EXHIBIT 10.36
LICENSE AGREEMENT
LICENSE AGREEMENT, dated November 16, 2001 (the "Agreement"), is made
between Celgene Corporation, a Delaware corporation ("Celgene"), Pharmion GmbH,
a Swiss limited liability company ("Pharmion"), and, solely for purposes of
guaranteeing the obligations of Pharmion hereunder, Pharmion Corporation, a
Delaware corporation ("Guarantor").
WHEREAS, Celgene has developed the Products (as defined herein); and
WHEREAS, Pharmion wishes to receive a license from Celgene for the
Products in the Territory (as defined herein), and Celgene is willing to grant
Pharmion a license for the Products in the Territory, all on the terms and
conditions set forth below.
NOW THEREFORE, in consideration of the premises and of the covenants
herein contained, Celgene and Pharmion mutually agree as follows:
ARTICLE I.
DEFINITIONS
For purposes of this Agreement, the following capitalized terms shall have
the meanings specified below.
"AFFILIATE" shall mean any corporation or other entity which controls, is
controlled by or is under common control with a party. A corporation or other
entity shall be regarded as in control of another corporation or entity if it
owns or directly or indirectly controls at least fifty percent (50%) of the
voting stock or other ownership interest of the other corporation or entity, or
if it possesses, directly or indirectly, the power to direct or cause the
direction of the management and policies of the corporation or other entity or
the power to elect or appoint fifty percent (50%) or more of the members of the
governing body of the corporation or other entity.
"APPROVAL PERIOD" shall have the meaning ascribed thereto in Section 9.4
hereof.
"CELGENE PATENT RIGHTS" shall mean (i) the patents and patent applications
listed on Exhibit A hereto, and (ii) any patents hereafter issued or patent
applications hereafter filed by or on behalf of Celgene or any of its
Affiliates, in either case, necessary or useful for the registration,
distribution, marketing or sale of any of the Products in the Territory during
the term of this Agreement.
"CELGENE TECHNOLOGY" shall mean data, manufacturing know-how, regulatory
submissions and other intellectual property that is either in the possession of
Celgene as of the date hereof or developed by Celgene during the term of this
Agreement in connection with any additional regulatory approvals to market
Products in the United
States, (including,, without limitation, S.T.E.P.S., as hereinafter defined, and
any clinical data from pivotal studies relating to the Products as well as
additional clinical studies relating to the Products conducted from time to time
by or on behalf of Celgene or any of its Affiliates) in either case, owned or
controlled by, or licensed (with the right to sublicense) to, Celgene and that
is necessary or useful to register, distribute, market or sell the Products in
the Territory.
"CMCC" shall have the meaning ascribed thereto in Section 3.9 hereof.
"CMCC LICENSE" shall have the meaning ascribed thereto in Section 3.9
hereof.
"EMEA" shall mean the European Agency for the Evaluation of Medicinal
Products.
"ENTREMED" shall have the meaning ascribed thereto in Section 3.9 hereof.
"ENTREMED LICENSE" shall have the meaning ascribed thereto in Section 3.9
hereof.
"FIRST COMMERCIAL SALE" shall mean, with respect to any country in the
Territory, the first sale of any of the Products to an unaffiliated customer in
such country following Regulatory Approval in such country.
"NET SALES" shall mean Pharmion's and its Affiliates invoiced sales price
of Product billed to unaffiliated customers, less: (i) to the extent such
amounts are included in the invoiced sales price, actual credited allowances
and/or charge-backs for spoiled, damaged, out-dated and returned product, (ii)
quantity and other trade discounts and early settlement discounts (where such
discounts are effectively non-discretionary and are given as a matter of course)
actually allowed and taken, (iii) transportation, insurance and handling
expenses to the extent chargeable to such sales, (iv) sales, value-added and
other direct taxes incurred, (v) customs duties and surcharges and other
governmental charges incurred in connection with the exportation or importation
of any Product, and (vi) legally mandated rebates, if any.
"PRIME RATE" shall mean the prime rate announced from time to time by
Citibank, N.A., plus 2%.
"PRODUCTS" shall mean each article of manufacture, substance, material,
chemical, formulation or composition which is or includes Thalidomide as an
active ingredient, including, without limitation, any composition that comprises
Thalidomide and a non-steroidal anti-inflammatory compound(s). The term
"Products" expressly excludes Thalidomide analogs.
"QUARTERLY REPORT" shall have the meaning ascribed thereto in Section 3.6
hereof.
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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.
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3.9. CMCC LICENSE. To the extent the Celgene Patent Rights and the
Celgene Technology Rights licensed to Pharmion under this Agreement are rights
which Children's Medical Center Corporation ("CMCC") has licensed to Celgene
Pursuant to the Agreement among Celgene, CMCC, Bioventure Investments KFT and
Entremed, Inc. dated August __, 2001 (the "CMCC License"), the license granted
to Pharmion pursuant to Section 3.1 hereof is subject to the terms, limitations,
restrictions and obligations provided for in the CMCC License. Sections 2, 4.7,
4.8, 4.9, 9, 10, 11, 12, 15 and 16 of the CMCC License, and, to the extent
applicable pursuant to the terms of this Agreement, Sections 7.2, 7.3, 7.4, 7.5,
and 7.6 thereof, shall be binding upon Pharmion as if it were a party to the
CMCC License. A true and correct copy of the foregoing provisions of the CMCC
License are annexed hereto as Exhibit D and a true and correct copy of the CMCC
License in the form filed by Celgene with the Securities and Exchange Commission
shall be provided by Celgene to Pharmion contemporaneously with the filing
thereof with the Securities and Exchange Commission.
3.10. TAIWAN. Notwithstanding anything to the contrary contained in this
Agreement,
(a) If Celgene has not prior to the third anniversary of the date of
this Agreement, granted to any Third Party a license to distribute, market, use
or sell the Products in Taiwan (a "Third Party License"), the Territory shall,
at Pharmion's election,
include Taiwan, such election to be made by written notice to Celgene at any
time after the third anniversary of the date of this Agreement; and
(b) Pharmion may at any time, but shall not be required to, register
the Products and/or otherwise seek Regulatory Approval in Taiwan, provided that
it notifies Celgene of its actions not later than the initiation of its first
filing with Taiwanese authorities. Notwithstanding the receipt of any such
registration or Regulatory Approval, Pharmion will not distribute, market, use
or sell the Products in Taiwan prior to the time, Celgene shall have granted it
a license to do so. If Celgene shall grant a Third Party License prior to the
third anniversary of the date hereof, Pharmion shall, to the extent legally
permissible, take all action reasonably necessary to assign all of its right,
title and interest in and transfer possession and control to Celgene of the
regulatory filings prepared by Pharmion, and regulatory approvals received by
Pharmion, to the extent that such filings relate to the Product and Taiwan.
ARTICLE IV.
MARKETING
4.1. SALES AND MARKETING DUTIES OF PHARMION. In connection with the sales
and marketing of Products in the Territory, Pharmion shall, at its own expense,
(a) use commercially reasonable efforts to commence a market launch
of the Products within the Territory within three months of the receipt of UK
Regulatory Approval;
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(b) pay or have paid all marketing and distribution costs associated
with the sales and distribution of the Products within the Territory;
(c) maintain or have maintained the Products, pending their sale to
customers, in a facility that is properly equipped (including temperature and
humidity control) to store pharmaceutical and other sensitive products. Subject
to the terms of any agreements with third parties with respect to the
maintenance of the Products, Celgene will have the right to inspect, from time
to time, such facility and all government inspection reports and certificates
relating thereto. Pharmion shall use commercially reasonable efforts to
incorporate in any such agreements a right of Celgene to conduct such
inspections;
(d) collect from customers customs, handling, freight and like
charges, and sales, value added tax, if any, and other taxes;
(e) use commercially reasonable efforts to actively promote the
distribution and sale of the Products within the Territory so as to maximize
sales of the Products therein. Without limiting the generality of the preceding
sentence, Pharmion shall call upon customers in the Territory at regular
intervals to solicit purchases, furnish current information and display and
distribute information and materials regarding the Products. Each party shall
provide the other with copies of materials it creates and uses for its own
marketing purposes relating to the Products in its respective territory.
Pharmion shall use such selling, marketing and packaging materials pertaining to
the Products as Celgene shall consent to in writing, such consent not to be
unreasonably withheld or delayed. Pharmion shall provide Celgene any
translations necessary for Celgene to give such consent;
(f) comply in all material respects with all applicable laws,
regulations and approvals governing the registration, importation, distribution,
marketing and sale of the Products, and conduct itself in a professional manner
in accordance with industry standards so as not to cause disrepute or ill favor
to Celgene or the Products;
(g) maintain a technically competent and experienced sales force
(including a product or market specialist) assigned to market the Products and
devoted to maintaining accounts with present customers and developing new
accounts for sales of the Products, and disseminate to the sales personnel any
sales aids and literature developed by Pharmion relating to the Products;
(h) maintain the highest standards of quality to protect the
integrity of the Products, including providing laboratory services for quality
control and general housekeeping;
(i) study market trends in the Territory and communicate perceived
market changes to Celgene;
(j) immediately report to Celgene all governmental action relating
to any of the Products of which it has knowledge and consult with Celgene in the
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handling of such governmental action (provided, that, final determination with
respect to any such governmental action within the Territory shall be made by
Pharmion after such consultation, provided such determination would not be
reasonably likely to have a material adverse effect on Celgene); and, during the
Term of this Agreement and for a period of five years thereafter, maintain
records of all sales of Products and customers in order to assist Celgene in
tracking the Products sold in the event of a recall or withdrawal of any of the
Products from the marketplace due to a mandate of the United States Food and
Drug Administration ("FDA") or otherwise (it being understood and agreed that
Celgene will immediately report to Pharmion any governmental action relating to
any of the Products of which it has knowledge and will maintain similar records
during the Term of this Agreement and for a period of five years thereafter);
(k) establish and, except as modified as a condition to any
Regulatory Approval, strictly adhere to a system consistent with Celgene's
System for Thalidomide Education and Prescribing Safety ("S.T.E.P.S.") for the
safe and effective dispensing of the Products, a complete description of which
is attached hereto as Exhibit B; provided, however, that Pharmion may effect
such modifications of S.T.E.P.S. as Celgene shall have approved in advance, on a
country by country basis, the consideration of such approval by Celgene not to
be unreasonably delayed by it; and
(l) provide Celgene, no later than October 1 of each year during the
term of this Agreement, with an annual marketing plan for the Products in the
Territory and consult with Celgene with respect to such plan and consider, in
good faith, Celgene's views with regard thereto.
4.2. DUTY NOT TO COMPETE. Pharmion will not sell, market or distribute
any pharmaceutical product containing thalidomide or any combination
pharmaceutical product in a single dosage formulation that includes thalidomide
(other than the Products).
4.3. MARKETING SUPPORT DUTIES OF CELGENE. In connection with the
marketing of the Product, Celgene shall:
(a) make available in the United States by telephone and/or
meetings, during reasonable business hours, persons of authority to assist
Pharmion in performing the duties of Pharmion required hereunder and to answer
appropriate inquiries of Pharmion;
(b) refer all inquiries to Pharmion which are received by Celgene
from customers in the Territory; and
(c) provide initial training for a limited number of Pharmion's
marketing/medical staff at Celgene at the expense of Pharmion (including per
diem, transportation costs and other expenses).
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ARTICLE V.
REGULATORY MATTERS
5.1. REPORTING OF ADVERSE EVENTS. Each party will give prompt notice to
the other party of any information it receives regarding the safety of the
Product, including any confirmed or unconfirmed information on adverse, serious,
or unexpected events associated with the use of the Product (i) by telephone by
the end of the next calendar day and (ii) in writing via facsimile within three
calendar days after receipt of the information. Pharmion will file any reports
concerning such incidents required by law or regulation in the Territory.
5.2. OTHER REGULATORY COMPLIANCE MATTERS. Pharmion shall comply with all
applicable guidelines of the U.S. Food and Drug Administration and/or the
International Committee for Harmonization (ICH) relating to expedited reports
and periodic safety update reports. Upon written request of Celgene, Pharmion
shall permit Celgene or its representative, at Celgene's expense, to have access
during normal business hours to such records of Pharmion as may be reasonably
necessary to review Pharmion's drug safety operations. All such reviews shall be
conducted upon reasonable prior notice and not more than twice in each calendar
year.
ARTICLE VI.
INTELLECTUAL PROPERTY RIGHTS
6.1. NO OTHER TECHNOLOGY RIGHTS. Except as otherwise expressly provided
in this Agreement, under no circumstances shall a party hereto, as a result of
this Agreement, obtain any ownership interest in or other right to any
technology, trade secrets, know-how, patents, pending patent applications,
products or biological materials of the other party, including items owned,
controlled or developed by the other party, or transferred by the other party to
said party, at any time pursuant to this Agreement.
6.2. ENFORCEMENT OF PATENT RIGHTS. Celgene and Pharmion shall each
promptly notify the other in writing of any alleged or threatened infringement
of patents or patent applications relating to the Products of which they become
aware. Celgene shall have the first right to bring any action or legal
proceeding to enforce any Celgene Patent Right and/or to protect any Celgene
Technology. If, within ninety (90) days from the date of notice of any such
alleged or threatened infringement, Celgene has not initiated action to 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
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of a patent because of the manufacture, use or sale of the Product, the party
which has been sued (or whose Affiliate or Recognized Agent has been sued) shall
promptly notify the other party hereto in writing of the institution of such
suit. Celgene may, at its option and at its sole expense, control and defend
such suit. If, within a reasonable time after receiving notice of such suit,
Celgene does not notify the party that has been sued of its intention to control
and defend such suit or advises such party that it does not intend to control
and defend such suit, the party that has been sued may control and defend such
suit. The controlling party (a) may not settle such suit or otherwise consent to
an adverse judgment in such suit that materially diminishes the rights or
interests of the other party hereto without the express written consent of such
other party (which consent shall not be unreasonably withheld or delayed), and
(b) shall keep the other party hereto at all times reasonably informed as to the
status of the suit. Such other party shall have the right to be represented by
advisory counsel of its own selection (and such counsel's opinion shall be
reasonably considered by the controlling party), at its own expense, and shall
provide reasonable cooperation in the defense of such suit and furnish to the
party controlling such suit all evidence and reasonable assistance within its
control.
6.4. DEFENSE OF JOINT INFRINGEMENT ACTIONS. If Celgene or any of its
Affiliates, on the one hand, or Pharmion or any of its Affiliates or Recognized
Agents, on the other hand, shall be jointly named as defendants for infringement
of a patent for making, using, selling, offering to sell or importing any of the
Products, Celgene shall be entitled to control the defense of such suit, and all
expenses thereof including costs and attorney fees, shall be paid by Celgene.
Pharmion, its Affiliate or Recognized Agent, as the case may be, shall have the
right to be represented by counsel of its own selection, but at its sole
expense. Celgene will consult in good faith with Pharmion regarding the
litigation. Pharmion, its Affiliate or Recognized Agent, as the case may be,
shall provide reasonable cooperation in the defense of such suit and furnish to
Celgene all evidence and reasonable assistance within its control. With respect
to any judgments, settlements or damages payable with respect to the defense of
joint infringement actions, Celgene and Pharmion shall contribute to the amount
owed in an equitable manner, reflecting the relative financial benefits enjoyed
by each of them with respect to the Net Sales of the Products. In the event a
license from a third party is required, the parties shall share the cost of such
license equitably. Notwithstanding the foregoing, Pharmion shall not be
obligated to contribute to any settlement costs described above unless it has
given its express written consent (which consent shall not be unreasonably
withheld or delayed) to such settlement.
ARTICLE VII.
CONFIDENTIALITY
7.1. NONDISCLOSURE OBLIGATIONS.
(a) Except as otherwise provided in this Agreement, during the term
of this Agreement and for a period of ten (10) years thereafter, both Parties
shall maintain in confidence (a) information and data received from the other
party resulting from or related to the Product and (b) all information and data
not described in clause (a)
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but supplied by the other party under this Agreement marked "Confidential." For
purposes of this Article 6, information and data described in clause (a) or (b)
shall be referred to as "Information."
(b) To the extent it is reasonably necessary or appropriate to
fulfill its obligations or exercise its rights under this Agreement, a party may
disclose Information it is otherwise obligated under this Section not to
disclose to its Affiliates, consultants, outside contractors and clinical
investigators, on a need-to-know basis on condition that such entities or
persons agree to keep the Information confidential for the same time periods and
to the same extent as such party is required to keep the Information
confidential; and a party may disclose such Information to government or other
regulatory authorities to the extent that such disclosure is reasonably
necessary to obtain patents or authorizations to conduct clinical trials of, and
to commercially market, the Product. The obligation not to disclose Information
shall not apply to any part of such Information that: (a) is or becomes part of
the public domain other than by unauthorized acts of the party obligated not to
disclose such Information or its Affiliates; (b) can be shown by written
documents to have been disclosed to the receiving party or its Affiliates by a
Third Party, provided such Information was not obtained by such Third Party
directly or indirectly from the other party pursuant to a confidentiality
agreement; (c) prior to disclosure under this Agreement, was already in the
possession of the receiving party or its Affiliates, provided such Information
was not obtained directly or indirectly from the other party pursuant to a
confidentiality agreement; (d) can be shown by written documents to have been
independently developed by the receiving party or its Affiliates without breach
of any of the provisions of this Agreement; (e) is disclosed by the receiving
party pursuant to interrogatories, requests for information or documents,
subpoena, civil investigative demand issued by a court or governmental agency or
as otherwise required by law; provided that the receiving party notifies the
other party immediately upon receipt thereof (and provided that the disclosing
party furnishes only that portion of the Information which it is advised by
counsel is legally required); or (f) bioavailability and clinical data used for
marketing purposes following receipt of UK Regulatory Approval.
7.2. TERMS OF THIS AGREEMENT. Celgene and Pharmion each agree not to
disclose any terms or conditions of this Agreement to any Third Party without
the prior consent of the other party, except as required by applicable law.
Notwithstanding the foregoing, prior to execution of this Agreement, Celgene and
Pharmion shall agree upon the substance of information that can be used as a
routine reference in the usual course of business to describe the terms of this
transaction, and Celgene and Pharmion may disclose such information, as modified
by mutual agreement from time to time, without the other party's consent.
7.3. INJUNCTIVE RELIEF. The Parties hereto understand and agree that
remedies at law may be inadequate to protect against any breach of any of the
provisions of this Article 7 by either party or their employees, agents,
officers or directors or any other person acting in concert with it or on its
behalf. Accordingly, each party shall be
12
entitled to the granting of injunctive relief by a court of competent
jurisdiction against any action that constitutes any such breach of this Article
7.
ARTICLE VIII.
INDEMNITY
8.1. PHARMION INDEMNITY OBLIGATIONS. Pharmion shall defend, indemnify and
hold Celgene, its Affiliates and their respective employees, officers,
directors, counsel and agents harmless from all claims, losses, damages or
expenses (including, without limitation, reasonable attorneys' fees and expenses
and costs of investigation) arising as a result of: (a) the breach by Pharmion
of any covenant, representation or warranty contained in this Agreement; (b)
actual or asserted violations of any applicable law or regulation by Pharmion,
its Affiliates or Recognized Agents by virtue of which any Product distributed,
marketed or sold shall be alleged or determined to be adulterated, misbranded,
mislabeled or otherwise not in compliance with any applicable law or regulation;
(c) claims for bodily injury, death or property damage attributable to the
distribution, marketing or sale of the Product by Pharmion, its Affiliates or
Recognized Agents; (d) any negligent act or omission of Pharmion, its Affiliates
or Recognized Agents in the distribution, marketing and sale of any Product or
any other activity conducted by Pharmion, its Affiliates or Recognized Agents
under this Agreement which is the proximate cause of injury, death or property
damage to a third party; or (e) any failure of Pharmion to comply with any
recall of a Product marketed, distributed or sold by Pharmion, its Affiliates or
Recognized Agents that is ordered by a governmental agency or required by a
confirmed failure of such Product.
8.2. CELGENE INDEMNITY OBLIGATIONS. Celgene shall defend, indemnify and
hold Pharmion, its Affiliates and their respective employees, officers,
directors, counsel and agents harmless from all claims, losses, damages or
expenses (including, without limitation, reasonable attorneys' fees and
expenses, and costs of investigation) arising as a result of: (a) the breach by
Celgene of any covenant, representation or warranty contained in this Agreement;
(b) actual or asserted violations of any applicable law or regulation by Celgene
or its Affiliates by virtue of which any Product manufactured, distributed,
marketed or sold shall be alleged or determined to be adulterated, misbranded,
mislabeled or otherwise not in compliance with any applicable law or regulation;
(c) claims for bodily injury, death or property damage attributable to the
manufacture, distribution, marketing or sale of the Product by Celgene or its
Affiliates; (d) any negligent act or omission of Celgene (or any Affiliate or
sublicensee thereof) in the manufacture, distribution, marketing or sale of any
Product or any other activity conducted by Celgene or its Affiliates under this
Agreement which is the proximate cause of injury, death or property damage to a
third party; or (e) any failure of Celgene to comply with any recall of a
Product manufactured, distributed, marketed or sold by Celgene or its Affiliates
that is ordered by a governmental agency or required by a confirmed failure of
such Product.
8.3. PROCEDURE. A party or any of its Affiliates or their respective
employees or agents (the "Indemnitee") that intends to claim indemnification
under this
13
Article 8 shall promptly notify the other party (the "Indemnitor") of
any loss, claim, damage, liability or action in respect of which the Indemnitee
intends to claim such indemnification, and the Indemnitor shall assume the
defense thereof with counsel mutually satisfactory to the parties; provided,
however, that an Indemnitee shall have the right to retain its own counsel, with
the fees and expenses to be paid by the Indemnitor, if representation of such
Indemnitee by the counsel retained by the Indemnitor would be inappropriate due
to actual or potential differing interests between such Indemnitee and any other
party represented by such counsel in such proceedings. The indemnity agreement
in this Article 8 shall not apply to amounts paid in settlement of any loss,
claim, damage, liability or action if such settlement is effected without the
consent of the Indemnitor, which consent shall not be withheld or delayed
unreasonably. The Indemnitor may not settle, or otherwise consent to an adverse
judgment with respect to, any loss, claim, liability or action without the
consent of the Indemnitee, which consent shall not be withheld or delayed
unreasonably. The failure to deliver notice to the Indemnitor within a
reasonable time after the commencement of any such action, if prejudicial to its
ability to defend such action, shall relieve such Indemnitor of any liability to
the Indemnitee under this Article 8 to the extent of such prejudice, but the
omission so to deliver notice to the Indemnitor will not relieve it of any
liability that it may have to any Indemnitee otherwise than under this Article
8. The Indemnitee, its employees and agents, shall cooperate fully with the
Indemnitor and its legal representatives in the investigation of any action,
claim or liability covered by this indemnification. In the event that each party
claims indemnity from the other and one party is finally held liable to
indemnify the other, the Indemnitor shall additionally be liable to pay the
reasonable legal costs and attorneys' fees incurred by the Indemnitee in
establishing its claim for indemnity.
8.4. INSURANCE.
(a) Pharmion shall purchase and maintain in effect at its own
expense, throughout the term of this Agreement, general liabilities insurance
with limits of not less than U.S.$10,000,000 per occurrence and U.S.$50,000,000
in the aggregate. Such policy shall cover Celgene as an additional insured with
respect to liability arising out of Pharmion's activities with respect to the
Products, and shall provide that the issuer of such policy shall be required to
give Celgene and Pharmion not less than 30 days written notice prior to the
cancellation of the policy or policies. Upon Celgene's request, a memorandum
certificate of the aforementioned insurance policy or policies shall be
deposited with Celgene; provided, however, that failure of Celgene to make such
a request shall in no way be construed in such a way as to relieve Pharmion from
its obligation to procure such insurance coverage. Prior to expiration and/or
cancellation of the aforementioned policy or policies, Pharmion shall promptly
secure replacement of such insurance coverage upon the same terms and conditions
and furnish Celgene with a memorandum certificate as heretofore described.
(b) Celgene shall purchase and maintain in effect at its own
expense, throughout the term of this Agreement, general liabilities insurance
with limits of not less than U.S.$10,000,000 per occurrence and U.S.$50,000,000
in the aggregate.
14
Such policy shall cover Pharmion as an additional insured with respect to
liability arising out of Celgene's activities with respect to the Products, and
shall provide that the issuer of such policy shall be required to give Pharmion
and Celgene not less than 30 days written notice prior to the cancellation of
the policy or policies. Upon Pharmion's request, a memorandum certificate of the
aforementioned insurance policy or policies shall be deposited with Pharmion;
provided, however, that failure of Pharmion to make such a request shall in no
way be construed in such a way as to relieve Celgene from its obligation to
procure such insurance coverage. Prior to expiration and/or cancellation of the
aforementioned policy or policies, Celgene shall promptly secure replacement of
such insurance coverage upon the same terms and conditions and furnish Pharmion
with a memorandum certificate as heretofore described.
ARTICLE IX.
TERM AND TERMINATION
9.1. TERM. Unless sooner terminated pursuant to this Article 9, this
Agreement shall expire on the 10-year anniversary of the date of Regulatory
Approval in the United Kingdom. The term shall be extended thereafter for
additional successive two-year periods, unless and until either party notifies
the other party, in writing, of its intention to cancel such extension as of the
end of the then current term; PROVIDED, that, any such non-extension notice
shall be given not less than 180 days prior to the end of the then current term.
9.2. EXISTING OBLIGATIONS. Termination pursuant to Section 9.1 of this
Agreement for any reason shall not relieve the Parties of any obligation
accruing prior to such expiration or termination and any obligation under this
Agreement which, pursuant to the express terms hereof, survives such
termination.
9.3. TERMINATION BY EITHER PARTY.
(a) Celgene or Pharmion may terminate this Agreement on 60 days
prior written notice to the other party following (i) a material breach by the
other party of any covenant, duty or undertaking herein, or in the letter
agreement of even date entered into among Pharmion, Guarantor and Celgene (the
"Letter Agreement"), which is not cured within 60 days of written notice
thereof; or (ii) if the other party shall become insolvent or shall file or have
filed by its creditors a petition in bankruptcy or similar proceeding, if a
court of competent jurisdiction appoints a receiver over the business or assets
of the other party, or the making by the party of a general assignment for the
benefit of creditors.
(b) In addition, Celgene may terminate this Agreement on 30 days
prior written notice to Pharmion following (i) Pharmion's failure to apply for
UK Regulatory Approval, which application may be to the EMEA, within twelve (12)
months after the date of this Agreement or Pharmion's failure to obtain
Regulatory Approval in the United Kingdom within three (3) years after the date
of this Agreement, (ii) Pharmion's failure to pay Celgene any amount hereunder
when due, unless Pharmion is
15
disputing such payment in good faith or otherwise cures such default within 30
days of Celgene's delivery of the notice, (iii) Pharmion's discontinuance of the
active conduct of its business for a period in excess of 30 days, (iv)
Pharmion's failure to commence a market launch of the Products within the United
Kingdom within three months after receipt of UK Regulatory Approval, or (v) any
change in control of Pharmion that Celgene does not consent to, such consent not
be unreasonably withheld or delayed. For purposes of the preceding clause (v), a
"change in control" shall be deemed to occur upon (A) the acquisition by any
Scheduled Entity (as hereinafter defined) of 50% or more of Pharmion's voting
shares, (B) directors elected to the Board of Directors of Pharmion over any
24-month period nominated by any Scheduled Entity representing 30% or more of
the total number of directors constituting the Board at the beginning of the
period, (C) any merger, consolidation or other corporate combination upon the
completion of which shares of any Scheduled Entity outstanding prior to such
transaction represent more than 50% of the combined voting power of the
resulting entity, or (D) the sale of all or substantially all of the assets of
Pharmion to any Scheduled Entity. For purposes of this Agreement, the term
"Scheduled Entity" means (i) any of the entities listed on Exhibit C to this
Agreement, (ii) any entity which Celgene at any time, and from time to time,
during the term of this Agreement, shall add to the entities listed on Exhibit
C, if, at any time within five (5) years prior to the date Celgene adds such
entity to the list on Exhibit C, (A) Celgene has been in litigation or
arbitration proceedings with such entity, (B) such entity has, in writing,
threatened Celgene, or been threatened by Celgene, with litigation or
arbitration proceedings, or (C) 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/multisourced 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
16
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 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.
17
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 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
18
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
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
19
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 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
20
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 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.
21
IN WITNESS WHEREOF, the parties have executed this Agreement as of the
date first set forth above.
CELGENE CORPORATION
By:
--------------------------------------------
Name: Xxx X. Xxxxx, Ph.D.
Title: President and Chief Operating Officer
PHARMION GMBH
By:
--------------------------------------------
Name: Xxxxxxx X. Xxxxxxx
Title: Chief Executive Officer
PHARMION CORPORATION
By:
--------------------------------------------
Name: Xxxxxxx X. Xxxxxxx
Title: Chief Executive Officer
22
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 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 THALIDOMIDE 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 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 advisibility 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.
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.
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 THALIDOMIDE 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 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 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, 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
THALIDOMIDE 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 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 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 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.
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 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, 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. 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.
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 PARTIES. 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 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
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.
