Confidential Treatment has been requested for portions of this document marked with asterisks. RESEARCH AND LICENSE AGREEMENT
Exhibit 10.6
Confidential Treatment has been requested
for portions of this document marked with asterisks.
for portions of this document marked with asterisks.
This Agreement, effective as of August 10, 1998 (the “Effective Date”), is by and between:
The South Alabama Medical Science Foundation (hereinafter “SAMSF”), a corporation organized
and existing under the laws of the State of Alabama and having a place of business at 000
Xxxxxxxxxx Xxxxxxxxx, Xxxxxx, Xxxxxxx 00000-0000.
Mindset Limited (hereinafter “CORPORATION”), a corporation involved in healthcare research,
organized and existing under the laws of the British Virgin Islands, having an office at 0 Xxxx
Xxxxx Xx., Xxx Xxxxxxx, Xxxxxxxxx 00000, ISRAEL.
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for portions of this document marked with asterisks.
(hereinafter “the MAYO license”)
for the use of Tg 2576 transgenic mice and related mice as defined in the MAYO license as “Licensed
Technology” (hereinafter “the MAYO mice”) for the development of commercial technology, said
license being without the right to sublicense;
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 (including affiliates or
subsidiaries) 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 research, development and testing within pharmaceutical, diagnostic and
biotechnological development programs in the field of Alzheimer’s Disease and other central nervous
system and neurodegenerative diseases.
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for portions of this document marked with asterisks.
e. “License” shall mean the exclusive worldwide license to practice the SAMSF Research
Technology (as hereinafter defined) for the development, manufacture, use, import and sale of the
Licensed Products (as hereinafter defined).
f. “Licensed Products” shall mean all materials and technologies, including, without
limitation, rodents or other transgenic animals, products, drugs, therapeutic agents and
therapeutic methods covered by a claim of any unexpired SAMSF Patent (as hereinafter defined) which
has not been disclaimed or held invalid by a court of competent jurisdiction from which no appeal
has been or can be taken.
g. “Net Sales” shall mean the CORPORATION’S and its sublicensees’ billing for Licensed
Products and Licensed Processes produced hereunder less the sum of the following:
i) | all trade, case and quantity credits, discounts, refunds or rebates; | ||
ii) | allowances or credits for returns; | ||
iii) | sales taxes (including value-added tax). |
h. “SAMSF Know-How” shall mean the Pre-Existing Inventions and 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, software, and/or other documents containing such information, discovered,
developed or acquired by, or on behalf of SAMSF investigators during
the term and in the course of the Research Project, with the exception of any such know-how
which is Corporation Know-How as hereinafter defined.
i. “CORPORATION Know-How” shall mean any information and materials including, but not limited
to, pharmaceutical; chemical, biological and biochemical products,
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for portions of this document marked with asterisks.
technical and non-technical
data, materials, methods and processes and any drawings, plans, diagrams, specification, software
and/or other documents containing such information discovered, developed or acquired by employees
of CORPORATION during the term and in the course of the Research Project.
j. “SAMSF 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:
(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, as a result of the research
conducted through SAMSF during the term and in the course of the Research Project; with the
exception of all such patents which are CORPORATION Patents as hereinafter defined.
k. “CORPORATION 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 CORPORATION.
l. “Payment Term” shall mean the period of time commencing on the Effective Date and
continuing on a country-by-country basis, if not previously terminated under the terms of this
Agreement, for fifteen (15) years) from the Date of First Commercial Sale in
such country or until the expiration date of the last to expire of the SAMSF Patents whichever
shall be later.
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m. “Research Period” shall mean the 3-year period commencing on the Effective Date hereof and
any extension thereof as to which SAMSF and CORPORATION shall mutually agree in writing.
n. “Research Project” shall mean the investigations at SAMSF during the Research Period into
the Field under the supervision of the SAMSF Scientist in accordance with the research program (as
sponsored by CORPORATION), and described in annexed Appendix II, which forms an integral part
hereof.
o. “Research Technology” shall mean all SAMSF Patents, SAMSF Know-How, CORPORATION Patents and
CORPORATION Know-How.
p. “CORPORATION Research Technology” shall mean all CORPORATION Patents and all CORPORATION
Know-How.
q. “SAMSF Research Technology” shall mean all SAMSF Patents and all SAMSF Know-How.
This Agreement shall be effective as of the Effective Date and shall remain in full force and
effect until expires or is terminated in accordance with Section 17 hereof.
a. In consideration of the sums to be paid to SAMSF as set forth in Section 4 below, SAMSF
undertakes to perform the Research Project under the supervision of the SAMSF Scientist during the
Research Period. If, during the Research Period the SAMSF Scientist shall cease to supervise the
Research Project, and SAMSF has not designated a replacement within 45
days, CORPORATION shall have the option to terminate its funding of the SAMSF Research
Project. CORPORATION shall promptly advise SAMSF in writing if CORPORATION so
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elects. Such
termination of funding pursuant to this Section 3.a. shall not terminate this Agreement. Nothing
herein contained shall be deemed to impose an obligation on SAMSF to find a replacement for the
SAMSF Scientist.
b. Nothing contained in this Agreement shall be construed as a warranty on the part of SAMSF
that any results or inventions will be achieved by the Research Project, or that the Research
Technology and/or any other results or inventions achieved by the Research Project, if any, are or
will be commercially exploitable and furthermore SAMSF 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 Research Project.
c. Within sixty (60) days after the end of each year of the Research Period, SAMSF shall
prepare a written report summarizing the results of the work conducted on the Research Project
during the preceding year, and submit such report to CORPORATION. SAMSF shall also prepare and
submit to CORPORATION quarterly summaries of such work conducted during the previous quarter. It
is hereby agreed that such written report and quarterly summaries shall include reports on all
clinical trials carried out during the relevant period.
d. SAMSF will have full authority and responsibility for its part of the Research Project.
Students and SAMSF employees who work on the Research Project will do so as in those roles and not
as employees of CORPORATION.
e. Corporation shall be free to undertake any development of technology not covered by the
Research Project. Corporation may elect to perform research and development in-house, through
other academic collaborations, or through outsourcing.
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a. As compensation to SAMSF for work to be performed on the SAMSF Research Project during the
Research Period, subject to any earlier termination of the Research Project pursuant to Section
3.a. hereof, CORPORATION will pay SAMSF the total sum of $79,000 (USD$) per year, payable in 2
equal installments of $39,500 each, commencing upon the Effective Date and according to the
following schedule:
$39,500 on the Effective Date, and
$39,500 after each six month (6) interval thereafter.
$39,500 after each six month (6) interval thereafter.
b. Nothing in this Agreement shall be interpreted to prohibit SAMSF (or the SAMSF Scientists)
from obtaining additional financing or research grants for the Research Project from government or
not-for-profit agencies, which grants or financing may render all or part of the 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. 200 et seq. so long as the terms of such grants or financing do not
preclude any results of the Research Project being included in the License.
a. Subject to the terms specified hereunder, it is hereby agreed that all right, title and
interest, in and to the CORPORATION Research Technology, and in and to any drawings, plans,
diagrams, specifications, software, and other documents containing any of the CORPORATION Research
Technology shall vest solely in CORPORATION.
b. Subject to the License granted to CORPORATION hereunder, it is hereby agreed that all
right, title and interest, in and to the SAMSF Research Technology, and in and to any drawings,
plans, diagrams, specifications, software, or other documents containing any of
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the SAMSF Research Technology, shall vest solely in SAMSF. At the request of SAMSF,
CORPORATION shall take all steps as may be necessary to give full effect to any said right, title
and interest of SAMSF 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.
a. CORPORATION shall, simultaneously with the signing of this Agreement pay SAMSF a Fee in the
amount of $10,000 (USD$) related to all non-provisional patent applications that have been filed in
the name of Xx. Xxxxxx Xxxxxxxx related to the use of melatonin and melatonin analogs in
Alzheimer’s Disease.
b. SAMSF will promptly disclose to CORPORATION in writing any related inventions which
constitute potential SAMSF Patents.
c. The Patent applications pending at the date hereof shall continue to be maintained by
Xxxxxxx Xxxxxxxxxxx & Mugel, LLP or such other patent counsel selected by SAMSF and CORPORATION.
All other patent applications shall be filed and prosecuted and maintained by Xxxxxx and Neimark or
other patent counsel selected by SAMSF and CORPORATION. Copies of all such patent applications and
patent office actions shall be forwarded to CORPORATION. SAMSF 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 SAMSF or CORPORATION at the cost of SAMSF or
CORPORATION, as the case may be, and upon prior notice to and with the consent of the other party
hereto, such consent not to be unreasonably withheld.
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d. The CORPORATION will promptly disclose to SAMSF any inventions which relate to the SAMSF
Research Technology and which are conceived by employees or consultants of CORPORATION.
e. [Upon prior written approval by CORPORATION, all applications and proceedings with respect
to the SAMSF Patents shall be filed, prosecuted and maintained by SAMSF at the expense of
CORPORATION. Against the submission of invoices, CORPORATION shall reimburse SAMSF for all costs
and fees incurred by SAMSF during the team of this Agreement, in connection with the filing,
maintenance, prosecution and protection and the like of the SAMSF Patents.
f. All applications and proceedings with respect to the CORPORATION Patents shall be filed,
prosecuted and maintained by CORPORATION at the expense of CORPORATION.
g. SAMSF and CORPORATION shall assist, and cause their respective investigators 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.
h. 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 SAMSF Patents, it shall give prompt written (within thirty days (30))
notice thereof to SAMSF, 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 SAMSF shall be free to grant rights in and to such
subject matter deleted from the Research Technology in such countries to
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third parties, without further notice or obligation to CORPORATION, and the CORPORATION shall
have no rights whatsoever to exploit such subject matter deleted from the Research Technology in
such countries.
i. Nothing herein contained shall be deemed to be a warranty by SAMSF
i) | that CORPORATION can or will be able to obtain any patent or patents on any patent application or applications in the CORPORATION Patents or any portion thereof, or that any of the CORPORATION Patents will afford adequate or commercially worthwhile protection, or | ||
ii) | that SAMSF can or will be able to obtain any patent or patents on any patent application or applications in the SAMSF Patents or any portion thereof, or that any of the SAMSF Patents will afford adequate or commercially worthwhile protection, or | ||
iii) | that the manufacture, use, or sale of any element of the Research Technology or any resulting Product will not infringe any patent(s) of a third party. |
a. Subject to the terms and conditions hereinafter set forth and subject to all United States
Government rights whether now existing or arising after the date hereof, SAMSF hereby grants to
CORPORATION and CORPORATION hereby accepts from SAMSF 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 First Commercial Sale in such country
or until the expiration date of the last to expire of the SAMSF Patents whichever shall be later.
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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 SAMSF 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 any License Agreement and shall contain (inter-alia) the following
provisions:
(1) the sublicense shall expire automatically on the termination of the License;
(2) the sublicense shall not be assignable, in whole or in part;
(3) the sublicensee shall not grant further sublicenses; and
(4) both during the term of the sublicense and thereafter the sublicensee shall agree to a
confidentiality obligation similar to that imposed on CORPORATION in Section 10 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 15 and 16 of this Agreement
and shall state that SAMSF is third party beneficiary of such sublicense agreement for the purpose
of enforcing such indemnification and insurance provisions.
d. SAMSF reserves the right to use and distribute tangible research products to third parties
for non-commercial, research use.
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a. In consideration for the License granted herein, and during the Payment Term, with respect
to each Licensed Product, CORPORATION shall pay to SAMSF a royalty of *** of the Net Sales of
CORPORATION or of Corporation Entity or of a licensee or sublicensee of CORPORATION or Corporation
Entity. CORPORATION shall inform SAMSF in writing of the Date of First Commercial Sale with
respect to each Licensed Product in each country as soon as practicable after making of each such
first commercial sale.
b. For the purpose of computing the royalties due to SAMSF hereunder, the year shall be
divided into two parts ending on June 30 and December 31. Not later than ninety (90) days after
each December and June in each Calendar Year during the Payment Term, CORPORATION shall submit to
SAMSF a full and detailed report of royalties or payments due SAMSF under the terms of this
Agreement for the preceding half year (hereinafter “the Half-Year Report”), setting forth the Net
Sales upon which such royalties are computed and including at least
i) | the quantity of Products used, sold, transferred or otherwise disposed of; | ||
ii) | the selling price of each 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 SAMSF stating such fact.
Payment of the full amount of any royalties or other payments due to SAMSF for the preceding half
year shall be made within ninety (90) days of each Half-Year Report on royalties and
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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
SAMSF from CORPORATION pursuant to the terms 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 SAMSF with a report (hereinafter “the Annual
Report”), certified by any CORPORATION’S President or Chief Financial Officer, relating to the
royalties and other payments due to SAMSF 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, SAMSF, or the authorized
representative of SAMSF shall each have the right to inspect the books of accounts, records and
other relevant documentation of CORPORATION or of Corporation Entity and the licensees or
sublicensees of CORPORATION insofar as they relate to the production, marketing and sale of the
Products, in order to ascertain or verify the amount of royalties and other payments due to SAMSF
hereunder, and the accuracy of the information provided to SAMSF in the aforementioned reports.
Should such inspection lead to the discovery of a greater than ten percent (10%) discrepancy in
reporting to SAMSF’s detriment, CORPORATION agrees to pay the full cost of such inspection.
a. Royalties and other payments due to SAMSF hereunder shall he paid to SAMSF in United States
dollars(USD$). Any such royalties on or other payments relating to transactions in a foreign
currency shall be converted into United States dollars(USD$) based on
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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 SAMSF of all royalties due on sale,
transfer or disposition of Products by Corporation Entity or by the licensees of CORPORATION or of
Corporation Entity.
a. Except as otherwise provided in Section 10.c and Section 11 below, [SAMSF 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 10.c. and 10.d. below, CORPORATION shall maintain
any and all of the SAMSF 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 SAMSF to said release or disclosure.
c. The obligations of confidentiality on SAMSF and CORPORATION set forth in Section 10a. and
b. respectively 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 was 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 10.b. notwithstanding, CORPORATION may disclose the SAMSF
Research Technology to third parties who need to know the same in order to secure regulatory
approval for the sale of Products.
a. Prior to submission for publication of a manuscript describing the results of any aspect of
the Research Project, SAMSF shall send CORPORATION a copy of manuscript to be submitted, and shall
allow CORPORATION thirty (30) days from the date of such mailing to determine whether manuscript
contains such subject matter for which patent protection should be sought prior to publication of
manuscript, for the purpose of protecting an invention made by the SAMSF Scientist during the
course and within the term of the Research Project. Should CORPORATION believe the subject matter
of manuscript contains a patentable invention, then, prior to the expiration of such 30-day period
from the mailing date of manuscript to CORPORATION by SAMSF and CORPORATION shall give written
notification to the sender of the manuscript of its determination that such manuscript contains
patentable subject matter for which patent protection should be sought.
b. After the expiration of such 30-day period from the date of mailing such manuscript to
CORPORATION, unless SAMSF has received the written notice specified above from CORPORATION, SAMSF
shall be free to submit 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, SAMSF will thereafter delay
submission of the manuscript for an additional period of up to sixty (60) days to permit the
preparation and filing in accordance with Section 6. hereof of a U.S. patent application by
CORPORATION on the subject matter to be disclosed in such manuscript. After
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expiration of such 60-day period, or the filing of a patent application on each such
invention, whichever shall occur first, SAMSF shall be free to submit the manuscript and to publish
the disclosed results.
d. All such publications shall within the body of the same contain a written acknowledgment of
CORPORATION’s support of the Research Project. In addition, Xx. Xxxxxx Chain and any other
employees of CORPORATION involved in the Research Project shall be recognized in any such
publication as co-author(s) or in a written acknowledgment as shall be determined on a case by case
in accordance with accepted principles for determining authorship of scholarly publications.
a. In the event that the SAMSF acquires information that a third party is infringing one or
more of the CORPORATION Patents, shall promptly notify CORPORATION in writing of such infringement.
b. SAMSF shall cooperate and shall endeavor to cause the SAMSF Scientist 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
CORPORATION Patents; provided, that CORPORATION shall pay all reasonable expenses (including
attorneys’ fees) incurred by SAMSF in connection with such cooperation.
a. In the event a party to this Agreement acquires information that a third party is
infringing one or more of the SAMSF Patents, the party acquiring such information shall promptly
notify the other parties to the Agreement in writing of such infringement.
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b. In the event of an infringement of a SAMSF Patent, CORPORATION shall be privileged but not
required to bring suit against the infringer. Should CORPORATION elect to bring suit against an
infringer and SAMSF is joined as a party plaintiff in any such suit, SAMSF shall have the right to
approve the counsel selected by CORPORATION to represent CORPORATION and SAMSF such approval shall
not be unreasonably withheld. The expenses of such suit or suits that CORPORATION elects to bring,
including any expenses of SAMSF incurred in conjunction with the prosecution of such suit or the
settlement thereof, shall be paid for entirely by CORPORATION and CORPORATION shall hold SAMSF
free, clear and harmless from and against any and all costs of such litigation, including
attorneys’ fees. CORPORATION shall not compromise or settle such litigation without the prior
written consent of SAMSF 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 SAMSF an amount equal to
twenty-five percent (25%) of such remainder or four and one-half percent of Net Sales of the
infringer, whichever is lesser, 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, SAMSF shall have the right, but shall not be
obligated, to bring suit for such infringement. Should SAMSF elect to
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bring suit against an infringer and CORPORATION is joined as a party plaintiff in any such
suit, SAMSF 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 SAMSF 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 SAMSF may bring suit for such
infringement. In the event SAMSF brings suit for infringement of any SAMSF Patent, SAMSF 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, SAMSF shall promptly pay to CORPORATION an amount equal to
fifty percent (50%) of such remainder and SAMSF 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 SAMSF Patents instituted by any other party to this Agreement
under the terms hereof. The expense of such counsel shall be borne by such party.
f. CORPORATION agrees to cooperate fully with SAMSF at the request of SAMSF, including, by
giving testimony and producing documents lawfully requested in the prosecution of any suit by SAMSF
for infringement of the SAMSF Patents; provided, SAMSF shall pay all reasonable expenses (including
attorneys’ fees) incurred by CORPORATION in connection with such cooperation.
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a. All Investigational New Drug applications(IND’s) and All New Drug Applications (NDA’s)
submitted to any appropriate regulatory agency relating to Research Technology will be submitted in
the name of CORPORATION. CORPORATION shall assist SAMSF Scientist with such filing. SAMSF shall
not carry out any experiments on the MAYO mice before the filing of an IND for melatonin.
b. SAMSF will request MAYO for its agreement to the termination of its academic research
agreement with regard to three quarters of the MAYO-mice subject thereto and the transfer of such
mice to CORPORATION to be held by it under CORPORATION’s MAYO License (thereby creating two
separate mouse colonies). If MAYO shall agree, then SAMSF shall not use the mice remaining subject
to its academic research agreement for any purpose which is part of, or connected in any way with,
the Research Project. If MAYO should not agree, then CORPORATION will transfer a colony of its
licensed mice to SAMSF for use in the Research Project only and SAMSF shall not use the mice
subject to its academic research agreement in connection with the Research Project.
c. All royalties or other payments due to MAYO under the MAYO license for products developed
using the MAYO mice in the course of the Research Project will be paid by CORPORATION.
d. The SAMSF Scientist shall be the chief coordinator of all clinical trials. CORPORATION
shall consult with the SAMSF scientist with regard to the timing and selection of sites for
conducting clinical trials. SAMSF shall not commence or participate in any clinical trials
relating to the Research Technology without the express written approval of CORPORATION.
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e. If the National Institute of Health or other not-for-profit funding source gives SAMSF
and/or the SAMSF Scientist a grant for a pilot Phase I clinical trial for melatonin on not more
than 45 patients, such trial shall take place at SAMSF, New York University, or other location as
determined by the chief coordinator. Results from this trial will be published after full
completion of the study; preliminary results will be published in abstract form only.
f. Nothing in this section 14 shall apply to clinical trials carried out by any sublicensee of
corporation.
g. All MAYO mice covered by CORPORATION’S MAYO License shall remain under the control of
CORPORATION and shall not become the property of SAMSF. If CORPORATION shall give written notice
to SAMSF of the termination of the MAYO license SAMSF shall forthwith deliver up to CORPORATION all
MAYO mice covered by the MAYO License in the possession of SAMSF.
a. CORPORATION shall indemnify, defend and hold harmless SAMSF, 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 or by licensees or sublicensees, Corporation Entity or agent of
CORPORATION of any Licensed Product or Licensed Process, 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.
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b. With respect to an Indemnitee, CORPORATION’s indemnification obligation under subsection a.
of this Section 15 shall not apply to any liability, damage, loss or expense to the extent that it
is attributable to the negligent activities or willful default of any such Indemnitee.
c. CORPORATION agrees, at its own expense, to provide attorneys reasonably acceptable to SAMSF
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 and CORPORATION shall have the conduct of the defense of any such actions.
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 licensee or sublicensee, Corporation Entity
or agent of CORPORATION, CORPORATION shall at its sole costs and expense, procure and maintain
policies of comprehensive general liability insurance in amounts not less than $1,000,000 per
incident and $5,000,000 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 15 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 SAMSF. The minimum amounts of insurance coverage
required under this Section
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16 shall not be construed to create a limit of CORPORATION’s liability with respect to its
indemnification under Section 15 of this Agreement.
b. CORPORATION shall provide SAMSF with written evidence of such insurance upon request of
SAMSF. CORPORATION shall provide SAMSF with written notice at least ten (10) days prior to the
cancellation, non-renewal or material change in such insurance; if CORPORATION does not obtain
replacement insurance providing comparable coverage within such sixty (60) day period, SAMSF 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
licensee, 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.
a. Unless earlier terminated pursuant to this Section 17, this Agreement shall expire upon the
expiration of the Payment Term in all countries.
b. For the purpose of this Section 17, SAMSF shall be considered to be one “party” to this
Agreement and CORPORATION the other party. 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
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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 party 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 prior to expiration as set forth in
Section 17.a. hereof, all rights in and to the SAMSF Research Technology shall revert to SAMSF, and
CORPORATION shall not be entitled to make any further use whatsoever of the SAMSF 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, 10, 15, 16, 17 and 21 hereof shall survive and remain in full force and effect
after any termination, cancellation or expiration of this Agreement.
CORPORATION hereby represents and warrants to SAMSF as follows:
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(1) CORPORATION is a corporation duly organized, validly existing and in good standing under
the laws of the British Virgin Islands. CORPORATION 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 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 obligation 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.
SAMSF hereby represents and warrants to CORPORATION as follows:
(1) SAMSF is a corporation duly organized, validly existing and in good standing under the
laws of the State of Alabama. SAMSF 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 SAMSF.
(2) There is no pending or, to SAMSF’s knowledge, threatened litigation involving SAMSF which
would have any effect on this Agreement or on SAMSF’s ability to perform its obligations hereunder;
and
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(3) There is no indenture, contract, or agreement to which SAMSF is a party or by which SAMSF
is bound which prohibits or would prohibit the execution and delivery by SAMSF of this Agreement or
the performance or observance by SAMSF of any term or condition of this Agreement.
20. | No Assignment |
Except as specifically provided herein, neither CORPORATION nor SAMSF 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.
Without the prior written consent of any of the other party, neither CORPORATION nor SAMSF
shall use the name of any of the others or any adaptation thereof or of any staff member, employee
or student of the others:
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 of
the parties may make factual statements concerning the Agreement or file copies of the Agreement
after providing the others with an opportunity to comment and reasonable time within which to do so
on such statement in draft.
Except as provided herein, neither SAMSF nor CORPORATION will issue public announcements about this
Agreement or the status or existence of the Research Project without prior written approval of the
other.
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a. If any provision of this Agreement is determined to be invalid or void, the remaining
provisions shall remain in effect.
b. 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, with a national postal service by registered or certified mail (airmail if international),
addressed as follows:
To SAMSF:
South Alabama Medical Science Foundation
P.X. XXX X 0000
Xxxxxx, Xxxxxxx 00000-0000
P.X. XXX X 0000
Xxxxxx, Xxxxxxx 00000-0000
Attention: Xx. Xxxxxx X. Xxxxxx
To CORPORATION:
MINDSET LTD.
1 Xxxx Xxxxx Xx.
Xxx Xxxxxxx
Xxxxxxxxx 00000, ISRAEL
1 Xxxx Xxxxx Xx.
Xxx Xxxxxxx
Xxxxxxxxx 00000, ISRAEL
Attention: Xx. Xxxxxx Chain
or such other address or addresses as any party may hereafter specify by written notice to the
others. 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.
c. 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 all parties hereto. This Agreement supersedes
any and all prior agreements or understandings, whether oral or written, between CORPORATION and
SAMSF.
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d. No waiver by any party of any non-performance or violation by any 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.
e. 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.
f. 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.
g. Neither party shall be responsible for delay or failure in performance of any of the
obligations imposed by this Agreement, provided such failure shall be occasioned by fire, flood,
explosion, lightning, windstorm, earthquake, subsidence of soil, court order of government
interference, civil commotion, riot, war or by any cause of like or unlike nature beyond the
reasonable control and without fault or negligence of such party.
SOUTH ALABAMA MEDICAL SCIENCE FOUNDATION | ||||||
By: | /s/ Illegible | |||||
Title: | President | |||||
Date: | August 19, 1998 |
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MINDSET, LIMITED | ||||||
By: | Xxxxxx Chain | |||||
Title: Date: |
President August 5th 1998 |
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Appendix I
U.S. Patent Application Serial No. 08/801,301, filed February 18, 1997 entitled USE OF MELATONIN TO
PREVENT CYTOTOXIC EFFECTS OF AMYLOID PROTEIN by Pappolla.
U.S. Provisional Patent Application Serial No. 60/075,555 filed February 23, 1998 entitled-USE OF
3-INDOL-PROPRIONIC ACID by Pappolla.
U.S. Provisional Patent Application Serial No. 60/079,349 filed March 25, 1998 entitled INHIBITION
OF ALZHEIMER BETA-FIBRILLOGENESIS BY MELATONIN by Pappolla.
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PROJECT DESCRIPTION
Study of melatonin as neuroprotective and anti-amyloidogenic agent in the Alzheimer’s mouse
model Tg2576 (Hsiao’s mouse)
Multiple lines of evidence support the hypothesis that the widespread neuronal degeneration that
characterizes Alzheimer’s disease is the result of the neurotoxic properties of the Alzheimer’s
amyloid peptide (AB). We have recently reported that melatonin, a hormone with a proposed role in
the aging process, prevents death and oxidative damage of cultured neuronal cells exposed to AB.
We have also discovered that the hormone interacts with the Alzheimer’s amyloid peptide and
inhibits the spontaneous increase in beta-sheets structures and the formation of amyloid fibrils.
Because the ability of AB to promote neurodegeneration is known to correlate with the amount of
beta-sheets and amyloid fibrils, it appears the phenomenon of neuroprotection depends on
synergistic antioxidant and anti-amyloidogenic properties of this hormone
Mindset sponsored research agreement will subsidised the expenses to determine whether the novel in
vitro effects of melatonin can be verified in an in vivo paradigm. To accomplish this goal, we
will treat tg+ mice, known to develop Alzheimer-like neuropathology and behavioral abnormalities
with two doses of melatonin and conduct 1) behavioral, 2) neuropathologic and 3) biochemical
studies in order to determine whether the in vitro effects can be corroborated in vivo. Procedural
details of each of these objectives are described in the NIH grant application provided to Mindset
under our confidentiality agreement.
Time table. A total of 150 mice will be employed in this study. Each experimental group
will include 25 mice. We have already achieved a breeding nucleus which will make the first two
groups of mice available by August 1998. We plan to stagger two groups of 25 mice each, every two
months thereafter as follows.
August 1998... 50 mice
October 1998.. 50 mice
December 1998. 50 mice
October 1998.. 50 mice
December 1998. 50 mice
Each group will begin treatment at age 4 months. Behavioral testing will be performed at ages
12-14 and 21-24 months. Neuropathologic and biochemical studies will begin immediately after the
firsts groups are sacrificed. Prior to this time, we will standardize and optimize the various
biochemical, imaging and behavioral methods to be employed. Preliminary pharmacokinetics studies
will be also pursued during the course of the investigation. We estimate to complete the project
approximately 6 months after the last groups of mice have been sacrificed at 24 months of age
(approximately July-August 2001).
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AMENDMENT I
THIS AMENDMENT I TO THE RESEARCH AND LICENSE AGREEMENT (hereinafter the “Amendment”) is
effective as of the last date of execution by the parties hereto and is made by and between the
South Alabama Medical Science Foundation (hereinafter “SAMSF”), with an address of Box U-1060, 300
Xxxxxxxxxx Xxxxxxxxx, Xxxxxx, Xxxxxxx 00000-0000 xnd Mindset Biopharmaceuticals, Inc. (hereinafter
“Mindset Biopharmaceuticals”) with an address of Kiryat Mada 5, Xxx Building, Har Hotzfim, POB
45032, Jexxxxxxx 00000, XXXXXX.
WHEREAS, Mindset Limited and SAMSF have entered into a Research and License Agreement dated
August 10, 1998, (hereinafter the “Agreement”);
1. Section7.d of the Agreement is hereby deleted and replaced in its entirety with the following
new Section 7.d:
7.d. SAMSF reserves the right to use and practice the SAMSF Research Technology
for its own non-commercial, educational or research purposes. SAMSF further
reserves the right to distribute any materials considered SAMSF Research Technology
to third parties for non-commercial, research use. Any such distribution by SAMSF
will be accompanied by a notice that the distributed materials maybe subject to the
rights of CORPORATION under this Agreement.
2. All other terms and conditions of the Agreement will remain in full force and effect.
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South Alabama Medical Science Foundation
|
Mindset Biopharmaceuticals, Inc. | |||
/s/ Xxxxxx X. Xxxxxx
|
/s/ Xxxxxx Chain | |||
Xxxxxx X. Xxxxxx, Ph.X.
|
Xxxxxx Chain, Ph.D. | |||
President
|
Chairman/CEO | |||
9-7-00
|
9-11-00 | |||
Date
|
Date |
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AMENDMENT II
TO THE RESEARCH AND LICENSE AGREEMENT
TO THE RESEARCH AND LICENSE AGREEMENT
THIS AMENDMENT, effective as of September 1, 2002, is by and between the SOUTH ALABAMA MEDICAL
SCIENCE FOUNDATION (“SAMSF”), a corporation organized and existing under the laws of the State of
Alabama, MINDSET LIMITED, a corporation organized and existing under the laws of the British Virgin
Islands and MINDSET BIOPHARMACEUTICALS (USA), INC. (''CORPORATION”), a Delaware corporation having
an address at 1400 Xxxxxxxx, Xxx Xxxx, XX 00000.
WHEREAS, SAMSF and Mindset Limited entered into a Research and License Agreement with an
effective date of August 10, 1998 (the “Principal Agreement”); and
WHEREAS, by a document entitled “Amendment I to the Research and License Agreement” with an
effective date of October 22, 2000 (the “Amendment I”) made between SAMSF and CORPORATION,
incorrectly described therein as “Mindset Biopharmaceuticals, Inc.” and which was a successor in
interest to Mindset Limited by virtue of an Assignment and Assumption Agreement made as of May 18,
2000 between said Mindset Limited and CORPORATION, the parties thereto amended and/or clarified
their respective rights and responsibilities under the Principal Agreement, said Principal
Agreement and said Amendment I collectively being referred to hereinafter as the “Modified
Principal Agreement”; and
1. | Definitions. Capitalized terms not otherwise defined herein shall have the same respective meanings given to them by the Modified Principal Agreement. | |
2. | It is the parties’ understanding that all rights conferred by SAMSF under the Modified Principal Agreement presently rest solely with CORPORATION. It is the parties’ further understanding that no sublicenses have been granted by CORPORATION, by Mindset Limited or by any other entity. It is the parties’ further understanding that the Modified Principal Agreement confers no rights to Mindset Limited or to any other Corporation Entity, except to the extent that a Corporation Entity may secure rights by virtue of a sublicense from CORPORATION in accordance with the provisions of Section 7c. It is the parties’ further understanding that a Corporation Entity who is a sublicensee of CORPORATION may not assign the sublicense to any other entity and may not grant further sublicenses. Since the Modified Principal Agreement may have contained language which is inconsistent with this understanding and to further clarify |
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the Modified Principal Agreement, Sections 8d. and 9b. of the Principal Agreement are hereby
amended as follows:
2.1 | Section 8d. shall be amended by substituting “of CORPORATION, of any Corporation Entity, and/or of any sublicensee of CORPORATION” for “of CORPORATION or of Corporation Entity and the licensees or sublicenses of CORPORATION” in the fourth and fifth lines thereof. | ||
2.2 | Section 9b. shall be amended by substituting “of Licensed Products by any Corporation Entity and/or by any other sublicensee of CORPORATION” for “of Products by Corporation Entity or by the licensees of CORPORATION or of Corporation Entity” in the third and fourth lines thereof. |
3. | Other Amendments |
3.1 | Section 1b. shall be amended by substituting “over fifty percent” for “twenty-five and one tenth percent (25.1%) or more” in the fourth and fifth lines thereof. | ||
3.2 | Section 7c. shall be amended by substituting “this” for “any License” in the twelfth line thereof. | ||
3.3 | Section 10d. shall be amended by substituting “of Licensed Products” for “of Products” in the fourth line thereof. | ||
3.4 | Section 8a. of the Principal Agreement shall be deleted and the following shall be substituted therefor: |
“In consideration for the License granted herein, and during the Payment Term, CORPORATION shall
make the following payments to SAMSF:
(i) | With respect to each Licensed Product, CORPORATION shall pay to SAMSF a royalty of *** of Net Sales of CORPORATION and a royalty of *** of Net Sales of each sublicensee of CORPORATION, provided always as follows: |
(A) | If at any time on or after January 1, 2009 any Licensed Product is in clinical development for any disease indication, but no Licensed Product is then being sold commercially as an approved drug, CORPORATION shall pay an annual minimum royalty payment of fifty thousand dollars ($50,000) or a proportionate part thereof for the relevant part of the first applicable year if such condition is satisfied after January 1 in such year. | ||
(B) | If at any time on or after January 1, 2009 there is no Licensed Product in clinical development for any disease indication and/or if at any time on or after January 2009 any Licensed Product is being sold commercially as an approved drug, CORPORATION shall pay an aggregate annual minimum royalty payment of one hundred and fifty thousand dollars ($150,000) or a proportionate part thereof for the relevant part of any applicable year if the |
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condition contained in paragraph A above or the second condition contained in this paragraph (B) is satisfied after January 1 in such year. | |||
(C) | All minimum royalty payments shall be credited against the percentage royalty payable with respect to Net Sales for the year for which the minimum royalty is due but may not be credited against any percentage royalties payable in respect of Net Sales in any other year. | ||
(D) | Minimum royalty payments shall be made as specified in Section 8b. hereof except that, if the royalty payments based on Net Sales paid pursuant to Section 8.a. hereof for the first six (6) months of the year exceed the minimum royalty payment for that year, no further minimum royalty payment shall be made for that year. | ||
(E) | CORPORATION shall inform SAMSF in writing of the Date of First Commercial Sale with respect to each Licensed Product in each country as soon as practicable after such First Commercial Sale is made. |
(ii) | CORPORATION shall make the following further payments to SAMSF: |
(A) | In connection with Alzheimer’s Disease (“AD”), subject to the provisions of Sections 8(a)(ii)(C), (D) and (E) hereof: |
(1) | On the execution of this Amendment, the sum of fifty thousand dollars, ($50,000); | ||
(2) | On the commencement of the first Phase I trial of an AD Licensed Product anywhere in the world, the sum of fifty thousand dollars ($50,000); | ||
(3) | On the commencement of the first Phase II trial of an AD Licensed Product anywhere in the world, the sum of ***, but if CORPORATION funds a portion or all of the first Phase II trial of an AD Licensed Product, CORPORATION may defer payment of an amount equal to *** multiplied by a fraction, the numerator of which is equal to the costs contributed by CORPORATION to the total costs of such trial and the denominator of which is equal to the total costs of such trial, until the first payment pursuant to paragraph (4) hereof is due. | ||
(4) | On the commencement of the first Phase III trial of an AD Licensed Product anywhere in the world, the sum of ***, but if CORPORATION funds a portion or all of the first Phase III trial of an AD Licensed Product, CORPORATION may defer payment of an amount equal to *** multiplied by a fraction, the numerator of which is equal to the costs contributed by CORPORATION to the total costs of such trial, and the denominator of which is equal to |
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the total coats of such trial, until the first payment pursuant to paragraph (5) hereof is due; and | |||
(5) | On the date of approval of the first New Drug Application related to an AD Licensed Product by the US Food and Drug Administration or the earlier approval of an equivalent application by an equivalent non-US regulatory agency anywhere in the world, the sum of *** but, if CORPORATION shall elect to fund the cost of marketing of such Licensed Product itself in whole or in part and shall give notice in writing of such election to SAMSF no more than three (3) months after the date of the relevant approval, payment of that portion of said *** calculated by multiplying said sum by a fraction the numerator of which is the amount of such cost funded by CORPORATION and the denominator of which is the total cost of such marketing may be deferred until twelve (12) months after the date of the relevant approval. | ||
(6) | All payments made pursuant to the provisions of this Section 8.a.(ii)(A) shall be credited against and deducted from any payments otherwise due pursuant to the provisions of Sections 8.a.(ii)(C), (D) and (E). |
(B) | In connection with all indications other than AD: |
(1) | On the date of approval of each first New Drug Application related to a non-AD Licensed Product which is a non-orphan drug, by US Food and Drug Administration or the earlier approval of an equivalent application by an equivalent non-US regulatory agency anywhere in the world, the sum of ***; and | ||
(2) | On the date of approval of each first New Drug Application re1ated to a non-AD Licensed Product which is an orphan drug, by US Food and Drug Administration or the earlier approval of an equivalent application by an equivalent non-US regulatory agency anywhere in the world, the sum of ***. |
(C) | CORPORATION shall pay to SAMSF an amount equal to *** of payments and ***, other than royalties, received by CORPORATION from a sublicensee or any other entity receiving any rights to the Research Technology under an agreement executed prior to the commencement of a Phase I clinical trial of a Licensed Product, provided always as follows: |
(1) | There shall not be included in the calculation of any such payment any amounts paid to CORPORATION for or towards the cost of research or development under a written agreement with a detailed budget for such research and development OR by way of equity investment (including, without limitation, debt convertible into or |
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exchangeable for equity) in CORPORATION at a price for such equity that an unconnected third party would pay on a venture capital basis, but not less than the price per share paid by the last preceding investor on such basis, with any excess over such price being included in the calculation of such payment; and | |||
(2) | CORPORATION will provide SAMSF with a copy of the written agreement and detailed budget providing for such research and development described in the section above within thirty (30) days of CORPORATION’S receipt of payment for such research and development; and | ||
(3) | All payments made pursuant to the provisions of this Section 8.a.(ii)(C) shall be credited against and deducted from any payments otherwise due pursuant to the provisions of Section 8(a)(ii)(A) hereof; and | ||
(4) | All payments, other than royalties, received by CORPORATION from a sublicensee or any other entity receiving any rights to the Research Technology shall be promptly disclosed in writing to SAMSF along with a calculation of the amount payable to SAMSF and along with copies of any relevant written agreements contemplated in 8a.(ii)(C)(l) hereof. |
(D) | CORPORATION shall pay to SAMSF an amount equal to *** of payments, and ***, other than royalties, received by CORPORATION from a sublicensee or any other entity receiving rights to the Research Technology under an agreement executed concurrently with or after the commencement of a Phase I clinical trial, but before the commencement of a Phase II clinical trial, of a Licensed Product, subject to the provisions specified in Section 8a.(ii)(C) hereof. | ||
(E) | CORPORATION shall pay to SAMSF an amount equal to *** of payments and ***, other than royalties, received by CORPORATION from a sublicensee or any other entity receiving rights to the Research Technology under an agreement executed concurrently with or after the commencement of a Phase II clinical trial of a Licensed Product, subject to the provisions specified in Section 8a.(ii)(C) hereof. |
(iii) | The following provisions shall apply to this Section 8a.: |
(A) | All payments to be made pursuant to the provisions of sub-paragraph (ii) of this Section 8a., other than the payment specified in clause (A)(1) of sub-paragraph (ii), shall be paid by CORPORATION to SAMSF within ninety (90) days of the occurrence of the relevant event or of the relevant payment. The payment specified in clause (A)(I) of sub-paragraph (ii), |
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shall be paid by CORPORATION to SAMSF within ten (10) days of the occurrence of the relevant event. |
(B) | For the purposes of sub clauses (3), (4) and (5) of clause (A) of sub-paragraph (iii) of this Section 8a., the ratio of costs contributed by CORPORATION to total costs shall be calculated as follows: |
(1) | If an agreement between CORPORATION and a sublicensee or another entity specifics the proportion of costs to be borne by each party, then the proportion borne by CORPORATION to the total cost, pursuant to such agreement, shall constitute the relevant fraction. | ||
(2) | If an agreement between CORPORATION and a sublicensee or another entity does not specify such proportions, then, in each such case, CORPORATION shall make a good faith estimate of the proportion of costs being borne by each party and shall give notice in writing to SAMSF of such estimate, specifying how CORPORATION arrived at such estimate; and the proportion borne by CORPORATION to the total cost, pursuant to such estimate, shall constitute the relevant fraction. | ||
(3) | With regard to the trials contemplated in Sections 8a.(ii)(A)(3) and 8a.(ii)(A)(4) hereof, if, at the termination of the relevant trial, the event to which payment is deferred shall not have occurred, CORPORATION shall provide to SAMSF in writing details of the actual total costs of the relevant trial, details of the actual costs of the relevant trial borne by CORPORATION, and details of the actual costs of the relevant trial borne by each sublicensee and/or each other entity. If it shall appear that the actual the actual proportion borne by CORPORATION to the total cost differs from the fraction as provided by the agreement contemplated in Section 8a.(iii)(B)(l) or as provided by the estimate contemplated in Section 8a.(iii)(B)(2); then CORPORATION shall make the necessary payment to SAMSF or CORPORATION may apply any overpayment to SAMSF as a credit against future milestone payments due to SAMSF. as the case may be. |
3.5 The following paragraph shall be inserted into the Principal Agreement as new Section 22k:
k. CORPORATION shall exercise, and shall require its sublicensees to exercise,
continuous and commercially reasonable efforts to develop and market Licensed Products.
Within sixty (60) days after the end of each Calendar year, CORPORATION shall provide SAMSF
with a written report detailing the efforts of CORPORATION and the efforts of its
sublicensees to develop and market Licensed Products during such Calendar year.
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4. | Substitution of Mindset Biopharmaceuticals (USA), Inc. It is hereby agreed that henceforth the Principal Agreement shall be read, construed and take effect for all the purposes thereof as if Mindset Biopharmaceuticals (USA), Inc. were the party thereto and not Mindset Limited. Moreover, it is hereby agreed that henceforth the Amendment I shall be read, construed and take effect for all the purposes thereof as if Mindset Biopharmaceuticals (USA), Inc. were the party thereto and not Mindset Biopharmaceuticals, Inc. | |
5. | Except as otherwise provided herein, the Modified Principal Agreement shall remain in full force and effect. |
SOUTH ALABAMA MEDICAL SCIENCE FOUNDATION |
MINDSET BIOPHARMACEUTICALS (USA), INC. | |||||||
By:
|
By: | /s/ Xxxxxx Chain | ||||||
Name: | Name: Xxxxxx Chain | |||||||
Title: | Title: President | |||||||
MINDSET BIOPHARMACEUTICALS (USA), INC. | ||||||||
By: | /s/ Xxxxxxx Xxxxxxxxx | |||||||
Name: Xxxxxxx Xxxxxxxxx | ||||||||
Title: Chairman | ||||||||
MINDSET LIMITED | ||||||||
By: | /s/ Xxxxxx Chain | |||||||
Name: Xxxxxx Chain | ||||||||
Title: President |
39
Confidential Treatment has been requested
for portions of this document marked with asterisks.
for portions of this document marked with asterisks.
Appendix I
U.S. Patent Application Serial No. 08/801,301, filed February 18, 1997 entitled USE OF MELATONIN TO
PREVENT CYTOTOXIC EFFECTS OF AMYLOID PROTEIN by Pappolla.
U.S. Provisional Patent Application Serial No. 60/075,555 filed February 23, 1998 entitled USE OF
3-INDOL-PROPRIONIC ACID by Pappolla.
U.S. Provisional Patent Application Serial No. 60/079,349 filed March 25, 1998 entitled INHIBITION
OF ALZHEIMER BETA-FIBRILLOGENESIS BY MELATONIN by Pappolla.
40