SECOND AMENDED AND RESTATED RESEARCH AND LICENSE AGREEMENT
Exhibit
10.4
SECOND
AMENDED AND RESTATED RESEARCH AND LICENSE AGREEMENT
This
Second Amended and Restated Research and License Agreement is entered into
as of
this 26th
day of
July, 2007, by and between Brainstorm Cell Therapeutics Inc., a company formed
under the laws of the State of Delaware, having a place of business at 0000
Xxxxxx xx xxx Xxxxxxxx Xxx Xxxx, XX 00000 (“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 Xxxxx-Xxxx, Xxx
Xxxx 00000, Xxxxxx (“Ramot”),
for the
purpose of amending and replacing the Research and License Agreement between
the
parties dated March 30, 2006 (the "First Amended and Restated Research and
License Agreement"), which replaced the previous 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 Xxxxxxxxx Xxxxx Xxxxxxx, Xx. Xxxxxx Xxxxx, Xxxxxx Xxxx and Xx.
Xxxxx Xxxxx 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 of
the
First Amended and Restated Research and License Agreement; and
WHEREAS,
in order to give effect to such wish, the parties agree to amend and replace
the
First Amended and Restated Research and License 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 "Additional
Ingredient"
shall
mean a therapeutically active ingredient other than one developed using Ramot
Technology. Unless recognized as active ingredients by the FDA (or equivalent
body), drug delivery vehicles, non-therapeutic adjuvants, and excipients are
hereby deemed not to be “therapeutically active ingredients”, and their presence
alone shall not be deemed to create a Combined Product for purposes of this
Agreement.
1.3. “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.
1.4 “Combined
Product”
shall
mean a product or service which comprises a Licensed Product and one or more
Additional Ingredients. To be a Combined Product, a Licensed Product must be
sold together with Additional Ingredients as a single product and invoiced
as
one (1) product.
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1.5 “Development
Milestones” shall
mean the development milestones set forth in Exhibit 1.5 hereto.
1.6 “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.
1.7. “FDA”
shall
mean the United States Food and Drug Administration.
1.8 “Generic
Version”
shall
mean, with respect to a Licensed Product that is sold in a particular
jurisdiction: any third party product or service that (i) contains or utilizes
the same therapeutically active ingredient as such Licensed Product, and (ii)
that is lawfully marketed, sold and/or provided in such country for the same
indications as such Licensed Product, pursuant to an approved application
for a license to market a generic or a duplicate version of such Licensed
Product (e.g.
an
Abbreviated New Drug Application in the United States) in the relevant
jurisdiction.
1.9. “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.
1.10. “Joint
Patent Rights”
shall
mean any and all Patent Rights claiming Joint Inventions.
1.11. “Joint
Technology”
shall
mean Joint Patent Rights and Joint Inventions.
1.12. “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, if Ramot shall in good faith first provide the Company with a
reasonable written opinion of an independent pharmaceutical expert that such
Product is a Licensed Product.
1.13. “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.
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1.14. “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 or ordinary course of business trade, quantity, patient
program, prompt payment or cash discounts to the extent actually allowed and
taken; (b) amounts repaid or credited by reason of rejection, return or
retroactive price reduction, chargebacks, administrative fees or rebates; (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, (d) credit or refunds for Products
which
are rejected or returned; (e) Out bound transportation expenses and
transportation insurance premiums to the extend separately stated on the
invoice; (f) delayed ship order credits; (g) credits for uncollectible amounts
on previously sold Product, provided that such amounts have been written off
in
the books of the Company in accordance with generally accepted accounting
principles
as in
effect in the United States from time to time "(GAAP"),
and
provided that such amounts are not subsequently collected;
(h)
any
other
reduction or specifically identifiable amounts included in the Product's gross
invoice price that should be credited for reasons substantially equivalent
to
those listed above, so long as not prohibited by GAAP.
(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) through (h)
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.
1.15. “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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1.16. “Other
Research”
shall
have the meaning set forth in Section 5.1.
1.17.
“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.
1.18. “Principal
Investigators” shall
mean Xxxxxxxxx Xxxxx Xxxxxxx and Xx. Xxxxxx Xxxxx, or such other principal
investigator who may replace either or both of them pursuant to Section
2.
1.19. “Product”
shall
mean: (i) any product or service 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; or (ii) any neuron-like or glial-like cell generated through
use of a product described in clause (i) of this Section 1.16.
1.20. “Ramot
Results”
shall
mean (a) any and all inventions, materials, methods, processes, know-how,
improvements 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.
1.21. “Ramot
Patent Rights” shall
mean (i) the Patent Rights described in Exhibit 1.21(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
1.21(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.
1.22. “Ramot
Technology”
shall
mean the Ramot Patent Rights, the invention disclosed in Exhibit 1.21(a) and
the
Ramot Results.
1.23. “Regulatory
Agency” shall
mean the FDA or equivalent agency or government body of another country.
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1.24. “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.
1.25. “Research”
shall
mean the research actually conducted by the TAU Team under the terms of this
Agreement in accordance with the Research Plan.
1.26. “Research
Plan”
shall
mean the research plan attached hereto as Exhibit 1.26, 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.
1.27.
“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.
1.28.
“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.
1.29.
“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.
1.30.
“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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1.31. “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.
1.32. “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.
1.33. “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.
2.2 Funding
of the Research Project.
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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.
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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.
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 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
4.5. 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, and to otherwise practice and exploit the Ramot
Technology and Ramot's interest in the Joint Technology solely for the purpose
of developing and/or commercializing 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.
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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.
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 be entitled to sublicense its rights under such sublicense
agreement, provided that the provisions of this Section 5.2 shall apply to
the
grant of such sublicense; 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 and acknowledgement of satisfaction
contemplated in this Section 5.2.2.4 shall not be unreasonably withheld or
delayed.
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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.
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
jurisdiction, 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 jurisdiction. Licensee and/or its Affiliates and/or Sublicensees activities
shall include but not be limited to:
12
(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.
13
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 jurisdiction-by-jurisdiction 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 jurisdiction:
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
jurisdiction: 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 jurisdiction.
7.3.1.3
Notwithstanding
the foregoing, if, in a given calendar quarter in a given country, sales of
Generic Versions of a Licensed Product (or Combined Product) represent ten
(10%)
or more of the total combined sales of such Licensed Product (or Combined
Product) and such Generic Versions in such country, the royalties payable with
respect to Net Sales of such Licensed Product (or the portion of Net Sales
attributed to the Licensed Product in such Combined Product pursuant to Section
7.5) in such country shall be reduced to 2.5% for such calendar
quarter.
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 jurisdiction (including Licensed Products
that are included in a Combined Product, but not including any other ingredient
of such Combined Product), Licensee may offset such third-party payments against
the royalty payments that are due to Ramot pursuant to Section 7.3.1.1 (but
not
pursuant to Section 7.3.1.2 or 7.3.1.3) with respect to sales in such
jurisdiction; provided
that,
14
(a) royalty
payments under Section 7.3.1.1 to Ramot may not be reduced pursuant to this
Section 7.3.2 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
(b) in
no
event, shall the royalty payments to Ramot under Section 7.3.1.1 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 jurisdiction as a result of
reductions pursuant to this Section 7.3.2.
7.4. Sublicense
Receipts. In
addition, Licensee shall pay Ramot an amount equal to a percentage of all
Sublicense Receipts as follows:
(a)
25%
of Sublicense Receipts, with respect to Sublicenses granted prior to completion
of Phase II Clinical Studies, and
(b)
20%
of Sublicense Receipts, with respect to Sublicenses granted following completion
of Phase II Clinical Studies.
7.5 Combined
Products. For
purposes of determining royalty payments on sales of Combined Products, “Net
Sales” shall be determined by multiplying the actual Net Sales of such Combined
Product during the applicable royalty reporting period and in the applicable
jurisdiction, by the fraction A/(A+B) where: “A” is the average sale price of
the Licensed Product contained in the Combined Product when sold separately
by
Licensee or its Affiliate; and “B” is the average price of the Additional
Ingredients included in the Combined Product when sold separately by its
supplier, in each case during the applicable royalty reporting period or if
sales of both the Licensed Product and/or other Additional Ingredients did
not
occur in such period, then in the most recent royalty reporting period in which
sales of both occurred. In the event that such average sale price cannot be
determined for both the Licensed Product and all other Additional Ingredients
included in the Combined Product, Net Sales for the purpose of determining
royalty payments shall be calculated by multiplying the Net Sales of the
Combined Products by the fraction of C/(C+D) where “C” is the fair market value
of the Licensed Product and “D” is the fair market value of all other Additional
Ingredients included in the Combined Product. In such event, the parties shall
negotiate in good faith to arrive at a determination of the respective fair
market values of the Licensed Product and all other Additional Ingredients
included in the Combined Product, provided that the portion of Net Sales
attributed to the Licensed Product in such event shall not be less than 50%
of
the relevant Net Sales.
15
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:
(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,
subject to credit for amounts paid to Ramot previously that were excessive
under
the definition of Net Sales herein.
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.
16
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.
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.
17
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 monthly interest at a simple annual
interest, equal to three percent (3%) above the 30 day 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.
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
(or
their Affiliates) who have a “need to know” such information in order to enable
Licensee to exercise or exploit 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 proprietary
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 (A) 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;
(iv) is independently developed by Licensee without the use of or reference
to
the Confidential Information, as demonstrated by documentary evidence; and
(B)
disclosure of such information is reasonably necessary in (i)
filing
or prosecuting patents and patent applications; (ii)
conducting
research, development and/or commercialization activities and regulatory filings
for products or services; (iii)
prosecuting or defending litigation; (iv) complying
with applicable law, including court orders or governmental
regulations;
and (v)
disclosure to third parties in connection with due diligence or similar
investigations by such third parties or potential investment.
18
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.
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. Publication of the fact of this Agreement and its subject matter
shall be deemed to be approved.
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.
19
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 ninety (90) 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.
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 xxx 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.
20
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 xxx 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.
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.
21
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.
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). The foregoing indemnity
shall be the exclusive remedy of the Ramot Indemnitees with respect to liability
arising from any such Claims.
22
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.
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
jurisdiction-by-jurisdiction basis until the expiration of all payment
obligations pursuant to Section 7 for such Licensed Product.
23
13.2. Effect
of Expiration. Following
the expiration pursuant to Section 13.1 of this Agreement on a Licensed
Product-by-Licensed Product and jurisdiction-by-jurisdiction 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.
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
xxx Xxxxx 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.
24
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.
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.
25
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:
(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.
26
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, including the
Original Agreement and the First Amended and Restated Research and License
Agreement.
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. If Ramot does not consent to such
use it shall notify Licensee within one Israeli business day of a request for
approval and provide its required changes to the proposed material. If such
notice is not provided within the designated time period, Ramot will be deemed
to have given its approval.
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:
If
to Licensee:
|
Brainstorm
Cell Therapeutics, Inc.
0000
Xxxxxx xx xxx Xxxxxxxx
Xxx
Xxxx,
XX
00000
XXX
|
With
a copy to:
Xxxxxxxxxx,
Xxxxx & Co, Law Offices
Abba
Hillel 14
Beit
Oz
Ramat
Gan 52506
|
27
If
to Ramot:
|
Ramot
at Tel Aviv University Ltd.
X.X.
Xxx 00000
Xxx
Xxxx 00000
Xxxxxx
Attn:
CEO
Fax:
000-0-000-0000
|
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.
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.
28
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.
[REMAINDER
OF PAGE INTENTIONALLY LEFT BLANK]
29
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.
By: /s/
Xxxxxx
Niv
Name:
Xxxxxx Niv
Title:
CEO
|
Brainstorm
Cell Therapeutics, Inc.
By:
/s/ Xxxx
Xxxxxxx
Name:
Xxxx Xxxxxxx
Title:
CFO
|
By:
/s/ Ze'xx Xxxxxxxx, Ph.D.
Executive
Vice
President
Business
Development
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.
____________________________
Xxxxxxxxx
Xxxxx Xxxxxxx
|
________________________
Xx.
Xxxxxx Xxxxx
|
30