AGREEMENT
Between
NEW YORK UNIVERSITY
and
COLLATERAL THERAPEUTICS, INC.
NYU/COLLATERAL THERAPEUTICS
Research & License Agreement
INDEX
Section l Definitions page 1
Section 2 Effective Date page 4
Section 3 Performance of the NYU Research Project page 4
Section 4 Funding of the NYU Research Project page 5
Section 5 Title page 5
Section 6 Patents and Patent Applications page 6
Section 7 Grant of License page 8
Section 8 Payments for License page 9
Section 9 Method of Payment page 12
Section 10 Development and Commercialization page 13
Section 11 Confidential Information page 15
Section 12 Publication page 15
Section 13 Liability and Indemnification page 16
Section 14 Security for Indemnification page 17
Section 15 Expiry and Termination page 18
Section 16 Representations and Warranties by CORPORATION page 19
Section 17 Representations and Warranties by NYU page 20
Section 18 No Assignment page 21
Section 19 Use of Xxxxx page 21
Section 20 Miscellaneous page 22
Appendix I Pre Existing Inventions
Appendix II Research Program
Appendix III Development Plan
RESEARCH AND LICENSE AGREEMENT
This Agreement, effective as of March 24, 1997 (the "Effective Date"), is
by and between NEW YORK UNIVERSITY (herein-after "NYU"), a 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 COLLATERAL
THERAPEUTICS, INC. (hereinafter "CORPORATION"), a corporation organized and
existing under the laws of the State of California, having its principal office
at 0000 Xxxxx Xxxxxx Xxxxx, Xxx Xxxxx, Xxxxxxxxxx 00000.
RECITALS
WHEREAS, Xx Xxxxxxx Xxxxxxxx of NYU (hereinafter "the NYU Scientist"),
together with other co-inventors, has made certain inventions all as more
particularly described in an issued U S. patent and U. S patent applications and
foreign patent applications owned by NYU, in each case identified in annexed
Appendix I and forming an integral part hereof (hereinafter "the PreExisting
Inventions");
WHEREAS, NYU is willing to perform the NYU Research Project (as
hereinafter defined);
WHEREAS, CORPORATION is prepared to sponsor the NYU Research Project;
WHEREAS, subject to the terms and conditions hereinafter set forth, NYU is
willing to grant to CORPORATION and CORPORATION is willing to accept from NYU
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" it 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 fifty percent (50%)
or more of (i) the capital and/or (ii) the voting rights and/or
(iii) the right to elect or appoint directors.
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(c) "Date of First Commercial Sale" shall have the meaning set forth in
Section 7(b) hereof.
(d) "FGF-4" shall mean Fibroblast Growth Factor 4 the amino acid
sequence of which is provided in Figure 1 in the article by X. Xxxxx
Bovi, A.M. Xxxxxxxx, X. X. Xxxx, X. Xxxxx, X. Xxxxxxx, and X.
Xxxxxxxx published in Cell, Volume 50, pages 729-737, August 28,
1987.
(e) "Field" shall mean gene therapy for coronary artery disease,
congestive heart failure, and peripheral vascular disease.
(f) ***
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(g) "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) in the Field and the exclusive worldwide right to
sublicense such rights in accordance with Section 7(c).
(h) "Licensed Products" shall mean products comprising a nucleic acid
sequence encoding FGF-4 or fragments or analogs thereof, in each
case which are covered by a claim of any unexpired patent within the
NYU Patents (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 of any active patent application within the
NYU Patents, or which utilize all or any portion of NYU Know-How.
(i) "Net Sales" shall mean the total amount invoiced in connection with
sales of Licensed Products by CORPORATION, any Corporation Entity or
any sublicensee of CORPORATION, any Corporation Entity or a
sublicensee in accordance with Section 7(c)(iii), in each case to
end users; provided that Net Sales shall (i) not include any amounts
invoiced in connection with sales of Licensed Products for (A)
transportation charges, including insurance relating thereto, or (B)
sales and excise taxes, value-added taxes or customs duties paid by
the
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person selling or distributing any Licensed Product or any other
governmental charges imposed upon the sale or distribution of any
Licensed Product; and (ii) be adjusted to reflect any deductions to
amounts invoiced to take account of (X) distributors' fees, rebates,
allowances or sales commissions actually granted, allowed or
incurred and credits for returns or (Y) quantity or case discounts,
cash discounts or chargebacks actually granted, allowed or incurred
in the ordinary course of business in connection with the sale or
distribution of any Licensed Product; provided, further, that Net
Sales shall not include amounts invoiced by CORPORATION to any
person or entity that is a Corporation Entity or a sublicensee of
CORPORATION or a Corporation Entity under the License.
(j) "NYU Know-How" shall mean the Pre-Existing Inventions, any
proprietary information or proprietary materials including, but not
limited to, pharmaceutical, chemical, biological and biochemical
products, information and trade secrets, know-how, technical and
nontechnical 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 students or employees of NYU during the term and in
the course of the NYU Research Project.
(k) "NYU Patents" shall mean all United States and foreign patents and
patent applications, and any divisions, continuations, in whole or
in part, reissues, re-examinations, renewals and extensions thereof,
and pending applications therefor:
(1) which claim Pre-Existing Inventions and which are identified
on annexed Appendix I; or
(2) which claim inventions that are made, in whole or in part, by
students or employees of NYU during the term and in the course
of the NYU Research Project.
(l) "Research Period" shall mean the three-year period commencing on the
Effective Date hereof and any extension thereof as to which NYU and
CORPORATION shall mutually agree in writing.
(m) "NYU Research Project" shall mean the investigations at NYU during
the Research Period into the Field under the supervision of the NYU
Scientist in
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accordance with the research program, described in annexed Appendix
II, which forms an integral part hereof.
(n) "Research Technology" shall mean all NYU Patents and NYU Know-How.
(o) "Total Net Sales" shall mean the aggregate Net Sales of CORPORATION,
any Corporation Entity and any sublicensee of CORPORATION or any
Corporation Entity to end users of Licensed Products.
2. Effective Date.
This Agreement shall be effective as of the date first written above and
shall remain in full force and effect until it expires or is terminated in
accordance with Section 16 hereof.
3. Performance of the NYU Research Project.
(a) In consideration of the sums to be paid to NYU as set forth in
Section 4 below, NYU undertakes to perform the NYU Research
Project under the supervision of the NYU Scientist during the
Research Period, as such Project may be amended in accordance
with Section 20(f). If, during the Research Period the NYU
Scientist shall cease to supervise the NYU Research Project,
then NYU shall promptly so notify CORPORATION and shall
endeavor to find among the scientists of NYU a Scientist
acceptable to CORPORATION to continue the supervision of the
NYU Research Project. If NYU is unable to find such a
Scientist acceptable to CORPORATION within three months after
such notice to CORPORATION, CORPORATION shall have the option
to terminate its funding of the NYU Research Project.
CORPORATION shall promptly advise NYU 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 NYU to find a replacement
for the NYU Scientist.
(b) Nothing contained in this Agreement shall be construed as a
warranty on the part of NYU that any results or inventions
will be achieved by the NYU Research Project, or that the
Research Technology and/or any other results or inventions
achieved by the NYU Research Project, if any, are or will be
commercially exploitable and furthermore, NYU makes
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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 NYU Research Project.
(c) NYU will have full authority and responsibility for the NYU
Research Project. All students and employees of NYU who work
on the NYU Research Project will do so as employees or
students of NYU, and not as employees of CORPORATION.
(d) NYU shall provide to CORPORATION a report on the NYU Research
Project within ninety (90) days following the end of each
twelve-month period occurring during the Research Period.
4. Funding of the NYU Research Project.
(a) As compensation to NYU for work to be performed on the NYU
Research Project during the Research Period, subject to any
earlier termination of the Research Project pursuant to
Section 3(a) hereof, CORPORATION will pay NYU the total sum of
*** *** ***.
(b) Nothing in this Agreement shall be interpreted to prohibit NYU
(or the NYU Scientist) from obtaining additional financing or
research grants for the NYU Research Project from government
agencies, which grants or financing may render all or part of
the NYU 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 NYU. At the
request of NYU, CORPORATION 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.
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(b) Subject to the License granted to CORPORATION hereunder, for
so long as the NYU Scientist is employed by NYU, any and all
inventions made by such NYU Scientist and relating to the
Field shall be owned solely by NYU.
6. Patents and Patent Applications.
(a) NYU will promptly disclose to CORPORATION in writing any
inventions which constitute potential NYU Patents developed in
the course of the NYU Research Project.
(b) At the initiative of CORPORATION or NYU, the parties shall
consult with each other regarding the prosecution of all
patent applications within NYU Patents (excluding any
Pre-Existing Invention). Such patent applications shall be
filed, prosecuted and maintained by the law fire of Xxxxx &
Xxxxx or by other patent counsel jointly selected by NYU and
CORPORATION. Copies of all such patent applications and patent
office actions shall be forwarded to each of NYU and
CORPORATION.
NYU 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 NYU or CORPORATION, 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 NYU Patents
(other than those relating to any Pre-Existing Invention)
shall be filed, prosecuted and maintained by NYU at the
expense of CORPORATION. Against the submission or invoices,
CORPORATION shall reimburse NYU for all costs and fees
incurred by NYU during the term of this Agreement, in
connection with the filing, maintenance, prosecution,
protection and the like of such patents.
(d) NYU 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.
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(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 NYU Patents (other than those relating to any
Pre-Existing Invention), it shall give prompt written notice
thereof to NYU, 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 NYU 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) Under the *** provisions exist to determine the circumstances
under which patent, protection will be obtained by NYU with
respect to any Pre-Existing Invention. For patent applications
with respect to Pre-Existing Inventions, copies of such
applications and office actions shall be forwarded to
CORPORATION who may consult with NYU with regard thereto.
CORPORATION agrees, upon presentation of supporting
documentation, to reimburse NYU for *** of the expenses
incurred by NYU as of the Effective Date in connection with
obtaining such patent protection. In the event that such
separate provisions result in a situation where patent
protection in any country is not pursued by NYU because of a
lack of funding pursuant to such provisions, then NYU shall
notify CORPORATION thereof and CORPORATION shall have the
option to pay NYU to pursue such patent protection.
(g) 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
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(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.
7. Grant of License.
(a) Subject to the terms and conditions hereinafter set forth, and
subject to any rights of the U.S. Government pursuant to Title
35 of the United States Code ss.200 et seq., NYU hereby grants
to CORPORATION and CORPORATION hereby accepts from NYU the
License.
(b) The License granted to CORPORATION in Section 7(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 patent within the NYU
Patents in any such country to expire, whichever shall be
later CORPORATION 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) 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 NYU 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:
(1) the sublicense shall expire automatically on the
termination of the License;
(2) the sublicense shall not be assignable, in whole or in
part;
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(3) the sublicensee shall not grant further sublicenses,
except that a sublicensee may grant a further sublicense
solely for purposes of effecting distribution of
Licensed Products to end users on the same terms
required for sublicenses under this Section 7(c);
(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 13 and 14 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.
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 NYU:
(1) On the Effective Date, a non-refundable, noncreditable
license issue fee of one hundred thousand dollars
($100,000);
(2) On the *** of the *** *** and *** ***, a *** license ***
of *** *** ; provided that such fee *** on the *** ***
following the completion by CORPORATION of *** *** of
*** in accordance with the terms of this Agreement;
(3) Upon the achievement of the following technical
milestones with respect to any Licensed Product, the
payments as indicated below:
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Milestone Payments
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Upon the filing of an initial Investigational New Drug Application (or foreign
equivalent thereof) for each new Licensed Product
$250,000
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(4) With respect to sales of Licensed Products a *** of Total Net
Sales during each calendar year.
(b) For the purpose of computing the royalties due to NYU hereunder, the
year shall be divided into two parts ending on June 30 and December
31. Not later than one hundred thirty (130) days after each December
and June in each Calendar Year during the term of the License,
CORPORATION shall submit to NYU a full and detailed report of
royalties or payments due NYU under the terms of this Agreement for
the preceding half year (hereinafter "the Half-Year Report"),
setting forth the Total Net Sales and Net Sales of each of
CORPORATION, each Corporation Entity and each sublicensee of
CORPORATION, any Corporation Entity or sublicensee permitted under
Section 7(c)(iii) 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 on a country-by-country basis;
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(ii) the selling price of each Licensed Product;
(iii) the deductions permitted under subsection 1(i) 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 NYU stating such fact. Payment of the full amount of any
royalties or other payments due to NYU for the preceding half year
shall accompany each Half-Year Report on royalties and payments.
CORPORATION shall keep for a period of at least *** after the date
of entry, full, accurate and 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 CORPORATION pursuant to the xxxxx of this Agreement.
(c) Within ninety (90) days after the end of each Calendar Year,
commencing on the Date of First Commercial Sale CORPORATION
shall furnish NYU with a report (hereinafter the "Annual
Report"), certified by an independent certified public
accountant, 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 8(b) above in respect of
the Half-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 CORPORATION or of Corporation Entity and the
sublicensees of CORPORATION, Corporation Entity and any
sublicensee 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. NYU shall also
have the right, not more than once each calendar year, to
audit CORPORATION's books and financial records for the
purpose of verifying full
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payment by CORPORATION of its royalty obligations hereunder.
Such audits shall be conducted during normal business hours
and shall not interfere with CORPORATION's conduct of its
business. Each such audit shall be at NYU's expense, unless a
particular audit reveals an underpayment of *** or more of the
amount that should have been paid to NYU for the period
audited, in which case CORPORATION shall bear the expense of
such audit. In the event of any underpayment of royalties,
CORPORATION shall promptly remit to NYU all amounts due.
(e) Beginning in the year in which CORPORATION completes one full
year of sales of Licensed Products and continuing thereafter
until this Agreement shall terminate or expire, CORPORATION
agrees that if the total royalties paid to NYU under
subsection 8(a)(4) hereof do not amount to *** in each
Calendar Year, CORPORATION will pay to NYU within one hundred
thirty (130) days after the end of each such Calendar Year,
*** *** the *** *** *** *** failing which NYU shall have the
right solely at its election, upon written notice to
CORPORATION, to either terminate this Agreement for cause or
to declare the License granted herein to CORPORATION to be
non-exclusive.
(f) CORPORATION shall, and shall cause each Corporation Entity and
sublicensee of CORPORATION, Corporation Entity or a
sublicensee, to effect sales of Licensed Products to third
parties on commercially reasonable, arm's length terms.
9. 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 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.
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(b) CORPORATION shall be responsible for payment to NYU of all
royalties due on sale, transfer or disposition of Licensed
Products by Corporation Entity or by the sublicensees of
CORPORATION, Corporation Entity or a sublicensee.
10. Development and Commercialization.
(a) It shall be within the judgment of CORPORATION
in what manner to proceed with the development
of Licensed Products for commercialization;
provided that CORPORATION shall use efforts,
consistent with its sound and reasonable
business practices and technical judgment, to
effect introduction of Licensed Products into
the commercial market. CORPORATION shall be
deemed to satisfy the due diligence requirements
of this Section 10(a) by: ***
***
***
***
***
***
***
***
***
***
***
*** .
Corporation's Development Plan is annexed hereto as Appendix III.
(b) Provided that applicable laws, rules and regulations require that
the performance of the tests, trials, studies and other activities
required by subsection (a) above shall be carried out in accordance
with FDA current Good Laboratory Practices, current Good
Manufacturing Practices and current Good Clinical 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 such Practices and in a manner acceptable to the
relevant health authorities. Furthermore, the Licensed Products
shall be produced in accordance with FDA current Good Manufacturing
Practice procedures in a facility which has been licensed by the FDA
to manufacture such Licensed Products, provided that applicable
laws, rules and regulations so require.
(c) CORPORATION undertakes to begin the regular commercial production,
use, and sale of the Licensed
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Products in each counted in which approve has been received (as
described in Section 10(a)) and to continue diligently thereafter to
commercialize the Licensed Products in each such country in a manner
consistent with sound and reasonable business practices.
(d) CORPORATION shall provide NYU 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 satisfy the requirements set forth in
Section 10(a) (unless such delay or failure is necessitated by FDA
or other regulatory agencies or unless NYU and CORPORATION have
mutually agreed to amend the Development Plan because of
unforeseen circumstances) NYU shall notify CORPORATION in writing
of CORPORATION's failure and shall allow CORPORATION *** to cure
such failure Upon receiving such notice, CORPORATION may elect to
extend such diligence period and all subsequent diligence periods
relating to such Licensed Product for *** upon written certification
to NYU that CORPORATION is continuing product development work with
respect to a Licensed Product and payment to NYU of a *** *** .
After the expiration of any such *** CORPORATION may elect to
further extend its diligence obligations under Section 10(a) with
respect to such Licensed Product for successive *** upon (i) written
notice to NYU, (ii) certification by CORPORATION that it is
continuing to diligently develop such Licensed Product and, together
with its sublicensee(s), will spend no less than *** *** in each
Calendar Year on development of such Product and (iii) payment to
NYU prior to the beginning of such year of an amount equal to ***
representing *** *** . CORPORATION's failure to cure a delay in the
diligence requirements to NYU's reasonable satisfaction or elect and
satisfy the requirements of one of the options set forth above
within such *** shall be a material breach of this Agreement.
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11. Confidential Information.
(a) Except as otherwise provided in Section 11(b) and 11(c) 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 NYU to
said release or disclosure; provided that CORPORATION may,
without NYU's consent, disclose Research Technology to
sublicensees pursuant to Section 7, CORPORATION Entities and
consultants engaged by CORPORATION, in each case pursuant to a
confidentiality agreement requiring such party to maintain any
and all of the Research Technology in confidence and 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 Section 11(a)
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
CORPORATION after the effective date of this Agreement or
which is disclosed to CORPORATION by a third party who has the
right to make such disclosure.
(c) The provisions of Section 11(a) 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 NYU Research Project, NYU
shall send CORPORATION a copy of the manuscript to be
submitted by overnight mail or facsimile transmission, and
shall allow CORPORATION *** 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 NYU Scientist during the course and
within the term of the NYU Research Project.
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Should CORPORATION believe the subject matter of the
manuscript contains a patentable invention, then, prior to the
expiration of such *** from the mailing date of such
manuscript to CORPORATION by NYU, CORPORATION shall give
written notification to NYU 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 *** from the date of mailing such
manuscript to CORPORATION, unless NYU has received the written
notice specified above from CORPORATION, NYU Shall be free to
submit such manuscript for publication to publish the
disclosed research results in any manner consistent with
academic standards.
(c) Upon receipt of such written notice from CORPORATiON, NYU will
thereafter delay submission of the manuscript for an
additional period of up to *** to permit the preparation and
filing in accordance with Section 6 hereof of a U.S. patent
application by NYU on the subject matter to be disclosed in
such manuscript. After expiration of such *** or the filing of
a patent application on each such invention, whichever shall
occur first, NYU shall be free to submit the manuscript and
to publish the disclosed results.
13. Liability and Indemnification.
(a) CORPORATION 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 CORPORATION, a Corporation Entity or an agent of
CORPORATION, or by a sublicensee of CORPORATION, a
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
17
Corporation Entity or a sublicensee, 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 13 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 13 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 NYU to defend against any actions
brought or filed against any Indemnitee with respect to the
subject indemnity to which such Indemnitee is entitled
hereunder, whether or not such actions are rightfully brought.
14. 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 CORPORATION or by a
sublicensee, Corporation Entity or agent of CORPORATION,
CORPORATION shall at its sole cost and expense procure and
maintain, or cause a sublicensee, Corporation Entity or agent
of CORPORATION to procure and maintain, policies of
comprehensive general liability insurance in amounts not
less than *** per incident and *** 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 13 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 *** annual aggregate) such
self-insurance program must be acceptable to NYU.
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18
The minimum amounts of insurance coverage required under this
Section 14 shall not be construed to create a limit of
CORPORATION's liability with respect to its indemnification
under Section 13 of this Agreement.
(b) CORPORATION shall provide NYU with written evidence of such
insurance upon request of NYU. CORPORATION shall provide NYU
with written noticed at least *** prior to the cancellation,
nonrenewal or material change in such insurance; if
CORPORATION does not obtain replacement insurance providing
comparable coverage within such *** *** NYU shall have the
right to terminate this Agreement effective at the end of
such *** 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 *** *** .
15. Expiry and Termination.
(a) Unless earlier terminated pursuant to this Section 15 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
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
19
any amounts due hereunder, *** (unless otherwise specified
herein) after the giving of notice by the other party
specifying such breach or default, or if either NYU or
CORPORATION discontinues its business or becomes insolvent or
bankrupt.
(c) In the event that CORPORATION determines, at any time
following the end of the Research Period, to cease all
development or commercialization of all Licensed Products
covered by this Agreement, CORPORATION may terminate this
Agreement by notifying NYU in writing thereof no less than ***
*** prior to the date of termination.
(d) 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 earn interest from such date until the
date on which such payment is made, at the rate of *** *** ***
during the period of arrears and such amount and the interest
thereon may be set of against any amount due, whether in terms
of this Agreement or otherwise, to the party in default by any
non-defaulting party.
(e) Upon termination of this Agreement for any reason and prior to
expiration as set forth in Section 15(a) hereof, all rights in
and to the Research Technology shall revert to NYU, and
CORPORATION shall not be entitled to make any further use
whatsoever of the Research Technology.
(f) Termination of this Agreement shall not relieve either party
of any obligation to the other party incurred prior to such
termination.
(g) Sections 5, 11, 13, 14, 15 and 19 hereof shall survive and
remain in full force and effect after any termination,
cancellation or expiration of this Agreement.
16. Representations and Warranties by CORPORATION.
CORPORATION hereby represents and warrants to NYU as follows:
(1) CORPORATION is a corporation duly organized, validly existing
and in good standing under the laws of the State of
California. CORPORATION has been granted all requisite power
and authority to carry
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20
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 CORPORATION;
(2) There is no pending or, to CORPORATION's kowledge, threatened
litigation involving CORPORATION which would have any effect
on this Agreement or on CORPORATION's ability to perform its
obligations hereunder;
(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; and
(4) CORPORATION has received and reviewed copies of the *** (with
the exception of those sections of the February 6, 1989
Agreement following section 4.1) and understands and accepts
the terms thereof that it has received and reviewed.
17. Representations and Warranties by NYU.
NYU hereby represents and warrants to CORPORATION 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 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; and
(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.
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21
(4) As of the Effective Date, NYU is not aware of any prior art
that would invalidate any patent or patent claim, or that
would prevent from issuing any patent application covered by
the NYU Patents.
18. No Assignment.
Neither CORPORATION 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 that (i)
CORPORATION may, without the prior consent of NYU, assign all of its
rights and obligations under this Agreement to a third party in
connection with a merger or corporate restructuring of CORPORATION
or a sale of all or substantially all of its assets, following
written notice thereof and execution by the third party with NYU of
an agreement to be bound by the terms of this Agreement and (ii) NYU
may assign its interest in this Agreement in whole or in part
without the consent of CORPORATION if such assignee (A) is a parent,
subsidiary, affiliate or related entity to NYU or (B) is a entity
that acquires substantially all of the ownership interests or assets
of NYU or New York University Medical Center (or any successor to
the foregoing) or (C) is an entity formed by NYU or New York
University Medical Center (or any successor to the foregoing) and
other institutions, one of the purposes of which is to perform the
activities for which NYU is obligated pursuant to this Agreement.
19 Use of Name.
Without the prior written consent of the other party, neither
CORPORATION nor NYU 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;
(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
the Agreement after providing the other party with an
oppor-
22
tunity to comment and reasonable time within which to do
so on such statement in draft.
Except as provided herein, neither NYU nor CORPORATION will issue
public announcements about this Agreement or the status or existence
of the NYU Research Project without prior written approval of the
other party.
20. 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 State of New York.
(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 NYU: New York University Medical Center
000 Xxxxx Xxxxxx
Xxx Xxxx, XX 00000
Attention: Xxxxx X. Xxxxxxxx
Vice President for
Industrial Liaison
and
23
Office of Legal Counsel
New York University
Xxxxx Library
00 Xxxxxxxxxx Xxxxxx Xxxxx
Xxx Xxxx, XX 00000
Attention: Xxxxx X. Xxxxxx
Associate General Counsel
TO CORPORATION:
Collateral Therapeutics, Inc.
0000 Xxxxx Xxxxxx Xxxxx
Xxx Xxxxx, Xxxxxxxxxx 00000
Attention: Xxxx X. Xxxxx, PhD
President and Chief
Executive Officer
or such other address or addresses as either parry 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 Agreement supersedes any and all
prior agreements or understandings, whether oral or written,
between CORPORATION 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 nonperformance.
(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
24
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
By: /s/ Xxxxx X. Xxxxxxxx
-------------------------------------------
Xxxxx X. Xxxxxxxx
Title: Vice President for Industrial Liaison
----------------------------------------
Date: 3/24/87
-----------------------------------------
Collateral Therapeutics, Inc.
By: /s/ Xxxxxxxxxxx X. Xxxxxxxx
-------------------------------------------
Xxxxxxxxxxx X. Xxxxxxxx
Title: Chief Operating Officer
----------------------------------------
Date: 3-21-97
-----------------------------------------
Appendix I
Pre-existing NYU Patent and Patent Applications:
*** entitled *** *** and US patent applications *** filed *** filed *** ***
filed *** Rule 60 continuing patent application filed *** and US divisional
patent application filed *** .
PCT filing *** filed ***
***
***
***
***
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Confidential Treatment and filed separately with the Commission.
APPENDIX I
PRE-EXISTING NYU PATENTS AND PATENT APPLICATIONS
U.S. APPLICATIONS Serial No. Filing Date Status
*** *** 6/16/87 ABANDONED
*** *** 4/4/88 ABANDONED
***
*** *** 12/6/91 ABANDONED
***
*** *** 6/22/92 ABANDONED
***
*** *** 5/3/93 Allowed - Issue
*** Fee Paid 1/1/97
*** *** 1/25/94 Issued -
*** U.S. Patent No.
*** ***
*** *** 6/7/95 Pending
***
*** *** 6/7/95 Pending
***
*** Not yet assigned 12/31/96 Pending
***
*** Not yet assigned 2/13/97 Pending
***
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Confidential Treatment and filed separately with the Commission.
APPENDIX I (Contd.)
FOREIGN APPLICATIONS
The following patents and patent applications are based upon International
Application No. *** filed November 15, 1990 and all are entitled *** .
Country Application No. Filing Date Status
--------------------------------------------------------------------------------
*** *** 11/15/90 ***
***
*** *** 11/15/90 pending
*** *** 11/15/90 Pending
*** *** 11/15/90 Pending
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Confidential Treatment and filed separately with the Commission.
APPENDIX II
***
***
BACKGROUND
***
***
***
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Confidential Treatment and filed separately with the Commission.
2
***
***
***
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Confidential Treatment and filed separately with the Commission.
3
***
***
***
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
4
***
***
***
SPECIFIC AIMS OF THE RESEARCH PROGRAM
***
***
***
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Confidential Treatment and filed separately with the Commission.
5
***
***
***
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
6
***
***
***
REFERENCES
***
***
***
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Confidential Treatment and filed separately with the Commission.
7
***
***
***
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
8
***
***
***
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
APPENDIX III. Collateral Therapeutics Development Plan
***
***
***
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
APPENDIX III. (cont'd) Collateral Therapeutics Development Plan
***
***
***
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Confidential Treatment and filed separately with the Commission.
FIRST AMENDMENT TO AGREEMENT
This First Amendment to Agreement (hereafter "Amendment") is effective on
April 28, 1998 by and between COLLATERAL THERAPEUTICS INC., a corporation
organized and existing under the laws of California, having a place of business
at 0000 Xxxx Xxxxxx Xxxxx, Xxx Xxxxx, Xxxxxxxxxx 00000 (hereafter
"CORPORATION"); and NEW YORK UNIVERSITY, a corporation organized and existing
under the laws of the State of New York, having a place of business at 00
Xxxxxxxxxx Xxxxxx Xxxxx, Xxx Xxxx, Xxx Xxxx 00000 (hereafter "NYU").
WITNESSETH:
WHEREAS, CORPORATION and NYU entered into a certain agreement made and
effective as of March 24, 1997 (the "Agreement"), pursuant to which, INTER ALIA,
CORPORATION undertook to sponsor certain research at NYU and NYU granted to
CORPORATION a license to certain Research Technology (as such term is defined in
the Agreement); and
WHEREAS, CORPORATION and NYU desire to expand the scope of the research
under the terms and conditions of the Agreement as specified herein; and
WHEREAS, NYU desires to perform such research; and
WHEREAS, CORPORATION desires to provide additional research funds to NYU
for the performance of such research by NYU.
NOW, THEREFORE, in consideration of the premises and the covenants,
conditions and promises set forth below, the parties hereto hereby agree as
follows:
1. Except as expressly provided for herein, all terms and conditions of
the Agreement shall remain in full force and effect.
2. Terms which are defined in the Agreement shall have the same meanings
when used in this Amendment, unless a different definition is given
herein.
3. Section 1(m) of the Agreement shall be, and hereby is, amended in its
entirety so that, as amended, said Section 1(m) shall read as follows:
1(m) "NYU Research Project" shall mean the investigations at NYU
during the Research Period into the Field under the supervision of the
NYU Scientist in 2accordance with the research program, described in
annexed Appendix II and in annexed Exhibit A to the Amendment, each of
which forms an integral part hereof.
4. Section 4(a) of the Agreement shall be, and hereby is, amended in its
entirety so that, as amended, said Section 4(A) shall read as follows:
4(a) As compensation to NYU for work to be performed on the NYU
Research Project during the Research Period, subject to any earlier
termination of the Research Project pursuant to Section 3(a) hereof,
CORPORATION will pay NYU the total sum ***
***
***
***
***
***.
IN WITNESS WHEREOF, the parties hereto have executed this Amendment as
follows:
NEW YORK UNIVERSITY COLLATERAL THERAPEUTICS, INC.
By: /s/ Xxxxx X. Xxxxxxxx By: /s/ Xxxxxxxxxxx X. Xxxxxxxx
-------------------------------- --------------------------------
Title: Vice President Title: COO & CFO
for Industrial Liaison -----------------------------
Date: 5-1-98 Date: April 29, 1998
----------------------------- ------------------------------
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Confidential Treatment and filed separately with the Commission.
EXHIBIT A
SPECIFIC AIMS
***
***
***
RESEARCH PLAN
***
***
***
***Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
EXHIBIT A (continued)
***
***
***
***Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
EXHIBIT A (continued)
***
***
***
***Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
