EXHIBIT 10.1
[".........." INDICATES MATERIAL HAS BEEN OMITTED PURSUANT TO A CONFIDENTIAL
TREATMENT REQUEST, WHICH THE COMPANY HAS FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION]
AGREEMENT
by and among
CHILDREN'S MEDICAL CENTER CORPORATION,
CELGENE CORPORATION,
BIOVENTURE INVESTMENTS KFT
and
ENTREMED, INC.
(Solely for purposes of Sections 2.2.5, 2.7, 5, 7, 8.1, 12, 13, 15.2, 15.7,
15.9 and 16)
AGREEMENT
This Agreement, dated this ___ day of August, 2001, is made by and
among CELGENE CORPORATION, a Delaware corporation located at 0 Xxxxxx Xxxx
Xxxxx, Xxxxxx, Xxx Xxxxxx 00000 ("CELGENE"), CHILDREN'S MEDICAL CENTER
CORPORATION, a corporation duly organized and existing under the laws of the
Commonwealth of Massachusetts and having its principal office at 000 Xxxxxxxx
Xxxxxx, Xxxxxx, Xxxxxxxxxxxxx 00000 ("CMCC"), BIOVENTURE INVESTMENTS KFT, a
company located at Wesselenyi ut 00, Xxxxxxxx, Xxxxxxx, organized under the laws
of Hungary ("BIOVENTURE"), and, solely for purposes of Sections 2.2.5, 2.7, 5,
7, 8.1, 12, 13, 15.2, 15.7, 15.9 and 16 of this Agreement, EntreMed, Inc., a
Delaware corporation located at 0000 Xxxxxxx Xxxxxx Xxxxx, Xxxxx 000, Xxxxxxxxx,
Xxxxxxxx 00000 ("ENTREMED").
WHEREAS, CMCC is the owner of certain PATENT RIGHTS, as hereinafter
defined, relating to THALIDOMIDE (as hereinafter defined) and certain analogs of
THALIDOMIDE, and has the right to grant licenses under said PATENT RIGHTS;
WHEREAS, pursuant to that certain License Agreement, dated as of May
26, 1994, by CMCC and ENTREMED (as subsequently amended, the "ENTREMED
LICENSE"), CMCC licensed to ENTREMED the PATENT RIGHTS;
WHEREAS, pursuant to that certain Agreement, dated as of December 9,
1998 by and between ENTREMED and CELGENE (the "CELGENE SUBLICENSE"), ENTREMED
exclusively sublicensed to CELGENE its THALIDOMIDE rights under the PATENT
RIGHTS, as set forth in the ENTREMED LICENSE; and
1
WHEREAS, BIOVENTURE desires to buy, and ENTREMED has agreed to sell to
BIOVENTURE, all of ENTREMED'S right, title and interest to certain payments
otherwise due ENTREMED under the CELGENE SUBLICENSE, net of any payments owed to
CMCC by ENTREMED pursuant to the ENTREMED LICENSE;
WHEREAS, ENTREMED, BIOVENTURE, CMCC and CELGENE desire to terminate the
ENTREMED LICENSE and the CELGENE SUBLICENSE and for CELGENE to enter into this
Agreement, pursuant to which CMCC shall directly grant CELGENE an exclusive
license under the PATENT RIGHTS relating to THALIDOMIDE, which will supercede
and replace in its entirety the ENTREMED LICENSE, to the extent same relates to
THALIDOMIDE, and the CELGENE SUBLICENSE;
WHEREAS, CMCC and ENTREMED shall execute, concurrently herewith, a new
agreement relating to the THALIDOMDE analog rights licensed to ENTREMED under
the ENTREMED LICENSE (the "NEW ANALOG AGREEMENT"), which will supercede and
replace in its entirety the ENTREMED LICENSE to the extent same relates to
THALIDOMIDE analogs;
WHEREAS, the ENTREMED LICENSE and the CELGENE SUBLICENSE will
automatically terminate upon execution of both this Agreement and the NEW ANALOG
AGREEMENT;
NOW, THEREFORE, in consideration of the mutual promises and other good
and valuable consideration, the parties agree as follows:
SECTION 1 - DEFINITIONS
The terms used in this Agreement have the following meaning:
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1.1 The term "AFFILIATE" as applied to either party shall mean any company
or other legal entity other than the party in question in whatever
country organized, controlling controlled by or under common control
with that party. The term "control" means ownership or control,
directly or indirectly, of at least fifty percent (50%) of the
outstanding stock or voting rights entitled to elect directors.
1.2 The term "CALENDAR QUARTER" shall mean the period of three (3)
consecutive calendar months ending on March 31, June 30, September 30
or December 31, as the case may be.
1.3 The term "CELGENE DEVELOPED INTELLECTUAL PROPERTY" shall mean CELGENE
DEVELOPED PATENT RIGHTS and CELGENE DEVELOPED TECHNOLOGY RIGHTS.
(a) The term "CELGENE DEVELOPED PATENT RIGHTS" The term "CELGENE
DEVELOPED PATENT RIGHTS" shall mean any United States or foreign
patents or patent applications filed by CELGENE, or an AFFILIATE,
successor or assign thereof at any time subsequent to December 9,
1998, in which CELGENE has a transferrable interest, relating to
a modification of a PRODUCT described in any of the PATENT RIGHTS
or a method of using such PRODUCT, which modification is (a)
necessary for the manufacture, use, or sale of such PRODUCT, and
(b) then currently in use by CELGENE at the time CMCC exercises
its rights under Section 15.4(b), for the manufacture, use, or
sale of such PRODUCT.
(b) The term "CELGENE DEVELOPED TECHNOLOGY RIGHTS" shall mean any
TECHNOLOGY RIGHTS developed, obtained, or acquired by CELGENE or
an AFFILIATE, successor or assign thereof at any time subsequent
to December 9,
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1998 in which CELGENE has a transferrable interest, relating to a
modification of a PRODUCT described in any of the PATENT RIGHTS
or a method of using or use of such PRODUCT, which modification
is (a) necessary for the manufacture, use, or sale of such
PRODUCT, and (b) then currently in use by CELGENE at the time
CMCC exercises its rights under Section 15.4(b) for the
manufacture, use, or sale of such PRODUCT.
1.4 The term "CMCC Royalty Purchaser(s)" shall mean the buyers, if any, of
all or a portion of CMCC's right, title and interest to certain
payments otherwise due CMCC under this Agreement, as expressly
permitted pursuant to Section 13 hereof.
1.5 The term "EFFECTIVE DATE" shall mean the date of this Agreement.
1.6 The term "FIELD" shall mean the use of THALIDOMIDE, alone or in
combination, in humans or animals, including without limitation any and
all diagnostic, prophylactic, therapeutic, and research and development
uses.
1.7 The term "FIRST COMMERCIAL SALE" shall mean, in each country of the
TERRITORY, the first sale after December 9, 1998, whether prior to or
after the EFFECTIVE DATE hereof, in such country to a THIRD PARTY in
connection with the nationwide introduction of any PRODUCT by CELGENE,
its AFFILIATES or SUBLICENSEES following marketing and/or pricing
approval by the appropriate governmental agency for the country in
which the sale is to be made and, when governmental approval is not
required, the first sale in that country in connection with the
nationwide introduction of a PRODUCT in that country.
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1.8 The term "LICENSED METHOD" shall mean any method the practice of which,
by an unlicensed third party, would infringe any VALID CLAIM of the
PATENT RIGHTS in the country in which it is practiced.
1.9 The term "MIXED PATENT RIGHTS" shall mean any of the PATENT RIGHTS that
claim, either generically or specifically, either (i) both (a)
THALIDOMIDE and/or the use or manufacture thereof and (b) THALIDOMIDE
analogs and/or the use or manufacture thereof; or (ii) THALIDOMIDE
analogs and/or the use or manufacture thereof, but not THALIDOMIDE
and/or the use or manufacture thereof; which MIXED PATENT RIGHTS, as of
the EFFECTIVE DATE, are set forth on Appendix B, which may be amended
from time to time as necessary to accurately identify same.
1.10 The term "MIXED PATENT THALIDOMIDE CLAIM" shall mean any claim of any
MIXED PATENT RIGHTS that would be infringed by the making, using,
offering for sale, selling or importing of THALIDOMIDE and/or a
PRODUCT.
1.11 The term "NDA" shall mean a New Drug Application filed with the United
States Food and Drug Administration.
1.12 The term "NET SALES" means the gross amount received by CELGENE or its
AFFILIATES or SUBLICENSEES for sale of PRODUCTS to THIRD PARTIES, less:
(i) cost of freight, postage, and freight insurance, (if paid by
seller); (ii) sales taxes, value added taxes, excise taxes, and customs
duties; (iii) cost of export licenses and any taxes, fees or other
charges associated with the exportation or importation of PRODUCTS;
(iv) rebates accrued, incurred or paid to Federal Medicare and State
Medicaid and any other price reductions required by a governmental
agency; (v) rejected shipments, returns, and retroactive deductions;
(vi) the amount received for sales which become the
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subject of a subsequent temporary or partial recall by a regulatory
agency for safety or efficacy reasons outside the control of CELGENE;
and (vii) customary cash, quantity, and trade discounts; provided,
however, that a sale or transfer to an AFFILIATE or SUBLICENSEE for
re-sale by such AFFILIATE or SUBLICENSEE shall not be considered a sale
for the purpose of this provision but the resale by such AFFILIATE or
SUBLICENSEE shall be a sale for such purposes. A "sale" shall also
include a transfer or other disposition for consideration, but not such
transfers or dispositions, without consideration, for pre-clinical,
clinical, regulatory or governmental purposes prior to receiving
marketing approval for the specific indication for which such transfer
is made. In the event that consideration in addition to or in lieu of
money is received for PRODUCT, such consideration shall be added to the
NET SALES as valued on the day of receipt thereof by CELGENE. To the
extent that a PRODUCT is sold in other than an arms length transaction,
NET SALES shall be the fair market value of such PRODUCT if sold in an
arms length transaction, less the costs identified in subsections
(i)-(vi) of this Section 1.12. PRODUCT shall be considered "sold" at
the earlier of (a) the transfer of title in such PRODUCT to a person
other than an AFFILIATE or SUBLICENSEE of CELGENE or (b) the shipment
of such PRODUCT from the manufacturing or warehouse facilities of
CELGENE or its AFFILIATE or SUBLICENSEE to a THIRD PARTY.
1.13 The term "PATENT RIGHT(s)" shall mean:
(a) the United States patent applications and patents listed in
Appendix A;
(b) the United States and foreign patents issued from applications
listed in Appendix A and from divisionals and continuations of
such applications;
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(c) claims of United States continuation-in-part applications and of
equivalent foreign applications, and of the resulting patent(s),
that are directed to subject matter described in the United
States and foreign applications listed in Appendix A;
(d) claims of all later-filed foreign patent applications, and of the
resulting patents, that are directed to subject matter described
in the United States patents and/or patent applications in the
foregoing subsections of this Section 1.13;
(e) any reissues, re-examinations, renewals or extensions of United
States patents described in the foregoing subsections of this
Section 1.13.
1.14 The term "PRODUCT" shall mean any article of manufacture, substance,
material, chemical, formulation or composition for use in the FIELD
which is or includes THALIDOMIDE as an active ingredient, including,
without limitation, a composition that comprises THALIDOMIDE and a
non-steroidal anti-inflammatory compound(s). PRODUCT expressly excludes
THALIDOMIDE analogs.
1.15 The term "SUBLICENSEE" shall mean any THIRD PARTY licensed by CELGENE
to make, have made, use, offer to sell, sell or import any PRODUCT
and/or practice any LICENSED METHOD in the FIELD or any portion
thereof.
1.16 The term "TERRITORY" shall mean the entire world.
1.17 The term "THALIDOMIDE" shall mean a compound with the chemical
structure described as 2-(2,6-Dioxo-3-piperidinyl)-1H-isoindole-
1,3(2H)-dione, or as otherwise defined in the Merck Index, entry 9390,
12th ed., and pharmaceutically acceptable salts thereof.
1.18 The term "TECHNOLOGY RIGHTS" shall mean any information relating to
PRODUCTS that is not covered by a patent or patent application,
including without
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limitation technical and non-technical information, know-how, methods,
processes, procedures, compositions, devices, formulae, protocols,
techniques, software, designs, drawings, plans, diagrams,
specifications, data, the results of tests or assays, and all other
information relating to PRODUCTS.
1.19 The term "THALIDOMIDE PATENT RIGHT(s)" shall mean any of the PATENT
RIGHTS that claim, either generically or specifically, (a) THALIDOMIDE
and/or the use or manufacture thereof but not (b) THALIDOMIDE analogs
and/or the use or manufacture thereof; which THALIDOMIDE PATENT RIGHTS,
as of the EFFECTIVE DATE, are set forth on Appendix C, which may be
amended from time to time as necessary to accurately identify same.
1.20 The term "THIRD PARTY(IES)" shall mean a person or entity who or which
is neither a party hereto nor an AFFILIATE of a party hereto. Except
for purposes of Sections 2.2.5, 2.7, 5, 7, 8.1, 12, 13, 15.2, 15.7,
15.9 and 16, ENTREMED shall be considered a THIRD PARTY.
1.21 The term "VALID CLAIM" shall mean an issued claim of an unexpired
patent ("ISSUED VALID CLAIM") or a claim of a pending patent
application, which shall not have been withdrawn, canceled or
disclaimed, or held invalid or unenforceable by a court of competent
jurisdiction in an unappealed or unappealable decision. Notwithstanding
the foregoing to the contrary, a claim of a pending patent application,
divisional application or continuation-in-part shall cease to be a
VALID CLAIM if no patent has issued on such claim within five (5) years
of the filing of such claim, provided that such claim shall once again
become a VALID CLAIM on the issue date of a patent that subsequently
issues and covers such claim.
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1.22 The use herein of the plural shall include the singular, and the use of
the masculine shall include the feminine.
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
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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
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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
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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
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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
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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
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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.
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(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.
SECTION 3 - DUE DILIGENCE
3.1 In the United States.
---------------------
(a) CELGENE shall initiate and diligently use reasonable efforts to
develop, or to file for regulatory approval of or register, and
to market and sell PRODUCTS in the
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Xxxxxx Xxxxxx. Reasonable efforts with respect to the development
and/or pursuit of regulatory approval or registration for
PRODUCTS in the United States shall be demonstrated by CELGENE or
a SUBLICENSEE thereof, either prior to or after the EFFECTIVE
DATE hereof, (i) developing and pursuing regulatory approval for
PRODUCTS for those uses CELGENE, in good faith, determines to be
commercially and scientifically reasonable, including but not
limited to (a) one (1).........., (b) one (1)........., and (c)
one (1).........; and (ii) funding and conducting clinical trials
for PRODUCTS for other uses in order to enhance scientific
knowledge with regard to such PRODUCTS, including for the
publication of data and results in scientific journals, whether
or not such clinical trials result in or facilitate the pursuit
of regulatory approval.
(b) CELGENE shall provide a written summary report to CMCC within
thirty (30) days after June 30th and December 31st of each
calendar year concerning the efforts being made in accordance
with this Section 3.1 with respect to PRODUCTS. CELGENE shall
provide CMCC with any additional information reasonably requested
by CMCC in this respect. All information provided to CMCC
pursuant to this Section 3.1 shall be treated by CMCC as
CELGENE's CONFIDENTIAL INFORMATION, in accordance with Section 5
hereof. Except as set forth in Section 3.4, in the event that
CELGENE fails to meet any of its obligations under this Section
3.1 with respect to PRODUCTS in the United States, and such
failure is not cured within sixty (60) days after written notice
thereof is received by CELGENE from CMCC, then CMCC shall have
the right and option to terminate the license granted in this
Agreement and this Agreement
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by giving CELGENE sixty (60) days prior written notice thereof,
in accordance with Section 15.4(b)(ii).
3.2 Outside the United States.
--------------------------
(a) Diligence. CELGENE shall initiate and diligently use reasonable
efforts to develop, or to file for regulatory approval of or
register, and to market and sell PRODUCTS in Europe, in Canada,
and in the Pacific Rim, Japan, and Australia (collectively, the
"PACIFIC RIM"). Reasonable efforts with respect to the
development and/or pursuit of regulatory approval or registration
for PRODUCTS in Europe, Canada, and the PACIFIC RIM shall be
demonstrated by CELGENE, or a SUBLICENSEE thereof, either prior
to or after the EFFECTIVE DATE hereof, pursuing regulatory
approval for PRODUCTS (a) in Italy, France, the United Kingdom,
and Germany (in the case of Europe), and in Japan and one other
country of the PACIFIC RIM (in the case of the PACIFIC RIM),
within.........from the date of the first FDA approval of a
PRODUCT for an.........or........., whichever occurs earlier; and
(b) in Canada, within.........from the date of the first FDA
approval of a PRODUCT for an.........or........., whichever
occurs earlier.
(b) Cooperation. If CELGENE fails to use reasonable efforts in
Europe, Canada, or the PACIFIC RIM, as set forth in Section
3.2(a) of this Agreement, or to sublicense such rights to a THIRD
PARTY, then CMCC shall have the right to COOPERATE with CELGENE
to find an appropriate SUBLICENSEE for such rights. For purposes
of this Section 3.2(b), and for Sections 3.3(b) and 3.4, the term
"COOPERATE" means that (i) CMCC shall have the right to (a)
identify for
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CELGENE a THIRD PARTY interested in entering into a sublicense
agreement with CELGENE, pursuant to which CELGENE would grant
such THIRD PARTY a sublicense of the rights, duties and/or
obligations granted to CELGENE hereunder in the THALIDOMIDE
PATENT RIGHTS and/or the MIXED PATENT RIGHTS, in whole or in
part, in the relevant region and/or for the relevant indication
and (b) to the extent CELGENE so requests, assist or participate
in the drafting and/or negotiation of such sublicense agreement,
and (ii) CELGENE shall have the obligation to negotiate in good
faith with such THIRD PARTY for such sublicense agreement. Prior
to and from time to time during the exercise of its right to
COOPERATE, CMCC shall consult with BIOVENTURE as to potential
SUBLICENSEES; provided that (x) CMCC shall not be required to
obtain the consent of BIOVENTURE; (y) BIOVENTURE's right to
consult shall not create in CELGENE or in CMCC any right to
withhold or delay the fulfillment of its obligation to COOPERATE.
If CELGENE fails to negotiate in good faith with such THIRD PARTY
to execute such a sublicense agreement within a reasonable period
of time, and CELGENE has not, within such time period, entered
into such a sublicense agreement with another THIRD PARTY or
otherwise cured the relevant breach of its diligence obligations
under this Section 3.2, then CMCC shall have the right and option
to terminate the licenses granted in the region where such
failure has occurred, i.e., Europe, Canada, or the PACIFIC RIM,
respectively, by giving CELGENE sixty (60) days prior written
notice thereof, in accordance with Section 15.4(b)(ii).
-19-
3.3 For PRODUCTS For Use In Animals.
-------------------------------
(a) Diligence. CELGENE shall initiate and diligently use reasonable
efforts to develop, or to file for regulatory approval of or
register, and to market and sell PRODUCTS for use in animals.
Such reasonable efforts shall be demonstrated by CELGENE
obtaining regulatory approval for the sale of a PRODUCT for use
in animals within ......... of the EFFECTIVE DATE in the United
States and, outside the United States, in one of the following
countries: Italy, France, the United Kingdom, or Germany.
(b) Cooperation. If CELGENE fails to use reasonable efforts either in
the United States or outside the United States, as set forth in
Section 3.3(a) of this Agreement, or to sublicense its rights in
such regions to a THIRD PARTY, then CMCC shall have the right to
COOPERATE with CELGENE to find an appropriate SUBLICENSEE for
such rights. Prior to and from time to time during the exercise
of its right to COOPERATE, CMCC shall consult with BIOVENTURE as
to potential SUBLICENSEES; provided that (x) CMCC shall not be
required to obtain the consent of BIOVENTURE and (y) BIOVENTURE's
right to consult shall not create in CELGENE or CMCC any right to
withhold or delay the fulfillment of its obligation to COOPERATE.
If CELGENE fails to negotiate in good faith with such THIRD PARTY
to execute such a sublicense agreement within a reasonable period
of time, and CELGENE has not, within such time period, entered
into such a sublicense agreement with another THIRD PARTY or
otherwise cured the relevant breach of its diligence obligations
under
-20-
this Section 3.3, then CMCC shall have the right and option to
terminate the licenses granted in and to such PRODUCTS for use in
animals in the region where such failure has occurred, i.e.,
inside the United States or outside the United States, as
applicable, by giving CELGENE sixty (60) days prior written
notice thereof, in accordance with Section 15.4(b)(ii).
3.4 For PRODUCTS For Ophthalmologic Use. If CELGENE fails to use reasonable
efforts in the United States to develop, or to file for regulatory
approval of or register, and to market and sell PRODUCTS for
ophthalmologic use or to sublicense its rights in the United States for
such indication to a THIRD PARTY, or CELGENE notifies CMCC that it does
not intend to take any further activities with respect to PRODUCTS for
ophthalmologic use in the United States, then CMCC shall have the right
to COOPERATE with CELGENE to find an appropriate SUBLICENSEE for such
rights. Prior to and from time to time during the exercise of its right
to COOPERATE, CMCC shall consult with BIOVENTURE as to potential
SUBLICENSEES; provided that (x) CMCC shall not be required to obtain
the consent of BIOVENTURE and (y) BIOVENTURE's right to consult shall
not create in CELGENE or CMCC any right to withhold or delay the
fulfillment of its obligation to COOPERATE. If CELGENE fails to
negotiate in good faith with such THIRD PARTY to execute such a
sublicense agreement within a reasonable period of time, and CELGENE
has not, within such time period, entered into such a sublicense
agreement with another THIRD PARTY or otherwise cured the relevant
breach of its diligence obligations under this Section 3.4, then CMCC
shall have the right and option to terminate the licenses granted in
and to
-21-
PRODUCTS for ophthalmologic use in the United States by giving CELGENE
sixty (60) days prior written notice thereof, in accordance with
Section 15.4(b)(ii).
3.5 CELGENE's Discretion. CMCC agrees that (i) the decision regarding which
uses to pursue regulatory approval of PRODUCTS for, and/or to fund and
conduct clinical trials of PRODUCTS for, pursuant to Sections 3.1, 3.2,
3.3 and 3.4 of this Agreement, shall be made by and in the sole
discretion of CELGENE; and (ii) with respect to the manner in which
regulatory approval is sought and/or clinical trials are funded and
conducted, CELGENE shall have sole discretion, including, without
limitation, complete control over all regulatory submissions of
PRODUCTS to the appropriate regulatory agencies worldwide, including
whether, when, and how to file, maintain, withdraw, or abandon an
application for regulatory approval of PRODUCTS.
SECTION 4 - ROYALTIES
4.1 Royalty Payments.
----------------
(a) First Twelve Years From FIRST COMMERCIAL SALE. CELGENE shall pay
to CMCC ......... of, and shall pay to BIOVENTURE ......... of,
the following royalties on the NET SALES of PRODUCTS sold by
CELGENE or its AFFILIATES in each country of the TERRITORY: (i)
for the first consecutive twelve (12) years from the date of the
FIRST COMMERCIAL SALE of a PRODUCT in each country of the
TERRITORY, and, separately and independently, (ii) for the first
consecutive twelve (12) years from the date of the FIRST
COMMERCIAL SALE of each PRODUCT that contains, as a second
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active ingredient, a compound other than THALIDOMIDE, in each
country of the
TERRITORY:
(i) ......... of NET SALES up to ......... of such sales;
(ii) ........ of NET SALES between ......... and ......... of such sales;
(iii) ....... of NET SALES between ......... and ......... of such sales; and
(iv) ........ of NET SALES over ......... of such sales.
(b) After Twelve Years From FIRST COMMERCIAL SALE. For each PRODUCT
in each country in the TERRITORY in which the twelve (12) year
period provided for in Section 4.1(a) of this Agreement shall
have terminated, CELGENE shall pay to CMCC.........of, and shall
pay to BIOVENTURE.........of, the following royalties on the NET
SALES of such PRODUCT covered by an ISSUED VALID CLAIM of the
PATENT RIGHTS that are sold by CELGENE or its AFFILIATES in such
country:
(i) ...... of NET SALES up to.........of such sales;
(ii) ...... of NET SALES between.........and.........of such sales;
(iii) ...... of NET SALES between.........and.........of such sales; and
(iv) ...... of NET SALES over.........of such sales;
and such royalties under this Section 4.1(b) shall be payable
until the last to expire PATENT RIGHT containing an ISSUED VALID
CLAIM covering such PRODUCT sold by CELGENE or its AFFILIATES in
such country.
4.2 Sublicensing Payments and Royalties.
-----------------------------------
(a) If CELGENE grants a sublicense of its exclusive rights under this
Agreement, pursuant to Section 2.3 of this Agreement, in any
country(ies) of the
-00-
XXXXXXXXX, XXXXXXX shall pay to CMCC ......... of, and shall pay
to BIOVENTURE ......... of, (i) ......... of any non-royalty
consideration, including but not limited to any sublicensing
and/or milestone payments received by CELGENE pursuant to such
sublicense for the sublicense of CELGENE's rights hereunder, and
(ii) ......... of the royalty income paid by SUBLICENSEES to
CELGENE on NET SALES of PRODUCTS including, without limitation,
......... of any lump-sum commercialization milestone payments
due to CELGENE upon the occurrence of certain threshold levels of
NET SALES of PRODUCTS by such SUBLICENSEE.
(b) If CELGENE grants a sublicense of any of its rights under this
Agreement in any area of the FIELD or any country of the
TERRITORY with respect to which CMCC and CELGENE are COOPERATING
pursuant to Sections 3.2(b), 3.3(b) and 3.4 of this Agreement,
CELGENE shall pay to CMCC.........of, and shall pay to
BIOVENTURE.........of,.........of any non-royalty consideration,
including but not limited to any sublicensing and/or milestone
payments received by CELGENE pursuant to such sublicense. CELGENE
shall also pay to CMCC.........of, and shall pay to
BIOVENTURE.........of, the following, as applicable: (i) if
CELGENE and CMCC are COOPERATING in any country(ies) pursuant to
Section 3.2(b) of this Agreement,.........of the royalty income
paid by SUBLICENSEES to CELGENE on NET SALES, in such
country(ies), of PRODUCTS; and (ii) if CELGENE and CMCC are
COOPERATING in any country(ies) with regard to PRODUCTS for use
in animals pursuant to Section 3.3(b) of this
Agreement,.........of the royalty income paid by SUBLICENSEES
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to CELGENE on NET SALES in such country(ies) of such PRODUCTS;
and (iii) if CELGENE and CMCC are COOPERATING in the United
States with regard to PRODUCTS for ophthalmologic use pursuant to
Section 3.4 of this Agreement,.........of the royalty income paid
by SUBLICENSEES to CELGENE on NET SALES in the United States of
such PRODUCTS for such use.
4.3 Later-Issued VALID CLAIM. In the event that there is no ISSUED VALID
CLAIM of a PATENT RIGHT in a country within the TERRITORY on the date
the twelve (12) year period provided for in Section 4.1(a) of this
Agreement expires, no royalties shall be owed by CELGENE under Sections
4.1(b) and 4.2 of this Agreement on PRODUCTS sold by CELGENE or its
AFFILIATES or SUBLICENSEES in such country; provided, however, that if
a VALID CLAIM of a PATENT RIGHT thereafter issues in such country,
CELGENE shall thereafter pay to CMCC ......... of, and shall pay to
BIOVENTURE ......... of, royalties on the NET SALES in such country of
PRODUCTS covered by such ISSUED VALID CLAIM of the PATENT RIGHTS that
are sold by CELGENE or its AFFILIATES or SUBLICENSEES, according to the
royalty rates set forth in Sections 4.1(b) and 4.2 of this Agreement,
and such royalties under this Section 4.3 shall be payable until the
last to expire PATENT RIGHT containing an ISSUED VALID CLAIM covering
the PRODUCTS sold by CELGENE or its AFFILIATES or SUBLICENSEES in such
country.
4.4 No Multiple Royalties. No multiple royalties shall be payable because
any PRODUCT, its manufacture, use, importation, lease, offer for sale
or sale is or shall be covered by more than one PATENT RIGHT.
-25-
4.5 Milestone Payment. CELGENE will, at its own expense, timely pay to CMCC
a milestone payment of ......... upon the first filing, after the
EFFECTIVE DATE, of a Product License Application, NDA or supplemental
NDA in the United States for a PRODUCT for any indication, unless such
milestone payment has otherwise been paid by CELGENE pursuant to
Section 8.2(e) hereof.
4.6 THIRD PARTY Sales. In any country where sales by a THIRD PARTY of a
PRODUCT(s) for a similar dosage form and/or route of administration
(except where sales by a THIRD PARTY are made pursuant to a sublicense
from CELGENE):
(a) are equal to or greater than ......... of the dollar market share
for such PRODUCT in such country ("MARKET SHARE"), but less than
......... of the MARKET SHARE, then the royalty payable to CMCC
and BIOVENTURE pursuant to Sections 4.1 and 4.3 of this Agreement
in respect of such country shall be reduced by ......... ;
(b) are equal to or greater than ......... of the MARKET SHARE, but
less than ......... of the MARKET SHARE, then the royalty payable
to CMCC and BIOVENTURE pursuant to Sections 4.1 and 4.3 of this
Agreement in respect of such country shall be reduced by
......... ;
(c) are equal to or greater than ......... of the MARKET SHARE, but
less than ......... of the MARKET SHARE, then the royalty payable
to CMCC and BIOVENTURE pursuant to set Sections 4.1 and 4.3 of
this Agreement in respect of such country shall be reduced by
.........; and
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(d) are equal to or greater than ......... of the MARKET SHARE, then
the royalty payable to CMCC and BIOVENTURE pursuant to Sections
4.1 and 4.3 of this Agreement in respect of such country shall be
reduced by .........;
provided that, with respect to (a), (b), (c) and/or (d) above,
royalties payable to CMCC and BIOVENTURE in respect of any country,
based on NET SALES by CELGENE or its AFFILIATES in such country, shall
never be reduced below ......... of NET SALES in each royalty bracket.
For purposes of this Section 4.6, oral dosage forms shall include,
without limitation, all capsule, caplet, tablet, and liquid
formulations for oral administration.
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 ......... or more, which
-27-
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 .........
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.
-28-
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
(f) Names and addresses of all SUBLICENSEES of CELGENE.
SECTION 5 - CONFIDENTIALITY
5.1 Confidential Information. During the term of this Agreement, it is
contemplated that each of CMCC, CELGENE, ENTREMED and BIOVENTURE (the
"disclosing party") may disclose to the other(s) proprietary and
confidential technology, inventions, technical information, material,
reagents, biological materials and the like, and any other information
which is deemed to be confidential pursuant to this Agreement, which
are owned or controlled by the disclosing party or which the disclosing
party is obligated to
-29-
maintain in confidence and which is designated by the disclosing party
as confidential ("CONFIDENTIAL INFORMATION"). Each of CMCC, CELGENE,
ENTREMED and BIOVENTURE agrees (a) not to disclose the disclosing
party's CONFIDENTIAL INFORMATION to any other person or entity,
including THIRD PARTIES, other than its AFFILIATES, agents,
representatives and employees, and (b) to maintain the disclosing
party's CONFIDENTIAL INFORMATION in strict confidence, to cause all of
its AFFILIATES, agents, representatives and employees to maintain the
disclosing party's CONFIDENTIAL INFORMATION in confidence and not to
disclose any such CONFIDENTIAL INFORMATION to a THIRD PARTY without the
prior written consent of the disclosing party, and not to use such
CONFIDENTIAL INFORMATION for any purpose other than as provided under
this Agreement. The secrecy obligations of the parties with respect to
CONFIDENTIAL INFORMATION shall continue for a period ending ten (10)
years from the termination of this Agreement.
5.2 Non-Confidential Information. The obligations of confidentiality will
not apply to information that:
(a) was known to the receiving party or generally known to the public
prior to its disclosure hereunder through no fault of the
disclosing party or any agent, representative or employee
thereof; or
(b) subsequently becomes known to the public by some means other than
a breach of this Agreement, including publication and/or laying
open to inspection of any patent applications or patents;
-30-
(c) is subsequently disclosed to the receiving party by a THIRD PARTY
having a lawful right to make such disclosure and who is not
under an obligation of confidentiality to the disclosing party;
(d) is required by law, rule, regulation or bona fide legal process
to be disclosed, to the extent so required, provided that the
party wishing to make such disclosure takes all reasonable steps
to restrict and maintain confidentiality of such disclosure and
provides reasonable notice to the disclosing party; or
(e) is approved for release by the parties.
5.3 Disclosure To THIRD PARTIES. The obligations of Section 5.1
notwithstanding,
(a) CELGENE may disclose CONFIDENTIAL INFORMATION disclosed to it
hereunder to THIRD PARTIES:
(i) who need to know the same in order to obtain regulatory
approval for a PRODUCT under this Agreement,
(ii) who need to know the same in order to work towards the
commercial development of PRODUCT(s) on behalf of CELGENE,
provided that, with respect to (i) and (ii) above, such THIRD
PARTIES are bound by obligations of confidentiality and non-use
at least as stringent as those set forth herein; and
(b) each party hereto may disclose CONFIDENTIAL INFORMATION disclosed
to it hereunder to a THIRD PARTY to the extent such disclosure is
required by any applicable laws or the rules or regulations of
any applicable securities exchange or quotation system or market.
-31-
5.4 Disclosure To Sublicensees and CMCC ROYALTY PURCHASER(S). CELGENE may
disclose CMCC's CONFIDENTIAL INFORMATION to an actual or potential
SUBLICENSEE without CMCC's consent, provided that such actual or
potential SUBLICENSEES are bound by obligations of confidentiality and
non-use at least as stringent as those set forth herein. CMCC may
disclose to actual and potential CMCC ROYALTY PURCHASERS the following
information without CELGENE's, ENTREMED's or BIOVENTURE's consent,
provided that such CMCC ROYALTY PURCHASERS first agree in writing to be
bound by obligations of confidentiality and non-use at least as
stringent as those set forth herein: (a) this Agreement, including any
amendments thereto, and the Consents (as defined in Section 5.5); (b)
information disclosed to CMCC pursuant to Section 4 hereof; (c)
information disclosed to CMCC pursuant to Sections 2.3 and 2.4(b)
hereof; and (d) any notices provided to CMCC pursuant to the
requirements of this Agreement, and the disclosures of (a) through (d)
above may include without limitation any CONFIDENTIAL INFORMATION
contained therein.
5.5 Public Statements. Neither CELGENE, BIOVENTURE, ENTREMED, CMCC nor any
CMCC ROYALTY PURCHASER(S) may issue a public statement, including
without limitation a press release, with regard to (1) this Agreement,
(2) the CMCC Acknowledgment and Consent made and entered into August
__, 2001 by and among CMCC, ENTREMED and BIOVENTURE, or (3) the Celgene
Acknowledgment and Consent made and entered into as of August __, 2001
by and among CELGENE, ENTREMED and BIOVENTURE ((2) and (3), together,
the "Consents") without the prior written consent of the other parties,
which consent in any case shall not be
-32-
unreasonably withheld; provided that (a) to the extent required by any
applicable law, including without limitation any applicable securities
law or the rules or regulations of any applicable securities exchange
or quotation system or market or any legal or administrative
proceeding, any of CELGENE, BIOVENTURE, ENTREMED, CMCC or the CMCC
ROYALTY PURCHASER(S), may make public statements or otherwise disclose
the matters covered by this Agreement or the Consents and (b) nothing
herein shall prohibit any party hereto or the CMCC ROYALTY
PURCHASER(S), or any of their respective AFFILIATES, from disclosing
such party's (or the CMCC ROYALTY PURCHASER's, as applicable) royalty
interest hereunder (1) to any of their respective AFFILIATES, agents,
representatives and employees, (2) in any annual or other periodic
corporate report, (3) to any financing sources (whether equity or debt)
and its legal, financial and industry advisors, or (4) to any actual or
potential underwriter, and its legal, accounting and industry advisors,
in connection with securing financing. In accordance with the rules and
regulations promulgated by the Securities and Exchange Commission, if
this Agreement is required to be filed by any party hereto or by the
CMCC ROYALTY PURCHASER(S), the filing party will request that this
Agreement be treated as confidential to the maximum permissible extent.
SECTION 6 - ADVERSE MEDICAL EXPERIENCES
6.1 Adverse Medical Experience Reporting. CELGENE shall comply fully with
all applicable medical/adverse experience reporting requirements in all
countries where CELGENE intends to carry out clinical trials and/or
market PRODUCT.
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SECTION 7 - PATENTS
7.1 Patent Prosecution
------------------
(a) THALIDOMIDE PATENT RIGHTS.
--------------------------
(1) By CELGENE. CELGENE shall have the right, but not the
obligation, to prepare, file, prosecute and maintain the
THALIDOMIDE PATENT RIGHTS, at CELGENE's sole expense,
through patent counsel selected by CELGENE and reasonably
acceptable to CMCC. CELGENE agrees to ADVISE CMCC and
BIOVENTURE with respect thereto. For purposes of this
Section 7, to "ADVISE" shall mean to provide copies of all
substantive documents received from or filed in any patent
office, including without limitation copies of each patent
application, office action, response to office action,
declaration, information disclosure statement, request for
terminal disclaimer, request for patent term extension and
request for reissue or reexamination.
(2) By CMCC. In the event that CELGENE decides not to prepare,
file, prosecute and/or maintain any of the THALIDOMIDE
PATENT RIGHTS in any country(ies) or region(s) in the
TERRITORY, CELGENE shall notify CMCC and BIOVENTURE
promptly, and in any event in sufficient time for CMCC to
preserve its rights thereunder, and (a) any rights granted
to CELGENE in and to such THALIDOMIDE PATENT
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RIGHTS, in the relevant country or region in the TERRITORY,
shall terminate; (b) CELGENE shall have no obligation to pay
for any costs incurred after the receipt of such notice by
CMCC in connection with the preparation, filing, prosecution
or maintenance of any such THALIDOMIDE PATENT RIGHTS in the
relevant country or region in the TERRITORY; and (c) CMCC
shall thereafter have the sole right, but not the
obligation, to prepare, file, prosecute and/or maintain such
THALIDOMIDE PATENT RIGHTS in such country(ies) or region(s)
in the TERRITORY, at CMCC's sole expense. CMCC agrees to
ADVISE BIOVENTURE with respect thereto.
(3) By BIOVENTURE. In the event that CMCC decides not to
prepare, file, prosecute and/or maintain any of the
THALIDOMIDE PATENT RIGHTS in any country(ies) or region(s)
in the TERRITORY, CMCC shall notify BIOVENTURE promptly, and
in any event in sufficient time for BIOVENTURE to preserve
its economic rights hereunder, CMCC shall have no obligation
to pay for any costs incurred after the receipt of such
notice by BIOVENTURE in connection with the preparation,
filing, prosecution or maintenance of any such THALIDOMIDE
PATENT RIGHTS in the relevant country or region in the
TERRITORY; and BIOVENTURE shall thereafter have the sole
right, but not the obligation, to prepare, file, prosecute
and/or maintain such THALIDOMIDE PATENT RIGHTS in such
country(ies) or region(s) in the TERRITORY, at BIOVENTURE's
sole expense, using patent counsel selected by
-00-
XXXXXXXXXX and reasonably acceptable to CMCC. BIOVENTURE
agrees to ADVISE CMCC with respect thereto.
-36-
(b) MIXED PATENT RIGHTS.
--------------------
(1) By ENTREMED. Subject to Section 7.1(b)(2), ENTREMED shall
have the sole right, but not the obligation, to prepare,
file, prosecute and maintain the MIXED PATENT RIGHTS, at
ENTREMED's sole expense, through patent counsel selected by
ENTREMED and reasonably acceptable to CELGENE and CMCC.
ENTREMED shall ADVISE CMCC with respect to any MIXED PATENT
RIGHTS, and shall ADVISE BIOVENTURE with respect to any
MIXED PATENT THALIDOMIDE CLAIMS.
(2) Cooperation on MIXED PATENT THALIDOMIDE CLAIMS. Whichever
parties are prosecuting the THALIDOMIDE PATENT RIGHTS and
the MIXED PATENT RIGHTS, respectively, shall consult with
each other in good faith regarding the preparation, filing,
prosecution and maintenance of all MIXED PATENT THALIDOMIDE
CLAIMS, and, to the extent necessary to accomplish same, the
MIXED PATENT RIGHTS, including without limitation the
content, timing and jurisdiction of the filing of
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same. A copy of each document or a draft thereof pertaining
to the preparation, filing, prosecution, or maintenance of
each MIXED PATENT THALIDOMIDE CLAIM, including but not
limited to each patent application, office action, response
to office action, declaration, information disclosure
statement, request for terminal disclaimer, request for
patent term extension and request for reissue or
reexamination of any MIXED PATENT RIGHTS, to the extent
MIXED PATENT THALIDOMIDE CLAIMS are or may be affected,
shall be provided to the party prosecuting the MIXED PATENT
THALIDOMIDE CLAIMS as follows: documents received from any
patent office and/or counsel's analysis thereof shall be
provided promptly after receipt; and drafts of all documents
to be filed in any patent office shall be provided
sufficiently prior to their filing deadlines to allow for
review and comment by the party(ies) prosecuting the
THALIDOMIDE PATENT RIGHTS, which comments the party(ies)
prosecuting the MIXED PATENT RIGHTS shall incorporate in
good faith. In order to protect its commercial interests,
the party(ies) prosecuting the THALIDOMIDE PATENT RIGHTS may
request that certain MIXED PATENT THALIDOMIDE CLAIMS be
prepared, filed, prosecuted, and/or maintained, or that such
steps be undertaken in certain countries or regions in the
TERRITORY, and patent counsel of the relevant party(ies)
prosecuting the MIXED PATENT RIGHTS shall follow such
request, at a cost to be shared by the parties on a basis to
be determined in good faith by such parties, taking into
account
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the relative commercial value of such MIXED PATENT
THALIDOMIDE CLAMS to each. ENTREMED or, in accordance with
Section 7.1(b)(4), CMCC, shall have the right to take any
action that, in its judgment, is necessary to preserve any
claims of any MIXED PATENT RIGHTS that are not MIXED PATENT
THALIDOMIDE CLAIMS. In the event that information relating
to the prosecution of MIXED PATENT RIGHTS generally, and not
solely to the MIXED PATENT THALIDOMIDE CLAIMS, is provided
to the party(ies) prosecuting the THALIDOMIDE PATENT RIGHTS
pursuant to this Section 7.1(b)(2), ENTREMED or CMCC, as the
case may be, may require that the party(ies) prosecuting the
THALIDOMIDE PATENT RIGHTS limit disclosure of such
information, as it relates to MIXED PATENT RIGHTS generally,
to such party's outside counsel, and such party agrees to do
so, unless otherwise agreed by the parties.
(3) By CELGENE. In the event that ENTREMED decides not to
prepare, file, prosecute and/or maintain any MIXED PATENT
THALIDOMIDE CLAIM(s) in any country(ies) or region(s) in the
TERRITORY, ENTREMED shall notify CELGENE and CMCC promptly,
and in any event in sufficient time for CELGENE and CMCC to
preserve their rights hereunder, and: (a) any rights granted
to ENTREMED pursuant to the NEW ANALOG AGREEMENT in and to
such MIXED PATENT
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THALIDOMIDE CLAIMS, in the relevant country or region in the
TERRITORY, shall terminate; and (b) CELGENE shall thereafter
have the sole right, but not the obligation, to prepare,
file, prosecute and/or maintain such MIXED PATENT
THALIDOMIDE CLAIM(s) in such country(ies) or region(s) in
the TERRITORY, at CELGENE's sole expense, and shall ADVISE
CMCC and BIOVENTURE with respect thereto.
(4) By CMCC. In the event that CELGENE decides not to prepare,
file, prosecute and/or maintain any of the MIXED PATENT
THALIDOMIDE CLAIMS in any country(ies) or region(s) in the
TERRITORY, or in the event that ENTREMED decides not to
prepare, file, prosecute and/or maintain any of the MIXED
PATENT RIGHTS that are not MIXED PATENT THALIDOMIDE CLAIMS,
CELGENE or ENTREMED, as the case may be, shall notify CMCC
and, in the case of MIXED PATENT THALIDOMIDE CLAIMS only,
BIOVENTURE, promptly, and in any event in sufficient time
for CMCC to preserve its rights thereunder, and: (a) any
rights granted to CELGENE in and to such MIXED PATENT
THALIDOMIDE CLAIMS, or, any rights granted to ENTREMED in
and to such MIXED PATENT RIGHTS, as the case may be, in the
relevant country or region in the TERRITORY, shall
terminate; (b) CELGENE or
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ENTREMED, as the case may be, shall have no obligation to
pay for any costs incurred after the receipt of such notice
by CMCC in connection with the preparation, filing,
prosecution or maintenance of any such MIXED PATENT
THALIDOMIDE CLAIMS and/or MIXED PATENT RIGHTS in the
relevant country or region in the TERRITORY; and (c) CMCC
shall thereafter have the sole right, but not the
obligation, to prepare, file, prosecute and/or maintain such
MIXED PATENT THALIDOMIDE CLAIMS and/or MIXED PATENT RIGHTS
in such country(ies) or region(s) in the TERRITORY, at
CMCC's sole expense. CMCC shall ADVISE BIOVENTURE with
respect thereto.
(5) By BIOVENTURE. In the event that CMCC decides not to
prepare, file, prosecute and/or maintain any of the MIXED
PATENT THALIDOMIDE CLAIMS in any country(ies) or region(s)
in the TERRITORY, CMCC shall notify BIOVENTURE promptly, and
in any event in sufficient time for BIOVENTURE to preserve
its economic rights hereunder, CMCC shall have no obligation
to pay for any costs incurred after the receipt of such
notice by BIOVENTURE in connection with the preparation,
filing, prosecution or maintenance of any such MIXED PATENT
THALIDOMIDE CLAIMS in the relevant country or region in the
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TERRITORY; and BIOVENTURE shall thereafter have the sole
right, but not the obligation, to prepare, file, prosecute
and/or maintain such MIXED PATENT THALIDOMIDE CLAIMS in such
country(ies) or region(s) in the TERRITORY, at BIOVENTURE's
sole expense. BIOVENTURE shall ADVISE CMCC with respect
thereto.
(c) Change In Status of Patent Rights. In the event that, during the
course of prosecution in accordance with this Section 7.2, any
patent application within the MIXED PATENT RIGHTS becomes a
patent application within the THALIDOMIDE PATENT RIGHTS, or vice
versa, the parties agree to promptly notify each other, and to
cooperate in good faith to preserve the rights of the parties
thereunder and to effectuate the foregoing provisions.
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
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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
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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
-44-
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
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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.
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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
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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
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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
-49-
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-
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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
-51-
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.
7.7 THIRD PARTY Royalty Reduction. In the event that an infringement action
is brought by a THIRD PARTY against CELGENE alleging that CELGENE's
making, using, offering for sale, selling or importing of a PRODUCT
infringes a THIRD PARTY patent, and results in a judgment or settlement
requiring royalties to be paid by CELGENE to such THIRD PARTY, the
royalties owed by CELGENE to CMCC and BIOVENTURE under Section 4 of
this Agreement shall be reduced pro rata by an amount equal to
......... of the royalties owed to such THIRD PARTY, provided that the
royalties owed to CMCC and BIOVENTURE shall not be reduced under this
Section 7.7 to less than ......... of NET SALES, nor shall any specific
royalty payment be reduced under this Section 7.7 by more than.........
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SECTION 8 - REPRESENTATIONS AND WARRANTIES
8.1 Each party hereby represents and warrants that each has the full right
and authority to enter into this Agreement and that the entry into this
Agreement does not require the consent of a THIRD PARTY whose consent
has not been obtained.
8.2 CELGENE hereby represents and warrants to CMCC as follows:
(a) Prior to the EFFECTIVE DATE, the CELGENE SUBLICENSE contained all
of the understandings and agreements between CELGENE and ENTREMED
with respect to the subject matter thereof, and, prior to the
EFFECTIVE DATE, the CELGENE SUBLICENSE was in existence in full
force and effect. There are no written amendments or
modifications in effect with respect to the CELGENE SUBLICENSE.
(b) CELGENE has no actual knowledge of any legal claims asserted by
any third parties against CELGENE relating to the PRODUCTS, other
than any product liability claims for which CELGENE has adequate
insurance.
(c) Except as previously disclosed to CMCC, CELGENE has not actually
received any written notice that it is in violation of any
governmental law or regulation applicable to the sale of the
PRODUCTS, and does not believe that there are valid grounds for
any claim of any such violation.
(d) CELGENE confirms that, to its knowledge, all of ENTREMED's
obligations under Sections 2.4, 2.5, 2.7(c) and 3.1(c), and the
first sentence of Section 2.6 of the CELGENE SUBLICENSE have been
fully performed and satisfied prior to the date hereof and that
ENTREMED has no further obligations under such sections.
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(e) CELGENE agrees that it shall pay directly to CMCC any milestone
payment that would have been due to ENTREMED, pursuant to Section
2.7(d) of the CELGENE SUBLICENSE, for the milestone payment
described therein if such milestone payment was reached after
December 8, 1998 but before the Effective Date of this Agreement,
it being understood that if such milestone is reached after the
Effective Date hereof, such milestone shall be payable to CMCC
pursuant to Section 4.5 hereof.
(f) No right of off-set pursuant to Section 7.3(g) of the CELGENE
SUBLICENSE has been asserted by CELGENE under the CELGENE
SUBLICENSE .
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
-54-
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
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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
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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).
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SECTION 13 - ASSIGNMENT AND SUCCESSORS
13.1 By Any Party. This Agreement shall not be assignable by CELGENE, CMCC,
ENTREMED or BIOVENTURE without the prior written consent of the other
parties to this Agreement, except that (a) CELGENE, CMCC, ENTREMED
and/or BIOVENTURE may assign this Agreement to an AFFILIATE, successor
in interest or transferee of all or substantially all of the portion of
the business to which this Agreement relates without the consent of any
other party; and (b) CMCC may assign its right, title and interest to
certain payments due to CMCC pursuant to Section 4 of this Agreement to
the CMCC ROYALTY PURCHASER(S) provided that such CMCC ROYALTY PURCHASER
first agrees in writing to be bound by the terms and conditions of
Section 5 hereof as they apply to CMCC. Notwithstanding the foregoing,
nothing contained herein shall prevent CMCC, the CMCC ROYALTY PURCHASER
or BIOVENTURE from assigning, pledging or otherwise encumbering any of
their respective rights to receive payments hereunder (but not any
other rights or any obligations hereunder) in connection with any
financing of CMCC, the CMCC ROYALTY PURCHASERS or BIOVENTURE, as
applicable, by a financial institution regularly engaged in the
business of providing financing. In the event that CMCC assigns such
rights to the CMCC ROYALTY PURCHASER(s), CMCC shall be solely
responsible for delivery to and distribution among any CMCC ROYALTY
PURCHASERS of any payments so assigned. CELGENE shall not have any
liability with respect to any aspect of the delivery to or distribution
among any CMCC ROYALTY PURCHASER(S) of any payments due to CMCC
hereunder, and delivery to CMCC, in accordance with the terms and
conditions of this Agreement, of any payments due hereunder by CELGENE
to CMCC shall satisfy in
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full any obligations CELGENE may have to CMCC and/or the CMCC ROYALTY
PURCHASERS with respect thereto. Each CMCC ROYALTY PURCHASER shall be
able to exercise certain of the rights of CMCC under Section 4 of this
Agreement to the extent provided in the agreement between CMCC and such
CMCC ROYALTY PURCHASER, and shall be considered an assignee of such
rights of CMCC for such purposes, provided that, cumulatively, CMCC and
any CMCC ROYALTY PURCHASERS may conduct no more than one (1) inspection
pursuant to Section 4.7 hereof in any consecutive twelve (12) month
period. Any attempted assignment in violation of this Section 13.1
shall be null, void and of no effect.
13.2 Satisfaction of Obligations. Performance or satisfaction of any
obligations of CELGENE under this Agreement by any of its AFFILIATES or
SUBLICENSEES shall be deemed performance or satisfaction of such
obligation by CELGENE.
13.3 Binding Effect. This agreement shall be binding upon and inure to the
benefit of said successors in interest and permitted assignees to the
parties. Any such successor or assignee of a party's interest shall
expressly assume in writing the performance of all the terms and
conditions of this Agreement to be performed by said party and such
Assignment shall not relieve the Assignor of any of its obligations
under this Agreement.
SECTION 14 - FORCE MAJEURE
14.1 None of the parties shall be liable to any other party for damages or
loss occasioned by failure of performance by the defaulting party if
the failure is occasioned by war, fire,
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explosion, flood, strike or lockout, embargo, or any similar cause
beyond the control of the defaulting party, provided that the party
claiming this exception has exerted all reasonable efforts to avoid or
remedy such event and provided such event does not extend for more than
six (6) months.
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
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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.
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(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");
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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
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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
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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
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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.........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.........of
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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.
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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.
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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
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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
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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.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK.]
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IN WITNESS WHEREOF, the parties have executed this Agreement as of the date set
forth above.
CELGENE CORPORATION
By: ______________________________
Name: ____________________________
Title: _____________________________
CHILDREN'S MEDICAL CENTER
CORPORATION
By: ______________________________
Name: ____________________________
Title: _____________________________
BIOVENTURE INVESTMENTS KFT
By: ______________________________
Name: ____________________________
Title: _____________________________
ENTREMED, INC.
(Solely for purposes of Sections
2.2.5, 2.7, 5, 7, 8.1, 12, 13, 15.2,
15.7, 15.9 and 16)
By: ______________________________
Name: ____________________________
Title: _____________________________
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