Exhibit 10.1
RESEARCH AND LICENSE AGREEMENT
This License Agreement is entered into as of this 30th day of March,
2006 (the "Restated Effective Date"), by and between Brainstorm Cell
Therapeutics Inc.(formerly Golden Hand Resources, Inc.), a company formed under
the laws of the State of Washington, having a place of business at 1350 Avenue
of the Americas New York, NY 10019 ("Licensee") and Ramot at Tel Aviv University
Ltd., a company formed under the laws of Israel, having a place of business at
Tel Aviv University in Ramat-Aviv, Tel Aviv 61392, Israel ("Ramot"), for the
purpose of amending and replacing the Research and License Agreement between the
parties dated July 12, 2004 (the "Original Agreement").
WHEREAS, Tel Aviv University ("TAU") owns exclusive rights to certain
technology developed by Professor Eldad Melamed, Dr. Daniel Offen, Yossef Levy
and Dr. Pnina Green at the Felsenstein Medical Research Center of Tel Aviv
University relating to processes for the transformation of bone marrow and cord
blood stem cells into neuron-like and glial-like cells; and
WHEREAS, pursuant to agreement between TAU and Ramot, all rights, title
and interest in and to any and all inventions and other results arrived at by
scientists of TAU are owned solely and exclusively by Ramot; and
WHEREAS, pursuant to the Original Agreement, Licensee funds research at
TAU through Ramot for the purpose of furthering research related to processes
for the transformation of bone marrow and cord blood stem cells into neuron-like
and glial-like cells; and
WHEREAS, pursuant to the Original Agreement, Licensee has obtained a
license from Ramot with respect to such technology and the results of such
research, in order to develop, obtain regulatory approval for and commercialize
products based on such technology and the results of such funded research;
WHEREAS, the parties wish to amend some of the terms of the Original
Agreement; and
WHEREAS, in order to give effect to such wish, the parties agree to
amend and replace the Original Agreement with this Agreement, such that the
terms of this Agreement shall be deemed to apply as of July 12, 2004 (the
"Effective Date");
NOW, THEREFORE, the parties hereto, intending to be legally bound,
hereby agree as follows:
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1. Definitions.
Whenever used in this Agreement with an initial capital letter, the
terms defined in this Section 1, whether used in the singular or the plural,
shall have the meanings specified below.
1.1. "Affiliate" shall mean, with respect to either party, any person,
organization or entity controlling, controlled by or under common control with,
such party. For purposes of this definition only, "control" of another person,
organization or entity shall mean the possession, directly or indirectly, of the
power to direct or cause the direction of the activities, management or policies
of such person, organization or entity, whether through the ownership of voting
securities, by contract or otherwise. Without limiting the foregoing, control
shall be presumed to exist when a person, organization or entity (i) owns or
directly controls twenty percent (20%) or more of the outstanding voting stock
or other ownership interest of the other organization or entity, or (ii)
possesses, directly or indirectly the power to elect or appoint twenty percent
(20%) or more of the members of the governing body of the organization or other
entity.
1.2. "Calendar Quarter" shall mean the respective periods of three (3)
consecutive calendar months ending on March 31, June 30, September 30 or
December 31, for so long as this Agreement is in effect.
1.3 "Development Milestones" shall mean the development milestones set
forth in Exhibit 1.3 hereto.
1.4 "First Commercial Sale" shall mean the first sale of a Licensed
Product by Licensee, an Affiliate of Licensee or a Sublicensee to an
unaffiliated third party after Regulatory Approval has been achieved in the
country in which such Licensed Product is sold. Sales for test marketing,
sampling and promotional uses, clinical trial purposes or compassionate or
similar use shall not be considered to constitute a First Commercial Sale.
1.5. "FDA" shall mean the United States Food and Drug Administration.
1.6. "Joint Inventions" shall mean any and all inventions made jointly
by (a) one or more members of the TAU Team in the performance of the Research
and (b) one or more employees or consultants of Licensee.
1.7. "Joint Patent Rights" shall mean any and all Patent Rights
claiming Joint Inventions.
1.8. "Joint Technology" shall mean Joint Patent Rights and Joint
Inventions.
1.9. "Licensed Product" shall mean: (i) any Product (as defined below)
that is/was designed, developed, produced or manufactured with the Use of or
based on or under license to the Ramot Technology and/or the Joint Technology,
in whole or in part; (ii) any Product the making, producing, manufacturing,
using, selling, importing or exporting of which is covered by a Valid Claim; and
(iii) any service that makes use of any Licensed Product described in clause (i)
and/or (ii) of this Section 1.9. In the event of a dispute between the parties
as to whether a Product is a Licensed Product, the burden of proof shall be on
Licensee to prove that the Product is not a Licensed Product.
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1.10. "NDA" means a New Drug Application or Product License Application
(or Biologics License Application), as appropriate, and all supplements filed
pursuant to the requirements of the FDA, including all documents, data and other
information concerning Licensed Products that are necessary for or included in
FDA approval to market a Licensed Product, or the equivalent application in any
other country or jurisdiction.
1.11. "Net Sales" shall mean the gross amount billed or invoiced by or
on behalf of Licensee, its Affiliates and its Sublicensees on sales of Licensed
Products (whether made before or after the First Commercial Sale of the Licensed
Product), less the following: (a) customary trade, quantity, or cash discounts
to the extent actually allowed and taken; (b) amounts repaid or credited by
reason of rejection or return; (c) to the extent separately stated on purchase
orders, invoices, or other documents of sale, any taxes or other governmental
charges levied on the production, sale, transportation, delivery, or use of a
Licensed Product which is paid by or on behalf of Licensee or such Sublicensee,
and (d) amounts not actually collected, despite Licensee, its Affiliates and
Sublicensees taking all reasonable measures to collect same; provided that:
(i) In any transfers of Licensed Products between
Licensee or a Sublicensee to an Affiliate of Licensee or such Sublicensee other
than for resale by such Affiliate, Net Sales shall be equal to the fair market
value of the Licensed Products so transferred, assuming an arm's length
transaction made in the ordinary course of business, after deducting the amounts
referred to in clauses (a), (b) (c) and (d) above, to the extent applicable; and
(ii) In the event that Licensee or a Sublicensee, or the
Affiliate of Licensee or such Sublicensee, receives non-monetary consideration
for any Licensed Products or in the case of transactions not at arm's length
with a non-Affiliate of Licensee or such Sublicensee, Net Sales shall be
calculated based on the fair market value of such consideration or transaction,
assuming an arm's length transaction made in the ordinary course of business.
Sales of Licensed Products by Licensee or a Sublicensee to an
Affiliate of Licensee or such Sublicensee, for resale by such Affiliate, shall
not be deemed Net Sales and Net Sales shall be determined based on the total
amount invoiced or billed by such Affiliate on resale to an independent third
party purchaser.
1.12. "Orphan Drug" shall mean a Licensed Product that is protected (a)
by "Orphan Drug" status under the U.S. Orphan Drug Act, (b) by a Supplementary
Protection Certificate, as such term is defined in Council Regulation (EU) No.
1768/92, or (c) by a similar status granted under similar statutory provisions
of another jurisdiction granting exclusive marketing rights in such
jurisdiction.
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1.13 "Other Research" shall have the meaning set forth in Section 5.1.
1.14. "Patent Rights" shall mean any and all (a) patents, (b) pending
patent applications, including, without limitation, all provisional
applications, continuations, continuations-in-part, divisions, reissues,
renewals, and all patents granted thereon, and (c) all patents-of-addition,
reissue patents, reexaminations and extensions or restorations by existing or
future extension or restoration mechanisms, including, without limitation,
supplementary protection certificates or the equivalent thereof.
1.15. "Principal Investigators" shall mean Professor Eldad Melamed and
Dr. Daniel Offen, or such other principal investigator who may replace either or
both of them pursuant to Section 2.
1.16. "Product" shall mean: (i) any product that incorporates
differentiation factors and other materials which is capable of inducing bone
marrow or cord blood stem cells to differentiate into neuron-like or glial-like
cells that can be transplanted into patients for the treatment of neurological
and ophthalmic diseases in humans; and (ii) any neuron-like or glial-like cell
generated through use of a product described in clause (i) of this Section 1.16.
1.17. "Ramot Results" shall mean (a) any and all inventions, materials,
methods, processes, know-how and results made, created, developed, discovered,
conceived or acquired by, or on behalf of, members of the TAU Team (including,
without limitation, the Principal Investigators) in the course of the
performance of the Research, except Joint Inventions and/or (b) any and all
inventions, materials, methods, processes, know-how and results made, created,
developed, discovered or conceived by either of the Principal Investigators,
either alone or together with one or more third parties, in the performance of
services for, the Company, except Joint Inventions.
1.18. "Ramot Patent Rights" shall mean (i) the Patent Rights described
in Exhibit 1.18(a) attached hereto, (ii) any other Patent Rights owned by Ramot
which claim, and only to the extent they so claim, the invention disclosed in
the Patent Rights described in Exhibit 1.18(a) and (iii) all Patent Rights owned
by Ramot, to the extent they claim any of the Ramot Results. Exhibit 1.18(b)
shall set forth and shall be updated from time to time to include new Ramot
Patent Rights.
1.19. "Ramot Technology" shall mean the Ramot Patent Rights, the
invention disclosed in Exhibit 1.18(a) and the Ramot Results.
1.20. "Regulatory Agency" shall mean the FDA or equivalent agency or
government body of another country.
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1.22. "Regulatory Approval" shall mean (i) approval of an NDA by the
FDA permitting commercial sale of a Licensed Product or (ii) any comparable
approval permitting commercial sale of a Licensed Product granted by the
applicable Regulatory Agency in any other country or jurisdiction.
1.22. "Research" shall mean the research actually conducted by the TAU
Team under the terms of this Agreement in accordance with the Research Plan.
1.23. "Research Plan" shall mean the research plan attached hereto as
Exhibit 1.23, as amended from time to time in accordance with the provisions of
this Agreement, which sets forth the research to be undertaken by the TAU Team
under the direction of the Principal Investigators during the Research Period.
1.24. "Research Period" shall mean an initial term of three years
commencing on the Effective Date, and in the event the TAU Team meets the
milestones set forth in the Research Plan in accordance with Section 2.2.1, a
total term of six years ending on June 30, 2010.
1.24. "Sublicense Receipts" shall mean any payments or other
consideration that Licensee or an Affiliate receives, other than amounts
received on account of Net Sales, in consideration of the sublicense or other
grant of rights with respect to some or all of the rights granted to Licensee
under Section 5.1, or the grant of an option to obtain a sublicense or such
other rights, including without limitation license fees, milestone payments,
license maintenance fees and reimbursement for research and development
expenses, but excluding payments specifically committed to cover development
costs to be actually incurred by Licensee in the development of Licensed
Products under, and in accordance with detailed budgets and workplans included
in, sublicense agreements with Sublicensees. In the event that Licensee or an
Affiliate of Licensee receives non-monetary consideration for any such
sublicense or other grant of rights or in the case of transactions not at arm's
length, Sublicense Receipts shall be calculated based on the fair market value
of such consideration or transaction, assuming an arm's length transaction made
in the ordinary course of business. For the avoidance of doubt, "Sublicense
Receipts" shall not include payments made in consideration for the issuance of
equity or debt securities of the Licensee at fair market value and not as direct
or indirect consideration (in whole or in part) for the sublicense, or the grant
of an option to obtain a sublicense, of some or all of the rights granted
Licensee under Section 5.1.
1.25. "Sublicensee" shall mean any permitted sublicensee of all or part
of the rights granted Licensee under Section 5.1, as further described in
Section 5.2.
1.26. "TAU Team" shall mean the Principal Investigators and those
students, scientists and technicians working under their direction at the
Felsenstein Medical Research Center of Tel Aviv University on the Research.
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1.27. "Third Party License" shall mean a license from an unaffiliated
third party to one or more valid and enforceable patents issued in the United
States or any other jurisdiction, the claims of which cover one or more
functional components that is essential for the efficacy of a Licensed Product.
1.28. "Use" shall mean the use of the Ramot Technology and/or Joint
Technology in any stage of the research, development, manufacture or production
of a Product.
1.29. "Valid Claim" shall mean a claim of a Ramot Patent Right or Joint
Patent Right so long as such claim shall not have been held invalid in a final
non-appealable court judgment or patent office decision, in the relevant
jurisdiction.
2. Research Project.
2.1 Performance.
2.1.1. Ramot shall cause TAU, under the direction of the
Principal Investigators, to use reasonable efforts to perform the Research in
accordance with the Research Plan; however, Ramot and TAU make no warranties
regarding the completion of the Research or the achievement of any particular
results.
2.1.2. The Research will be directed and supervised by the
Principal Investigators, who shall have primary responsibility for the
performance of the Research. If both of the Principal Investigators cease to
supervise the Research for any reason, Ramot will so notify Licensee, and Ramot
shall endeavor to find among the scientists at TAU a scientist or scientists
acceptable to Licensee to continue the supervision of the Research in place of
the Principal Investigators. If Ramot is unable to find such a scientist
acceptable to Licensee, within sixty (60) days after such notice to Licensee,
Licensee shall have the option to terminate the funding of the Research.
Licensee shall promptly advise Ramot in writing if Licensee so elects. Such
termination of funding shall terminate Ramot's and TAU's obligations pursuant to
Section 2.1.1 above, but shall not terminate this Agreement or any of the other
rights or obligations of the parties under this Agreement. Nothing contained in
this Section 2.1.2, shall be deemed to impose an obligation on Ramot or TAU to
successfully find a replacement for the Principal Investigators who is
acceptable to Licensee.
2.1.3. The Principal Investigators shall provide Licensee,
within thirty (30) days after the end of every six-month period during the
Research Period, a written report summarizing the Ramot Results obtained during
the preceding six-month period.
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2.2 Funding of the Research Project.
2.2.1. Licensee shall fund the Research during the initial
term of the Research Period in accordance with the schedule set forth in Exhibit
2.2.1 hereto. In addition, in the event the TAU Team meets the milestones set
forth in Section (b) of Exhibit 1.23, Licensee shall provide funding for the
second phase of the Research in the total amount of US$1,140,000 during the
additional 3-years term of the Research Period. The Parties shall meet no later
than six months prior to completion of initial term of the Research to discuss
and agree upon the research program, milestones, and payment schedule for the
second phase of the Research. Any and all funding provided by the Licensee
pursuant to this Section 2.2.1 shall be applied by Ramot exclusively in support
of the Research, including salaries and Ramot's standard rates of overhead in
effect at such time, in accordance with the procedures established at TAU.
2.2.2. Nothing in this Agreement shall be interpreted to
prohibit Ramot, TAU or the Principal Investigators from seeking and receiving
funding from non-commercial sources, including government agencies and
foundations, or from commercial entities for non-commercial purposes, to further
support the Research or Other Research performed at TAU with the use of the
Ramot Technology or the Joint Technology; provided that such funding shall not
be on terms that give such entity(ies) any rights, contractual, commercial or
otherwise, to any Ramot Technology or Joint Technology without the prior written
consent of Licensee (subject to any non-exclusive license for governmental
purposes or other governmental rights required as a condition for such
non-commercial funding). Ramot shall notify Licensee upon the Principal
Investigators' or TAU's applying for such funding, which notice shall include a
copy of any notices awarding such funding.
2.2.3. Ramot shall submit the Licensee: (i) an interim written
report on the progress of the Research in each 6 (six) month period during the
Research Period, within 60 (sixty) days of the end of each such 6 (six) month
period, and a written report summarizing the results of the Research within 60
(sixty) days of the end of the first 3 years and the additional three years of
Research Period; and (ii) reports of any significant findings in the Research
promptly upon such findings being made.
3. Title.
3.1. Ramot Technology. All rights, title and interest in and to the
Ramot Technology, and in and to any drawings, plans, diagrams, specifications
and other documents containing any of the Ramot Technology shall be owned solely
and exclusively by Ramot.
3.2. Joint Technology. All rights, title and interest in and to the
Joint Technology are and shall be owned jointly by Licensee and Ramot.
3.3. Determination. All determinations of inventorship under this
Agreement shall be made in accordance with United States patent law. In case of
dispute between Ramot and Licensee over inventorship, a mutually acceptable
outside patent counsel shall make the determination of the inventor(s) by
applying the standards contained in United States patent law.
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4. Patent Filing, Prosecution and Maintenance.
4.1. Ramot Patent Rights. Ramot shall be responsible for the
preparation, filing, prosecution, protection and maintenance of all Ramot Patent
Rights, using patent counsel reasonably acceptable to Licensee. Ramot shall
consult with Licensee as to the preparation, filing, prosecution, protection and
maintenance of the Ramot Patent Rights reasonably prior to any deadline or
action with the U.S. Patent & Trademark Office or any other patent office and
shall furnish Licensee with copies of all relevant documents reasonably in
advance of such consultation.
4.2. Joint Patent Rights.
4.2.1. Consultation. Ramot and Licensee shall consult each other
regarding the preparation, filing and prosecution of all patent applications,
and the maintenance of all patents, included within the Joint Patent Rights,
including, without limitation, the content, timing and jurisdiction of the
filing of such patent applications and their prosecution, and other details and
overall global strategy pertaining to the procurement and maintenance of the
Joint Patent Rights.
4.2.2. Filing. All Joint Patent Rights shall be filed,
prosecuted and maintained by the parties through an independent patent firm or
firms as shall be mutually agreed upon by Ramot and Licensee. Such counsel shall
be charged with the duty to act in the best interests of each of Ramot and
Licensee, taking into account their relative status as licensors/licensee under
this Agreement and the parties' intension to prepare, file, prosecute, obtain
and maintain the Joint Patent Rights in a manner that will provide the maximum
economic advantage and return to the parties. Such counsel shall confer with
each of Ramot and Licensee and attempt to achieve a consensus in all decisions
made relative to the content of applications, the prosecution of the Joint
Patent Rights and the content of communications with the relevant patent
agencies, prior to any communications with such agencies.
4.3. Expenses. Subject to Section 4.4 below, Licensee shall reimburse
Ramot for all documented patent-related expenses incurred by Ramot pursuant to
this Section 6 within thirty (30) days after Ramot invoices Licensee. In
addition, in December 2004, , Licensee paid Ramot a total amount of $16,908
(sixteen thousand, nine hundred and eight US Dollars) as a reimbursement for
expenses incurred by Ramot prior to the execution of the Original Agreement with
respect to the filing and prosecution of Ramot Patent Rights.
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4.4. Abandonment. Should Licensee elect not to reimburse or fail to
reimburse Ramot for the filing, prosecution or maintenance of a patent
application in any country, on any invention included in the Ramot Technology or
Joint Technology or to cease reimbursing Ramot for the prosecution, protection
and/or maintenance of any Ramot Patent Right or Joint Patent Rights in any such
country (an "Abandoned Country"), Licensee shall provide Ramot with prompt
written notice of such election. Upon written receipt of such notice by Ramot,
Licensee shall be released from its obligations to reimburse Ramot for the
expenses incurred thereafter as to such Abandoned Country in conjunction with
such Patent Rights. In such event, any license with respect to such Patent
Rights will terminate with respect to such Abandoned Country, and Licensee shall
have no rights whatsoever to exploit such Patent Rights in such Abandoned
Country. Ramot shall then be free, without further notice or obligation to
Licensee, to grant rights in and to such Patent Rights with respect to such
Abandoned Country to third parties, which rights shall not include the right to
offer, sell or market the resulting Licensed Product(s) in, or to export such
Licensed Product(s) to, any country which is not an Abandoned Country
4.4. No Warranty. Nothing contained herein shall be deemed to be a
warranty that: (a) Ramot can or will be able to obtain patents on patent
applications included within the Ramot Patent Rights or on patent applications
relating to the Ramot Results, or that any of the Ramot Patent Rights will
afford adequate or commercially worthwhile protection, (b) the parties can or
will be able to obtain patents of patent applications relating to Joint
Inventions or (c) the manufacture, use or sale of any element of the Ramot
Technology or Joint Technology or any Licensed Product will not infringe any
patent(s) of any third party.
5. License Grant.
5.1. License. Subject to the terms and conditions set forth in this
Agreement, Ramot hereby grants to Licensee an exclusive, worldwide,
royalty-bearing license under the Ramot Technology and Ramot's interest in the
Joint Technology solely to research, develop, make, have made, use, offer for
sale, sell, have sold, import and export Licensed Products. For purposes of this
Section 5.1, the term "exclusive" means that Ramot shall not have any right to
grant such licenses or rights to any third party, subject, however, to Ramot's
right to license TAU, the Principal Investigators and the other members of the
TAU Team to practice or utilize such rights and licenses to conduct the
Research, and subject further, to the right of employees, researchers and
students of Tel Aviv University to use the Ramot Technology and the Joint
Technology for academic research purposes, alone or in collaboration with third
parties ("Other Research"). To the extent such utilization should require
publication or disclosure to persons who are not a part of the TAU Team or
disclosure to parties who are not employees, researchers or students of Tel Aviv
University the provisions of Section 9.2 shall govern any such publication or
disclosure.
5.2 Sublicense.
5.2.1. Sublicense Grant. Licensee shall be entitled, without
any requirement for Ramot's prior agreement, to grant sublicenses to third
parties under the license granted pursuant to Section 5.1 on terms and
conditions in compliance with and not inconsistent with the terms of this
Agreement (except that the royalty rates may be higher than those set forth in
this Agreement). Such sublicenses shall only be made for consideration and in
bona-fide arm's length transactions.
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5.2.2. Sublicense Agreements. Sublicenses shall only be
granted pursuant to written agreements, which shall be in compliance and not
inconsistent with and shall be subject and subordinate to the terms and
conditions of this Agreement. Such sublicense agreements shall contain, among
other things, provisions to the following effect:
5.2.2.1. All provisions necessary to ensure
Licensee's ability to perform its obligations under this Agreement, including
without limitation its obligations under Sections 6.1, 8.5, 8.6 and 13.4.3;
5.2.2.2. In the event of termination of the license
(in whole or in part - e.g. termination in a particular country) set forth in
Section 5.1 above, any existing agreements that contain a sublicense of the
Ramot Technology or Ramot's interest in Joint Inventions shall terminate to the
extent of such sublicense; provided, however, that, for each Sublicensee, upon
termination of the sublicense agreement with such Sublicensee, if the
Sublicensee is not then in breach of its sublicense agreement with Licensee such
that Licensee would have the right to terminate such sublicense, Ramot shall be
obligated, at the request of such Sublicensee, to enter into a new license
agreement with such Sublicensee on substantially the same terms as those
contained in such sublicense agreement, provided that such terms shall be
amended, if necessary, to the extent required to ensure that such Sublicense
Agreement does not impose any obligations or liabilities on Ramot which are not
included in this Agreement;
5.2.2.3. The Sublicensee shall not be entitled to
sublicense its rights under such sublicense agreement; provided that the parties
agree that in the event that (a) Licensee is in the final stages of negotiations
with a potential Sublicensee regarding the grant by Licensee of a Sublicense to
such Sublicensee, and such Sublicensee refuses to enter into such a Sublicense
agreement unless the restrictions set forth in this sub-Section 5.2.2.3 are
limited or removed and (b) Licensee provides Ramot with a written request to
amend this sub-Section 5.2.2.3 in order to enable Licensee to consummate the
proposed transaction which request shall include the reasoning for accepting
such request under the circumstances, Ramot shall not unreasonably withhold its
approval to make such amendment to this Agreement, which amendment shall be
contingent on the inclusion of clauses, reasonably satisfactory to Ramot, that
shall ensure Ramot's rights hereunder and the execution of the contemplated
Sublicense agreement.; and
5.2.2.4. The sublicense agreement may not be assigned
by Sublicensee without the prior written consent of Ramot, except that
Sublicensee may assign the sublicense agreement to a successor in connection
with the merger, consolidation, or sale of all or substantially all of its
assets or that portion of its business to which the sublicense agreement
relates; provided that any such assignee agrees in writing in a manner
reasonably satisfactory to Ramot to be bound by the terms of such sublicense
agreement. The consent contemplated herein shall not be unreasonably withheld or
delayed.
5.2.3. Delivery of Sublicense Agreement. Licensee shall
furnish Ramot with a fully executed copy of any such sublicense agreement,
promptly after its execution.
5.2.4. Breach by Sublicensee. Any act or omission by a
Sublicensee, which would have constituted a breach of this Agreement had it been
an act or omission by Licensee, shall constitute a breach of this Agreement.
Licensee shall indemnify Ramot for, and hold it harmless from, any and all
damages or losses caused to Ramot as a result of any such breach by a
Sublicensee. In the event of a breach by a Sublicensee, the cure of such breach
or the termination by Licensee of the sublicense agreement with such Sublicensee
within Licensee's cure period, as set forth in Section 13.3.3.1, shall
constitute a cure of Licensee's breach under this Agreement for purposes of
Section 13.3.3.1.
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5.3. No Other Grant of Rights. Other than as specifically set forth in
Section 5.2, Licensee and Sublicensees shall not be entitled to grant, directly
or indirectly, to any person or entity any right of whatever nature (a) under,
or with respect to, or permitting any use or exploitation of, any of the Ramot
Technology or Joint Technology or (b) to develop, manufacture, market or sell
Licensed Products.
6. Development and Commercialization.
6.1. Diligence.
6.1.1. Reasonable Efforts. Licensee shall use its reasonable
efforts, and/or shall cause its Affiliates or Sublicensees to use their
reasonable efforts: (i) to develop Licensed Products, (ii) to introduce Licensed
Products into the commercial market and (iii) to market Licensed Products
following such introduction into the market. Specifically, Licensee and/or its
Affiliates and/or Sublicensees shall fulfill the following obligations:
6.1.1.1. Licensee, by itself or through Affiliates or
Sublicensees, undertakes to employ its reasonable efforts, including funding
consistent with such efforts, to carry out all efficacy, pharmaceutical, safety,
toxicological and clinical tests, trials and studies and all other activities
necessary in order to obtain Regulatory Approval for the production, use and
sale of Licensed Products in each country in which Licensee, its Affiliates or
Sublicensees intend to produce, use, offer to sell and sell Licensed Products
and in any case, in the United States, the European Union and Japan.
6.1.1.2. During the period commencing with the
receipt of Regulatory Approval in a given country, Licensee and its Affiliate
shall, and shall ensure that Sublicensees shall, use its or their reasonable
efforts, including funding consistent with such efforts, to promote, market and
sell Licensed Products in such country. Licensee and/or its Affiliates and/or
Sublicensees activities shall include but not be limited to:
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(a) Using their reasonable efforts to
establish and maintain good business relationships with hospitals, health care
systems, doctors and other medical professionals in accordance with standard and
customary practices;
(b) Establishing and maintaining a sales
force consisting of reasonably qualified personnel to promote and market the
Licensed Products;
(c) Advertising the Licensed Products in
professional journals and publications and sponsoring or attending appropriate
symposia, trade exhibitions and medical education programs; and
(d) Formulating and using their reasonable
efforts to implement annual sales and marketing plans for the Licensed Products.
6.1.2. Milestones. Without limiting the foregoing, Licensee,
by itself or through Affiliates or Sublicensees, shall meet each of the
Development Milestones.
6.2. The Principal Investigators, a Licensee representative and a Ramot
representative shall meet no less than once every six (6) months during the term
commencing with the Effective Date and ending upon the First Commercial Sale of
a Licensed Product, at locations and times to be mutually agreed upon by the
parties, (i) to review the progress being made under the research and
development activities conducted by Licensee relating to Licensed Products, (ii)
to review the progress being made towards fulfilling the Development Milestones
and (iii) to discuss intended efforts for fulfilling such milestones.
6.3. Within sixty (60) days after the end of each calendar year,
Licensee shall furnish Ramot with a written report on the progress of its, its
Affiliate's and Sublicensees' efforts during the prior year to develop and
commercialize Licensed Products, including without limitation research and
development efforts, efforts to obtain Regulatory Approval, marketing efforts,
and sales figures. The report shall also contain a discussion of intended
efforts and sales projections for the then current year.
6.4. Failure. If Licensee breaches any of its obligations pursuant to
Section 6.1, unless and to the extent the failure is due solely to delay
necessitated by regulatory agencies, Ramot shall notify Licensee in writing of
Licensee' failure and shall allow Licensee ninety (90) days to cure or to
demonstrate that it has begun to cure its failure. Licensee' failure to cure or
demonstrate that it has begun to cure such delay to Ramot's reasonable
satisfaction within such 90-day period shall constitute a material breach of
this Agreement and Ramot shall have the right to terminate this Agreement
forthwith.
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7. Consideration for Grant of License
7.1. Upfront Payments. The Parties confirm that Licensee has delivered
to Ramot, in December 2004, an upfront license fee payment in the sum of
$100,000 (one-hundred thousand US Dollars
7.2. Warrants. In addition, pursuant to the terms of the Original
Agreement, effective November 4, 2004, Licensee issued to Ramot and its
designees warrants to purchase an aggregate of 10,606,415 shares of our common
stock at a purchase price of $.01 per share (29% of the issued and outstanding
shares of our capital stock on a fully diluted and as converted basis as of
November 4, 2004). The form of these warrants is attached hereto as Exhibit 7.2.
7.3. Net Sales.
7.3.1. Royalties. In addition, Licensee shall pay Ramot
royalties on Net Sales on a Licensed Product-by-Licensed Product and
country-by-country basis as follows:
7.3.1.1. So long as (a) the making, producing,
manufacturing, using, marketing, selling, importing or exporting of such
Licensed Product is covered by a Valid Claim or (b) the Licensed Product is
covered by Orphan Drug status in such country: an amount equal to 5% (five
percent) of all Net Sales; and
7.3.1.2. In the event that (a) the making, producing,
manufacturing, using, marketing, selling, importing or exporting of such
Licensed Product is not covered by a Valid Claim and (b) the Licensed Product is
not covered by Orphan Drug status in such country: an amount equal to 3% (three
percent) of all Net Sales until the expiration of fifteen (15) years from the
date of the First Commercial Sale of such Licensed Product in such country.
7.3.2. Third-Party Royalties. In the event that Licensee is
required to make royalty payments, at fair market terms after arms' length
negotiations, pursuant to the terms of a Third Party License that Licensee is
legally required to obtain in order to make use of and/or to sell Licensed
Products in a particular country, Licensee may offset such third-party payments
against the royalty payments that are due to Ramot pursuant to Section 7.3.1
with respect to sales in such country; provided that
(a) royalty payments under Section 7.3.1 to Ramot may
not be reduced unless all other parties who are entitled to receive royalties on
Net Sales of Licensed Products pursuant to agreements or licenses (including
Third Party Licenses) made or obtained by Licensee prior to the grant of the
Third Party License in question are subject to a proportionate reduction of
their royalties; and
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(b) in no event, shall the royalty payments to Ramot
under Section 7.3.1 with respect to such Licensed Product be reduced to less
than an amount equal to 3% of Net Sales with respect to such Licensed Product in
such country.
7.4. Sublicense Receipts. In addition, Licensee shall pay Ramot an
amount equal to 30% (thirty percent) of all Sublicense Receipts.
In the event that Licensee is required to pay a percentage of
Sublicense Receipts to a third party, at fair market terms after arms' length
negotiations, pursuant to the terms of a Third Party License that Licensee is
legally required to obtain in order to make use of and/or to sell Licensed
Products, or any part thereof, Licensee may offset such third-party payments on
account of Sublicense Receipts against the payments in respect of Sublicense
Receipts that are due to Ramot pursuant to this Section 7.4 with respect to the
grant of the relevant Sublicense; provided that
(a) payments in respect of Sublicense Receipts under
this Section 7.4 to Ramot may not be reduced unless all other parties who are
entitled to receive a percentage of Sublicense Receipts pursuant to agreements
or licenses (including Third Party Licenses) made or obtained by Licensee prior
to the Third Party License in question are subject to a proportionate reduction
of the payments to which they are entitled on account of such Sublicense
Receipts; and
(b) in no event, shall the payments to Ramot in
respect of Sublicense Receipts under this Section 7.4 be reduced to less than an
amount equal to: (i) 25% of Sublicense Receipts, with respect to Sublicenses
granted prior to completion of Phase II Clinical Studies, or (ii) 20% of
Sublicense Receipts, with respect to Sublicenses granted following completion of
Phase II Clinical Studies.
8. Reports; Payments; Records.
8.1. First Commercial Sale. Licensee shall inform Ramot 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 and shall describe such Licensed Product.
8.2. Reports and Payments.
8.2.1 Reports. Within sixty (60) days after the conclusion of
each Calendar Quarter commencing with the first Calendar Quarter in which
Licensee or a Sublicensee first receives Net Sales or Licensee or an Affiliate
receives Sublicense Receipts, Licensee shall deliver to Ramot a report
containing the following information:
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(a) the number of units of Licensed Products sold by
Licensee, its Affiliates and Sublicensees to independent third parties in each
country for the applicable Calendar Quarter;
(b) the gross amount billed for each unit of a
Licensed Product sold by Licensee, its Affiliates and Sublicensees during the
applicable Calendar Quarter in each country;
(c) a calculation of Net Sales for the applicable
Calendar Quarter in each country, including a listing of applicable deductions;
(d) the total amount payable to Ramot in U.S. dollars
on Net Sales for the applicable Calendar Quarter, together with the exchange
rates used for conversion.
If no amounts are due to Ramot for any Calendar Quarter, the
report shall so state.
8.2.2. Payment for Net Sales. Within 60 days of end of each
Calendar Quarter, Licensee shall remit to Ramot all amounts due with respect to
Net Sales for the applicable Calendar Quarter.
8.2.3 Payment for Sublicense Receipts. In addition to the
reports delivered pursuant to Section 8.2.1, Licensee shall notify Ramot in
writing within fifteen (15) days of the receipt of any Sublicense Receipts.
Licensee shall remit to Ramot all amounts due with respect to such Sublicense
Receipts within thirty (30) of the receipt of such Sublicense Receipts by
Licensee.
8.3. Payments in U.S. Dollars. All payments due under this Agreement
shall be payable in United States dollars. Conversion of foreign currency to
U.S. dollars shall be made at the conversion rate existing in the United States
(as reported in the Wall Street Journal) on the last working day of the
applicable Calendar Quarter. Such payments shall be without deduction of
exchange, collection, or other charges.
8.4. Payments in Other Currencies. If by law, regulation, or fiscal
policy of a particular country, conversion into United States dollars or
transfer of funds of a convertible currency to the United States is restricted
or forbidden, Licensee shall give Ramot prompt written notice of such
restriction, which notice shall satisfy the payment deadlines described in
Section 8.2. Licensee shall pay any amounts due Ramot through whatever lawful
methods Ramot reasonably designates; provided, however, that if Ramot fails to
designate such payment method within thirty (30) days after Ramot is notified of
the restriction, Licensee may deposit such payment in local currency to the
credit of Ramot in a recognized banking institution selected by Licensee and
identified by written notice to Ramot, and such deposit shall fulfill all
obligations of Licensee to Ramot with respect to such payment.
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8.5. Records. Licensee shall maintain, and shall cause its Affiliates
and Sublicensees to maintain, complete and accurate records of Licensed Products
that are made, used or sold under this Agreement, any amounts payable to Ramot
in relation to such Licensed Products and all Sublicense Receipts received by
Licensee and its Affiliates, which records shall contain sufficient information
to permit Ramot to confirm the accuracy of any reports or notifications
delivered to Ramot under Section 8.2. The relevant party shall retain such
records relating to a given Calendar Quarter for at least three (3) years after
the conclusion of that Calendar Quarter, during which time Ramot shall have the
right, at its expense, to cause an independent, certified public accountant to
inspect such records during normal business hours for the sole purpose of
verifying any reports and payments delivered under this Agreement. Such
accountant shall not disclose to Ramot any information other than information
relating to the accuracy of reports and payments delivered under this Agreement.
The parties shall reconcile any underpayment or overpayment within thirty (30)
days after the accountant delivers the results of the audit. In the event that
any audit performed under this Section 8.5 reveals an underpayment in excess of
five percent (5%) in any calendar year, the audited party shall bear the full
cost of such audit. Ramot may exercise its rights under this Section 8.5 only
once every year per audited party and only with reasonable prior notice to the
audited party. Licensee shall cause its Affiliates and Sublicensees to fully
comply with the terms of this Section 8.5.
8.6. Audited Report. Licensee shall furnish Ramot, and shall cause its
Affiliates and Sublicensees to furnish Ramot, within one hundred twenty (120)
days after the end of each calendar year, commencing at the end of the calendar
year of the First Commercial Sale, with a report, certified by an independent
certified public accountant, relating to royalties and other payments due to
Ramot pursuant to this Agreement in respect to the previous calendar year and
containing the same details as those specified in Section 8.2 above in respect
to the previous calendar year.
8.7. Late Payments. Any payments by Licensee that are not paid on or
before the date such payments are due under this Agreement shall bear interest
at an annual interest, compounded monthly, equal to three percent (3%) above the
London Interbank Offer Rate (LIBOR) as determined for each month on the last
business day of that month, assessed from the day payment was initially due
until the date of payment.
8.8. Payment Method. Each payment due to Ramot under this Agreement
shall be paid in U.S. currency by wire transfer of funds to Ramot's account in
accordance with written instructions provided by Ramot.
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8.9. VAT; Withholding and Similar Taxes. All amounts to be paid to
Ramot pursuant to this Agreement are exclusive of Value Added Tax but inclusive
of all other taxes or withholding amounts. Licensee shall add value added tax,
as required by law, to all such amounts. If applicable laws require that taxes
be withheld from any amounts due to Ramot under this Agreement, Licensee shall
(a) deduct these taxes from the remittable amount, (b) pay the taxes to the
proper taxing authority, and (c) promptly deliver to Ramot a statement including
the amount of tax withheld and justification therefore, and such other
information as may be necessary for tax credit purposes.
9. Confidential Information
9.1 Confidentiality.
9.1.1. Confidential Information. Licensee agrees that, without
the prior written consent of Ramot, in each case, during the term of this
Agreement, and for five (5) years thereafter, it will keep confidential, and not
disclose or use Confidential Information (as defined below) other than for the
purposes of this Agreement, without the express written consent of Ramot.
Licensee shall treat such Confidential Information with the same degree of
confidentiality as it keeps its own confidential information, but in all events
no less than a reasonable degree of confidentiality. Licensee may disclose the
Confidential Information only to employees and consultants of Licensee or of its
Affiliates or Sublicensees who have a "need to know" such information in order
to enable Licensee to exercise its rights and fulfill its obligations under this
Agreement and are legally bound by agreements which impose confidentiality and
non-use obligations comparable to those set forth in this Agreement. For
purposes of this Agreement, "Confidential Information" means any scientific,
technical, trade or business information relating to the subject matter of this
Agreement designated as confidential or which otherwise should reasonably be
construed under the circumstances as being confidential disclosed by or on
behalf of Ramot, TAU, or any of their employees, researchers or students
(including members of the TAU Team) to Licensee, whether in oral, written,
graphic or machine-readable form, except to the extent such information: (i) was
known to Licensee at the time it was disclosed, other than by previous
disclosure by or on behalf of Ramot, TAU or any of their employees, researchers
or students, as evidenced by Licensees' written records at the time of
disclosure; (ii) is at the time of disclosure or later becomes publicly known
under circumstances involving no breach of this Agreement; (iii) is lawfully and
in good faith made available to Licensee by a third party who is not subject to
obligations of confidentiality to Ramot or TAU with respect to such information;
or (iv) is independently developed by Licensee without the use of or reference
to the Confidential Information, as demonstrated by documentary evidence.
9.1.2. Disclosure of Agreement. Each party may disclose the
terms of this Agreement to the extent required, in the reasonable opinion of
such party's legal counsel, to comply with applicable laws.
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9.1.3. Publicity. Except as expressly permitted under Section
9.1.2, no party will make any public announcement regarding this Agreement
without the prior written approval of the other party.
9.2. Academic Publications and Third Party Collaboration. Ramot shall
have the right to allow the Principal Investigators and other members of the TAU
Team to publish the results of the Research, if any, in scientific publications,
to present such results at scientific symposia, or to transfer such results to
third parties for the purpose of conducting Other Research in collaboration with
TAU, provided that the following procedure is followed:
9.2.1. Ramot shall cause the members of the TAU Team to comply
with standard academic practice regarding authorship of scientific publications
and recognition of contribution of other parties in any publications relating to
the Research.
9.2.2 The results of the Research shall only be transferred to
a third party for the purpose of conducting Other Research after such third
party has executed a material transfer agreement on terms approved in advance by
the Company, which shall contain appropriate protections for the rights of the
Company hereunder;
9.2.3. No later than thirty (30) days prior to submission for
publication of any scientific articles, abstracts or papers concerning the
results of the Research, the presentation of such results at any scientific
symposia, or the transfer of such results to third parties for the purpose of
Other Research, Ramot shall send to Licensee a written copy of the material to
be so submitted, presented, or transferred and shall allow Licensee to review
such submission to determine whether the material to be publication or
presentation contains subject matter for which patent protection should be
sought prior to publication, presentation or transfer for the preservation of
Ramot Patent Rights.
9.2.4. Licensee shall provide its written comments with
respect to such publication or presentation within thirty (30) days following
its receipt of such written material.
9.2.5. If Licensee, in its written comments, identifies
material for which patent protection should be sought, then Ramot shall cause
the publication, presentation or transfer of such material to be delayed for a
further period of up to sixty (60) days from the receipt of such written
comments to enable Ramot to make the necessary patent filings in accordance with
Section 4.
9.2.6. After compliance with the foregoing procedures with
respect to an academic, scientific or medical publication and/or public
presentation, members of the TAU Team shall not have to resubmit any such
information published according to this Section 9.2 for re-approval should such
same information be republished or publicly disclosed in another form.
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10. Enforcement of Patent Rights.
10.1. Notice. In the event either party becomes aware of any possible
or actual infringement or unauthorized possession, knowledge or use of any Ramot
Patent Rights (collectively, an "Infringement"), that party shall promptly
notify the other party and provide it with details regarding such Infringement
10.2. Suit by Licensee. Licensee shall have the right, but not the
obligation, to take action in the prosecution, prevention, or termination of any
Infringement of Ramot Patent Rights. Should Licensee elect to bring suit against
an infringer and Ramot is joined as party plaintiff in any such suit, Ramot
shall have the right to approve the counsel selected by Licensee to represent
Licensee, such approval not to be unreasonably withheld. The expenses of such
suit or suits that Licensee elects to bring, including any expenses of Ramot
incurred in conjunction with the prosecution of such suits or the settlement
thereof, shall be paid for entirely by Licensee and Licensee shall hold Ramot
free, clear and harmless from and against any and all costs of such litigation,
including attorney's fees. Licensee shall not compromise or settle such
litigation without the prior written consent of Ramot, which consent shall not
be unreasonably withheld or delayed. In the event Licensee exercises its right
to sue pursuant to this Section 10.2, it shall 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 attorney's fees, necessarily
involved in the prosecution of any such suit. If, after such reimbursement, any
funds shall remain from said recovery, then Ramot shall receive an amount equal
to one-third of such funds and the remaining two-thirds of such funds shall be
retained by Licensee, provided that with respect to amounts awarded for loss of
sales, Ramot shall only be entitled (after such amounts shall first have been
applied to cover out-of-pocket expenses of both parties) to 5% from the awarded
lost Net Sales or the lost Net Sales grossed up from the loss of profit awarded
by the court.
10.3. Suit by Ramot. If Licensee does not take action in the
prosecution, prevention, or termination of any Infringement pursuant to Section
10.2 above, and has not commenced negotiations with the infringer for the
discontinuance of said Infringement, within ninety (90) days after receipt of
notice to Licensee by Ramot of the existence of an Infringement, Ramot may elect
to do so. Should Ramot elect to bring suit against an infringer and Licensee is
joined as party plaintiff in any such suit, Licensee shall have the right to
approve the counsel selected by Ramot to represent Ramot, such approval not to
be unreasonably withheld. The expenses of such suit or suits that Ramot elects
to bring, including any expenses of Licensee incurred in conjunction with the
prosecution of such suits or the settlement thereof, shall be paid for entirely
by Ramot and Ramot shall hold Licensee free, clear and harmless from and against
any and all costs of such litigation, including attorney's fees. Ramot shall not
compromise or settle such litigation without the prior written consent of
Licensee, which consent shall not be unreasonably withheld or delayed. In the
event Ramot exercises its right to sue pursuant to this Section 10.3, it shall
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 attorney's fees, necessarily involved in the prosecution of any such
suit. If, after such reimbursement, any funds shall remain from said recovery,
then Licensee shall receive an amount equal to one-third of such funds and the
remaining two-thirds of such funds shall be retained by Ramot.
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10.4. Own Counsel. Each party shall always have the right to be
represented by counsel of its own selection and at its own expense in any suit
instituted under this Section 10 by the other party for Infringement.
10.5. Cooperation. Each party agrees to cooperate fully in any action
under this Section 10 which is controlled by the other party, provided that the
controlling party reimburses the cooperating party promptly for any costs and
expenses incurred by the cooperating party in connection with providing such
assistance.
10.6. Standing. If a party lacks standing and the other party has
standing to bring any such suit, action or proceeding, then such other party
shall do so at the request of and at the expense of the requesting party. If
either party determines that it is necessary or desirable for another party to
join any such suit, action or proceeding, the other party shall execute all
papers and perform such other acts as may be reasonably required in the
circumstances.
11. Warranties; Limitation of Liability.
11.1. Compliance with Law. Licensee warrants that it will comply with,
and shall ensure that its Affiliates and Sublicensees comply with, all local,
state, federal, and international laws and regulations relating to the
development, manufacture, use, and sale of Licensed Products.
11.2. Representations by Ramot. Ramot represents that: (a) it is the
owner of the Ramot Patent Rights set forth in Exhibit 1.18(a) free and clear of
all liens and encumbrances; (b) it has the right to grant the licenses granted
pursuant to this Agreement; (c) it has not granted any rights in or to Ramot
Technology which are inconsistent with the rights granted to Licensee under this
Agreement to any other party.
11.3. No Warranty.
11.3.1. Nothing in this Agreement (including, without
limitation, any exhibits or attachments hereto) shall be construed as a warranty
on the part of Ramot that any results or inventions will be achieved in the
Research or that the Ramot Technology, Joint Technology and/or any other results
or inventions achieved in the Research are or will be commercially exploitable,
and furthermore, Ramot makes no warranties whatsoever as to the commercial or
scientific value of the Ramot Technology, Joint Technology and/or as to any
results which may be achieved in the Research and/or that any patent will issue
from any pending patent applications in the Ramot Patent Rights. Ramot makes no
representation that use of the Ramot Technology or Joint Technology will not
infringe the patent or proprietary rights of any third party.
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11.3.2. Except as otherwise expressly provided in this
Agreement, no party makes any warranty with respect to any technology, patents,
goods, services, rights or other subject matter of this Agreement and hereby
disclaims warranties of merchantability, fitness for a particular purpose and
noninfringement with respect to any and all of the foregoing.
11.4. Limitation of Liability. Notwithstanding anything else in this
Agreement or otherwise, Ramot shall not be liable to Licensee with respect to
any subject matter of this Agreement under any contract, negligence, strict
liability or other legal or equitable theory for (i) any indirect, incidental,
consequential or punitive damages or lost profits or (ii) cost of procurement of
substitute goods, technology or services.
12. Indemnification.
12.1 Indemnity. Licensee shall indemnify, defend, and hold harmless
Ramot, TAU, the Principal Investigators, the other members of the TAU Team,
their Affiliates and their respective governors, directors, officers, employees,
and agents and their respective successors, heirs and assigns (the "Ramot
Indemnitees"), against any liability, damage, loss, or expense (including
reasonable attorneys fees and expenses of litigation) incurred by or imposed
upon any of the Ramot Indemnitees in connection with any claims, suits, actions,
demands or judgments ("Claims") arising out of any theory of liability
(including without limitation actions in the form of tort, warranty, or strict
liability and regardless of whether such action has any factual basis)
concerning the use of any Ramot Technology or Joint Technology by Licensee, or
any of its Affiliates or Sublicensees, or concerning any product, process, or
service that is made, used, or sold pursuant to any right or license granted by
Ramot to Licensee under this Agreement (except in cases where such claims,
suits, actions, demands or judgments result from a willful material breach of
this Agreement, gross negligence or willful misconduct on the part of any of the
Ramot Indemnitees).
12.2 Procedures. If any Ramot Indemnitee receives notice of any Claim,
such Ramot Indemnitee shall, as promptly as is reasonably possible, give
Licensee notice of such Claim; provided, however, that failure to give such
notice promptly shall only relieve Licensee of any indemnification obligation it
may have hereunder to the extent such failure diminishes the ability of Licensee
to respond to or to defend the Ramot Indemnitee against such Claim. Ramot and
Licensee shall consult and cooperate with each other regarding the response to
and the defense of any such Claim and Licensee shall, upon its acknowledgment in
writing of its obligation to indemnify the Ramot Indemnitee, be entitled to and
shall assume the defense or represent the interests of the Ramot Indemnitee in
respect of such Claim, that shall include the right to select and direct legal
counsel and other consultants to appear in proceedings on behalf of the Ramot
Indemnitee and to propose, accept or reject offers of settlement, all at its
sole cost; provided, however, that no such settlement shall be made without the
written consent of the Ramot Indemnitee, such consent not to be unreasonably
withheld. Nothing herein shall prevent the Ramot Indemnitee from retaining its
own counsel and participating in its own defense at its own cost and expense.
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12.3 Insurance. Commencing with the commencement of clinical trials in
humans with respect to the first Licensed Product, Licensee shall maintain
insurance that is reasonably adequate to insure its liability pursuant to clause
12.1 above. Such insurance shall be in reasonable amounts (but in any event not
less than five million US dollars (US$5,000,000) for injuries to any one person
arising out of a single occurrence and ten million US dollars (US$10,000,000)
for injuries to all persons arising out of a single occurrence) and on
reasonable terms in the circumstances, having regard, in particular, to the
nature of the Licensed Products, and shall be subscribed for from a reputable
insurance company. Licensee shall provide Ramot, upon request, with written
evidence of such insurance. Licensee shall continue to maintain such insurance
after the expiration or termination of this Agreement during any period in which
Licensee or any Affiliate or Sublicensee continues to make, use, or sell a
Licensed Product, and thereafter for a period of seven (7) years.
13. Term and Termination.
13.1. Term. The term of this Agreement shall commence on the Effective
Date and, unless earlier terminated as provided in this Section 13, shall
continue in full force and effect on a Licensed Product-by-Licensed Product and
country-by-country basis until the expiration of all payment obligations
pursuant to Section 7 for such Licensed Product.
13.2. Effect of Expiration. Following the expiration pursuant to
Section 13.1 of this Agreement on a Licensed Product-by-Licensed Product and
country-by-country basis (and provided the Agreement has not been earlier
terminated pursuant to Section 13.3, in which case Section 13.4 shall apply):
(a) Licensee shall have a fully-paid up, nonexclusive license (with the right to
grant sublicenses) under the Ramot Technology solely to develop, make and have
made, use, offer to sell, sell, have sold, import, export, otherwise transfer
physical possession of or otherwise transfer title to such Licensed Product in
such country; (b) Ramot shall be free to use the Ramot Technology to develop,
make and have made, use, offer to sell, sell, have sold, import, export,
otherwise transfer physical possession of or otherwise transfer title to such
Licensed Product in such country and to grant others licenses under the Ramot
Technology to do the same; and (c) each of the parties shall have a fully-paid
up, non-exclusive, worldwide license (with the right to grant sublicenses) under
the other party's interest in the Joint Technology for any and all purposes.
13.3. Termination.
13.3.1 Termination Without Cause. Licensee may terminate this
Agreement upon sixty (60) days prior written notice to Ramot, provided however,
that, subject to Section 2.1.2, Licensee may not terminate its obligation to
fund the Research under Section 2.2.1.
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13.3.2. Termination for Default.
13.3.2.1 In the event that either party commits a
material breach of its obligations under this Agreement and fails to cure that
breach within thirty (30) days after receiving written notice thereof, the other
party may terminate this Agreement immediately upon written notice to the party
in breach. Notwithstanding the foregoing, in the event of a breach pursuant to
Section 5.2.4 (i.e. a breach by a Sublicensee) that is not susceptible of cure
by Licensee within the thirty (30) day period set forth above and License uses
diligent good faith efforts to cure such breach, the thirty (30) day cure period
shall be extended by an additional period of thirty (30) days.
13.3.3.2 In the event of an uncured material breach
by Ramot as described in the foregoing paragraph, Licensee may elect not to
terminate this Agreement but, instead, to sue Ramot for damages arising from
such breach, provided however, that in no event will Licensee seek damages
against Ramot in any such action which exceed amounts actually paid to Ramot
under this Agreement.
13.3.3. Bankruptcy. Either party may terminate this Agreement
upon notice to the other if the other party becomes insolvent, is adjudged
bankrupt, applies for judicial or extra-judicial settlement with its creditors,
makes an assignment for the benefit of its creditors, voluntarily files for
bankruptcy or has a receiver or trustee (or the like) in bankruptcy appointed by
reason of its insolvency, or in the event an involuntary bankruptcy action is
filed against the other party and not dismissed within ninety (90) days, or if
the other party becomes the subject of liquidation or dissolution proceedings or
otherwise discontinues business.
13.4. Effect of Termination.
13.4.1. Termination of Rights. Upon termination by Licensee
pursuant to Sections 13.3.1, 13.3.2 or 13.3.3 hereof or by Ramot pursuant to
Sections 6.4, 13.3.2 or 13.3.3 hereof: (a) the rights and licenses granted to
Licensee under Section 5 shall terminate; (b) all rights in and to the Ramot
Technology shall revert to Ramot and Licensee, its Affiliates and Sublicensees
shall not be entitled to make any further use whatsoever of the Ramot Technology
nor shall Licensee, its Affiliates or Sublicensees develop, make, have made,
use, offer to sell, sell, have sold, import, export, otherwise transfer physical
possession of or otherwise transfer title to Licensed Products; and (c) any
existing agreements that contain a sublicense of the Ramot Technology shall
terminate to the extent of such sublicense; provided, however, that, for each
Sublicensee, upon termination of the sublicense agreement with such Sublicensee,
Ramot shall be obligated, at the request of such Sublicensee, to enter into a
new license agreement with such Sublicensee on substantially the same terms as
those contained in such sublicense agreement, provided that such terms shall be
amended, if necessary, to the extent required to ensure that such Sublicense
Agreement does not impose any obligations or liabilities on Ramot which are not
included in this Agreement.
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13.4.2. Accruing Obligations. Termination of this Agreement
shall not relieve the parties of obligations occurring prior to such
termination, including obligations to pay amounts accruing hereunder up to the
date of termination.
13.4.3. Transfer of Regulatory Filings and Know How.
13.4.3.1. In the event that Ramot terminates this
Agreement pursuant to Section 6.4, 13.3.2 or 13.3.3, Licensee shall promptly
deliver and assign to Ramot (a) all documents and other materials filed by or on
behalf of Licensee and its Affiliates with Regulatory Agencies in furtherance of
applications for Regulatory Approval in the relevant country with respect to
Licensed Products and (b) all intellectual property, inventions, conceptions,
compositions, materials, methods, processes, data, information, records,
results, studies and analyses, discovered or acquired by, or on behalf of
Licensee and its Affiliates which relate directly to actual or potential
Products, including without limitation Licensee's interest in Joint Technology.
Ramot and TAU shall be entitled to freely use and to grant others the right to
use all such materials, documents and know-how delivered pursuant to this
13.4.3.1 without any obligations to Licensee.
13.4.3.2. In the event Licensee terminates this
Agreement pursuant to Section 13.3.1, Licensee shall promptly deliver and assign
to Ramot (a) all documents and other materials filed by or on behalf of Licensee
and its Affiliates with Regulatory Agencies in furtherance of applications for
Regulatory Approval in the relevant country with respect to Products and (b) all
intellectual property, inventions, conceptions, compositions, materials,
methods, processes, data, information, records, results, studies and analyses,
discovered or acquired by, or on behalf of Licensee and its Affiliates which
relate directly to actual or potential Licensed Products, including without
limitation Licensee's interest in Joint Technology. Ramot and TAU shall be
entitled to freely use and to grant others the right to use all such materials,
documents and know-how delivered pursuant to this 13.4.3.1 (the "Assigned IP");
provided that in the event Ramot grants a third party a license under or with
respect to any of the Assigned IP, Ramot shall pay Licensee royalties in the
amount of thirty (30%) of all Net Ramot Receipts (as defined below) actually
received by Ramot in consideration for the license of such Assigned IP. All such
royalties shall be paid by Ramot on a quarterly basis, within thirty days of the
end of the calendar quarter in which the consideration was received. Ramot shall
report to Licensee and pay the said amounts to Licensee in accordance with the
procedures set forth in this Agreement with respect to Licensee's payment and
reporting obligations to Ramot as described in section 8 above, mutatis
mutandis. For purposes of this Section 13.4.3.2, the following words shall have
the following meanings:
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(a) "Net Ramot Receipts" shall mean Ramot
Receipts less Ramot Expenses.
(b) "Ramot Receipts" shall mean all amounts
in cash and other consideration actually received by Ramot from the sale,
transfer, assignment, lease, grant of licenses under or with respect to, or the
assignment of rights in, any or all of the Assigned IP; provided that "Ramot
Receipts" does not include payments specifically committed to cover future costs
to be actually incurred by Ramot (including customary overhead, not exceeding
30%) in accordance with detailed budgets and research workplans included in,
sponsored research or research and license agreements relating to the Assigned
IP.
(c) "Ramot Expenses" shall mean all
out-of-pocket expenses and professional fees, including legal fees, patent agent
fees and fees paid to other experts, incurred by Ramot in connection with: (a)
the filing, prosecution, maintenance or enforcement of any patent application or
patent covering or included in the Assigned IP; or (b) the preparation,
negotiation, execution and/or enforcement of any agreement relating to the sale,
lease, license or assignment of any or all of or under the Assigned IP.
13.5. Survival. The parties' respective rights, obligations and duties
under Sections 8.5, 9, 11, 12, 13, 14.2 and 14.4, as well as any rights,
obligations and duties which by their nature extend beyond the expiration or
termination of this Agreement, shall survive any expiration or termination of
this Agreement.
14. Miscellaneous.
14.1. Entire Agreement. This Agreement is the sole agreement with
respect to the subject matter hereof and except as expressly set forth herein,
supersedes all other agreements and understandings between the parties with
respect to the same.
14.2. Publicity Restrictions. Subject to Section 9.1.2, Licensee and
its Affiliates and Sublicensees shall not use the name of Ramot, TAU, either
Principal Investigator or any of their trustees, officers, faculty, researchers,
students, employees, or agents, or any adaptation of such names, in any
promotional material or other public announcement or disclosure relating to the
subject matter of this Agreement without the prior written consent of Ramot.
14.3. Notices. Unless otherwise specifically provided, all notices
required or permitted by this Agreement shall be in writing and may be delivered
personally, or may be sent by facsimile or certified mail, return receipt
requested, to the following addresses, unless the parties are subsequently
notified of any change of address in accordance with this Section 14.3:
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If to Licensee: Brainstorm Cell Therapeutics, Inc.
1350 Avenue of the Americas
New York,
NY 10019
USA
With a copy to:
Tulchinsky, Stern & Co, Law Offices
Abba Hillel 14
Beit Oz
Ramat Gan 52506
If to Ramot: Ramot at Tel Aviv University Ltd.
P.O. Box 39296
Tel Aviv 61392
Israel
Attn: CEO
Fax: 972-3-640-5064
Any notice shall be deemed to have been received as follows: (i) by
personal delivery, upon receipt; (ii) by facsimile, one business day after
transmission or dispatch; (iii) by airmail, seven (7) business days after
delivery to the postal authorities by the party serving notice. If notice is
sent by facsimile, a confirming copy of the same shall be sent by mail to the
same address.
14.4. Governing Law and Jurisdiction. This Agreement shall be governed
by and construed in accordance with the laws of Israel, without regard to the
application of principles of conflicts of law, except for matters of patent law,
which, other than for matters of inventorship on patents, shall be governed by
the patent laws of the relevant country of the patent. The parties hereby
consent to personal jurisdiction in Israel and agree that the competent court in
Tel Aviv, Israel shall have sole jurisdiction over any and all matters arising
from this Agreement, except that Ramot may bring suit against the Licensee in
any other jurisdiction outside Israel in which the Licensee has assets or a
place of business.
14.5. Binding Effect. This Agreement shall be binding upon and inure to
the benefit of the parties and their respective legal representatives,
successors and permitted assigns.
14.6. Headings. Section and subsection headings are inserted for
convenience of reference only and do not form a part of this Agreement.
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14.7. Counterparts. This Agreement may be executed simultaneously in
two or more counterparts, each of which shall be deemed an original.
14.8. Amendment; Waiver. This Agreement may be amended, modified,
superseded or canceled, and any of the terms may be waived, only by a written
instrument executed by each party or, in the case of waiver, by the party
waiving compliance. The delay or failure of any party at any time or times to
require performance of any provisions hereof shall in no manner affect the
rights at a later time to enforce the same. No waiver by either party of any
condition or of the breach of any term contained in this Agreement, whether by
conduct, or otherwise, in any one or more instances, shall be deemed to be, or
considered as, a further or continuing waiver of any such condition or of the
breach of such term or any other term of this Agreement.
14.9. No Agency or Partnership. Nothing contained in this Agreement
shall give any party the right to bind another, or be deemed to constitute
either parties as agents for each other or as partners with each other or any
third party.
14.10. Assignment and Successors. This Agreement may not be assigned by
either party without the consent of the other, which consent shall not be
unreasonably withheld.
14.11. Force Majeure. Neither party will be responsible for delays
resulting from causes beyond the reasonable control of such party, including
without limitation fire, explosion, flood, war, strike, or riot, provided that
the nonperforming party uses commercially reasonable efforts to avoid or remove
such causes of nonperformance and continues performance under this Agreement
with reasonable dispatch whenever such causes are removed.
14.12. Interpretation. The parties hereto acknowledge and agree that:
(i) each Party and its counsel reviewed and negotiated the terms and provisions
of this Agreement and have contributed to its revision; (ii) the rule of
construction to the effect that any ambiguities are resolved against the
drafting party shall not be employed in the interpretation of this Agreement;
and (iii) the terms and provisions of this Agreement shall be construed fairly
as to both parties hereto and not in favor of or against either party,
regardless of which party was generally responsible for the preparation of this
Agreement.
14.13. Severability. If any provision of this Agreement is or becomes
invalid or is ruled invalid by any court of competent jurisdiction or is deemed
unenforceable, it is the intention of the parties that the remainder of this
Agreement shall not be affected.
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IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by
their duly authorized representatives as of the date first written above.
Ramot at Tel Aviv University Ltd. Brainstorm Cell Therapeutics, Inc.
By: /s/ Ze'ev Weinfeld, Ph.D. By: /s/ Yoram Drucker
-------------------------------- -----------------------------------
Name: Ze'ev Weinfeld, Ph.D. Name: Yoram Drucker
Title: Executive Vice President, Title: Chief Operating Officer
Business Development (Principal executive officer)
By: /s/ Yehuda Niv
--------------------------------
Name: Yehuda Niv
Title: CEO
We, the undersigned, hereby confirm that we have read the Agreement, that its
contents are acceptable to us and that we will act in accordance with its terms.
/s/ Eldad Melamed /s/ Daniel Offen
- -------------------------------- --------------------------------
Professor Eldad Melamed Dr. Daniel Offen
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