RESEARCH AND LICENSE AGREEMENT
This Agreement, effective as of July 1, 1998 (the "Effective Date"), is
by and between: NORTH SHORE UNIVERSITY HOSPITAL RESEARCH CORPORATION
(hereinafter "NSUH"), a corporation organized and existing under the laws of the
State of New York and having a place of business at 000 Xxxxxxxxx Xxxxx,
Xxxxxxxxx, XX 00000
AND
Gentest, Inc. (hereinafter "CORPORATION"), a corporation organized and
existing under the laws of the State of Florida having its principal office at
0000 Xxxx Xxxxx, Xxxxx Xxxx, Xxxxxxx 00000, including any successor to
CORPORATION through merger or corporate reorganization.
RECITALS
WHEREAS, CORPORATION has already licensed technology developed by Xx.
Xxxxxx Xxxxxxxxxx at the University of South Florida for the screening of colon,
testicular and ovarian cancer;
WHEREAS, CORPORATION desires NSUH and Xx. Xxxxxx Xxxxxxxxxx
(hereinafter the "NSUH Scientist") to conduct research on the development of
laboratory assay kits for the screening of colon, ovarian and testicular cancer;
WHEREAS, NSUH and Xx. Xxxxxxxxxx are willing to conduct such research
(hereinafter the "NSUH Research Project");
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WHEREAS, CORPORATION is prepared to sponsor the NSUH Research Project;
WHEREAS, subject to the terms and conditions hereinafter set forth,
NSUH is willing to grant to CORPORATION and CORPORATION is willing to accept
from NSUH the License (as hereinafter defined);
NOW, THEREFORE, in consideration of the mutual promises and agreements
contained herein, the parties hereto hereby agree as follows:
1. Definitions.
a. "Calendar Year" shall mean any consecutive period of twelve
months commencing on the first day of January of any year.
b. "Corporation Entity" shall mean any company or other legal entity
which controls, or is controlled by, or is under common control
with, CORPORATION; 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.
c. "Date of First Commercial Sale" shall have the meaning set forth
in Section 7.b. hereof.
d. "Field" shall mean screening assays for colon, ovarian and
testicular cancer.
e. "License" shall mean the exclusive worldwide license to practice
the Research Technology (as hereinafter defined) for the
development, manufacture, use and sale of the Licensed Products
(as hereinafter defined).
f. "Licensed Products" shall mean assay kits for the screening of
colon, ovarian and testicular cancer, covered by a claim of any
unexpired NSUH Patent (as
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hereinafter defined) which has not been disclaimed or held
invalid by a court of competent jurisdiction from which no appeal
can be taken.
g. "Net Sales" shall mean the total amount invoiced in connection
with sales of the Licensed Products to an end user by CORPORATION
or a Corporation Entity or any sublicensee of CORPORATION or a
Corporation Entity 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;
ii) allowances or credits for returns;
iii) sales commissions; and
iv) sales taxes (including value-added tax).
h. "NSUH Know-How" shall mean any information and materials
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, discovered, developed or acquired by, or on behalf
of:
i) students or employees of NSUH or of North Shore University
Hospital during the term and in the course of the NSUH
Research Project;
ii) employees or consultants of CORPORATION and which is related
to the Licensed Products.
i. "NSUH Patents" shall mean all United States and foreign patents
and patent applications, and any divisions, continuations, in
whole or in part, reissues, renewals and extensions thereof, and
pending applications therefor: which claim inventions that are
made, in whole or in part, by
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i) students or employees of NSUH or of North Shore University
Hospital during the term and in the course of the NSUH
Research Project;
ii) employees or consultants of CORPORATION and which is related
to the Licensed Products.
j. "Research Period" shall mean the two-year period commencing on
the Effective Date hereof and any extension thereof as to which
NSUH and CORPORATION shall mutually agree in writing.
k. "NSUH Research Project" shall mean the investigations at NSUH
during the Research Period into the Field under the supervision
of the NSUH Scientist(s) in accordance with the research program,
described in annexed Appendix I, which forms an integral part
hereof.
l. "Research Technology" shall mean all NSUH Patents and NSUH
Know-How.
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 16. hereof.
3. Performance of the NSUH Research Project.
a. In consideration of the sums to be paid to NSUH as set forth in
Section 4 below, NSUH undertakes to perform the NSUH Research
Project under the supervision of the NSUH Scientists during the
Research Period. If during the Research Period all of the NSUH
Scientists shall cease to supervise the NSUH Research Project,
then NSUH shall promptly so notify CORPORATION and
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CORPORATION shall have the option to terminate its funding of the
NSUH Research Project. CORPORATION shall promptly advise NSUH in
writing if CORPORATION so elects. Such termination of funding
pursuant to this Section 3.a. shall not terminate this Agreement
or the License granted herein. Nothing herein contained shall be
deemed to impose an obligation on NSUH to find a replacement for
the NSUH Scientists.
b. Nothing contained in this Agreement shall be construed as a
warranty on the part of NSUH that any results or inventions will
be achieved by the NSUH Research Project, or that the Research
Technology and/or any other results or inventions achieved by the
NSUH Research Project, if any, are or will be commercially
exploitable and furthermore, NSUH makes no warranties whatsoever
as to the commercial or scientific value of the Research
Technology and/or as to any results which may be achieved in the
NSUH Research Project.
c. Within sixty (60) days after the end of each year of the Research
Period, NSUH shall prepare a written report summarizing the
results of the work conducted on the NSUH Research Project during
the preceding year.
d. NSUH will have full authority and responsibility for the NSUH
Research Project. All students and employees of NSUH who work on
the NSUH Research Project will do so as employees or students of
NSUH, and not as employees of CORPORATION.
4. Funding of the NSUH Research Project
a. As compensation to NSUH for work to be performed on the NSUH
Research Project during the Research Period, subject to any
earlier termination of the
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Research Project pursuant to Section 3.a. hereof, CORPORATION
will pay NSUH the total sum of Three Hundred Eleven Thousand Two
Hundred Fifty Dollars ($311,250.00), within thirty (30) days of
the Effective Date.
b. Nothing in this Agreement shall be interpreted to prohibit NSUH
(or the NSUH Scientists) from obtaining additional financing or
research grants for the NSUH Research Project from government
agencies, which grants or financing may render all or part of the
NSUH Research Project and the results thereof subject to the
patent rights of the U.S. Government and its agencies, as set
forth in Title 35 U.S.C. ss.200 et seq.
5. Title.
a. Subject to the License granted to CORPORATION hereunder, it is
hereby agreed that all right, title and interest, in and to the
Research Technology, and in and to any drawings, plans, diagrams,
specifications, and other documents containing any of the
Research Technology shall vest solely in NSUH. At the request of
NSUH, CORPORATION shall take all steps as may be necessary to
give full effect to said right, title and interest of NSUH
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.
b. Subject to the License granted to CORPORATION hereunder, any and
all inventions made by the NSUH Scientist and relating to the
Field shall be owned solely by NSUH.
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6. Patents and Patent Applications.
a. NSUH will promptly disclose to CORPORATION in writing any
inventions which constitute potential NSUH Patents. CORPORATION
will promptly disclose to NSUH any inventions which constitute
potential NSUH Patents and which are conceived by employees or
consultants of CORPORATION.
b. At the initiative of CORPORATION or NSUH, the parties shall
consult with each other regarding the prosecution of all patent
applications with respect to the Research Technology. Such patent
applications shall be filed, prosecuted and maintained by the law
firm of Xxxxxx & Xxxxxx or by other patent counsel jointly
selected by NSUH and CORPORATION. Copies of all such patent
applications and patent office actions shall be forwarded to each
of NSUH and CORPORATION.
NSUH and CORPORATION shall each also have the right to have such
patent applications and patent office actions independently
reviewed by other patent counsel separately retained by NSUH or
CORPORATION, upon prior notice to and consent of the other party,
which consent shall not unreasonably be withheld.
c. Upon prior written approval by CORPORATION, all applications and
proceedings with respect to the NSUH Patents shall be filed,
prosecuted and maintained by NSUH at the expense of CORPORATION.
Against the submission of invoices, CORPORATION shall reimburse
NSUH for all costs and fees incurred by NSUH during the term of
this Agreement, in connection with the filing, maintenance,
prosecution, protection and the like of the NSUH Patents.
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d. NSUH and CORPORATION shall assist, and cause their respective
employees and consultants to assist each other, in assembling
inventorship information and data for the filing and prosecution
of patent applications on inventions pertaining to the Research
Technology.
e. If at any time during the term of this Agreement CORPORATION
decides that it is undesirable, as to one or more countries, to
prosecute or maintain any patents or patent applications within
the NSUH Patents, it shall give prompt written notice thereof to
NSUH, and upon receipt of such notice CORPORATION 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 Research Technology and
NSUH shall be free to grant rights in and to the Research
Technology in such countries to third parties, without further
notice or obligation to CORPORATION, and the CORPORATION shall
have no rights whatsoever to exploit the Research Technology in
such countries.
f. Nothing herein contained shall be deemed to be a warranty by NSUH
that
i) NSUH can or will be able to obtain any patent or
patents on any patent application or applications in
the NSUH Patents or any portion thereof, or that any
of the NSUH Patents will afford adequate or
commercially worthwhile protection, or
ii) that the manufacture, use, or sale of any element of
the Research Technology or any Licensed Product will
not infringe any patent(s) of a third party.
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7. Grant of License.
a. Subject to the terms and conditions hereinafter set forth, NSUH
hereby grants to CORPORATION and CORPORATION hereby accepts from
NSUH the License.
b. The License granted to CORPORATION in Section 7.a. hereof 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 (hereinafter the "Date of First Commercial
Sale") of Licensed Products in such country or until the
expiration date of the last to expire of the NSUH Patents
whichever shall be later. CORPORATION shall inform NSUH 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. CORPORATION 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 a Corporation Entity or
(ii) to other third parties for consideration and in an
arms-length transaction. All sublicenses shall only be granted by
CORPORATION under a written agreement, a copy of which shall be
provided by CORPORATION to NSUH as soon as practicable after the
signing thereof. Each sublicense granted by CORPORATION hereunder
shall be subject and subordinate to the terms and conditions of
this License Agreement and shall contain (inter-alia) the
following provisions:
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(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 CORPORATION in
Section 11 below, and that the sublicensee shall impose
on its employees, both during the terms of their
employment and thereafter, a similar undertaking of
confidentiality; and
(5) the sublicense agreement shall include the text of
Sections 14 and 15 of this Agreement and shall state
that each of NSUH and North Shore University Hospital
is an intended third party beneficiary of such
sublicense agreement for the purpose of enforcing such
indemnification and insurance provisions.
8. Payments for License.
a. In consideration for the grant and during the term of the License
with respect to each Licensed Product, CORPORATION shall pay to
NSUH:
(1) on the Effective Date, a non-refundable, non-creditable
license issue royalty of Five Thousand Dollars ($55,O0O.O0);
and
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(2) A royalty of one-half percent (0.5%) of the Net Sales of
CORPORATION or of Corporation Entity or of any sublicensee
of CORPORATION or Corporation Entity; and
(3) Ten percent (10%) of any consideration, monetary or
otherwise (not based on Net Sales), received by CORPORATION
from any sublicensee of CORPORATION or a Corporation Entity
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 NSUH hereunder,
the year shall be divided into two parts ending on June 30 and
December 31. Not later than sixty (60) days after each December
and June in each Calendar Year during the term of the License,
CORPORATION shall submit to NSUH a full and detailed report of
royalties or payments due NSUH under the terms of this Agreement
for the preceding half year (hereinafter "the Half-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 and subject of payment.
If no royalties or other payments are due, a statement shall be
sent to NSUH stating such fact. Payment of the full amount of any
royalties or other payments
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due to NSUH for the preceding half year shall accompany each
Half-Year Report on royalties and payments. CORPORATION shall
keep for a period of at least six (6) years after the date of
entry, full, accurate and complete 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 NSUH from CORPORATION 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 CORPORATION shall
furnish NSUH with a report (hereinafter "the Annual Report"),
certified by an independent certified public accountant, relating
to the royalties and other payments due to NSUH 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 8.b. above in respect of the Half-Year Report.
d. On reasonable notice and during regular business hours, NSUH or
the authorized representative of NSUH shall each have the right
to inspect the books of accounts, records and other relevant
documentation of CORPORATION or of Corporation Entity and the
sublicensees of CORPORATION 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 NSUH hereunder, and the accuracy of the information
provided to NSUH in the aforementioned reports.
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9. Method of Payment.
a. Royalties and other payments due to NSUH hereunder shall be paid
to NSUH 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 the Xxxxxx Guaranty Trust Company of 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.
b. CORPORATION shall be responsible for payment to NSUH of all
royalties due on sale, transfer or disposition of Licensed
Products by Corporation Entity or by the sublicensees of
CORPORATION or of Corporation Entity.
10. Development and Commercialization.
a. CORPORATION undertakes to use its best efforts to carry out the
development and commercialization of the Licensed Products,
including but not limited to, the performance of 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. CORPORATION 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
13
CORPORATION 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, CORPORATION shall
carry out such tests, trials, studies and other activities in
accordance with FDA Good Laboratory Practices and in a manner
acceptable to the relevant health authorities. Furthermore, the
Licensed Products shall be produced in accordance with FDA Good
Manufacturing Practice ("GMP") procedures in a facility which has
been certified by the FDA as complying with GMP, provided that
applicable laws, rules and regulations so require.
c. CORPORATION undertakes to begin the regular commercial
production, use, and sale of the Licensed Products in good faith
in accordance with the development plan to be provided to NSUH by
the end of the Research Period and to continue diligently
thereafter to commercialize the Licensed Products.
d. CORPORATION shall provide NSUH with written reports on all
activities and actions undertaken by CORPORATION to develop and
commercialize the Licensed Products; such reports shall be made
within sixty (60) days after each six (6) months of the duration
of this Agreement, commencing six months after the Effective
Date.
e. If CORPORATION shall not commercialize the Licensed Products
within a reasonable time frame, unless such delay is necessitated
by FDA or other regulatory agencies or unless NSUH and
CORPORATION have mutually agreed
14
to amend the Development Plan because of unforeseen
circumstances, NSUH shall notify CORPORATION in writing of
CORPORATION's failure to commercialize and shall allow
CORPORATION sixty (60) days to cure its failure to commercialize.
CORPORATION's failure to cure such delay to NSUH's reasonable
satisfaction within such 60-day period shall be a material breach
of this Agreement.
11. CONFIDENTIAL INFORMATION.
a. Except as otherwise provided in Section 11.c. and Section 12
below, NSUH shall maintain any and all of the Research Technology
in confidence and shall not release or disclose any tangible or
intangible component thereof to any third party without first
receiving the prior written consent of CORPORATION to said
release or disclosure.
b. Except as otherwise provided in Section 11.c. and 11.d. below
CORPORATION shall maintain any and all of the Research Technology
in confidence and shall not release or disclose any tangible or
intangible component thereof to any third party without first
receiving the prior written consent of NSUH to said release or
disclosure.
c. The obligations of confidentiality on each party set forth in
Sections 11 .a. and b. shall not apply to any component of the
Research Technology which 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 the receiving party after the effective date of this Agreement
or which is disclosed to the receiving party by a third party who
has the right to make such disclosure.
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d. The provisions of Section 11.b. notwithstanding, CORPORATION may
disclose the Research Technology to third parties who need to
know the same in order to secure regulatory approval for the sale
of Licensed Products.
12. Publication.
a. Prior to submission for publication of a manuscript describing
the results of any aspect of the NSUH Research Project, NSUH
shall send CORPORATION a copy of the manuscript to be submitted,
and shall allow CORPORATION thirty (30) days from the date of
such mailing to determine whether the manuscript contains such
subject matter for which patent protection should be sought prior
to publication of such manuscript, for the purpose of protecting
an invention made by the NSUH Scientists during the course and
within the term of the NSUH Research Project. Should CORPORATION
believe the subject matter of the manuscript contains a
patentable invention, then, prior to the expiration of such
30-day period from the mailing date of such manuscript to
CORPORATION by NSUH, CORPORATION shall give written notification
to NSUH of:
i) its determination that such manuscript contains
patentable subject matter for which patent protection
should be sought; and
ii) the countries in which such patent protection should be
sought.
b. After the expiration of such 30-day period from the date of
mailing such manuscript to CORPORATION, unless NSUH has received
the written notice specified above from CORPORATION, NSUH shall
be free to submit such manuscript for publication to publish the
disclosed research results in any manner consistent with academic
standards.
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c. Upon receipt of such written notice from CORPORATION, NSUH will
thereafter delay submission of the manuscript for an additional
period of up to thirty (30) days to permit the preparation and
filing in accordance with Section 6. hereof of a U.S. patent
application by NSUH on the subject matter to be disclosed in such
manuscript. After expiration of such 30-day period, or the filing
of a patent application on each such invention, whichever shall
occur first, NSUH shall be free to submit the manuscript and to
publish the disclosed results.
13. Infringement of NSUH Patent.
a. In the event a party to this Agreement acquires information that
a third party is infringing one or more of the NSUH 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 NSUH Patent, CORPORATION
shall be privileged but not required to bring suit against the
infringer. Should CORPORATION elect to bring suit against an
infringer and NSUH is joined as a party plaintiff in any such
suit, NSUH shall have the right to approve the counsel selected
by CORPORATION to represent CORPORATION and NSUH. The expenses of
such suit or suits that CORPORATION elects to bring, including
any expenses of NSUH incurred in conjunction with the prosecution
of such suit or the settlement thereof, shall be paid for
entirely by CORPORATION and CORPORATION shall hold NSUH free,
clear and harmless from and against any and all costs of such
litigation, including attorneys' fees. CORPORATION shall
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not compromise or settle such litigation without the prior
written consent of NSUH which shall not be unreasonably withheld.
c. In the event CORPORATION 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, necessarily involved in the
prosecution of any such suit, and if after such reimbursement,
any funds shall remain from said recovery, CORPORATION shall
promptly pay to NSUH an amount equal to fifty percent (50%) of
such remainder and CORPORATION shall be entitled to receive and
retain the balance of the remainder of such recovery.
d. If CORPORATION does not bring suit against said infringer
pursuant to Section 13.b. herein, or has not commenced
negotiations with said infringer for discontinuance of said
infringement, within ninety (90) days after receipt of such
notice, NSUH shall have the right, but shall not be obligated, to
bring suit for such infringement. Should NSUH elect to bring suit
against an infringer and CORPORATION is joined as a party
plaintiff in any such suit, CORPORATION shall have the right to
approve the counsel selected by NSUH to represent NSUH and
CORPORATION, and NSUH shall hold CORPORATION free, clear and
harmless from and against any and all costs and expenses of such
litigation including attorneys' fees. If CORPORATION has
commenced negotiations with an alleged infringer of the NSUH
Patent for discontinuance of such infringement within such 90-day
period, CORPORATION shall have an additional ninety (90) days
from the termination of such initial 90-day period to conclude
its negotiations before NSUH may bring suit for such
infringement. In the event
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NSUH brings suit for infringement of any NSUH Patent, NSUH 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 said recovery, NSUH shall promptly pay to CORPORATION an
amount equal to fifty percent (50%) of such remainder and NSUH
shall be entitled to receive and retain the balance of the
remainder of such recovery.
e. Each party shall always have the right to be represented by
counsel of its own selection in any suit for infringement of the
NSUH Patents instituted by the other party to this Agreement
under the terms hereof. The expense of such counsel shall be
borne by the party initiating such infringement suit.
f. CORPORATION agrees to cooperate fully with NSUH at the request of
NSUH, including, by giving testimony and producing documents
lawfully requested in the prosecution of any suit by NSUH for
infringement of the NSUH patents; provided, NSUH shall pay all
reasonable expenses (including attorneys' fees) incurred by
CORPORATION in connection with such cooperation. NSUH shall
cooperate and shall endeavor to cause the NSUH Scientists to
cooperate with CORPORATION at the request of CORPORATION,
including by giving testimony and producing documents lawfully
requested, in the prosecution of any suit by CORPORATION for
infringement of the NSUH Patents; provided, that CORPORATION
shall pay all reasonable expenses (including attorneys' fees)
incurred by NSUH in connection with such cooperation.
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14. Liability and Indemnification.
a. CORPORATION shall indemnify, defend and hold harmless NSUH and
its trustees, directors, 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 judgements (i)
arising out of the design, production, manufacture, sale, use in
commerce or in human clinical trials, lease, or promotion by
CORPORATION or by a sublicensee, Corporation Entity or agent of
CORPORATION 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, CORPORATION's indemnification
under subsection a.(i) of this Section 14 shall apply to any
liability, damage, loss or expense whether or not it is
attributable to the negligent activities of such Indemnitee.
CORPORATION's indemnification obligation under subsection a.(ii)
of this Section 14 shall not apply to any liability, damage, loss
or expense to the extent that it is attributable to the negligent
activities of any such Indemnitee.
c. CORPORATION agrees, at its own expense, to provide attorneys
reasonably acceptable to NSUH 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.
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d. All references in this Section 14 and in Section 15 below to
"NSUH" shall be deemed to include North Shore University Hospital
Research Corporation and North Shore University Hospital.
15. Security of 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 CORPORATION or by a
sublicensee, Corporation Entity or agent of CORPORATION,
CORPORATION shall at its sole cost and expense, procure and
maintain policies of comprehensive general liability insurance in
amounts not less than $5,000,000 per incident and $10,000,000
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 CORPORATION's indemnification
under Section 14 of this Agreement. If CORPORATION elects to
self-insure all or part of the limits described above (including
deductibles or retentions which are in excess of $250,000 annual
aggregate) such self-insurance program must be acceptable to
NSUH.
The minimum amounts of insurance coverage required under this
Section 15 shall not be construed to create a limit of
CORPORATION's liability with respect to its indemnification under
Section 14 of this Agreement.
b. CORPORATION shall provide NSUH with written evidence of such
insurance upon request of NSUH. CORPORATION shall provide NSUH
with written notice at least sixty (60) days prior to the
cancellation, non-renewal or material
22
change in such insurance; if CORPORATION does not obtain
replacement insurance providing comparable coverage within such
sixty (60) day period, NSUH 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. CORPORATION 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 CORPORATION or by a
sublicensee, Corporation Entity or agent of CORPORATION 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.
16. Expiry and Termination.
a. Unless earlier terminated pursuant to this Section 16 or Section
8.e., hereof, this Agreement shall expire upon the expiration of
the period of the License in all countries as set forth in
Section 7.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 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
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 NSUH or
CORPORATION discontinues its business or becomes insolvent or
bankrupt.
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 two percent (2%) 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.
d. Upon termination of this Agreement for any reason and prior to
expiration as set forth in Section 16.a. hereof, all rights in
and to the Research Technology shall revert to NSUH, and
CORPORATION shall not be entitled to make any further use
whatsoever of the Research Technology.
e. Termination of this Agreement shall not relieve either party of
any obligation to the other party incurred prior to such
termination.
f. Sections 5, 11, 14, 15, 16 and 20 hereof shall survive and remain
in full force and effect after any termination, cancellation or
expiration of this Agreement.
17. Representations and Warranties of CORPORATION.
CORPORATION hereby represents and warrants to NSUH as follows:
(1) CORPORATION is a corporation duly organized, validly existing and
in good standing under the laws of the State of Florida.
CORPORATION has been granted all requisite power and authority to
carry on its business and to own and
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operate its properties and assets. The execution, delivery and
performance of this Agreement have been duly authorized by the
Board of Directors of CORPORATION if such authorization is
required for the execution, delivery and/or performance of this
Agreement. This Agreement has been duly executed and delivered by
CORPORATION.
(2) There is no pending or, to CORPORATION's knowledge, threatened
litigation involving CORPORATION which would have any effect on
this Agreement or on CORPORATION's ability to perform its
obligations hereunder; and
(3) There is no indenture, contract, or agreement to which
CORPORATION is a party or by which CORPORATION is bound which
prohibits or would prohibit the execution and delivery by
CORPORATION of this Agreement or the performance or observance by
CORPORATION of any term or condition of this Agreement.
18. Representations and Warranties of NSUH.
NSUH hereby represents and warrants to CORPORATION as follows:
(1) NSUH is a corporation duly organized, validly existing and in
good standing under the laws of the State of New York. NSUH 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 NSUH if such
authorization is required for the execution, delivery and/or
performance of this Agreement. This Agreement has been duly
executed and delivered by NSUH.
(2) There is no pending or, to NSUH's knowledge, threatened
litigation involving NSUH which would have any effect on this
Agreement or on NSUH's ability to perform its obligations
hereunder; and
(3) There is no indenture, contract, or agreement to which NSUH is a
party or by which NSUH is bound which prohibits or would prohibit
the execution and delivery by NSUH of this Agreement or the
performance or observance by NSUH of any term or condition of
this Agreement.
19. No Assignment.
Neither CORPORATION nor NSUH 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, except
that NSUH shall have the right at any time to assign, delegate or
transfer, in whole or in part, its rights, duties or interest herein to
North Shore University Hospital. Nothing contained herein prohibits the
transfer of this Agreement to successors through merger or other
corporate restructurings involving the CORPORATION.
20. Use of Name.
Without the prior written consent of the other party, neither
CORPORATION nor NSUH shall use the name of the other party or any
adaptation thereof or of any staff member, employee or student of the
other party:
i) in any product labeling, advertising, promotional or sales
literature;
25
ii) in connection with any public or private offering or in
conjunction with any application for regulatory approval, unless
disclosure is otherwise required by law, in which case either
party may make factual statements concerning the Agreement or
file copies of thc Agreement after providing the other party with
an opportunity to comment and reasonable time within which to do
so on such statement in draft.
Except as provided herein, neither NSUH nor CORPORATION will issue
public announcements about this Agreement or the status or existence of
the NSUH Research Project without prior written approval of the other
party. References in this Section 20 to "NSUH" shall be deemed to
include North Shore University Hospital Research Corporation and North
Shore University Hospital.
21. 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 Xxxxx 00 Xxxxxx Xxxxxx Code ss.200
et seq. and 15 CFR ss.368 et seq.
b. If any provision of this Agreement is determined to be invalid or
void, the remaining provisions shall remain in effect.
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 Staze of New York.
26
d. Any dispute arising under this Agreement shall be resolved in an
action in the courts of New York State or the federal courts
located in New York State, and the parties hereby consent to
personal jurisdiction of such courts in any action.
e. 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 NSUH: North Shore University Hospital Research Corporation
000 Xxxxxxxxx Xxxxx
Xxxxxxxxx, XX 00000
Attn: Xxxx S.T. Xxxxxxxxx
President
And
Copy to: North Shore Health System
000 Xxxxxxxxx Xxxxx
Xxxxx Xxxx, XX 00000
Attn: Xxxxx X. Xxxxx
Vice President/Legal Affairs
To CORPORATION: Gentest, Inc.
0000 Xxxx Xxxxx
Xxxxx Xxxx, Xxxxxxx 00000
Attn: Xxxxx Xxxxx, President
And
Copy to: UTEK Corporation
000 Xxxxx Xxxxxxx Xxxxxx
Xxxxx Xxxx, Xxxxxxx 00000
27
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 four (4) 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 Agreement supersedes any and all prior agreements or
understandings, whether oral or written, between CORPORATION and
NSUH with respect to the subject matter of this Agreement.
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.
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IN WITNESS WHEREOF, the parties hereto have executed this Agreement
effective as of the date and year first above written.
NORTH SHORE UNIVERSITY HOSPITAL
RESEARCH CORPORATION
By: /s/ XXXX S.T. XXXXXXXXX
Title: President
Date: 6/23/98
GENTEST, INC.
By: /s/ XXXXXXXX XXXXX
Title: President
Date: 6/22/98
29
