EXHIBIT 10.73
DATED MAY 19, 2004
-----------------------------
IMPERIAL COLLEGE INNOVATIONS LIMITED
AND
IMPERIAL COLLEGE OF SCIENCE AND TECHNOLOGY
AND
CYTRX CORPORATION
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PATENT LICENCE AGREEMENT
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[WRAGGE&CO LOGO]
BIRMINGHAM LONDON BRUSSELS
TEL x00 (0)000 000 0000 FAX x00 (0)000 000 0000 XXXX@XXXXXX.XXX
XXX.XXXXXX.XXX
THIS AGREEMENT is made on May 19, 2004
BETWEEN:
(1) IMPERIAL COLLEGE INNOVATIONS LIMITED (Registered in England No 2060639)
whose registered office is at Xxxxxxxxx Xxxxxxxx, Xxxxxxxx Xxxxxxx,
Xxxxxx XX0 0XX ("ICIL"), and
(2) IMPERIAL COLLEGE OF SCIENCE, TECHNOLOGY & MEDICINE a college
incorporated by royal charter, of Xxxxxxxxxx Xxxx, Xxxxxx XX0 0XX
("IMPERIAL"); and
(3) CYTRX CORPORATION, a company established under the laws of the State of
Delaware, U.S.A. and having its principal place of business at 00000
Xxx Xxxxxxx Xxxxxxxxx, Xxxxx 000, Xxx Xxxxxxx, Xxxxxxxxxx 00000 XXX
("CYTRX").
BACKGROUND:
(a) Xxxxxxxxx Xxxxxx is a full-time employee of Imperial, engaged by
Imperial to carry out research. In the course of his normal employment
duties for Imperial Xxxxxxxxx Xxxxxx made inventions and developed
technology, materials and know-how relating to the potential role of
RIP140 in obesity and anorexia including without limitation inventions
in respect of which a patent application has been made (defined below
as the "Patent Application") and consequently Xxxxxxxxx Xxxxxx'x share
in the Licensed Patents belongs to Imperial pursuant to Section 39 of
the Patents Xxx 0000. In order to further the clinical applications and
commercial exploitation of the above technology, Imperial has assigned
to Innovations all its rights, title and interest in the Patent
Application and Materials under an assignment agreement dated 14th May
2004. Accordingly ICIL is the sole legal owner of the Patent
Application and the Materials.
(b) CytRx is a biopharmaceutical company dedicated to the commercialisation
of high value human therapeutics, including those for the treatment of
obesity and diabetes.
(c) CytRx wishes to obtain a licence to the Materials in the Field and the
Licensed Patents (as defined below).
(d) ICIL is willing to grant a licence to CytRx under the conditions set
out in this Agreement including the payment of royalties and
milestones.
In consideration of the mutual covenants and undertakings set out below, THE
PARTIES AGREE as follows:
1 DEFINITIONS
1.1 In this Agreement, the terms defined in this Clause shall have the
meanings specified below:
"AFFILIATE" means any company, partnership or other entity which
directly or indirectly Controls, is Controlled by or is under common
Control with any other entity.
"AGREEMENT" means this agreement and any and all Schedules, appendices
and other addenda to it as may be amended from time to time in
accordance with the provisions of this agreement.
"BIOLOGICAL MATERIALS" means tangible biological or biochemical
materials that are necessary for the effective exercise of the Licensed
Patents (e.g., reagents, cell lines, cDNAs, DNA constructs, animal
models), to the extent that Imperial is free and able to grant access
and commercialisation rights to such materials, which materials are set
out in Schedule 2. Schedule 2 shall be periodically amended by mutual
consent to include any additional Biological Materials that Imperial
may furnish to CytRx.
"BUSINESS DAY" means a day (other than a Saturday or Sunday) on which
the banks are ordinarily open for business in both the City of London
and the City of Los Angeles.
"COMBINATION PRODUCT" means a product (for which Marketing
Authorisation has been granted) sold in the form of a combination
product containing a Licensed Product as an active component and one or
more Other Elements. As used herein, "OTHER ELEMENTS" shall mean either
one or more active components which are not Licensed Products or one or
more other components (such as a delivery device) which are not
Licensed Products.
"COMMENCEMENT DATE" means the date of this Agreement.
"COMPETENT AUTHORITY" means any national or local agency, authority,
department, inspectorate, minister, ministry official, parliament or
public or statutory person or other entity (whether autonomous or not)
of any government of any country having jurisdiction or authority over
either any of the activities and functions contemplated or described by
this Agreement or the Parties including the European Commission, the
Court of First Instance and the European Court of Justice.
"CONFIDENTIAL INFORMATION" means Know How and trade secrets or
confidential information relating to the business affairs or finances
of the other Party supplied or otherwise made available to them or
coming into their possession in relation to the performance of this
Agreement, irrespective of form.
"CONTROL" means either (a) in the case of (i) corporate entities,
direct or indirect ownership of at least fifty percent (50 %) of the
stock or shares entitled to vote for the election of director, (ii)
non-corporate entities, direct or indirect ownership of at least fifty
percent (50 %) of the equity interest with the power to direct the
management and policies of such noncorporate entities or (b) with
respect to any item of or right under the Licensed Patents, the
possession of (whether by ownership or licence, other than pursuant to
this Agreement) or the ability of a Party to grant access to, or a
licence or sublicence of, such item or right as provided for herein
without violating the terms of any agreement or other arrangement with
any Third Party existing at the time such Party would be required
hereunder to grant the other Party such access or licence or
sublicence. "CONTROLS" and "CONTROLLED BY" shall be construed
accordingly.
"CYTRX FOREGROUND IMPROVEMENTS" has the meaning set out in Clause 7.1.
"CYTRX MATERIALS IMPROVEMENTS" has the meaning set out in Clause 8.3.
"CYTRX SUBLICENSEE" means any Third Party that acquires rights to the
use of the Materials and under the Licensed Patents through CytRx or
its Affiliates by virtue of this Agreement.
"DIAGNOSTIC PRODUCT" means any preparation in the form of a device,
compound, kit or service with utility in the diagnosis, prognosis,
prediction or management of obesity, anorexia or diabetes in humans
which contains or comprises:
(a) either in its entirety or in shortened form the RIP140 gene or
RIP140 gene product howsoever modified including without
limitation nucleotides, oligonucleotides, nucleic acid
vectors, peptides, polypeptides, proteins etc.; or
(b) an agent that binds to the RIP140 gene or an RIP140 gene
product (excluding the RIP140 protein or any subunit thereof)
with the purpose of enhancing, interfering with, silencing,
suppressing or modulating the expression thereof such agents
including without limitation complementary sequences, ligands,
cDNA, mRNA, tRNA, antibodies, antibody fragments, peptides,
fusion proteins, mimetics, aptamers, antisense (or other
nucleic acid based gene or gene product modulators),
ribozymes, molecular imprinted polymers, RNAi, microRNA,
dsRNA, siRNA, shRNA, vaccines, immunotherapeutics and gene
therapy products; or
(c) an agent (including without limitation small molecule
entities) that has a mechanism of action through interaction
with or binding to the RIP140 protein (or a subunit thereof);
and
which have been identified by CytRx, a CytRx Affiliate or a CytRx
Sublicensee as a direct result of (i) the use of the Materials (or the
use of an Improvement to the Materials licensed to CytRx under Clauses
8.1 and/or 8.2) or (ii) an activity that falls within a Valid Claim.
"DIRECTIVE" means any present or future directive, regulation,
requirement, instruction, direction or rule of any Competent Authority
including any amendment, extension or replacement thereof then in
force.
"DISCLOSING PARTY" means a Party which discloses Confidential
Information to another Party.
"DOCUMENTS" means any graphic, written or computer readable material on
which Know How can be permanently stored.
"EXPLOIT" means to develop, make, have made, use, have used, sell, have
sold, or import, or have imported and "EXPLOITATION" shall be construed
accordingly.
"FDA" means the United States Food and Drug Administration, the
equivalent Competent Authority in any country of the Territory or any
successor bodies thereto.
"FIELD" means the in vitro or in vivo screening of compounds, molecules
or compositions of matter acting against or as agonists or antagonists
of RIP140 to select compounds, molecules or compositions of matter
which may be useful in the treatment or prevention of obesity, anorexia
or diabetes.
"FIRST COMMERCIAL SALE" means in respect of a Licensed Product the
first commercial sale of any such product by CytRx, a CytRx Affiliate
or a CytRx Sublicensee in any country after grant of a Marketing
Authorisation.
"FORCE MAJEURE" means any event outside the reasonable control of
either Party affecting its ability to perform any of its obligations
(other than payment) under this Agreement, including Act of God, fire,
flood, lightning, war, revolution, act of terrorism, riot or civil
commotion, but excluding strikes, lock-outs or other industrial action,
whether of the affected Party's own employees or others, failure of
supplies of power, fuel, transport, equipment, raw materials or other
goods or services.
"GAAP" means United States generally accepted accounting principles,
consistently applied.
"IMPROVEMENT" means any improvement or enhancement or modification,
whether patentable or otherwise.
"IND" means investigational new drug application filed with, and
accepted by, the FDA prior to Initiation of clinical trials in humans
in the USA, or any comparable application filed with the Regulatory
Authority of a country or group of countries other than the U.S.A. or
any successor body thereto prior to Initiation of clinical trials in
humans in that country or in that group of countries.
"INITIATION" of a clinical trial shall mean the enrolment of the first
human subject into the trial.
"INVESTIGATION AUTHORISATION APPLICATION" means an IND, an IDE or any
other equivalent application not covered by an IND or IDE required by a
Competent Authority anywhere in the Territory.
"KNOW-HOW" means unpatented technical and other information which is
not in the public domain. Know-How includes Documents. The fact that an
item is known to the public shall not be taken to exclude the
possibility that a compilation including the item, and/or a development
relating to the item, is (and remains) not known to the public.
Know-How includes any rights including copyright, database or design
rights protecting such Know-How.
"LICENSED PATENTS" means (a) the Patent Application listed in Schedule
1 which may be updated from time to time as applicable and as mutually
agreed between the Parties, and any non-provisional applications
claiming priority thereto; (b) any patents issued from any such
applications described in (a) anywhere in the world; (c) any divisions,
registrations, confirmations, reissues, re-examinations, extensions,
renewals, continuations, continuations-in-part, revalidations,
additions, substitutions, or renewals entitled to claim priority to any
such patent applications or patents described in (a); and (d) all
national, regional and foreign counterparts or other forms of
protection, including supplementary protection certificates, claiming
priority from the patents or patent applications described in (a) to
(c) above.
"LICENSED PRODUCT" means any preparation for the treatment or
prevention of obesity, anorexia or diabetes in humans that:
(d) incorporates either in its entirety or in shortened form the
RIP140 gene or RIP140 gene product howsoever modified
including without limitation nucleotides, oligonucleotides,
nucleic acid vectors, peptides, polypeptides, proteins etc.;
or
(e) is an agent that binds to the RIP140 gene or an RIP140 gene
product (excluding the RIP140 protein or any subunit thereof)
with the purpose of enhancing, interfering with, silencing,
suppressing or modulating the expression thereof such agents
including without limitation complementary sequences, ligands,
cDNA, mRNA, tRNA, antibodies, antibody fragments, peptides,
fusion proteins, mimetics, aptamers, antisense (or other
nucleic acid based gene or gene product modulators),
ribozymes, molecular imprinted polymers, RNAi, microRNA,
dsRNA, siRNA, shRNA, vaccines, immunotherapeutics and gene
therapy products; or
(f) is an agent (including without limitation small molecule
entities) that has a mechanism of action through interaction
with or binding to the RIP140 protein (or a subunit thereof);
and
which have been identified by CytRx, a CytRx Affiliate or a CytRx
Sublicensee as a direct result of (i) the use of the Materials (or the
use of an Improvement to the Materials licensed to CytRx under Clauses
8.1 and/or 8.2) or (ii) an activity that falls within a Valid Claim.
"LICENCE" has the meaning set out in Clause 2.1.
"LICENSED SERVICES" means services using the Licensed Patents,
Materials or Licensed Products (for example a screening service against
RIP140, where such service is provided to a Third Party).
"MAJOR MARKET" means any one of the following: (i) the United States of
America, (ii) the European Union, (iii) Japan, (iv) Canada or (v)
Australia.
"MARKETING AUTHORISATION" means any approval (including all applicable
pricing and governmental reimbursement approvals in those countries
where such approvals are necessary to sell medicines to a substantial
segment of that country's market for the medicine that is the subject
of the marketing authorisation) required from the FDA or relevant
Competent Authority to market and sell a Licensed Product in a
particular country.
"MARKETING AUTHORISATION APPLICATION" means an application for a
Marketing Authorisation including but not limited to a New Drug
Application or a Biologics License Application as required by the FDA
or its foreign equivalents.
"MATERIALS" means Biological Materials and Related Technology.
"NET SALES VALUE" means in relation to any Licensed Product, the gross
invoice price of Licensed Products sold, leased or disposed of by or on
behalf of CytRx (including by any CytRx Affiliate or CytRx Sublicensee)
to independent third parties in arm's length transactions exclusively
for money or where a transaction is not at arm's length the price which
would have been invoiced if the transaction had been at arms length
less the following deductions applicable to the Licensed Product for:
(a) transportation charges and insurance charges paid by or on
behalf of CytRx (or any CytRx Affiliate or CytRx Sublicensee);
(b) sales and excise taxes or customs duties paid by or on behalf
of CytRx (or any CytRx Affiliate or CytRx Sublicensee) or any
other governmental charges imposed upon the sale of the
Licensed Product and paid by or on behalf of CytRx (or any
CytRx Affiliate or CytRx Sublicensee) (excluding income,
corporation or similar taxes);
(c) fees paid to distributors, consignees or agents in connection
with the sale of the Licensed Product;
(d) rebates and premiums actually granted or allowed in connection
with the sale of a Licensed Product;
(e) allowances or credits actually given to customers on account
of governmental requirements, price differences, rejection,
outdating, returns or recalls of the Licensed Product;
(f) quantity discounts, cash discounts or chargebacks actually
granted in connection with the sale of the Licensed Product;
and
(g) provisions for price reductions actually given after any sale
of a product, for example but not by way of limitation for
late delivery.
If an invoice in respect of the sale or lease of Licensed Products has
not been paid within four months of the due date for payment of the
invoice then ICIL shall credit (against future royalties, milestones
and other amounts payable to ICIL) CytRx in respect of any royalties
paid on such invoice (a "Bad Debt Credit"). The Bad Debt Credit will be
given in respect of the Quarter in which the date four months from the
due date for payment of the invoice falls. Should CytRx subsequently be
paid in relation to an invoice in respect of which a Bad Debt Credit
has been given then royalties on such invoice will again become payable
by CytRx. The royalties will be payable in respect of the Quarter in
which the payment is received.
No royalties shall be payable by CytRx to ICIL in relation to any
disposals of Licensed Products among CytRx and any of CytRx's
Affiliates (or any CytRx Sublicensee or any Affiliates of such CytRx
Sublicensee) provided that the recipient does not consume or use the
Licensed Products save for testing, quality control and research and
development purposes where such testing, quality control and research
and development relates to the testing, quality control and research
and development of such Licensed Products. No royalties shall be paid
on any sales or donations of Licensed Products by CytRx (or any CytRx
Affiliate or CytRx Sublicensee) at or below CytRx's (or CytRx
Affiliate's or CytRx Sublicensee's) fully loaded cost for the Licensed
Products as part of any government or other charitable assistance
program.
In the event that a Licensed Product is sold as part of a Combination
Product in any country, the Net Sales Value of the Licensed Product in
that country for the purposes of
determining royalty payments shall be determined by multiplying the Net
Sales Value of the Combination Product in that country by the fraction
(A/A+B) where A is the average sale price in the relevant Quarter (as
hereinafter defined) of the Licensed Product in that country when sold
separately in finished form and B is the average sale price in the
relevant Quarter of the Other Element in that country sold separately
in finished form.
In the event that the average sale price of the Licensed Product in
that country can be determined but the average sale price of the Other
Element in that country cannot be determined, the Net Sales Value of
the Licensed Product in that country for the purposes of determining
royalty payments shall be calculated by multiplying the Net Sales Value
of the Combination Product in that country by the fraction (C/D) where
C is the selling Party's average sales price in the relevant Quarter of
the Licensed Product and D is the average selling price in the relevant
Quarter of the Combination Product in that country.
If the average sale price of the Other Element in that Quarter can be
determined but the average price of the Licensed Product in that
country cannot be determined, Net Sales Value of the Combination
Product in that country for the purposes of determining royalty
payments shall be calculated by multiplying the Net Sales Value of the
Combination Product in that country by the following formula: one (1)
minus E/D where E is the average selling price in the relevant Quarter
of the Other Element in that country and D is the average selling price
of the Combination Product in that country in the relevant Quarter.
If the average sale price of both the Product and the Other Element
cannot be determined, the Net Sales Value of Product shall be
reasonably agreed upon by the Parties and if the Parties fail to agree
on a calculation method within thirty (30) days of commencing
negotiations the matter shall be referred to Expert's Decision
Procedure in Schedule 3.
"NON-COMMERCIALLY SENSITIVE" means that CytRx in its sole discretion
has determined that (a) no information relating to the CytRx Foreground
Improvement is confidential and (b) it does not wish to Exploit such an
Improvement itself or by way of the grant of commercial licences.
"NON-SEVERABLE IMPROVEMENT" means an Improvement to the technology
disclosed in the Licensed Patents that cannot be Exploited without
infringing a Valid Claim of the Licensed Patents.
"OPTION NOTICE" has the meaning set out in Clause 15.1.
"PARTY" means ICIL, Imperial or CytRx.
"PATENT APPLICATION" means the PCT application PCT/2004/000413 filed on
3rd February 2004 and claiming priority from UK priority patent
application number 0302446.0 filed 3rd February 2003 entitled
"Screening for Modulators of Fat Storage".
"PATENTING TERRITORIES" means USA, Canada, Australia, Europe (EPO
designating all states), Japan, New Zealand and Mexico.
"PATENT RIGHTS" - shall mean patent applications and patents, author
certificates, inventor certificates, utility certificates, improvement
patents and models and certificates of addition and all foreign
counterparts thereof, including any divisional applications and
patents, refilings, renewals, continuations, continuations-in-part,
patents of addition, extensions, reissues, substitutions,
confirmations, registrations, revalidation and additions of or to any
of them, as well as any supplementary protection certificates and
equivalent protection rights in respect of any of them.
"PHASE I CLINICAL TRIAL" means the first administration of a Licensed
Product in human subjects that would satisfy the requirements of 21 CFR
312.21(a) or its non-U.S.A. equivalent.
"PHASE II CLINICAL TRIAL" means a human clinical trial in any country
that is intended to initially evaluate the effectiveness of a Licensed
Product in the targeted patient population for a particular indication
or indications in human subjects with the disease or indication under
study that would satisfy the requirements of 21 CFR 312.21(b) or its
non-U.S.A. equivalent.
"PHASE III CLINICAL TRIAL" means a controlled human clinical trial in
any country involving patients with the disease or condition of
interest the results of which could be
used to establish safety and efficacy of a Licensed Product as a basis
for a Marketing Authorisation that would satisfy the requirements of
X.X. 00 XXX 312.21(c) or its non-U.S.A. equivalent.
"QUARTER" means each period of three (3) months ending on March 31,
June 30, September 30, or December 31 and "QUARTERLY" shall be
construed accordingly.
"RECIPIENT PARTY" means a Party that receives Confidential Information
from another Party.
"RELATED TECHNOLOGY" means Know-How, technical information, research
and development information, test results, and data necessary for the
effective exercise of the Licensed Patents by the Licensee in order to
identify and/or generate and/or develop Licensed Products and/or
Diagnostic Products which are Controlled by ICIL and have been
developed by the Research Group .
"RESEARCH GROUP" MEANS Xxxxxxxxx Xxxxxxx Xxxxxx and/or his associates
in their laboratories at the Institute of Reproductive and
Developmental Biology at Imperial.
"RIP140" means (a) nuclear receptor interacting protein 140 also known
as Nrip1 (nuclear receptor interacting protein 1), and /or (b) a target
protein for nuclear receptor interacting protein 140 and/or (c) a
complex of nuclear receptor interacting protein 140 and its target
protein(s).
"ROYALTY" means the sums payable by CytRx to ICIL based on Net Sales
Value of Licensed Products as set out in Clauses 4.11 to 4.13.
"SEVERABLE IMPROVEMENT" means an Improvement to the technology
disclosed in the Licensed Patents that can be Exploited without
infringing a Valid Claim of the Licensed Patents.
"SIGNATURE FEE" has the meaning set out in Clause 4.1.2.
"SUBLICENSING REVENUE" means milestone payments and upfront fees that
CytRx receives from a CytRx Sublicensee in consideration of a
sublicence of the Licence (in
whatever form, for example but not limited to cash, warrants, loans,
debentures, swaps etc.), but excluding the following payments: (a)
royalties, (b) payments made in consideration for the issuance of
equity or debt securities of CytRx at fair market value (taking into
account customary discounts for restricted securities), and (c)
payments specifically committed to the development of Licensed
Products, Diagnostic Products or Licensed Services on behalf, or for
the benefit of a Sublicensee subject to such payments and their
application to such development being available for audit under clause
5.7 .
"THIRD PARTY" means any person or entity other than ICIL, Imperial or
CytRx and their respective Affiliates.
"U.S.A." means the United States of America and its territories,
possessions and commonwealths.
"VALID CLAIM" means a claim of an issued and unexpired patent included
within the Licensed Patents which has not been held permanently
revoked, unenforceable or invalid by a decision of a court or other
governmental agency of competent jurisdiction unappealed within the
time allowed for appeal, and which has not been admitted to be invalid
or unenforceable through reissue or disclaimer or otherwise.
"YEAR" means the period of twelve months commencing on the Commencement
Date and on each successive anniversary of the Commencement Date and
ending on the day before each successive anniversary of the
Commencement Date.
1.2 The headings to clauses are inserted for convenience only and shall not
affect the interpretation or construction of this Agreement.
1.3 Words imparting the singular shall include the plural and vice versa.
References to persons include an individual, company, corporation, firm
or partnership.
1.4 The words and phrases "other", "including" and "in particular" shall
not limit the generality of any preceding words or be construed as
being limited to the same class as any preceding words where a wider
construction is possible.
1.5 References to any statute or statutory provisions of the United
Kingdom, the USA or the European Union, shall include (i) any
subordinate legislation made under it, (ii) any provision which it has
superseded or re-enacted (whether with or without modification), and
(iii) any provision which subsequently supersedes it or re-enacts it
(whether with or without modification).
2 GRANT OF LICENCE
2.1 ICIL grants to CytRx and, and for such time as they hold that status,
its Affiliates:
2.1.1 a worldwide, exclusive licence, with the right to grant
sublicences, under the Licensed Patents to do all acts which
would otherwise infringe the Licensed Patents including,
without limitation, the right to Exploit the Licensed Products
and Diagnostic Products and provide Licensed Services or
otherwise do all acts which would otherwise infringe a Valid
Claim of the Licensed Patents; and
2.1.2 a worldwide, exclusive license, with the right to grant
sublicenses in connection with a grant of sublicences of the
Licensed Patents, to use the Biological Materials in the
Field, including, without limitation, the right to Exploit the
Licensed Products and Diagnostic Products and provide Licensed
Services; and
2.1.3 a worldwide, non-exclusive license, with the right to grant
sublicenses in connection with a grant of sublicences of the
Licensed Patents, to use the Related Technology in the Field,
including, without limitation, the right to Exploit the
Licensed Products and Diagnostic Products and provide Licensed
Services
(all the licences in this Clause 2.1 being the "LICENCE").
2.2 CytRx and/or its Affiliates grants to ICIL and Imperial an irrevocable,
royalty-free, non-assignable (other than to successors in business),
non-sublicensable, non-exclusive license for (a) ICIL and Imperial and
every employee, student, agent and appointee of Imperial to use the
Licensed Patents, Materials and Related Technology solely for internal
non-commercial academic research and teaching purposes and (b) for ICIL
and Imperial to make the Licensed Patents, Materials and Related
Technology available to
other academic institutions solely for non-commercial research and
teaching purposes under written material transfer agreements that
adequately protect any intellectual property rights created through
such research; provided that in the case of both (a) and (b) and
subject to Clause 2.3, ICIL and/or Imperial shall not jeopardize the
confidential nature of any Know-How. Imperial shall have the right to
use the Licensed Patents, Materials and Related Technology as enabling
technology in non-commercial research projects, including projects
which benefit from external funding.
2.3 If Imperial's scientific research activities conducted by the Research
Group for non-commercial purposes in relation to the Materials in the
Field or Licensed Patents or Improvements licensed to Imperial under
Clause 7.2 where such Improvements have been disclosed to the Research
Group at Imperial produce information that Imperial wishes to present
or publish within twenty four (24) months of the date of this
Agreement, then the proposed text shall be disclosed to CytRx in
advance of its submission for presentation or publication. CytRx shall
have thirty (30) Business Days to review the text during which period
the information may not be presented or published. CytRx may suggest
amendments or omissions to be made to any proposed text, which Imperial
shall reasonably accept, provided that such amendments are reasonably
necessary to prevent any commercial damage to CytRx except where
failure to publish would materially prevent the advancement of medical
science;
2.4 If Imperial's scientific research activities conducted by the Research
Group for non-commercial purposes in relation to the:
2.4.1 Materials within the Field,
2.4.2 Licensed Patents within the Field; or
2.4.3 Improvements within the Field licensed to Imperial under
Clause 7.2 where such Improvements have been disclosed to the
Research Group at Imperial
produce information that Imperial wishes to present or publish after
twenty four (24) months of the date of this Agreement, then Imperial
shall use reasonable efforts to ensure
that the proposed text shall be disclosed to CytRx at least thirty (30)
days in advance of its submission for presentation or publication.
2.5 Sub-licensing.
CytRx shall be entitled to grant sub-licences of its rights under the
terms and conditions of Clause 2.1 of this Agreement to any person,
provided that:
(a) the sub-licence shall include performance and financial
obligations on the sub-licensee which are at least equivalent
to the obligations on CytRx under this Agreement;
(b) the sub-licence shall continue following the termination of
this Agreement for any reason as a licence between ICIL and
the sub-licensee pursuant to clause 14.5.2, provided that if
the royalties and other consideration provided for in the
sub-licence are less that that provided for in this Agreement
such royalties or other consideration shall be increased to be
the same as provided for in this Agreement and further
provided that the sub-licensee agrees in writing to such new
financial terms and to the substitution of CytRx by ICIL;
(c) within thirty (30) days of the grant of any sub-licence CytRx
shall provide to ICIL a summary of the material terms of the
sub-licence and a written agreement from the sub-licensee to
be bound by the provisions of this Agreement to the extent
applicable;
(d) except in the case of the continuation of the licence pursuant
to Clause 2.5(b) CytRx shall be responsible for any breach of
the sub-licence by the sub-licensee, as if the breach had been
that of CytRx under this Agreement, and CytRx shall indemnify
ICIL against any loss, damages, costs, claims or expenses
which are awarded against or suffered by ICIL as a result of
any such breach by the sub-licensee; and
(e) no sub-licence shall carry any right to sub-sub-licence all of
the rights granted to CytRx under this Agreement without the
consent of ICIL (such consent not to be unreasonably withheld)
save that a sub-licence can be sub-licensed for the purposes
of manufacture or co-marketing without the consent of ICIL.
2.6 CytRx shall use commercially reasonable endeavours to ensure that all
of the Licensed Products marketed by it and its sub-licensees are of
satisfactory quality and comply with all material applicable laws in
each country. CytRx shall maintain, or cause a CytRx Sublicensee to
maintain, adequate product liability insurance from the date of first
commercial sale of a Licensed Product for the term of this Agreement.
2.7 CytRx or any CytRx Sublicensees shall be exclusively responsible for
the technical and commercial development and manufacture of Licensed
Products and for incorporating any modifications or developments
thereto that may be necessary or desirable and for all Licensed
Products sold or supplied, and accordingly CytRx shall indemnify ICIL
in the terms of Clause 12.7.
3 MATERIALS
3.1 Within a reasonable time after the Commencement Date Imperial will, at
the cost of CytRx, and in accordance with shipping instructions from
CytRx, deliver sufficient Materials as set out in Schedule 2 to CytRx
at its laboratories in Worcester, Massachusetts, U.S.A. to allow CytRx
to develop RIP140 screening assays and functional assays in their own
laboratories.
4 CONSIDERATION
4.1 In consideration of the grant of the Licence to CytRx, CytRx shall on
signature of this Agreement:
4.1.1 allot and issue to ICIL, credited as fully paid, {***} shares
of common stock in CytRx (the "CONSIDERATION SHARES"); and
4.1.2 pay ICIL {***} (the "SIGNATURE FEE").
4.2 In the event of a delisting from Nasdaq of the Consideration Shares
within the Lock In Period (as defined below):
4.2.1 the Consideration Shares shall be immediately cancelled and
returned to CytRx; and
4.2.2 CytRx shall pay ICIL {***}.
4.3 The Consideration Shares will rank pari passu in all respects with the
existing issued shares of CytRx common stock. CytRx shall cause the
consideration shares to be listed on the Nasdaq Small Cap market or
such other principal market on which CytRx's common stock is then
traded.
4.4 Subject to Clause 4.5, the Consideration Shares shall not be sold,
disposed of or otherwise transferred (in whole or part) by ICIL for a
period of seven (7) months after the Commencement Date (the "LOCK IN
PERIOD"). Any public resale of the Consideration Shares after the Lock
In Period will be subject to compliance with all U.S. securities laws,
which require the registration of those shares or an applicable
exemption from registration, such as the rule known as "Rule 144".
CytRx agrees that upon signature of this Agreement, CytRx will use its
commercially reasonable best efforts to comply with all U.S. securities
laws in order for ICIL to be in a position to execute a public resale
of the Consideration Shares immediately after the Lock In Period and
will file a registration statement with the US Securities and Exchange
Commission covering ICIL's public resale of the Consideration Shares
and use its commercially reasonable best efforts to have that
registration become effective prior to the end of the Lock In Period.
ICIL will provide reasonable assistance to CytRx in this regard .
4.5 The Consideration Shares will be transferable by ICIL to the inventors
of the Licensed Patents before the end of the Lock In Period but the
inventors will be not be able to further sell, dispose of or transfer
such Consideration Shares (in whole or part) during the Lock in Period.
Milestones
4.6 Subject to Clauses 4.7, 5.4 and 5.5, CytRx shall pay to ICIL the
following payments upon achievement of the specified milestones by
CytRx or a CytRx Affiliate or a CytRx Sublicensee for the first
Licenced Product to reach such milestone:
Payable upon Initiation of the first Phase I {***}
Clinical Trial
Payable upon Initiation of the first Phase II {***}
Clinical Trial
Payable upon Initiation of the first Phase III {***}
Clinical Trial
Payable upon first grant of Marketing {***}
Authorisation in a Major Market
4.7 CytRx shall pay to ICIL {***} of any Sublicensing Revenue. In relation
to milestone payments, if {***} of any milestone payment received by
CytRx from a CytRx Sublicensee is less than the sum payable by CytRx in
respect of the same milestone under Clause 4.6, then CytRx shall pay
ICIL the amount set out in Clause 4.6.
4.8 If CytRx is paid any Sublicensing Revenue in the form of non-cash
consideration, ICIL and CytRx will meet to agree the value of such
non-cash consideration and the {***} proportion payable to ICIL will be
paid immediately (unless otherwise agreed between the parties) by CytRx
to ICIL, at the option of CytRx, in cash or in kind. If CytRx and ICIL
cannot agree, then the issue will be referred to the Expert's Decision
Procedure in Schedule 3.
4.9 CytRx shall pay to ICIL {***} of any fees received by CytRx from the
provision by CytRx of Licensed Services.
4.10 CytRx shall notify ICIL in writing within thirty (30) days upon the
achievement of each milestone set forth in Clause 4.6 and shall make
the appropriate milestone payment within thirty (30) days of the
achievement of such milestone.
ROYALTIES
4.11 Subject to Clause 4.12, CytRx shall pay to ICIL a royalty of {***} of
Net Sales Value of Licensed Product(s) sold by CytRx or a CytRx
Affiliate or a CytRx Sublicensee. CytRx
shall only be obliged to pay royalties to ICIL on sales by a CytRx
Sublicensee or a CytRx Affiliate on receipt by CytRx of royalty
payments from a CytRx Sublicensee or a CytRx Affiliate in respect of
such sales.
4.12 Where in addition to the rights licensed by ICIL to CytRx under this
Agreement, CytRx (or a CytRx Affiliate or CytRx Sublicensee) requires
one or more licences from a Third Party to carry out research in
relation to, or Exploit, a Licensed Product (each, a "THIRD PARTY
LICENCE") because, absent such Third Party Licence, CytRx's (or a CytRx
Affiliate or CytRx Sublicensee's) research relating to, or the
Exploitation of, the Licensed Product would infringe a claim of a
patent or patent application or other intellectual property of such
Third Party, the provisions of this Clause 4.12 shall apply. Any
royalty payments on Licensed Products due to such Third Party from
CytRx (or a CytRx Affiliate or CytRx Sublicensee) under any Third Party
Licence shall be credited against any royalty payments due to ICIL
under Clause 4.11, provided however, that under no circumstances shall
the aggregate of the set offs in this Clause 4.12 reduce the royalty
rate for payments due to ICIL from CytRx under Clause 4.11 to below
{***}.
4.13 CytRx shall pay to ICIL a royalty of {***} of Net Sales Value (such
definition being varied mutatis mutandis to substitute Diagnostic
Products for Licensed Products) of Diagnostic Product(s) sold by CytRx
or a CytRx Affiliate or a CytRx Sublicensee. CytRx shall only be
obliged to pay royalties to ICIL on sales by a CytRx Sublicensee on
receipt by CytRx of royalty payments from a CytRx Sublicensee in
respect of such sales.
4.14 All royalties due to ICIL under this Agreement for any Licensed Product
shall be payable on a country-by-country basis until the last Valid
Claim for that country expires.
4.15 For the purpose of calculating royalties under this Clause 4, a
Licensed Product or a Diagnostic Product shall be regarded as sold,
leased or licensed by CytRx when invoiced, or if not invoiced, when
shipped or delivered by CytRx. If a Licensed Product is transferred to
and further sold on by an Affiliate, the royalty on each such Licensed
Product shall be calculated on prices at which it is sold by the
Affiliate; provided, however, that in no event shall royalty be paid
more than once on each Licensed Product.
5 PROVISIONS RELATING TO PAYMENT OF CONSIDERATION
5.1 All sums payable under this Agreement by CytRx shall be paid in US
Dollars. For any payment to CytRx (where ICIL is due a share of that
payment) and where CytRx receives the payment in a currency other than
US Dollars, CytRx will convert the relevant sum due to ICIL into US
Dollars. CytRx will use the conversion rate reported in the Wall Street
Journal two (2) Business Days before the day on which CytRx pays ICIL.
5.2 Within fifty (50) days of the end of each Quarter (and within fifty
(50) days of termination of this Agreement) after the First Commercial
Sale of each Licensed Product in any country, CytRx shall prepare a
statement which shall show on a country-by-country basis for the
previous Quarter all monies due to ICIL under Clause 4.11. That
statement shall include details of Net Sales Value showing the country
of the sales and the total Net Sales Value on a Licensed Product by
Licensed Product and/or Diagnostic Product by Diagnostic Product basis
together with the quantities sold in such country and shall be
submitted to ICIL within such fifty (50) day period together with
remittance of the monies due.
5.3 All lump sum payments under this Agreement (including the Signature Fee
and milestone payments) shall be paid by CytRx within thirty (30) days
of the due date (which in the case of milestone payments shall be in
accordance with Clause 4.10).
5.4 If the US$/L rate exceeds 2.00:1.00 at the time that a milestone
payment is due under Clause 4.10 then that milestone payment will be
increased using the following formula:
5.4.1 If the US$/L rate (as shown in the Wall Street Journal
averaged over the five Business Days before that milestone
payment is due under Clause 4.10) is between 2.0001 and 2.1000
then the appropriate milestone payment set out in Clause 4.6
will be increased by seven and a half percent (7.5%);
5.4.2 If the US$/L rate (as shown in the Wall Street Journal
averaged over the five Business Days before that milestone
payment is due under Clause 4.10) is between 2.1001 and 2.2000
then the appropriate milestone payment set out in Clause 4.6
will be increased by twelve percent (12.0%);
5.4.3 If the US$/L rate (as shown in the Wall Street Journal
averaged over the five Business Days before that milestone
payment is due under Clause 4.10) is between 2.2001 and 2.3000
then the appropriate milestone payment set out in Clause 4.6
will be increased by sixteen percent (16.0%); and
5.4.4 If the US$/L rate (as shown in the Wall Street Journal
averaged over the five Business Days before that milestone
payment is due under Clause 4.10) increases above 2.3000 then
the appropriate milestone payment set out in Clause 4.6 will
be not be increased by more than sixteen percent (16.0%).
5.5 If the US$/L rate goes below 1.700:1.000 at the time that a milestone
payment is due under Clause 4.10 then that milestone payment will be
decreased using the following formula:
5.5.1 If the US$/L rate (as shown in the Wall Street Journal
averaged over the five Business Days before that milestone
payment is due under Clause 4.10) is between 1.69999 and
1.69000 then the appropriate milestone payment set out in
Clause 4.6 will be decreased by seven and a half percent
(7.5%);
5.5.2 If the US$/L rate (as shown in the Wall Street Journal
averaged over the five Business Days before that milestone
payment is due under Clause 4.10) is between 1.68999 and
1.68000 then the appropriate milestone payment set out in
Clause 4.6 will be decreased by twelve percent (12.0%);
5.5.3 If the US$/L rate (as shown in the Wall Street Journal
averaged over the five Business Days before that milestone
payment is due under Clause 4.10) is between 1.67999 and
1.67000 then the appropriate milestone payment set out in
Clause 4.6 will be decreased by sixteen percent (16.0%); and
5.5.4 If the US$/L rate (as shown in the Wall Street Journal
averaged over the five Business Days before that milestone
payment is due under Clause 4.10) falls below 1.67:1 then the
appropriate milestone payment set out in Clause 4.6 will not
be decreased by any more than sixteen percent (16.0%).
5.6 All payments shall be made free and clear of and without deduction or
deferment in respect of any disputes or claims whatsoever and/or as far
as is legally possible in respect of any taxes imposed by or under the
authority of any government or public authority. Any tax (other than
VAT) which CytRx is required to pay or withhold in respect of the
payments to be made to ICIL hereunder shall be deducted from the amount
otherwise due provided that, in regard to any such deduction, CytRx
shall give ICIL reasonable assistance, which shall include the
provision of such documentation as may be required by any revenue
authority and other revenue services, as may be necessary to enable
ICIL to claim exemption therefrom or obtain a repayment thereof or a
reduction thereof and shall upon request provide such additional
documentation from time to time as is needed to confirm the payment of
tax.
5.7 CytRx shall keep and shall procure that CytRx Sublicensees keep true
and accurate records and books of account containing all data necessary
for the production of the royalty statements under Clause 5.2 and the
calculation of the amounts payable by it to ICIL pursuant to this
Agreement. Those records and books of account shall be kept for two (2)
years following the end of the Year to which they relate. Upon ICIL's
written request and, except as set forth in Clause 5.7.6, at ICIL's
expense, a firm of independent certified accountants appointed by ICIL
(which accountants shall not have performed auditing or other services
for any Party or their Affiliates):
5.7.1 shall be given access to and shall be permitted to examine and
copy any books and records of CytRx, its Affiliates
Sublicensees at all reasonable times on Business Days in a
manner calculated so as not to disturb the business affairs of
the auditee for the purpose of certifying that the Net Sales
Value or other relevant sums calculated by CytRx, its
Affiliates and Sublicensees during any Year and previous Years
were reasonably calculated, true and accurate or, if this is
not their opinion, certify the Net Sales Value figure or other
relevant sums for such period which in their judgment is true
and correct;
5.7.2 the examination in Clause 5.7.1 may cover books and records
that are in existence and currently held by Cytrx, its
Affiliates or Sublicensees at the date of the inspection;
5.7.3 prior to any such examination taking place, such firm of
accountants shall undertake to CytRx that they shall keep all
information and data contained in such books and records,
strictly confidential and shall not disclose such information
or copies of such books and records to any third person
including ICIL, but shall only use the same for the purpose of
calculations which they need to perform in order to issue the
certificate to which this Clause envisages;
5.7.4 any such access examination and certification shall occur no
more than once per Year, save that in the event that the
certification of the accountant shows that CytRx has underpaid
sums to ICIL by more than the greater of five thousand US
Dollars ($5,000) and five percent (5%) of the amount properly
owing, such access, examination and certification shall occur
no more than twice in the Year following the certification of
such discrepancy;
5.7.5 CytRx and CytRx Sublicensees shall make available personnel to
answer queries on all books and records required for the
purpose of that certification; and
5.7.6 the cost of the accountant shall be the responsibility of
CytRx if the certification shows it to have underpaid monies
to ICIL by more than the greater of five thousand US Dollars
($5,000) and five percent (5%) of the amount properly owing,
or shall be the responsibility of ICIL otherwise.
5.8 If the accountant concludes that additional royalties or other sums
under this Agreement were owed for the two (2) year period prior to the
inspection, CytRx shall pay the additional royalties or other sums
within thirty (30) days of the date ICIL delivers to CytRx such
accountant's written report so concluding. No additional royalties or
other sums under this Agreement shall be payable by CytRx in relation
to any period more than two (2) years before any inspection. In the
event that the accountant concludes that there has been an overpayment
of royalties or other sums under this Agreement, then subject to
Clause 14.5.5, the amount of the overpayment shall be credited against
the next and any following royalty or milestone payments of CytRx under
this Agreement.
5.9 No royalties payable by CytRx to ICIL shall be refundable or creditable
against any other sum payable by CytRx to ICIL under this Agreement.
5.10 All payments due to ICIL under the terms of this Agreement are
expressed to be exclusive of value added or other sales tax howsoever
arising.
5.11 All payments made to ICIL under this Agreement shall be made to the
bank account of ICIL as notified by ICIL to CytRx from time to time.
6 CONDUCT IN RELATION TO THE FIELD
6.1 CytRx shall, at its own expense, use Reasonable Commercial Efforts to
develop and commercialise at least one Licensed Product (being either a
product directed at the treatment or prevention of obesity or a product
directed at the treatment or prevention of diabetes or a product
directed at the treatment or prevention of both clinical indications)
under the Licence. For the purposes of this Clause 6.1 "REASONABLE
COMMERCIAL EFFORTS" shall mean efforts which are similar to the efforts
used by CytRx in pursuing the development, commercialisation and
marketing of other products under similar commercial circumstances that
have similar commercial value, status and potential to the Licensed
Product in question. In the event that CytRx has not developed any
other products under similar commercial circumstances that have similar
commercial value, status and potential to the Licensed Product in
question then the efforts of CytRx shall be those employed by similar
companies to CytRx in terms of their size and financial resources.
Notwithstanding the foregoing, and for the avoidance of doubt, CytRx
shall not be required by this Clause 6.1 or otherwise to continue with
its commercialisation or development efforts of any Licensed Product in
any country if for safety, efficacy, technical or reasonable business
reasons it decides in good faith to abandon the same.
6.2 CytRx shall provide a report to ICIL on each anniversary of the
Commencement Date which shall be deemed Confidential Information and
shall include:
6.2.1 the status and any outcomes of research and development
carried out by CytRx, any CytRx Affiliate or CytRx Sublicensee
in the Field;
6.2.2 a general statement on the progress of the development by
CytRx,any CytRx Affiliate or CytRx Sublicensee of Licensed
Products;
6.2.3 in addition to CytRx's ongoing obligation under Clause 4.10,
confirmation of the achievement of any of the milestones in
Clause 4.6 by CytRx, its Affiliates or Sublicensees; and
6.2.4 following the payment of the milestone payment payable upon
Initiation of the first Phase II Clinical Trial a
commercialisation plan showing all past, current and proposed
actions by CytRx, a CytRx Affiliate of CytRx Sublicensee to
market any Licensed Product that has reached at least the
Initiation of a Phase II Clinical Trial.
6.3 Any failure by CytRx, a CytRx Affiliate or CytRx Sublicensee to comply
with a timetable or action set out in a report under Clause 6.2 shall
not of itself be deemed to be a failure to employ Reasonable Commercial
Efforts.
6.4 ICIL's receipt of any report under Clause 6.2 shall not be taken to
waive or qualify the Licensee's obligations under Clause 6.1
7 IMPROVEMENTS TO THE LICENSED PATENTS.
7.1 Both Severable Improvements and Non-Severable Improvements made by
CytRx and any Patent Rights therein ("CYTRX FOREGROUND Improvements")
will be owned by CytRx. CytRx shall have responsibility for filing any
Patent Rights relating to CytRx Foreground Improvements and shall own
any subsequent patents. Except as set forth in Clause 7.2, Imperial and
ICIL shall have no rights in CytRx Foreground Improvements or be
entitled to any additional payments with respect to CytRx's
exploitation of the CytRx Foreground Improvements.
7.2 CytRx will notify ICIL of all Non-Commercially Sensitive CytRx
Foreground Improvements which are limited to Non-Severable Improvements
(after CytRx has taken
all steps it believes necessary to protect such Improvements). Upon
such notification CytRx will grant to Imperial a royalty-free
non-exclusive, non-sublicensable, world-wide licence to use such
Non-Severable Improvements solely for the purpose of teaching and
scientific research for non-commercial purposes.
7.3 Both Severable Improvements and Non-Severable Improvements made by
Imperial and any Patent Rights therein ("IC FOREGROUND Improvements")
will be owned by ICIL. Imperial's obligations set out in Clause 2.3 in
relation to the publication of its results shall apply to all IC
Foreground Improvements arising from the Research Group.
7.4 For 24 months after the date of this Agreement, ICIL and/or Imperial
shall notify CytRx of all Severable and Non-Severable Improvements
arising from the Research Group promptly after they are created, the
date that such notification is received by CytRx being the
"NOTIFICATION DATE".
7.5 If under Clause 7.4 ICIL notifies CytRx of the creation of a
Non-Severable Improvement made by Imperial it shall also state in such
notice whether or not it intends to patent such Non-Severable
Improvement. CytRx shall within forty five (45) days of the
Notification Date inform ICIL whether it wishes to takes a licence of
such Non-Severable Improvement.
7.6 If CytRx does not reply within such forty five (45) day period or
states that it does not wish to take a licence of the Non-Severable
Improvement then ICIL shall be free to Exploit, license or assign such
Non-Severable Improvement as it sees fit.
7.7 If CytRx notifies ICIL in accordance with Clause 7.5 that it wishes to
take a licence of such Non-Severable Improvement and ICIL has indicated
that it intends to file a patent on such Non-Severable Improvement then
ICIL will be entitled to control in its sole discretion the prosecution
of any Patent Rights relating to such Non-Severable Improvement, and
such control shall include, but not be limited to, deciding which
patent attorney shall have the conduct of the prosecution, what claims
to prosecute and the terms of such claims, which countries in which to
file for Patent Rights, the conduct of any defence to an opposition (if
any) and whether to appeal any decision. Such Patent Rights
will become part of the Licensed Patents and will be automatically
licensed to CytRx under Clause 2.1.1 of this Agreement provided that
such licence will be limited to the Field. ICIL and CytRx will decide
what proportion of the patenting costs associated with the prosecution
of such Patent Rights will be paid by either Party, which will be
dependant on factors such as the scope of the claims and their
relationship to the subject matter of this Agreement and the benefit
that each Party is likely to obtain from such patent protection. In
default of agreement the dispute will be subject to the dispute
resolution procedure in Clause 11.
7.8 If CytRx notifies ICIL in accordance with Clause 7.5 that it wishes to
take a licence of such Non-Severable Improvement and ICIL has indicated
that it does not intend to file a patent on such Non-Severable
Improvement and CytrX believes that the Non-Severable Improvement
should be patented then:
7.8.1 ICIL shall file for Patent Rights in relation to such
Non-Severable Improvement and shall own all subsequent Patents
Rights; and
7.8.2 the length of time that publication is delayed under Clause
2.3 in relation to any such Improvement shall be extended by
thirty (30) Business Days to a total of sixty (60) Business
Days.
7.9 CytRx will be entitled to control in its sole discretion the
prosecution of any Patent Rights filed under Clause 7.8.1, and such
control shall include, but not be limited to, deciding which patent
attorney shall have the conduct of the prosecution, what claims to
prosecute and the terms of such claims, which countries in which to
file for Patent Rights, the conduct of any defence to an opposition (if
any) and whether to appeal any decision. If ICIL file and prosecute the
Patent Rights then CytRx will within 30 days or receipt of an invoice
from ICIL, pay the patenting costs associated with the filing and
prosecution of such Patent Rights and such Patent Rights will become
part of the Licensed Patents and will be automatically licensed to
CytRx under Clause 2.1.1 of this Agreement.
7.10 If CytRx notifies ICIL in accordance with Clause 7.5 that it wishes to
take a licence of such Non-Severable Improvement and neither ICIL nor
CytRx wishes to patent such
Non-Severable Improvement then it will be automatically licensed to
CytRx (a) to the extent that it falls within the scope of a Valid Claim
of the Licensed Patents under Clause 2.1.1 of this Agreement in
addition to the Licensed Patents, and to extent that it does not falls
within the scope of a Valid Claim of the Licensed Patents under clauses
2.1.2 or 2.1.3 as appropriate depending on the nature of the
Improvement.
7.11 ICIL grants CytRx a first right to be granted a worldwide, exclusive
licence to commercialise any Severable Improvements in the Field to the
Licensed Patents made by Imperial and notified to CytRx under Clause
7.4, where such Severable Improvements are unencumbered by any rights
of any Third Party. In relation to any Severable Improvement CytRx
shall notify ICIL within sixty (60) Business Days of the Notification
Date for that Severable Improvement (the "DECISION PERIOD") whether or
not it wishes to take a licence of such Severable Improvement. If CytRx
notifies ICIL that it does wish to take a licence then the parties will
negotiate in good faith to agree terms. If:
7.11.1 CytRx notifies ICIL that it does not wish to take a licence of
such Severable Improvement; or
7.11.2 CytRx does not notify ICIL within the Decision Period; or
7.11.3 the Parties cannot agree the terms of a licence to such
Severable Improvement within six (6) months of the end of the
Decision Period (the "NEGOTIATION PERIOD")
then ICIL will be free, subject to Clause 7.12, to license or assign
the Severable Improvement to a Third Party.
7.12 If a Third Party makes a genuine offer to take a licence or an
assignment of a Severable Improvement that ICIL is free to license or
assign under Clause 7.11 (a "THIRD PARTY OFFER") (in circumstances
where CytRx and ICIL have previously failed to agree terms under
7.11.3) within a period of twenty four (24) months from the end of the
Negotiation Period then ICIL will notify CytRx immediately and CytRx
will have the option to match the Third Party Offer within forty-five
(45) days of being so notified. If CytRx does match the offer then it
shall be granted a licence or assignment of the Severable
Improvement provided that it executes a licence or assignment agreement
within forty-five (45) days (or such longer period agreed by the
Parties) of being notified by ICIL of the Third Party Offer. The
Parties will use reasonable endeavours to agree and execute the licence
or assignment agreement within the three (3) month period. If the
Parties do not execute a licence or assignment agreement in respect of
the Severable Improvement within the three (3) month period then ICIL
will be free to license or assign the Severable Improvement to a Third
Party without any further reference to CytRx.
8 IMPROVEMENTS TO THE MATERIALS
8.1 If the Research Group at Imperial creates an Improvement to the
Biological Materials within 24 months of the date of this Agreement
then such Improvement will be owned by ICIL and become part of the
Biological Materials. It will be exclusively licensed to CytRx for the
Field under the terms of Clause 2.1.2 of this Agreement and Imperial
will supply CytRx with a reasonable quantity of such Biological
Materials within a reasonable time of notification of the Improvement
under Clause 7.4.
8.2 If the Research Group at Imperial creates an Improvement to the Related
Technology within 24 months of the date of this Agreement then such
Improvement will become part of the Related Technology and will be
non-exclusively licensed to CytRx for the Field under the terms of
Clause 2.1.3 of this Agreement.
8.3 Any Improvement made by CytRx to the Materials and any Patent Rights
therein ("CYTRX MATERIALS IMPROVEMENTS") will be owned by CytRx. CytRx
shall have responsibility for filing any Patent Rights relating to
CytRx Materials Improvements and shall own any subsequent patents.
9 PROSECUTION OF THE PATENTS
9.1 Subject to Clause 9.3, CytRx will control in its sole discretion the
prosecution of any Patent Rights included within the Licensed Patents.
Such control shall include, but not be limited to, deciding which
patent attorney shall have the conduct of the prosecution, what claims
to prosecute and the terms of such claims, the conduct of any defence
to an opposition (if any) and whether to appeal any decision.
9.2 Subject to Clause 9.4, CytRx shall only be obliged to prosecute the
Licensed Patents within the Patenting Territories but it may at its
sole discretion prosecute the Licensed Patents outside such
territories. CytRx and its Affiliates and Sublicensees shall not
conduct screening activities relating to the identification of Licensed
Products or Diagnostic Products outside of the Patenting Territories.
9.3 CytRx will not narrow any claims, or abandon any patent applications
within the Licensed Patents in any Patenting Territory without the
consent of ICIL, such consent not to be unreasonably withheld or
delayed.
9.4 If CytRx does not wish to apply for, maintain or register Patent Rights
in connection with the Licensed Patents in one or more of the Patenting
Territories then ICIL shall not unreasonably withhold its consent to
the removal of such country from the list of Patenting Territories.
ICIL shall have the right to file, maintain or register patent
applications at its own expense in such country so removed, and such
applications and resultant patents shall not be subject to this
Agreement.
9.5 CytRx will pay for all ongoing and future patent expenses in relation
to the Licensed Patents prosecuted under Clause 9.1 incurred from the
Commencement Date until termination or expiry of the Agreement and will
instruct and settle all costs directly with the relevant patent agents
or other bodies requiring payment for patent expenses or maintenance
fees as authorized by a letter of instruction from ICIL.
9.6 CytRx shall be entitled to register this licence, if possible in
abbreviated form, in whichever territories it wishes. Imperial and ICIL
shall provide all reasonable assistance to CytRx to:
9.6.1 register this Agreement throughout the world; and
9.6.2 prosecute any Patent Rights within the Licensed Patents
including, without limitation, providing scientific support and advice,
providing laboratory notebooks and signing further documentation and
handing over any current files relating to the prosecution of the
Licensed Patents. CytRx will meet Imperial's and
ICIL's reasonable out of pocket external legal costs and travel
expenses incurred in providing such assistance.
10 PROCEEDINGS RELATING TO THE LICENSED PATENTS
10.1 Each Party shall notify the other promptly during the term of the
Agreement if it becomes aware of:
10.1.1 any proceedings or applications emanating from a Third Party
challenging the validity or enforceability of the Licensed
Patents including, without limitation, any revocation,
interference or opposition proceedings; or
10.1.2 a Third Party taking or threatening to take any proceedings
for infringement of any patents of that Third Party by reason
of CytRx's or CytRx Sublicensees' operation of the Licensed
Patents or the manufacture, use or sale of Licensed Products;
or
10.1.3 any patent infringement or potential patent infringement of
the Licensed Patents by a Third Party (all such proceedings in
Clauses 10.1.1 to 10.1.3 being "ACTIONS").
10.2 CytRx shall have the first right at its sole discretion and cost to
conduct (or have a CytRx Sublicensee conduct) any lawsuits, claims or
proceedings relating to any Actions. ICIL and Imperial shall provide
CytRx (or the CytRx Sublicensee) with all reasonable assistance in
relation to any such lawsuits, claims or proceedings and shall, if
necessary, consent to be joined as a party to them.
10.3 If CytRx (or the CytRx Sublicensee) does not bring or defend any Action
within ninety (90) days of the date that such Action is first notified
by one Party to both of the other Parties then ICIL can bring or defend
such Action and CytRx and Imperial shall provide reasonable assistance
to ICIL at ICIL's cost. ICIL can require CytRx to grant a sublicence
under this Agreement to any infringer that is the subject of an Action
brought by ICIL under this Clause 10.3, provided that the terms of such
sub-licence are reasonably acceptable to CytRx and Imperial.
10.4 If CytRx brings proceedings against a Third Party for infringement of
the Licensed Patents, or any of them, and ICIL is joined in as a party
to such proceedings then ICIL will have the option to pay two percent
(2%) of the legal costs associated with such proceedings including two
percent (2%) of any costs awarded against the Parties. If ICIL
exercises this option then it will share any damages awarded (after all
patenting costs incurred in relation to the Licensed Patents at the
point that the damages are awarded have been deducted from such damages
and paid to the Party who incurred such patenting costs) in the
proportion ninety eight percent (98%) to CytRx and two percent (2%) to
ICIL. If CytRx pays all the legal costs it shall retain all the damages
awarded.
10.5 If ICIL brings proceedings against a Third Party for infringement of
the Licensed Patents, or any of them, and CytRx is joined in as a party
to such proceedings then CytRx will have the option to pay half the
legal costs associated with such proceedings including half of any
costs awarded against the Parties. If CytRx exercises this option then
it will share any damages awarded (after all patenting costs incurred
in relation to the Licensed Patents at the point that the damages are
awarded have been deducted from such damages and paid to CytRx) in the
proportion fifty per cent (50%) to CytRx and fifty percent (50%) to
ICIL. If ICIL pays all the legal costs it shall retain all the damages
awarded.
11 DISPUTE RESOLUTION PROCEDURE
11.1 The Parties will use all reasonable endeavours to resolve disputes
arising out of this Agreement. The Parties may refer any dispute to the
CEO of CytRx and Managing Director of ICIL, who shall co-operate in
good faith to resolve the dispute as amicably as possible within 15
Business Days of the dispute being referred to them.
11.2 If the CEO of CytRx and Managing Director of ICIL fail to resolve the
dispute in the allotted time, the Parties may within that period on the
written request of both Parties agree in writing to enter into an
alternative dispute resolution procedure with the assistance of a
mediator agreed by the parties or, in default of such agreement
appointed by the Centre for Dispute Resolution, Harbour Exchange
Square, London.
11.3 If the alternative dispute procedure fails to resolve the dispute then
the dispute will be resolved by arbitration in accordance with Clause
26.
12 REPRESENTATIONS AND WARRANTIES
12.1 Each Party represents, warrants, undertakes and agrees for the benefit
of the other that:
12.1.1 it has full power to enter into and perform this Agreement;
12.1.2 so far as it is aware the execution and delivery of this
Agreement and the performance of and compliance with its terms
and provisions will not:
(i) conflict with or result in a breach of, or constitute
a default under, any agreement or instrument to which
it is a party or by which it is bound or with its
memorandum and articles of association or certificate
of incorporation; or
(ii) conflict with or result in a breach of any law,
regulation or order of any court.
12.2 ICIL represents, warrants, undertakes and agrees that:
12.2.1 full and accurate details of all registrations of and
applications for registration of the Licensed Patents as at
the Commencement Date are set out Schedule 1;
12.2.2 to the best of its actual knowledge (and without having made
any special enquiries) it is the sole legal and beneficial
owner of the Licensed Patents and Materials;
12.2.3 to the best of its actual knowledge (and without having made
any special enquiries) it does not know of any reason why the
Patent Application will not be granted at least in part and
with commercially significant claims or any Patent Rights
based on it will not be granted in any country;
12.2.4 to the best of its actual knowledge (and without having made
any special enquiries) it does not know of any activities
carried out now by any Third Party
which if carried out after any of the Licensed Patents are
granted would infringe such Licensed Patents;
12.2.5 to the best of its knowledge (and without having made any
special enquiries) it does not own nor is it licensed to use
any intellectual property that relates to RIP140 in the area
of obesity or diabetes other than the Licensed Patents;
12.2.6 to the best of its knowledge (and without having made any
special enquiries) it does not own nor is it licensed to use
any intellectual property that:
(a) would prevent CytRx Exploiting the rights granted
under this Agreement; or
(b) would result in CytRx being liable to pay a royalty
or any other sum, in addition to the sums set out in
Clause 4 above, to Exploit the Licensed Patents or
Materials; or
12.2.7 to the best of its actual knowledge and without having
conducted any special enquiries, all necessary registration,
maintenance and renewal fees currently due in connection with
the Licensed Patents have been made and all necessary
documents and certificates in connection with such Licensed
Patents have been filed with the relevant patent or other
authorities in the United Kingdom for the purposes of
maintaining such Licensed Patents;
12.3 Imperial represents, warrants, undertakes and agrees that it will use
its best endeavours to ensure that any Biological Materials supplied to
CytRx under this Agreement are in accordance with the description of
such Biological Materials. If they are found by CytRx not be in
accordance with such description then, without prejudice to any other
rights accrued by CytRx as a result of the breach of Imperials
obligation in this Clause 12.3, Imperial will use its best endeavours
to provide Biological Materials in accordance with the description.
12.4 Without limiting the scope of Clause 12.2 and 12.3, ICIL does not give
any warranty, representation or undertaking:
12.4.1 as to the efficacy, scope or usefulness of the Licensed
Patents or Materials; or
12.4.2 except as expressly set forth in clause 12.2.6 that the use of
any of the Licensed Patents or Related Technology, the
manufacture, sale or use of the Licensed Products or the
exercise of any of the rights granted under this Agreement
after the date of this Agreement will not infringe any other
intellectual property or other rights of any other person; or
12.4.3 that the Licensed Patents or Materials or any other
information communicated by ICIL to CytRx under or in
connection with this Agreement will produce Licensed Products
of satisfactory quality or fit for the purpose for which CytRx
intended; or
12.4.4 subject to Clause 10.2, as imposing any obligation on ICIL to
bring or prosecute actions or proceedings against third
parties for infringement or to defend any action or
proceedings for revocation of any of the Licensed Patents; or
12.4.5 as imposing any liability on ICIL in the event that any third
party supplies Licensed Products to end-user customers.
12.5 CytRx acknowledges that the Materials and Related Technology are at an
early stage of development. Accordingly, but subject to Clause 12.3,
specific results cannot be guaranteed and any results, materials,
information or other items (together "Delivered Items") provided under
this Agreement are provided "as is" and without any express or implied
warranties, representations or undertakings other than that the
Delivered Items have been created and provided in good faith. As
examples, but without limiting the foregoing, ICIL does not give any
warranty that Delivered Items are of merchantable or satisfactory
quality, are fit for any particular purpose, or are viable,
uncontaminated, safe or non-toxic.
12.6 Except as expressly stated in this Clause 12, no representations, or
warranty whatsoever are made or given by or on behalf of the Parties.
12.7 Subject always to the provisions of Clause 12.11, CytRx shall indemnify
ICIL and Imperial against any loss, damages, costs, expenses or other
liabilities which are awarded against or incurred by ICIL and Imperial
as a result of any claim or threatened claim against them by a Third
Party concerning the use by CytRx, its Affiliates or any of its
sub-licensees of the Licensed Patents or Materials or otherwise in
connection with the manufacture, use or sale of or any other dealing in
any of the Licensed Products by CytRx or its Affiliates or any of its
sub-licensees (hereinafter a "CLAIM"), provided:
12.7.1 CytRx shall not be obligated to indemnify ICIL and/or Imperial
under this Clause if it is shown by evidence acceptable in a
court of law having jurisdiction over the subject matter and
meeting the appropriate degree of proof for such action, that
the Claim was the result of the negligence, failure to
reasonably act or wilful misconduct of any employee or agent
of ICIL and/or Imperial or the conduct of any activity to be
performed by ICIL and/or Imperial pursuant to this Agreement;
and
12.7.2 CytRx shall have no obligation under this Clause 12.7 unless
ICIL and/or Imperial:
(a) gives CytRx prompt written notice of any Claim for
which it seeks to be indemnified under this
Agreement;
(b) CytRx is granted full authority and control over the
defence (at the cost of CytRx), including settlement,
against such Claim; and
(c) ICIL and/or Imperial co-operates as reasonably
required with CytRx and its agents in defence of such
Claim at the cost of CytRx.
12.8 Imperial and/or ICIL shall have the right to participate in the defence
of any such Claim referred to in Clause 12.7 utilising attorneys of its
choice at its own cost and expense, provided, however, that CytRx shall
have full authority and control to handle any such Claim, including any
settlement or other disposition thereof, for which the ICIL and/or
Imperial seeks indemnification under Clause 12.7.
12.9 CytRx undertakes to make no claim against any employee, student, agent
or appointee of ICIL or Imperial, being a claim which seeks to enforce
against any of them any liability whatsoever in connection with this
Agreement or its subject matter save that CytRx can apply for
injunctive relief in relation to an employee, student, agent or
appointee of ICIL or Imperial if they have (or are threatening to)
wilfully disclose any Confidential Information under this Agreement.
12.10 In any event, the maximum liability of ICIL to CytRx under or otherwise
in connection with this Agreement or its subject-matter shall not
exceed the return of all monies paid by CytRx under this Agreement,
together with interest on the balance of such monies from time to time
outstanding, accruing from day to day at the National Westminster Bank
plc base rate from time to time in force.
12.11 Notwithstanding any other provision of this Agreement, no Party shall
be liable to any other Party to this Agreement in contract, tort,
negligence, breach of statutory duty or otherwise for any loss, damage,
costs or expenses of any nature whatsoever incurred or suffered by that
other party or its Affiliates of an indirect or consequential nature
including without limitation any economic loss or other loss of
turnover, profits, business or goodwill.
13 CONFIDENTIALITY
13.1 The Parties each undertake and agree to:
13.1.1 only use the Confidential Information for the purposes
envisaged under this Agreement and not to use the same for any
other purpose whatsoever;
13.1.2 ensure that only those of its officers and employees who are
directly concerned with the carrying out of this Agreement
have access to the Confidential Information on a strictly
applied "need to know" basis and are informed of the secret
and confidential nature of it;
13.1.3 keep the Confidential Information secret and confidential and
not to directly or indirectly disclose or permit to be
disclosed the same to any Third Party excluding
any consultants or other advisors for any reason without the prior
written consent of the Disclosing Party;
13.2 Subject to clause 24, the Parties each agree not to disclose any of the
terms of this Agreement or its existence to any Third Party without the
prior consent of the other Party, except as may be required by law or
to fulfil any other obligations under this Agreement.
13.3 The obligations of confidence referred to in Clause 13.1 shall not
extend to any Confidential Information which:
13.3.1 is or becomes generally available to the public otherwise than
by reason of breach by a Recipient Party of the provisions of
this Clause;
13.3.2 is known to the Recipient Party and is at its free disposal
(having been generated independently by the Recipient Party or
a Third Party in circumstances where it has not been derived
directly or indirectly from the Disclosing Party's
Confidential Information prior to its receipt from the
Disclosing Party provided that evidence of such knowledge is
furnished by the Recipient Party to the Disclosing Party
within 28 days of receipt of that Confidential Information);
13.3.3 is subsequently disclosed to the Recipient Party without
obligations of confidence by a Third Party owing no such
obligations to the Disclosing Party in respect of that
Confidential Information; or
13.3.4 is required by law to be disclosed (including as part of any
regulatory submission or approval process) and then only when
prompt written notice of this requirement has been given to
the Disclosing Party so that it may, if so advised, seek
appropriate relief to prevent such disclosure provided always
that in such circumstances such disclosure shall be only to
the extent so required and shall be subject to prior
consultation with the Disclosing Party with a view to agreeing
timing and content of such disclosure.
13.4 All Confidential Information disclosed by one Party to the other shall
remain the property of the Disclosing Party. In the event that a court
or Competent Authority assumes partial
or complete control over the assets of a Recipient Party based on the
insolvency or bankruptcy of that Party, the Recipient Party shall:
13.4.1 promptly notify such court or Competent Authority:
(a) that Confidential Information received from the Disclosing
Party under this Agreement remains the property of the
Disclosing Party; and
(b) of the confidentiality obligations under this Agreement; and
13.4.2 to the extent permitted by law, take all steps necessary or
desirable to maintain the confidentiality and security of the
Disclosing Party's Confidential Information and to ensure that
the court or Competent Authority maintains that Confidential
Information in confidence in accordance with this Agreement.
13.5 The obligations of the Parties under Clause 13.1 to 13.4 shall survive
the expiration or termination of this Agreement for whatever reason for
a period of 7 years.
13.6 The Parties understand and agree that remedies in damages may be
inadequate to protect against any breach of any of the provisions of
this Clause 13 by either Party or their employees, officers or any
other person acting in concert with it or on its behalf. Accordingly,
each Party shall be entitled to seek the granting of interim and final
injunctive relief by a court of competent jurisdiction in the
discretion of that court against any action that constitutes any breach
of this Clause without the necessity of posting a bond or proving
damages.
14 DURATION AND TERMINATION
14.1 The term of this Agreement shall extend to the expiry of the last Valid
Claim in any country or the earlier termination of this Agreement in
accordance with Clauses 14.2 or 14.3 below.
14.2 CytRx shall have the right to terminate this Agreement upon three (3)
months written notice.
14.3 CytRx shall have the right to terminate the Agreement and the Licence
forthwith in the event that:
(a) ICIL or Imperial commit a material or persistent breach of any
of their material obligations under this Agreement which is
incapable of remedy; or
(b) ICIL or Imperial fail to remedy, where it is capable of
remedy, or persists in any breach of any of their obligations
under this Agreement after having been required in writing to
remedy or desist from such breach within a period of sixty
(60) days of receipt of a notice from CytRx detailing such
breach and of its intention to exercise its rights under this
Clause.
14.4 ICIL shall have the right to terminate the Agreement and the Licence
forthwith in the event that:
(a) CytRx commits a material or persistent breach of any of its
material obligations under this Agreement which is incapable
of remedy; or
(b) CytRx fails to remedy, where it is capable of remedy, or
persists in any material breach of any of its obligations
under this Agreement after having been required in writing to
remedy or desist from such breach within a period of sixty
(60) days of receipt of a notice from ICIL detailing such
breach and of its intention to exercise its rights under this
Clause.
14.5 Upon termination or expiry of this Agreement for any reason whatsoever:
14.5.1 the relationship of the Parties hereunder shall cease save as
(and to the extent) expressly provided for in this Clause
14.5;
14.5.2 ICIL shall grant licences to each CytRx Sublicensee on the
equivalent terms as those set out in this Agreement which will
allow such CytRx Sublicensee to continue to Exploit or use the
rights granted to it by CytRx under this Agreement (with no
obligation for CytRx to make payments to ICIL based on sales
of Licensed Products by the CytRx Sublicensee), provided
always that the termination of this Agreement was not caused
directly or indirectly by a CytRx
Sublicensee in which case ICIL shall have no obligation under
this Clause 14.5.2 with respect to such CytRx Sublicensee;
14.5.3 CytRx and any CytRx Sublicensee shall be entitled to fulfill
any orders which, as at the date of termination, they are
contracted to fulfill and otherwise sell or dispose of any
stock which is in their possession, custody or control at the
date of termination provided that CytRx shall pay royalties on
such sales on the terms of this Agreement. Within six (6)
months of the date of expiry or termination of this Agreement,
CytRx will return to ICIL or dispose of all Materials or
Related Technology in its possession and cease to Exploit
Licensed Products which incorporate Biological Materials that
have been provided to CytRx under this Agreement by ICIL or
Imperial, provided that, following termination of this
Agreement by CytRx, CytRx may continue to Exploit Licensed
Products subject to CytRx continuing to comply with the
provisions of Clauses 4 and 5 relating to the payment of
milestones and royalties and Clauses 12.7 to 12.11. If
following termination of this Agreement CytRx does so continue
to Exploit Licensed Products in any country where there is no
Valid Claim still in force the royalty payable pursuant to
Clause 4 on Licensed Products sold in that country will be
reduced by fifty (50) per cent;
14.5.4 CytRx shall have no obligation to prosecute, maintain or
enforce the Licensed Patents and any patented Non-Severable
Improvements and shall transfer to ICIL all right and title to
the Licensed Patents, any patented Non-Severable Improvements
and intellectual property rights in any Related Technologies;
and
14.5.5 Any overpayments made by CytRx to ICIL, that have not been
credited against royalties or other amounts payable by CytRx
to ICIL under Clause 5.8 will become immediately due and
payable by ICIL to CytRx.
14.6 The obligation to make payments under this Agreement with respect to
any period prior to its expiry or termination shall survive the expiry
or termination of this Agreement.
14.7 Termination of this Agreement for whatever reason shall not affect the
accrued rights of the Parties arising in any way out of this Agreement
as at the date of termination including without limitation the right to
recover damages against each other and all provisions which are
expressed or are implied to survive this Agreement shall remain in full
force and effect.
15 COMMERCIALISATION OPTION
15.1 Following termination of this Agreement, if CytRx notifies in writing
ICIL (an "OPTION NOTICE") that it no longer wishes to develop and/or
market a Licensed Product for the treatment of obesity (an "OPTION
PRODUCT") ICIL will have a first right to take over the development of
such an Option Product and to purchase from CytRx at a commercially
reasonable rate all information, data, intellectual property, Know-How,
regulatory approval data, marketing authorisations relating to it.
15.2 If ICIL notifies CytRx in writing within thirty (30) days of the Option
Notice that it wishes to enter into negotiations to take over the
development of such an Option Product and to purchase the rights set
out in Clause 15.1, then the Parties will promptly enter into
negotiations to agree terms.
15.3 The value of the Option Product will be based on:
15.3.1 the direct costs incurred by CytRx in developing the product
up to the date of any agreement between CytRx and ICIL to
transfer the development of such a Licensed Product and to
purchase the rights set out in Clause 15.1; and
15.3.2 a premium to take account of the risk taken by CytRx in
developing the Option Product up to that point, the likelihood
of the product reaching the market and its potential sales.
The valuation of the Option Product shall be carried out by
the Parties according to reasonable and mutually agreed
principles at the time that ICIL notifies CytRx that it wishes
to enter into negotiations.
15.4 If the negotiations described in Clause 15.2 do not result in an
executed agreement within seven (7) months of the date of the Option
Notice then CytRx will be free to negotiate
with a Third Party and dispose to them the Option Product and all
information, data, intellectual property, Know-How, regulatory approval
data, marketing authorisations relating to it.
15.5 If ICIL notifies CytRx in writing within thirty (30) days of the Option
Notice that it does not wish to enter into negotiations, or does not
respond within such thirty (30) day period, then CytRx will be free to
negotiate with a Third Party and dispose to them the Option Product and
all information, data, intellectual property, Know-How, regulatory
approval data, marketing authorisations relating to it.
16 ASSIGNMENT
16.1 This Agreement may not be assigned by either Party without the prior
written consent of the other Party (such consent not to be unreasonably
withheld and such consent or refusal of consent to be given within 30
days of a request), except that either Party may assign the Agreement
to any of its Affiliates or to a successor in connection with the
merger, consolidation, or sale of all or substantially all of its
assets or that portion of its business pertaining to the subject matter
of the Agreement, with prompt notice to the other party of any such
assignment. The Agreement shall inure to the benefit of and be binding
upon the Parties and their respective lawful successors and assigns.
17 FORCE MAJEURE
17.1 If a Party (the "Non-Performing Party") is unable to carry out any of
its obligations under this Agreement due to Force Majeure this
Agreement shall remain in effect but the Affected Party's relevant
obligations under this Agreement and the corresponding obligations of
the other Party under this Agreement, shall be suspended for a period
equal to the circumstance of Force Majeure.
18 WAIVER
18.1 Save as expressly provided in this Agreement neither Party shall be
deemed to have waived any of its rights or remedies whatsoever provided
by law or under this Agreement unless the waiver is made in writing,
signed by a duly authorised representative of that
Party and may be given subject to any conditions thought fit by the
grantor. Unless otherwise expressly stated any waiver shall be
effective only in the instance and for the purpose for which it is
given.
18.2 No delay or failure of any Party in exercising or enforcing any of its
rights or remedies whatsoever shall operate as a waiver of those rights
or remedies or so as to preclude or impair the exercise or enforcement
of those rights or remedies. No single or partial exercise or
enforcement of any right or remedy by any Party shall preclude or
impair any other exercise or enforcement of that right or remedy by
that Party.
19 SEVERANCE OF TERMS
19.1 If the whole or any part of this Agreement (including any one or more
of the clauses of this Agreement or any sub-clause or paragraph or any
part of one or more of these clauses) is or becomes or is declared
illegal, invalid or unenforceable in any applicable jurisdiction for
any reason (including both by reason of the provisions of any
legislation and also by reason of any decision of any court or
Competent Authority which either has jurisdiction over this Agreement
or has jurisdiction over any of the Parties) then:
19.1.1 in the case of the illegality, invalidity or un-enforceability
of the whole of this Agreement it shall terminate in relation
to the jurisdiction in question; or
19.1.2 in the case of the illegality, invalidity or un-enforceability
of part of this Agreement that part shall be severed from this
Agreement in the jurisdiction in question and that illegality,
invalidity or un-enforceability shall not in any way
whatsoever prejudice or affect the remaining parts of this
Agreement which shall continue in full force and effect.
20 ENTIRE AGREEMENT/VARIATIONS
20.1 This Agreement constitutes the entire agreement and understanding
between the Parties and supersedes all prior oral or written
understandings, arrangements, representations or agreements between
them relating to the subject matter of this Agreement. The Parties
acknowledge that no claims shall arise in respect of any
understandings, arrangements,
representations or agreements so superseded. No director, employee or
agent of any Party is authorised to make any representation or warranty
to another Party not contained in this Agreement, and each Party
acknowledges that it has not relied on any such oral or written
representations or warranties. Nothing in this Agreement removes or
overrides any right of action by any Party in respect of any fraudulent
misrepresentation, fraudulent concealment or other fraudulent action.
20.2 No variation, amendments, modification or supplement to this Agreement
shall be valid unless made in writing in the English language and
signed by a duly authorised representative or representatives of each
Party.
21 NOTICES
21.1 Any notice or other communication to be given pursuant to or made under
or in connection with the matters contemplated by this Agreement shall
be in writing in the English language and shall be delivered by
courier, sent by post or sent by facsimile to the address or facsimile
number of the recipient set out in Schedule 4 or as specified by the
recipient from time to time in accordance with this Clause 21. Notices
sent by e-mail shall not be valid of themselves and must be confirmed
in hard copy form by courier, by post or facsimile.
21.2 Any notice given pursuant to this Clause 21 shall be deemed to have
been received:
21.2.1 in the case of delivery by hand, when delivered; or
21.2.2 in the case of sending by post:
(a) where posted in the country of the addressee, on the second
working day following the day of posting, and
(b) where posted in any other country, on the fifth working day
following the day of posting; or
21.2.3 in the case of facsimile, on acknowledgement by the
recipient's facsimile receiving equipment on a Business Day if
the acknowledgement occurs before
1700 hours local time of the recipient and in any other case
on the following Business Day.
22 COUNTERPARTS
22.1 This Agreement may be executed in any number of counterparts and by the
different Parties on separate counterparts, each of which when so
executed shall be an original of this Agreement, and all of which shall
together constitute one and the same instrument. Complete sets of
counterparts shall be lodged with each Party.
23 THIS AGREEMENT NOT TO CONSTITUTE A PARTNERSHIP; THIRD PARTIES.
23.1 Nothing on this Agreement and no action taken by the Parties pursuant
to this Agreement shall constitute or be deemed to constitute a
partnership association, joint-venture or other co-operative entity
between the Parties and none of the Parties shall have any authority to
bind the others in any way except as provided in this Agreement.
23.2 The Contracts (Rights of Third Parties) Act 1999 will not apply to this
Agreement. No person who is not a party to this Agreement (including
any employee, officer, agent, representative or subcontractor of either
party) except any Affiliates of CytRx will have the right (whether
under the Contracts (Rights of Third Parties) Xxx 0000 or otherwise) to
enforce any term of this Agreement which expressly or by implication
confers a benefit on that person without the express prior agreement in
writing of the Parties which agreement must refer to this Clause 23.2.
24 PRESS RELEASES
24.1 Subject to Clause 24.2, no public announcement or other disclosure to
Third Parties (except to Affiliates of the Parties) concerning this
Agreement shall be made, whether directly or indirectly, by any Party
to this Agreement without first obtaining the approval of the other
Party and agreement upon the nature and text of such announcement or
disclosure with the exception that:
24.1.1 a Party may disclose the full terms of this Agreement to its
investment bankers, lawyers, accountants and other
professional advisors without the other Party's
prior approval provided that such disclosure is made under the
terms of confidentiality whether express or implied; and
24.1.2 a Party may disclose those terms which it is required by a
Directive to disclose and CytRx may file a copy of the
Agreement with the United States Securities and Exchange
Commission provided that it takes advantage of all provisions
to keep confidential as many terms of the Agreement as
possible.
24.1.3 a Party may further disclose the terms where such disclosure
is a repeat of a previous disclosure or items included in such
previous disclosure..
24.2 CytRx will use reasonable commercial endeavours to provide a draft
press release to ICIL by 18 May 2004. Such press release will not be
issued for publication until its contents have been agreed by CytRx and
ICIL. The Parties will use reasonable endeavours to agree the terms of
such press release within a reasonable time with a view to CytRx
publishing the press release on 19 or 20 May 2004.
25 GOVERNING LAW
25.1 The validity and construction and interpretation of this Agreement and
any determination of the performance which it requires shall be
governed by the internal laws of the State of New York, USA.
26 JURISDICTION
26.1 Subject to Clauses 11 and 26.2, all disputes between the Parties
arising under, out of or relating to this Agreement or arising out of
the circumstances and relationships contemplated by this Agreement
including disputes relating to the validity, construction or
interpretation of this Agreement and including its formation, validity,
binding effect, interpretation, performance, breach or termination as
well as non-contractual claims and including disputes relating to
pre-contractual representations which result in any action or
proceeding shall be referred to and finally resolved by arbitration
under the Rules of the ICC International Court of Arbitration which
Rules are deemed to be incorporated by reference into this Clause. The
number of arbitrators shall be one. The place of
arbitration shall be New York. The language to be used in the arbitral
proceedings shall be English.
26.2 Clauses 11 and 26.1 shall not prevent either Party applying for and
obtaining interim relief from a court.
IN WITNESS OF THE ABOVE the Parties have signed this Agreement on the date
written at the head of this Agreement.
SIGNED by ) /s/ XXXXX XXXXXX
for and on behalf of ) ..................................
IMPERIAL COLLEGE INNOVATIONS ) Authorised Signatory
LIMITED )
SIGNED by ) /s/ XXXXX XXXXXXX
for and on behalf of ) ..................................
IMPERIAL COLLEGE ) Authorised Signatory
SIGNED for and on behalf of ) /s/ XXXXXX XXXXXXXXX
CYTRX CORPORATION by ) ..................................
) Authorised Signatory
SCHEDULE 1
LICENSED PATENTS
PCT application PCT/2004/000413 filed on 3rd February 2004 and claiming priority
from UK priority patent application number 0302446.0 filed 3rd February 2003
entitled "Screening for Modulators of Fat Storage"
SCHEDULE 2
BIOLOGICAL MATERIALS
- ANIMALS: RIP140 null mice - upon request 3 pairs of heterozygous
males and females
- CELLS: RIP140 null cells called RIPKO-1.
- RIP140/ NUCLEAR RECEPTOR RESPONSIVE REPORTER CELL LINES (e.g.,
PPRE-luciferase, ERE Luc, SRE-Luc
- DNA CLONES: Expression vectors for RIP140 and mutant version thereof.
- EXPRESSION VECTORS FOR RIP140 expressed as GST or other fusion
protein
- REPORTER ASSAYS & NR VECTORS
- ANTIBODIES: MP45 polyclonal antibody and 6D7 MAb.
SCHEDULE 3
EXPERT'S DECISION
1. Any matter or dispute relating to (a) the calculation method for
royalty payments to be made on any Combination Product or (b) the
valuation of any Sublicensing Revenue received by CytRx in a form
other than cash shall be referred to a person suitably qualified to
determine that matter or dispute (an "EXPERT") who shall be
nominated jointly by the Parties or, failing agreement between the
Parties within twenty (20) Business Days of a written request by
either Party to the other seeking to initiate the Experts' Decision
procedure set out below, either Party may request the president or
chairman for the time being of The American Pharmaceutical
Manufacturers Association or any successor body to it to nominate
the Expert.
2. The Parties shall within fourteen (14) days of the appointment of the
Expert meet with him or her in order to agree a program for the exchange
of any relevant information and the structure to be adopted for the
negotiations.
3. In all cases the terms of appointment of the Expert by whomsoever
appointed shall include:
3.1. a commitment by the Parties to share equally the payment of
the Expert's fee;
3.2. a requirement on the Expert to act fairly as between the
Parties and according to the principles of natural justice;
3.3. a requirement on the Expert to hold professional indemnity
insurance both then and for three (3) years following the date
of his or her determination;
3.4. a commitment by the Parties to supply to the Expert all such
assistance, documents and information as he or she may require
for the purpose of his or her determination; and
3.5. a commitment by the Parties that all negotiations connected
with the dispute shall be conducted in confidence and without
prejudice to the rights of the Parties in any future
proceedings.
4. The Expert's recommendations shall be reduced to writing and once signed
by their duly authorised representatives, shall be binding on the Parties
(save in the case of negligence or manifest error on the part of the
Expert).
SCHEDULE 4
Addresses for Notices
ICIL and Imperial: Imperial College Innovations
Imperial College London
00xx Xxxxx, XXX Xxxxxxxx, Xxxxx
Xxxxxxxxxx Xxxxxx, Xxxxxx XX0 0XX, XX
Facsimile: (0000) 000 0000 or (0207)
594 6584
Attention: Managing Director
CytRx CytRx Corporation
00000 Xxx Xxxxxxx Xxxxxxxxx,
Xxxxx 000,
Xxx Xxxxxxx,
Xxxxxxxxxx 00000 XXX
Facsimile: x000 000 0000
Attention: Xxxxxx Xxxxxxxxx, CEO
