EXHIBIT 10.8
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 States, (including without limitation, S.T.E.P.S.,
as hereinafter defined, and any clinical
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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.
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"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).
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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.
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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.
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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.
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
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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;
(b) pay or have paid all marketing and distribution
costs associated with the sales and distribution of the Products within the
Territory;
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(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 handling of such governmental action (provided, that, final
determination with respect to any such governmental action within the Temtory
shall be made by Pharmion after such consultation, provided such determination
would not be reasonably likely to have a
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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).
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
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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
xxxxx such infringement, Pharmion shall have the right, but not the obligation,
to seek to xxxxx 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 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
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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) 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
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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 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
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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 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
-13-
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) Phamlion 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 its
$50,000,000 in the aggregate. 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
memorial 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.
-14-
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 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
-15-
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) such entity is or has been the subject of any
material government action, investigation or proceedings arising from alleged
non-compliance with applicable law; (iii) any entity that derives its revenues
primarily from generic/multi sourced pharmaceuticals, including new dosage
forms/delivery systems of generic or multisourced products, or (iv) any
Affiliate of any entity described in the preceding clauses (i), (ii) or (iii).
9.4. CO-EXCLUSIVITY WITH CELGENE AND REVERSION.
Notwithstanding anything to the contrary contained in this Agreement:
(a) In the event Pharmion fails to obtain Regulatory
Approval in the United Kingdom within three years after the date hereof (the
"Approval Period") and Celgene has not exercised its right to terminate this
Agreement pursuant to Section 9.3(b)(i), the license and rights granted by
Celgene to Pharmion pursuant to Article 3 of this Agreement shall thereafter be
exclusive only as to Third Parties and shall not be exclusive as to Celgene or
its Affiliates.
(b) In the event Pharmion fails to achieve Target
Volume (as hereinafter defined) with respect to any calendar year, the license
and rights granted by Celgene to Pharmion pursuant to Article 3 of this
Agreement shall thereafter be exclusive only as to Third Parties and shall not
be exclusive as to Celgene or its Affiliates, unless Pharmion, on the latest
date payments are required to made to Celgene in respect of the last quarter
occurring in such calendar year, pays to Celgene an amount equal to eight (8%)
percent of the difference between the Target Volume and the Net Sales with
respect to such year (the "Shortfall Payment"). The term "Target Volume" shall
mean Net Sales of at least U.S. $6 million with respect to the first year
following the First Commercial Sale in the United Kingdom, U.S. $13.5 million
with respect to the second year following the First Commercial Sale in the
United Kingdom, U.S. $18.5 million with respect to the third year following the
First Commercial Sale in the United Kingdom, U.S.$20 million with respect to the
fourth year following the First Commercial Sale in the United Kingdom and U.S.
$22 million with respect to the fifth year following the First Commercial Sale
in the United Kingdom, or, if Celgene or any licensee of Celgene commenced
commercial sales (following regulatory approval) of an analog of thalidomide
(referred to by Celgene currently as an "IMiD") at any time prior to such fifth
year, U.S. $18.5 million with respect to such fifth year.
(c) In the event Pharmion fails to achieve at least
fifty (50%) of Target Volume in any year and fails to make a Shortfall Payment
with respect to such year (such payment to be made as provided in clause (b)
above), at Celgene's option, such
-16-
option to be exercisable solely for a period of sixty (60) days after such
payment is otherwise due, the license and rights granted by Celgene to Pharmion
pursuant to Article 3 of this Agreement shall terminate upon the date set forth
in Celgene's written notice of termination to Pharmion.
(d) In the event the license and rights granted by
Celgene to Pharmion pursuant to Article 3 of this Agreement become co-exclusive
with Celgene, Pharmion shall provide Celgene with access to all regulatory
filings prepared by Pharmion, and regulatory approvals received by Pharmion, to
the extent that such filings and approvals relate to the Product.
9.5. CONSEQUENCES OF TERMINATION BY CELGENE.
(a) If this Agreement is terminated by Celgene, all
licenses and rights granted to Pharmion hereunder shall terminate and Pharmion
will immediately cease to distribute, market or sell the Product; and Celgene
shall be entitled to claim from Pharmion all damages which would be due to
Celgene under law and equity.
(b) Pharmion may dispose of its inventory of Product
on hand as of the effective date of termination, and may fill any orders for
Product accepted prior to the effective date of termination, for a period of
twelve (12) months after the effective date of termination.
(c) Within thirty (30) days after disposition of such
inventory and fulfillment of such orders Pharmion will forward to Celgene a
final report and pay Celgene all amounts due for Net Sales in such period.
(d) Pharmion shall to the extent legally permissible,
take all additional 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 and approvals relate to the Product.
9.6. OBLIGATION TO PAY SURVIVES TERMINATION. The termination
of this Agreement shall not affect Pharmion' s obligation to pay Celgene any
amounts due Celgene for Product sold prior to termination or pursuant to Section
9.5(c) hereof.
ARTICLE X.
MISCELLANEOUS
10.1. FORCE MAJEURE. Neither party shall be held liable or
responsible to the other party nor be deemed to have defaulted under or breached
this Agreement for failure or delay in fulfilling or performing any term of this
Agreement when such failure or delay is caused by or results from causes beyond
the reasonable control of the affected party, including but not limited to fire,
floods, embargoes, war, acts of war (whether war is declared or not),
insurrections, riots, civil commotions, strikes, lockouts or other labor
disturbances, acts of God or acts, omissions or delays in acting by any
governmental authority or the other party; provided, however, that the party so
affected shall use
-17-
reasonable commercial efforts to avoid or remove such causes of nonperformance,
and shall continue performance hereunder with reasonable dispatch whenever such
causes are removed. Either party shall provide the other party with prompt
written notice of any delay or failure to perform that occurs by reason of force
majeure. The parties shall mutually seek a resolution of the delay or the
failure to perform as noted above.
10.2. ASSIGNMENT. Except as otherwise provided herein, neither
the rights nor the obligations hereunder of any party hereto may be assigned
without the prior written consent of the other party hereto. Celgene may assign
its rights and obligations hereunder to any subsidiary or successor to its
business. This Agreement shall be binding upon and inure to the benefit of the
parties hereto and their respective successors and permitted assignees.
10.3. SEVERABILITY. Each party hereby agrees that it does not
intend to violate any public policy, statutory or common laws, rules,
regulations, treaty or decision of any government agency or executive body
thereof of any country or community or association of countries. Should one or
more provisions of this Agreement be or become invalid, the Parties hereto shall
substitute, by mutual consent, valid provisions for such invalid provisions
which valid provisions in their economic effect are sufficiently similar to the
invalid provisions that it can be reasonably assumed that the Parties would have
entered into this Agreement with such valid provisions. In case such valid
provisions cannot be agreed upon, the invalidity of one or several provisions of
this Agreement shall not affect the validity of this Agreement as a whole,
unless the invalid provisions are of such essential importance to this Agreement
that it is to be reasonably assumed that the' Parties would not have entered
into this Agreement without the invalid provisions.
10.4. NOTICES. All notices and other communications under this
Agreement shall be in writing and may be given by any of the following methods:
(a) personal delivery; (b) facsimile transmission; (c) registered or certified
mail, postage prepaid, return receipt requested; or (d) overnight delivery
service. Notices shall be sent to the appropriate party at its address or
facsimile number given below (or at such other address or facsimile number for
such party as shall be specified by notice given under this Section 10.4):
If to Celgene:
Celgene Corporation
0 Xxxxxx Xxxx Xxxxx
Xxxxxx, Xxx Xxxxxx 00000
Attention: Chief Executive Officer
Tel: (000) 000-0000
Fax: (000) 000-0000
with a copy to:
Proskauer Rose LLP
0000 Xxxxxxxx
-00-
Xxx Xxxx, Xxx Xxxx 00000-0000
Attn: Xxxxxx X. Xxxxxxx, Esq.
Tel: (000) 000-0000
Fax: (000) 000-0000
If to Pharmion:
Pharmion GmbH
c/x Xxxx Xxxxxx Partner
Xxxxxxxxxxxxxx.0
0000 Xxxxx Xxxxxxxxxxx
with a copy to:
Pharmion Corporation
0000 Xxxxxxxxx Xxxx
Xxxxxxx, XX 00000
Attention: Xxxxxxx X. Xxxxxxx,
Chief Executive Officer
Facsimile No.: (000) 000-0000
and with a copy to Pharmion's counsel at:
Xxxxxxx Xxxx & Xxxxxxxxx
000 Xxxxxxx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000
Attention: Xxxxx X. Xxxxx, Esq.
Facsimile No.: (000) 000-0000
All such notices and communications shall be deemed received upon (a) actual
receipt by the addressee, (b) actual delivery to the appropriate address or (c)
in the case of a facsimile transmission, upon transmission by the sender and
issuance by the transmitting machine of a confirmation slip confirming that the
number of pages constituting the notice have been transmitted without error. In
the case of notices sent by facsimile transmission, the sender shall
contemporaneously mail a copy of the notice to the addressee at the address
provided for above. However, such mailing shall in no way alter the time at
which the facsimile notice is deemed received.
10.5. GOVERNING LAW. This Agreement shall be governed by and
construed in accordance with the laws of the State of New York, without giving
effect to the choice of laws provisions thereof.
10.6. DISPUTE RESOLUTION, CHOICE OF FORUM. Any disputes
arising between the parties relating to, arising out of or in any way connected
with this Agreement or any term or condition hereof, or the performance by
either party of its obligations hereunder, whether before or after the
expiration pursuant to Section 9.1 or termination pursuant to Section 9.3 of
this Agreement, shall be promptly presented to the President or Chief Executive
Officer of Celgene and the President or Chief Executive
-19-
Officer of Pharmion for resolution and if they or their designees cannot
promptly resolve such disputes, then either party shall have the right to bring
an action to resolve such dispute before a court of competent jurisdiction. The
Parties hereby submit to the jurisdiction of the federal or state courts located
within the State of New York for the conduct of any suit, action or proceeding
arising out of or relating to this Agreement. Pharmion hereby agrees that
Celgene may effect service of process upon Pharmion by delivery (other than
facsimile) in the manner provided for the giving of notices under Section 10.4
hereof.
10.7. ENTIRE AGREEMENT. This Agreement, together with the
Letter Agreement, constitutes the entire understanding of the parties with
respect to the subject matter hereof. All express or implied agreements and
understandings, either oral or written, heretofore made are expressly merged in
and made a part of this Agreement. This Agreement may be amended, or any term
hereof modified, only by a written instrument duly executed by both parties.
10.8. HEADINGS. The captions to the several Articles and
Sections hereof are not a part of this Agreement, but are merely guides or
labels to assist in locating and reading the several Articles and Sections
hereof.
10.9. INDEPENDENT CONTRACTORS. Pharmion and Celgene shall each
act as independent contractors. Celgene shall not exercise control over the
activities and operations of Pharmion; accordingly, Pharmion shall be
responsible for paying all applicable social security, withholding, other
employment and income taxes for itself and its employees. Pharmion shall bear
all expenses incurred in its sales endeavors, except those for which Celgene
agrees in writing to pay. Pharmion and Celgene shall each conduct all of its
business in its own name and as it deems fit, provided it is not in derogation
of the other's interests. Neither party shall engage in any conduct inconsistent
with its status as an independent contractor, have authority to bind the other
with respect to any agreement or other commitment with any third party, nor
enter into any commitment on behalf of the other.
10.10. WAIVER. The waiver by either party hereto of any right
hereunder or of the failure to perform or of a breach by the other party shall
not be deemed a waiver of any other right hereunder or of any other breach or
failure by said other party whether of a similar nature or otherwise.
10.11. COUNTERPARTS. This Agreement may be executed in two or
more counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
10.12. SUBLICENSE AND ASSIGNMENT. Pharmion may not sublicense
and/or assign any rights under this Agreement without the prior written consent
of Celgene; provided, however, that no such consent shall be required if (i)
such sublicensee or assignee is an entity controlled by, in control of, or under
common control with, Pharmion, (ii) the sublicense is required under applicable
law to enable a Recognized Agent to market and distribute the Products, or (iii)
in the case of an assignee, such
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assignee is a successor or assignee of all or substantially all of Pharmion' s
business and such assignee is not a Scheduled Entity. Any sublicensee or
assignee of Pharmion shall agree in writing to be bound by the terms of this
Agreement applicable to the sublicense or assignment and, except with respect to
an assignee of the type described in clause (iii) above, Pharmion shall remain
responsible to Celgene for the performance of such sublicensee or assignee's
obligations under this Agreement.
10.13. GUARANTEE. Guarantor hereby unconditionally guarantees
the prompt payment and full performance by Pharmion of its obligations under
this Agreement.
IN WITNESS WHEREOF the parties have executed this Agreement as
of the date first set forth above.
CELGENE CORPORATION
By: /s/ Xxx X. Xxxxx
--------------------------------
Name: Xxx X. Xxxxx, Ph.D.
Title: President and Chief Operating Officer
PHARMION GMBH
By: /s/ Xxxxxxx X. Xxxxxxx
---------------------------------
Name: Xxxxxxx X. Xxxxxxx
Title: Chief Operating Officer
PHARMION CORPORATION
By: /s/ Xxxxxxx X. Xxxxxxx
---------------------------------
Name: Xxxxxxx X. Xxxxxxx
Title: Chief Operating Officer
-21-
Exhibit A
to License Agreement
Australian Xxxxxx Xxxxxxxxxxx Xx. 00000/00
Xxx Xxxxxxx Patent Application No. 262676
European Patent Application No. 94909773
European Patent Application PCT/US00/29303
Exhibit B
to License Agreement
[Description of S.T.E.P.S.]
Exhibit C
to License Agreement
Xxxxxx Pharmaceuticals, Inc.
ICN Pharmaceuticals, Inc.
Exhibit D
to License Agreement
SECTION 2 - GRANT
2.1 Grant. CMCC hereby grants to CELGENE an exclusive, worldwide right and
license under the THALIDOMIDE PATENT RIGHTS and the MIXED PATENT
RIGHTS, subject to the provisions of Sections 2.2 and 2.6 herein, to
make, have made, use, lease, offer for sale, sell and import PRODUCTS
and practice LICENSED METHODS in the FIELD.
2.2 Reservation of Research Rights.
2.2.1 CMCC-Retained Rights. The license granted in Section 2.1 of
this Agreement is subject to, and expressly limited by, CMCC's
non-exclusive rights to make and use, and to grant to other
research and educational institutions (each, a "THIRD PARTY
RESEARCHER"), subject to their prior written agreement to be
bound by the terms and conditions of this Section 2.2, a
non-exclusive license to make and use, the technology and the
subject matter described and claimed in the PATENT RIGHTS for
research and educational purposes only, whether or not such
activities are sponsored by or otherwise paid for by or
performed in conjunction with or on behalf of any commercial
entity (the "CMCC RETAINED RIGHTS")
2.2.2 Option(s) to Celgene on THALIDOMIDE INVENTIONS. If, in the
exercise of the CMCC RETAINED RIGHTS, CMCC or any THIRD PARTY
RESEARCHER makes any potentially patentable inventions or
discoveries relating to THALIDOMIDE or to PRODUCTS
("THALIDOMIDE INVENTION"), including without limitation any
modifications to any PRODUCT or any improvement to any of the
THALIDOMIDE PATENT RIGHTS or any MIXED PATENT THALIDOMIDE
CLAIMS, CMCC shall, and CMCC shall contractually obligate any
such THIRD PARTY RESEARCHER to, promptly notify CELGENE and
BIOVENTURE in writing, provided that the notice to BIOVENTURE
need not contain any confidential technical information. CMCC
hereby grants, and shall contractually obligate each such
THIRD PARTY RESEARCHER to grant, CELGENE an exclusive option
("Option") to enter into a license agreement granting CELGENE
an exclusive, worldwide, royalty-bearing license, with the
right to sublicense, under any patent applications and patents
directed to such THALIDOMIDE INVENTION, to make, have made,
use, lease, offer for sale, sell, and import PRODUCTS and
practice methods in the FIELD.
2.2.3 Exercise of Option(s). The term of each Option granted to
CELGENE hereunder shall run and be exercisable independently
on a THALIDOMIDE INVENTION-by-THALIDOMIDE INVENTION basis,
beginning on the date on which CELGENE receives notice thereof
pursuant to Section 2.2.2 and continuing for a period of three
(3) months ("Option Period"). In the event that this Agreement
terminates during any Option Period(s) for any reason other
than due to
CELGENE's breach of this Agreement, each such Option Period,
and the rights and obligations of the parties under Sections
2.2.3, 2.2.4 and 2.2.5 with respect to the relevant
THALIDOMIDE INVENTION, shall continue in full force and effect
for the duration of each such three (3) month period and, if
applicable, the relevant Negotiation Period. The relevant
THALIDOMIDE INVENTION shall be deemed to be CMCC's
CONFIDENTIAL INFORMATION, pursuant to the terms of this
Agreement. CELGENE may exercise its Option with respect to any
THALIDOMIDE INVENTION at any time during the relevant Option
Period by providing written notice to CMCC and/or such THIRD
PARTY RESEARCHER, as applicable, with a copy to BIOVENTURE,
stating its intention to exercise such Option. CELGENE agrees
that it shall reimburse CMCC for all reasonable out-of-pocket
expenses, including reasonable attorney's fees, incurred in
connection with the preparation, filing and prosecution of
patent applications directed towards the relevant THALIDOMIDE
INVENTION in the FIELD ("Patent Costs") during the Option
Period, provided that if CELGENE notifies CMCC in writing that
it rejects its Option with respect to the relevant THALIDOMIDE
INVENTION, CELGENE shall have no obligation to pay for any
Patent Costs incurred after the receipt of such notice by
CMCC. If CELGENE expressly rejects its Option or the Option
Period lapses without any such written notice from CELGENE,
then CMCC and such THIRD PARTY RESEARCHER shall have no
further obligation to CELGENE with respect to the relevant
THALIDOMIDE INVENTION.
2.2.4 Negotiation of License Agreement. Upon the exercise by CELGENE
of the Option set forth in Section 2.2.2, CELGENE and CMCC
and/or such THIRD PARTY RESEARCHER, as applicable, shall
negotiate in good faith for up to three (3) months for the
financial and other material terms, including diligence and
indemnification terms, of the license agreement ("Initial
Negotiation Period"). If written agreement has been reached
between CMCC and/or the THIRD PARTY RESEARCHER, as applicable,
on the one hand, and CELGENE, on the other hand, regarding
such terms during such three (3) month period, then the
Initial Negotiation Period shall automatically, without any
further action by either party, be extended for an additional
three (3) months (or any longer period as agreed to by the
parties) (together with the Initial Negotiation Period, the
"Negotiation Period") to permit negotiation and execution of a
mutually-agreeable license agreement. CELGENE agrees that it
shall reimburse CMCC for all Patent Costs incurred during the
Negotiation Period, provided that (a) if the parties cease
good faith negotiations with respect to the relevant
THALIDOMIDE INVENTION, CELGENE may notify CMCC in writing, and
CELGENE shall have no obligation to pay for any Patent Costs
incurred after the receipt of such notice by CMCC and (b) if
CMCC and/or the THIRD PARTY RESEARCHER, as applicable, on the
one hand, and CELGENE, on the other hand, execute a license
agreement relating to the relevant THALIDOMIDE INVENTION, the
terms and conditions of such agreement shall govern the
payment of Patent Costs incurred thereafter. CELGENE agrees
that it shall not be entitled to reduce the royalties owed
under Section 4 of this Agreement, pursuant to the terms of
Section 7.7 hereof or otherwise, to offset payments owed to a
THIRD PARTY
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RESEARCHER pursuant to a license agreement executed as set
forth in this Section 2.2. CELGENE and CMCC agree that the
payments due pursuant to Section 4 of this Agreement shall not
be affected by any payment terms of a license agreement
between CELGENE and CMCC executed as set forth in this Section
2.2, it being understood that CELGENE and CMCC are free to
agree that payments due under such license agreement may be
offset or otherwise reduced by payments due hereunder.
BIOVENTURE agrees that it shall not be entitled to any portion
of any amount that becomes payable by CELGENE to CMCC or any
THIRD PARTY RESEARCHER pursuant to a license agreement
executed as set forth in this Section 2.2. CMCC agrees, and
shall contractually obligate such THIRD PARTY RESEARCHER, as
applicable, to agree, that it will not, during the Option
Period and the Negotiation Period, enter into or negotiate
with any third party any agreement or contract that would be
inconsistent with the grant of the Option to CELGENE
hereunder. If the parties are unable to negotiate and execute
a mutually acceptable license agreement within the Negotiation
Period, CMCC and such THIRD PARTY RESEARCHER shall have no
further obligation to CELGENE with respect to the relevant
THALDOMIDE INVENTION. CMCC shall notify BIOVENTURE if the
Negotiation Period expires without execution of a license
agreement between CELGENE and CMCC.
2.2.5 Entremed Release. ENTREMED agrees that all rights ENTREMED may
have in any THALIDOMIDE INVENTION, and any obligations of CMCC
to disclose to ENTREMED a THALIDOMIDE INVENTION or to grant
to, or negotiate with, ENTREMED a license to a THALIDOMIDE
INVENTION, shall be subject to the terms of Sections 2.2.2,
2.2.3 and 2.2.4.
2.3 CELGENE'S Right To Sublicense. Subject to the provisions of Section
7.5, CMCC hereby grants to CELGENE the right to sublicense the rights,
duties and/or obligations granted to it hereunder in the THALIDOMIDE
PATENT RIGHTS and/or the MIXED PATENT RIGHTS, in whole or in part, in
the FIELD, provided that, in all cases, CELGENE shall first (a) provide
CMCC with such commercially relevant, publicly available information
about the potential SUBLICENSEE as CELGENE determines, in its sole good
faith judgment, to be necessary to enable CMCC to make a reasonably
informed decision regarding the relevant commercial capacity of such
potential SUBLICENSEE, such information to be provided to CMCC
sufficiently in advance of CELGENE's expected date of entering into a
sublicense agreement with the potential SUBLICENSEE so as to allow CMCC
to reasonably consider such information, and (b) obtain the written
consent of CMCC to the potential SUBLICENSEE, which consent shall not
be unreasonably withheld, delayed, or conditioned. Prior to granting or
withholding its consent, CMCC shall provide to BIOVENTURE copies of any
information received from CELGENE about the potential SUBLICENSEE and
shall consult with BIOVENTURE thereon; provided that CMCC shall not be
required to obtain the consent of BIOVENTURE in providing or
withholding CMCC's consent to such potential SUBLICENSEE, and that
neither such consultation nor any consultation with any CMCC ROYALTY
PURCHASER(s) shall in any way delay or otherwise obstruct the delivery
of CMCC's notice regarding its consent. In the event that CMCC
reasonably
-3-
withholds consent to any potential SUBLICENSEE, CELGENE shall
nonetheless have the right to enter into a sublicense agreement with
such SUBLICENSEE and, in such event, CELGENE shall guarantee and be
responsible for the payment of all royalties and other amounts due and
the making of reports under this Agreement by such SUBLICENSEE and
SUBLICENSEE's compliance with all applicable terms of this Agreement.
CMCC and CELGENE acknowledge and agree that CMCC shall have no right of
consent with respect to the terms and conditions of the relevant
sublicense agreement, and that CELGENE shall use reasonable efforts to
negotiate sublicense agreements that are commercially reasonable
according to contemporaneous prevailing standards within the
pharmaceutical industry.
2.4 Sublicense Obligations.
(a) CELGENE agrees that any sublicense granted by it shall provide
that the obligations to CMCC of Sections 2, 4.7, 4.8, 4.9, 9,
10, 11, 12, 15 and 16 of this Agreement, and, to the extent
applicable pursuant to the terms of the relevant sublicense,
Sections 7.2, 7.3, 7.4, 7.5, 7.6, shall be binding upon the
SUBLICENSEE as if it were a party to this Agreement. CELGENE
further agrees to attach copies of the above-identified
Sections to any such sublicense agreements. Further, CELGENE
hereby agrees that every sublicensing agreement to which it
shall be a party and which shall relate to the rights,
privileges and license granted hereunder shall contain a
statement setting forth the event or date upon which CELGENE'S
exclusive rights, privileges and license hereunder shall
terminate.
(b) CELGENE agrees to forward to each of CMCC and BIOVENTURE a
copy of any and all fully executed sublicense agreements and
any amendments thereto, and further agrees to forward to each
of CMCC and BIOVENTURE annually a copy of such reports
received by CELGENE from its SUBLICENSEES during the preceding
twelve (12) month period under the sublicenses as shall be
pertinent to a royalty accounting under said sublicense
agreements.
(c) CELGENE shall not receive from SUBLICENSEES anything of value
in lieu of cash payments based upon payment obligations of any
sublicense under this Agreement, without the express prior
written permission of CMCC which shall not be unreasonably
withheld or delayed. Prior to granting or withholding its
consent, CMCC shall consult with BIOVENTURE as to the
advisability of granting or withholding consent; provided that
CMCC shall not be required to obtain the consent of
BIOVENTURE, and that such consultation shall in no way delay
or otherwise obstruct the delivery of CMCC's notice regarding
its consent.
2.5 No Other Rights. The license granted hereunder shall not be construed
to confer any rights upon CELGENE by implication, estoppel or otherwise
as to any technology not specifically set forth in Appendices A, B
and/or C hereof.
-4-
2.6 Government Rights. The license granted in Section 2.1 of this Agreement
is subject to, and expressly limited by, any rights the United States
government may have pursuant to Public Laws 96-517 and 98-620.
2.7 Acknowledgement of Transfers Under Celgene Sublicense. CELGENE and
ENTREMED represent and warrant that the obligations described in
Sections 2.5 and 2.6 of the CELGENE SUBLICENSE necessary for CELGENE to
fulfill its obligations under this Agreement were fully satisfied.
4.7 Recordkeeping. CELGENE shall keep, and shall require each of its
AFFILIATES and SUBLICENSEES to keep, full and accurate books of account
containing all particulars relevant to its sales of PRODUCTS that may
be necessary for the purpose of calculating all royalties payable to
CMCC and BIOVENTURE pursuant to Sections 4.1, 4.2 and 4.3 of this
Agreement. Such books of account, as well as all reasonably necessary
supporting data, shall be kept at the principal place of business of
CELGENE and each AFFILIATE and SUBLICENSEE, as applicable, for the five
(5) years next following the end of the calendar year to which each
shall pertain, and shall be open for inspection by an independent
certified public accountant reasonably acceptable to CELGENE, upon
reasonable notice during normal business hours at BIOVENTURE or CMCC'S
expense, as the case may be, for the sole purpose of verifying royalty
statements or compliance with this Agreement. In the event the
inspection determines that royalties due BIOVENTURE or CMCC for any
period have been underpaid by five percent (5%) or more, which
underpayment has not since been remedied, then CELGENE and/or its
AFFILIATE or SUBLICENSEE, as applicable, shall pay for all costs of the
inspection. All royalty payments set forth in this Agreement shall, if
overdue, bear interest until payment at a per annum rate of two percent
(2%) above the prime rate in effect at Fleet Bank on the due date. The
payment of such interest shall not foreclose BIOVENTURE or CMCC, as the
case may be, from exercising any other rights it may have as a
consequence of the lateness of any payment. All information and data
reviewed in the inspection shall be used only for the purpose of
verifying royalties and shall be treated as CELGENE'S CONFIDENTIAL
INFORMATION subject to the obligations of this Agreement. No audit
shall be conducted hereunder more frequently than once during any
twelve (12) month period, irrespective of whether such audit is on
behalf of CMCC or on behalf of BIOVENTURE.
4.8 Quarterly Payments and Reports. In each year the amount of royalty due
shall be calculated quarterly as of the end of each CALENDAR QUARTER
and shall be paid quarterly within the forty-five (45) days next
following such date. Every such payment shall be supported by the
accounting described in Section 4.9 of this Agreement. All royalties
due BIOVENTURE and CMCC are payable in United States dollars.
BIOVENTURE and CMCC shall each designate, in writing, one bank account
to which CELGENE shall make all payments due hereunder to each,
respectively. When PRODUCTS are sold for currency other than United
States dollars, the earned royalties will first be determined in the
foreign currency of the country in which such PRODUCTS were sold and
then converted into equivalent United States funds. The exchange rate
will be that rate quoted in The Wall Street Journal, NY Edition on the
last business day of the CALENDAR QUARTER in which such sales were
made.
-5-
4.9 Accounting Reports. With each quarterly payment, CELGENE shall deliver
to each of BIOVENTURE and CMCC a full and accurate accounting to
include at least the following information:
(a) Quantity of PRODUCT subject to royalty sold, by country, by
CELGENE, its AFFILIATES or SUBLICENSEES;
(b) Total receipts for each PRODUCT subject to royalty, by country
and, to the extent used in any royalty calculations during
such quarter, the exchange rate set forth in Section 4.8 of
this Agreement;
(c) Deductions applicable as provided in Section 1.12;
(d) Compensation on PRODUCTS received from SUBLICENSEES pursuant
to a sublicense of CELGENE's rights under this Agreement;
(e) Total royalties and/or compensation payable to BIOVENTURE and
CMCC, as the case may be; and
Names and addresses of all SUBLICENSEES of CELGENE.
7.2 Infringement Actions.
(a) Notification. In the event that any party learns of the
infringement of any THALIDOMIDE PATENT RIGHT and/or MIXED
PATENT RIGHT by a THIRD PARTY, or the filing of a Declaratory
Judgment action by a third party alleging the invalidity,
unenforceability, or noninfringement of any of same ("DJ
ACTION"), that party must promptly notify the other parties to
this Agreement of the infringement or DJ ACTION, as the case
may be, in writing, and must provide reasonable evidence of
the infringement. The notifying party shall also inform the
other parties to this Agreement whether, in its reasonable
judgment, the infringement is alleged to be (1) the making,
using, offering for sale, selling or importing of a product
that is or contains THALIDOMIDE in such a way as to infringe
any of the THALIDOMME PATENT RIGHTS and/or any MIXED PATENT
THALIDOMIDE CLAIMS ("THALIDOMIDE INFRINGEMENT"); and/or (2)
the making, using, offering for sale, selling or importing of
a product that is or contains an analog of THALIDOMIDE in such
a way as to infringe any claim of any MIXED PATENT RIGHTS
("NON-THALIDOMIDE INFRINGEMENT"). If any party disagrees with
the characterization of the infringement as THALIDOMIDE
INFRINGEMENT or NON-THALIDOMIDE INFRINGEMENT, the parties
hereto shall promptly negotiate in good faith a resolution to
such dispute. If the parties are unable to resolve such
dispute within three (3) months, the matter shall be resolved
in accordance with the provisions of Section 12. If the
parties determine that such infringement is both a THALIDOMIDE
INFRINGEMENT and a NON-THALIDOMIDE INFRINGEMENT, the parties
shall cooperate in good faith to effectuate the applicable
provisions of this Section 7 to the fullest extent possible,
taking into account the relative commercial interests of the
parties. None of the parties will
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notify a THIRD PARTY (except their attorneys) of the
infringement of any THALIDOMIDE PATENT RIGHT or MIXED PATENT
RIGHT (including without limitation the foregoing
characterization of the infringement), or of the filing of a
DJ ACTION directed to any PATENT RIGHT, without first
obtaining the consent of each party to this Agreement having
rights in such PATENT RIGHT and/or in the relevant claims
thereof, including without limitation any economic rights
therein BIOVENTURE may have, either pursuant to this Agreement
or pursuant to the NEW ANALOG AGREEMENT, which rights are
actually or potentially impacted by such alleged infringement
or DJ ACTION ("INTERESTED PARTY"), which consent shall not be
unreasonably withheld or delayed.
(b) Enforcement by CELGENE of Certain PATENT RIGHTS against
THALIDOMIDE INFRINGEMENT. If, at any time during the term of
this Agreement, any party hereto furnishes notice, pursuant to
Section 7.2(a), of a THALIDOMIDE INFRINGEMENT, then CELGENE
shall have the right, but not the obligation, to bring a suit
or action to compel termination of such infringement, at
CELGENE's sole expense. CELGENE may join CMCC, ENTREMED and/or
BIOVENTURE as parties as required, at CELGENE's sole expense.
CMCC, ENTREMED and BIOVENTURE independently shall each have
the right to join, at its own expense, any such suit or action
brought by CELGENE, to the extent same are INTERESTED PARTIES
therein.
(c) Enforcement by ENTREMED of Certain PATENT RIGHTS against
NON-THALIDOMIDE INFRINGEMENT. If, at any time during the term
of this Agreement, any party hereto furnishes notice, pursuant
to Section 7.2(a), of a NON-THALIDOMIDE INFRINGEMENT, then
ENTREMED shall have the right, but not the obligation, to
bring a suit or action to compel termination of such
infringement, at ENTREMED's sole expense. ENTREMED may join
CMCC, CELGENE and/or BIOVENTURE as parties as required, at
ENTREMED's sole expense. CMCC, CELGENE and BIOVENTURE
independently shall each have the right to join, at its own
expense, any such suit or action brought by ENTREMED, to the
extent same are INTERESTED PARTIES therein.
(d) Enforcement of PATENT RIGHTS by CMCC. If within six (6) months
after the date of any notice provided under Section 7.2(a) of
this Agreement with respect to any THALIDOMIDE INFRINGEMENT,
CELGENE fails to cause such infringement to terminate, to
enter into negotiations to sublicense such alleged infringer,
or to bring a suit or action to compel termination, or if
CELGENE notifies CMCC that it does not intend to take any
action in such regard (which CELGENE shall do promptly upon
making such decision, and which notice CELGENE shall likewise
promptly provide to ENTREMED and BIOVENTURE, to the extent
same are INTERESTED PARTIES), CMCC shall thereafter have the
sole right, but not the obligation, to cause such infringement
to terminate, including without limitation by granting a
sublicense hereunder in accordance with Section 7.5 hereof,
and/or to bring such suit or action to compel termination
-7-
at CMCC's sole expense. If within six (6) months after the
date of any notice provided under Section 7.2(a) of this
Agreement with respect to any NON-THALIDOMIDE INFRINGEMENT,
ENTREMED fails to cause such infringement to terminate, to
enter into negotiations to sublicense such alleged infringer,
or to bring a suit or action to compel termination, or if
ENTREMED notifies CMCC that it does not intend to take any
action in such regard (which ENTREMED shall do promptly upon
making such decision, and which notice ENTREMED shall likewise
promptly provide to CELGENE and BIOVENTURE, to the extent same
are INTERESTED PARTIES), CMCC shall thereafter have the sole
right, but not the obligation, to cause such infringement to
terminate, including without limitation by granting a
sublicense hereunder in accordance with Section 7.5 hereof,
and/or to bring such suit or action to compel termination at
CMCC's sole expense. CMCC may join ENTREMED, CELGENE and/or
BIOVENTURE as parties as required, at CMCC's sole expense.
ENTREMED, CELGENE and BIOVENTURE independently shall each have
the right to join, at its own expense, any such suit or action
brought by CMCC, to the extent same are INTERESTED PARTIES
therein.
(e) Enforcement by BIOVENTURE of Certain PATENT RIGHTS against
THALIDOMIDE INFRINGEMENT. If, within three (3) months after
the date on which CMCC's right to bring any suit or action
under Section 7.2(d) with respect to THALIDOMIDE INFRINGEMENT
commences, CMCC fails to cause such infringement to terminate,
to enter into negotiations to sublicense such alleged
infringer, or to bring a suit or action to compel termination
of such infringement, or if CMCC notifies BIOVENTURE that it
does not intend to take any action in such regard (which CMCC
shall do promptly upon making such decision), BIOVENTURE shall
thereafter have the sole right, but not the obligation, to
bring such suit or action to compel termination at
BIOVENTURE's sole expense. BIOVENTURE may join ENTREMED,
CELGENE and/or CMCC as parties as required, at BIOVENTURE's
sole expense. ENTREMED, CELGENE and CMCC independently shall
each have the right to join, at its own expense, any such suit
or action brought by BIOVENTURE, to the extent same are
INTERESTED PARTIES therein.
7.3 Declaratory Judgment Actions.
(a) THALIDOMIDE DJ ACTIONS Defended by CELGENE. In the event that
a DJ ACTION relating to the making, using, offering for sale,
selling or importing of a product that is or contains
THALIDOMIDE ("THALIDOMIDE DJ ACTION") is brought against CMCC,
CELGENE, ENTREMED or BIOVENTURE concerning any of the PATENT
RIGHTS, CELGENE, at its option, shall have the right, within
thirty (30) days after commencement of such THALIDOMIDE DJ
ACTION, to intervene, as applicable, and to assume control of
the defense of such DJ ACTION, at its sole expense. CMCC,
ENTREMED and BIOVENTURE shall each have the right, at its own
expense, to join any THALIDOMIDE DJ ACTION defended by CELGENE
hereunder, to the extent same are INTERESTED PARTIES therein.
Except as otherwise stated in Section 7.5 of this Agreement,
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CELGENE shall have the sole right, but not the obligation, to
grant a sublicense of its rights hereunder for future use of
any THALIDOMIDE PATENT RIGHTS and/or MIXED PATENT THALIDOMIDE
CLAIMS in connection with any THALIDOMIIME DJ ACTION.
(b) NON-THALIDOMIDE DJ ACTIONS Defended by ENTREMED. In the event
that a DJ ACTION relating to the making, using, offering for
sale, selling or importing of a product that is or contains an
analog of THALIDOMIDE ("NON-THALIDOMIDE DJ ACTION") is brought
against CMCC, CELGENE, ENTREMED or BIOVENTURE concerning any
of the PATENT RIGHTS, ENTREMED, at its option, shall have the
right, within thirty (30) days after commencement of such DJ
ACTION, to intervene, as applicable, and to assume control of
the defense of such NON-THALIDOMIDE DJ ACTION, at its sole
expense. CMCC, CELGENE and BIOVENTURE shall each have the
right, at its own expense, to join any NON-THALIDOMIDE DJ
ACTION defended by ENTREMED hereunder, and to the extent same
are INTERESTED PARTIES therein. Except as otherwise stated in
Section 7.5 of this Agreement, ENTREMED shall have the sole
right, but not the obligation, to grant a sublicense of its
rights hereunder for future use of any THALIDOMIDE PATENT
RIGHTS and/or MIXED PATENT THALIDOMIDE CLAIMS in connection
with any NON-THALIDOMIDE DJ ACTION.
(c) Defense of THALIDOMIDE DJ ACTIONS By CMCC. In the event of any
THALIDOMIDE DJ ACTION in which CELGENE does not assume control
of the defense, as provided for in Section 7.3(a) hereof, or
any NON-THALIDOMIDE DJ ACTION in which ENTREMED does not
assume control of the defense, as provided for in Section
7.3(b) hereof, CMCC shall thereafter have the sole right, but
not the obligation, to intervene and assume control of the
defense of such THALIDOMIDE DJ ACTION, at its sole expense.
CELGENE, BIOVENTURE, and/or ENTREMED shall each have the
right, at its own expense, to join in any such THALIDOMIDE DJ
ACTION or NON-THALIDOMIDE DJ ACTION defended by CMCC
hereunder, to the extent same are INTERESTED PARTIES therein.
(d) Defense of THALIDOMIDE DJ ACTIONS By BIOVENTURE. If CMCC fails
to assume defense of any THALIDOMIDE DJ ACTION within thirty
(30) days of CMCC's right to do so, pursuant to Section
7.3(c), BIOVENTURE shall thereafter have the sole right, but
not the obligation, to intervene and assume control of the
defense of such THALIDOMIDE DJ ACTION, at its sole expense.
CMCC, CELGENE and/or ENTREMED shall each have the right, at
its own expense, to join in any such THALIDOMIDE DJ ACTION
defended by BIOVENTURE hereunder, to the extent same are
INTERESTED PARTIES therein.
7.4 Allocation of any Damages Award. Any damages recovered in connection
with any suit or action brought pursuant to Section 7.2, or any DJ
ACTION defended pursuant to section 7.3 shall be used (a) first to
reimburse the party primarily responsible for conduct
-9-
or defense of the litigation (i.e., CELGENE if the action is brought
pursuant to Section 7.2(b) or defended pursuant to Section 7.3(a),
ENTREMED if the action is brought pursuant to Section 7.2(c) or
defended pursuant to Section 7.3(b), CMCC if the action is brought
pursuant to Section 7.2(d) or defended pursuant to Section 7.3(c), and
BIOVENTURE if the action is brought pursuant to Section 7.2(e) or
defended pursuant to Section 7.3(d)) (each, as applicable, the "PRIMARY
LITIGANT") for the cost of such suit or action (including attorney's
fees) actually paid by such PRIMARY LITIGANT, then (b) to reimburse any
INTERESTED PARTY that has, pursuant to the terms of Section 7.2 or 7.3,
voluntarily joined any action brought or defended hereunder, for the
cost of such suit or action (including attorney's fees) actually paid
by such voluntarily joined INTERESTED PARTY, then (c) to reimburse CMCC
and BIOVENTURE pro rata for any loss of royalties payable hereunder or
under the NEW ANALOG AGREEMENT, as applicable. In the event that
CELGENE and/or ENTREMED has, pursuant to the terms of Section 7.2 or
7.3, voluntarily joined any action brought or defended hereunder, then
any damages remaining after the distributions set forth in subsections
(a) through (c) of this Section 7.4 ("RESIDUAL DAMAGES") shall first be
used to reimburse CELGENE and/or ENTREMED, as applicable, for their
lost profits. Any remaining RESIDUAL DAMAGES shall next be distributed
to or among the PRIMARY LITIGANT and any INTERESTED PARTIES that have,
pursuant to the terms of Section 7.2 or 7.3, voluntarily joined any
action brought or defended hereunder, on a basis to be determined in
good faith by such INTERESTED PARTIES and the PRIMARY LITIGANT based on
each such party's respective commercial interest in the subject matter
of such suit or action.
7.5 Settlement of Enforcement Actions and DJ ACTIONS. In the event that any
INTERESTED PARTY has, pursuant to the terms of Section 7.2 or 7.3,
voluntarily joined any action brought or defended hereunder, then no
settlement, consent judgment or other voluntary final disposition of
such suit or action may be entered into without the prior consent of
all such joined INTERESTED PARTIES, which consent shall not be
unreasonably withheld or delayed. Except as otherwise stated below in
this Section 7.5, (i) CELGENE shall have the sole right but not the
obligation, in accordance with the terms and conditions of this
Agreement, to sublicense any alleged infringer for future use of any
THALIDOMIDE PATENT RIGHTS and/or any MIXED PATENT THALIDOMIDE CLAIMS
with respect to any THALIDOMIDE INFRINGEMENT and (ii) ENTREMED shall
have the sole right but not the obligation, in accordance with the
terms and conditions of the NEW ANALOG AGREEMENT, to sublicense any
alleged infringer for future use of any MIXED PATENT RIGHTS with
respect to any NON-THALIDOMIDE INFRINGEMENT. CELGENE and ENTREMED shall
each have the right to grant such sublicenses in accordance with the
terms and conditions of this Agreement and the NEW ANALOG AGREEMENT,
respectively, provided that neither shall grant any such sublicense to
the detriment of the rights of CMCC or any such joined INTERESTED PARTY
hereunder or under the NEW ANALOG AGREEMENT. In the event that CELGENE
and/or ENTREMED elect not to exercise their right to initiate
litigation against an alleged infringer, as set forth in Sections
7.2(b) and (c), respectively, or to defend a DJ ACTION, as set forth in
Sections 7.3(a) and (b), respectively, then the PRIMARY LITIGANT shall
have the right, but no obligation, to license or sublicense, as
applicable, any alleged infringer for future use of any THALIDOMIDE
PATENT
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RIGHTS and/or any MIXED PATENT RIGHTS, provided, however, that (1) the
terms and conditions of such license or sublicense shall be
commercially reasonable and commensurate in scope with the alleged
infringement, (2) such license or sublicense shall not permit the
further sublicensing, assignment or transfer of any right or license
under the PATENT RIGHTS granted therein, and (3) but for a change in
the grant under the relevant PATENT RIGHTS, as set forth in Section
2.1, from exclusive to co-exclusive in the region where such
infringement has occurred and in the field to which such infringement
relates, neither CELGENE's rights and licenses hereunder, nor
ENTREMED's rights and licenses under the NEW ANALOG AGREEMENT, shall be
affected.
7.6 Cooperation. In any suit or action any party may institute or control
with respect to the enforcement or defense of any of the PATENT RIGHTS
pursuant to this Agreement, the other parties hereto shall, at the
request of the PRIMARY LITIGANT, cooperate in all respects and, to the
extent possible, have its employees testify when requested and make
available relevant records, papers, information, samples, specimens,
and the like. All reasonable out-of-pocket costs incurred in connection
with rendering cooperation requested hereunder shall be paid by the
PRIMARY LITIGANT, except as otherwise set forth in this Section 7. In
any such suit or action that involves any MIXED PATENT THALIDOMIDE
CLAIMS, all INTERESTED PARTIES shall consult and cooperate in good
faith to the extent any argument, claim, counterclaim or defense
advanced by any party to such suit or action actually or potentially
impacts the rights of any other INTERESTED PARTY including, without
limitation, with respect to any claim construction and infringement
issues.
SECTION 9 - INDEMNIFICATION AND INSURANCE
9.1 By CELGENE. CELGENE will defend, indemnify and hold harmless each of
CMCC, BIOVENTURE, their successors and AFFILIATES and their employees,
agents, officers, trustees, shareholders and directors and each of them
(the "Indemnified Parties") from and against any and all THIRD PARTY
claims, causes of action and costs (including reasonable attorney's
fees) of any nature made or lawsuits or other proceedings filed or
otherwise instituted against the applicable Indemnified Parties in
connection with any claims, suits or judgments arising out of any
theory of product liability concerning the development, testing,
manufacture, sale or use of any PRODUCT by CELGENE, its AFFILIATES or
its SUBLICENSEES.
(a) CELGENE's indemnification under this Section 9.1 shall not
apply to any liability, damage, loss or expense to the extent
that it is directly attributable to the negligent activity,
reckless misconduct or intentional misconduct of any
Indemnified Party.
(b) Commencing not later than the date of FIRST COMMERCIAL SALE of
a PRODUCT, CELGENE shall obtain and carry in full force and
effect product liability insurance against any claims,
judgments, liabilities and expenses for which it is obligated
to indemnify CMCC and others to the extent required under
Section 9.1 of this Agreement, in such amounts and with such
deductibles as are
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customary at the time for companies engaged in a similar
business, and shall provide CMCC and BIOVENTURE with written
evidence of such insurance upon request.
9.2 Conditions to Indemnification. CELGENE's obligations under this Section
9 shall apply only if the Indemnified Parties promptly notify CELGENE
of any loss, claim, damage, liability or action in respect of which the
Indemnified Parties intend to claim such indemnification. CELGENE shall
assume the defense thereof with counsel mutually satisfactory to the
Indemnified Parties whether or not such claim is rightfully brought.
Each Indemnified Party shall have the right to retain its own counsel,
at its own expense, provided that CELGENE shall reimburse such
Indemnified Party for such expense if representation of such
Indemnified Party by the counsel retained by CELGENE would be
inappropriate due to actual or potential differing interests between
such Indemnified Party and any other person represented by such counsel
in such proceedings. The failure to deliver notice to CELGENE within a
reasonable time after the commencement of any such action, only if
prejudicial to its ability to defend such action, shall relieve CELGENE
of any liability to any Indemnified Party under this Section 9, but the
omission so to deliver notice to CELGENE will not relieve it of any
liability that it may have to any Indemnified Party otherwise than
under this Section 9. Each Indemnified Party under this Section 9 shall
cooperate fully with CELGENE and its legal representatives in the
investigations of any action, claim or liability covered by this
indemnification.
SECTION 10 - EXPORT CONTROLS
10.1 It is understood that CMCC is subject to United States laws and
regulations controlling the export of technical data, computer
software, laboratory prototypes and other commodities (including the
Arms Export Control Act, as amended and the Export Administration Act
of 1979) and that its obligations hereunder are contingent on
compliance with applicable United States export laws and regulations.
The transfer of certain technical data and commodities may require a
license from the cognizant agency of the United States Government
and/or written assurances by CELGENE that CELGENE shall not export data
or commodities to certain foreign countries without prior written
approval of such agency. CMCC neither represents that a license shall
not be required nor that, if required, it shall be issued.
SECTION 11- NON-USE OF NAMES
11.1 No party hereunder shall use the names of any other party hereunder,
nor of any of its employees, nor any adaptation thereof, in any
advertising, promotional or sales literature without prior written
consent obtained from the party to be named, except that CELGENE and
CMCC may state that CELGENE is licensed by CMCC under the PATENT RIGHTS
in the FIELD.
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SECTION 12 - ARBITRATION
12.1 Any and all claims, disputes or controversies arising under, out of, or
in connection with the this Agreement, which have not been resolved by
good faith negotiations between the parties, shall be resolved by final
and binding arbitration in Boston, Massachusetts, under patent
arbitration rules of the American Arbitration Association then
obtaining. The arbitrators shall have no power to add to, subtract from
or modify any of the terms or conditions of this Agreement. Any award
rendered in such arbitration may be enforced by any party in either the
courts of the Commonwealth of Massachusetts or in the United States
District Court for the District of Massachusetts, to whose jurisdiction
for such purposes each of CMCC, CELGENE, BIOVENTURE and ENTREMED hereby
irrevocably consents and submits.
12.2 Notwithstanding the foregoing, nothing in this Section 12 shall be
construed (a) to waive any rights or timely performance of any
obligations existing under this Agreement or (b) to apply to the
provisions of Section 7.2 (Infringement Actions) (other than the fourth
sentence of Section 7.3(a)) or Section 7.4 (Declaratory Judgment
Actions).
SECTION 15 - TERMINATION
15.1 Term. Unless earlier terminated as hereinafter provided, this Agreement
shall remain in full force and effect until CELGENE's obligations to
pay royalties or other compensation under Section 4 of this Agreement,
either directly or pursuant to a sublicense, terminate.
15.2 By Reason Of FDA Action. If the FDA withdraws or recalls THALIDOMIDE
from the market permanently, or in any other way permanently revokes or
terminates CELGENE's regulatory approval to market and sell THALIDOMIDE
and/or PRODUCTS, CELGENE shall promptly notify CMCC and BIOVENTURE in
writing, and this Agreement and all of CELGENE's, CMCC's, BIOVENTURE's
and ENTREMED's rights and obligations hereunder shall terminate with
respect to THALIDOMIDE and/or such PRODUCTS, as applicable, upon
receipt by CMCC and BIOVENTURE of such notice.
15.3 Termination Of Royalty Obligations. Upon termination of CELGENE's
obligation to pay royalties and other compensation hereunder with
respect to a specific country and specific PRODUCT as to which
CELGENE's license is then in effect, the license granted to CELGENE
with respect to such country and such PRODUCT pursuant to Section 2 of
this Agreement shall be deemed to be fully paid and CELGENE shall
thereafter have a royalty free, exclusive right to use the PATENT
RIGHTS to make, have made, use, offer to sell, sell and import such
PRODUCT in such country.
15.4 Breach.
(a) By Either CMCC or CELGENE. This Agreement shall be terminable
by CELGENE or CMCC, respectively, upon the material breach or
default of either CMCC or CELGENE, as applicable. In the event
of a material breach or default by CMCC or CELGENE
("Defaulting Party"), the other party ("Non-Defaulting Party")
shall give the Defaulting Party written notice of the default.
The Defaulting Party will then have sixty (60) days to cure
the breach. If cure has not
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been effected within said sixty (60) days, the Non-Defaulting
Party shall have the right to terminate this Agreement.
Notwithstanding anything in this Agreement to the contrary,
CMCC agrees not to terminate this Agreement, for any reason,
including pursuant to Sections 3.1(b), 3.2(b), 3.3(b), 3.4 and
15.4(b), without the prior written consent of BIOVENTURE,
provided that (i) CMCC shall not be required to obtain the
prior consent of BIOVENTURE prior to any termination based
upon (1) a material breach of payment provisions of this
Agreement or (2) a material breach of this Agreement the
action or circumstances of which are, or may reasonably be
expected to be, deleterious to CMCC's reputation and good
standing within the healthcare community and (ii) CMCC shall
terminate this Agreement if BIOVENTURE so requests in writing
if the material breach entitling CMCC to terminate falls
within Section 15.4(b)(i) of this Agreement.
(b) By CELGENE.
(i) Payments. If and only if CELGENE materially breaches
this Agreement by failure to pay royalties and/or
sublicensing or milestone payments due under Section
4 of this Agreement, and fails to cure such material
breach within sixty (60) days of receiving written
notice thereof pursuant to Section 15.4(a) of this
Agreement, then CELGENE's rights under this Agreement
shall terminate, and CELGENE shall grant to CMCC, to
the extent not prohibited by the United States
Government or by prior contractual obligations to any
THIRD PARTY:
(a) an exclusive, worldwide, royalty-free
license, with the right to sublicense, under
CELGENE DEVELOPED INTELLECTUAL PROPERTY; and
(b) a non-exclusive, worldwide, irrevocable,
royalty-free license, with the right to
sublicense, under (1) that certain Agreement
by and between the Division of Cancer
Treatment at the National Cancer Institute
("NCI") and ENTREMED, dated November 16,
1994, and executed on behalf of ENTREMED on
November 23, 1994, and on behalf of NCI on
November 18, 1994, as assigned by ENTREMED
to CELGENE ("NCI AGREEMENT"), and (2) any
Orphan Drug Status and Investigational New
Drug applications filed by ENTREMED as of
December 9, 1998, as set forth in Appendix C
of the CELGENE SUBLICENSE, to the extent
same were assigned or licensed to CELGENE
pursuant to Section 2.4 of the CELGENE
SUBLICENSE ("REGULATORY APPLICATIONS");
in the case of both (a) and (b), to make, have made,
use, lease, offer to sell, sell, and import PRODUCTS
in the TERRITORY.
(ii) Diligence. If and only if (i) CMCC exercises its
right and option to terminate the license granted to
CELGENE in the entire TERRITORY,
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pursuant to Section 3.1 (b) of this Agreement, or
(ii) CMCC exercises its right and option to terminate
the license granted to CELGENE in Europe, Canada, or
the PACIFIC RIM, pursuant to Section 3.2(b) of this
Agreement, or (iii) CMCC exercises its right and
option to terminate the license granted to CELGENE
for use in animals, pursuant to Section 3.3(b) of
this Agreement or (iv) CMCC exercises its right and
option to terminate the license granted to CELGENE
for PRODUCTS for ophthalmologic use in the United
States pursuant to Section 3.4 of this Agreement,
then, only in the region in which such termination
has occurred, and only to the extent of such
termination as specified in Section 3.1(b), 3.2(b),
3.3(b) and/or 3.4, as applicable:
a) CELGENE's rights under this Agreement shall
terminate; and
b) CELGENE shall grant to CMCC, to the extent
not prohibited by the United States
Government or by prior contractual
obligations to any THIRD PARTY, solely to
the extent necessary to permit CMCC to
exercise its rights under such terminated
PATENT RIGHTS in the relevant region or
territory and solely to the extent CELGENE's
rights thereunder have terminated, pursuant
to Section 3: (1) a non-exclusive,
worldwide, royalty-free license, with the
right to sublicense, under the NCI AGREEMENT
and any REGULATORY APPLICATIONS, to make,
have made, use, lease, offer to sell, sell,
and import PRODUCTS in the TERRITORY; and
(2) immunity from suit for any causes of
action CELGENE may have arising out of or in
connection with any CELGENE DEVELOPED
INTELLECTUAL PROPERTY that would otherwise
be infringed by the making, having made,
using, leasing, offering for sale, selling,
or importing of any PRODUCTS in such region
or TERRITORY. The term of the rights granted
to CMCC under this Section 15.4(b)(ii)(b)
shall continue for so long as any PATENT
RIGHT exists, within the relevant region or
TERRITORY, that contains an ISSUED VALID
CLAIM covering a PRODUCT (only for animal
use in the case of termination pursuant to
Section 3.3(b), and only for ophthalmologic
use, in the case of termination pursuant to
Section 3.4), provided that if any patent
applications within the PATENT RIGHTS are
pending, in the relevant region or
TERRITORY, at the end of such term, and any
ISSUED VALID CLAIM covering a PRODUCT (only
for animal use in the case of termination
pursuant to Section 3.3(b), and only for
ophthalmologic use, in the case of
termination pursuant to Section 3.4)
subsequently issues from such PATENT RIGHTS,
then CMCC's rights under this Section
15.4(b)(ii)(b) shall recommence, in the
relevant region or TERRITORY, on the
issuance date of such ISSUED VALID CLAIMS
and continue until the date of expiration or
termination of the last to expire of such
ISSUED VALID CLAIMS in such region or
TERRITORY.
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CMCC shall have the right to sublicense the
rights granted to it under this Section
15.4(b)(ii)(b), with CELGENE's prior written
consent, as set forth herein, only to its
AFFILIATES and other THIRD PARTIES in
connection with and commensurate in scope
with a bona fide license of CMCC's rights
under the PATENT RIGHTS. Prior to granting
any such sublicense, CMCC shall notify
CELGENE in writing of such AFFILIATE or
THIRD PARTY and CELGENE shall have the right
to consent to such AFFILIATE or THIRD PARTY
(which consent shall not be unreasonably
withheld or delayed) on the basis of such
AFFILIATE or THIRD PARTY's safety record and
capacity to satisfy all applicable health
and safety laws, rules and regulations
governing the manufacture, use, offer for
sale, sale and/or importation of PRODUCTS.
(c) Termination under this Section 15.4 will be effective upon the
date specified in the written notice. All termination rights
shall be in addition to and not in substitution for any other
remedies that may be available to the Non-Defaulting Party.
Termination pursuant to this Section 15.4 shall not relieve
the Defaulting Party from liability and damages to the
Non-Defaulting Party for default. Waiver by either party of a
single default or a succession of defaults shall not deprive
such party of any right to terminate or convert this Agreement
arising by reason of any subsequent default.
(d) Upon any termination of this Agreement in its entirety, or
with respect to any PATENT RIGHTS pursuant to Section
15.4(b)(ii), for any reason, whether by CELGENE or by CMCC,
each of CMCC and CELGENE agrees not to enter into any other
agreement, arrangement or understanding with each other
granting a license to CELGENE under any PATENT RIGHTS in the
FIELD without providing for the payment to BIOVENTURE of 75%
of royalties and other consideration payable to CMCC under
such other agreement, arrangement or understanding. In
addition, upon any termination of this Agreement in its
entirety or with respect to any PATENT RIGHTS pursuant to
Section 15.4(b)(ii), for any reason, CMCC agrees not to enter
into any other agreement, arrangement or understanding with a
THIRD PARTY granting a license under PATENT RIGHTS in the
FIELD without providing for the payment to BIOVENTURE of 75%
of royalties and other consideration payable to CMCC under
such other agreement, arrangement or understanding.
15.5 Insolvency. CMCC may terminate this Agreement upon receipt of notice
that CELGENE has become insolvent or has suspended business in all
material respects hereof, or has consented to an involuntary petition
purporting to be pursuant to any reorganization or insolvency law of
any jurisdiction, or has made an assignment for the benefit of
creditors or has applied for or consented to the appointment of a
receiver or trustee for a substantial part of its property, by giving
written notice to all other parties, and termination of this Agreement
will be effective upon receipt of such notice.
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15.6 Work-In-Progress. Upon termination of this Agreement, CELGENE shall be
entitled, but shall not be obligated, to finish any work-in-progress at
the time of termination and sell the same as well as all completed
inventory of PRODUCTS which remains on hand as of the date of the
termination, so long as CELGENE pays to CMCC and BIOVENTURE the
royalties applicable to said subsequent sales in accordance with the
same terms and conditions as set forth in this Agreement.
15.7 Survival. The obligations of Sections 2.2.3, 2.2.4, 2.2.5, 2.4, 2.5,
4.7, 5, 9, 11, 12 and 13.3, as well as Sections 15.4(b)(i),
15(b)(ii)(b), 15.4(d), 15.5, 15.6, 15.7, 15.8, 16.2, 16.3, 16.4, 16.5,
16.6, 16.7 and 16.9 shall survive any termination of this Agreement.
Any payment obligations accrued and owing as of the date of termination
or expiration of this Agreement shall survive such termination or
expiration. The rights and obligations of CMCC and ENTREMED relating to
MIXED PATENT RIGHTS, as set forth in Section 7 of this Agreement, shall
survive termination or expiration hereof pursuant to the terms and
conditions of the NEW ANALOG AGREEMENT.
15.8 Reversion of Rights. Upon termination of this Agreement or of the
rights and licenses granted to CELGENE in any country of the TERRITORY,
CELGENE agrees not to use the PATENT RIGHTS in any country other than
those countries in which CELGENE retains a license under this
Agreement. In addition, all rights to the PATENT RIGHTS in any such
country shall revert to CMCC and, subject to Section 15.4(d), may be
used by CMCC without restriction in any country other than those
countries in which CELGENE retains a license under this Agreement.
15.9 Termination or Expiration of NEW ANALOG AGREEMENT. In the event that
the NEW ANALOG AGREEMENT terminates or expires during the Term of this
Agreement, EntreMed's rights and obligations hereunder shall, as of the
effective date of such termination or expiration, immediately cease,
except for any rights and obligations which survive termination or
expiration of this Agreement, pursuant to Section 15.7 hereof.
SECTION 16 - GENERAL PROVISIONS
16.1 Relationship of Pasties. The relationship between CMCC, CELGENE,
BIOVENTURE and ENTREMED is that of independent contractors. CMCC,
CELGENE, BIOVENTURE and ENTREMED are not joint venturers, partners,
principal and agent, master and servant, employer or employee, and have
no relationship other than as independent contracting parties. None of
the parties shall have any power to bind or obligate any of the other
parties in any manner.
16.2 Entire Understanding. This Agreement, the NEW ANALOG AGREEMENT and the
Consents sets forth the entire agreement and understanding among the
parties as to the subject matter thereof and supersede all prior
agreements in this respect, including without limitation the ENTREMED
LICENSE and the CELGENE SUBLICENSE, both of which shall automatically
and without any further action of the parties terminate on the
EFFECTIVE DATE hereof. Notwithstanding anything to the contrary set
forth herein, ENTREMED shall be and remain solely liable and
responsible for the past breach of
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performance of any duties, obligations and covenants under the ENTREMED
LICENSE, and the performance of any duties, obligations and covenants
that survive termination of the ENTREMED LICENSE.
16.3 Governing Law. This Agreement shall be construed and enforced in
accordance with the laws of the Commonwealth of Massachusetts, U.S.A.
without reference to its choice of law principles. Each party agrees
that the state and federal courts located in the Commonwealth of
Massachusetts, including any courts of appeal therefrom, shall have
exclusive jurisdiction over any dispute arising under this Agreement,
and the parties hereby consent to personal jurisdiction of such courts
in any such action.
16.4 Headings. The headings in this Agreement have been inserted for the
convenience of reference only and are not intended to limit or expand
on the meaning of the language contained in the particular or section
or paragraph.
16.5 Amendments. Any provisions of this Agreement may be amended, modified
or waived, if and only if, such amendment, modification or waiver is in
writing and signed by all parties to this Agreement, including, without
limitation, BIOVENTURE, or, in the case of a waiver, by the party
against whom the waiver is to be effective. The consent of ENTREMED
shall not be required with respect to any amendment or modification of
this Agreement, except any such amendment or modification to Section 7.
16.6 No Waiver. Any delay in enforcing a party's rights under this Agreement
or any waiver as to a, particular default or other matter shall not
constitute a waiver of a party's right to the future enforcement of its
rights under this Agreement, excepting only as to an expressed written
and signed waiver as to a particular matter for a particular period of
time.
16.7 Severability. The provisions of this Agreement are severable, and in
the event that any provisions of this Agreement shall be determined to
be invalid or unenforceable under any controlling body of law, such
invalidity or unenforceability shall not in any way affect the validity
or enforceability of the remaining provisions hereof.
16.8 Patent Marking. CELGENE agrees to xxxx the labels of PRODUCTS with all
applicable patent numbers in accordance with standard practice in the
pharmaceutical industry.
16.9 Notices. Any notices given pursuant to this Agreement shall be in
writing and shall be deemed delivered upon the earlier of (i) when
received at the address set forth below, or (ii) three (3) business
days after mailed by certified or registered mail postage prepaid and
properly addressed, with return receipt requested, or (iii) when sent,
if sent by facsimile, as confirmed by certified or registered mail.
Notices shall be delivered to the respective parties as indicated
below:
If to CMCC: Children's Medical Center Corporation
c/o Children's Hospital Boston
Intellectual Property Xxxxxx
000 Xxxxxxxx Xxxxxx
Xxxxxx, XX 00000
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Attn: Chief Intellectual Property Officer
Fax: (000) 000-0000
If to CELGENE: Celgene Corporation
0 Xxxxxx Xxxx Xxxxx
Xxxxxx, XX 00000
Attn: President and COO
Fax: (000) 000-0000
If to BIOVENTURE: Bioventure Investments kft
c/o Royalty Pharma Management
000 Xxxxx Xxxxxx, Xxxxx 0000
Xxx Xxxx, XX 00000
Attn: Xxxx Xxxxxx
Xxxxx Xxxxxxxxx
Fax: (000) 000-0000
If to ENTREMED: EntreMed, Inc.
0000 Xxxxxxx Xxxxxx Xxxxx, Xxxxx 000
Xxxxxxxxx, XX 00000
Attn: Xxxxxx X. Xxxxx
Fax: (000) 000-0000
16.10 Original Counterparts. This Agreement may be executed in four separate
counterparts, each of which shall be deemed to be an original, but
which together shall constitute one and the same instrument.
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