Exhibit 10.36
CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT
PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
LICENSE AGREEMENT
This Agreement, effective as of June 2, 2003 (the "Effective Date"), is
by and between:
NEW YORK UNIVERSITY (hereinafter "NYU"), a not-for-profit corporation
organized and existing under the laws of the State of New York and having a
place of business at 00 Xxxxxxxxxx Xxxxxx Xxxxx, Xxx Xxxx, Xxx Xxxx, 00000
AND
Cell-Matrix, Inc., (hereinafter "Cell-Matrix"), a corporation organized
and existing under the laws of the State of Nevada having its principal office
at 0000 Xxxxxxxxxx Xxxx, Xxxxxxxx, Xxxxxxxxxx, 00000.
RECITALS
WHEREAS, Dr. Xxxxx Xxxxxx of NYU (hereinafter "the NYU Scientist") has
made certain inventions relating to [***]-Peptides and [***]-Peptides and
[***]-Peptides, all as more particularly described in certain invention
disclosures attached hereto as Exhibits A and B (hereinafter "the Pre-Existing
Inventions"), in a pending U.S. patent application owned by NYU, filed on [***],
entitled "[***]-Peptide and [***]-Peptide" and/or in a pending U.S. patent
application owned by NYU, filed on [***] entitled "[***]-Peptides" (hereinafter
"the Pre-Existing Patent Applications");
WHEREAS, subject to the terms and conditions hereinafter set forth, NYU
is willing to grant to Cell-Matrix and Cell-Matrix is willing to accept from NYU
the License (as hereinafter defined);
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the Commission. Confidential treatment has been requested with respect to the
omitted portions.
NOW, THEREFORE, in consideration of the mutual promises and agreements
contained herein, the parties hereto hereby agree as follows:
1. DEFINITIONS.
a. "Affiliate" shall mean any company or other legal entity which
controls, or is controlled by, or is under common control with, Cell-Matrix;
control means the holding of twenty five and one tenth percent (25.1%) or more
of (i) the capital and/or (ii) the voting rights and/or (iii) the right to elect
or appoint directors.
b. "Calendar Year" shall mean any consecutive period of twelve
months commencing on the first day of January of any year.
c. "License" shall mean the exclusive worldwide license,
including the right to sublicense, to make, to have made, to import, to use, to
offer for sale, and to sell the Licensed Products (as hereinafter defined), and
to practice the NYU Technology (as hereinafter defined) for the development,
manufacture, use and sale of the Licensed Products.
d. "Licensed Products" shall mean [***]-Peptides and
[***]-Peptides and [***]-Peptides, covered by a claim of any unexpired NYU
Patent (as hereinafter defined) which has not been disclaimed or held invalid by
a court of competent jurisdiction from which no appeal can be taken, or which
incorporates or is developed using NYU Know-How.
e. "Net Sales" shall mean the total amount invoiced in connection
with sales of the Licensed Products to any person or entity that is not a
Affiliate or a sublicensee of Cell-Matrix or an Affiliate under the License,
after deduction of all the following to the extent applicable to such sales;
i) all trade, case and quantity credits, discounts,
refunds or rebates;
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the Commission. Confidential treatment has been requested with respect to the
omitted portions.
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ii) allowances or credits for returns;
iii) sales commissions; and
iv) prepaid freight, transportation insurance, sales
taxes and other government charges (including
value-added tax).
Sales of Licensed Products by Cell-Matrix, or an Affiliate or sublicensee of
Cell-Matrix to any Affiliate or sublicensee which is a reseller thereof shall be
excluded, and only the subsequent sale of such Licensed Products by Affiliates
or sublicensees of Cell-Matrix to unrelated parties shall be deemed Net Sales
hereunder.
f. "NYU Know-How" shall mean information and materials related to
the Pre-Existing Inventions made by the NYU Scientist and owned or controlled by
NYU, including, but not limited to, pharmaceutical, chemical, biological and
biochemical products, technical and non-technical data, materials, methods and
processes and any drawings, plans, diagrams, specifications and/or other
documents containing such information, and including any additional peptides,
peptide analogs or peptide homologs that (i) bind to denatured collagen or
denatured laminin preferentially, or (ii) are directed towards the same, any
adjacent, or any subpart of the epitopes to which the Pre-Existing Inventions
are directed, that are conceived, invented or developed by NYU during the period
of the Research Agreement (as such term is defined below), including any
extensions thereof, and for which Dr. Xxxxx Xxxxxx is an inventor.
g. "NYU Patents" shall mean all rights arising out of or
resulting from (i) any and all U.S. and foreign patent applications covering the
NYU Know-How including, without limitation, the Pre-Existing Patent
Applications, (ii) the patents proceeding from such
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applications, (iii) all claims of and any divisions, continuations, in whole or
in part, reissues, re-examinations, renewals and extensions of any such patents
or patent applications.
h. "NYU Technology" shall mean all NYU Patents and NYU Know-How.
i. "Research Agreement" shall mean the Research Support Agreement
between NYU and CancerVax Corporation, effective as of December 18, 2002, as
amended.
j. "USC Claim" shall mean a valid claim of an issued patent owned
by the University of Southern California (hereinafter "USC") and licensed by USC
to Cell-Matrix for which Dr. Xxxxx Xxxxxx is an inventor.
2. EFFECTIVE DATE.
This Agreement shall be effective as of the Effective Date and shall
remain in full force and effect until it expires or is terminated in accordance
with Section 13 hereof.
3. TITLE.
a. Subject to the License granted to Cell-Matrix hereunder, it is
hereby agreed that all right, title and interest, in and to the NYU Technology,
and in and to any drawings, plans, diagrams, specifications, and other documents
containing any of the NYU Technology shall vest solely in NYU. At the request of
NYU, Cell-Matrix shall take all steps as may be necessary to give full effect to
said right, title and interest of NYU including, but not limited to, the
execution of any documents that may be required to record such right, title and
interest with the appropriate agency or government office.
4. PATENTS AND PATENT APPLICATIONS.
a. Cell-Matrix shall, within thirty (30) days following the signing
of this Agreement, pay NYU the sum of U.S. [***]
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the Commission. Confidential treatment has been requested with respect to the
omitted portions.
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[***], being the amount of all costs and fees incurred by NYU up to the date
hereof in connection with the Pre-Existing Patent Applications.
b. At the initiative of Cell-Matrix or NYU, the parties shall
consult with each other regarding the prosecution of all patent applications
with respect to the NYU Technology and each party shall use reasonable efforts
to implement all reasonable requests made by the other party with regard to the
preparation, filing, prosecution and/or maintenance of the patent applications
and/or patents within NYU Technology. Such patent applications shall be filed,
prosecuted and maintained by the law firm of Xxxxx & Xxxxx or by other patent
counsel jointly selected by NYU and Cell-Matrix. Copies of all such patent
applications, patent office actions and related correspondence shall be
forwarded on a timely basis to each of NYU and Cell-Matrix.
NYU and Cell-Matrix shall each also have the right to have such patent
applications and patent office actions independently reviewed by other patent
counsel separately retained by NYU or Cell-Matrix, upon prior notice to and
consent of the other party, which consent shall not unreasonably be withheld.
c. All applications and proceedings with respect to the NYU
Patents shall be filed, prosecuted and maintained by NYU at the expense of
Cell-Matrix. Against the submission of invoices, Cell-Matrix shall reimburse NYU
for all costs and fees invoiced by outside patent counsel to NYU during the term
of this Agreement, in connection with the filing, maintenance, prosecution,
protection and the like of the NYU Patents.
d. If at any time during the term of this Agreement Cell-Matrix
decides that it is undesirable, as to one or more countries, to prosecute or
maintain any patents or patent applications within the NYU Patents, it shall
give prompt written notice thereof to NYU, and
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the Commission. Confidential treatment has been requested with respect to the
omitted portions.
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upon receipt of such notice Cell-Matrix shall be released from its obligations
to bear all of the expenses to be incurred thereafter as to such countries in
conjunction with such patent(s) or patent application(s) and such patent(s) or
application(s) shall be deleted from the NYU Technology and NYU shall be free to
grant rights in and to the NYU Technology in such countries to third parties,
without further notice or obligation to Cell-Matrix, and Cell-Matrix shall have
no rights whatsoever to exploit the NYU Technology in such countries.
e. Nothing herein contained shall be deemed to be a warranty by
NYU that
i) NYU can or will be able to obtain any patent or
patents on any patent application or applications in the NYU
Patents or any portion thereof, or that any of the NYU Patents
will afford adequate or commercially worthwhile protection, or
ii) that the manufacture, use, or sale of any element of
the NYU Technology or any Licensed Product will not infringe
any patent(s) of a third party.
5. GRANT OF LICENSE.
a. Subject to the terms and conditions hereinafter set forth, NYU
hereby grants to Cell-Matrix and Cell-Matrix hereby accepts from NYU the
License. The License is subject to (i) the right of NYU to use and to permit
other non-commercial entities to use the NYU Technology for non-commercial
educational and research purposes only, and (ii) the rights of the U.S.
Government. Permission to use the NYU Technology shall only be granted to
non-commercial entities by NYU under a written agreement, a copy of which shall
be provided by NYU to Cell-Matrix as soon as practicable after the signing
thereof, and which shall contain, at a minimum, the provisions listed in Exhibit
C to this Agreement. Cell-Matrix agrees to consider, in good faith, reasonable
changes to the provisions listed in Exhibit C requested by NYU.
6
b. The License granted to Cell-Matrix in Section 5.a. hereto
shall commence upon the Effective Date and shall remain in force on a
country-by-country basis, if not previously terminated under the terms of this
Agreement, for fifteen (15) years from the date of first commercial sale in such
country or until the expiration date of the last to expire of the NYU Patents,
whichever shall be later. Cell-Matrix shall inform NYU in writing of the date of
first commercial sale with respect to each Licensed Product in each country as
soon as practicable after the making of each such first commercial sale.
c. Cell-Matrix shall be entitled to grant sublicenses under the
License on terms and conditions in compliance and not inconsistent with the
terms and conditions of this Agreement (except that the rate of royalty may be
at higher rates than those set forth in this Agreement) (i) to an Affiliate or
(ii) to other third parties for consideration and in arms-length transactions.
All sublicenses to third parties shall only be granted by Cell-Matrix under a
written agreement, a copy of which shall be provided by Cell-Matrix to NYU as
soon as practicable after the signing thereof. Each sublicense granted by
Cell-Matrix hereunder shall be subject and subordinate to the terms and
conditions of this License Agreement and shall contain (inter-alia) the
following provisions:
(1) the sublicense shall expire automatically on the
termination of the License;
(2) the sublicense shall not be assignable, in whole or
in part;
(3) the sublicensee shall not grant further sublicenses;
and
(4) both during the term of the sublicense and thereafter
the sublicensee shall agree to a confidentiality obligation
similar to that imposed on Cell-Matrix in Section 9 below, and
the sublicensee shall impose on its employees, both during the
7
terms of their employment and thereafter, a similar
undertaking of confidentiality; and
(5) the sublicense agreement shall include the text of
Sections 11 and 12 of this Agreement and shall state that NYU
is an intended third party beneficiary of such sublicense
agreement for the purpose of enforcing such indemnification
and insurance provisions.
6. PAYMENTS FOR LICENSE.
a. In consideration for the grant and during the term of the
License, Cell-Matrix shall pay to NYU:
(1) a non-refundable, non-creditable license issue fee of
two hundred thousand dollars ($200,000.00) payable as
follows: (i) sixty-six thousand, six hundred and
sixty-six dollars ($66,666.00) within thirty (30)
days after the Effective Date; (ii) sixty-six
thousand, six hundred and sixty-seven dollars
($66,667.00) on or before the first anniversary of
the Effective Date; and (iii) sixty-six thousand, six
hundred and sixty-seven dollars ($66,667.00) on or
before the second anniversary of the Effective Date;
and
(2) on the first and each succeeding anniversary of the
Effective Date until approval to market a Licensed
Product is received by Cell-Matrix, non-refundable,
non-creditable license maintenance fees of fifteen
thousand dollars ($15,000.00) each; and
(3) upon the achievement of the following technical
milestones, with respect to a Licensed Product, the payments as indicated below:
8
Milestone Payment
--------- -------
-------------------------------------------------------------
i) Upon the first approval of an Investigational [***]
New Drug Application by the FDA
-------------------------------------------------------------
ii)Upon commencement of the first Phase III [***]
clinical trial of a Licensed Product for
therapeutic purposes
-------------------------------------------------------------
iii) Upon receipt of the first approval to market [***]
a Licensed Product for therapeutic purposes
-------------------------------------------------------------
provided that if a milestone payment is owed to USC under
Cell-Matrix's license agreement with USC with respect to the Licensed Product
generating the milestone payment and a milestone payment is paid by Cell-Matrix
to USC based on the same milestone for the same Licensed Product under an
agreement in effect prior to the Effective Date, then Cell-Matrix may credit the
milestone payment paid to USC for the respective milestone against the milestone
payment due to NYU, provided that the milestone payment to NYU shall not be
reduced by more than fifty percent (50%);
(4) a royalty of [***] of the Net Sales of Cell-Matrix or
of an Affiliate or of a sublicensee of Cell-Matrix or an
Affiliate, provided that if a royalty is owed to USC under
Cell-Matrix's license agreement with USC with respect to the
Licensed Product generating the royalty, and a royalty is paid
by Cell-Matrix to USC for the same Licensed Product under an
agreement in effect prior to the Effective Date, then
Cell-Matrix may credit the royalty payments paid to USC
against the royalty payments due to NYU, provided that the
royalty payments to NYU shall not be reduced by more than
fifty percent (50%); and
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the Commission. Confidential treatment has been requested with respect to the
omitted portions.
9
(5) [***] of any revenue (including any monetary payments
not based on Net Sales, but not including any non-monetary
consideration), received by Cell-Matrix from a sublicensee of
Cell-Matrix (not being a Affiliate) under the terms of, or as
a consideration for the grant of, a sublicense of any rights
or for grant of an option to acquire such a sublicense.
b. For the purpose of computing the royalties due to NYU
hereunder, the year shall be divided into four parts ending on March 31, June
30, September 30, and December 31. Not later than sixty (60) days after each
December, March, June, and September in each Calendar Year during the term of
the License, Cell-Matrix shall submit to NYU a full and detailed report of
royalties or payments due NYU under the terms of this Agreement for the
preceding quarter year (hereinafter "the Quarter-Year Report"), setting forth
the Net Sales and/or lump sum payments and all other payments or consideration
from sublicensees upon which such royalties are computed and including at least
i) the quantity of Licensed Products used,
sold, transferred or otherwise disposed of;
ii) the selling price of each Licensed Product;
iii) the deductions permitted under subsection
1.g. hereof to arrive at Net Sales; and
iv) the royalty computations.
If no royalties or other payments are due, a statement shall be sent to
NYU stating such fact. Payment of the full amount of any royalties or other
payments due to NYU for the preceding quarter shall accompany each Quarter-Year
Report on royalties and payments. Cell-Matrix shall keep for a period of at
least six (6) years after the date of entry, full, accurate and
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the Commission. Confidential treatment has been requested with respect to the
omitted portions.
10
compete books and records consistent with sound business and accounting
practices and in such form and in such detail as to enable the determination of
the amounts due to NYU from Cell-Matrix pursuant to the terms of this Agreement.
c. Within sixty (60) days after the end of each Calendar Year,
commencing on the Date of First Commercial Sale, Cell-Matrix shall furnish NYU
with a report (hereinafter "the Annual Report"), relating to the royalties and
other payments due to NYU pursuant to this Agreement in respect of the Calendar
Year covered by such Annual Report and containing the same details as those
specified in Section 6.b. above in respect of the Quarter-Year Report.
d. On reasonable notice and during regular business hours, NYU
or the authorized representative of NYU shall each have the right to inspect the
books of accounts, records and other relevant documentation of Cell-Matrix or
any of its Affiliates insofar as they relate to the production, marketing and
sale of the Licensed Products, in order to ascertain or verify the amount of
royalties and other payments due to NYU hereunder, and the accuracy of the
information provided to NYU in the aforementioned reports.
7. METHOD OF PAYMENT.
a. Royalties and other payments due to NYU hereunder shall be
paid to NYU in United States dollars. Any such royalties on or other payments
relating to transactions in a foreign currency shall be converted into United
States dollars based on the closing buying rate of Citibank, N.A., in New York
applicable to transactions under exchange regulations for the particular
currency on the last business day of the accounting period for which such
royalty or other payment is due.
11
b. Cell-Matrix shall be responsible for payment to NYU of all
royalties due on sale, transfer or disposition of Licensed Products by Affiliate
or by the sublicensees of Cell-Matrix or of Affiliate.
c. Any amount payable hereunder by one of the parties to the
other, which has not been paid by the date on which such payment is due, shall
bear interest from such date until the date on which such payment is made, at
the rate of one percent (1%) per annum in excess of the prime rate prevailing at
the Citibank, N.A., in New York, during the period of arrears and such amount
and the interest thereon may be set off against any amount due, whether in terms
of this Agreement or otherwise, to the party in default by any non-defaulting
party.
8. DEVELOPMENT AND COMMERCIALIZATION.
a. Cell-Matrix shall use reasonable efforts and due diligence to
develop Licensed Products, as promptly as is reasonably and commercially
feasible, and to perform all efficacy, pharmaceutical, safety, toxicological and
clinical tests, trials and studies and all other activities necessary in order
to obtain the approval of the FDA for the production, use and sale of the
Licensed Products. Cell-Matrix further undertakes to exercise due diligence and
to employ its reasonable diligence to obtain or to cause its sublicensees to
obtain, the appropriate approvals of the health authorities for the production,
use and sale of the Licensed Products, in each of the other countries of the
world in which Cell-Matrix or its sublicensees intend to produce, use, and/or
sell Licensed Products.
b. Provided that applicable laws, rules and regulations require
that the performance of the tests, trials, studies and other activities
specified in subsection a. above shall be carried out in accordance with FDA
Good Laboratory Practices and in a manner acceptable to the relevant health
authorities, Cell-Matrix shall carry out such tests, trials, studies and other
activities in
12
accordance with FDA Good Laboratory Practices and in a manner acceptable to the
relevant health authorities. Furthermore, the Licensed Products for commercial
sale shall be produced in accordance with FDA Good Manufacturing Practice
("GMP") procedures in a facility that has been certified by the FDA as complying
with GMP, provided that applicable laws, rules and regulations so require.
c. Cell-Matrix shall provide NYU with written reports on
significant activities and actions undertaken by Cell-Matrix to develop and
commercialize the Licensed Products; such reports shall be made within sixty
(60) days after each twelve (12) months of the duration of this Agreement,
commencing twelve months after the Effective Date.
e. In the event that Cell-Matrix shall not meet its commercial
development obligations, as set forth in paragraph (a) of this Section 8, unless
such delay is necessitated by FDA or other regulatory agencies or unless NYU and
Cell-Matrix have mutually agreed to extend the period of time in which
Cell-Matrix is obligated, under paragraph (a) of this Section 8, to
commercialize a Licensed Product because of unforeseen circumstances, NYU shall
notify Cell-Matrix in writing of Cell-Matrix's failure to commercialize and
shall allow Cell-Matrix one (1) year to materially cure its failure to
commercialize. Cell-Matrix's failure to materially cure such delay to NYU's
reasonable satisfaction within such one (1) year period shall be a material
breach of this Agreement..
f. Cell-Matrix shall give NYU the option to participate as a
clinical site in any clinical trials of Licensed Products sponsored by
Cell-Matrix or its Affiliates, under the same compensation and other terms as
those offered to other clinical sites participating in such trials, provided
that NYU meets the reasonable qualification criteria established by Cell-Matrix
for its other clinical sites for any such clinical trials.
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g. Licensed Products sold by Cell-Matrix, its Affiliates, or its
sublicensees in the United States shall be substantially manufactured in the
United States.
9. CONFIDENTIAL INFORMATION.
a. Except as otherwise provided in Section 9.b and 9.c below
Cell-Matrix shall maintain any and all of the NYU Technology in confidence to
the same extent Cell-Matrix maintains its own proprietary industrial information
and shall not release or disclose any tangible or intangible component thereof
to any third party without first receiving the prior written consent of NYU to
said release or disclosure.
b. The obligations of confidentiality set forth in Sections 9.a
shall not apply to any component of the NYU Technology which: (i) was in
Cell-Matrix's possession prior to the date of its actual receipt from NYU; (ii)
was part of the public domain prior to the Effective Date of this Agreement or
which becomes a part of the public domain not due to some unauthorized act by or
omission of Cell-Matrix after the effective date of this Agreement; (iii) is
disclosed to Cell-Matrix by a third party who has the right to make such
disclosure; or (iv) is developed independently by Cell-Matrix without use of the
NYU Technology.
c. The provisions of Section 9.a notwithstanding, Cell-Matrix may
disclose the NYU Technology (i) to third parties who need to know the same in
order to secure regulatory approval for the sale of Licensed Products; and (ii)
to Cell-Matrix's Affiliates, sublicensees, prospective sublicensees and
assignees of Cell-Matrix and its Affiliates, attorneys and other agents who are
bound by confidentiality obligations equivalent to those provided herein.
d. Upon the expiration or termination of this Agreement, any and
all NYU Technology possessed in tangible form by Cell-Matrix, its Affiliates or
its or any of its officers, directors, employees, agents, consultants or
clinical investigators and belonging to NYU, shall, upon
14
written request, be returned to NYU (or destroyed if so requested); provided,
however, that Cell-Matrix may retain one (1) copy of the NYU Technology, which
by applicable laws, rules or regulations it is obligated to retain, for the
later of: (a) the period in which any such applicable laws, rules or regulations
require such retention; or (b) the expiration of the statute of limitations
applicable to actions arising under this Agreement or Cell-Matrix's receipt of
NYU's release from any actions by Cell-Matrix under this Agreement.
10. INFRINGEMENT OF NYU PATENT.
a. In the event a party to this Agreement acquires information
that a third party is infringing one or more of the NYU Patents, the party
acquiring such information shall promptly notify the other party to the
Agreement in writing of such infringement.
b. In the event of an infringement of an NYU Patent, Cell-Matrix
shall have the right but not required to bring suit against the infringer.
Should Cell-Matrix elect to bring suit against an infringer and NYU is joined as
a party plaintiff in any such suit, NYU shall have the right to approve the
counsel selected by Cell-Matrix to represent Cell-Matrix and NYU, which approval
shall not be unreasonably withheld. The expenses of such suit or suits that
Cell-Matrix elects to bring, including any expenses of NYU incurred in
conjunction with the prosecution of such suit or the settlement thereof, shall
be paid for entirely by Cell-Matrix and Cell-Matrix shall hold NYU free, clear
and harmless from and against any and all costs of such litigation, including
attorneys' fees. Cell-Matrix shall not compromise or settle such litigation
without the prior written consent of NYU, which shall not be unreasonably
withheld.
c. In the event Cell-Matrix exercises the right to xxx herein
conferred, it shall have the right to first reimburse itself out of any sums
recovered in such suit or in settlement thereof for all costs and expenses of
every kind and character, including reasonable attorneys' fees
15
necessarily involved in the prosecution of any such suit, and if after such
reimbursement, any funds shall remain from said recovery, Cell-Matrix shall
promptly pay to NYU an amount equal to thirty percent (30%) of such remainder
and Cell-Matrix shall be entitled to receive and retain the balance of the
remainder of such recovery.
d. If Cell-Matrix does not bring suit against said infringer
pursuant to Section 10.b. herein, or has not commenced negotiations with said
infringer for discontinuance of said infringement, within ninety (90) days after
receipt of such notice, NYU shall have the right, but shall not be obligated, to
bring suit for such infringement. Should NYU elect to bring suit against an
infringer and Cell-Matrix is joined as a party plaintiff in any such suit,
Cell-Matrix shall have the right to approve the counsel selected by NYU to
represent NYU and Cell-Matrix, which approval shall not be unreasonably
withheld, and NYU shall hold Cell-Matrix free, clear and harmless from and
against any and all costs and expenses of such litigation, including attorneys'
fees. If Cell-Matrix has commenced negotiations with an alleged infringer of the
NYU Patent for discontinuance of such infringement within such 90-day period,
Cell-Matrix shall have an additional ninety (90) days from the termination of
such initial 90-day period to conclude its negotiations before NYU may bring
suit for such infringement. In the event NYU brings suit for infringement of any
NYU Patent, NYU shall have the right, following consultation with Cell-Matrix,
to settle any such suit by licensing the alleged infringer on terms
substantially equivalent to those included in this Agreement. In the event NYU
brings suit for infringement of any NYU Patent, NYU shall have the right to
first reimburse itself out of any sums recovered in such suit or settlement
thereof for all costs and expenses of every kind and character, including
reasonable attorneys' fees necessarily involved in the prosecution of such suit,
and if after such reimbursement, any funds shall remain from
16
said recovery, NYU shall promptly pay to Cell-Matrix an amount equal to thirty
percent (30%) of such remainder and NYU shall be entitled to receive and retain
the balance of the remainder of such recovery.
e. Each party shall always have the right, at its own expense, to
be represented by counsel of its own selection in any suit for infringement of
the NYU Patents instituted by the other party to this Agreement under the terms
hereof.
f. Cell-Matrix agrees to cooperate fully with NYU at the request
of NYU, including by giving testimony and producing documents lawfully requested
in the prosecution of any suit by NYU for infringement of the NYU patents;
provided, NYU shall pay all reasonable expenses (including attorneys' fees)
incurred by Cell-Matrix in connection with such cooperation. NYU shall cooperate
fully with Cell-Matrix and shall endeavor to cause the NYU Scientists to
cooperate with Cell-Matrix at the request of Cell-Matrix, including by giving
testimony and producing documents lawfully requested in the prosecution of any
suit by Cell-Matrix for infringement of the NYU Patents; provided, that
Cell-Matrix shall pay all reasonable expenses (including attorneys' fees)
incurred by NYU in connection with such cooperation.
11. LIABILITY AND INDEMNIFICATION.
a. Cell-Matrix shall indemnify, defend and hold harmless NYU and
its trustees, officers, medical and professional staff, employees, students and
agents and their respective successors, heirs and assigns (the "Indemnitees"),
against any liability, damage, loss or expense (including reasonable attorneys'
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 (i) arising out of the design, production, manufacture, sale, use in
commerce or in human clinical trials, lease, or promotion by Cell-Matrix or by a
sublicensee,
17
Affiliate or agent of Cell-Matrix of any Licensed Product, process or service
relating to, or developed pursuant to, this Agreement or (ii) arising out of any
other activities to be carried out pursuant to this Agreement.
b. With respect to an Indemnitee, Cell-Matrix's indemnification
under subsection a(i) of this Section 11 shall apply to any liability, damage,
loss or expense, whether or not it is attributable to the negligent activities
of such Indemnitee; however, Cell-Matrix's indemnification obligation under
subsection a(ii) of this Section 11 shall not apply to any liability, damage,
loss or expense to the extent that it is attributable to the negligent
activities or willful misconduct of any such Indemnitee.
c. Cell-Matrix agrees, at its own expense, to provide attorneys
reasonably acceptable to NYU to defend against any actions brought or filed
against any Indemnitee with respect to the subject of indemnity to which such
Indemnitee is entitled hereunder, whether or not such actions are rightfully
brought.
12. SECURITY FOR INDEMNIFICATION.
a. At such time as any Licensed Product, process or service
relating to, or developed pursuant to, this Agreement is being commercially
distributed or sold (other than for the purpose of obtaining regulatory
approvals) by Cell-Matrix or by a licensee, Affiliate or agent of Cell-Matrix,
Cell-Matrix shall at its sole costs and expense, procure and maintain policies
of comprehensive general liability insurance in amounts not less than
$10,000,000 per incident and $20,000,000 annual aggregate and naming the
Indemnitees as additional insureds. Such comprehensive general liability
insurance shall provide (i) product liability coverage and (ii) broad form
contractual liability coverage for Cell-Matrix's indemnification under Section
11 of this Agreement. If Cell-Matrix elects to self-insure all or part of the
limits described above
18
(including deductibles or retentions which are in excess of $250,000 annual
aggregate) such self-insurance program must be reasonably acceptable to NYU.
The minimum amounts of insurance coverage required under this Section
12 shall not be construed to create a limit of Cell-Matrix's liability with
respect to its indemnification under Section 11 of this Agreement.
b. Cell-Matrix shall provide NYU with written evidence of such
insurance upon request of NYU. Cell-Matrix shall provide NYU with written notice
at least sixty (60) days prior to the cancellation, non-renewal or material
change in such insurance; if Cell-Matrix does not obtain replacement insurance
providing comparable coverage within such sixty (60) day period, NYU shall have
the right to terminate this Agreement effective at the end of such sixty (60)
day period without notice or any additional waiting periods.
c. Cell-Matrix shall maintain such comprehensive general
liability insurance beyond the expiration or termination of this Agreement
during (i) the period that any product, process or service, relating to, or
developed pursuant to, this Agreement is being commercially distributed or sold
(other than for the purpose of obtaining regulatory approvals) by Cell-Matrix or
by a sublicensee, Affiliate or agent of Cell-Matrix and (ii) a reasonable period
after the period referred to in (c)(i) above, which in no event shall be less
than fifteen (15) years.
13. EXPIRY AND TERMINATION
a. Unless earlier terminated pursuant to this Section 13 hereof,
this Agreement shall expire upon the expiration of the period of the License in
all countries as set forth in Section 5.b. above.
b. At any time prior to expiration of this Agreement, either
party may terminate this Agreement forthwith for cause, as "cause" is described
below, by giving written notice to the
19
other party. Cause for termination by one party of this Agreement shall be
deemed to exist if the other party materially breaches or defaults in the
performance or observance of any of the provisions of this Agreement and such
breach or default is not materially cured within sixty (60) days or, in the case
of failure to pay any amounts due hereunder, thirty (30) days (unless otherwise
specified herein) after the giving of notice by the other party specifying such
breach or default, or if either NYU or Cell-Matrix discontinues its business or
becomes insolvent or bankrupt.
c. Cell-Matrix may terminate this Agreement at any time in
Cell-Matrix's sole discretion, upon not less than one hundred eighty (180) days'
prior written notice to NYU.
d. Upon termination of this Agreement for any reason and prior to
expiration as set forth in Section 13.a and 13.b hereof, all rights in and to
the NYU Technology shall revert to NYU, and, except as provided in Section 9.d,
Cell-Matrix shall not be entitled to make any further use whatsoever of the NYU
Technology.
e. Cell-Matrix shall promptly, without further consideration,
provide to NYU copies of all data and regulatory documents, including INDs,
NDAs, Orphan Drug applications, or their equivalents in all countries, directly
related to the development of Licensed Products (the "Regulatory Information"),
provided that NYU and any of its sublicensees who utilize such .Regulatory
Information shall agree to indemnify, defend and hold harmless Cell-Matrix and
its Affiliates and sublicensees against any liability, damage, loss or expense
(including reasonable attorney's fees and expenses of litigation) incurred by or
imposed upon Cell-Matrix, its Affiliates or sublicensees, or any one of them in
connection with any claims, suits, actions, demands or judgments arising out of
any use by NYU or its sublicensees of such Regulatory Information.
20
f. Termination of this Agreement shall not relieve either party
of any obligation to the other party incurred prior to such termination.
g. Sections 3, 9, 11, 12, 16, 17, and 18 hereof shall survive and
remain in full force and effect after any termination, cancellation or
expiration of this Agreement.
14. REPRESENTATIONS AND WARRANTIES BY CELL-MATRIX.
Cell-Matrix hereby represents and warrants to NYU as follow:
(1) Cell-Matrix is a corporation duly organized, validly existing
and in good standing under the laws of the State of Nevada. Cell-Matrix has been
granted all requisite power and authority to carry on its business and to own
and operate its properties and assets. The execution, delivery and performance
of this Agreement have been duly authorized by the Board of Directors of
Cell-Matrix.
(2) There is no pending or, to Cell-Matrix's knowledge, threatened
litigation involving Cell-Matrix which would have any effect on this Agreement
or on Cell-Matrix's ability to perform its obligations hereunder; and
(3) There is no indenture, contract, or agreement to which
Cell-Matrix is a party or by which Cell-Matrix is bound which prohibits or would
prohibit the execution and delivery by Cell-Matrix of this Agreement or the
performance or observance by Cell-Matrix of any term or condition of this
Agreement.
15. REPRESENTATIONS AND WARRANTIES BY NYU.
NYU hereby represents and warrants to Cell-Matrix as follows:
(1) NYU is a corporation duly organized, validly existing and in
good standing under the laws of the State of New York. NYU has been granted all
requisite power and authority to carry on its business and to own and operate
its properties and assets. The execution, delivery
21
and performance of this Agreement have been duly authorized by the Board of
Trustees of NYU.
(2) There is no pending or, to NYU's knowledge, threatened
litigation involving NYU which would have any effect on this Agreement or on
NYU's ability to perform its obligations hereunder;
(3) There is no indenture, contract, or agreement to which NYU is
a party or by which NYU is bound which prohibits or would prohibit the execution
and delivery by NYU of this Agreement or the performance or observance by NYU of
any term or condition of this Agreement; and
(4) NYU shall provide to Cell-Matrix the materials and information
listed in Exhibit D hereto (the "Supporting Data") within thirty (30) days
following the Effective Date. In the event that Supporting Data are not provided
within this time period, Cell-Matrix may delay payment of [***] from the portion
of the License Issue Fee that would otherwise be payable within thirty (30) days
following the Effective Date under Section 6(a)(1) of this Agreement until such
time as all of Supporting Data are received by Cell-Matrix.
16. NO ASSIGNMENT.
Neither Cell-Matrix nor NYU shall have the right to assign, delegate or
transfer at any time to any party, in whole or in part, any or all of the
rights, duties and interest herein granted without first obtaining the written
consent of the other to such assignment, which consent shall not be unreasonably
withheld, provided, however, that no prior written consent shall be required in
the event that a third party acquires substantially all of the assigning party's
assets or outstanding shares, or merges with the assigning party. No assignment
of this Agreement shall
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
22
relieve the assigning party of any of its obligations or liability hereunder.
Any attempted assignment not in compliance with this Section 16 shall be of no
force or effect.
17. USE OF NAME.
Without the prior written consent of the other party, neither
Cell-Matrix nor NYU shall use the name of the other party or any adaptation
thereof:
i) in any product labeling, advertising, promotional or sales
literature;
ii) in connection with any public or private offering, in
conjunction with any application for regulatory approval, in reports or
documents or other disclosures sent to stockholders or filed with or
submitted to any government authority or stock exchange, unless
disclosure is otherwise required by law, in which case either party may
make factual statements concerning the Agreement or file copies of the
Agreement.
Except as provided herein, neither NYU nor Cell-Matrix will issue
public announcements about this Agreement without prior written approval of the
other party, which approval shall not be unreasonably withheld. The parties each
agree that once approval for disclosure of information subject to this Section
17 has been obtained, the party that requested such approval shall be entitled
to use such information substantially in the form initially presented without an
obligation to seek further approval.
18. MISCELLANEOUS.
a. In carrying out this Agreement the parties shall comply with
all local, state and federal laws and regulations including but not limited to,
the provisions of Title 35 United States Code Section 200 et seq. and 15 CFR
Section 368 et seq.
b. If any provision of this Agreement is determined to be invalid
or void, the remaining provisions shall remain in effect.
23
c. This Agreement shall be deemed to have been made in the State
of New York and shall be governed and interpreted in all respects under the laws
of the State of New York.
d. All payments or notices required or permitted to be given
under this Agreement shall be given in writing and shall be effective when
either personally delivered or deposited, postage prepaid, in the United States
registered or certified mail, addressed as follows:
To: NYU:
New York University School of Medicine
000 Xxxxx Xxxxxx, 0xx Xxxxx
Xxx Xxxx, XX 00000
Attention: Xxxxx X. Xxxxxxxxxx
Executive Director, Industrial Liaison/Technology Transfer
With a copy to:
Office of Legal Counsel
New York University
Xxxxx Library
00 Xxxxxxxxxx Xxxxxx Xxxxx
Xxx Xxxx, XX 00000
Attention: Xxxxxxx X. Xxxxxxx, Esq.
Vice Xxxx & Senior Counsel for Medical School Affairs
To: Cell-Matrix:
Cell-Matrix, Inc.
0000 Xxxxxxxxxx Xxxx
Xxxxxxxx, XX 00000
Attention: General Counsel
or such other address or addresses as either party may hereafter
specify by written notice to the other. Such notices and communications shall be
deemed effective on the date of delivery or fourteen (14) days after having been
sent by registered or certified mail, whichever is earlier.
f. This Agreement (and the annexed Appendices) constitute the
entire Agreement between the parties and no variation, modification or waiver of
any of the terms or conditions hereof shall be deemed valid unless made in
writing and signed by both parties hereto. This
24
Agreement supersedes any and all prior agreements or understandings, whether
oral or written, with respect to the NYU Technology between Cell-Matrix and NYU.
g. No waiver by either party of any non-performance or violation
by the other party of any of the covenants, obligations or agreements of such
other party hereunder shall be deemed to be a waiver of any subsequent violation
or non-performance of the same or any other covenant, agreement or obligation,
nor shall forbearance by any party be deemed to be a waiver by
such party of its rights or remedies with respect to such violation or
non-performance.
h. The descriptive headings contained in this Agreement are
included for convenience and reference only and shall not be held to expand,
modify or aid in the interpretation, construction or meaning of this Agreement.
i. It is not the intent of the parties to create a partnership or
joint venture or to assume partnership responsibility or liability. The
obligations of the parties shall be limited to those set out herein and such
obligations shall be several and not joint.
IN WITNESS WHEREOF, the parties hereto have executed this Agreement
effective as of the date and year first above written.
NEW YORK UNIVERSITY CELL-MATRIX, INC.
By: /s/ Xxxxx X. Xxxxxxxxxx By: /s/ Xxxxxxx X. XxXxx
------------------------------- -----------------------
Xxxxx X. Xxxxxxxxxx Xxxxxxx X. XxXxx
Executive Director, President
Industrial Liaison/Technology Transfer
Date: 6/2/03 Date: 5/30/03
25
EXHIBIT A
[***]-Peptide and [***]-Peptide
Invention Disclosure
(NYU # 2002-41)
[15 Pages of Proprietary Information Deleted Pursuant to Confidential Treatment
Request]
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
the omitted portions.
26
EXHIBIT B
[***]-Peptide
Invention Disclosure
(NYU # 2002-40)
[15 Pages of Proprietary Information Deleted Pursuant to Confidential Treatment
Request]
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
the omitted portions.
27
EXHIBIT C
- "Material(s)" shall mean the NYU Technology.
- "Derivatives" shall mean and shall only include progeny of the Material(s)
or their Derivatives.
- "New Substance" shall mean any material produced or isolated by Transferee
in connection with Transferee's use of Materials which is not a Derivative.
- Transferor shall transfer to Transferee the Materials following the
execution of the Agreement or as otherwise agreed upon by the parties, and
grants Transferee a nonexclusive license to use and modify the Materials for
non-commercial, non-clinical educational and research purposes only, as
fully described in Attachment X hereto.
- Transferee represents and warrants that the Materials will not be given or
made available to any other person, firm or corporation, but are to remain
under Transferee's immediate and direct control. Transferee further
represents and warrants that the Materials will not be used in humans or,
directly or indirectly, in any "sponsored" research or other research
programs if the terms of such sponsorship or program would entitle the
sponsor or any third party to any rights or interests in such research or
its results, including the right to review and/or publish such results. Any
other uses of the Materials by Transferee are prohibited.
- TRANSFEREE AGREES TO USE THE MATERIALS IN COMPLIANCE WITH ALL APPLICABLE
FEDERAL, STATE, NATIONAL, OR LOCAL LAWS AND REGULATIONS. TRANSFEREE
UNDERSTANDS AND ACKNOWLEDGES THAT THE USE OF THE MATERIALS IN HUMANS WITHOUT
THE EXPRESS WRITTEN PERMISSION OF TRANSFEROR IS EXPRESSLY PROHIBITED.
- Transferee agrees to return all unused Materials to Transferor upon the
termination or expiration of the Agreement or upon written request of
Transferor within ten (10) business days of such request.
- All right, title and interest to all Materials shall remain in or are hereby
assigned to Transferor. All right, title and interest to all Derivatives and
New Substances (and any patent and other intellectual property rights to the
Derivatives and New Substances) shall vest in or are hereby assigned to
Transferor.
- Transferee shall keep Transferor and Cell-Matrix, Inc., informed of all uses
made of the Materials, and shall provide Transferor and Cell-Matrix, Inc.,
with a report summarizing
28
the results of experiments and data generated utilizing the Materials
quarterly during the course of the research and within thirty days following
the conclusion of such research.
- CONFIDENTIALITY. THE MATERIALS SHALL BE RECEIVED AND HELD IN CONFIDENCE BY
TRANSFEREE, WHICH ACKNOWLEDGES THAT THEY ARE CONSIDERED PROPRIETARY TO
TRANSFEROR. TRANSFEREE SHALL EXECUTE A CONFIDENTIAL DISCLOSURE AGREEMENT
WITH TRANSFEROR PRIOR TO THE TRANSFER BY TRANSFEROR OF THE MATERIALS. THE
CONFIDENTIAL DISCLOSURE AGREEMENT SHALL SURVIVE ANY TERMINATION OR
EXPIRATION OF THE AGREEMENT.
- Publications. Transferee shall have the right to publish or present
information which results from Transferee's research using the Materials,
provided that such publication or presentation (and any revisions thereto):
(a) does not disclose Confidential Information (as such term is defined in
the Confidential Disclosure Agreement referenced in Section 3, above) of
Transferor; and (b) is submitted to Transferor and Cell-Matrix, Inc., at
least ninety (90) days prior to the date of submission of such proposed
publication or presentation. Upon notice by Transferor or Cell-Matrix, Inc.,
that Transferor's or Cell-Matrix, Inc.'s legal counsel recommends delaying
or modifying the proposed publication or presentation in order to protect
intellectual property rights and/or as otherwise required by applicable law
or regulation, Transferee agrees that the submission of the publication or
presentation shall be delayed by the period of time reasonably recommended
by such legal counsel and/or the publication or presentation shall be
modified in accordance with comments or changes as directed by Transferor or
Cell-Matrix, Inc..
- TERM. THIS AGREEMENT WILL TERMINATE ON THE EARLIEST OF THE FOLLOWING DATES:
(I) UPON COMPLETION OF TRANSFEREE'S CURRENT INVESTIGATION WITH THE MATERIAL,
OR (II) ON TEN (10) BUSINESS DAYS PRIOR WRITTEN NOTICE BY EITHER PARTY TO
THE OTHER.
- This Agreement may not be assigned by either party without the written
consent of the other party, except to a person or entity acquiring all or
substantially all of the assigning party's business or voting power through
merger, consolidation or otherwise. This Agreement may be modified only in
writing, signed by both parties.
29
EXHIBIT D
"Supporting Data"
The following list refers only to data already in existence as of the Effective
Date:
1. Raw data from which the graphs that we received were generated and data
from the repeat studies that were done with the peptides in the CAM,
proliferation and adherence assays.
2. Raw data that was generated on the effect of the peptides in the mouse
tumor model along with the protocol that was used.
3. Comparative data with the other peptides that were generated and tested
and did not show activity
4. Any comparative data on soluble vs less soluble forms of the peptides
5. List of peptides tested
30
