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Exhibit 10.56
[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.]
EXCLUSIVE LICENSE AGREEMENT
(OXYPURINOL)
THIS AGREEMENT is made as of November 27, 1996, by and between MGI
PHARMA, INC. (MGI"), 300E Opus Center, 0000 Xxxx Xxxx Xxxx, Xxxxxxxxxx,
Xxxxxxxxx 00000-0000 and ILEX ONCOLOGY, INC. (ILEX"), 00000 Xxxxxxx Xxxxx,
Xxxxx 000, Xxx Xxxxxxx, Xxxxx 00000-0000
Recitals
A. MGI acquires, develops and markets pharmaceuticals that it
believes address currently unmet medical needs or significantly improve upon
current therapies.
B. Pursuant to that certain license agreement, dated as of March 1,
1995 among Xxxxxxxxx Wellcome Co. (now known as Glaxo Wellcome, Inc., and
referred to herein as "Glaxo"), the Wellcome Foundation Limited ("WFL") and
ILEX (the "Glaxo Agreement"), ILEX was granted a license to use certain know-
how and clinical data relating to a compound called oxypurinol (the
"Compound"), as the Compound is more fully described in Exhibit A hereto, in
the field of cancer treatment.
C. ILEX has undertaken to amend the Glaxo Agreement to enlarge the
license granted to it under such agreement to include the know-how and data for
use in the treatment of any Indication.
D. MGI desires to develop, make or have made, sell and distribute
products containing the compound for any indication on a worldwide basis, and
ILEx desire to grant to MGI an exclusive, worldwide license and sublicense to
develop, make, have made, import, offer for sale, sell, promote and distribute
such products, all upon the terms and conditions set forth in this Agreement.
E. MGI desires for ILEx to prepare a data package with respect to
the compound and ILEX desires to perform such service, all upon the terms and
conditions set forth in this Agreement.
NOW THEREFORE, in consideration of the premises and the mutual covenants
hereinafter set forth, the parties hereto have agreed as follows:
ARTICLE 1 INTRODUCTION PROVISIONS
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1.1 Defined Terms. The following terms, when used in capitalized form in
this Agreement, shall have the meanings set forth below.
(a) "Affiliate" when used with reference to either party shall mean
any entity controlling, controlled by or under common control
with the said party. For purposes hereof, "control" shall mean
ownership, directly or indirectly, of more than [**]
([**]%) of the securities having the right to vote for the
election of directors, in the case of a corporation, and more
than [**] ([**]%) of the beneficial interest in the
capital, in the case of a business entity other than a
corporation.
(b) Best Efforts" shall mean those efforts that would be made by a
reasonably prudent business persona acting in good faith, in the
exercise of reasonable commercial judgment and in a manner
consistent with those efforts the applicable party devotes to its
own business and pharmaceutical products resulting from its own
research efforts and having a similar market potential, profit
potential or strategic value.
(c) "Confidential Information" shall mean all proprietary
information, including the Know-how, Proprietary Product
Information of a party, including any information on the markets,
customers, suppliers, patents or patent applications, inventions,
products, procedures, designs, formulas, business plans,
financial projections, organizations, employees or consultants or
any other similar aspects of a party's present or future
business, the secrecy of which confers a competitive advantage
upon that party.
(d) "Data Package" shall mean review and analysis by ILEx of the
clinical data which is a part of the Know-how, documentation of
the conclusions reached and preparation of a package of data for
submission by MGI to the FDA, all as further described on Exhibit
B.
(e) "Drug Master File" shall mean a Type II Drug Master File for any
Product created by ILEX or its agents and on file with the FDA,
any supplementary or successor drug master file that is submitted
by ILEX or its agents to the FDA, or any corresponding drug
master file or similar file in respect of any Product that may be
submitted to the FDA or other applicable governmental agency; in
each case, by ILEX or its agents as of the Effective Date or by
Glaxo or its agents at any time (provided that ILEX has rights
from Glaxo with respect thereto).
(f) "Effective Date shall mean the date first above written.
(g) "Europe" shall mean all countries that are member states, from
time to time, of the European Economic Union.
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(h) "Field" means use for all Indications, or if Glaxo does not agree
to such Field, such Indications as the parties and Glaxo may
mutually agree in writing. Such Field shall be added as an
Exhibit C to this Agreement which shall be initialled by the
parties.
(i) "First Commercial Sale" shall mean the date that MGI or a
sublicensee first transfers title to a Product to a Third Party
for monetary consideration.
(j) "FDA" shall mean the United States Food and Drug Administration
or any successor entity.
(k) "Health Registration Dossier" shall mean all documentation which
is now or shall hereafter be on file with the FDA or other
applicable governmental agency, which comprises the information
and data submitted to such agency in support of an application
made by ILEX, MGI, or a sublicensee of MGI or ILEX, to such
agency for Marketing Authorization for a Product to treat any
Indication.
(l) "Indication" shall mean any medical condition or set of symptoms
for the treatment of which a Product may be determined to be safe
and efficacious.
(m) "Know-how" shall mean all information and data, regardless of
form, which is necessary or useful to the development (including,
without limitation, clinical or preclinical testing or results,
and any other information necessary or supportive of a request
for Marketing Authorization) or manufacture of a Product or to
the development or manufacture of dose forms or means of delivery
of a Product, including, without limitation, the Data Package,
the Proprietary Product Information, and B.W. Co. Know-how and
the WFL Know-how, as those terms are defined in the Glaxo
Agreement, attached hereto as Exhibit D., (i) which (A) may have
been developed by ILEX or Third Parties or (b) is owned,
developed, acquired or otherwise licensable by IlEX to MGI and
(ii) which is in ILEX's possession or control as of the Effective
Date, or with respect to any of the foregoing received by ILEX
from Glaxo, as of the Effective Date or thereafter.
(n) "Marketing Authorization" shall mean any governmental approval by
the FDA or other applicable governmental agency which is legally
required under applicable laws, regulations or administrative
decisions to put a pharmaceutical product on the market in such
country for use in the treatment of any Indication (including
pricing and reimbursement approvals, if applicable).
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(o) "New Sales" shall mean,
(i) with respect to any Product containing the Compound as the
sole active ingredient, the gross sales (i.e., gross
invoice prices) of such Product billed by MGI and its
sublicensees to Third Party customers, less: (A) actual,
credited allowances to such Third Party customers for
spoiled, damaged, outdated and returned Product and for
allowances in lieu of returned Product following price
increases; (b) the amounts of customary trade and cash
discounts are not deducted by MGI or its sublicensees at
the time of invoice in order to arrive at the gross
invoice prices; (c) all transportation and handling
charges, sales taxes, excise taxes, use taxes, value added
taxes, other similar taxes, or import/export duties
actually paid; and (D) 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 prod, as defined in
Section 7.1, or not.
(ii) with respect to any product containing one or more active
ingredients in addition to the Compound, the gross sales
of such Product billed by MGI and its sublicensees to
third party customers, less all the allowances,
adjustments, discounts, taxes, duties and other charges
referred to in clauses (a) through (D) above, multiplied
by a fraction, the numerator of which shall be the
manufacturing cost or acquisition cost, as applicable, of
the Compound included in such Product and the denominator
of which shall be the manufacturing cost or acquisition
cost, as applicable, of all active ingredients in such
Product, including the Compound.
(p) "NDA" shall mean a New Drug Application, or a successor
application.
(q) "Product" shall mean the compound or any pharmaceutical product
having the Compound as an active ingredient, either alone or in
combination with other substances, whether or not such products
are known or in existence on the Effective Date.
(r) "Proprietary Product information" shall mean (i) all information
and data now or hereafter contained in any Drug Master File or
Health Registration Dossier to which either Party, or any
sublicensee of either Party, shall have the right under
applicable law, regulations and administrative decisions to
refer, to authorize third parties to refer and to prohibit third
parties from referring, for purposes of any application for
Marketing Authorization for any Product; (ii) all data concerning
any serious or unexpected adverse effects, side effects and
contraindications of any Product which may come to the attention
of either Party or of any sublicensee; (iii) all data and
information in the possession of either Party
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or any permitted sublicensee of a Party relating to (A) the
pharmacological or toxicological properties of a Product, (B)
pre-clinical or clinical testing and experience in relation to a
Product which is not included in any Health Registration Dossier
and (c) to the extent reasonably required for purposes of any
application for Marketing Authorization, the chemical
composition, manufacturing processes and quality control testing
of a Product and (iv) all other information and data now or
hereafter in existence and in the possession of either party
which relates to the development, testing manufacture, marketing
or use of any Product which is not in the public domain.
Notwithstanding the foregoing, as used herein, Proprietary
Product Information of ILEX shall be limited to (1) any of the
foregoing in ILEX's possession or control as of the Effective
Date and (2) any of the foregoing received by ILEx from Glaxo as
of the Effective Date or thereafter.
(s) "Third Party" shall mean any party other than ILEX, MGI, their
respective Affiliates and MGI's sublicensees.
1.2 Other Rules of Interpretation. Unless the context clearly indicates
otherwise, the following rules shall govern the interpretation of the
Agreement.
(a) The definition of all terms defined herein shall apply equally to
the singular, plural, and possessive forms of such terms;
(b) All references herein to "days" shall mean calendar days;
(c) All references herein to "quarters" shall mean calendar quarters;
and
(d) All references herein to "Sections" shall mean the corresponding
Sections of this Agreement and all references to "Articles" shall
mean the corresponding Articles of this Agreement.
ARTICLE 2 WARRANTIES AND REPRESENTATIONS; LIMITATIONS
2.1 ILEX Warranties. ILEX represents and warrants to MGI that:
(a) it has the legal right and power to enter into this Agreement;
(b) it has taken all necessary corporate action to authorize and
perform this Agreement;
(c) it has not entered into any inconsistent prior obligation that
would prevent the sublicense of the Know-how to MGI or
preparation of the Data Package hereunder;
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(d) it owns or has the right to license or sublicense all the rights
granted to MGI herein with respect to the Know-how and such
information and data in any applicable Drug Master Files which
ILEX owns, possesses or controls as of the Effective Date;
(e) it will own or have the right to license or sublicense all the
remaining rights granted to MGI herein with respect to the Know-
how and such information and data in any applicable Drug Master
Files that ILEX is receiving hereunder from Glaxo after the
Effective Date, such that as of the last date of such license or
transfers, ILEX will own or have the right to license or
sublicense all of the rights granted to MGI herein;
(f) to the best of its knowledge, there is no Know-how, technology or
data relating to the Compound that will not be provided to MGI;
and
(g) to the bet of its knowledge, there are not claims that would
challenge or impair the rights of MGI under the sublicense of the
know-how or with respect to the data Package hereunder,
including, without limitation, any claims based upon patents,
copyrights or trade secret laws.
(h) to the best of its knowledge, the manufacture, use or sale of the
Products under the license granted herein under the Know-how in
the Field will not infringe any patents, copyrights, trade
secrets or any other intellectual property right of any third
parties.
2.2 MGI Warranties. MGI respects and warrants to ILEX that:
(a) it has the legal right and power to enter into this Agreement;
and
(b) it has taken all necessary corporate action to authorize ad
perform this Agreement.
2.3 DISCLAIMER OF WARRANTIES. EXCEPT AS EXPRESSLY SET FORTH IN SECTIONS 2.1
AND 2.2, NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY WITH RESPECT
TO THE KNOW-HOW OR THE PRODUCTS AND EACH PARTY HEREBY EXPRESSLY
DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WARRANTIES
OR MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR PATENT ABILITY.
2.4 LIMITATION OF LIABILITY. EXCEPT AS PROVIDED IN SECTIONS 2.1, 2.2,
ARTICLE 8 OR IN THE EVENT OF A MATERIAL BREACH BY EITHER PARTY OF THE
LIMITATIONS SET FROTH IN ARTICLE 10 BELOW, NEITHER PARTY SHALL BE LIABLE
TO THE OTHER FOR ANY LOSS, EXPENSE OR DAMAGE ARISING OUT OF OR RESULTING
FROM THIS AGREEMENT. IN ANY EVENT, NEITHER PARTY SHALL BE LIABLE FOR
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ANY SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL LOSS OR DAMAGES. IN
THE EVENT OF ANY CLAIM FOR SUCH LOSS OR DAMAGES, THE SOLE AND EXCLUSIVE
REMEDY FOR ANY LIABILITY UNDER THIS AGREEMENT SHALL BE LIMITED TO A
REFUND OF ANY SUMS PAID AND/OR THE TERMINATION OF ANY RIGHTS GRANTED
UNDER THIS AGREEMENT.
ARTICLE 3 GLAXO AGREEMENT
3.1 License from Glaxo. ILEX acknowledges that MGI's obligation under this
agreement, including its obligations to pay fees or royalties to ILEX, are
dependent upon Glaxo's agreement to license to ILEX (with right of sublicense
to MGI) the rights to the Know-how for the Compound in a Field including all
Indications, or such Indications as the parties and Glaxo may agree, on terms
consistent with the terms of the existing license under the Glaxo Agreement.
ILEX shall use its Best Efforts to obtain an agreement by Glaxo, in a form
acceptable to MGI, to include all Indications in the Field. If Glaxo refuses
in writing to execute such an agreement, or if it fails to execute such
agreement on or before March 15, 1997 or if the parties and Glaxo otherwise do
not agree on the Field, MGI or IlEX shall have the right to terminate this
Agreement as provided in Section 11.5.
3.2 Assignment of Glaxo Agreement to MGI. MGI shall have the right to
require ILEX to request the approval of Glaxo to transfer ILEX's rights and
obligations under the Glaxo Agreement to MGI. Such right shall survive
termination of this Agreement as provided in Section 11.6(c). If this
Agreement is in force at the time of assignment of ILEX's rights and
obligations under the Glaxo Agreement to MGI, such assignment shall serve to
terminate this Agreement. Upon notification by MGI of its desire to assume the
Glaxo Agreement, ILEX shall promptly request Glaxo to give such approval. The
parties'[ rights and obligation under Article 6 shall survive such assignment
of the Glaxo Agreement and the termination of this Agreement as provided in
this Section 3.2.
ARTICLE 4 LICENSE; TECHNOLOGY TRANSFER
4.1 Grant of License. Subject to the terms and conditions of this
Agreement, ILEX hereby grants MGI an exclusive, worldwide, perpetual,
irrevocable license (with the right of sublicense) under the Know-how, to
develop, make, have made, use, offer to sell, sell and distribute Products in
the Field. Such license shall be subject to the reserved right of Glaxo and
WFL under the Glaxo Agreement to use the B.W. Co. Know-how and the WFL Know-how
for research purposes.
4.2 Technology Transfer. Within seven days of the Effective Date, ILEX
shall (a) provide MGI all bulk drug substance of the Compound and Know-how then
in its possession and necessary or useful in development or commercialization
of the Products, including chemistry, manufacturing and controls, preclinical
and clinical data, published literature and the like, for MGI's use and (b)
transfer to MGI any Drug Master Files relating to the Products. ILEX may
retain formulated capsules of the
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Compound in any amount needed to administer the compassionate use program
referred to in Article 9 (the "Compassionate Plea Program").
ARTICLE 5 DATA PACKAGE
5.1 Data Package Services. ILEX shall prepare the Data Package on behalf of
MGI and deliver to MGI on or before March 15, 1997. ILEX shall prepare the
Data Package with that degree of skill expected of properly qualified
professionals performing such obligations and in a prompt manner and in
accordance with ILEX's own internal standards for preparing submissions to FDA.
5.2 FDA Meeting. ILEX shall participate, as and when requested by MGI, in
one meeting and associated conferences between MGI and the FDA concerning the
Data Package and the NDA. MGI will reimburse ILEX's out of pocket travel and
living costs associated with attending such FDA meeting, promptly after receipt
of appropriate supporting documentation.
5.3. Assignment to MGI. ILEX hereby assigned to MGI all right, title and
interest to any tangible materials resulting from preparation of the Data
Package. ILEX further assigns to MGI any and all copyrights, patents,
trademarks, know-how, trade secret rights, and any other intellectual property
arising from preparation of the Data Package. ILEX shall execute all papers,
including patent applications, assignment of inventions, patents and
copyrights, and other instruments that MGI shall deem necessary or convenient
in order to perfect MGI's intellectual property rights.
5.4 Non-Compete. During the term of this Agreement (and if this Agreement
is terminated by MGI pursuant to Section 11.2, then for any additional period
of five (5) years thereafter), ILEX covenants and agrees that it shall not
market, promote, supply or sell Products, directly or indirectly through any
Affiliate or Third Party, unless MGI consents in writing, such consent not to
be unreasonable withheld. For the purposes of this Section 5.4,. MGI's refusal
to consent shall not be deemed to be unreasonable if MGI determines, in its
sole discretion, that the Product in question would be competitive to any
current or future Product of MGI or its sublicensees. Notwithstanding the
foregoing, ILEX shall be entitled to manufacture any Product for any third
party provided that it can do so without using or disclosing any Know-how
licensed hereunder.
5.5 Non-Exclusive Use of Consultant. It is contemplated by the parties that
ILEX will hire a consultant to prepare the Data Package and that MGI may wish
to engage the consultant to perform additional, related services after the Data
Package has been completed. If ILEX hires the consultant as an employee or
continues his consulting arrangement, ILEX shall use its Best Efforts to make
that individual available to assist MGI in preparation of the clinical portion
of its NDA, on such terms as the parties may then agree. At MGI's option, such
services may be provided as part of the research and development work to be
performed pursuant to Section 5.2 of that certain Exclusive License Agreement
(DHAC) dated as of November __, 1996. If ILEX does not hire the
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consultant as an employee or continue his consultancy, ILEX shall not hinder or
interfere with MGI's ability to engage the consultant to perform services
related to the Data Package or the Products after preparation of the Data
Package.
ARTICLE 6 FEES
6.1 License Fee. Subject to the fulfillment of the conditions set forth in
Section 3.1 hereto, MGI shall pay to ILEX [**] Dollars
($ [**] ) as a fee for the grant of the license to the Know-how to MGI,
payable by wire transfer on the later of the Effective Date or receipt by MGI
of a copy of the appropriate amendment to the Glaxo Agreement providing for an
expansion of the license as contemplated in Section 3.1.
6.2 Data Package Fee. Subject to the fulfillment of the conditions set
forth in Section 3.1. hereto, MGI shall pay to ILEX a fee of
[**] Dollars ($ [**] ) for the preparation of the Data
Package, payable by wire transfer thirty (30) days after completion of the Data
Package by ILEX and delivery thereof to MGI. This fee includes all expenses
incurred by ILEX in connection with its preparation of the data Package
(including travel and living costs, except as provided in Section 5.2).
6.3 Milestone Payment. Subject to the fulfillment of the conditions set
forth in Section 3.1 hereto, MGI shall pay to ILEX a milestone payment of
[**] Dollars ($ [**] ) if, an only if, it proceeds with the
submission of an NDA for a Product. If MGI decides to proceed with such NDA
submission, it shall so notify ILEX in writing and such payment will be made by
wire transfer within thirty (3)) days of receipt of such notice.
6.4 Taxes. ILEX shall be responsible for the payment of income taxes
resulting from payment from MGI to ILEX hereunder.
ARTICLE 7 ROYALTIES
7.1 Earned Royalties. Subject to the fulfillment of the conditions set
forth in Section 3.1 hereto and to adjustment as set forth in Section 7.2, MGI
shall pay ILEX a royalty of [**] percent ([**]%) of Net Sales of
Products. The obligation to pay royalties shall cease in each country ten (10)
years after the date of the First Commercial Sale of the first Product in each
such country. Notwithstanding the foregoing, royalties on Net Sales of any
Product sold in Europe shall be payable on a country-by-country basis
commencing with the First Commercial Sale of such Product in such country and
ending on the earlier of: (a) the date on which the Know-how becomes published
or generally known to the public through no fault of Ilex or MGI or their
Affiliates or MGI's sublicensees or (b) eight (8) years after the date of the
First Commercial Sales of the first Product in each such country. Upon
expiration of such royalty obligations, the license granted under Section 4.1
shall be deemed to be fully paid-up, irrevocable and perpetual. The parties
acknowledge and agree that the royalty
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obligation hereunder is designed solely as a pass through of ILEX's royalty
obligation under the Glaxo Agreement.
7.2 Credits Against Royalties. Any costs incurred by MGI or ILEX (including
costs incurred prior to the Effective Date) in the implementation and
maintenance of the compassionate Plea Program may be credited by MGI against
earned royalties payable pursuant to Section 7.1 hereof, provided that (i) the
amount of such credit for program costs shall not exceed [**] percent
([**]%) of the royalties that would otherwise by payable; and (ii) program costs
which are not ultimately credited against earned royalties during the term of
this Agreement shall lapse and shall be of no further value. Within seven days
of the Effective Date, ILEX shall provide MGI with a written accounting of
expenses incurred by ILEX prior to the Effective Date in the implementation and
maintenance of the Compassionate Plea Program, and thereafter shall provide MGI
with quarterly accountings and documentation of expenses incurred in
maintaining the Compassionate Plea Program, all in a form acceptable to MGI for
reimbursement as provided in Section 9.1.
7.3 Accrual of Royalties. No royalty shall be payable on a Product made,
sold or used for tests for development purposes or distributed as samples. No
royalties shall be payable on sales among MGI and MGI's sublicensees, but
royalties shall be payable upon sales by MGI or MGI's sublicensees to third
Parties.
7.4 Third Party Royalties. If MGI or its sublicensees are required to pay
royalties to any Third Party because the manufacture, use or sale of the
Compound contained in a given Product infringes any patent or other
intellectual property rights of such third party in a given country, MGI may
deduct from royalties thereafter due to ILEX with respect to Net Sales of such
Product in such country the royalties or such other fees paid to such Third
Party.
7.5 Glaxo Agreement. MGI shall comply with the terms of the Glaxo Agreement
applicable to sublicensees of ILEX relating to the payment of or accounting for
royalties or documentation of sales of Products (including without limitation
payment of audit expenses if so required under Section 6.2 of the Glaxo
Agreement) and shall, at the request of ILEX, submit to audits and take other
actions necessary for ILEX to fulfill its obligations under the Glaxo
Agreement, provided, however, that MGI shall not be obligated to take any
action that would cause it to pay or incur fees or royalties greater than those
provided for Articles 6 and 7 of this Agreement.
ARTICLE 8 INDEMNIFICATION
8.1 Indemnification by MGI.
(a) MGI hereby indemnifies and holds harmless ILEX and its Affiliates
and their respective officers, directors, employees and agents
(an "ILEX Indemnified Party") from and against all liabilities,
damage,s losses, costs and expenses (including reasonable
attorney's fees) arising out of: (i)
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breach of any warranty, covenant or agreement of MGI contained in
this Agreement; (ii) use of the results of the Data Package,
except to the extent such liabilities, damages, losses, costs and
expenses arise from the preparation by ILEX of the Data Package;
(iii) claims, suits or proceedings (a "Legal Action") brought by
a third party alleging actual negligence, gross negligence or
willful misconduct of MGI or its sublicensees resulting in
personal injury or death related to the use of any Product
developed or marketed by MGI or its sublicensees; (iv) any Legal
Action arising out of MGI's operation and administration of the
Compassionate Plea Program, and (v) any Legal Action alleging
personal injury or death or damage to property arising out of the
use of any Product developed or marketed by MGI or its
sublicensees.
(b) Whenever an ILEX Indemnified Party become aware of a claim, suit
or proceeding as to which it believes it is entitled to
indemnification under this Article 8, such ILEX Indemnified Party
shall give notice in writing to MGI in sufficient time so as not
to materially and adversely prejudice MGI's rights with respect
to such Legal Action, shall permit MGI to assume exclusive
control of the defense or settlement of the matter, and shall
provide, at the expense of MGI, all authority, information and
assistance which MGI may reasonable request for purposes of such
defense. If a single law firm engaged by MGI would be subject to
any material conflict of interest in representing one or more of
such parties MGI shall not be required to waive such conflict and
may, instead, request separate representation by an independent
law firm of the ILEx Indemnified Party at the expense of MGI. An
ILEX Indemnified Party may engage its own counsel, at its own
expense, to monitor the defense of any such matter. MGI will
maintain general and products liability insurance with
contractual liability coverage and limits of at least [**]
dollar ($[**] ).
8.2 Indemnification by ILEX.
(a) ILEX hereby indemnifies and holds harmless MGI, its Affiliates
and any parties to which it sublicenses rights to
manufacture,market, or distribute Products ad their respective
officers, directors, employees and agents (a "MGI Indemnified
Party") from and against all liabilities, damages, losses, costs
and expense (including reasonable attorney's fees) arising out
of: (i) any Legal Action brought alleging negligence, gross
negligence or willful misconduct of ILEX with respect to the
preparation of the Data Package or failure of ILEX to comply with
any applicable laws, regulations and/or administrative decisions
relating to the preparation of the Data Package; (ii) any Legal
Action arising out of ILEX's operation ad administration of the
Compassionate Plea Program, ad (iii) breach of any warranty,
covenant or agreement of ILEX contained in this Agreement.
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(b) Whenever an MGI indemnified Party becomes aware of a claim, suit
or proceedings as to which it believes it is entitled to
indemnification under this Article 8, it shall give notice in
writing to ILEX in sufficient time so as not to materially and
adversely prejudice ILEX's rights with respect to such Legal
Action, shall permit ILEX to assume exclusive control of the
defense or settlement of the matter and shall provide, at the
expense of ILEX all authority, information and assistance which
ILEX may reasonably request for purposes of such defense. If a
single law firm engaged by ILEX would be subject to any material
conflict of interest in representing one or more of such parties,
ILEX shall not be required to waive such representation by an
independent law firm of the MGI Indemnified Party at the expense
of ILEX. An MGI Indemnified Party may engage its own counsel, at
its own expense, to monitor the defense of any such matter.
8.3 Survival. The parties' obligations under this Article 8 shall survive
the termination of this Agreement for any reason.
ARTICLE 9 COMPASSIONATE PLEA PROGRAM
9.1 Continuing Obligation of ILEX. The parties acknowledge that ILEX has
assumed the duties and obligation of a Compassionate Plea Program with respect
to the Compound under the Glaxo Agreement. ILEX shall continue to administer
and shall remain solely responsible for the operation of the Compassionate Plea
Program until such time as: (i) MGI notifies ILEX of its intent to assume
ILEX's duties and obligations of the Compassionate Plea Program, in MGI's sole
discretion, or (ii) upon submission of an NDA for a Product, whichever shall
first occur. In the event of (i) or (ii), MGI shall assume responsibility for
the operation and administration of the Compassionate Plea Program. MGI shall
reimburse ILEX's reasonable expense for administration of the Compassionate
Plea Program, in an amount up to [**] Dollars ($ [**] ) per month
(but not to exceed ILEX's actual expenses), until the earliest of the
occurrence of (i) or (ii) or termination of this Agreement. MGI shall pay such
expense (up to such capped amount) upon presentation of documentation as set
forth in Section 7.2; provided, however, that any such expense incurred after
the Effective Date and prior to the date on which Glaxo signs the amendment to
the Glaxo Agreement contemplated in Section 3.1 shall accrue and MGI shall
reimburse ILEX for such expenses within thirty (3) days of the later date. If
Glaxo fails to sign such an amendment, MGI shall have no obligation hereunder
to reimburse IlEX for such expenses.
9.2 Cooperation. In the event that MGI assumes the duties and obligations
of ILEX under the Compassionate Plea Program, the parties shall work
cooperatively to facilitate the orderly transfer of administration of the
Compassionate Plea Program to MGI, including, but not limited to prompt
delivery to ILEx of all documentation concerning the Compassionate Plea Program
and all formulated Compound in its possession.
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ARTICLE 10 CONFIDENTIALITY
10.1 Non-Use and Non-Disclosure. Each party acknowledges and agrees that all
the other party's Confidential Information is confidential and proprietary to
the disclosing party. Each party shall not use or disclose to any third party
the other party's confidential Information without the other party's prior
written consent for any purpose other than as permitted or required hereunder.
Each party shall take the same reasonable measures necessary to prevent any
unauthorized use or disclosure by its employees, agent, contractors,
sublicensees, or consultants of the other party's Confidential Information as
it applies to the protection of its own Confidential Information.
10.2 Marking To be entitled to protection as Confidential Information, all
ILEX or MGI documents containing that party's Confidential Information shall be
appropriately and clearly marked as "Proprietary," "Secret," "Confidential," or
other words to similar effect. If a disclosure of confidential Information is
made orally, as in a meeting, the disclosing party shall indicate the nature of
that information at the time of its disclosure and shall confirm such
designation in writing within ten (10) days of the date of such disclosure to
the receiving party.
10.3 Exclusions. Information shall not be considered Confidential
Information hereunder if it:
(a) was already in the possession of the receiving party prior to its
receipt from the disclosing party, as shown by the receiving
party's books and records;
(b) is, or becomes, part of the public knowledge or literature
through no fault, act or omission of the receiving party,
provided, however, that Proprietary Product Information shall not
be deemed to have entered the public domain by reason of its
having been filed with the FDA or any other applicable
governmental agency;
(c) is, or becomes, available to the receiving party from a source
other than the disclosing party, which source has rightfully
obtained the same information and has no obligation of
confidentiality to the disclosing party with respect to it;
(d) is made available on an unrestricted basis by the disclosing
party to a Third party unaffiliated with the disclosing party; or
(e) is required to be revealed pursuant to law, provided, however,
the receiving party which is under any such requirement of law
shall give reasonable notice (pursuant to the provisions of
Section 13.5) to the disclosing party of such requirement and
shall cooperate with the disclosing party in reasonable legal
efforts to limit or mitigate any such
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revelation so as to preserve the proprietary nature of any
Confidential Information contained therein.
10.4 Duration; Surviving Obligation. Each party's obligations of non-use and
non-disclosure of the other party's Confidential Information shall apply during
the term of this Agreement and shall also survive for a period of five (5)
years after its termination or expiration for any reason.
ARTICLE 11 TERM AND TERMINATION
11.1 Term Unless earlier terminated in accordance with Section 11.2, 11.3,
11.4 or 11.5, this Agreement shall be in effect, on a country-by-country basis,
for ten (1) years from the date of the First commercial Sale of the first
Product in such country or in the case of countries in Europe, eight (8) years
from the date of the First Commercial Sale of the first Product in such
country.
11.2 Termination for Cause. Either party may terminate this Agreement at any
time by giving notice in writing to the other party, which shall be effective
ninety (90) days after its date, in accordance with the following provisions:
(a) if the other party files a petition of any type as to its
bankruptcy, is declared bankrupt, becomes insolvent, makes an
assignment for the benefit of creditors, or goes into liquidation
or receivership; or
(b) if the other party is in material breach of this Agreement and
has failed to cure such breach within sixty (60) days of the
receipt of written notice of breach from the non-breaching party.
11.3 Termination by Mutual Agreement. The parties may agree in writing to
terminate this Agreement for their mutual convenience at any time and for any
reason, subject to such terms and conditions as they may adopt.
11.4 Termination by MGI. MGI may terminate this Agreement immediately upon
notice to ILEX if:
(a) for any reason upon sixty (60) days notice; or
(b) MGI assumes the Glaxo Agreement pursuant to Section 3.2 hereof;
(c) MGI informs ILEX after the meeting with the FDA that it will not
proceed to submit an NDA with respect to the Product and returns
all Know-how to ILEX; or
(d) immediately upon a decision by MGI to stop all clinical research
on the Products due to safety issues with respect to
administration of a Product to humans.
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11.5 Termination due to Glaxo. If Glaxo refuses in writing to execute an
amendment to the Glaxo Agreement, as required under Section 3.1, or it fails to
do so on or before March 15, 1997, either party may terminate this Agreement
effective immediately upon written notice to the other party. Upon such
termination, MGI shall have no further obligation, and ILEX shall have no
further rights, under Article 6.
11.6. Rights and Obligations on Termination. If this Agreement is terminated
for any reason, the parties shall have the following rights and obligations:
(a) Termination of this Agreement shall not release either party from
the obligation to make payment of all amounts then due and
payable.;
(b) If this Agreement expires as provided in Section 11.1, the
license granted under Section 4.1 shall continue on a fully paid-
up, irrevocable and perpetual basis for the Indications with the
Field. If this agreement is otherwise terminated, the license
granted under Section 3.1 shall terminate and MGI shall return to
ILEX and Know-how relating to the Products that MGI initially
received from ILEX, and if ILEX terminates this Agreement
pursuant to Section 11.2 or MGI terminates this Agreement
pursuant to Section 11.4(a), (c) or (d), ILEX shall have a
worldwide, nonexclusive, royalty-free license under any patent
rights and know-how developed by MGI during the term of this
agreement and relating directly to the Products.
(c) If this Agreement is terminated pursuant to Section 11.2 for
ILEX's breach, ad if MGI so requests, ILEx shall request Glaxo to
approve the assignment of ILEX's rights and obligations under the
Glaxo Agreement to MGI, as provided in Section 3.2
(d) Each party's respective obligation of indemnification under
Article 8 (as provided in Section 8.3), of non-use and non-
disclosure under Article 10 (as provide din Section 0.4) and to
settle all disputes,. controversies or claims under Article 12
(as provided in Section 12.5) shall survive such termination of
this Agreement. In addition, MGI shall comply with Section 11.4
of the Glaxo Agreement upon any termination of this Agreement.
11.7. Rights under U.S. Bankruptcy Laws. The parties acknowledge and agree
that all rights an licenses granted to MGI by ILEX pursuant to this Agreement
are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the
Bankruptcy Code, licenses of rights to "intellectual property" as defined under
Section 101952) of the Bankruptcy Code, and that MGI, as the licensee
hereunder, shall retain and may fully exercise all of its rights and elections
under the Bankruptcy code.
11.8 No Compensation. the parties agree that, subject to the above
provisions of Section 11.6, and without prejudice to any other remedies at law
or in equity that either
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party may have in respect of any breach of this agreement, neither party shall
be entitled to or claim that it is entitled to any compensation or like payment
as a result of or arising out of any termination in accordance with this
Article 11, whether claimed as loss of good will, foregone profits, lost
investments, or otherwise.
ARTICLE 12 DISPUTE RESOLUTION
12.1 Negotiation. The parties recognize that disputes as to certain matters
may from time to time arise during the term of this Agreement which relate to
either party's rights or obligation hereunder or thereunder. It is the
objective of the parties to establish procedures to facilitate the resolution
of disputes arising under this Agreement in an expedient manner by mutual
cooperation and without resort to litigation. The parties agree to consult and
negotiate in good faith to try to resolve any dispute, controversy or claim
that arises out of or relates to this Agreement.
12.2 Reservation for Litigation. Notwithstanding Section 12.1, each party
expressly reserve the right to seek judicial relief, including, without
limitation, any injunction or other preliminary relief from a court of
competent jurisdiction, if the other party is or appears to be in violation of
its obligations of non-use and non-disclosure under Article 10 above. Nothing
in this Section 12.2. shall preclude a party from seeking such interim relief
with respect to any disputes or claims arising under this Agreement as may be
available under the commercial arbitration rules a provided in Section 12.3.
12.3 Arbitration. Subject to the reservation of the parties under Section
12.2, all disputes, claim or controversies arising out of or in connection with
this Agreement shall be finally settled under the commercial arbitration rules
of the American Arbitration Association ("AAA"), as modified by Section 12.4
below. Judgment upon the award rendered by the arbitrators may be entered in
any court of competent jurisdiction. The place of arbitration shall be
Chicago, Illinois. The arbitration shall be conducted by three (3) neutral
arbitrators selected by mutual agreement of the parties or, if that is not
possible within thirty (3) days of the initial demand for such arbitration, by
the AAA. At least one (1) arbitrator shall have knowledge of and experience in
technology licensing.
12.4 Special Rules. Notwithstanding any provision to the contrary in the
commercial arbitration rules, the parties hereby stipulate that any arbitration
hereunder shall be subject to the following special rules:
(a) The arbitrators may not award or assess punitive damages against
either party; and
(b) Each party shall bear its own costs and expenses of the
arbitration and one-half (1/2) of the fees and costs of the
arbitrators, subject to the power of the arbitrators, in their
sole discretion, to award all such reasonable costs, expenses and
fees to the prevailing party.
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12.5 Survival. The duty of the parties to arbitrate any dispute, controversy
or claim under the Article 12 shall survive the termination of this Agreement
for any reason.
ARTICLE 13 GENERAL PROVISIONS
13.1 Entire Agreement. This Agreement, together with Exhibits hereto which
are incorporated herein by reference, constitutes the entire agreement of the
parties with respect to the subject matter hereof and supersede all the
parties' previous understandings, agreements and representations, oral or
written.
13.2 Assignment. ILEX shall not assign or otherwise transfer its rights or
obligations under this Agreement except with the prior written consent of MGI;
provided that no such consent for a transfer to an entity shall be required and
all right and obligations arising hereunder shall inure to the benefit of that
entity if it is (a) an Affiliate of ILEX, (b) the successor in interest of ILEx
by reason of sale, merger or operation of law, or (c) has acquired all or
substantially all of the assets and business of ILEX.
13.3 Amendment. This Agreement may not be modified or amended, in whole or
in part, except by a written agreement signed by both parties.
13.4 Severability. If one or more of the provision of this Agreement is
subsequently declared invalid or unenforceable, this Agreement shall be treated
as though that provision were not in this Agreement, and this shall not affect
the validity or enforceability of the remaining provisions of this Agreement
(unless those provision that are invalidated or unenforceable are clearly
material and inseparable from the other provisions). The agreement as modified
shall be applied and construed to reflect substantially the good faith intent
of the parties and to achieve the economic effects originally intended by the
terms hereof.
13.5 Notices. Except as may be otherwise provided in this Agreement, any
notice, demand or request given, made or required to be made shall be in
writing and shall be effective, unless otherwise provided herein, when received
after delivery by (a) registered air mail, postage prepaid; (b) facsimile with
electronic confirmation of receipt; or (c) by express mail or a reputable
courier at the addresses set forth below or to any other address that a party
specifies in writing.
If to MGI: MGI PHARMA, INC.
300E Opus Center
0000 Xxxx Xxxx Xxxx
Xxxxxxxxxx, XX 00000-0000
Attn: Xxxx-xxxx Xxxxx, Vice President,
General Counsel
Facsimile: (000) 000-0000
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With copy to: Xxxxxx & Whitney LLP
Pillsbury Center South
000 Xxxxx Xxxxx Xxxxxx
Xxxxxxxxxxx, XX 00000
Attn: Xxxxx X. Xxxxxx
Facsimile: (000) 000-0000
If to ILEX: ILEX Oncology, Inc.
Suite 101
00000 Xxxxxxx Xxxxx
Xxx Xxxxxxx, Xxxxx 00000-0000
Attn: Xxx Xxxxxxxxxx
Facsimile: (000) 000-0000
With Copy to: Fulbright & Xxxxxxxx
000 Xxxxxxx Xxxxxx
Xxxxx 0000
Xxx Xxxxxxx, Xxxxx 00000
Attn: Xxxxxxx X. Xxxxxxxx
Facsimile: (000) 000-0000
13.6 Waiver. Either party's failure or delay in exercising any remedy for
default shall not be deemed a waiver of that or any subsequent default of that
provision or of any other provision hereof.
13.7 Counterparts. This Agreement shall be executed in two (2) or more
counterparts, each of which shall be deemed an original.
13.8 Governing Law. This Agreement shall be governed by, and interpreted and
construed in accordance with, the laws of the State of New York, excluding (a)
its choice of law rules and (b) the United Nations Convention on the
International Sale of Goods and provided however that the operation of the
arbitration agreement contained in Section 12.3 hereof, and the enforcement of
any award rendered pursuant thereto, shall be governed by United States federal
law to the exclusion of any state law.
13.9 Relationship. The parties are independent contractor sand shall not be
deemed to have formed any partnership, joint venture or other relationship
hereunder. Neither party shall make, or represent to any other person that it
has the power or authority to make, any financial or other commitment on behalf
of the other party.
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IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed as of the date first above written.
MGI PHARMA, INC. ILEX ONCOLOGY, INC.
By By Xxxxxxx X. Love
------------------------------- --------------------------------------
Its Vice President, General Its President and CEO
----------------------------- -------------------------------------
Counsel
-----------------------------
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IN WITNESS WHEREOF, the parties have caused this Agreement to be executed as
of the date first above written.
MGI PHARMA, INC. ILEX ONCOLOGY, INC.
By By
------------------------------- --------------------------------------
Its Its
----------------------------- -------------------------------------
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EXHIBIT A
THE COMPOUND
Oxypurinol is a structural analog of the natural purine base xanthine and the
principal metabolite of allopurinol, a xanthine oxidase inhibitor that acts on
purine metabolism.
The molecular formula for oxypurinol is C(5)(H)(4)(N)(4)(O)(2)
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EXHIBIT B
OXYPURINOL DATA PACKAGE
A pre-NDA Data Package will be prepared by ILEX to allow its submission to the
FDA on or before 15 March 1997. This data will b submitted by MGI to the FDA
for presentation, with ILEX's assistance. The Data Package will be derived
form approximately 489 patients who have been enrolled in the compassionate use
program for oxypurinol. The data package will contain the following items;
however, additional items may be included as the data package evolves to a pre-
NDA document.
1. INDICATION(S) - An indication(s) for oxypurinol which would allow
for rapid acceptance and approval by the FDA, but will be as broad as is
reasonable. In its most narrow form, an indication for patients suffering from
gout who have experienced an adverse event from the use of Allopurinol will be
sought.
2. DEMOGRAPHICS - Demographic information will be included in the
pre-NDA package. This information will be extracted from the data collection
forms and will include things like age, sex, height and weight. In addition,
information will be summarized regarding the patient's reaction to Allopurinol;
e.g., exfoliative dermatitis, hepatic intolerance or leukopenia. Finally,
information regarding the indication, if other than untoward reaction to
Allopurinol, for gout patients will also be tabulated. Other possible
indications are urate nephrolithiasis, Xxxxx-Nyan Syndrome or hyperuricemia.
3. PHARMACOKINETICS - On occasion, Xxxxxxxxx-Wellcome Company did
oxypurinol determinations on blood samples received from physicians concerned
about the bioavailability of the drug. In addition, over 200 articles have
been identified which contain information on pharmacology and/or
pharmacokinetics. These articles and clinical data will be reviewed and
summarized for inclusion in the pre-NDA data package.
4. CLINICAL LABORATORY RESULTS - All available clinical laboratory
data from the Case Report Form review will be included in the pre-NDA data
package. Typically, these include RBC, hemoglobin, hematocrit, white cell
counts and leukocyte differential, also where available, urinalysis, serum uric
acid levels, BUN, and creatinine determinations will be provided for patients
before and during oxypurinol therapy.
5. CLINICAL RESPONSES - Clinical responses are described by many of
the investigators; however, since this was not requested information, it is
not available for all patients. We will, however, review this information and
decide at the conclusion of the review whether it will be included in the
preNDA package.
6. CONCOMITANT MEDICATIONS - This information appears to be readily
available on the Case Report Forms and will be recorded as part of the pre-NDA
package.
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7. TOXICITIES - This information is well documented on the CRFs and
in the annual report sent to the FDA. Overall, the toxicities associated with
the use of oxypurinol can be considered few in number and relatively mild when
compared to Allopurinol.
8. DOSAGE, SCHEDULE, AND LENGTH OF ADMINISTRATION OF OXYPURINOL -
This information will also be summarized in the pre-NDA package. It may be
necessary to refer to other documents to extract this data. This information
will lead to the preparation of a draft of labeling which will also be included
in the pre-NDA package.
As part of processing and analyzing this data, ILEX will perform the
following:
* design and create a database for clinical data
* input and verify entry of data
* perform a data check, followed by investigation and resolution
of data discrepancies
* maintain an audit trail of any edit changes
* generate reports for key data expected to be required for the
clinical section of an NDA submission
* analyze results and discuss clinical conclusions with MGI
* transfer datasets and associated documentation to MGI
In Summary, ILEX will prepare a pre-NDA meeting package and assist MGI
in a face-to-face meeting with the FDA. This meeting will be designed to
solicit the FDA's opinion on the filing of a paper NDA submission on currently
available patient data and on the current status of the IND.
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EXHIBIT C
FIELD
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EXHIBIT D
GLAXO AGREEMENT
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