License Agreement - Children's Medical Center Corp. and EntreMed Inc.
LICENSE AGREEMENT
This Agreement is made and entered into this _____ day December, 1996
(the Effective Date), by and between 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 300 Longwood Avenue, Boston,
Massachusetts, 02115, U.S.A. (hereinafter referred to as CMCC), and ENTREMED,
INC., a corporation duly organized under the laws of Maryland and having its
principal office at 9610 Medical Center Drive, Suite 200, Rockville, MD 20850
(hereinafter referred to as LICENSEE).
WITNESSETH
WHEREAS, CMCC is the owner of certain "Patent Rights" (as later
defined herein) relating to CMCC Case No. 474, "Endostatin, An Inhibitor of
Angiogenesis" (US. Patent Applications listed in Exhibit A attached hereto) and
has the right to grant licenses under said Patent Rights;
WHEREAS, CMCC desires to have the Patent Rights utilized in the public
interest and is willing to grant a license thereunder;
WHEREAS, LICENSEE has represented to CMCC, to induce CMCC to enter
into this Agreement, that LICENSEE is capable of the development, production,
manufacture, marketing and sale of products similar to the "Licensed
Product(s)" (as later defined herein) and/or the use of the "Licensed
Process(es)" (as later defined herein) and that it shall commit itself to a
thorough, vigorous and diligent program of exploiting the Patent Rights so that
public utilization shall result therefrom; and
WHEREAS, LICENSEE desires to obtain a license under the Patent Rights
upon the terms and conditions hereinafter set forth.
NOW, THEREFORE, in consideration of the premises and the mutual
covenants herein, the parties hereto agree as follows:
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ARTICLE I - DEFINITIONS
For the purpose of this Agreement, the following words and phrases
shall have the following meanings:
1.1 "LICENSEE" shall mean EntreMed, Inc. and any Subsidiary or joint
venture of EntreMed, Inc.
1.2 "Sublicensee" shall mean any corporation, partnership or business
organization which is not controlled directly or indirectly by
LICENSEE but to whom LICENSEE transfers know-how, rights or products
to enable said party to sell Licensed Products and/or Licensed
Processes.
1.3 "Subsidiary" shall mean any corporation, company or other entity more
than fifty percent (50%) of whose voting stock is owned or controlled
directly or indirectly by LICENSEE
1.4 "Patent Rights" shall mean all of the following CMCC intellectual
property:
1.4.1. The United States and foreign patents and/or patent
applications listed in AppendixEA;
1.4.2. United States and foreign patents issued from the applications
listed in Appendix A and from divisionals and continuations of
these applications;
1.4.3. Claims of U.S. and foreign continuation-in-part applications,
and of the resulting patents, which are directed to subject
matter specifically described in the U.S. and foreign
applications listed in Appendix A;
1.4.4. Claims of all later filed foreign patent applications, and of
the resulting patents, which are directed to subject matter
specifically described in the United States patent and/or
patent applications described in (a), (b), or (c) above;
1.4.5. Any reissues of United States patents described in (a), (b),
(c), or (d) above.
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1.5 A "Licensed Product" shall mean any product or part thereof which:
1.5.1. Is covered in whole or in part by an issued, unexpired claim
or a pending claim contained in the Patent Rights in the
country in which any Licensed Product is made, used, or sold;
1.5.2. Is manufactured by using a process which is covered in whole
or in part by an issued, unexpired claim or a pending claim
contained in the Patent Rights in the country in which any
Licensed Process is used or in which the Licensed Product is
used or sold.
1.6 A "Licensed Process" shall mean any process which is covered in whole
or in part by an issued, unexpired claim or a pending claim contained
in the Patent Rights.
1.7 "Net Sales" shall mean the gross amount invoiced for all sales of
Licensed Products by LICENSEE, its Subsidiaries or its Sublicensees
less:
1.7.1. trade, quantity and cash discounts, allowed, incurred or
actually taken;
1.7.2. sales taxes directly related to the sale to the extent
included in the gross invoice price;
1.7.3. the portion of freight, postage and shipping insurance
expenses paid by LICENSEE;
1.7.4. value added tax, sales or turnover tax, or excise taxes or
duties which are included in said invoiced amount;
1.7.5. rebates accrued, incurred or paid to Federal Medicaid or State
Medicare and amounts exactly repaid or credited by reason of
rejections or the return of Licensed Products (due to recalls,
dating or other reasons) and retroactive deductions; and
1.7.6. cost of export licenses and any taxes, fees or other charges
associated with the exportation or importation of Licensed
Products.
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1.7.7 No deductions shall be made for commissions paid to
individuals employed by LICENSEE and on its payroll, or for
the cost of collections.
1.7.8 Licensed Products shall be considered "sold" when billed out or
invoiced.
ARTICLE II - GRANT OF LICENSE
2.1 CMCC hereby grants to LICENSEE the exclusive worldwide right and
license to make, have made, use, lease and sell the Licensed Products,
and to practice the Licensed Processes to the end of the term for
which the Patent Rights are granted unless sooner terminated according
to the terms hereof. CMCC shall retain a royalty-free, nonexclusive,
irrevocable license to practice the Patent Rights for research
purposes only.
2.2 LICENSEE agrees that it will use its best efforts to manufacture
substantially in the United States the Licensed Products leased or
sold in the United States.
2.3 To establish exclusivity for LICENSEE, CMCC hereby agrees that it
shall not grant any other license to make, have made, use, lease
and/or sell Licensed Products or to utilize Licensed Processes during
the period of time in which this Agreement is in effect.
2.4 LICENSEE shall have the right to enter into sublicensing agreements
for the rights, privileges, and licenses granted hereunder. Such
sublicenses will expire upon the expiration of LICENSEE's rights
granted herein.
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2.5 LICENSEE agrees that any sublicense granted by it shall provide that
the obligations to CMCC of Articles II, V, VII, VIII, IX, X, XII,
XIII, and XV of this Agreement shall be binding upon the sublicensee
as if it were a party to this Agreement. LICENSEE further agrees to
attach copies of these Articles to sublicense agreements. Further,
LICENSEE 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 LICENSEE'S exclusive rights, privileges and
license hereunder shall terminate.
2.6 LICENSEE agrees to forward to CMCC a copy of any and all fully
executed sublicense agreements, and further agrees to forward to CMCC
annually a copy of such reports received by LICENSEE 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.
2.7 LICENSEE 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.
2.8 The license granted hereunder shall not be construed to confer any
rights upon LICENSEE by implication, estoppel or otherwise as to any
technology not specifically set forth in Appendix A hereof.
2.9 LICENSEE agrees, to the best of its ability, to adhere to Public Laws
96-517 and 98-620.
ARTICLE III - DUE DILIGENCE
3.1 LICENSEE shall use its best efforts to bring one or more Licensed
Products or Licensed Processes to market through a thorough, vigorous
and diligent program for exploitation of the Patent Rights.
Thereafter, LICENSEE agrees that until expiration or termination of
this Agreement, LICENSEE shall continue active and diligent efforts to
keep Licensed Products and/or Licensed Processes reasonably available
to the public. CMCC agrees that LICENSEE
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shall have complete control of all regulatory submissions of Licensed
Products to the appropriate regulatory agencies worldwide. In the
event LICENSEE decides not to exploit a licensed Patent Right, it
shall promptly inform CMCC in writing and shall surrender to CMCC its
license to that Patent Right. Only one payment will be made for each
of the milestones recited under 3.1.1, 3.1.2, 3.1.3 and 3.1.4. Due
diligence shall be demonstrated by attaining the following milestones:
3.1.1 -within 5 years of the Effective Date, the filing of an IND in
the U.S. for a Licensed Product by LICENSEE;
3.1.2 -within 6.5 years of the Effective Date, the initiation of
Phase II trials of a Licensed Product;
3.1.3 -within 8.5 years of the Effective Date, the initiation of
Phase III trials of a Licensed Product; and
3.1.4 -within 11 years of the Effective Date, the submission of an
NDA or similar application to gain regulatory approval for the
marketing of a Licensed Product; and by continuing sponsorship
of related preclinical studies at Children's Hospital, if
appropriate.
3.2 LICENSEE acknowledges that, prior to attaining the first milestone of
3.1.1 above, additional activities must be undertaken including but
not limited to: 1) development of a plan describing the scientific
and technical goals to be accomplished prior to attaining the
milestone of 3.1.1 and allocation the LICENSEE resources, either
internal or contracted, that will be applied in accomplishing those
goals, 2) confirmation of the antitumor activity of one or more
Licensed Products in one or more animal models, 3) development of
processes for manufacturing one or more Licensed Products on a scale
capable of producing sufficient material for testing and evaluation,
4) conduct of preclinical toxicology and pharmacology studies, and 4)
determination of whether Licensee or a sublicense will be initiating
clinical trials. Licensee agrees to keep CMCC reasonable informed of
the additional activities by preparing at least annually a
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written summary of the activities planned and completed and by
holding on at least annually a meeting with CMCC representatives to
review progress to date.
3.3 LICENSEE acknowledges that the primary objective of CMCC in entering
this License Agreement is to promote the development and marketing of
Licensed Products and Processes for the public good. To this end, CMCC
shall have the right to terminate this Agreement pursuant to Paragraph
13.3 below if LICENSEE fails to attain any of the above milestones for
more than six (6) months after the milestone time period because of
business circustances such as merger, acquisition or the like.
However, if LICENSEE can demonstrate to the satisfaction of CMCC, at
CMCC's sole discretion, that circumstances beyond LICENSEE's control
precluded LICENSEE from fulfilling its diligence obligations, and that
it is unlikely that any third party could overcome these circumstances
better than LICENSEE, then CMCC shall not exercise its termination
rights under this Article for one year from the date on which CMCC
give notice of termination and if LICENSEE reestablishes diligence
towards it objectives during this one year period, any prior lack of
diligence will be deemed cured.
ARTICLE IV - PAYMENTS AND ROYALTIES
4.1 For the rights, privileges and license granted hereunder, LICENSEE
shall pay to CMCC in the manner hereinafter provided to the end of the
term of the Patent Rights or until this Agreement shall be terminated
as hereinafter provided, whether the milestones are achieved under the
sponsorship of LICENSEE or a sublicensee, the following milestone
payments totaling $1,000,000 (one million dollars):
4.1.1 -$50,000 (fifty thousand dollars) due four (4) months from the
date of execution of this Agreement;
4.1.2 -$100,000 (one hundred thousand dollars) due upon initiation
of the first Phase I/II IND (Investigational New Drug
application) clinical trials for any indication;
4.1.3 -$350,000 (three hundred and fifty thousand dollars) due upon
completion of a Phase II clinical trials for any indication;
and
4.1.4 -$500,000 (five hundred thousand dollars) due upon submission
of a PLA (Product License Application) or NDA (New Drug
Application) for any indication.
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The information below marked by [****] has been omitted pursuant to a request
for confidential treatment. The omitted portion has been seperately filed with
the Commission.
4.2 A royalty based on the Net Sales Price of the Licensed Products or
Licensed Processes used, leased or sold by LICENSEE or a joint venture
in which LICENSEE is involved, which said royalty shall be [****]
of Net Sales Price.
4.3 Where sublicenses have been granted or strategic partnerships entered
into, EntreMed shall pay to CMCC [****] of any and all sublicensing
payments. Sublicensing payments are defined as any and all payments
made to EntreMed by the Sublicensee or strategic partner except for
payments to support research and development conducted by EntreMed,
for purchases of equity or for payments for goods and services.
EntreMed shall pay to CMCC [****] of the royalty income paid to
EntreMed up to $100,000,000 of cumulative Net Sales of the Licensed
Product and, after $100,000,000 of cumulative Net Sales, EntreMed
shall pay to CMCC [****] of royalty payments to EntreMed from the
Sublicensee with a minimum of [****] of net sales of the Licensed
Product made by the Sublicensee.
4.4 No multiple royalties shall be payable because any Licensed Product,
its manufacture, use, lease or sale are or shall be covered by more
than one Patent Rights Patent Application or Patent Rights Patent
licensed under this Agreement.
4.5 Royalty payments shall be paid in United States dollars in Boston,
Massachusetts, or at such other place as CMCC may reasonably designate
consistent with the laws and regulations controlling in any foreign
country. If any currency conversion shall be required in connection
with the payment of royalties hereunder, such conversion shall be made
by using the exchange rate prevailing at the Bank of Boston on the
last business day of the calendar quarterly reporting period to which
such royalty payments relate.
ARTICLE V -- REPORTS AND RECORDS
5.1 LICENSEE shall keep full, true and accurate books of account
containing all particulars that may be necessary for the purpose of
showing the amounts payable to CMCC hereunder. Said books of account
shall be kept at LICENSEE's principal place of business or the
principal place of business of the appropriate Division of
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LICENSEE to which this Agreement relates. Said books and the
supporting data shall be open at all reasonable times for five (5)
years following the end of the calendar year to which they pertain, to
the inspection of CMCC or its agents for the purpose of verifying
LICENSEE's royalty statement or compliance in other respects with
this Agreement. CMCC can request auditing of said books and supporting
data no more than once each calendar year.
5.2. LICENSEE, within forty-five (45) days after the initial sale or
sublicense of the product on March 31, June 30, September 30 and
December 31, of each year, shall deliver to CMCC true and accurate
reports, giving such particulars of the business conducted by LICENSEE
and its sublicensees during the preceding three month period under
this Agreement as shall be pertinent to a royalty accounting
hereunder. These shall include at least the following:
5.2.1 Number of Licensed Products manufactured and sold.
5.2.2 Total billings for Licensed Products sold.
5.2.3 Accounting for all Licensed Products used or sold.
5.2.4 Deductions applicable as provided in Paragraph 1.7
5.2.5 Total royalties due.
5.2.6 Names and addresses of all sublicensees of LICENSEE.
5.3 With each such report submitted, LICENSEE shall pay to CMCC the
royalties due and payable under this Agreement. If no royalties shall
be due after the initial sublicense agreement or sale, LICENSEE shall
so report. On or before the ninetieth (90th) day following the close
of LICENSEE's fiscal year, LICENSEE shall provide CMCC with LICENSEE's
certified financial statements for the preceding fiscal year
including, at a minimum, a Balance Sheet and an Operating Statement.
5.4 The royalty payments set forth in this Agreement shall, if overdue,
bear interest until payment at a per annum rate of two percent (2%)
above the prime rate in effect at the Bank of Boston on the due date.
The payment of such interest shall not foreclose CMCC from exercising
any other rights it may have as a consequence of the lateness of any
payment.
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ARTICLE VI -- PATENT PROSECUTION
6.1 CMCC and LICENSEE shall apply for, seek prompt issuance of, and
maintain during the term of this Agreement the Patent Rights set forth
in Appendix A. The prosecution, filing and maintenance of all Patent
Rights Patents and Applications shall be the primary responsibility of
LICENSEE; with appropriate and timely review and approval by CMCC.
LICENSEE shall solicit CMCC's comment prior to any significant actions
required during filing, prosecution, and maintenance and provide CMCC
with drafts of proposed actions and responses in advance and file
copies after the action is completed. If CMCC elects to consult with
patent attorneys more than is considered necessary and reasonable by
LICENSEE, such consultation shall be at CMCCGs expense.
6.2 Payment of all fees and costs relating to the filing, prosecution, and
maintenance of the Patent Rights shall be the responsibility of
LICENSEE, whether such fees and costs were incurred before or after
the date of this Agreement.
ARTICLE VII - INFRINGEMENT
7.1 LICENSEE shall inform CMCC promptly in writing of any alleged
infringement of the Patent Rights by a third party and of any
available evidence thereof.
7.2 If at any time during the term of this Agreement, LICENSEE furnishes
to CMCC reasonably convincing written evidence of an infringement of a
patent included in the Patent Rights covering the Inventions which
adversely and substantially affects the commercial operations of
LICENSEE in the country where the infringement of the patent is
occurring, under the license granted hereunder, and CMCC shall within
three (3) months after receipt of such evidence (the three month
period) fail to cause such infringement to terminate or to bring a
suit or action to compel termination, then payment of one half (1/2)
the royalties and one half (1/2) minimum amounts which are earned and
payable to CMCC on Net Sales by licensee or sublicensees under Article
IV hereof shall be waived in the country of the infringement, so long
as such infringement continues; provided, however, that such royalties
and minimum amounts shall not be waived so long as at least one suit
or action is being prosecuted by CMCC for infringement of a patent in
the country in which the infringement of the patent is occurring,
covering the
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Inventions. In no event shall such waiver of royalties and minimum
amounts exceed 50% of the royalties and minimum amounts payable
hereunder.
7.3 If after the three month period, CMCC fails to cause such infringement
to terminate or to bring a suit or action to compel termination,
LICENSEE shall have the right, but not the obligation, to bring such
suit or action to compel termination at LICENSEE's expense. CMCC
independently shall have the right to join any such suit or action
brought by LICENSEE and, in such event. No settlement, consent
judgment or other voluntary final disposition of the suit may be
entered into without the consent of CMCC which consent shall not
unreasonably be withheld. Any damages recovered by suit or action
shall be first used to reimburse each party hereto for the cost of
such suit or action (including attorney's fees) actually paid by each
party hereto as the case may be, then to reimburse CMCC for any
royalties and minimum royalties waived under this Section 7.3 and the
residue, if any, shall be belong to the party responsible for the
prosecution of the suit.
7.4 In the event that LICENSEE shall undertake the enforcement and/or
defense of the Patent Rights by litigation, LICENSEE may withhold up
to fifty percent (50%) of the royalties otherwise thereafter due CMCC
hereunder and apply the same toward reimbursement of its expenses,
including reasonable attorneys' fees, in connection therewith. Any
recovery of damages by LICENSEE for any such suit shall be applied
first in satisfaction of any unreimbursed expenses and legal fees of
LICENSEE relating to the suit, next toward reimbursement of CMCC for
any royalties past due or withheld and applied pursuant to this
Article VII, and to royalties due to CMCC for infringing sales as if
sales had been made by LICENSEE. The balance remaining from any such
recovery shall belong to LICENSEE.
7.5 In the event that a declaratory judgment action alleging invalidity or
non-infringement of any of the Patent Rights shall be brought against
LICENSEE, CMCC, at its option, shall have the right, within thirty
(30) days after commencement of such action, to intervene and take
over the sole defense of the action at its own expense.
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7.6 If, for any reason, LICENSEE should choose not undertake the
enforcement and/or defense of the Patent Rights by litigation after
the three month period, CMCC shall have the right, but not the
obligation, to prosecute, at its own expense, any such infringements
of the Patent Rights and, in furtherance of such right, CMCC hereby
agrees that LICENSEE may join CMCC as a party plaintiff in any such
suit, without expense to LICENSEE. The total cost of any such
infringement action commenced or defended solely by CMCC shall be
borne by CMCC and CMCC shall keep any recovery or damages for past
infringement derived therefrom.
7.7 In any infringement suit as either party may institute to enforce the
Patent Rights pursuant to this Agreement, the other party hereto
shall, at the request and the expense of the party initiating such
suit, cooperate in all respects and, to the extent possible, have its
employees testify when requested and make available relevant records,
papers, information, samples, specimens, and the like.
7.8 LICENSEE, during the period of this Agreement, shall have the sole
right in accordance with the terms and conditions herein to sublicense
any alleged infringer for future use of the Patent Rights.
ARTICLE VIII - INDEMNIFICATION, PRODUCT LIABILITY AND INSURANCE
8.1. Indemnification
8.1.1 LICENSEE shall indemnify, defend and hold harmless CMCC and
its trustees, officers, medical and professional staff,
employees, and agents and their respective successors, heirs
and assigns (the "Indemnitees"), against any liability,
damage, loss or expense (including reasonable attorney's fees
and expenses of litigation) incurred by or imposed upon the
Indemnitees or any one of them in connection with any claims,
suits, actions, demands or judgments arising out of any theory
of product liability (including, but not limited to, actions
in the form of tort, warranty, or strict liability) concerning
any product, process or service made, used or sold pursuant to
any right or license granted under this Agreement.
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8.1.2 LICENSEE's indemnification under (a) above shall not apply to
any liability, damage, loss or expense to the extent that it
is directly attributable to the negligent activities, reckless
misconduct or intentional misconduct of the Indemnitees.
8.1.3 LICENSEE agrees, at its own expense, to provide attorneys
reasonably acceptable to CMCC to defend against any actions
brought or filed against any party indemnified hereunder with
respect to the subject of indemnity contained herein, whether
or not such actions are rightfully brought.
8.1.4 CMCC shall indemnify, defend and hold harmless Licensee for
any damage, loss or expense to the extent that it is directly
attributable to the negligent activities, reckless misconduct,
or intentional misconduct of the employees or subcontractors
of CMCC.
8.1.5 This Section 8.1 shall survive expiration or termination of
this Agreement.
8.2. Insurance
8.2.1 Beginning at the time as any such product, process or service
is being commercially distributed or sold (other than for the
purpose of obtaining regulatory approvals) by LICENSEE or by a
sublicensee, affiliate or agent of LICENSEE, LICENSEE shall,
at its sole cost and expense, procure and maintain
comprehensive general liability insurance in amounts not less
than $2,000,000 per incident and $2,000,000 annual aggregate
and naming the Indemnitees as additional insureds. Such
comprehensive general liability insurance shall provide
8.2.1.1 product liability coverage and
8.2.1.2 broad form contractual liability coverage for
LICENSEE's indemnification under Section 8.1 of this
Agreement. If LICENSEE elects to selfinsure all or
part of the limits described
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above (including deductibles or retentions which are
in excess of $250,000 annual aggregate) such
self-insurance program must be acceptable to the CMCC
and the Risk Management Foundation of the Harvard
Medical Institutions, Inc. The minimum amount of
insurance coverage required under this Section 8.2
shall not be construed to create a limit of
LICENSEE's liability with respect to its
indemnification under Section 8.1 of this Agreement.
8.2.2 LICENSEE shall provide CMCC with written evidence of such
insurance upon request of CMCC. LICENSEE shall provide CMCC
with written notice at lease forty-five (45) days prior to any
material change in such insurance. If the insurnace is
canceled and if LICENSEE does not obtain replacement insurance
providing comparable coverage within such forty-five (45) day
period, CMCC shall have the right to terminate this Agreement
effective at the end of such forty-five (45) day period after
providing notice of CMCC's intent to do so.
8.2.3 LICENSEE shall maintain such comprehensive general liability
insurance during
8.2.3.1 the period that any such product, process or service
is being commercially distributed or sold (other than
for the purpose of obtaining regulatory approvals) by
LICENSEE or by a sublicensee, affiliate or agent of
LICENSEE, and
8.2.3.2 a reasonable period after the period referred to in
8.2.3.1 above which in no event shall be less than
five (5) years.
8.2.4 This ARTICLE 8.2 shall survive expiration or termination of
this Agreement.
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ARTICLE IX -- EXPORT CONTROLS
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 LICENSEE that LICENSEE shall not export
data or commodities to certain foreign countries without prior
approval of such agency. CMCC neither represents that a license shall
not be required nor that, if required, it shall be issued.
ARTICLE X -- NON-USE OF NAMES
LICENSEE shall not use the names of the Children's Medical Center
Corporation nor of any of its employees, nor any adaptation thereof,
in any advertising, promotional or sales literature without prior
written consent obtained from CMCC in each case except that LICENSEE
may state that it is licensed by CMCC under one or more of the patents
and/or applications comprising the Patent Rights, and LICENSEE may
comply with disclosure requirements of all applicable laws relating to
its business, including United States and state security laws.
ARTICLE XI -- ASSIGNMENT
Subject to the restrictions set forth herein, this Agreement, and
each and every provision hereof, shall be binding upon and shall inure
to the benefit of the parties, their respective successors,
successors-in-title, heirs and assigns, and each and every
successor-in-interest to any party, whether such successor acquires
such interest by way of gift, inheritance, purchase, foreclosure, or
by any other method, shall hold such interest subject to all the terms
and provisions of this Agreement; provided however that LICENSEE shall
not assign or transfer the whole or any part of this Agreement or its
rights hereunder without the express written agreement of CMCC which
agreement shall not be unreasonably withheld.
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ARTICLE XII -- ARBITRATION
12.1 Any and all claims, disputes or controversies arising under, out of,
or in connection with 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 either 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 CMCC and LICENSEE each hereby
irrevocably consents and submits.
12.2 Notwithstanding the foregoing, nothing in this Article shall be
construed to waive any rights or timely performance of any obligations
existing under this Agreement.
ARTICLE XIII -- TERM AND TERMINATION
13.1 Unless earlier terminated as hereinafter provided, this Agreement
shall remain in full force and effect for the life of the last to
expire patent issued under the Patent Rights.
13.2 If LICENSEE shall cease to carry on its business, this Agreement shall
terminate upon notice by CMCC.
13.3 Should LICENSEE fail to pay CMCC royalties due and payable hereunder,
CMCC shall have the right to terminate this Agreement on sixty (60)
days' notice, unless LICENSEE shall pay CMCC within the sixty (60) day
period, all such royalties and interest due and payable. Upon the
expiration of the sixty (60) day period, if LICENSEE shall not have
paid all such royalties and interest due and payable, the rights,
privileges and license granted hereunder shall terminate.
13.4 Upon any material breach or default of this Agreement by LICENSEE,
other than those occurrences set out in Paragraphs 13.2 and 13.3
herein above, which shall always take precedence in that order over
any material breach or default referred to in this Paragraph 13.3,
CMCC shall have the right to terminate this Agreement
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and the rights, privileges and license granted hereunder by ninety
(90) days' notice to LICENSEE. Such termination shall become effective
unless LICENSEE shall have cured any such breach or default prior to
the expiration of the ninety (90) day period.
13.5 LICENSEE shall have the right to terminate this Agreement at any time
on six (6) months' notice to CMCC, and upon payment of all amounts due
CMCC through the effective date of termination.
13.6 Upon termination of this Agreement for any reason, nothing herein
shall be construed to release either party from any obligation that
matured prior to the effective date of such termination. LICENSEE and
any sublicensee thereof may, however, after the effective date of such
termination, sell all Licensed Products, and complete Licensed
Products in the process of manufacture at the time of such termination
and sell the same, provided that LICENSEE shall pay to CMCC the
royalties thereon as required by Article IV of this Agreement and
shall submit the reports required by Article V hereof on the sales of
Licensed Products.
13.7 CMCC agrees that if LICENSEE has provided to CMCC notice that LICENSEE
has granted a sublicense to a sublicensee under this Agreement, then
in the event CMCC terminates this Agreement for any reason, CMCC shall
provide to such sublicensee no less than thirty (30) days prior to the
effective date of said termination, written notice of said termination
at the address specified by LICENSEE to CMCC in LICENSEE's notice to
CMCC under Article XIV. CMCC agrees that upon the sublicensee's notice
as described below and provided the sublicensee is not in breach of
its sublicense, CMCC shall grant to such sublicensee license rights
and terms equivalent to the sublicense rights and terms which the
sublicense shall have granted to said sublicensee; provided that the
sublicensee shall remain a sublicensee under this Agreement for a
period of at least sixty (60) days following receipt of notice from
CMCC. Sublicenses shall during said sixty (60) day period provide to
CMCC notice wherein the sublicensee;
13.7.1 reaffirms the terms and conditions of this Agreement as it
relates to the rights the sublicensee has been granted under
the sublicense;
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13.7.2 agrees to abide by all of the terms and conditions of this
Agreement applicable to sublicensees and to discharge directly
all pertinent obligations of LICENSEE which LICENSEE is
obligated hereunder to discharge excluding any financial
obligations; and
13.7.3 acknowledges that CMCC shall have no obligations to the
sublicensee other than its obligations set forth in this
Agreement with regard to LICENSEE.
ARTICLE XIV -- PAYMENTS, NOTICES, AND OTHER COMMUNICATIONS
Any payment, notice or other communication pursuant to this Agreement shall be
sufficiently made or given on the date of the mailing if sent to such party by
certified first class mail, postage prepaid, addressed to it at its address
below or as it shall designate by written notice given to the other party:
In the case of CMCC:
Director, Technology Transfer Office
Office of Research Administration
THE CHILDREN'S HOSPITAL
300 Longwood Avenue
Boston, MA 02115
In the case of LICENSEE:
John W. Holaday, Ph.D.
Chief Executive Officer
ENTREMED, INC.
9610 Medical Center Drive, Suite 200
Rockville, MD 20850
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With copy to:
James Dean Johnson, Ph.D.
JONES & ASKEW
37th Floor
191 Peachtree Street
Atlanta, GA 30303
ARTICLE XV -- MISCELLANEOUS PROVISIONS
15.1 This Agreement shall be construed, governed, interpreted and applied
in accordance with the laws of the Commonwealth of Massachusetts,
U.S.A., except that questions affecting the construction and effect of
any patent shall be determined by the law of the country in which the
patent was granted.
15.2 The parties hereto acknowledge that this Agreement sets forth the
entire Agreement and understanding of the parties hereto as to the
subject matter hereof, and shall not be subject to any change or
modification except by the execution of a written instrument
subscribed to by the parties hereto.
15.3 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.
15.4 LICENSEE agrees to mark the Licensed Products sold in the United
States with all applicable United States patent numbers. All Licensed
Products shipped to or sold in other countries shall be marked in such
a manner as to conform with the patent laws and practice of the
country of manufacture or sale.
15.5 The failure of either party to assert a right hereunder or to insist
upon compliance with any term or condition of this Agreement shall not
constitute a waiver of that right or excuse a similar subsequent
failure to perform any such term or condition by the other party.
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IN WITNESS WHEREOF this Agreement has been executed in duplicate on
behalf of the parties hereto by their respective authorized officers as of the
date first written above.
CHILDREN'S MEDICAL CENTER CORPORATION
Name /s/ William New
---------------------------------------
Title Vice President, Research Administration
---------------------------------------
Date Novmeber 29, 1996
ENTREMED, INC.
Name /s/ John W. Holaday, PhD.
---------------------------------------
Title Chairman, CEO and President
Date December 5, 1996
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Appendix A
CMCC No.: 474
Inventors: J. Folkman, M. O'Reilly
Title: Endostatin: an Endogenous Inhibitor of Angiogenesis and Tumor
Growth
Filings:
<TABLE>
<CAPTION>
Country Date Filed Serial No. Type Jones and Askew Ref. No.
------- ---------- ---------- ---- ------------------------
<S> <C> <C> <C> <C>
USA 10/23/95 60/005,835 Provsnl 05213-0220P
USA 8/2/96 tbd Provsnl 05213-0221P
USA 10/22/96 tbd Parent 05213-0223
PCT 10/22/96 tbd Internatl 05213-0223WP
</TABLE>
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