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EXHIBIT 10.18
[Confidential treatment has been requested for portions of this exhibit. The
confidential portions have been redacted and are denoted by [**]. The
confidential portions have been separately filed with the commission.]
DEVELOPMENT AND LICENSE AGREEMENT
AGREEMENT, made as of this 11th day of October, 1996 by and between ILEX
ONCOLOGY INCORPORATED, a company organized under Texas law, having its
principal office at 14785 Omicron, Xxx. 000, Xxx Xxxxxxx, Xxxxx 00000-0000
(hereinafter called "ILEX");
ON THE ONE HAND,
AND:
XXXXXXX PHARMACEUTICA, N.V., a Belgium corporation having its principal place
of business at Xxxxxxxxxxxxx 00, 0000 Xxxxxx, (hereinafter called "XXXXXXX");
ON THE OTHER HAND,
(ILEX and XXXXXXX are each referred to herein by name or as a "Party" or,
collectively, as "Parties").
WITNESSETH:
A. WHEREAS, ILEX has an on-going research program in the field of oncology
and has developed a certain candidate compound referred to as crisnatol,
and has developed certain inventions, proprietary materials and know-how
with respect thereto;
B. WHEREAS, ILEX has exclusive licenses to certain patent rights and know-
how concerning the compound crisnatol in the United States and other
territories pursuant to a License Agreement dated November 1, 1993 with
Xxxxxxxxx
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Wellcome Co. and The Wellcome Foundation Limited (the "BW AGREEMENT")
and has the ability to grant sublicenses thereunder;
C. WHEREAS, ILEX wishes to continue the ongoing development on crisnatol
for the purposes of developing a pharmaceutical product for the
treatment of cancer in humans;
D. WHEREAS, XXXXXXX has been engaged in research efforts focused on the
development of pharmaceutical products and has certain research and
development capabilities to support the further development of crisnatol
and to manufacture, market and sell the product;
E. WHEREAS, XXXXXXX is prepared to collaborate with ILEX in a program for
the development of crisnatol and to undertake a program for the
manufacture and sale of crisnatol, provided that XXXXXXX is able to
obtain a license under the PATENT RIGHTS and KNOW-HOW (as hereinafter
defined) with exclusivity to protect its investment in such program;
F. WHEREAS, ILEX recognizes that XXXXXXX requires such a license in order
to justify the investment in funding and personnel needed to develop and
market products developed hereunder and is willing to grant such rights.
G. WHEREAS, in connection herewith, XXXXXXX & XXXXXXX Development
Corporation, an AFFILIATE of XXXXXXX, has agreed to make an investment
of $ [**] in ILEX, pursuant to a Share Purchase Agreement executed
contemporaneously herewith;
NOW, THEREFORE, in consideration of the premises and the performance of the
covenants herein contained, IT IS AGREED AS FOLLOWS:
ARTICLE 1. DEFINITIONS
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For the purposes of this agreement (hereinafter called the "LICENSE
AGREEMENT"), and solely for such purposes, the terms hereinafter set forth
shall have the following respective meanings:
1.1 "AFFILIATE" or "AFFILIATES" shall mean any corporation(s) or
organization(s) which directly or indirectly CONTROLS, is (are)
CONTROLLED by, or is (are) under common CONTROL with XXXXXXX or ILEX, as
the case may be.
1.2 "COMPOUND" shall mean the chemical known as crisnatol mesylate, having
the chemical structure set forth on Appendix A attached hereto and made
a part hereof.
1.3 "CONTROL", "CONTROL(S)" or "CONTROLLED" shall mean the possession,
direct or indirect, of the power to direct or cause the direction of the
management and policies of the entity, whether through the ownership of
voting securities, by contract or otherwise.
1.4 "COST OF GOODS" means the cost of LICENSED PRODUCT inventory sold and
other manufacturing related costs with respect to the LICENSED PRODUCT.
These costs shall be defined as the sum of the applicable expenditures
incurred directly in bringing goods acquired and/or manufactured to
their existing condition or location. Cost of Goods Sold shall be
calculated in the manner set forth in Appendix B. In the event LICENSED
PRODUCT is sold in the form of combination products containing one or
more EXTRINSIC PRODUCTS, such EXTRINSIC PRODUCT component shall not be
included in the calculation of COST OF GOODS hereunder.
1.5 "DEVELOPMENT" shall mean INITIAL DEVELOPMENT and FULL DEVELOPMENT.
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1.6 "DEVELOPMENT PLAN" shall mean the plan for DEVELOPMENT of a LICENSED
PRODUCT attached hereto as APPENDIX C, and any and all amendments
recommended by the PMT and approved by XXXXXXX pursuant to Article
3.1.2.2(b) hereof.
1.7 "EFFECTIVE DATE" shall mean the date at the head of this LICENSE
AGREEMENT.
1.8 "EXTRINSIC PRODUCT" shall mean an active ingredient other than the
COMPOUND or other components in a convenience package of kit format
containing COMPOUND, or other components in non-consumable devices
containing COMPOUND (such as, for example, implantable pumps or
electronic stimulators; however, items such as, for example, disposable
transdermal patches or prefilled syringes shall constitute consumable
devices).
1.9 "EUROPEAN MAJOR MARKET COUNTRIES" shall mean the United Kingdom,
Germany, France, Italy and Spain.
1.10 "FDA" shall mean the United States Food and Drug Administration.
1.11 "FIELD" shall mean the treatment and/or prophylaxis of cancer in humans.
1.12 "FULL DEVELOPMENT" shall mean all work necessary to carry out the
development plan for the purpose of filing MARKETING AUTHORIZATION
APPLICATIONS in the United States and Europe for the LICENSED PRODUCT in
the LEAD INDICATION.
1.13 "ILEX CHANGE IN CONTROL" shall mean any transaction or series of related
transactions in which (i) a pharmaceutical or biotechnology company with
annual worldwide sales or Five Hundred Million United States Dollars
($500,000,000) or more acquires or becomes the beneficial owner of more
than thirty-three percent (33%) of the outstanding voting securities of
ILEX or the surviving
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entity of any such transaction, whether by merger, consolidation,
reorganization, tender offer or other means or (ii) ILEX is liquidated.
1.14 "ILEX KNOW-HOW" shall mean all (i) information, not generally known to
the public, including all experience, data, formulas, procedures,
methods, models, assays and results, and including all chemical,
pharmacological, toxicological, clinical, analytical and quality control
data, and (ii) all PROPRIETARY MATERIALS which, in the case of (i) or
(ii), are (a) licensed to ILEX pursuant to the BW AGREEMENT or are
otherwise now in possession or hereafter developed or acquired during
the term of this LICENSE AGREEMENT by ILEX, or to which ILEX has rights
to grant licenses, which are useful in the development, manufacture or
use of LICENSED PRODUCT or (b) developed by ILEX in performance of the
DEVELOPMENT PROGRAM.
1.15 "INITIAL DEVELOPMENT" shall mean that portion of the DEVELOPMENT PLAN up
to and including the completion of a stochastic curtailment analysis of
the ongoing PHASE III study for the LEAD INDICATION according to the
DEVELOPMENT PLAN.
1.16 "XXXXXXX KNOW-HOW" shall mean (i) such information, not generally known
to the public, including all experience, data, formulas, procedures,
methods, models, assays and results, and including all chemical,
pharmacological, toxicological, clinical, analytical and quality control
data, and (ii) all PROPRIETARY MATERIALS which in the case of either (i)
or (ii), are developed in the performance of the DEVELOPMENT program and
to which XXXXXXX has rights to grant licenses, which XXXXXXX discloses
to ILEX under this LICENSE AGREEMENT. Notwithstanding the foregoing,
XXXXXXX
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KNOW-HOW shall not include the subject matter covered by any published
patent or patent application.
1.17 "LEAD INDICATION" shall mean the treatment of glioblastoma multiforma.
1.18 "LICENSED PRODUCT" shall mean the COMPOUND or any product containing the
COMPOUND as an active ingredient, (excluding, however, any in vitro or
in vitro diagnostic products);
(i) the manufacture, USE or SALE of which is covered by a
VALID CLAIM of the PATENT RIGHTS or that is SOLD by XXXXXXX an
AFFILIATE of XXXXXXX under conditions or circumstances which, if
unlicensed, would amount to infringement or contributory
infringement or inducement of infringement of the PATENT RIGHTS;
or
(ii) is made by or developed by XXXXXXX through use of the ILEX
KNOW-HOW.
1.19 "MARKETING AUTHORIZATION" shall mean all allowances and approvals
(including pricing and reimbursement approvals) granted by the
appropriate federal, state and local regulatory agencies, departments,
bureaus or other governmental entities within a country necessary to
market and SELL LICENSED PRODUCT.
1.20 "MARKETING AUTHORIZATION APPLICATION" shall mean an application and all
supplements filed pursuant to the requirements of the appropriate
federal, state and local regulatory agencies, departments, bureaus or
other governmental entities within a country, including all documents,
data and other information concerning the LICENSED PRODUCT which are
necessary for or included in, an application for approval to market and
SELL LICENSED PRODUCT in such country. In the case of the United
States, MARKETING
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AUTHORIZATION APPLICATION shall mean a New Drug Application filed
pursuant to the requirements of the FDA as more fully defined in 21 CFR
Section 314.50 et seq.
1.21 "NET SALES," with respect to any LICENSED PRODUCT containing the
Compound as the sole active ingredient, means the gross sales (i.e.,
gross invoice prices) or such LICENSED PRODUCT billed by XXXXXXX and its
AFFILIATES and SUBLICENSEES to the Third Party customers, less; (i)
actual credited allowances to such Third Party customers, less; (i)
actual credited allowances to such Third Party customers for spoiled,
damaged, outdated and returned LICENSED PRODUCT and for allowances in
lieu of returned LICENSED PRODUCT following price increases; (ii) the
amounts of customary trade and cash discounts, to the extent such trade
and cash discounts are not deducted by XXXXXXX, its AFFILIATES its
SUBLICENSEES at the time of invoice in order to arrive at the gross
invoice prices; (iii) all transportation and handling charges, sales
taxes, excise taxes, use taxes or import/export duties actually paid;
and (iv) all other invoiced allowances and adjustments actually credited
to customers including, but not limited to, rebates paid to Third Party
payors, whether during the specific royalty period or not.
With respect to any LICENSED PRODUCT containing one or more active
ingredients in addition to the Compound, means the gross sales of such
LICENSED PRODUCT billed by XXXXXXX, its AFFILIATES and its SUBLICENSEES
to Third Party customers, less all the allowances, adjustments,
discounts, taxes, duties and other charges referred to in this Section
1.22, multiplied by a fraction, the numerator of which shall be the
manufacturing cost or acquisition cost, as applicable, of the Compound
included in such LICENSED
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PRODUCT and the denominator of which shall be the manufacturing or
acquisition cost as applicable, of all active ingredients in such
LICENSED PRODUCT, including the Compound.
1.22 "PATENT RIGHTS" shall mean (i) the B.W. Co. and WFL patents and patent
applications listed in Appendix D under which ILEX is licensed pursuant
to the BW AGREEMENT and any and all patents that may issue from said
patent applications which contain claims covering the manufacture or use
of the COMPOUND, including any and all divisions, continuations,
continuations-in-part, extensions, substitution, renewals,
confirmations, supplementary protective certificates, registrations,
revalidations, reissues or additions or to any of such patents or patent
applications (ii) any other patents or patent applications containing
one or more claims covering a LICENSED PRODUCT, processes, products and
intermediates useful for its production, its compounding into final
product form, and formulations thereof, or the use or sale thereof,
owned or controlled by ILEX, or to which ILEX has rights and under which
ILEX has the right, at any time while this Agreement is in effect, to
grant licenses to in accordance with this Agreement, subject to any pre-
existing third party or government rights therein.
1.23 "PHASE III" shall mean that portion of the DEVELOPMENT PLAN which
provides for continued trials of LICENSED PRODUCT on sufficient numbers
of patients to established the safety and efficacy of a LICENSED PRODUCT
to support MARKETING AUTHORIZATION in the proposed indication. In
addition, PHASE III shall include the completion of all other
development work on animal toxicity, metabolism, drug substance and drug
product formulation
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and manufacturing development necessary to support MARKETING
AUTHORIZATION.
1.24 "PLAN COSTS" shall mean all out-of-pocket, direct and allocated expenses
ordinary and necessary to the execution of the DEVELOPMENT PLAN. Such
expenses include: (i) out-of-pocket costs, which include payments to
Third Parties for supplies, materials, and contracted outside services,
(ii) direct labor costs which include the compensation, benefits and
travel costs of ILEX employees required to carry out the DEVELOPMENT
PLAN; (iii) ILEX research and development department overhead which is
an allocation of general operating expenses such as depreciation, rent,
utilities, taxes, insurance and administrative salaries; (iv) allocated
ILEX general and administrative overhead which includes administrative
costs such as legal, information services, human resources and general
management, but excluding business development, licensing and marketing.
PLAN COSTS shall be accumulated in accordance with generally accepted
accounting principles. Allocations shall be handled on a consistent
basis.
1.25 "PMT" shall mean the Project Management Team.
1.26 "PROPRIETARY MATERIALS" shall mean any composition of matter, including
any of the following:
(i) any nucleotide sequence including DNA and RNA structures;
(ii) genes;
(iii) vectors or constructs including plasmids, phages or
viruses;
(iv) host organisms including bacteria, fungi, algae, protozoa
and hybridomas;
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(v) any eukaryotic or prokaryotic cell lines or expression
systems or development strains thereof;
(vi) antibodies;
(vii) recombinant proteins; or
(viii) chemical compounds; or
(ix) formulations or delivery devices; or
(x) any other chemical or biological material or micro-
organism.
1.27 "PROCESS OPTIMIZATION DEVELOPMENT PLAN" shall mean the plan for scale-up
and optimization of the chemical manufacturing process for the COMPOUND
attached hereto as APPENDIX E.
1.28 "SELLER" shall mean one who SELLS.
1.29 "SOLD", "SALE", "SALES", "SELL", "SELLING" and "SELLS" shall refer to
the act of selling or disposing of for value.
1.30 "SUBLICENSEE" shall mean a third party to whom XXXXXXX has extended a
sublicense under Article 2.2 hereof.
1.31 "USE", "USES" and "USED" shall refer to the act of using for any
commercial purposes whatsoever.
1.32 "VALID CLAIM" shall mean a claim of an issued, unexpired patent within
the PATENT RIGHTS or a claim being prosecuted in a pending application
within the PATENT RIGHTS. A claim of an issued, unexpired patent shall
be presumed to be valid unless and until it has been held to be invalid
by a final judgment of a court of competent jurisdiction from which no
appeal can be or is taken. For the purposes of royalty determination
and payment under Article 5 hereof, any claim being prosecuted in a
pending patent application shall be deemed to be the equivalent of a
valid claim of an issued, unexpired patent.
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ARTICLE 2. LICENSES
2.1 Subject to the limited research license retained by the Licensor under
Article 3.3 of the B.W. AGREEMENT, ILEX hereby grants to XXXXXXX and
XXXXXXX hereby accepts for ILEX, upon the terms and conditions herein
specified, a worldwide exclusive license or sublicense, as applicable,
in the FIELD, under the PATENT RIGHTS and ILEX KNOW-HOW to develop,
make, have made, USE, SELL and have SOLD, LICENSED PRODUCTS.
2.2 The license granted under Article 2.1 shall remain exclusive (i) as to
the PATENT RIGHTS, for their respective lives on a country-by-country
basis, and (ii) as to the ILEX KNOW-HOW, until the termination of
XXXXXXX'x obligation to make royalty payments under Article 5.2 hereof,
at which time the license under the ILEX KNOW-HOW shall automatically
become a fully paid, exclusive license. Notwithstanding the foregoing,
however, with respect to any country of the European Union, the license
granted under Article 2.1 to the ILEX KNOW-HOW shall remain exclusive
until the earlier of (i) the date on which the ILEX KNOW-HOW becomes
published or generally known to the public through no fault on the part
of XXXXXXX, its AFFILIATES or SUBLICENSEES or (ii) the tenth (10th)
anniversary of the first commercial sale of the first LICENSED PRODUCT
in any country of the European Union, at which time the license under
the ILEX KNOW-HOW shall automatically become a fully paid, non-exclusive
license.
2.2 The license and sublicenses granted hereunder shall include the right to
grant sub-licenses to AFFILIATES and third party SUBLICENSEES, provided
that XXXXXXX agrees to be responsible for the performance hereunder by
its AFFILIATES and SUBLICENSEES to which the license and rights shall
have
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been extended. XXXXXXX may sell LICENSED PRODUCTS through its
AFFILIATES or agents in any country.
2.3 If XXXXXXX, ILEX or any of their sublicensees, AFFILIATES or assignees
discover a use, indication or potential use or indication of the
LICENSED PRODUCT which is outside the scope of the FIELD (such use,
indication or potential use or indication being referred to as an
"Additional Use"), the party discovering such Additional Use shall
notify the other in writing and XXXXXXX and ILEX shall promptly meet to
discuss the submission of a written proposal to Glaxo Wellcome Inc. to
obtain the rights to such Additional Use pursuant to the terms of the BW
AGREEMENT as amended October 5, 1996. At XXXXXXX'x option, any rights
obtained by ILEX to such Additional Use shall inure to the benefit of
XXXXXXX and such Additional Use shall be included in the license
hereunder, under the same terms and conditions as a LICENSED PRODUCT in
the FIELD, unless otherwise agreed to by the parties in writing.
2.3 No other, further or different license or right, except as expressly
provided in Article 2 hereof, is hereby granted or implied.
ARTICLE 3. DEVELOPMENT AND COMMERCIALIZATION
3.1 DEVELOPMENT
3.1.1 Development Program
(a) Promptly following execution of this LICENSE AGREEMENT,
ILEX shall use its best efforts based on ILEX's reasonable
business judgment, to execute the DEVELOPMENT PLAN and to
carry out the activities for FULL DEVELOPMENT of the
LICENSED PRODUCT so that XXXXXXX can launch the LICENSED
PRODUCT in the United States and Europe no later than the
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second quarter of the year 2000. In the course of such
efforts ILEX shall, under the direction of XXXXXXX as
coordinated by the PMT as set forth in Article 3.1.2
hereto, take appropriate steps including the following:
(i) Establish and maintain a program reasonably
designed, funded and resourced to complete PHASE
III trials on the LICENSED PRODUCT for the LEAD
INDICATION;
(ii) Proceed following successful completion of PHASE
III trials, other associated studies and all other
work which the PMT reasonably deems to be required,
to prepare and compile the necessary regulatory
documentation for inclusion in a filing of
MARKETING AUTHORIZATION APPLICATIONS in the United
States and Europe for the LICENSED PRODUCT for the
LEAD INDICATION. In the case of Europe, the filing
may be based on the EC multistate procedure or
individual filings in at least the EUROPEAN MAJOR
MARKET COUNTRIES.
(b) In carrying out the DEVELOPMENT PLAN, ILEX shall make
available the number of qualified "full time equivalents"
of its scientific, engineering, manufacturing and other
personnel specified in the DEVELOPMENT PLAN, and shall
take such steps as it deems necessary, in order to perform
its obligations in accordance with the terms hereof. ILEX
shall use its best based on its reasonable business
judgment efforts to carry out the DEVELOPMENT PLAN in
accordance with the agreed upon time
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and event schedule, in consultation with the PMT. XXXXXXX
shall have the right to control and direct performance of
the DEVELOPMENT PLAN through the PMT, and shall have the
right to approve any material agreement with third parties
to be made by ILEX related to performance of the
DEVELOPMENT PLAN hereunder which approval shall not be
unreasonably withheld.
(c) MARKETING AUTHORIZATION APPLICATIONS shall be compiled by
ILEX based on information generated during the FULL
DEVELOPMENT program. At XXXXXXX'x option, MARKETING
AUTHORIZATION APPLICATIONS shall either be filed by
XXXXXXX or filed by ILEX and transferred to XXXXXXX.
XXXXXXX shall own all such MARKETING AUTHORIZATIONS.
XXXXXXX shall exercise reasonable efforts, commensurate
with the efforts it would normally exercise for products
of similar potential sales volume and consistent with its
overall business strategy to obtain MARKETING
AUTHORIZATION for LICENSED PRODUCT in such countries as
XXXXXXX deems appropriate. XXXXXXX shall prosecute such
submissions and file the necessary reports and responses
to requests fromt he pertinent regulatory authorities.
ILEX shall prepare supporting documentation requested by
XXXXXXX. ILEX shall further assist XXXXXXX with the
preparation of supporting data to apply for and pursue
MARKETING AUTHORIZATION APPLICATIONS.
3.1.2 Management
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3.1.2.1 The PMT
Promptly after THE EFFECTIVE DATE HEREOF, the parties shall
establish the PMT. The PMT shall be formed from a number of
representatives of ILEX and a number of representatives of
XXXXXXX to be agreed upon by the parties from time to time. One
of the XXXXXXX members of the PMT, chosen at the sole discretion
of XXXXXXX, shall serve as chair of the PMT. Regardless of the
number of representatives form each party on the PMT, each party
shall present one consolidated view and have one vote on any
issue in dispute. All decisions of the PMT must be unanimous.
If the PMT fails to reach unanimous agreement on any matter
before it for consideration, the matter shall be submitted to the
Chief Executive of ILEX and the President of XXXXXXX RESEARCH
FOUNDATION for resolution. If the dispute is not so resolved,
then the President of XXXXXXX RESEARCH FOUNDATION shall have the
final decision. Meetings of the PMT shall be held at least
quarterly and may be called by either party with not less than
ten (10) working days notice to the other unless such notice is
waived, and meetings shall be held as agreed to by the parties
from time-to-time. The PMT may be convened, polled or consulted
from time to time by means of telecommunication or
correspondence. Each party will disclose to the other proposed
agenda items reasonably in advance of each meeting of the PMT.
Each party shall bear its own costs for participation in the PMT.
3.1.2.2 Functions of the PMT
The PMT shall be responsible for coordinating the management of
the DEVELOPMENT of LICENSED PRODUCTS performed under the
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provisions of this LICENSE AGREEMENT. In carrying out this
function, the PMT will:
(a) coordinate and oversee activities to be undertaken under
the DEVELOPMENT PLAN and specify the details under which
the DEVELOPMENT PLAN shall be carried out;
(b) review progress of the performance of the DEVELOPMENT PLAN
at lest monthly during the first six (6) months of
DEVELOPMENT and thereafter at least quarterly, and
recommend changes or modifications to the DEVELOPMENT
PLAN, including budgets and deadlines, which shall be
subject to approval by the Xxxxxxx Research Management
Board. The DEVELOPMENT PLAN shall be updated at least
annually;
(c) submit progress reports to XXXXXXX as to the performance
of THE DEVELOPMENT PLAN, the first such report to be
submitted two (2) months following the EFFECTIVE DATE and
at three (3) month intervals thereafter until the SALE of
LICENSED PRODUCT is approved and LICENSED PRODUCT is being
marketed on a regular commercial basis. Minutes of
meetings of the PMT may serve as such progress reports;
(d) attempt to settle disputes or disagreements between the
parties regarding the performance of the DEVELOPMENT PLAN;
(e) review any material agreements with third parties to be
made by ILEX related to performance of the DEVELOPMENT
PLAN hereunder prior to submission to XXXXXXX for their
approval;
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(f) review progress of the overall development of the LICENSED
PRODUCT, including activities outside of the DEVELOPMENT
PLAN and keep the parties informed to the progress
thereof;
(g) perform such other functions as are appropriate to further
the purposes of this LICENSE AGREEMENT as determined by
the parties.
ILEX shall designate a single project coordinator whose duties
shall be to oversee matters arising under the DEVELOPMENT PLAN
and to facilitate the communication of study results. Such
project coordinator shall be responsible for day-to-day worldwide
coordination of the DEVELOPMENT PLAN and to facilitate
communication between the parties relating to the DEVELOPMENT
PLAN.
3.1.2.3 Information and Access
ILEX and XXXXXXX shall provide the PMT, its members and
authorized representatives with reasonable access during regular
business hours to all records and documents relating to the
performance of this Agreement which it reasonably may request in
order to perform its obligations hereunder; provided that if such
documents are under a bona fide obligation of confidentiality to
a third party, ILEX and XXXXXXX, as the case may be, may withhold
access thereto to the extent necessary to satisfy such
obligation.
3.1.3 Development Funding
(a) Following the EFFECTIVE DATE hereof, XXXXXXX shall reimburse ILEX
for all PLAN COSTS incurred by ILEX in connection with the
activities carried out by ILEX during INITIAL DEVELOPMENT up to a
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maximum amount of [**] Dollars ($ [**] ). All costs
required to complete INITIAL DEVELOPMENT in accordance with the
DEVELOPMENT PLAN as attached hereto in excess of such amount
shall be for ILEX's account. All costs associated with
modifications to the DEVELOPMENT PLAN or associated with work
requested by XXXXXXX and not included in the DEVELOPMENT PLAN
shall be for XXXXXXX'x account.
(b) During the period of INITIAL DEVELOPMENT, both ILEX and XXXXXXX
will work cooperatively to reduce the COST OF GOODS to an amount
equal to or less than [**] percent ([**]%) of ESTIMATED
NET SALES by optimizing (i) the chemical manufacturing process
and (ii) the formulation of LICENSED PRODUCT. ILEX will be
responsible for optimizing and scale-up of the chemical
manufacturing process for compound in accordance with the PROCESS
OPTIMIZATION DEVELOPMENT PLAN, which shall be completed by March
1, 1997. XXXXXXX will be responsible for optimizing the
formulation for LICENSED PRODUCT. ILEX will actively assist
XXXXXXX in XXXXXXX'x efforts to optimize the formulation for
LICENSED PRODUCT and XXXXXXX will actively assist ILEX's efforts
to optimize and scale-up the chemical manufacturing process for
COMPOUND. XXXXXXX will reimburse ILEX for its costs incurred
prior to March 1, 1997 associated with ILEX's performance of the
PROCESS OPTIMIZATION DEVELOPMENT PLAN up to an amount equal to
[**] Dollars ($ [**] ). Costs shall be defined in the
same manner as PLAN COSTS.
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(c) Following the period of INITIAL DEVELOPMENT, provided XXXXXXX has
not elected to terminate this LICENSE AGREEMENT in accordance
with the provisions of Article 17.1, the parties shall proceed
with FULL DEVELOPMENT and XXXXXXX shall reimburse ILEX for all
PLAN COSTS associated with FULL DEVELOPMENT, up to a maximum
amount for all DEVELOPMENT costs, including INITIAL DEVELOPMENT,
of [**] Dollars ($ [**] ). All costs required to
complete DEVELOPMENT in accordance with the DEVELOPMENT PLAN as
attached hereto in excess of such amount shall be for ILEX's
account. Costs related to modifications to the DEVELOPMENT PLAN
or work performed by, or requested by XXXXXXX for developing the
LICENSED PRODUCT in excess of the work defined in the DEVELOPMENT
PLAN which result from additional requirements of Health
Authorities in one or more countries or for post-marketing
studies, or for other reasons shall be borne by XXXXXXX.
(d) XXXXXXX shall pay ILEX for PLAN COSTS and costs associated with
manufacturing optimization and scale-up activities performed by
ILEX pursuant to Article 3.1.3(b) hereof on a monthly basis.
ILEX shall invoice XXXXXXX monthly for PLAN COSTS incurred during
the preceding month. XXXXXXX shall pay such invoices by the end
of the month immediately following the month in which it receives
ILEX's invoices.
3.1.4 Recordkeeping and Audit
ILEX will maintain complete and accurate records which are relevant to
its execution of the DEVELOPMENT PLAN and manufacturing optimization
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activities pursuant to the SCALE-UP DEVELOPMENT PLAN, including records
concerning the expenditures associated therewith. ILEX shall maintain
all records relating thereto, including raw data, patient case reports,
microscope slides of tissues and the like in good order in the event
that the FDA or other regulatory authorities wish to inspect such data
as part of the regulatory approval of a LICENSED PRODUCT or as part of
their continuing oversight of the development and marketing of the
LICENSED PRODUCT. Such records shall be open during regular business
hours for a period of two (2) years from creation of individual records
for examination at XXXXXXX'x expense for the sole purpose of verifying
whether such expenditures are in accordance with the agreed DEVELOPMENT
PLAN as administered by the PMT; provided however, that such right may
not be exercised more than once in any calendar year. XXXXXXX shall be
entitled to a credit against future PLAN COST payments or a refund for
any expenditures which such audit reveals were not made in accordance
with the DEVELOPMENT PLAN as administered by the PMT.
3.1.5 Transfer of Know-How
Upon completion of FULL DEVELOPMENT, or otherwise upon XXXXXXX'x
request, ILEX agrees to use its best efforts to assure the complete
transfer to XXXXXXX of all existing ILEX KNOW-HOW reasonably necessary
for XXXXXXX to manufacture, USE and SELL LICENSED PRODUCT and otherwise
fulfill the purposes of this Agreement ILEX shall provide XXXXXXX with
such supporting documentation necessary for XXXXXXX to obtain MARKETING
AUTHORIZATION for LICENSED PRODUCT for the LEAD INDICATION or any other
indication for LICENSED PRODUCT and shall provide XXXXXXX with
appropriate regulatory letters of reference and certificates necessary.
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Thereafter during the term of this Agreement, any additional ILEX KNOW-
HOW relating to the FIELD developed by ILEX and which ILEX has the right
to disclose to XXXXXXX shall be disclosed within a reasonable time of
its receipt or development. XXXXXXX shall be free to use such ILEX
KNOW-HOW received hereunder for the purposes of this Agreement as it, in
its sole discretion, deems appropriate.
3.2 COMMERCIALIZATION
3.2.1 Once a LICENSED PRODUCT has been approved for marketing, XXXXXXX
shall be responsible, at its sole discretion, for the promotion,
advertising and SELLING of LICENSED PRODUCT under this LICENSE
AGREEMENT. In doing so, XXXXXXX shall exercise reasonable
efforts, commensurate with the efforts it would normally exercise
for products with similar potential sales volume and consistent
with its overall business strategy.
3.2.2 Notwithstanding any other provision hereunder, XXXXXXX makes no
representation or warranty that it will develop or market any
LICENSED PRODUCT covered by this Agreement unless XXXXXXX
determines, in its sole discretion, that such development and
marketing is economically or technically justified, or, if
XXXXXXX does develop or market any of the LICENSED PRODUCTS, that
such LICENSED PRODUCT shall be the exclusive means by which
XXXXXXX or its AFFILIATES will participate in the field in which
the LICENSED PRODUCT is marketed. In the event XXXXXXX decides
not to market any LICENSED PRODUCT hereunder, it shall promptly
notify ILEX and shall terminate this LICENSE AGREEMENT, pursuant
to Article 17 hereof. Furthermore,
22
all business decisions including, without limitation, the design,
sale, price and promotion of LICENSED PRODUCTS covered under this
Agreement and the decision whether to sell a LICENSED PRODUCT
shall be within the sole discretion of XXXXXXX. ILEX
acknowledges that XXXXXXX or its AFFILIATES may now or in the
future develop or acquire products for the treatment, diagnosis
and prevention of disease in the field in which LICENSED PRODUCTS
are developed or marketed.
ARTICLE 4. LICENSE FEES
4.1 In consideration of the rights and licenses granted to XXXXXXX under
this Agreement, XXXXXXX shall pay ILEX an initial license fee of
[**] Dollars ($ [**] ) within ten (10) Days of the EFFECTIVE
DATE.
4.2 In addition, XXXXXXX shall pay to ILEX, subject to Article 17, Milestone
License Fees in amounts and times as follows:
(i) in the event INITIAL DEVELOPMENT is completed with 50
evaluable patients prior to March 1, 1997, and provided
XXXXXXX has not terminated this LICENSE AGREEMENT in
accordance with Article 17.1 hereof: [**]
Dollars ($ [**] );
(ii) within thirty(30) days of the first filing of a MARKETING
AUTHORIZATION APPLICATION in the United States for the
LEAD INDICATION: [**] Dollars ($ [**] );
(iii) within thirty (30) days of the filing of MARKETING
AUTHORIZATION APPLICATIONS in the first country of the
EUROPEAN MAJOR MARKET COUNTRIES for the LEAD INDICATION:
[**] Dollars ($ [**] );
23
(iv) within thirty (30) days of the first filing of a MARKETING
AUTHORIZATION APPLICATION in Japan for the LEAD
INDICATION: [**] Dollars ($ [**] );
(v) within thirty (30) days of the receipt of the first
MARKETING AUTHORIZATION permitting commercial sale of
LICENSED PRODUCT for the LEAD INDICATION in the United
States: [**] Dollars ($ [**] );
(vi) within thirty (30) days of receipt of MARKETING
AUTHORIZATION permitting commercial sale of LICENSED
PRODUCT for the LEAD INDICATION in the first country of
the EUROPEAN MAJOR MARKET COUNTRIES: [**]
Dollars ($ [**] );
(vii) within thirty (30) days of the receipt of the first
MARKETING AUTHORIZATION permitting commercial sale of
LICENSED PRODUCT for the LEAD INDICATION in Japan:
[**] Dollars ($ [**] );
(viii) within thirty (30) days of the receipt of the first
MARKETING AUTHORIZATION permitting commercial sale of
LICENSED PRODUCT for one additional indication other than
the LEAD INDICATION in the United States:
[**] Dollars ($ [**] );
(ix) within thirty (30) days of the receipt of the first
MARKETING AUTHORIZATION permitting commercial sale of
LICENSED PRODUCT for one additional indication other than
the LEAD
24
INDICATION in the first country of the EUROPEAN MAJOR
MARKET COUNTRIES: [**] Dollars
($ [**] );
(x) within thirty (30) days of the receipt of the first
MARKETING AUTHORIZATION permitting commercial sale of
LICENSED PRODUCT for one additional indication other than
the LEAD INDICATION in Japan: [**] Dollars
($ [**] ).
ARTICLE 5. ROYALTIES, RECORDS AND REPORTS
5.1 For the rights and privileges granted under this LICENSED AGREEMENT,
XXXXXXX shall pay to ILEX, subject to Article 17, earned royalties on
the NET SALES of all LICENSED PRODUCTS that are SOLD by or for XXXXXXX
or AFFILIATES or SUBLICENSEES under this LICENSE AGREEMENT. The royalty
rate shall increase or decrease in accordance with the following formula
as a result of changes in the COST OF GOODS made as a result of
optimizing the formulation and bulk production of LICENSED PRODUCT:
(a) for all sales in a calendar year up to and including
[**] Dollars ($ [**] ), a royalty based on the
Actual Cost of Goods Percentage (ACOG%, as defined below
in paragraph 5.1(d)) as follows:
(i) where the ACOG% is [**] percent ([**]%) or
less: a royalty of [**] percent ([**]%);
(ii) where the ACOG% is [**] percent ([**]%) or
more: a royalty of [**] percent ([**]%);
25
(iii) where the ACOG% is between [**] percent ([**]%)
and [**] percent ([**]%): a royalty
calculated in accordance with the following
formula:
[**]
wherein AR is the adjusted royalty rate, and AR1 is
the Royalty Rate Adjustment for Cost of Goods
Percentage Changes, calculated as set forth in
Article 5.1(d).
(b) for all sales in a calendar year greater than
[**] Dollars ($ [**] ), up to and including
[**] Dollars ($ [**] ), a royalty based on the
ACOG% as follows:
(i) where the ACOG% is [**] percent ([**]%) or
less: a royalty of [**] percent ([**]%);
(ii) where the ACOG% is [**] percent ([**]%) or
more: a royalty of [**] percent ([**]%);
(iii) where the ACOG% is between [**] percent ([**]%)
and [**] percent ([**]%): a royalty
calculated in accordance with the following
formula:
[**]
wherein AR is the adjusted royalty rate, and AR is
the Royalty Rate Adjustment for Cost of Goods
Percentage Changes, calculated as set forth in
Article 5.1(d).
(c) for all sales in a calendar year exceeding
[**] Dollars ($ [**] ), a royalty based on
the ACOG% as follows:
26
(i) where the ACOG% is [**] percent ([**]%) or
less: a royalty of [**] percent ([**]%);
(ii) where the ACOG% is [**] percent ([**]%) or
more: a royalty of [**] percent ([**]%);
(iii) where the ACOG% is between [**] percent
([**]%) and [**] percent ([**]%): a
royalty calculated in accordance with the following
formula:
[**]
wherein AR is the adjusted royalty rate, and AR is
the Royalty Rate Adjustment for Cost of Goods
Percentage Changes, calculated as set forth in
Article 5.1(d).
(d) As used herein, the Actual Cost of Goods Percentage
(ACOG%) is calculated in accordance with the formula:
ACOG% = [**] where ACOG is the Actual COST OF
GOODS and RP is the Reference Net Sales Price as defined
below. The Royalty Rate Adjustment for Cost of Good
Percentage Changes (AR) shall be calculated in accordance
with the following formula:
[**]
wherein RCOG is the Reference Cost of Goods, ACOG is the
Actual COST OF GOODS and RP is the Reference Net Sales
Price. The Reference Net Sales Price (RP) is $ [**] and
the Reference Cost of Goods (RCOG) equals $ [**] and
reflects the projected Net Sales Price and COST OF GOODS
of the current contemplated base therapy using [**] cycles
of [**] grams of COMPOUND per cycle ([**] cycle -
[**] ). Should the required
27
dose not equal [**] grams COMPOUND per cycle for [**]
cycles, but rather some other dose, the Reference Cost of
Goods and Reference Net Sales Price shall be adjusted
accordingly to reflect such change. The Actual Cost of
Goods (ACOG) shall be calculated based on the same base
therapy as set forth above and shall be adjusted annually
at the beginning of each calendar year by taking the
average COST OF GOODS sold for the previous calendar year.
Thus, by way of non-limiting example, if the Actual Cost
of Goods is reduced to $ [**] and the Reference Net
Sales Price is $ [**] , the Actual Cost of Goods
Percentage (ACOG%) will be [**]% and paragraph (iii)
above will apply in each instance. AR(1) will be: [**]
and the Royalty Rate under paragraph (a)(iii) above will be
[**] .
5.2 Earned royalty shall be paid pursuant to Article 5.1 hereof on all
LICENSED PRODUCTS, on a country-by-country basis for eight (8) years
from first commercial sale of the first LICENSED PRODUCT in such
country. Thereafter, royalties shall be paid in respect of a given
LICENSED PRODUCT until the expiration of the last to expire of the
PATENT RIGHTS containing a VALID CLAIM covering the LICENSED PRODUCT in
such country. Notwithstanding the foregoing, however, with respect to
any country of the European Union, royalties on NET SALES of LICENSED
PRODUCT which are payable only by virtue of the ILEX KNOW-HOW shall be
payable commencing from the date of first commercial sale of the first
LICENSED PRODUCT in such country and ending on the earlier of (i) the
date on which the ILEX KNOW-HOW becomes
28
published or generally known to the public through no fault on the part
of XXXXXXX, its AFFILIATES or SUBLICENSEES or (ii) the eighth (8th)
anniversary of the first commercial sale of the first LICENSED PRODUCT
in such country.
5.3 Earned royalty shall be paid pursuant to Article 5.1 hereof on all
LICENSED PRODUCTS SOLD under this LICENSE AGREEMENT; however, the earned
royalty payable on a given LICENSED PRODUCT made hereunder shall not
become due and owing until such LICENSED PRODUCT is SOLD. The earned
royalty for any particular LICENSED PRODUCT shall be due upon the first
bona fide arm's length SALE thereof and any subsequent SALE of such
LICENSED PRODUCT by other than XXXXXXX, an AFFILIATE or SUBLICENSEE
shall be royalty free.
5.4 Notwithstanding the provisions of Article 5.3 hereof, in the case of
transfers or SALES of any LICENSED PRODUCT between XXXXXXX and an
AFFILIATE or SUBLICENSEES or between AFFILIATES, one and only one
royalty shall be payable thereon and such royalty shall become payable
upon the final SALE thereof to a third party.
5.5 For the purposes of reporting and making payments of earned royalties
under this LICENSE AGREEMENT, the manufacture, SALE or USE of LICENSED
PRODUCTS by any AFFILIATE, or SUBLICENSEE to which the license and
rights shall have been extended shall be considered the manufacture,
SALE or USE of such LICENSED PRODUCT by XXXXXXX and any such AFFILIATE
or SUBLICENSEE may make the pertinent reports and royalty payments
specified in this Article 5 hereof directly to ILEX on behalf of
XXXXXXX; otherwise, such reports and payments on account of SALES of
LICENSED
29
PRODUCTS by each AFFILIATE and SUBLICENSEE shall be made by XXXXXXX;
and, in ny event the SALES of LICENSED PRODUCT by each such AFFILIATE
shall be separately shown in the reports to ILEX if such information is
readily available to XXXXXXX.
5.6 ILEX hereby agrees, at the request of XXXXXXX, to grant direct licenses
containing the same terms, conditions and provisions as this Agreement
to any AFFILIATE under LICENSED PATENTS and ILEX KNOW-HOW to make, have
made, use, sell and have sold LICENSED PRODUCTS. Any such licensed
AFFILIATE shall thereafter report NET SALES directly to ILEX and the
activities of any such AFFILIATE shall not be includable in any reports
made by XXXXXXX to ILEX.
5.7 XXXXXXX shall keep full, true and accurate books of account containing
all particulars in accordance with XXXXXXX'X normal accounting
procedures then in effect for the purpose of showing the amount payable
to ILEX by way of royalty as aforesaid or by way of any other provision
hereunder. Said books of account shall be kept at XXXXXXX'x principal
place of business. Said books and the supporting data shall be
maintained and kept open during reasonable business hours, for four (4)
years following the end of the calendar year to which they pertain (and
access shall not be denied thereafter, if reasonably available), to the
inspection of an independent certified public accountant retained by
ILEX and reasonably acceptable to XXXXXXX for the purpose of verifying
XXXXXXX'x royalty statements, or XXXXXXX'x compliance in other respects
with this LICENSE AGREEMENT, but this right to inspect may not be
exercised more than one in any year and once a calendar year is audited,
it may not be re-audited. Said accountant shall disclose to ILEX only
information relating solely
30
to the accuracy of the royalty reports and the royalties paid under this
Agreement. Names of customers and other confidential information shall
not be disclosed to ILEX by such independent accountant. Such
accountant shall be retained at ILEX'S sole expense.
5.8 As soon as possible after the first day of January, April, July and
October of each year, and in no event later than forty-five (45) days
after each such date, XXXXXXX shall deliver to ILEX a true and accurate
report, in respect of LICENSED PRODUCTS SOLD by XXXXXXX, AFFILIATES, and
SUBLICENSEES and the NET SALES due during the preceding three (3) months
("Accounting Period") under this LICENSE AGREEMENT showing (i) the NET
SALES of all LICENSED PRODUCTS in the United States or the Non-U.S.
Territory, as applicable; during the Accounting Period; (ii) the
royalties which have accrued hereunder in respect of such sales (iii)
withholding taxes, if any, required by law to be deducted in respect of
such sales; and (iv) the exchange rates used in determining the amount
of royalties payable.
ILEX will then promptly deliver an invoice to XXXXXXX in a form
acceptable to XXXXXXX. Within thirty (30) days of receipt of such
invoice, XXXXXXX shall pay to ILEX the royalty and any other payments
due under this LICENSE AGREEMENT for the period covered by such report.
If no royalties are due, it shall be so reported. Royalties shall be
paid to ILEX in United States Dollars at ILEX'S office specified for
the purposes of giving notice in Article 22 hereof.
5.9 The remittance of royalties payable on sales outside the United States
will be payable to ILEX in United States Dollars equivalents at the
official rate of exchange of the currency of the country from which
31
the royalties are payable as quoted by The Wall Street Journal, New York
Edition, for the day upon which the transfer of funds for the royalty
payment is made. If the transfer or the conversion into United States
Dollar equivalents in any such instance is not lawful or possible, the
payment of such part of the royalties as is necessary shall be made by
the deposit thereof, in the currency of the country where the sales were
made on which the royalty was based, to the credit and account of ILEX
or its nominee in any commercial bank or trust company of its choice
located in that country, prompt notice of which shall be given by
XXXXXXX to ILEX.
5.10 In any country where the rate of royalty is limited by law, the royalty
payment shall be made to ILEX at the highest rate permitted by law or
allowed for tax deductibility purposes in that county for licenses of
the type herein granted provided that such rate is equal to or less than
the rate specified in this LICENSE AGREEMENT.
5.11 Any tax required to be withheld on royalties payable to ILEX under the
laws of any foreign country shall be promptly paid by XXXXXXX for and on
behalf of ILEX to the appropriate governmental authority, and XXXXXXX
shall furnish ILEX with proof of payment of such tax together with
official or other appropriate evidence issued by the appropriate
governmental authority sufficient to enable ILEX to support a claim for
income tax credit in respect of any sum so withheld. Any such tax
required to be withheld shall be an expense of and borne by ILEX.
5.12 XXXXXXX'X obligation to make payments of royalties under this Article
shall be waived an excused to the extent that the statutes, laws, codes,
or government regulations of the country from which such payments are to
be paid prohibit or prevent such payments.
32
ARTICLE 6. CONFIDENTIALITY
6.1 Disclosures of confidential and proprietary information hereunder by
either party to the other shall be made in writing (or promptly
confirmed in writing if made in another form), and shall be clearly
market "Confidential". Such confidential information shall be
safeguarded by the recipient, shall not be disclosed to third parties
and shall be made available only to recipient's employees or independent
contractors who agree in writing to equivalent conditions and who have a
need to know the information for the purposes specified under this
Agreement. All confidential information shall remain the property of
the disclosing party and be returned to the disclosing party within
thirty (30) days of termination of this Agreement except for one (1)
copy which may be retained by the receiving party for purposes of
determining its legal rights hereunder. Notwithstanding the foregoing
however, XXXXXXX may retain confidential information of ILEX upon normal
expiration of this LICENSE AGREEMENT pursuant to Article 16. These
mutual obligations of confidentiality shall apply for a period of five
(5) years after the termination of this Agreement, but such obligations
shall not apply to any information that:
(i) is published or hereafter becomes generally available to the public
other than by reason of any default with respect to a confidentiality
obligation under this Agreement; or
(ii) was already known to the recipient as evidenced by prior written
documents in its possession; or
(iii) is disclosed to the recipient by a third party who is not in default of
any confidentiality obligation to the disclosing party hereunder; or
(iv) is developed by or on behalf of the receiving party, without reliance on
confidential information received hereunder; or
33
(v) is provided to third parties under appropriate terms and conditions
including confidentiality provisions equivalent to those in this
Agreement for consulting, manufacturing development, manufacturing,
external testing nd marketing trials with respect to the products
covered by this Agreement; or
(vi) is used with the consent of the disclosing party (which consent shall
not be unreasonably withheld) in applications for patents or copyrights
under the terms of this Agreement; or
(vii) has been approved in writing for publication by the disclosing party; or
(viii) is required to be disclosed in compliance with applicable laws or
regulations in connection with the manufacture or sale of products
covered by this Agreement; or
(ix) is otherwise required to be disclosed in compliance with applicable laws
or regulations or order by a court or other regulatory body having
competent jurisdiction; or
(x) is product-related information which is reasonably required to be
disclosed in connection with marketing of products covered by this
Agreement.
6.2 Notwithstanding any provision herein to the contrary, with respect to
any confidential information disclosed to ILEX under the BW AGREEMENT
and identified as such, XXXXXXX agrees to comply with the
confidentiality provisions of the BW AGREEMENT with respect thereto.
The parties recognize the importance of publishing the information
developed in the FULL DEVELOPMENT Program under the provisions of this
Agreement. Accordingly, ILEX agrees to provide XXXXXXX with a copy of
any proposed written or oral paper, abstract, or public presentation
concerning LICENSED PRODUCTS at least sixty (60) days before submission
to a journal and at least ninety (90) days
34
prior to an anticipated actual publication date for its consent to
publish. XXXXXXX will endeavor to provide its consent within sixth (60)
days of receipt of such request to publish. The failure of XXXXXXX to
respond to such a request within such sixth (60) day period shall be
deemed to be an approval of such request and ILEX shall then be free to
publish such paper, abstract or presentation.
ARTICLE 7. ADVERSE EVENT REPORTING
ILEX shall promptly inform XXXXXXX in writing within twenty-four (24)
hours of its receipt of any information which it receives regarding or
related to any serious, unexpected adverse reaction to LICENSED PRODUCT.
Each party shall comply with each Adverse Drug Experience reporting
requirement of it in the United States Federal Food Drug and Cosmetic
Act, as amended (22 US Section 301 et seq.) and the similar requirements
of international regulatory authorities. In addition, on an on-going
basis, each party agrees to make a good faith effort to promptly provide
the other party with any additional information in its possession which
indicates adverse effects in humans associated with LICENSED PRODUCT.
The obligations of this Article shall survive termination of this
Agreement as to LICENSED PRODUCT continued to be sold by XXXXXXX.
ARTICLE 8. PATENT FILING, PROSECUTION AND MAINTENANCE
8.1 Title to all know-how, proprietary materials or patents claiming
inventions made solely by an employee of a Party in the course of
performing the DEVELOPMENT PLAN shall be owned by such Party, subject to
the license provisions of Article 2 hereunder. Title to all know-how,
proprietary materials or patents claiming inventions made jointly by
employees of ILEX and XXXXXXX
35
shall be jointly owned by ILEX and XXXXXXX, subject to the license
provisions of Article 2 hereunder. The laws of the United States with
respect to joint ownership of inventions shall apply in all
jurisdictions. Each Party shall be responsible for filing patent
applications on inventions made solely by an employee of a Party hereof.
The Parties shall mutually agree on mutually acceptable outside counsel
for the filing of any jointly owned patent applications and shall
equally share the expenses associated therewith.
8.2 ILEX shall ensure that all patents and patent applications owned or
controlled by ILEX within the PATENT RIGHTS are diligently filed,
maintained and prosecuted. Further with respect to the B.W. Co. and WFL
patents and patent applications listed in Appendix D, ILEX agrees to
exert reasonable efforts to ensure that such patents are diligently
maintained. ILEX agrees to request from B.W. Co. and WFL, and to
provide XXXXXXX with documentary evidence concerning the maintenance and
payment of taxes on such patents. ILEX does not represent or warrant
that patents on any such patent applications will be obtained and ILEX
shall in its sole discretion be responsible for determining whether to
abandon any or all of said patent applications.
8.3 With respect to all patents and patent applications owned or controlled
by ILEX, ILEX agrees to promptly provide XXXXXXX with copies of:
1. All patent applications included in PATENT RIGHTS;
2. All prior art searches in its possession related to said patent
applications and the subject matter of this License Agreement;
and
3. All correspondence to and from the United States Patent and
Trademark Office related to said patent applications as well as
all requested
36
correspondence relating to corresponding national and
international patent applications.
8.4 XXXXXXX shall have the right to consult with ILEX regarding the content
of said patent applications, prior art searches and correspondence, and
to comment thereon. ILEX shall consider all such comments offered by
XXXXXXX, it being agreed, however, that all final decisions respecting
conduct of the prosecution of said patent applications shall rest solely
in the discretion of ILEX.
8.5 Within nine (9) months of the initial filing date of any patent
application, or at least three (3) months prior to entering the national
phase of any International Patent Application within the PATENT RIGHTS,
ILEX shall consult with XXXXXXX and request a list of foreign countries
where such patent application shall be filed. ILEX shall file patent
applications in those foreign countries which may be designated in
writing by XXXXXXX and XXXXXXX shall be permitted to consult with ILEX
in the selection of foreign patent counsel and in the preparation and
prosecution of said foreign patent applications.
8.6 In the event ILEX decides to abandon or allow to lapse any of the B.W.
Co. or WFL patents or patent applications listed in Appendix D, it shall
inform XXXXXXX and XXXXXXX shall be given the opportunity to prosecute
such patent application and/or maintain such patent at its own expense
and XXXXXXX shall receive a royalty credit for any expenses associated
therewith. With respect to any patents or patent applications owned or
controlled by ILEX other than the B.W. Co. or WFL patents (the "ILEX
patents"), ILEX shall promptly notify XXXXXXX in the event ILEX decides
not to file, to abandon or discontinue prosecution or maintenance of any
such ILEX patents. Such notification will be given as early as possible
which in no event will be less than
37
sixty (60) days prior to the date on which said application(s) will
become abandoned. XXXXXXX shall have the option, exercisable upon
written notification to ILEX, to assume full responsibility for the
filing, prosecution or maintenance of the affected ILEX patents or
patent application(s), in which event all such affected patents or
patent application(s) shall be promptly assigned by ILEX to XXXXXXX and
all royalty obligations with respect to said ILEX patents or patent
applications shall cease.
8.7 XXXXXXX shall co-operate with ILEX, and ILEX agrees to diligently seek
any extension under the U.S. Drug Price Competition and patent Term
Restoration Act of 1984, the Supplementary Certificate of Protection of
the Member States of the European Community or other similar measure in
any other country that is available or that becomes available in respect
of the term of any patent within the PATENT RIGHTS including any patent
that may issue on a patent application within the PATENT RIGHTS.
XXXXXXX shall diligently advise ILEX in a timely manner of approval by
the Food and Drug Administration of the United States of America to USE,
SELL or market LICENSED PRODUCTS or any other governmental approval
obtained by or on behalf of XXXXXXX or an AFFILIATE that is pertinent to
any such extension and XXXXXXX shall supply ILEX with any pertinent
information and data in its possession or control or that is in the
possession or control of any AFFILIATE or SUBLICENSEE and shall
cooperate fully in assisting ILEX to obtain any such extension that it
may seek and XXXXXXX shall supply ILEX in a timely manner with any
information and data and any supporting affidavits or documents required
to comply with 35 US 156 Extension of Patent Term (and any successor
legislation) and any administrative rules or regulation thereunder or
required to comply with any
38
corresponding laws and regulations that are or shall be in effect in any
country within the PATENT RIGHTS, all without further consideration.
XXXXXXX shall require its AFFILIATES to comply with this Article 8.7.
ARTICLE 9. INFRINGEMENT
9.1 (a) In the event that there is infringement on a commercial scale by
a third party of any patent licensed to XXXXXXX hereunder,
XXXXXXX shall notify ILEX in writing to that effect, including
with said written notice evidence establishing a prima facie case
of infringement by such third party. If, prior to the expiration
of one hundred and twenty (120) days from the date of said
notice, ILEX obtains a discontinuance of such infringement or
suit is brought against the third party infringer either by ILEX
or its Licensor under the B.W. AGREEMENT, then the obligation of
XXXXXXX to pay royalties under such licensed patent shall
continue unabated. Such party bringing suit shall bear all the
expenses of any suit brought by it. In the event damages or
other monies are awarded or received in settlement of such suit,
ILEX and such Licensor shall be entitled to deduct an amount to
cover their out-of-pocket expenses, including attorneys fees,
incurred for such suit. XXXXXXX shall be entitled to receive
[**] percent ([**]%) of the balance of any recoveries.
XXXXXXX will cooperate with ILEX in any such suit and shall have
the right to consult with ILEX and be represented by its own
counsel at its own expense.
(b) If, after the expiration of said one hundred and twenty (120)
days from the date of said notice, ILEX has not overcome the
prima facie case of infringement, obtained a discontinuance of
such infringement, or suit has
39
not been brought against the third party infringer, then
XXXXXXX shall have the right, after such one hundred twenty (120)
da notice period, but not the obligation, to bring suit against
such infringer and join ILEX and its Licensor under the B.W.
AGREEMENT as a party plaintiff, provided that XXXXXXX shall bear
all the expenses of such suit. Any damages or other monies
awarded or received in settlement of such suit shall first be
used to reimburse XXXXXXX for its out-of-pocket costs and
expenses of litigation, and the remainder shall be retained by
XXXXXXX subject only to the payment of royalties thereupon as
required under the terms of the B.W. AGREEMENT. ILEX will
cooperate with XXXXXXX in any suit for infringement of a licensed
patent brought by XXXXXXX against a third party, and shall have
the right to consult with XXXXXXX and to participate in and be
represented by independent counsel in such litigation at its own
expense. XXXXXXX shall incur no liability to ILEX as a
consequence of such litigation or any unfavorable decision
resulting therefrom, including any decision holding any patent in
the PATENT RIGHTS invalid or unenforceable.
(c) During the pendency of any suit for infringement brought by
XXXXXXX , XXXXXXX shall continue to pay ILEX royalties
corresponding to the royalties ILEX must pay pursuant to the B.W.
AGREEMENT. Any additional royalties payable which accrue during
the pendency of any suit for infringement brought by XXXXXXX
shall be held in escrow by XXXXXXX until a final decision is
rendered by a court of competent jurisdiction from which no
appeal can be or is taken. In the event the patent under which
such royalties are payable is held to be invalid, the
40
accrued royalties shall be retained by XXXXXXX to offset
litigation expenses. In the event the validity of the patent is
upheld, the accrued royalties shall be paid to ILEX, and any
damages or other monies awarded or received in settlement of such
suit shall be retained by XXXXXXX subject to the payment of
royalties pursuant to the B.W. AGREEMENT as hereinbefore
addressed.
9.2 In the event either party hereto shall initiate or carry on legal
proceedings to enforce the PATENT RIGHTS against an alleged infringer,
as provided herein, the other party hereto shall fully co-operate with
the party initiating or carrying on such proceedings.
9.3 ILEX warrants that it is presently aware of no enforceable issued
patents owned by a third party which would be infringed by reason of the
manufacture, use or sale of any LICENSED PRODUCT. In the event XXXXXXX
is charge with such infringement by a third party, XXXXXXX shall have
the right to defend against such charge of infringement and, during the
period in which such litigation is pending, XXXXXXX shall have the right
to apply up to [**] percent ([**]%) of the royalties, license
fees or milestone payments due ILEX on development or sales of the
allegedly infringing LICENSED PRODUCT against its litigation expenses.
If, as a result of judgment in the litigation or settlement with the
third party, XXXXXXX is required to pay royalties or other monies to
such third party, XXXXXXX may thereafter deduct from the amount of
royalties, license fees or milestone payments due ILEX on NET SALES or
DEVELOPMENT of the XXXXXXX may thereafter deduct from the amount of
royalties, license fees or milestone payments due ILEX on NET SALES or
DEVELOPMENT of the LICENSED PRODUCT charged to infringe, an amount which
is the lesser of
41
[**] percent ([**]%) of all sums actually paid by XXXXXXX to
such third party or [**] percent ([**]%) of all royalty or
other payments otherwise payable to ILEX on the NET SALES or DEVELOPMENT
of such LICENSED PRODUCT, provided however, that in no event shall the
royalties payable by XXXXXXX hereunder to ILEX be less than the amount
ILEX is required to pay B.W. Co. and WFL under the terms of the B.W.
AGREEMENT.
ARTICLE 10. PUBLICITY
10.1 Except as required by law or applicable regulation or the terms of this
LICENSE AGREEMENT or otherwise mutually agreed to by the Parties, each
Party shall treat as confidential the terms, conditions and existence of
this LICENSE AGREEMENT. Notwithstanding the foregoing, a party may
disclose the terms, conditions and existence to an AFFILIATE or
SUBLICENSEE which agrees to be bound by this Article 10 to the same
extent as such Party.
10.2 In the absence of specific agreement between the Parties, neither
parties, neither Party shall, without the prior written consent of the
other Party (which consent shall not be unreasonably withheld or
delayed), originate any publicity, news release or public announcement,
written nor oral, whether to the public or press, relating to this
Agreement, including its existence, the subject matter to which it
relates, performance under it or any of its terms or to any amendment
hereto, excepting only such announcements as in the opinion of counsel
for the Party making such announcement is required by law to be made.
Any such announcements shall be factual and as brief as possible. If a
party decides to make an announcement required by law, it will give the
other Party 10 business days' advance written notice, where possible, of
the text of the announcement so that the other Party will
42
PAGES 36 THROUGH 40 ARE NOT INCLUDED
43
14.3 Each respective Indemnitee and Indemnitor hereunder hereby agrees to
cooperate in the defense of any such claim, lawsuit or action.
Indemnitee further agrees to make available to Indemnitor its employees,
document and expertise in the mutual defense of such action. Indemnitee
hereby agrees to immediately notify Indemnitor within five (5) days of
Indemnitee's receipt thereof of any claim, lawsuit or action which is
within the scope of Indemnitor's undertaking. Failure to provide such
notification shall terminate Indemnitor's obligation as to such lawsuit,
claim or action. Indemnitor shall bear no responsibility for any
expenses incurred by Indemnitee prior to such notice.
14.4 The respective Indemnitor hereunder shall control the management of any
such claim, lawsuit or action, including, without limitation, the
selection of counsel, trial strategy, and determination of the
appropriateness and reasonableness of any settlement.
ARTICLE 15. BANKRUPTCY
All rights and licenses granted under or pursuant to this Agreement by
each Party are, and shall otherwise be deemed to be, for purposes of
Section 365(n) of Title 11, U.S. code (the "Bankruptcy Code"), licenses
of rights to "intellectual property" as defined under Section 101(6) of
the Bankruptcy Code. The Parties agree that XXXXXXX, shall retain and
may fully exercise all of its rights and elections under the Bankruptcy
Code. ILEX agrees, during the term of this Agreement, to create and
maintain current copies or, if not amenable to copying, detailed
descriptions or other appropriate embodiments, of all such intellectual
property. ILEX further agrees that in the event of the commencement of
a bankruptcy proceeding by or against it under the Bankruptcy Code,
XXXXXXX shall be entitled to a complete duplicate of (or complete access
to, as appropriate)
44
any such intellectual property and all embodiments of such intellectual
property, and same, if not already in its possession shall be promptly
delivered to XXXXXXX (a) upon such commencement of a bankruptcy
proceeding upon written request therefor by XXXXXXX, unless ILEX elects
to continue to perform all of its obligations under this Agreement or
(b) if not delivered under (a) above, upon the rejection of this
Agreement by or on behalf of ILEX upon written request therefor by
XXXXXXX.
ARTICLE 16. DURATION
16.1 This Agreement shall commence upon the EFFECTIVE DATE and shall, unless
sooner terminated pursuant to any other provision of this Agreement,
continue in full force and effect for as long as royalties are payable
according to the provisions of Article 5 herein. Pursuant to Article
2.2 hereof, on a country-cy-country basis, once XXXXXXX has paid
royalties for the full period under which such royalty payments are due
under Articles 5.1 and 5.2 hereunder, XXXXXXX and its AFFILIATES shall
have a fully paid-up, irrevocable license under the ILEX KNOW-HOW to
make, have made, USE, SELL and HAVE SOLD LICENSED PRODUCTS.
ARTICLE 17. TERMINATION
17.1 Notwithstanding any other provision herein, within thirty (30) days of
completion of INITIAL DEVELOPMENT or, if INITIAL DEVELOPMENT is not
completed by March 1, 1997, at any time thereafter prior to April 1,
1997, XXXXXXX may immediately terminate this LICENSE AGREEMENT in its
entirety for any reason. In such event, XXXXXXX shall pay ILEX for its
expenses associated with termination of the PHASE III study, up to a
maximum of [**] Dollars ( [**] ). Thereafter,
XXXXXXX may
45
terminate this LICENSE AGREEMENT in its entirety at any time during FULL
DEVELOPMENT upon three (3) months' written notice to ILEX, at no further
expense to XXXXXXX beyond any expenses incurred during such three (3)
month notice period.
17.2 Notwithstanding any other provision herein, upon completion of FULL
DEVELOPMENT, XXXXXXX may terminate this LICENSE AGREEMENT on a country-
by-country basis or in its entirety for any reason upon three (3)
months' written notice to ILEX.
17.3 Notwithstanding any other provisions of this Agreement, either party, at
its option, may terminate this Agreement on ninety (90) days prior
written notice served by one party should the other party fail to comply
with or perform its obligations hereunder, unless such failure or non-
performance is corrected within the ninety (90) day period following
notification, or such extended period as shall be agreed between the
parties.
17.4 Should a party commit an act of bankruptcy, be declared bankrupt,
voluntarily file or have filed against it a petition for bankruptcy or
reorganization unless such petition is dismissed within sixth (60) days
of filing, enter into an arrangement for the benefit of creditors, enter
into a procedure of winding up to dissolution or should a Trustee or
Receiver be appointed for its business assets or operations, the other
party shall be entitled to terminate this LICENSE AGREEMENT forthwith by
giving written notice to the first party.
17.5 Subject to Article 18.3(ii), failure to terminate this Agreement
following breach or failure to comply with this Agreement shall not
constitute a waiver of a party's defenses, rights or causes of action
arising from such or any future breach or noncompliance.
46
ARTICLE 18. RIGHTS AND OBLIGATIONS UPON TERMINATION
18.1 In the event this LICENSE AGREEMENT is terminated in its entirety by
XXXXXXX in accordance with Articles 17.1 and 17.2 hereunder, or by ILEX
under Article 17.3 or 17.4 hereunder, XXXXXXX undertakes:
(a) to deliver to ILEX any ILEX KNOW-HOW or XXXXXXX KNOW-HOW in its
possession;
(b) not to use the ILEX KNOW-HOW as long as it has to be kept
confidential pursuant to Article 6 hereunder;
(c) to terminate its rights under the PATENT RIGHTS;
(d) to transfer, at ILEX's written request, all MARKETING
AUTHORIZATIONS and regulatory filings to ILEX or its designee;
and
(e) to transfer to ILEX responsibility for and control of ongoing
DEVELOPMENT work being performed by XXXXXXX, including contracts
with Third Parties for such work, in an expeditious and orderly
manner with the costs for such work assumed by ILEX as of the
date of notice.
18.2 In the event of (a) a material default by ILEX, or (b) an ILEX CHANGE IN
CONTROL under Article 19.2 hereof, then, XXXXXXX, at its option, may (i)
elect to terminate this LICENSE AGREEMENT in its entirety, or (ii)
terminate the provisions of Articles 3.1.1, 3.1.2 and 3.1.3. and
continue the LICENSE AGREEMENT. In the event of termination in its
entirety under (i) above, all rights and licenses to the PATENT RIGHTS
and ILEX KNOW-HOW shall revert to ILEX. In the event of partial
termination under (ii) above, all provisions of this LICENSE AGREEMENT
shall survive except Articles 3.1.1, 3.1.2, and 3.1.3. and XXXXXXX shall
be entitled to use all ILEX KNOW-HOW and other
47
information generated under this LICENSE AGREEMENT, and shall have an
exclusive, worldwide license under the PATENT RIGHTS and ILEX KNOW-HOW,
to make, have made, USE, SELL and HAVE SOLD LICENSED PRODUCTS for the
remaining duration of this LICENSE AGREEMENT, provided however, that in
the event of a material default by ILEX, all further payments due ILEX
under Articles 4 and 5 hereof shall be reduced by [**] percent ([**]).
Further, in either event of (a) or (b) above, ILEX will provide XXXXXXX
with all reasonable assistance to transfer the ILEX KNOW-HOW and enable
XXXXXXX to continue DEVELOPMENT and to make, have made, USE, SELL and
HAVE SOLD LICENSED PRODUCT.
18.3 Termination of this Agreement for any reason shall be without prejudice
to:
(i) ILEX'S right to receive all payments accrued and unpaid on the
effective date of such termination; and
(ii) Any other remedies which either party may then or thereafter have
hereunder or otherwise, provided however, that ILEX's remedies
shall be limited to those recited in Articles 17.3 and 18.1
should XXXXXXX fail to perform under Article 3, particularly
Article 3.2.1, and, as a result XXXXXXX shall not be liable to
ILEX under any contract, negligence, strict liability or other
legal or equitable theory for any incidental or consequential
damages for failure to perform under Article 3.
18.4 Articles 6, 7, 10, 14, 15 and 20 shall survive the expiration and any
termination of the LICENSE AGREEMENT for any reason.
ARTICLE 19. ASSIGNMENT
19.1 This Agreement or any interest herein shall not be assigned or
transferred, in whole or in part, by either party hereto without the
prior written consent of the
48
other party hereto. However, without securing such prior written
consent, but subject to Article 19.2 hereof, either party may assign
this Agreement to an AFFILIATE or a successor of all or substantially
all of its business to which this Agreement relates provided, that no
such assignment shall be binding and valid until and unless the assignee
shall have assumed in a writing, delivered to the non-assigning party,
all of the duties and obligations of the assignor, and, provided,
further, that the assignor shall remain liable and responsible to the
non-assigning party hereto for the performance and observance of all
such duties and obligations.
19.2 This LICENSE AGREEMENT shall be binding upon, and inure to, the benefit
of the parties hereto, to the benefit of any permitted assignee or
successor to substantially the entire assets of XXXXXXX to which this
LICENSE AGREEMENT relates, and to the benefit of any permitted assignee
or successor to substantially the entire assets of ILEX to which this
LICENSE AGREEMENT relates. If, at any time during the term of this
LICENSE AGREEMENT, an ILEX CHANGE IN CONTROL occurs, XXXXXXX shall have
the right, upon notice, to terminate this LICENSE AGREEMENT, partially
or in its entirety, and the provisions of Article 18.2 shall apply.
XXXXXXX shall also have the right, whether or not it elects to terminate
this LICENSE AGREEMENT in whole or in part, to require that all steps it
may reasonably specify be taken to prevent disclosure of its
confidential information to any such acquiror or assignee in any way
deemed adverse to its interests.
ARTICLE 20. DISPUTE RESOLUTION
20.1 Any controversy or claim arising out of or relating to the Agreement, or
the parties' decision to enter into this Agreement, or their breach
thereof, shall be
49
settled by arbitration in accordance with the Commercial Arbitration
Rules of the American Arbitration Association with a panel of three (3)
arbitrators. The Arbitrators shall be selected from the National Panel
of Arbitrators of the American Arbitration Association. Each party
shall select one arbitrator and the two selected arbitrators shall
select the third arbitrator. If the two selected arbitrators cannot
agree on a third arbitrator then the American Arbitration Association
shall select said arbitrator from the National Panel of Arbitrators.
All arbitrators shall be selected from a pool of independent arbitrators
who are willing to serve within 45 days of receipt of the request to do
so. Each Party shall make its appointment within twenty (20) days of
receipt of the request for Arbitration and the third member shall be
selected by the two other members within ten (10) days of the selection
of the first two panel members.
20.2 The parties shall be entitled to discovery not to exceed four (4) months
from the date of filing of the notice of arbitration of all documents
and information reasonably necessary for a full understanding of any
legitimate issue raised in the arbitration. They may use all methods of
discovery including but not limited to depositions, requests for
admissions and requests for production of documents. The time periods
for compliance shall be set by the arbitrator who may also set
reasonable limits on the scope of such discovery and shall not permit
either party to take in excess of five depositions except in exceptional
circumstances and for good cause shown. The Federal Rules of Evidence
shall govern the admissibility of evidence in the arbitration
proceeding. The proceeding shall be confidential and the arbitrator
shall issue appropriate protective orders to safeguard both parties'
confidential information.
50
20.3 The arbitrator shall not award punitive damages to either party and the
parties shall be deemed to have waived any right to such damages. The
arbitrator shall render his or her decision within thirty (30) days of
completion of the hearing and, in rendering his or her decision, shall
apply the substantive law of the State of New Jersey except the
interpretation of and enforcement of this provision shall be governed by
the Federal Arbitration Act. Arbitration shall take place in the City
of New York. The fees of the arbitrator and the American Arbitration
Association shall be split equally between the parties. Any judgment
upon the award rendered by the arbitrator may be entered in any count
having jurisdiction thereof, and shall not be subject to being vacated
and shall not be appealable.
ARTICLE 21. MANUFACTURE AND SUPPLY
XXXXXXX shall have the exclusive right to manufacture or have
manufactured LICENSED PRODUCT. In the event XXXXXXX decides to out-
source the manufacture of LICENSED PRODUCT in bulk form, it shall
request a bid from ILEX. Such bid shall be considered if ILEX is able
to produce LICENSED PRODUCT in bulk form at a competitive price and
according to XXXXXXX'x specifications, and in a manner which meets the
requirements for United States and European sales, including cGMP
requirements, but any final decision concerning out-sourcing of
manufacture shall be solely at XXXXXXX'x discretion.
ARTICLE 22. GENERAL
22.1 Before signing this LICENSE AGREEMENT the parties have had numerous
conversations, including preliminary discussions, formal negotiations
and informal conversations at meals and social occasions, and have
generated correspondence and other writings, in which the parties
discussed the
51
transaction which is the subject of this LICENSE AGREEMENT and their
aspirations for its success. In such conversations and writings,
individuals representing the parties may have expressed their judgments
and beliefs concerning the intentions, capabilities, and practices of
the parties, and may have forecasted future events. The parties
recognize that such conversations and writings often involve an effort
by both sides to be positive and optimistic about the prospects for the
transaction. It is also recognized, however, that all business
transactions contain an element of risk, as does the transaction
contemplated by this LICENSE AGREEMENT and that it is normal business
practice to limit the legal obligations of contracting parties to only
those promises and representations which are essential to their
transaction so as to provide certainty as to their respective future
rights and remedies. Accordingly, it is agreed that this LICENSE
AGREEMENT, including the Appendices hereto attached, (and the
accompanying Stock Purchase Agreement) constitutes the entire agreement
and understanding between the parties as to the legal undertakings
hereunder. All prior negotiations, representations, agreements,
contracts, offers and earlier understandings of whatsoever kind, whether
written or oral between ILEX and XXXXXXX in respect of this LICENSE
AGREEMENT, are superseded by, merger into, extinguished by and
completely expressed by this LICENSE AGREEMENT. No aspect, part or
wording of this LICENSE AGREEMENT may be notified except by mutual
agreement between ILEX and XXXXXXX taking the form of an instrument in
writing signed and dated by duly authorized representatives of both ILEX
and XXXXXXX.
52
22.2 All communications, reports, payments and notices required by this
License agreement by one party to the other shall be addressed to the
parties at their respective addresses set forth below or to such other
address as requested by either party by notice in writing to the other.
If to ILEX:
ILEX ONCOLOGY, INC.
14785 Omicron, Xxxxx 000
Xxx Xxxxxxx, Xxxxx 00000-0000
Attention: __________________________
Telefax No.: (000) 000-0000
If to XXXXXXX:
XXXXXXX PHARMACEUTICA, N.V.
Xxxxxxxxxxxxx 00,
0000 Xxxxxx, Xxxxxxx
ATTENTION: President, JRF
Telefax No.: (32 + 14) 60-28-41
With a copy to:
Chief Patent Counsel
Xxxxxxx & Xxxxxxx
Xxx Xxxxxxx & Xxxxxxx Xxxxx
Xxx Xxxxxxxxx, Xxx Xxxxxx 00000
Telefax No.: (000) 000-0000
All such notices, reports, payments and communications shall be made in
writing and shall be deemed given if delivered personally or by telefax
(receipt verified)
53
to the numbers set forth above or by registered or certified mail
(return receipt requested), postage prepaid, or sent by express courier
service and shall be considered made as of the date sent or when
received by telefax.
22.3 All matters affecting the interpretation, validity, and performance of
this Agreement shall be governed by the internal laws of the State of
Delaware without regard to its conflict of law principles, except as to
any issue which by Delaware law depends upon the validity, scope of
enforceability of any patent within the PATENT RIGHTS, which issue shall
be determined in accordance with the applicable patent laws of the
country of such patent.
22.4 Should any part or provision of this Agreement be held unenforceable or
in conflict with the law of any jurisdiction, the validity of the
remaining part or provisions shall not be affected by such holdings.
22.5 Any provision hereof which is prohibited or unenforceable in any
jurisdiction shall, as to such jurisdiction, be ineffective only to the
extent of such prohibition or unenforceability without invalidating the
remaining provisions hereof or affecting the validity or enforceability
of such provision in any other jurisdiction.
22.6 The waiver by either party, whether express or implied, of any
provisions of this Agreement, or of any breach or default of either
party, shall not be construed to be a continuing waiver of such
provision, or of any succeeding breach or default or of a waiver of any
other provisions of this Agreement.
22.7 Notwithstanding anything to the contrary in this LICENSE AGREEMENT,
nothing herein contained shall be construed as a representation by ILEX
that the PATENT RIGHTS can be or will be used to prevent the importation
by a third party hereto of a product into or the SALE or USE by a third
party hereto of a product in any country within the PATENT RIGHTS where
such product
54
shall have been placed in commerce under circumstances which preclude
the use of the PATENT RIGHTS to prevent such importation or SALE or USE
by reason of any applicable law or treaty.
22.8 As used in this LICENSE AGREEMENT, singular includes the plural and
plural includes the singular, wherever so required by the context. The
headings appearing at the beginning of the numbered Articles hereof have
been inserted for convenience only and do not constitute a part of this
LICENSE AGREEMENT.
22.9 Nothing herein shall be deemed to create an agency, joint venture or
partnership between the parties hereto.
22.10 Notwithstanding any other provisions of this LICENSE AGREEMENT, neither
of the parties hereto shall be liable in damages or have the right to
terminate this LICENSE AGREEMENT for any delay or default in performing
hereunder if such delay or default is caused by conditions beyond its
control including, but not limited to acts of GOD, governmental
restrictions, wars, or insurrections, strikes, floods, work stoppages
and/or lack of materials, and any time for performance hereunder shall
be extended for the actual time of delay caused by such occurrence;
provided, however, that the party suffering such delay or default shall
notify the other party in writing of the reasons for the delay or
default and shall diligently seek to correct such conditions. If such
reasons for delay or default continuously exist for six (6) months, this
LICENSE AGREEMENT may be terminated by the other party.
IN WITNESS WHEREOF, the parties hereto have hereunto set their hands and duly
executed this LICENSE AGREEMENT on the date(s) indicated below, to be effective
the day and year first above written.
55
For and on Behalf of ILEX ONCOLOGY INCORPORATED
By:___________________________________
Name:_________________________________
Title:________________________________
Date:_________________________________
For and on Behalf of XXXXXXX PHARMACEUTICA, N.V.
By:___________________________________
Name: Gustaaf Van Reet, Ph.D.
Title: Managing Director
Date:_________________________________
