EXHIBIT 10.3
EXECUTION COPY (V5)
SAFESCIENCE LICENSE AGREEMENT
***TEXT OMITTED AND FILED SEPARATELY
CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. SECTIONS 200.80(B)(4),
200.83 AND 240.24B-2
29 June 2001
LICENSE AGREEMENT
BETWEEN
SAFESCIENCE, INC.
AND
SAFESCIENCE NEWCO, LTD.
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TABLE OF CONTENTS
1 DEFINITIONS
2 SAFESCIENCE LICENSE TO NEWCO
3 INTELLECTUAL PROPERTY
4 [...***...]
5 FINANCIAL PROVISIONS
6 RIGHT OF INSPECTION AND AUDIT
7 REPRESENTATIONS AND WARRANTIES
8 TERM AND TERMINATION
9 CONFIDENTIAL INFORMATION
10 GOVERNING LAW AND JURISDICTION
11 IMPOSSIBILITY OF PERFORMANCE - FORCE MAJEURE
12 ASSIGNMENT
13 NOTICES
14 MISCELLANEOUS
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THIS AGREEMENT dated 29 June 2001 and effective as of the Effective Date (as
defined below)
between:
(1) SafeScience, Inc., a corporation duly incorporated and validly existing
under the laws of the State of Nevada and having its principal place of
business at 00 Xx. Xxxxx Xxxxxx, Xxxxxx, XX 00000, Xxxxxx Xxxxxx of
America; and
(2) SafeScience Newco, Ltd., an exempted limited liability company incorporated
under the laws of Bermuda and having its registered office at Xxxxxxxxx
Xxxxx, 0 Xxxxxx Xx., Xxxxxxxx, Xxxxxxx ("Xxxxx").
RECITALS:
---------
A. Simultaneously herewith, SafeScience, 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 SafeScience so as to permit
Newco to utilize the SafeScience 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 by
or under the common control of Elan or SafeScience or any third party, as
the case may be, excluding, in the case of Elan, an Elan JV. For the
purpose of this definition, (i)"control" shall mean direct or indirect
ownership of [...***...] or more of the stock or shares entitled to vote
for the election of directors; and (ii) Newco shall not be an Affiliate of
Elan, Elan Corp or EIS, nor shall Elan, Elan Corp or EIS be an Affiliate of
Newco.
"After Acquired Technology" shall have the meaning as such term is defined
in Clause 4.1.
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"Agreement" shall mean this license agreement (which expression shall be
deemed to include the Recitals and Schedules hereto).
"Change of Control of SafeScience/Newco" shall have the meaning as such
term is defined in the Elan License Agreement.
"Compounds" shall mean SafeScience's human therapeutic drug GBC-590, the
structure of which is described in Schedule 1, such derivatives or analogs
thereof, or other compounds which are approved in writing by the Steering
Committee, in accordance with Clause 2.4 of the JDOA.
"Confidential Information" shall have the meaning as such term is defined
in Clause 9.
"Definitive Documents" shall mean the definitive agreements relating to the
transaction including finance, stock purchase, research and license
agreements.
"Effective Date" shall mean the Initial Closing Date.
"EIS" shall mean Elan International Services, Ltd., a Bermudan exempted
limited liability company having its registered office at Xxxxxxxxx Xxxxx,
0 Xxxxxx Xx., Xxxxxxxx, Xxxxxxx.
"Elan" shall mean Affiliates and subsidiaries of Elan Corp within the
division of Elan Corp carrying on business as Elan Pharmaceutical
Technologies. For the avoidance of doubt, "Elan" shall exclude the
Excluded Entities.
"Elan Corp" shall mean Elan Corporation, plc., a public limited company
incorporated under the laws of Ireland.
"Elan Improvements" shall have the meaning as such term is defined in the
Elan License Agreement.
"Elan Intellectual Property" shall mean the Elan Know-How, the Elan Patents
and the Elan Improvements.
For the avoidance of doubt, Elan Intellectual Property shall exclude
inventions, patents and know-how owned, licensed or controlled by the
Excluded Entities.
"Elan JV" shall mean an entity that Elan and a third party (i) establish or
have established, (ii) take shareholdings in or have a right to take
shareholdings in, and (iii) grant certain licenses in and to certain
intellectual property rights for the purpose of implementing a strategic
alliance.
"Elan Know-How" shall have the meaning as such term is defined in the Elan
License
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Agreement.
"Elan License Agreement" shall mean that certain license agreement, of even
date herewith, entered into between Elan and Newco.
"Elan Patents" shall have the meaning as such term is defined in the Elan
License Agreement.
"Excluded Entities" shall mean The Liposome Company, Inc. and its
subsidiaries; Axogen Limited; Neuralab Limited; Dura Pharmaceuticals, Inc.
and its subsidiaries; and Affiliates (present or future) of Elan Corp
within the division of Elan Corp carrying on business as Elan
Pharmaceuticals which incorporates, inter alia, EPIL (only to the extent
that it is the owner of patents, know-how or other intellectual property or
technology invented and/or developed within the division of Elan Corp
carrying on business as Elan Pharmaceuticals), Athena Neurosciences, Inc.,
Elan Pharmaceuticals, Inc. and Elan Europe Limited.
"Field" shall mean the prevention and treatment of oncology indications in
humans.
"Financial Year" shall mean each year commencing on 1 January (or in the
case of the first Financial Year, the Effective Date) and expiring on 31
December of each year.
"Initial Closing Date" shall have the meaning as such term is defined in
Section 1(a) of the SafeScience Securities Purchase Agreement.
"Initial Formulation" shall have the meaning as such term is defined in
Clause 2.3 of the JDOA.
"Initial Mode of Administration" shall have the meaning as such term is
defined in Clause 2.3 of the JDOA.
"JDOA" shall mean that certain subscription, joint development and
operating agreement, of even date herewith, by and between Elan,
SafeScience, EIS and Newco.
"NDA" shall mean New Drug Application.
"Newco Intellectual Property" shall mean all rights to patents, know-how
and other intellectual property arising out of the conduct of the Project
by any person, including any technology acquired by Newco from a third
party that does not constitute Elan Intellectual Property or SafeScience
Intellectual Property.
For the avoidance of doubt (i) any preclinical and clinical data and/or
toxicity, stability and pharmacological data generated pursuant to the
Project shall constitute Newco Intellectual Property; and (ii) any patent
application filed by Newco, or by Elan or SafeScience on behalf of Newco,
and any patent issued pursuant thereto, covering a Product shall constitute
Newco Intellectual Property.
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"Party" shall mean SafeScience or Newco, as the case may be, and "Parties"
shall mean both parties together.
"Xxxxx and Xxxxx State Agreements" shall mean the Xxxxx License Agreement
and/or the Xxxxx State License Agreement.
"Xxxxx License Agreement" shall mean that certain agreement entered into
between International Gene Group, Inc., a wholly-owned subsidiary of
SafeScience, Inc., and Xxxxx Xxxxx, Ph.D., an individual, dated 7 January
1994 and amendments thereto, which amendments shall be subject to Clause 7,
below.
"Product" shall mean the Initial Formulation and Initial Mode of
Administration of the Compound in the Field, and such other formulations
and modes of administration of the Compound as may be agreed to by the
Steering Committee in accordance with Clause 2.4 of the JDOA.
"Project" shall mean all activities as undertaken by Elan, SafeScience and
Newco in order to develop the Products.
"SafeScience" shall mean SafeScience, Inc., a Nevada corporation and its
Affiliates.
"SafeScience Improvements" shall mean improvements to the SafeScience
Patents and/or the SafeScience Know-How, developed (i) by SafeScience
outside the Project, (ii) by SafeScience, Elan or Newco or by a third party
(under contract with Newco) pursuant to the Project, and/or (iii) jointly
by any combination of SafeScience, Elan, Newco or a third party (under
contract with Newco) pursuant to the Project, except as limited by
agreements with third parties.
Subject to third party agreements, SafeScience Improvements shall
constitute part of SafeScience Intellectual Property and be included in the
SafeScience License pursuant to Clause 2.1 solely for the purposes set
forth therein. If the inclusion of a SafeScience Improvement in the
SafeScience License is restricted or limited by a third party agreement,
SafeScience shall use reasonable commercial efforts to minimize any such
restriction or limitation.
"SafeScience Intellectual Property" shall mean the SafeScience Know-How,
the SafeScience Patents and the SafeScience Improvements.
"SafeScience Know-How" shall mean, subject to Clause 4.1, any and all
rights owned, licensed or controlled by SafeScience to any scientific,
pharmaceutical or technical information, data, discovery, invention
(whether patentable or not), know-how, substances, techniques, processes,
systems, formulations and designs and expertise relating to the Compound,
which is not generally known to the public.
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"SafeScience License" shall have the meaning set forth in Clause 2.1.
"SafeScience Licensors" shall mean Xxxxx Xxxxx, Ph.D., in respect of the
Xxxxx License Agreement and Xxxxx State University and Xxxxxxx Xxx Karmanos
Cancer Institute, in respect of the Xxxxx State License Agreement.
"SafeScience Patents" shall mean, subject to Clause 4.1, any and all rights
under any and all patent applications and/or patents, now existing,
currently pending or hereafter filed or obtained or licensed by SafeScience
relating to the Compound, as set forth in Schedule 2, and any foreign
counterparts thereof and all divisionals, continuations, continuations-in-
part, any foreign counterparts thereof and all patents issuing on any of
the foregoing and any foreign counterparts thereof, together with all
registrations, reissues, re-examinations, supplemental protection
certificates, or extensions thereof, and any foreign counterparts thereof.
"SafeScience Securities Purchase Agreement" shall mean that certain
securities purchase agreement, dated June 22, 2001, by and between
SafeScience and EIS.
"SafeScience Trademark(s)" shall mean one or more trademarks, trade names,
or service marks that are owned or licensed by or on behalf of SafeScience
which SafeScience may nominate and approve in writing from time to time for
use in connection with the sale or promotion of the Products by Newco.
"Steering Committee" shall have the meaning, as such term is defined in the
JDOA.
"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.
"Xxxxx State License Agreement" shall mean that certain License Agreement
by and among Xxxxx State University, Xxxxxxx Xxx Karmanos Cancer Institute
and SafeScience, Inc., dated 26 January 2001 and amendments thereto, which
amendments shall be subject to Clause 7, below.
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.
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2 SAFESCIENCE LICENSE TO NEWCO
2.1 SafeScience hereby grants to Newco for the Term [...***...] sublicense (the
"SafeScience License") to the SafeScience Intellectual Property to make,
have made, import, use, offer for sale and sell the Product in the Field in
the Territory, subject to [...***...].
2.2 [...***...] shall be responsible for payments related to the financial
provisions and obligations of any third party agreement with respect to the
SafeScience Intellectual Property to which it is a party on the Effective
Date (including amendments thereto) (the "[...***...] 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 SafeScience 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 [...***...] will be responsible under
this Clause 2.2.
2.3 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 SafeScience.
2.4 Notwithstanding anything contained in this Agreement to the contrary,
SafeScience shall have the right outside the Field, to exploit and grant
licenses and sublicenses of the SafeScience Intellectual Property.
For the avoidance of doubt, Newco shall have no right to use the
SafeScience Intellectual Property outside the Field.
2.5 Newco shall not be permitted to assign, or, except as provided in Clause 11
of the JDOA, license or sublicense any of its rights under the SafeScience
Intellectual Property without the prior consent in writing of SafeScience.
The granting of such license or sublicense shall be subject to any
contractual obligations that SafeScience has as of the Effective Date with
respect to the Xxxxx and Xxxxx State Agreements.
2.6 Any agreement between Newco and any permitted third party for the
development or exploitation of the SafeScience Intellectual Property shall
require such third party to maintain the confidentiality of all information
concerning the SafeScience Intellectual Property.
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Insofar as the obligations owed by Newco to SafeScience 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 SafeScience shall own the SafeScience Intellectual Property.
-----
3.2 Trademarks:
-----------
3.2.1 SafeScience hereby grants to Newco for the Term a [...***...]
license to use the SafeScience Trademarks solely to make, have made,
import, use, offer for sale and sell the Products in the Field in
the Territory and the following provisions shall apply as regards
the license of the SafeScience Trademarks by SafeScience to Newco
hereunder:
3.2.1.1 Newco shall ensure that each reference to and use of a
SafeScience Trademark by Newco is in a manner approved by
SafeScience and accompanied by an acknowledgement, in a
form approved by SafeScience, that the same is a trademark
(or registered trademark) of SafeScience.
From time to time, upon the reasonable request of
SafeScience, Newco shall submit samples of the Product to
SafeScience or its duly appointed agent to ensure
compliance with quality standards and specifications.
SafeScience, 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 SafeScience Trademarks
that fails to comply with the quality standards and
specifications referred to in this Clause 3.2, as
determined by SafeScience.
3.2.1.2 Newco shall not use a SafeScience Trademark in any way
which might materially prejudice its distinctiveness or
validity or the goodwill of SafeScience therein.
3.2.1.3 The Parties recognize that the SafeScience Trademarks have
considerable goodwill associated therewith. Newco shall not
use in relation to the
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Products any trademarks other than the SafeScience
Trademarks, except the Elan Trademarks (as such term is
defined in the Elan License Agreement) licensed to Newco
under the Elan License Agreement, without obtaining the
prior consent in writing of SafeScience, which consent may
not be unreasonably withheld. However, such use shall not
conflict with the use and display of the SafeScience
Trademark and such use and display shall require prior
written approval by SafeScience.
3.2.1.4 Newco shall not use in the Territory any trademarks or trade
names so resembling the SafeScience Trademark as to be
likely to cause confusion or deception.
3.2.1.5 Newco shall promptly notify SafeScience in writing of any
alleged infringement or unauthorized use of which it becomes
aware by a third party of the SafeScience Trademarks and
provide SafeScience with any applicable evidence of
infringement or unauthorized use.
3.2.1.6 Newco shall favorably consider promoting and using the
SafeScience Trademarks in each country of the Territory and
provide proof of such use upon request by SafeScience.
3.2.1.7 Newco shall not be permitted to assign or sublicense any of
its rights under the SafeScience Trademarks without the
prior written consent of SafeScience.
3.2.2 SafeScience may, at its sole discretion [...***...], file and
prosecute applications to register and maintain registrations of the
SafeScience Trademarks in the Territory. Newco shall reasonably co-
operate with SafeScience in such efforts. Upon the reasonable request
of Newco, SafeScience shall provide registration information,
including classifications, for each country where the SafeScience
Trademark has been registered.
3.2.3 SafeScience will be entitled to conduct all enforcement proceedings
relating to the SafeScience Trademarks and shall at its sole
discretion decide what action, if any, to take in respect to any
enforcement proceedings of the SafeScience Trademarks or any other
claim or counter-claim brought in respect to the use or registration
of the SafeScience Trademarks. Any such proceedings shall be conducted
[...***...] for its own benefit. Newco and Elan shall reasonably co-
operate with SafeScience in such efforts.
3.2.4 Newco shall promptly notify SafeScience in writing in the event that
any SafeScience Trademark has been challenged, or is threatened to be
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 SafeScience shall have the first
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right to decide whether or not to defend such allegations, or to
adopt an alternative xxxx. If SafeScience decides not defend the
SafeScience Trademark, then Newco may request SafeScience to
defend the SafeScience Trademark [...***...], unless such
requested defense is believed by SafeScience to be
unsubstantiated and without merit. In such a case, SafeScience
may elect not to initiate defense proceedings.
3.2.5 Newco will have no ownership rights in respect of the SafeScience
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
SafeScience.
3.2.6 Nothing in this Agreement shall be construed as a warranty on the
part of SafeScience regarding the SafeScience Trademarks,
including without limitation, that use of the SafeScience
Trademarks in the Territory will not infringe the rights of any
third parties. Accordingly, Newco acknowledges and agrees that
SafeScience makes no such warranty.
3.2.7 SafeScience assumes no liability to Newco, Elan, Elan Corp, 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 SafeScience Trademarks pursuant to this Agreement.
4 [...***...]
5 FINANCIAL PROVISIONS
5.1 Royalties: Prior to the commercialization of the Product, the Steering
---------
Committee shall consider and if appropriate, determine reasonable royalties
with respect to the commercialization of the Product by Newco that shall be
payable by Newco to Elan Corp and SafeScience, [...***...].
At such time, the Steering Committee will agree on an appropriate
definition of "Net Sales" as such term is used in this Agreement.
The provisions set forth in Clauses 5.1 to 5.7 and Clause 6 relate to the
payment of any royalties which the Steering Committee may determine to be
payable by Newco to SafeScience under this Agreement.
5.2 Payment of 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 SafeScience. Each payment
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made to SafeScience shall be accompanied by a true accounting of all
Products sold by Newco and 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 During the Term and for a period of five (5) years thereafter, Newco shall
maintain and keep clear, detailed, complete, accurate and separate records.
All costs and expenses incurred with respect to maintenance of such records
shall be borne by Newco for up to a period of three (3) years, from the
date such records are created, and thereafter, such costs and expenses
shall be borne solely by SafeScience:
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).
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
SafeScience 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 SafeScience's account in a
bank acceptable to SafeScience in the country the currency of which is
involved, or as otherwise agreed by the Parties.
5.6 Elan, SafeScience 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.
5.7 Any taxes payable by SafeScience on any payment made to SafeScience
pursuant to this Agreement shall be for the account of SafeScience. 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
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shall forthwith arrange payment to SafeScience of the amount so withheld.
6 RIGHT OF INSPECTION AND AUDIT
6.1 Once during each Financial Year, or more often not to exceed quarterly as
reasonably requested by SafeScience, Newco shall permit SafeScience or its
duly authorized 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.
Any such inspection of Newco's records shall be at the expense of
SafeScience, except that if any such inspection reveals a deficiency in the
amount of the royalty actually paid to SafeScience hereunder in any
Financial Year quarter of [...***...] or more of the amount of any royalty
actually due to SafeScience hereunder, then the expense of such inspection
shall be borne solely by Newco. Newco shall promptly pay to SafeScience
any amount of deficiency.
If such inspection reveals a surplus in the amount of royalties actually
paid to SafeScience by Newco, SafeScience 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 accountants chosen by agreement of
SafeScience and EIS 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 SafeScience represents and warrants to Newco and Elan, as of the Effective
Date, with respect to the Compound as it relates to the SafeScience
Intellectual Property, as follows:
7.1.1 SafeScience has the right to grant the SafeScience License;
7.1.2 there are no agreements between SafeScience and any third party that
conflict with the SafeScience License;
7.1.3 the patents and patent applications included in the SafeScience
Patents are free and clear of encumbrances and liens;
7.1.4 there are no proceedings pending against SafeScience in connection
with the SafeScience Intellectual Property in relation to the Field;
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7.1.5 [...***...];
7.1.6 [...***...]; and
7.1.7 [...***...].
7.2 Except to the extent Newco shall have the obligation to indemnify
SafeScience pursuant to Clause 7.5 hereof and Elan and SafeScience pursuant
to Clause 10 of the JDOA, in addition to any other indemnities provided for
herein, SafeScience shall indemnify and hold harmless 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 Newco
arising out of or in connection with any:
7.2.1 breach of any representation, covenant, warranty or obligation by
SafeScience hereunder; or
7.2.2 negligent act or omission on the part of SafeScience or any of its
employees, agents, officers or directors in the performance of this
Agreement.
7.3 SafeScience further agrees and represents and warrants to Newco and Elan as
follows:
7.3.1 as of the Effective Date, each of the Xxxxx and Xxxxx State
Agreements is valid and in full force and effect;
7.3.2 as of the Effective Date, there are no existing or claimed defaults
by SafeScience, and to SafeScience's best knowledge by any other
party, under any of Xxxxx and Xxxxx State 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 Xxxxx and Xxxxx State Agreements by
SafeScience, or to SafeScience's best knowledge by any other party;
7.3.3 during the Term, SafeScience will fully comply with all of the terms
and conditions of Xxxxx and Xxxxx State Agreements. SafeScience will
enforce its rights under Xxxxx and Xxxxx State Agreements and
SafeScience will not assign its rights under Xxxxx and Xxxxx State
Agreements; and
7.3.4 during the Term, SafeScience will keep Newco and Elan fully informed
with respect to SafeScience's transactions, arrangements and
business under Xxxxx and Xxxxx State Agreements that relate to Newco
and/or the transactions contemplated hereunder, and SafeScience
shall provide Newco and Elan with any written notices delivered by
any party thereunder.
7.3.5 During the Term, SafeScience shall not amend, modify, or waive any
of its rights
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under the Xxxxx and Xxxxx State Agreements without the prior written
consent of the Steering Committee (by the unanimous vote of its
members).
7.4 For the avoidance of doubt, SafeScience shall not terminate any of its
rights under Xxxxx and Xxxxx State Agreements without the prior written
consent of the Steering Committee (by the unanimous vote of its members).
7.5 In addition to any other indemnities provided for herein, Newco shall
indemnify and hold harmless SafeScience 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 SafeScience arising out of or
in connection with any:
7.5.1 breach of any representation, covenant, warranty or obligation by
Newco hereunder; or
7.5.2 negligent act or omission on the part of Newco or any of its
employees, agents, officers or directors in the performance of this
Agreement.
7.6 A party to this agreement seeking an indemnity (the "Indemnified Party")
pursuant to this Clause 7 shall:
7.6.1 fully and promptly notify the party responsible for indemnifying
such Indemnified Party (the `Indemnifying Party") of any claim or
proceeding, or threatened claim or proceeding;
7.6.2 permit the Indemnifying Party to take full care and control of such
claim or proceeding;
7.6.3 co-operate in the investigation and defense of such claim or
proceeding;
7.6.4 not compromise or otherwise settle any such claim or proceeding
without the prior written consent of the Indemnifying Party, which
consent shall not be unreasonably withheld or delayed; and
7.6.5 take all reasonable steps to mitigate any loss or liability in
respect of any such claim or proceeding.
7.7 EXCEPT AS SET FORTH IN THIS CLAUSE 7, SAFESCIENCE IS GRANTING THE
SAFESCIENCE 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.
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7.8 NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, SAFESCIENCE 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 CURRENT OR
FUTURE PROFITS, LOSS OF ENTERPRISE VALUE OR OTHERWISE) AND WHETHER
OCCASIONED BY THE NEGLIGENCE OF THE RESPECTIVE PARTIES, THEIR EMPLOYEES OR
AGENTS OR OTHERWISE.
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 and
to the provisions of applicable laws, expire on the last to occur of:
8.1.1 the date of expiration or lapse of the last to expire or lapse of
patent rights within the Elan Intellectual Property and the
SafeScience Intellectual Property in the Territory; or
8.1.2 the date which is [...***...] years following the date of the first
commercial sale of a Product in the Territory; provided, however,
that neither Elan nor SafeScience shall be obligated to license the
Elan Intellectual Property or the SafeScience Intellectual Property,
respectively, beyond any period in which Elan or SafeScience has
rights to such intellectual property pursuant to any agreement
between Elan or SafeScience and their respective licensors as such
agreements are in effect as of the Effective Date.
(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 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 by a
Party if:
8.3.1 such Party commits a material breach of its representations,
warranties or obligations under this Agreement or the JDOA and fails
to cure 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 cure the breach and is acting in
good faith to cure same but has not cured the breach by the 60th
day, such period shall be extended by such period as is reasonably
necessary to permit
16
the breach to be cured, provided that such period shall not be
extended by more than 90 days, unless otherwise agreed in writing by
the Parties;
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 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; or
8.3.6 an application or petition for bankruptcy, corporate re-
organization, composition, administration, examination, arrangement
or any other procedure similar to any of the foregoing under the law
of any applicable jurisdiction, including without limitation, the
United States of America, Bermuda or Ireland, is filed, and is not
discharged within 60 days, or a 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.
8.4 In the event Elan terminates the Elan License Agreement as a result of a
Change of Control of SafeScience/Newco pursuant to Clause 8.4 of the Elan
License Agreement, SafeScience shall, thereafter and upon written notice to
Elan and Newco, be entitled to forthwith terminate this Agreement.
8.5 Upon expiration or termination of the Agreement:
8.5.1 any sums that were due from Newco to SafeScience on Net Sales in any
part of the Territory shall be paid in full within 60 days;
8.5.2 any provisions that expressly survive termination or expiration of
this Agreement, including without limitation this Clause 8, shall
remain in full force and effect;
8.5.3 all representations, warranties and indemnities shall insofar as are
appropriate remain in full force and effect;
8.5.4 the rights of inspection and audit set out in Clause 6 shall
continue in force for a period of one year;
17
8.5.5 subject to Clause 8.5.7, all rights and licenses granted to Newco
pursuant to this Agreement and to the SafeScience Intellectual
Property pursuant to the JDOA (including the rights of Newco
pursuant to Clause 11 of the JDOA) shall cease for the Territory and
shall revert to or be transferred to SafeScience, and Newco shall
not thereafter use in the Territory any rights covered by this
Agreement;
8.5.6 subject to any license granted by Newco to Elan, if any, or granted
by Newco to SafeScience, if any, pursuant to the provisions of
Clause 11.3 of the JDOA, all rights to Newco Intellectual Property
shall be assigned to and jointly owned by SafeScience and Elan and
may be exploited by both Elan and SafeScience separately provided
that Elan and SafeScience shall co-operate reasonably in the
prosecution and maintenance of patents within the Newco Intellectual
Property and provided further that nothing hereunder shall grant, or
be construed to grant, a license to SafeScience under the Elan
Intellectual Property; and
8.5.7 the rights of permitted third party sub-licensees in and to the
SafeScience Intellectual Property shall survive the termination of
this Agreement; and Newco, Elan and SafeScience shall in good faith
agree upon the form most advantageous to Elan and SafeScience 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
SafeScience).
Any sublicense agreement between Newco and such permitted
sublicensee shall, inter alia, permit such an assignment of rights
by Newco to SafeScience and shall contain appropriate
confidentiality provisions.
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 the disclosing Party shall be
used by the receiving Party exclusively for the purposes of fulfilling the
receiving Party's obligations under this Agreement and for no other
purpose.
9.3 Save as otherwise specifically provided herein, each Party shall disclose
Confidential
18
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 relating to Confidential Information 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 promptly, 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 be deemed not to include:
9.5.1 information which 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 receiving Party on a non-
confidential basis, whether directly or indirectly, from a source
other than another Party hereto, which source did not acquire this
information on a confidential basis.
9.6 The receiving Party will be entitled to disclose Confidential Information
which the receiving Party is required to disclose pursuant to:
9.6.1 a valid order of a court or other governmental body; or
9.6.2 any other requirement of law;
provided that if the receiving Party becomes legally required to disclose
any Confidential Information hereunder, the receiving Party shall give the
disclosing Party prompt notice of such fact to enable the disclosing Party
to seek 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.
19
9.7 The provisions relating to confidentiality in this Clause 9 shall remain
in effect during the term of this Agreement, and for a period of 7 years
following the expiration or earlier termination of this Agreement.
9.8 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.
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 seek 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 damages and reasonable counsel fees and
expenses to enforce its rights hereunder.
10 GOVERNING LAW AND JURISDICTION
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 within 60 days of the commencement of such negotiations, the
Parties agree to consider other dispute resolution mechanisms including
mediation.
In the event that the Parties fail to agree on a mutually acceptable
dispute resolution mechanism within 10 days of either Party's demand for
such alternative dispute resolution hereunder, or in the event that the
dispute is not resolved pursuant to any dispute resolution mechanism
agreed by the Parties within 6 months, save as otherwise agreed by the
Parties, any such dispute shall be finally settled by the courts of
competent jurisdiction. For the purposes of this Agreement the parties
submit to the exclusive jurisdiction of the courts of the State and
Federal Courts located in the State, City and County of New York.
11 IMPOSSIBILITY OF PERFORMANCE - FORCE MAJEURE
Neither SafeScience 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,
20
including, without limitation, acts of God, 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.
13 NOTICES
13.1 Any notice to be given under this Agreement shall be sent in writing in
English by registered or recorded delivery post or reputable overnight
courier or telefaxed to the following addresses:
If to Newco at:
Xxxxxxxxx Xxxxx,
0 Xxxxxx Xx,
Xxxxxxxx,
Xxxxxxx.
Attention: Secretary
Telephone: 000 000 0000
Fax: 000 000 0000
with a copy to Elan at:
c/o Elan International Services, Ltd.,
000 Xx. Xxxxx Xxxxx,
Xxxxxx, Xxxxxx XX00,
Bermuda.
Attention: President
Telephone: 000-000-0000
Fax: 000-000-0000
If to SafeScience at:
Park Square Building
21
00 Xx. Xxxxx Xxxxxx, 0xx Xxxxx
Xxxxxx, XX 00000
XXX
Attention: President
Telephone (000) 000-0000
Fax: (000) 000-0000
with a copy to:
XxXxxxxxx, Will & Xxxxx
00 Xxxxxxxxxxx Xxxxx
Xxx Xxxx, Xxx Xxxx 00000-0000
Attention: Xxxxxx X. Xxxxxx
Telephone (000) 000-0000
Fax: (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 in the manner set forth
in Clause 13.2.
13.2 Any notice sent by mail shall be deemed to have been delivered within 7
working days after dispatch or delivery to the relevant courier and any
notice sent by telefax shall be deemed to have been delivered upon
confirmation of receipt. Notice of change of address shall be effective
upon receipt. Notices by telefax shall also be sent by another method
permitted hereunder.
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 deemed to be 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
22
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 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 Party to this Agreement, the other Party 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 and executed by a duly
authorized 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 act reasonably in giving effect to the provisions
of this Agreement.
23
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 SafeScience and Newco as partners, or SafeScience as an
employee of Newco, or Newco as an employee of SafeScience.
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.
14.11 Whole Agreement:
----------------
This Agreement (including the Schedules attached hereto) and the
Definitive Documents set forth all of the agreements and understandings
between the Parties with respect to the subject matter hereof, and
supersede and terminate all prior agreements and understandings between
the Parties with respect to the subject matter hereof. There are no
agreements or understandings with respect to the subject matter hereof,
either oral or written, between the Parties other than as set forth in
this Agreement and the Definitive Documents.
24
Schedule 1
----------
Structure of Compound
---------------------
[...***...]
25
Schedule 2
----------
SafeScience Patents
-------------------
[...***...]
26
IN WITNESS WHEREOF the Parties hereto have executed this Agreement.
SIGNED
BY /s/ Xxxxxxx X. Xxxxxx
--------------------------
for and on behalf of
SafeScience, Inc.
SIGNED
BY /s/ Xxxxx Xxxxxx
--------------------------
For and on behalf of
SafeScience Newco, Ltd.
AGREED TO AND ACCEPTED
BY /s/ Xxxxx Xxxxxxxxx
--------------------------
Elan Corporation, plc
27
