EXHIBIT 10.36
LICENSE AGREEMENT
LICENSE
AGREEMENT, dated November 16, 2001 (the "Agreement"), is made
between Celgene Corporation, a Delaware corporation ("Celgene"),
Pharmion GmbH,
a Swiss limited liability company ("Pharmion"), and, solely for
purposes of
guaranteeing the obligations of Pharmion hereunder, Pharmion
Corporation, a
Delaware corporation ("Guarantor").
WHEREAS,
Celgene has developed the Products (as defined herein); and
WHEREAS,
Pharmion wishes to receive a license from Celgene for the
Products in the Territory (as defined herein), and Celgene is
willing to grant
Pharmion a license for the Products in the Territory, all on the
terms and
conditions set forth below.
NOW
THEREFORE, in consideration of the premises and of the
covenants
herein contained, Celgene and Pharmion mutually agree as
follows:
ARTICLE I.
DEFINITIONS
For
purposes of this Agreement, the following capitalized terms shall
have
the meanings specified below.
"AFFILIATE" shall mean any corporation or other entity which
controls, is
controlled by or is under common control with a party. A
corporation or other
entity shall be regarded as in control of another corporation or
entity if it
owns or directly or indirectly controls at least fifty percent
(50%) of the
voting stock or other ownership interest of the other corporation
or entity, or
if it possesses, directly or indirectly, the power to direct or
cause the
direction of the management and policies of the corporation or
other entity or
the power to elect or appoint fifty percent (50%) or more of the
members of the
governing body of the corporation or other entity.
"APPROVAL
PERIOD" shall have the meaning ascribed thereto in Section 9.4
hereof.
"CELGENE
PATENT RIGHTS" shall mean (i) the patents and patent
applications
listed on Exhibit A hereto, and (ii) any patents hereafter issued
or patent
applications hereafter filed by or on behalf of Celgene or any of
its
Affiliates, in either case, necessary or useful for the
registration,
distribution, marketing or sale of any of the Products in the
Territory during
the term of this Agreement.
"CELGENE
TECHNOLOGY" shall mean data, manufacturing know-how, regulatory
submissions and other intellectual property that is either in the
possession of
Celgene as of the date hereof or developed by Celgene during the
term of this
Agreement in connection with any additional regulatory approvals to
market
Products in the United
<PAGE>
States, (including,, without limitation, S.T.E.P.S., as hereinafter
defined, and
any clinical data from pivotal studies relating to the Products as
well as
additional clinical studies relating to the Products conducted from
time to time
by or on behalf of Celgene or any of its Affiliates) in either
case, owned or
controlled by, or licensed (with the right to sublicense) to,
Celgene and that
is necessary or useful to register, distribute, market or sell the
Products in
the Territory.
"CMCC"
shall have the meaning ascribed thereto in Section 3.9 hereof.
"CMCC
LICENSE" shall have the meaning ascribed thereto in Section 3.9
hereof.
"EMEA" shall mean the
European Agency for the Evaluation of Medicinal
Products.
"ENTREMED"
shall have the meaning ascribed thereto in Section 3.9 hereof.
"ENTREMED
LICENSE" shall have the meaning ascribed thereto in Section 3.9
hereof.
"FIRST
COMMERCIAL SALE" shall mean, with respect to any country in the
Territory, the first sale of any of the Products to an unaffiliated
customer in
such country following Regulatory Approval in such country.
"NET
SALES" shall mean Pharmion's and its Affiliates invoiced sales
price
of Product billed to unaffiliated customers, less: (i) to the
extent such
amounts are included in the invoiced sales price, actual credited
allowances
and/or charge-backs for spoiled, damaged, out-dated and returned
product, (ii)
quantity and other trade discounts and early settlement discounts
(where such
discounts are effectively non-discretionary and are given as a
matter of course)
actually allowed and taken, (iii) transportation, insurance and
handling
expenses to the extent chargeable to such sales, (iv) sales,
value-added and
other direct taxes incurred, (v) customs duties and surcharges and
other
governmental charges incurred in connection with the exportation or
importation
of any Product, and (vi) legally mandated rebates, if any.
"PRIME
RATE" shall mean the prime rate announced from time to time by
Citibank, N.A., plus 2%.
"PRODUCTS"
shall mean each article of manufacture, substance, material,
chemical, formulation or composition which is or includes
Thalidomide as an
active ingredient, including, without limitation, any composition
that comprises
Thalidomide and a non-steroidal anti-inflammatory compound(s). The
term
"Products" expressly excludes Thalidomide analogs.
"QUARTERLY
REPORT" shall have the meaning ascribed thereto in Section 3.6
hereof.
2
<PAGE>
"RECOGNIZED AGENT" shall mean an entity other than an Affiliate
of
Pharmion through which Pharmion regularly distributes and sells
products in a
particular region.
"REGULATORY APPROVAL" shall mean, with respect to each country in
the
Territory, all required regulatory approvals (including, without
limitation, as
to pricing) in such country to market and sell the Product to
unaffiliated
customers.
"TARGET
VOLUME" shall have the meaning ascribed thereto in Section 9.4
hereof.
"TERRITORY" shall mean the world, except for North America
(consisting of
the United States, Canada and Mexico), Japan, Korea, Taiwan and
China.
"THIRD
PARTY" shall mean any entity other than Celgene or Pharmion,
their
respective Affiliates.
"UK
REGULATORY APPROVAL" shall mean Regulatory Approval in the
United
Kingdom.
ARTICLE II.
REPRESENTATIONS AND WARRANTIES; COVENANTS
2.1.
REPRESENTATIONS AND
WARRANTIES OF EACH PARTY. Each party represents
and warrants to the other that it has the legal right and power to
enter into
this Agreement, to extend the rights and licenses granted to the
other in this
Agreement, and that the performance of such obligations will not
conflict with
its charter documents or any agreements, contracts or other
arrangements to
which it is a party.
2.2.
REPRESENTATIONS OF
PHARMION. Pharmion and Guarantor jointly and
severally represent and warrant to, and covenant with, Celgene
that:
(a) Pharmion is a corporation duly organized, validly existing
and
in good standing under the applicable laws of Switzerland and has
taken all
necessary action to authorize the execution, delivery and
performance of this
Agreement, and
(b) Guarantor is a corporation duly organized, validly existing
and
in good standing under the applicable laws of Delaware and has
taken all
necessary action to authorize the execution, delivery and
performance of this
Agreement, and
(c) upon the execution and delivery of this Agreement, this
Agreement shall constitute a valid and binding obligation of
Pharmion and
Guarantor enforceable in accordance with its terms, except as
enforceability may
be limited by applicable bankruptcy, insolvency, reorganization,
moratorium or
similar laws affecting creditors' and contracting parties' rights
generally and
except as enforceability may be subject to general principles of
equity
(regardless of whether such enforceability is considered in a
proceeding in
equity or at law).
3
<PAGE>
2.3.
REPRESENTATIONS OF
CELGENE. Celgene represents and warrants to, and
covenants with, Pharmion that:
(a) Celgene is a corporation duly organized, validly existing and
in
good standing under the laws of the State of Delaware and has taken
all
necessary action to authorize the execution, delivery and
performance of this
Agreement;
(b) upon the execution and delivery of this Agreement, this
Agreement shall constitute a valid and binding obligation of
Celgene enforceable
in accordance with its terms, except as enforceability may be
limited by
applicable bankruptcy, insolvency, reorganization, moratorium or
similar law
affecting creditors' and contracting parties' rights generally and
except as
enforceability may be subject to general principles of equity
(regardless of
whether such enforceability is considered in a proceeding in equity
or at law);
and
(c) Exhibit A contains a complete and correct list of all
patents
and patent applications filed by or on behalf of Celgene or any of
its
Affiliates, necessary or useful for registration, distribution,
marketing or
sale of any of the Products.
2.4.
DISCLAIMER OF
WARRANTIES. NOTHING IN THIS AGREEMENT SHALL BE
CONSTRUED AS A REPRESENTATION MADE, OR WARRANTY GIVEN, BY CELGENE
OR PHARMION
(A) THAT ANY PATENT WILL ISSUE BASED UPON ANY PENDING PATENT
APPLICATION, (B)
THAT ANY PATENT WHICH HAS ISSUED OR HEREAFTER ISSUES WILL BE VALID,
OR (C) THAT
THE USE OF ANY LICENSE GRANTED HEREUNDER OR THE USE OF ANY PATENT
RIGHTS WILL
NOT INFRINGE THE PATENT OR PROPRIETARY RIGHTS OF ANY OTHER
PERSON.
ARTICLE III.
LICENSE GRANTS; RESERVED RIGHTS
3.1.
GRANT OF LICENSE
RIGHTS BY CELGENE TO PHARMION. Celgene hereby
grants to Pharmion, and Pharmion hereby accepts, an exclusive
(including as to
Celgene and its Affiliates) royalty-bearing license to register,
distribute,
market, use and sell the Products in the Territory under the
Celgene Patent
Rights and the Celgene Technology. Pharmion may not sublicense any
of the rights
granted by Celgene to Pharmion pursuant to this Section 3.1 and
Section 3.2
other than in accordance with Section 10.12 hereof.
3.2.
TRADEMARK. In
connection with the sale and marketing of the Product
by Pharmion in the Territory, Celgene hereby grants to Pharmion an
exclusive,
royalty-free license to use any Celgene trademark used by Celgene
in connection
with the Product. In the event a Celgene trademark is not available
in any
jurisdiction within the Territory, Pharmion may select a trademark
with
Celgene's written consent (such consent not to be unreasonably
withheld or
delayed) for registration in Celgene's name, and Celgene hereby
grants to
Pharmion a license thereto on the same basis as provided in the
preceding
sentence.
4
<PAGE>
3.3.
CELGENE RESERVED
RIGHTS. Except for the license expressly granted by
Celgene to Pharmion pursuant to Sections 3.1 and 3.2, Celgene
reserves all
rights under the Celgene Patent Rights and the Celgene Technology.
The foregoing
reserved rights shall include, but not be limited to, the rights to
develop,
make, use, sell and import Products outside the Territory. Without
limiting the
generality of the foregoing, it is understood and agreed that
Pharmion has no
right pursuant to this Agreement to manufacture the Products.
However, Celgene
and Pharmion hereby confirm that Celgene has authorized Penn
Pharmaceuticals
Ltd. (together with its successors and assigns, "Penn") to
manufacture the
Products for sale within the Territory, and that in connection
therewith
Pharmion is party to a certain Amended and Restated Distribution
and License
Agreement between Pharmion and Penn with respect to the manufacture
of the
Products (the "Penn Agreement"). Celgene shall use commercially
reasonable
efforts to establish a second source of supply of Product. If for
any reason at
any time during the term of this Agreement the supply of available
Product is
insufficient, Celgene and Pharmion shall, during such period of
short supply,
apportion available supply between them on the following basis: (a)
if the short
supply occurs during the period between the date of this Agreement
and December
31, 2003, 75% to Celgene and 25% to Pharmion (but, in the case of
Pharmion, not
more than that amount subject to firm purchase orders), and (b) if
the short
supply occurs from and after January 1, 2004, on a basis that is
proportional to
their respective sales of Product during the preceding 12-month
period. If there
shall occur a withdrawal or recall of the Product from the U.S.
market due to
any regulatory mandate or otherwise, from and after the second
anniversary of
such withdrawal or recall, Celgene shall have no obligation
whatsoever to
Pharmion with respect to the supply of the Products except to
license the
manufacture of the Products to Pharmion and/or its contract
manufacturers
reasonably acceptable to Celgene, on commercially reasonable
terms.
3.4.
PRESERVATION OF
LICENSES IN BANKRUPTCY.
(a) If Celgene should file a petition under bankruptcy laws, or
if
any involuntary petition shall be filed against Celgene, Pharmion
shall be
protected in the continued enjoyment of Pharmion's rights as
licensee hereunder
to the maximum feasible extent including, without limitation, if it
so elects,
the protection conferred upon licensees under Section 365(n) of
Title 11 of the
U.S. Code, or any similar provision of any applicable law. Celgene
shall give
Pharmion reasonable prior notice of the filing of any voluntary
petition, and
prompt notice of the filing of any involuntary petition, under any
bankruptcy
laws.
(b) The Celgene Technology, the Celgene Patent Rights shall be
deemed to be "intellectual property" as that term is defined in 11
U.S.C.
Section 101(56) or any successor provision.
3.5.
ROYALTIES. In
consideration of the license and rights granted by
Celgene to Pharmion pursuant to this Article 3, Pharmion shall pay
to Celgene a
royalty equal to eight percent (8%) of Net Sales, payable as
provided below.
5
<PAGE>
3.6.
ROYALTY REPORTS,
EXCHANGE RATES. During the term of this Agreement,
following the First Commercial Sale, Pharmion shall within thirty
(30) days
after each calendar quarter furnish to Celgene a written quarterly
report (the
"Quarterly Report") showing: (a) the gross sales of the Product
sold by Pharmion
and its Affiliates during the reporting period and the calculation
of Net Sales
from such gross sales on a country by country basis; (b) the
specific
deductions, by category, permitted by the definition of "Net Sales"
taken in
connection with the calculation of Net Sales; and (c) the exchange
rates used in
determining the amount of United States dollars reflected in the
report. For
purposes of calculating Net Sales, all Net Sales in each quarter
that are in
currencies other than United States dollars shall be converted into
United
States dollars as follows: the exchange rate will be the average
of: (1) the
rate applicable on the last business day of the month prior to the
month of
sale, and (2) the rate applicable on the last business day of the
month in which
the sale was made (each published in the New York edition of the
Wall Street
Journal). Pharmion shall keep complete and accurate records in
sufficient detail
to properly reflect all gross sales and Net Sales and to enable the
royalties
payable hereunder to be determined. All payments of royalties shall
be made in
U.S. dollars.
3.7.
AUDITS. Upon the
written request of Celgene, Pharmion shall permit
an independent public accountant selected by Celgene and acceptable
to Pharmion,
which acceptance shall not be unreasonably withheld or delayed, to
have access
during normal business hours to such records of Pharmion as may be
reasonably
necessary to verify the accuracy of the royalty reports described
herein, in
respect of any fiscal year ending not more than thirty-six (36)
months prior to
the date of such request. All such verifications shall be conducted
upon
reasonable prior notice and not more than once in each calendar
year. In the
event such Celgene representative concludes that additional
royalties were owed
to Celgene during such period, the additional royalty (together
with interest
thereon from the date such royalty was originally due to the date
actually paid,
at the Prime Rate) shall be paid by Pharmion within thirty (30)
days of the date
Celgene delivers to Pharmion such representative's written report
so concluding.
The fees charged by such representative shall be paid by Celgene
unless the
audit discloses that the royalties payable by Pharmion for the
audited period
are incorrect by more than five (5%) percent, in which case
Pharmion shall pay
the reasonable fees and expenses charged by such representative.
All information
subject to review under this Section 3.7 is confidential and
Celgene shall, and
shall cause its representatives to, retain all such information in
confidence in
accordance with Article 7 hereof.
3.8.
ROYALTY PAYMENT TERMS.
Royalties shown to have accrued by a
Quarterly Report provided for under this Agreement shall be
payable, with
respect to Net Sales within Italy and Spain, within seventy-five
(75) days
following the end of each calendar quarter, and with respect to Net
Sales
elsewhere, within forty-five (45) days following the end of each
calendar
quarter. Payment of royalties in whole or in part may be made in
advance of such
due date. Royalties not paid when due shall bear interest at the
Prime Rate from
the date due to the date actually paid.
6
<PAGE>
3.9.
CMCC LICENSE. To the
extent the Celgene Patent Rights and the
Celgene Technology Rights licensed to Pharmion under this Agreement
are rights
which Children's Medical Center Corporation ("CMCC") has licensed
to Celgene
Pursuant to the Agreement among Celgene, CMCC, Bioventure
Investments KFT and
Entremed, Inc. dated August __, 2001 (the "CMCC License"), the
license granted
to Pharmion pursuant to Section 3.1 hereof is subject to the terms,
limitations,
restrictions and obligations provided for in the CMCC License.
Sections 2, 4.7,
4.8, 4.9, 9, 10, 11, 12, 15 and 16 of the CMCC License, and, to the
extent
applicable pursuant to the terms of this Agreement, Sections 7.2,
7.3, 7.4, 7.5,
and 7.6 thereof, shall be binding upon Pharmion as if it were a
party to the
CMCC License. A true and correct copy of the foregoing provisions
of the CMCC
License are annexed hereto as Exhibit D and a true and correct copy
of the CMCC
License in the form filed by Celgene with the Securities and
Exchange Commission
shall be provided by Celgene to Pharmion contemporaneously with the
filing
thereof with the Securities and Exchange Commission.
3.10.
TAIWAN. Notwithstanding anything to the contrary contained in
this
Agreement,
(a) If Celgene has not prior to the third anniversary of the date
of
this Agreement, granted to any Third Party a license to distribute,
market, use
or sell the Products in Taiwan (a "Third Party License"), the
Territory shall,
at Pharmion's election,
include Taiwan, such election to be made by written notice to
Celgene at any
time after the third anniversary of the date of this Agreement;
and
(b) Pharmion may at any time, but shall not be required to,
register
the Products and/or otherwise seek Regulatory Approval in Taiwan,
provided that
it notifies Celgene of its actions not later than the initiation of
its first
filing with Taiwanese authorities. Notwithstanding the receipt of
any such
registration or Regulatory Approval, Pharmion will not distribute,
market, use
or sell the Products in Taiwan prior to the time, Celgene shall
have granted it
a license to do so. If Celgene shall grant a Third Party License
prior to the
third anniversary of the date hereof, Pharmion shall, to the extent
legally
permissible, take all action reasonably necessary to assign all of
its right,
title and interest in and transfer possession and control to
Celgene of the
regulatory filings prepared by Pharmion, and regulatory approvals
received by
Pharmion, to the extent that such filings relate to the Product and
Taiwan.
ARTICLE IV.
MARKETING
4.1.
SALES AND MARKETING
DUTIES OF PHARMION. In connection with the sales
and marketing of Products in the Territory, Pharmion shall, at its
own expense,
(a) use commercially reasonable efforts to commence a market
launch
of the Products within the Territory within three months of the
receipt of UK
Regulatory Approval;
7
<PAGE>
(b) pay or have paid all marketing and distribution costs
associated
with the sales and distribution of the Products within the
Territory;
(c) maintain or have maintained the Products, pending their sale
to
customers, in a facility that is properly equipped (including
temperature and
humidity control) to store pharmaceutical and other sensitive
products. Subject
to the terms of any agreements with third parties with respect to
the
maintenance of the Products, Celgene will have the right to
inspect, from time
to time, such facility and all government inspection reports and
certificates
relating thereto. Pharmion shall use commercially reasonable
efforts to
incorporate in any such agreements a right of Celgene to conduct
such
inspections;
(d) collect from customers customs, handling, freight and like
charges, and sales, value added tax, if any, and other taxes;
(e) use commercially reasonable efforts to actively promote the
distribution and sale of the Products within the Territory so as to
maximize
sales of the Products therein. Without limiting the generality of
the preceding
sentence, Pharmion shall call upon customers in the Territory at
regular
intervals to solicit purchases, furnish current information and
display and
distribute information and materials regarding the Products. Each
party shall
provide the other with copies of materials it creates and uses for
its own
marketing purposes relating to the Products in its respective
territory.
Pharmion shall use such selling, marketing and packaging materials
pertaining to
the Products as Celgene shall consent to in writing, such consent
not to be
unreasonably withheld or delayed. Pharmion shall provide Celgene
any
translations necessary for Celgene to give such consent;
(f)
comply in all material respects with all applicable laws,
regulations and approvals governing the registration, importation,
distribution,
marketing and sale of the Products, and conduct itself in a
professional manner
in accordance with industry standards so as not to cause disrepute
or ill favor
to Celgene or the Products;
(g) maintain a technically competent and experienced sales
force
(including a product or market specialist) assigned to market the
Products and
devoted to maintaining accounts with present customers and
developing new
accounts for sales of the Products, and disseminate to the sales
personnel any
sales aids and literature developed by Pharmion relating to the
Products;
(h) maintain the highest standards of quality to protect the
integrity of the Products, including providing laboratory services
for quality
control and general housekeeping;
(i) study market trends in the Territory and communicate
perceived
market changes to Celgene;
(j)
immediately report to Celgene all governmental action relating
to any of the Products of which it has knowledge and consult with
Celgene in the
8
<PAGE>
handling of such governmental action (provided, that, final
determination with
respect to any such governmental action within the Territory shall
be made by
Pharmion after such consultation, provided such determination would
not be
reasonably likely to have a material adverse effect on Celgene);
and, during the
Term of this Agreement and for a period of five years thereafter,
maintain
records of all sales of Products and customers in order to assist
Celgene in
tracking the Products sold in the event of a recall or withdrawal
of any of the
Products from the marketplace due to a mandate of the United States
Food and
Drug Administration ("FDA") or otherwise (it being understood and
agreed that
Celgene will immediately report to Pharmion any governmental action
relating to
any of the Products of which it has knowledge and will maintain
similar records
during the Term of this Agreement and for a period of five years
thereafter);
(k) establish and, except as modified as a condition to any
Regulatory Approval, strictly adhere to a system consistent with
Celgene's
System for Thalidomide Education and Prescribing Safety
("S.T.E.P.S.") for the
safe and effective dispensing of the Products, a complete
description of which
is attached hereto as Exhibit B; provided, however, that Pharmion
may effect
such modifications of S.T.E.P.S. as Celgene shall have approved in
advance, on a
country by country basis, the consideration of such approval by
Celgene not to
be unreasonably delayed by it; and
(l) provide Celgene, no later than October 1 of each year during
the
term of this Agreement, with an annual marketing plan for the
Products in the
Territory and consult with Celgene with respect to such plan and
consider, in
good faith, Celgene's views with regard thereto.
4.2.
DUTY NOT TO COMPETE.
Pharmion will not sell, market or distribute
any pharmaceutical product containing thalidomide or any
combination
pharmaceutical product in a single dosage formulation that includes
thalidomide
(other than the Products).
4.3.
MARKETING SUPPORT
DUTIES OF CELGENE. In connection with the
marketing of the Product, Celgene shall:
(a) make available in the United States by telephone and/or
meetings, during reasonable business hours, persons of authority to
assist
Pharmion in performing the duties of Pharmion required hereunder
and to answer
appropriate inquiries of Pharmion;
(b) refer all inquiries to Pharmion which are received by
Celgene
from customers in the Territory; and
(c) provide initial training for a limited number of Pharmion's
marketing/medical staff at Celgene at the expense of Pharmion
(including per
diem, transportation costs and other expenses).
9
<PAGE>
ARTICLE V.
REGULATORY MATTERS
5.1.
REPORTING OF ADVERSE
EVENTS. Each party will give prompt notice to
the other party of any information it receives regarding the safety
of the
Product, including any confirmed or unconfirmed information on
adverse, serious,
or unexpected events associated with the use of the Product (i) by
telephone by
the end of the next calendar day and (ii) in writing via facsimile
within three
calendar days after receipt of the information. Pharmion will file
any reports
concerning such incidents required by law or regulation in the
Territory.
5.2.
OTHER REGULATORY
COMPLIANCE MATTERS. Pharmion shall comply with all
applicable guidelines of the U.S. Food and Drug Administration
and/or the
International Committee for Harmonization (ICH) relating to
expedited reports
and periodic safety update reports. Upon written request of
Celgene, Pharmion
shall permit Celgene or its representative, at Celgene's expense,
to have access
during normal business hours to such records of Pharmion as may be
reasonably
necessary to review Pharmion's drug safety operations. All such
reviews shall be
conducted upon reasonable prior notice and not more than twice in
each calendar
year.
ARTICLE VI.
INTELLECTUAL PROPERTY RIGHTS
6.1.
NO OTHER TECHNOLOGY
RIGHTS. Except as otherwise expressly provided
in this Agreement, under no circumstances shall a party hereto, as
a result of
this Agreement, obtain any ownership interest in or other right to
any
technology, trade secrets, know-how, patents, pending patent
applications,
products or biological materials of the other party, including
items owned,
controlled or developed by the other party, or transferred by the
other party to
said party, at any time pursuant to this Agreement.
6.2.
ENFORCEMENT OF PATENT
RIGHTS. Celgene and Pharmion shall each
promptly notify the other in writing of any alleged or threatened
infringement
of patents or patent applications relating to the Products of which
they become
aware. Celgene shall have the first right to bring any action or
legal
proceeding to enforce any Celgene Patent Right and/or to protect
any Celgene
Technology. If, within ninety (90) days from the date of notice of
any such
alleged or threatened infringement, Celgene has not initiated
action to abate
such infringement, Pharmion shall have the right, but not the
obligation, to
seek to abate such infringement at its sole cost and expense. The
parties will
cooperate with and provide reasonable assistance to each other in
any such
action. Any monetary recoveries from any such action shall first be
applied to
reimburse the party who undertook such litigation for its costs and
expenses,
with the balance of any such recovery being divided in an equitable
manner
between the parties.
6.3.
DEFENSE OF INDIVIDUAL
INFRINGEMENT ACTIONS. If Celgene or Pharmion,
any of their respective Affiliates or any Recognized Agent shall be
individually
named as a defendant in a legal proceeding by a Third Party for
infringement
10
<PAGE>
of a patent because of the manufacture, use or sale of the Product,
the party
which has been sued (or whose Affiliate or Recognized Agent has
been sued) shall
promptly notify the other party hereto in writing of the
institution of such
suit. Celgene may, at its option and at its sole expense, control
and defend
such suit. If, within a reasonable time after receiving notice of
such suit,
Celgene does not notify the party that has been sued of its
intention to control
and defend such suit or advises such party that it does not intend
to control
and defend such suit, the party that has been sued may control and
defend such
suit. The controlling party (a) may not settle such suit or
otherwise consent to
an adverse judgment in such suit that materially diminishes the
rights or
interests of the other party hereto without the express written
consent of such
other party (which consent shall not be unreasonably withheld or
delayed), and
(b) shall keep the other party hereto at all times reasonably
informed as to the
status of the suit. Such other party shall have the right to be
represented by
advisory counsel of its own selection (and such counsel's opinion
shall be
reasonably considered by the controlling party), at its own
expense, and shall
provide reasonable cooperation in the defense of such suit and
furnish to the
party controlling such suit all evidence and reasonable assistance
within its
control.
6.4.
DEFENSE OF JOINT
INFRINGEMENT ACTIONS. If Celgene or any of its
Affiliates, on the one hand, or Pharmion or any of its Affiliates
or Recognized
Agents, on the other hand, shall be jointly named as defendants for
infringement
of a patent for making, using, selling, offering to sell or
importing any of the
Products, Celgene shall be entitled to control the defense of such
suit, and all
expenses thereof including costs and attorney fees, shall be paid
by Celgene.
Pharmion, its Affiliate or Recognized Agent, as the case may be,
shall have the
right to be represented by counsel of its own selection, but at its
sole
expense. Celgene will consult in good faith with Pharmion regarding
the
litigation. Pharmion, its Affiliate or Recognized Agent, as the
case may be,
shall provide reasonable cooperation in the defense of such suit
and furnish to
Celgene all evidence and reasonable assistance within its control.
With respect
to any judgments, settlements or damages payable with respect to
the defense of
joint infringement actions, Celgene and Pharmion shall contribute
to the amount
owed in an equitable manner, reflecting the relative financial
benefits enjoyed
by each of them with respect to the Net Sales of the Products. In
the event a
license from a third party is required, the parties shall share the
cost of such
license equitably. Notwithstanding the foregoing, Pharmion shall
not be
obligated to contribute to any settlement costs described above
unless it has
given its express written consent (which consent shall not be
unreasonably
withheld or delayed) to such settlement.
ARTICLE VII.
CONFIDENTIALITY
7.1.
NONDISCLOSURE
OBLIGATIONS.
(a) Except as otherwise provided in this Agreement, during the
term
of this Agreement and for a period of ten (10) years thereafter,
both Parties
shall maintain in confidence (a) information and data received from
the other
party resulting from or related to the Product and (b) all
information and data
not described in clause (a)
11
<PAGE>
but supplied by the other party under this Agreement marked
"Confidential." For
purposes of this Article 6, information and data described in
clause (a) or (b)
shall be referred to as "Information."
(b) To the
extent it is reasonably necessary or appropriate to
fulfill its obligations or exercise its rights under this
Agreement, a party may
disclose Information it is otherwise obligated under this Section
not to
disclose to its Affiliates, consultants, outside contractors and
clinical
investigators, on a need-to-know basis on condition that such
entities or
persons agree to keep the Information confidential for the same
time periods and
to the same extent as such party is required to keep the
Information
confidential; and a party may disclose such Information to
government or other
regulatory authorities to the extent that such disclosure is
reasonably
necessary to obtain patents or authorizations to conduct clinical
trials of, and
to commercially market, the Product. The obligation not to disclose
Information
shall not apply to any part of such Information that: (a) is or
becomes part of
the public domain other than by unauthorized acts of the party
obligated not to
disclose such Information or its Affiliates; (b) can be shown by
written
documents to have been disclosed to the receiving party or its
Affiliates by a
Third Party, provided such Information was not obtained by such
Third Party
directly or indirectly from the other party pursuant to a
confidentiality
agreement; (c) prior to disclosure under this Agreement, was
already in the
possession of the receiving party or its Affiliates, provided such
Information
was not obtained directly or indirectly from the other party
pursuant to a
confidentiality agreement; (d) can be shown by written documents to
have been
independently developed by the receiving party or its Affiliates
without breach
of any of the provisions of this Agreement; (e) is disclosed by the
receiving
party pursuant to interrogatories, requests for information or
documents,
subpoena, civil investigative demand issued by a court or
governmental agency or
as otherwise required by law; provided that the receiving party
notifies the
other party immediately upon receipt thereof (and provided that the
disclosing
party furnishes only that portion of the Information which it is
advised by
counsel is legally required); or (f) bioavailability and clinical
data used for
marketing purposes following receipt of UK Regulatory Approval.
7.2.
TERMS OF THIS
AGREEMENT. Celgene and Pharmion each agree not to
disclose any terms or conditions of this Agreement to any Third
Party without
the prior consent of the other party, except as required by
applicable law.
Notwithstanding the foregoing, prior to execution of this
Agreement, Celgene and
Pharmion shall agree upon the substance of information that can be
used as a
routine reference in the usual course of business to describe the
terms of this
transaction, and Celgene and Pharmion may disclose such
information, as modified
by mutual agreement from time to time, without the other party's
consent.
7.3.
INJUNCTIVE RELIEF. The
Parties hereto understand and agree that
remedies at law may be inadequate to protect against any breach of
any of the
provisions of this Article 7 by either party or their employees,
agents,
officers or directors or any other person acting in concert with it
or on its
behalf. Accordingly, each party shall be
12
<PAGE>
entitled to the granting of injunctive relief by a court of
competent
jurisdiction against any action that constitutes any such breach of
this Article
7.
ARTICLE VIII.
INDEMNITY
8.1.
PHARMION INDEMNITY
OBLIGATIONS. Pharmion shall defend, indemnify and
hold Celgene, its Affiliates and their respective employees,
officers,
directors, counsel and agents harmless from all claims, losses,
damages or
expenses (including, without limitation, reasonable attorneys' fees
and expenses
and costs of investigation) arising as a result of: (a) the breach
by Pharmion
of any covenant, representation or warranty contained in this
Agreement; (b)
actual or asserted violations of any applicable law or regulation
by Pharmion,
its Affiliates or Recognized Agents by virtue of which any Product
distributed,
marketed or sold shall be alleged or determined to be adulterated,
misbranded,
mislabeled or otherwise not in compliance with any applicable law
or regulation;
(c) claims for bodily injury, death or property damage attributable
to the
distribution, marketing or sale of the Product by Pharmion, its
Affiliates or
Recognized Agents; (d) any negligent act or omission of Pharmion,
its Affiliates
or Recognized Agents in the distribution, marketing and sale of any
Product or
any other activity conducted by Pharmion, its Affiliates or
Recognized Agents
under this Agreement which is the proximate cause of injury, death
or property
damage to a third party; or (e) any failure of Pharmion to comply
with any
recall of a Product marketed, distributed or sold by Pharmion, its
Affiliates or
Recognized Agents that is ordered by a governmental agency or
required by a
confirmed failure of such Product.
8.2.
CELGENE INDEMNITY
OBLIGATIONS. Celgene shall defend, indemnify and
hold Pharmion, its Affiliates and their respective employees,
officers,
directors, counsel and agents harmless from all claims, losses,
damages or
expenses (including, without limitation, reasonable attorneys' fees
and
expenses, and costs of investigation) arising as a result of: (a)
the breach by
Celgene of any covenant, representation or warranty contained in
this Agreement;
(b) actual or asserted violations of any applicable law or
regulation by Celgene
or its Affiliates by virtue of which any Product manufactured,
distributed,
marketed or sold shall be alleged or determined to be adulterated,
misbranded,
mislabeled or otherwise not in compliance with any applicable law
or regulation;
(c) claims for bodily injury, death or property damage attributable
to the
manufacture, distribution, marketing or sale of the Product by
Celgene or its
Affiliates; (d) any negligent act or omission of Celgene (or any
Affiliate or
sublicensee thereof) in the manufacture, distribution, marketing or
sale of any
Product or any other activity conducted by Celgene or its
Affiliates under this
Agreement which is the proximate cause of injury, death or property
damage to a
third party; or (e) any failure of Celgene to comply with any
recall of a
Product manufactured, distributed, marketed or sold by Celgene or
its Affiliates
that is ordered by a governmental agency or required by a confirmed
failure of
such Product.
8.3.
PROCEDURE. A party or
any of its Affiliates or their respective
employees or agents (the "Indemnitee") that intends to claim
indemnification
under this
13
<PAGE>
Article 8 shall promptly notify the other party (the "Indemnitor")
of
any loss, claim, damage, liability or action in respect of which
the Indemnitee
intends to claim such indemnification, and the Indemnitor shall
assume the
defense thereof with counsel mutually satisfactory to the parties;
provided,
however, that an Indemnitee shall have the right to retain its own
counsel, with
the fees and expenses to be paid by the Indemnitor, if
representation of such
Indemnitee by the counsel retained by the Indemnitor would be
inappropriate due
to actual or potential differing interests between such Indemnitee
and any other
party represented by such counsel in such proceedings. The
indemnity agreement
in this Article 8 shall not apply to amounts paid in settlement of
any loss,
claim, damage, liability or action if such settlement is effected
without the
consent of the Indemnitor, which consent shall not be withheld or
delayed
unreasonably. The Indemnitor may not settle, or otherwise consent
to an adverse
judgment with respect to, any loss, claim, liability or action
without the
consent of the Indemnitee, which consent shall not be withheld or
delayed
unreasonably. The failure to deliver notice to the Indemnitor
within a
reasonable time after the commencement of any such action, if
prejudicial to its
ability to defend such action, shall relieve such Indemnitor of any
liability to
the Indemnitee under this Article 8 to the extent of such
prejudice, but the
omission so to deliver notice to the Indemnitor will not relieve it
of any
liability that it may have to any Indemnitee otherwise than under
this Article
8. The Indemnitee, its employees and agents, shall cooperate fully
with the
Indemnitor and its legal representatives in the investigation of
any action,
claim or liability covered by this indemnification. In the event
that each party
claims indemnity from the other and one party is finally held
liable to
indemnify the other, the Indemnitor shall additionally be liable to
pay the
reasonable legal costs and attorneys' fees incurred by the
Indemnitee in
establishing its claim for indemnity.
8.4.
INSURANCE.
(a) Pharmion shall purchase and maintain in effect at its own
expense, throughout the term of this Agreement, general liabilities
insurance
with limits of not less than U.S.$10,000,000 per occurrence and
U.S.$50,000,000
in the aggregate. Such policy shall cover Celgene as an additional
insured with
respect to liability arising out of Pharmion's activities with
respect to the
Products, and shall provide that the issuer of such policy shall be
required to
give Celgene and Pharmion not less than 30 days written notice
prior to the
cancellation of the policy or policies. Upon Celgene's request, a
memorandum
certificate of the aforementioned insurance policy or policies
shall be
deposited with Celgene; provided, however, that failure of Celgene
to make such
a request shall in no way be construed in such a way as to relieve
Pharmion from
its obligation to procure such insurance coverage. Prior to
expiration and/or
cancellation of the aforementioned policy or policies, Pharmion
shall promptly
secure replacement of such insurance coverage upon the same terms
and conditions
and furnish Celgene with a memorandum certificate as heretofore
described.
(b) Celgene shall purchase and maintain in effect at its own
expense, throughout the term of this Agreement, general liabilities
insurance
with limits of not less than U.S.$10,000,000 per occurrence and
U.S.$50,000,000
in the aggregate.
14
<PAGE>
Such policy shall cover Pharmion as an additional insured with
respect to
liability arising out of Celgene's activities with respect to the
Products, and
shall provide that the issuer of such policy shall be required to
give Pharmion
and Celgene not less than 30 days written notice prior to the
cancellation of
the policy or policies. Upon Pharmion's request, a memorandum
certificate of the
aforementioned insurance policy or policies shall be deposited with
Pharmion;
provided, however, that failure of Pharmion to make such a request
shall in no
way be construed in such a way as to relieve Celgene from its
obligation to
procure such insurance coverage. Prior to expiration and/or
cancellation of the
aforementioned policy or policies, Celgene shall promptly secure
replacement of
such insurance coverage upon the same terms and conditions and
furnish Pharmion
with a memorandum certificate as heretofore described.
ARTICLE IX.
TERM AND TERMINATION
9.1.
TERM. Unless sooner
terminated pursuant to this Article 9, this
Agreement shall expire on the 10-year anniversary of the date of
Regulatory
Approval in the United Kingdom. The term shall be extended
thereafter for
additional successive two-year periods, unless and until either
party notifies
the other party, in writing, of its intention to cancel such
extension as of the
end of the then current term; PROVIDED, that, any such
non-extension notice
shall be given not less than 180 days prior to the end of the then
current term.
9.2.
EXISTING OBLIGATIONS.
Termination pursuant to Section 9.1 of this
Agreement for any reason shall not relieve the Parties of any
obligation
accruing prior to such expiration or termination and any obligation
under this
Agreement which, pursuant to the express terms hereof, survives
such
termination.
9.3.
TERMINATION BY EITHER
PARTY.
(a) Celgene or Pharmion may terminate this Agreement on 60 days
prior written notice to the other party following (i) a material
breach by the
other party of any covenant, duty or undertaking herein, or in the
letter
agreement of even date entered into among Pharmion, Guarantor and
Celgene (the
"Letter Agreement"), which is not cured within 60 days of written
notice
thereof; or (ii) if the other party shall become insolvent or shall
file or have
filed by its creditors a petition in bankruptcy or similar
proceeding, if a
court of competent jurisdiction appoints a receiver over the
business or assets
of the other party, or the making by the party of a general
assignment for the
benefit of creditors.
(b) In addition,
Celgene may terminate this Agreement on 30 days
prior written notice to Pharmion following (i) Pharmion's failure
to apply for
UK Regulatory Approval, which application may be to the EMEA,
within twelve (12)
months after the date of this Agreement or Pharmion's failure to
obtain
Regulatory Approval in the United Kingdom within three (3) years
after the date
of this Agreement, (ii) Pharmion's failure to pay Celgene any
amount hereunder
when due, unless Pharmion is
15
<PAGE>
disputing such payment in good faith or otherwise cures such
default within 30
days of Celgene's delivery of the notice, (iii) Pharmion's
discontinuance of the
active conduct of its business for a period in excess of 30 days,
(iv)
Pharmion's failure to commence a market launch of the Products
within the United
Kingdom within three months after receipt of UK Regulatory
Approval, or (v) any
change in control of Pharmion that Celgene does not consent to,
such consent not
be unreasonably withheld or delayed. For purposes of the preceding
clause (v), a
"change in control" shall be deemed to occur upon (A) the
acquisition by any
Scheduled Entity (as hereinafter defined) of 50% or more of
Pharmion's voting
shares, (B) directors elected to the Board of Directors of Pharmion
over any
24-month period nominated by any Scheduled Entity representing 30%
or more of
the total number of directors constituting the Board at the
beginning of the
period, (C) any merger, consolidation or other corporate
combination upon the
completion of which shares of any Scheduled Entity outstanding
prior to such
transaction represent more than 50% of the combined voting power of
the
resulting entity, or (D) the sale of all or substantially all of
the assets of
Pharmion to any Scheduled Entity. For purposes of this Agreement,
the term
"Scheduled Entity" means (i) any of the entities listed on Exhibit
C to this
Agreement, (ii) any entity which Celgene at any time, and from time
to time,
during the term of this Agreement, shall add to the entities listed
on Exhibit
C, if, at any time within five (5) years prior to the date Celgene
adds such
entity to the list on Exhibit C, (A) Celgene has been in litigation
or
arbitration proceedings with such entity, (B) such entity has, in
writing,
threatened Celgene, or been threatened by Celgene, with litigation
or
arbitration proceedings, or (C) s