitted
sub-licensee, including Elan, as if they were acts and omissions by Newco.
3 INTELLECTUAL PROPERTY
3.1 OWNERSHIP OF INTELLECTUAL PROPERTY:
3.1.1 Newco shall own the Newco Intellectual Property.
3.1.2 Photogen shall own the Photogen Intellectual Property.
3.2 TRADEMARKS:
3.2.1 Photogen hereby grants to Newco for the Term a [****]
license in the Territory to
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[****] REPRESENTS MATERIAL WHICH HAS BEEN REDACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
use and display the Photogen Trademarks to promote, offer
for sale and sell the Products in the Field in the
Territory and the following provisions shall apply as
regards the use of the Photogen Trademarks by Newco
hereunder:
(1) Newco shall ensure that each reference to and use of
a Photogen Trademark by Newco is in a manner approved
by Photogen and accompanied by an acknowledgement, in
a form approved by Photogen, that the same is a
trademark (or registered trademark) of Photogen.
From time to time, upon the reasonable request of
Photogen, Newco shall submit samples of the Product
to Photogen or its duly appointed agent to ensure
compliance with quality standards and specifications.
Photogen, or its duly appointed agent, shall have the
right to inspect the premises of Newco where the
Product is manufactured, held or stored, and Newco
shall permit such inspection, upon advance notice at
any reasonable time, of the methods and procedures
used in the manufacture, storage and sale of the
Product. Newco shall not sell or otherwise dispose of
any Product under the Photogen Trademarks that fails
to comply with the quality standards and
specifications referred to in this Clause 3.2, as
determined by Photogen.
(2) Newco shall not use an Photogen Trademark in any way
which might materially prejudice its distinctiveness
or validity or the goodwill of Photogen therein.
(3) The parties recognize that the Photogen Trademarks
have considerable goodwill associated therewith.
Newco shall not use in relation to the Products any
trademarks other than the Photogen Trademarks (except
the Photogen Trademarks (as defined in the Photogen
License Agreement) licensed to Newco under the
Photogen License Agreement) without obtaining the
prior consent in writing of Photogen, which consent
may not be unreasonably withheld. However, such use
must not conflict with the use and display of the
Photogen Trademark and such use and display must be
approved by Photogen.
(4) Newco shall not use in the Territory any trademarks
or trade names so resembling the Photogen Trademark
as to be likely to cause confusion or deception.
(5) Newco shall promptly notify Photogen in writing of
any alleged infringement or unauthorised use of which
it becomes aware by a third party of the Photogen
Trademarks and provide Photogen with any applicable
evidence of infringement or unauthorised use.
(6) Newco shall favourably consider promoting and using
the Photogen
Trademarks in each country of the Territory and
provide proof of such use upon request by Photogen.
(7) Newco shall not be permitted to assign or sublicense
any of its rights under the Photogen Trademarks
without the prior written consent of Photogen, which
consent shall not be unreasonably withheld or
delayed.
3.2.2 Photogen shall, [****], file and prosecute applications to
register and maintain registrations of the Photogen Trademarks
in the Territory. Newco shall reasonably co-operate with
Photogen in such efforts. In the event Photogen decides not to
file or prosecute such Photogen Trademark, Newco may request
Photogen to do the same at Newco's expense, and Photogen shall
file or prosecute such Photogen Trademark at Newco's request
and expense unless Photogen believes such action is without
merit.
3.2.3 Photogen will be entitled to conduct all enforcement
proceedings relating to the Photogen Trademarks and shall
at its [****] discretion decide what action, if any, to
take in respect to any enforcement proceedings of the
Photogen Trademarks or any other claim or counter-claim
brought in respect to the use or registration of the
Photogen Trademarks. Any such proceedings shall be
conducted at Photogen's [****] and for its own benefit.
Newco and Elan shall reasonably cooperate with Photogen in
such efforts. In the event Photogen decides not to engage
in enforcement proceedings of the Photogen Trademarks Newco
may request Photogen to do the same at Newco's expense
unless Photogen believes the basis for such enforcement
proceedings is without merit. In such a case, Photogen
shall have the sole discretion not to engage in any such
enforcement proceedings.
3.2.4 Newco shall promptly notify Photogen in writing in the
event that any Photogen 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 Photogen shall have the first right to
decide whether or not to defend such allegations, or to
adopt an alternative xxxx, or allow Newco to adopt an
alternative xxxx. If Photogen decides not to defend the
Photogen Trademark, then Newco may request Photogen to
defend the Photogen Trademark, at Newco's expense, unless
such requested defense is believed by Photogen to be
unsubstantiated and without merit. In such a case, Photogen
may elect not initiate defence proceedings.
3.2.5 Save where Newco adopts its own xxxx under Clause 3.2.4, Newco
will have no ownership rights in respect of the Photogen
Trademarks or of the goodwill
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[****] REPRESENTS MATERIAL WHICH HAS BEEN REDACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER THE
SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.
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
Photogen.
3.2.6 Nothing in this Agreement shall be construed as a warranty on
the part of Photogen regarding the Photogen Trademarks,
including without limitation, that use of the Photogen
Trademarks in the Territory will not infringe the rights of
any third parties. Accordingly, Newco acknowledges and agrees
that Photogen makes no such warranty.
3.2.7 Photogen 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
Photogen Trademarks pursuant to this Agreement.
4 [****]/AFTER ACQUIRED TECHNOLOGY
4.1 [****]
[****]
4.2 If, after the Effective Date, Photogen acquires know-how or patent
rights relating to the Field, or acquires or merges with a third
party entity that has know-how or patent rights relating to the
Field, Photogen shall offer to license such know-how and patent
rights to Newco (subject to existing contractual obligations), on
[****] terms on an arm's length basis for a [****] period under the
prevailing circumstances.
If Newco determines that Newco should not acquire such license,
Photogen shall be free to fully exploit such know-how and patent rights
with the Photogen Intellectual Property then licensed to Newco, whether
inside or outside the Field, and to grant to third parties licenses and
sublicenses with respect thereto.
5 FINANCIAL PROVISIONS
5.1 MILESTONE PAYMENTS AND ROYALTIES:
Prior to the commercialization of the Products, the Management
Committee shall consider and if appropriate, determine reasonable
royalties and milestone payments with respect to the commercialization
of the Products by Newco that shall be payable by Newco to Elan and
Photogen, and shared by Elan and Photogen [****] (whether common stock
and/or preferred stock) in Newco.
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[****] REPRESENTS MATERIAL WHICH HAS BEEN REDACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
At such time, the Management Committee will agree to an appropriate
definition of "Net Sales" as such term is used in this Agreement.
5.2 Payment of any royalties pursuant to Clause 5.1 shall be made quarterly
in arrears during each Financial Year within 30 days after the expiry
of the calendar quarter. The method of payment shall be by wire
transfer to an account specified by Photogen. Each payment made to
Photogen shall be accompanied by a true accounting of all Products sold
by Newco's permitted sublicensees, if any, during such quarter.
Such accounting shall show, 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.
5.3 Newco shall maintain and keep clear, detailed, complete, accurate and
separate records for a period of [****]:
5.3.1 to enable any royalties on Net Sales that shall have accrued
hereunder to be determined; and
5.3.2 to enable any deductions made in the Net Sales calculation to be
determined.
5.4 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 and then converted to United States
Dollars on the basis of the exchange rate in effect on the last working
day 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.
5.5 If, at any time, legal restrictions in the Territory prevent the prompt
payment when due of royalties or any portion thereof, the Parties shall
meet to discuss suitable and reasonable alternative methods of paying
Photogen the amount of such royalties. In the event that Newco is
prevented from making any payment under this Agreement 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 Photogen's
account in a bank acceptable to Photogen in the country the currency of
which is involved or as otherwise agreed by the Parties.
5.6 Photogen and Newco agree to co-operate in all respects necessary to
take advantage of any double taxation agreements or similar agreements
as may, from time to time, be available.
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[****] REPRESENTS MATERIAL WHICH HAS BEEN REDACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
5.7 Any taxes payable by Photogen on any payment made to Photogen pursuant
to this Agreement shall be for the account of Photogen. 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 co-operate to obtain the appropriate tax
clearance as soon as is practicable. On receipt of such clearance,
Newco shall forthwith arrange payment to Photogen of the amount so
withheld.
6 RIGHT OF INSPECTION AND AUDIT
6.1 [****] during each Financial Year, or more often not to exceed
quarterly as reasonably requested by Photogen, Newco shall permit
Photogen or its duly authorised representatives, upon reasonable notice
and at any reasonable time during normal business hours, to have access
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 submitted to Photogen.
Any such inspection of Newco's records shall be at the expense of
Photogen, except that if any such inspection reveals a deficiency in
the amount of the royalty actually paid to Photogen hereunder in any
Financial Year of [****]% or more of the amount of any royalty actually
due to Photogen hereunder, then the expense of such inspection shall be
borne [****] by Newco. Any amount of deficiency shall be paid promptly
to Photogen by Newco.
If such inspection reveals a surplus in the amount of royalties
actually paid to Photogen by Newco, Photogen shall reimburse Newco the
surplus within 15 days after determination.
6.2 In the event of any unresolved dispute regarding any alleged deficiency
or overpayment of royalty payments hereunder, the matter will be
referred to an independent firm of chartered or public accountants
chosen by agreement of Elan and Photogen for a resolution of such
dispute. Any decision by the said firm of chartered accountants shall
be binding on the Parties.
7 REPRESENTATIONS AND WARRANTIES
7.1 Photogen represents and warrants to Newco and Elan as of the
Effective Date, as set forth below:
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[****] REPRESENTS MATERIAL WHICH HAS BEEN REDACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
7.1.1 Photogen has the right to grant the Photogen License and
the General Nycomed Sublicense;
7.1.2 there are no agreements between Photogen and any third parties
that conflict with the Photogen License and/or the General
Nycomed Sublicense;
7.1.3 to Photogen's knowledge, there is no agreement to which
Photogen is a party, or otherwise, or by which it is bound
that restricts the use by Newco of the Photogen License or the
General Nycomed Sublicense;
7.1.4 the patents and patent applications included in the Photogen
Patents and, to Photogen's knowledge, the General Nycomed
Patents, are free and clear of encumbrances and liens except
for the lien on the Method Patents in favour of Imperial Bank
which Alliance is obliged to discharge and remove pursuant to
the Alliance Agreement and, if not released by the Effective
Date, Photogen will use its continuing best efforts to procure
that Alliance shall discharge its obligations to Imperial Bank
and obtain all releases relevant hereto; and
7.1.5 to the best of Photogen's knowledge, there are no proceedings
or threatened proceedings or substantive grounds for
proceedings against Photogen in connection with the Photogen
Intellectual Property or, to Photogen's knowledge, the General
Nycomed Sublicense in relation to the Field or, to Photogen's
knowledge, against General Nycomed or Alliance in connection
with the General Nycomed Sublicense or the Method Patents in
relation to the Field;
7.1.6 to Photogen's best knowledge there is no infringement by third
parties of any Photogen Intellectual Property or, to
Photogen's knowledge, the General Nycomed Patents;
7.1.7 to Photogen' s knowledge, there is no patent of others which
contains claims that they dominate the Photogen Patents or the
General Nycomed Patents;
7.1.8 to Photogen's knowledge, neither the Photogen Patents nor the
General Nycomed Patents nor any products, methods, or other
inventions related thereto interferes, infringes,
misappropriates or conflicts with the intellectual property
rights, contact or other rights of any third party;
7.1.9 Photogen has paid all payments due to relevant third parties
which have become payable on or prior to the date hereof
relating to the Photogen Intellectual Property.
7.2 Photogen further agrees and represents and warrants to Newco and
Elan as follows:
7.2.1 as of the Effective Date, each of the In-License Agreements is
valid and in full
force and effect;
7.2.2 as of the Effective Date, there are no existing or claimed
defaults by Photogen, and to Photogen's best knowledge by any
other party, under any of the In-License Agreements and no
event, act or omission has occurred which (with or without
notice, lapse of time or the happening or occurrence of any
other event) would result in a default under the In-License
Agreements by Photogen, or to Photogen's best knowledge by any
other party except Alliance's obligation to Photogen to
discharge the lien on the Method Patents as described in
Clause 7.1.4;
7.2.3 during the Term, Photogen will fully comply with all of the
terms and conditions of the In-License Agreements. Photogen
will enforce its rights under the In-License Agreements and
Photogen will not assign its rights under the In-License
Agreements; and
7.2.4 during the Term, Photogen will keep Newco and Elan reasonably
fully informed with respect to Photogen's transactions,
arrangements and business under the In-License Agreements that
relate to Newco and/or the transactions contemplated
hereunder, and Photogen shall provide Newco and Elan with any
written notices delivered by any party thereunder that relate
to Newco and/or the transactions contemplated hereunder, or
that may affect Newco;
7.2.5 Photogen to warrant to Newco in identical terms to any and all
warranties provided to Photogen in the In-License Agreements.
7.2.6 The phrase "TO PHOTOGEN'S KNOWLEDGE" in this Clause 7 is to
Photogen's actual knowledge based on reasonable investigation.
7.3 During the Term, Photogen shall not amend, modify, or waive any of its
rights under the In-License Agreements without the prior written
consent of the Management Committee (by the unanimous vote of its
members).
For the avoidance of doubt, Photogen shall not terminate any of its
rights under the In-License Agreements without the prior written
consent of the Management Committee (by the unanimous vote of its
members).
7.4 Photogen shall indemnify and hold harmless Newco and Elan against all
costs, claims and liabilities in respect of any claims or proceedings
which may be taken by a third party against Newco and/or Elan, or which
may arise in any way, in relation to or in connection with the
In-License Agreements except for any wilful wrongful act of Elan or
Newco.
In addition, Photogen shall indemnify and hold harmless Newco and Elan
against all costs, claims and liabilities in respect of any claims or
proceedings which may be taken by a third party against Newco and/or
Elan that any Product infringes the patent rights of
such third party by virtue of the Photogen Patents or the General
Nycomed Patents.
For the avoidance of doubt, the provisions of Clause 7.9 shall not
exclude or limit Newco's and Elan's rights to be fully indemnified by
Photogen hereunder against the full extent of any third party claim,
whether or not such third party claim, includes a claim for the
recovery of consequential loss or incidental or punitive loss or damage
(whether for loss of profits or otherwise).
7.5 In addition to any other indemnities provided for herein, Photogen
shall indemnify and hold harmless Elan, Newco and its Affiliates and
their respective employees, agents, officers and directors from and
against any claims, losses, liabilities or damages (including
reasonable attorney's fees and expenses) incurred or sustained by Elan
or Newco arising out of or in connection with any:
7.5.1 breach of any representation, covenant, warranty or
obligation by Photogen hereunder; or
7.5.2 act or omission on the part of Photogen or any of its
respective employees, agents, officers and directors in the
performance of this Agreement.
7.6 In addition to any other indemnities provided for herein, Newco shall
indemnify and hold harmless Photogen and its Affiliates and their
respective employees, agents, officers and directors from and against
any claims, losses, liabilities or damages (including reasonable
attorney's fees and expenses) incurred or sustained by Photogen arising
out of or in connection with any:
7.6.1 breach of any representation, covenant, warranty or
obligation by Newco hereunder; or
7.6.2 act or omission on the part of Newco or any of its agents or
employees in the performance of this Agreement.
7.7 The Party seeking an indemnity shall:
7.7.1 fully and promptly notify the other Party of any claim or
proceeding, or threatened claim or proceeding;
7.7.2 permit the indemnifying Party to take full care and control
of such claim or proceeding;
7.7.3 co-operate in the investigation and defence of such claim
or proceeding;
7.7.4 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
7.7.5 take all reasonable steps to mitigate any loss or liability in
respect of any such claim or proceeding.
7.8 EXCEPT AS SET FORTH IN THIS CLAUSE 7, PHOTOGEN IS GRANTING THE LICENSE
HEREUNDER ON AN "AS IS" BASIS WITHOUT 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.
7.9 EXCEPT AS SET FORTH IN CLAUSE 7.4, NOTWITHSTANDING ANYTHING TO THE
CONTRARY IN THIS AGREEMENT, PHOTOGEN AND NEWCO SHALL NOT 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, SPECIAL OR INCIDENTAL OR
PUNITIVE LOSS OR DAMAGE (WHETHER FOR LOSS OF PROFITS OR OTHERWISE) AND
WHETHER OCCASIONED BY THE NEGLIGENCE OF THE RESPECTIVE PARTIES, THEIR
EMPLOYEES OR AGENTS OR OTHERWISE.
7.10 On the Effective Date, Newco shall open a special purpose account (the
"SPECIAL PURPOSE ACCOUNT") with Bank of Bermuda and Photogen shall
lodge $100,000 to the Special Purpose Account which will be held by
Newco and applied by Newco to discharge the financial obligations of
Photogen to Alliance set forth in the Alliance Agreement, subject to
the following conditions:
7.10.1 each payment shall be made by Newco to Alliance from the
Special Purpose Account upon a determination by the Management
Committee that the relevant payment is due and owing to
Alliance in accordance with the Alliance Agreement;
7.10.2 each payment shall be made by Newco to Alliance within the
payment period specified for the relevant payment in the
Alliance Agreement;
7.10.3 in the event of a dispute within the Management Committee as
to whether any payment described in this Clause 7.10 should be
made to Alliance in accordance with the Alliance Agreement,
the representatives of Elan and Photogen on the Management
Committee will use best efforts to resolve such dispute
swiftly PROVIDED THAT in the event that any such dispute is
not settled within the Management Committee within 5 days,
Elan shall have absolute discretion and full signing authority
to forthwith make the relevant payment from the Special
Purpose Account to Alliance;
7.10.4 all interest which is paid by Bank of Bermuda to Newco on the
Special Purpose Account shall promptly be paid by Newco to
Photogen.
7.11 On the Effective Date, Photogen will deliver to Newco a fully executed
irrevocable Letter of Direction to its transfer agent, Xxxxxx Trust and
Savings Bank, to issue and deliver that number of shares of common
stock of Photogen in the name of Alliance if and to the extent that the
formula set forth in Section 9(b) of the Alliance Agreement (a copy of
which will be attached to the Letter of Direction) requires the
issuance of such contingent shares.
The Letter of Direction shall be delivered by Newco to Xxxxxx Trust and
Savings Bank hereunder upon a determination by the Management Committee
that Photogen is obliged to deliver the shares of common stock of
Photogen to Alliance in accordance with the formula set forth in
Section 9(b) of the Alliance Agreement.
In the event of a dispute within the Management Committee as to whether
the Letter of Direction should be delivered by Newco to Xxxxxx Trust
and Savings Bank hereunder, the representatives of Elan and Photogen on
the Management Committee will use best efforts to resolve such dispute
swiftly PROVIDED THAT in the event that any such dispute is not settled
within the Management Committee within 5 days, Elan shall have absolute
discretion to cause Newco to deliver the Letter of Direction to Xxxxxx
Trust and Savings Bank for the purposes contemplated herein.
If the Management Committee determines that the formula set forth in
Section 9(b) of the Alliance Agreement does not call for the issuance
of any contingent shares to Alliance, Newco shall promptly return the
Letter of Direction to Photogen.
8. TERM AND TERMINATION
8.1 The term of this Agreement shall commence as of the Effective Date and
shall, subject to the rights of termination outlined in this Clause 8,
expire on a Product-by-Product basis and on a country-by-country basis
on the last to occur of:
8.1.1 [****] starting from the date of the launch of the Product in
the country concerned; or
8.1.2 the date of expiration of the last to expire of the patents
included in the Elan Patents and the Elan Improvements and/or
the Photogen Patents and the Photogen Improvements
("THE TERM")
8.2 If either Party commits a Relevant Event, the other Party shall have,
in addition to all other legal and equitable rights and remedies
hereunder, the right to terminate this
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[****] REPRESENTS MATERIAL WHICH HAS BEEN REDACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Agreement upon 30 days' prior written notice to the defaulting Party.
8.3 For the purpose of this Clause 8, a "RELEVANT EVENT" is committed or
suffered by a Party if:
8.3.1 it commits a material breach of its obligations under
this Agreement and fails to remedy it within 60 days of being
specifically required in writing to do so by the other Party;
provided, that if the breaching Party has proposed a course of
action to rectify the breach and is acting in good faith to
rectify same but has not cured the breach by the 60th day,
such period shall be extended by such period as is reasonably
necessary to permit the breach to be rectified;
8.3.2 a distress, execution, sequestration or other process is
levied or enforced upon or sued out against a material part of
its property which is not discharged or challenged within 30
days;
8.3.3 it is unable to pay its debts in the normal course
of business;
8.3.4 it ceases wholly or substantially to carry on its
business, otherwise than for the purpose of a reconstruction
or amalgamation, without the prior written consent of the
other Party (such consent not to be unreasonably withheld);
8.3.5 the appointment of a liquidator, receiver, administrator,
examiner, trustee or similar officer of such Party or over all
or substantially all of its assets under the law of any
applicable jurisdiction, including without limitation, the
United States of America, Bermuda or Ireland;
8.3.6 an application or petition for bankruptcy, corporate
re-organisation, composition, administration, examination,
arrangement or any other procedure similar to any of the
foregoing under the law of any applicable jurisdiction,
including without limitation, the United States of America,
Bermuda or Ireland, is filed, and is not discharged within 60
days, or a Party applies for or consents to the appointment of
a receiver, administrator, examiner or similar officer of it
or of all or a material part of its assets, rights or revenues
or the assets and/or the business of a Party are for any
reason seized, confiscated or condemned.
8.4 Upon expiration or termination of the Agreement:
8.4.1. any sums that were due from Newco to Photogen 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 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);
8.4.2 any provisions that expressly survive termination or
expiration of this Agreement, including without limitation
this Clause 8, shall remain in full force and effect;
8.4.3 all representations, warranties and indemnities shall
insofar as are appropriate remain in full force and effect;
8.4.4 the rights of inspection and audit set out in Clause 6
shall continue in force for a period of one year; and
8.4.5 all rights and licenses granted pursuant to this Agreement
and to the Photogen Intellectual Property pursuant to the
JDOA (including the rights of Newco pursuant to Clause
11 of the JDOA) shall cease for the Territory or for such
particular country or countries in the Territory (as the case
may be) and shall revert to or be transferred to Photogen, and
Newco shall not thereafter use in the Territory or in such
particular country or countries in the Territory (as the case
may be) any rights covered by this Agreement;
8.4.6 subject to Clause 8.4.7 and to such license, if any, granted
by Newco to Photogen pursuant to the provisions of Clause 12
of the JDOA, all rights to Newco Intellectual Property shall
be transferred to and jointly owned by Photogen and Elan and
may be exploited by both Elan and Photogen separately
pursuant to a perpetual [****], world-wide fully paid
license granted to each of Elan and Photogen with the
right to sublicense;
8.4.7 the rights of permitted third party sub-licensees in and to
the Photogen Intellectual Property shall survive the
termination of the license and sublicense agreements
granting said intellectual property rights to Newco; and
Newco, Elan and Photogen shall in good faith agree upon
the form most advantageous to Elan and Photogen in which
the rights of Newco under any such licenses and 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 both Elan and Photogen).
Any sublicense agreement between Newco and such permitted
sublicensee shall permit an assignment of rights by Newco and
shall contain appropriate confidentiality provisions.
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[****] REPRESENTS MATERIAL WHICH HAS BEEN REDACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
9 CONFIDENTIAL INFORMATION
9.1 The Parties agree that it will be necessary, from time to time, to
disclose to each other confidential and proprietary information,
including without limitation, inventions, works of authorship, trade
secrets, specifications, designs, data, know-how and other proprietary
information relating to the Field, the Products, processes, services
and business of the disclosing Party.
The foregoing shall be referred to collectively as "CONFIDENTIAL
INFORMATION".
9.2 Any Confidential Information disclosed by one Party to another Party
shall be used by the receiving Party exclusively for the purposes of
fulfilling the receiving Party's obligations under this Agreement and
the JDOA and for no other purpose.
9.3 Each Party shall disclose Confidential Information of the other Party
only to those employees, representatives and agents requiring knowledge
thereof in connection with fulfilling the Party's obligations under
this Agreement. 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 agreement
hereto as a condition of receiving Confidential Information. Each Party
shall exercise the same standard of care as it would itself exercise in
relation to its own confidential information (but in no event less than
a reasonable standard of care) to protect and preserve the proprietary
and confidential nature of the Confidential Information disclosed to it
by the other Party. Each Party shall, upon request of the other Party,
return all documents and any copies thereof containing Confidential
Information belonging to, or disclosed by, such other Party.
9.4 Any breach of this Clause 9 by any person informed by one of the
Parties is considered a breach by the Party itself.
9.5 Confidential Information shall not be deemed to include:
9.5.1 information that is in the public domain;
9.5.2 information which is made public through no breach of this
Agreement;
9.5.3 information which is independently developed by a Party as
evidenced by such Party's records;
9.5.4 information that becomes available to a Party on a
non-confidential basis, whether directly or indirectly, from a
source other than a Party, which source did not acquire this
information on a confidential basis; or
9.5.5 information which the receiving Party is required to disclose
pursuant to:
(i) a valid order of a court or other governmental
body; or
(ii) any other requirement of law;
provided that if the receiving Party becomes legally required
to disclose any Confidential Information, the receiving Party
shall give the disclosing Party prompt notice of such fact so
that the disclosing Party may obtain a protective order or
other appropriate remedy concerning any such disclosure. The
receiving Party shall fully co-operate with the disclosing
Party in connection with the disclosing Party's efforts to
obtain any such order or other remedy. If any such order or
other remedy does not fully preclude disclosure, the receiving
Party shall make such disclosure only to the extent that such
disclosure is legally required.
9.6 The provisions relating to confidentiality in this Clause 9 shall
remain in effect during the term of this Agreement, and for a period of
[****] following the expiration or earlier termination of this
Agreement.
9.7 The Parties agree that the obligations of this Clause 9 are necessary
and reasonable in order to protect the Parties' respective businesses,
and each Party agrees that monetary damages would be inadequate to
compensate a Party for any breach by the other Party of its covenants
and agreements set forth herein.
Accordingly, the Parties agree that any such violation or threatened
violation shall cause irreparable injury to a Party and that, in
addition to any other remedies that may be available, in law and equity
or otherwise, each Party shall be entitled to obtain injunctive relief
against the threatened breach of the provisions of this Clause 9, 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.
10 GOVERNING LAW AND ARBITRATION
10.1 This Agreement shall be governed by and construed in accordance with
the laws of the State of New York.
10.2 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.
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[****] REPRESENTS MATERIAL WHICH HAS BEEN REDACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
In the event that the Parties fail to agree on a mutually acceptable
dispute resolution mechanism within 180 days of written notice of a
dispute by one Party to the other Party, any such dispute shall be
finally settled by arbitration pursuant to Clause 10.3.
10.3 Save any dispute under Clause 6.2 which will be resolved in accordance
with the provisions of Clause 6.2, any dispute under this Agreement
which is not settled by mutual consent under Clause 10.2 shall be
finally settled by binding arbitration, conducted in accordance with
the Commercial Arbitration Rules of the American Arbitration
Association by one arbitrator appointed in accordance with said rules.
Such arbitrator shall be reasonably satisfactory to each of the
Parties; provided, that if the Parties are unable to agree upon the
identity of such arbitrator within 15 days of demand by either Party,
then either Party shall have the right to petition a presiding justice
of the Supreme Court of New York, New York County, to appoint an
arbitrator.
The arbitration shall be held in New York, New York.
The arbitrator shall determine what discovery will be permitted,
consistent with the goal of limiting the cost and time which the
Parties must expend for discovery; provided the arbitrator shall permit
such discovery as he deems necessary to permit an equitable resolution
of the dispute.
Any written evidence originally in a language other than English shall
be submitted in English translation accompanied by the original or a
true copy thereof.
The costs of the arbitration, including administrative and arbitrator's
fee, shall be shared equally by the Parties and each Party shall bear
its own costs and attorneys' and witness' fees incurred in connection
with the arbitration.
In rendering judgement, the arbitrator shall be instructed by the
Parties that he shall be permitted to select solely from between the
proposals for resolution of the relevant issue presented by each Party,
and not any other proposal.
A disputed performance or suspended performances pending the resolution
of the arbitration must be completed within 30 days following the final
decision of the arbitrator or such other reasonable period as the
arbitrator determines in a written order.
The Parties will co-operate and use reasonable efforts to ensure that
any arbitration any arbitration hereunder shall be completed swiftly
and in any event within one year from the filing of notice of a request
for such arbitration.
The arbitration proceedings and the decision shall not be made public
without the joint consent of the Parties and each Party shall maintain
the confidentiality of such proceedings and decision unless otherwise
permitted by the other Party.
The Parties agree that the decision shall be the sole, exclusive and
binding remedy between them regarding any and all disputes,
controversies, claims and counterclaims presented to the arbitrator.
Application may be made to any court having jurisdiction over the Party
(or its assets) against whom the decision is rendered for a judicial
recognition of the decision and an order of enforcement.
11 IMPOSSIBILITY OF PERFORMANCE - FORCE MAJEURE
Neither Photogen nor Newco 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, intervention of a government
authority, but any such delay or failure shall be remedied by such
Party as soon as practicable.
12 ASSIGNMENT
This Agreement may not be assigned by either Party without the prior
written consent of the other, save that either Party may assign this
Agreement to its Affiliates or subsidiaries without such prior written
consent provided that such assignment does not have any adverse tax
consequences on the other Party and that the assignee shall be
obligated to the other Party for all of the assignor Party's
obligations hereunder which assignee shall be capable of fulfilling
such obligations.
13 NOTICES
13.1 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:
Xxxxxxxxx Xxxxx,
0 Xxxxxx Xxxxxx,
Xxxxxxxx,
Xxxxxxx,
Xxxxxxxxx: Secretary
Telephone: 000 000 0000
Fax: 000 000 0000
with a copy to Elan at:
Elan Corporation, plc
Xxxxxxx Xxxxx,
Xxxxxxx Xxxxx,
Xxxxxx 0,
Xxxxxxx.
Attention: Vice President, General Counsel,
Elan Pharmaceutical Technologies,
a division of Elan Corporation, plc
Telephone: + 000 0 000 0000
Telefax: + 353 1 709 4124
If to Photogen at:
0000 Xxx Xxxxx,
Xxxxxxxxx,
XX. 0000
XXX.
Attn: Chief Executive Officer
Telephone 000 000 000 0000
Fax: 000 000 000 0000
with a copy to:
Xxxxxx & Xxxxx
Suite 3600
000 Xxxx Xxxxxx
Xxxxxxx
Xxxxxxxx 00000
XXX
Attention: Xxxxxxxx X Xxxxxx
Telephone 000 000 000 0000
Fax: 000 000 000 0000
If to Elan at:
Elan Corporation, plc
Xxxxxxx Xxxxx,
Xxxxxxx Xxxxx,
Xxxxxx 0,
Xxxxxxx.
Attention: Vice President, General Counsel,
Elan Pharmaceutical Technologies,
a division of Elan Corporation, plc
Telephone: + 000 0 000 0000
Telefax: + 353 1 709 4124
or to such other address(es) and telefax numbers as may from time to
time be notified by either Party to the other hereunder.
13.2 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 24 hours
of the time of the dispatch. Notice of change of address shall be
effective upon receipt.
14 MISCELLANEOUS
14.1 WAIVER:
No waiver of any right under this Agreement shall be deemed effective
unless contained in a written document signed by the Party charged with
such waiver, and no waiver of any breach or failure to perform shall be
deemed to be a waiver of any other breach or failure to perform or of
any other right arising under this Agreement.
14.2 SEVERABILITY:
If any provision in this Agreement is agreed by the Parties to be, or
is deemed to be, or becomes invalid, illegal, void or unenforceable
under any law that is applicable hereto:
14.2.1 such provision will be deemed amended to conform to applicable
laws so as to be valid and enforceable; or
14.2.2 if it cannot be so amended without materially altering the
intention of the Parties, it will be deleted, with effect from
the date of such agreement or such earlier date as the Parties
may agree, and the validity, legality and enforceability of
the remaining provisions of this Agreement shall not be
impaired or affected in any way.
14.3 FURTHER ASSURANCES:
At the request of any of the Parties, the other Party or Parties shall
(and shall use reasonable efforts to procure that any other necessary
parties shall) execute and perform all such documents, acts and things
as may reasonably be required subsequent to the signing of this
Agreement for assuring to or vesting in the requesting Party the full
benefit of the terms hereof.
14.4 SUCCESSORS:
This Agreement shall be binding upon and enure to the benefit of the
Parties hereto, their successors and permitted assigns.
14.5 NO EFFECT ON OTHER AGREEMENTS/CONFLICT:
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 herein.
In the event of a conflict between the provisions of this Agreement and
the provisions of the JDOA, the terms of the JDOA shall prevail unless
this Agreement specifically provides otherwise.
14.6 AMENDMENTS:
No amendment, modification or addition hereto shall be effective or
binding on any Party unless set forth in writing after the Effective
Date and executed by a duly authorised representative of each Party.
14.7 COUNTERPARTS:
This Agreement may be executed in any number of counterparts, each of
which when so executed shall be deemed to be an original and all of
which when taken together shall constitute this Agreement.
14.8 GOOD FAITH:
Each Party 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.
14.9 NO RELIANCE:
Each Party hereby acknowledges that in entering into this Agreement it
has not relied on any representation or warranty save as expressly set
out herein or in any document referred to herein.
14.10 RELATIONSHIP OF THE PARTIES:
Nothing contained in this Agreement is intended or is to be construed
to constitute Photogen and Newco as partners, or Photogen as an
employee of Newco, or Newco as an employee of Photogen.
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.
SCHEDULE I
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PHOTOGEN PATAENTS AND PHOTOGEN KNOW-HOW
PHOTOGEN PATENTS
----------------
[****]
PHOTOGEN KNOW-HOW
-----------------
[****]
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[****] REPRESENTS MATERIAL WHICH HAS BEEN REDACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
SCHEDULE 2
GENNYC INTELLECTUAL PROPERTY
[****]
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[****] REPRESENTS MATERIAL WHICH HAS BEEN REDACTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
IN WITNESS WHEREOF the Parties hereto have executed this Agreement.
SIGNED BY /s/ Xxxx Xxxxxx
for and on behalf of
PHOTOGEN TECHNOLOGIES, INC
SIGNED BY /s/ Xxxx Xxxxxx
For and on behalf of
PHOTOGEN NEWCO LIMITED
AGREED TO AND ACCEPTED BY /s/ Xxxxx Xxxxxx
ELAN PHARMA INTERNATIONAL LIMITED
