EXCLUSIVE LICENSE
AGREEMENT
This Exclusive
License Agreement and the attached Appendix A (collectively, the
“Agreement”) is made and is effective this 26
th day of September 2008 (the "Effective Date")
between THE REGENTS OF THE UNIVERSITY OF CALIFORNIA ("The
Regents"), a California corporation having its corporate offices
located at 1111 Franklin Street, Oakland, California 94607-5200,
acting through The Office of Intellectual Property Administration
of the University of California, Los Angeles, located at 11000
Kinross Avenue, Suite 200, Los Angeles, CA 90095-1406 and Entest
BioMedical Inc. ("Licensee"), a corporation having a principal
place of business at 1010 University Avenue #40 , San Diego,
CA 92103.
RECITALS
WHEREAS, a
certain invention (the "Invention"), generally characterized as
“SCREENING TEST FOR GESTATIONAL DIABETES MELLITUS”
(UCLA Case No. 2007-523) was made in the course of research at the
University of California, Los Angeles by Brian J. Koos, and is and
claimed in Regents' Patent Rights as defined below;
WHEREAS, Brian
J. Koos is an employee of The Regents and as such is obligated to
assign his/her right, title and interest in and to the Invention to
The Regents;
WHEREAS, The
Regents wishes that Regents' Patent Rights be developed and
utilized to the fullest extent so that the benefits can be enjoyed
by the general public.
WHEREAS,
Licensee is a "small business concern" as defined in 15 U.S.C.
§§632; and
The parties
agree as follows:
1. DEFINITIONS
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1.1
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"Regents'
Patent Rights" means The Regents’ interest in any of the
patent applications listed in Appendix A attached to this Agreement
and assigned to The Regents (UCLA Case No. 2007-523); any
continuing applications thereof including divisions; but excluding
continuations-in-part except to the extent of claims entirely
supported in the specification and entitled to the priority date of
the parent application; any patents issuing on these applications
including reissues and reexaminations; and any corresponding
foreign patents or patent applications; all of which will be
automatically incorporated in and added to Appendix A and made a
part of this Agreement.
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1.2
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"Licensed
Product" means any article, composition, apparatus, substance,
chemical, or any other material covered by Regents' Patent Rights
or whose manufacture, use or sale would, absent the license granted
under this Agreement, constitute an infringement, inducement of
infringement, or contributory infringement, of any claim within
Regents' Patent Rights, or any service, article, composition,
apparatus, chemical, substance, or any other material made, used,
or sold by or utilizing or practicing a Licensed Method. This
definition of Licensed Product also includes a service either used
by Licensee or sublicensee or provided by Licensee or sublicensee
to its customers when such service requires the use of Licensed
Product or performance of Licensed Method. If the Licensed Product
is a component of another product such as a kit, composition of
matter or combination, such kit, composition of matter or
combination is deemed to be the Licensed Product for purposes of
this Agreement. Likewise, if the Licensee or sublicensees receives
a Licensed Product for incorporation into another product intended
for sales, transfer, lease or other disposition, then, for the
purposes of this Agreement, the Licensed Product is the product
intended for sale, transfer, lease, or other disposition by
recipient Licensee or sublicensee.
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1.3
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"Licensed
Method" means any process, service, or method which is covered by
Regents' Patent Rights or whose use or practice would, absent the
license granted under this Agreement, constitute an infringement,
inducement of infringement, or contributory infringement, of any
claim within Regents' Patent Rights.
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1.4
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The "Field of
Use" means all fields of use.
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1.5
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" Affiliate "
means any corporation or other business entity in which Licensee
owns or controls, directly or indirectly, at least fifty percent
(50%) of the outstanding stock or other voting rights entitled to
elect directors. In any country where the local law does not permit
foreign equity participation of at least fifty percent (50%), then
"Affiliate" means any company in which Licensee owns or controls,
directly or indirectly, the maximum percentage of outstanding stock
or voting rights that is permitted by local law.
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1.6
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“Joint
Venture” means any separate entity established pursuant to an
agreement between a third party and the Licensee and/or Sublicensee
to constitute a vehicle for a Joint Venture, in which the separate
entity manufactures, uses, purchases, Sells or acquires Licensed
Products from the Licensee or Sublicensee. Each reference to
Licensee herein will be meant to include its Joint Venture(s), and
Licensee will be responsible for all obligations of its Joint
Ventures.
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1.7
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"First
Commercial Sale" means the first sale of any Licensed Product by
Licensee or sublicensee, following approval of it's marketing by
the appropriate governmental agency for the country in which the
sale is to be made. When governmental approval is not required,
"First Commercial Sale" means the first sale in that
country.
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1.8
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"Final Sale"
means any sale, transfer, lease, exchange or other disposition or
provision of a Licensed Product and/or a Licensed Method to a
Customer by a Licensee or Sublicensee. A Final Sale will be deemed
to have occurred upon the earliest to occur of the following (as
applicable): (a) the transfer of title to such Licensed Product
and/or Licensed Method to a Customer, (b) the shipment of such
Licensed Product to a Customer, (c) the provision of a Licensed
Method to a Customer, (d) the provision of an invoice for such
Licensed Product or Licensed Method to a Customer, or (e) payment
by the Customer for Licensed Products or Licensed Methods. Exchange
of Licensed Products between Licensee and sublicense(s) is not a
Final Sale if the Licensed Product is intended for further sale,
transfer, lease, exchange or other disposition and instead the
Final Sale will be deemed to have occurred upon sale, transfer,
lease, exchange or other disposition or provision of Licensed
Product by recipient to the Customer. If the Licensee or sublicense
transfers Licensed Product at no cost during a clinical study,
clinical trial, or as a free sample in product promotion, then such
sale will not be considered a Final Sale and no royalty will be
owed hereunder.
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1.9
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"Net Sales"
means the total of the gross amount invoiced or otherwise charged
(whether consisting of cash or any other forms of consideration)
for all Final Sales, less the following deductions (to the extent
included in and not already deducted from the gross amount invoiced
or otherwise charged) to the extent reasonable and customary: cash,
trade or quantity discounts actually granted to Customers; sales,
use, tariff, import/export duties or other excise taxes imposed on
particular sales, and value added taxes (“vat”) to the
extent that such vat is incurred and not reimbursed, refunded, or
credited under a tax authority; and allowances or credits to
Customers because of rejections or returns. Income taxes are not an
allowed deduction under Net Sales. If the Licensee, a sublicense,
development partner or Joint Venture is a Customer, then Licensee
will pay royalties on Net sales based on the total gross amount
normally charged to other Customers in arms length
transactions.
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1.10
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Sublicensee"
means any party sublicensed by Licensee to make, have made, use,
sell, offer for sale or import any Licensed Product or to practice
any Licensed Method.
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1.11
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"Sublicensing
Income" means income received by Licensee under or on account of
sublicenses. Sublicensing Income includes income received from
Sublicensees attributable to the licensed Invention in the form of
license issue fees, milestone payments, and the like but
specifically excludes royalties on the sale or distribution of
Licensed Products or the practice of Licensed Methods. Not included
in the definition of Sublicensing Income is income received by
Licensee as payment or reimbursement for research costs applied to
the licensed Invention and conducted by or for Licensee, including
costs of materials, equipment or clinical testing.
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1.12
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“Customer” means any individual or
entity that receives Licensed Products or Licensed Methods,
provided however, that Licensee or sublicensee shall be deemed a
Customer only if it receives Licensed Products or Licensed Method
that are not intended for further sale, transfer, lease, exchange
or other disposition.
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2. GRANT
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2.1
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Subject to the
limitations set forth in this Agreement, The Regents hereby grants
to Licensee an exclusive license (the "License") under Regents'
Patent Rights, in jurisdictions where Regents' Patent Rights exist,
to make, have made, use, sell, offer for sale and import Licensed
Products and to practice Licensed Methods in the Field of Use to
the extent permitted by law. The Licensee will not make, use, sell,
import, or offer for sale, Licensed Products outside the Field of
Use.
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2.2
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The Regents
expressly reserves the right to: (a) use Regents' Patent Rights and
associated technology for educational and research purposes,
clinical research, and research sponsored by commercial entities
(b) to publicly disclose research results, and (c) allow other
non-profit research institutions to use Regents' Patent Rights and
associated technology for the same purposes as (a) and
(b).
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2.3
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The Agreement
will terminate immediately if Licensee files a claim including in
any way the assertion that any portion of Regents’ Patent
Rights is invalid or unenforceable where the filing is by the
Licensee, a third party on behalf of the Licensee, or a third party
at the written urging of the Licensee
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3. SUBLICENSES
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3.1
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The Regents
also grants to Licensee the right to issue exclusive or
nonexclusive sublicenses ("Sublicenses") to third parties to make,
have made, use, sell, offer for sale or import Licensed Products
and to practice Licensed Methods in any jurisdiction in which
Licensee has exclusive rights under this Agreement, but Sublicenses
will not include further right to sublicense on the part of the
Sublicensee. Each Sublicense will be issued in writing. To the
extent applicable, sublicenses must include all of the rights of
and will require the performance of obligations due to The Regents
(and, if applicable, the U.S. Government under 35 U.S. C.
§§201-212) contained in this Agreement. Affiliates have
no rights hereunder, unless, granted a Sublicense. For the purposes
of this Agreement, operations of Sublicensees are deemed to be the
operations of the Licensee, for which the Licensee is
responsible.
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3.2
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Licensee must
pay to The Regents Twenty-five percent (25%) of all Sublicensing
Income.
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3.3
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On Net Sales of
Licensed Products sold or disposed of by a Sublicensee, Licensee
must pay to The Regents an earned royalty in accordance with
Article 5 (Royalties) as if these were Licensee's Net Sales. Any
royalties received by Licensee in excess of royalties due to The
Regents under this Paragraph 3.3 belong to Licensee.
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3.4
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Licensee must
provide to The Regents a copy of each Sublicense within thirty (30)
days of execution, and a copy of all information submitted to
Licensee by Sublicensees relevant to the computation of the
payments due to The Regents under this Article 3.
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3.5
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If this
Agreement is terminated for any reason, all outstanding Sublicenses
not in default will be assigned by Licensee to The Regents, at the
option of The Regents. The Sublicenses will remain in full force
and effect with The Regents as the licensor or sublicensor instead
of Licensee, but the duties of The Regents under the assigned
Sublicenses will not be greater than the duties of The Regents
under this Agreement, and the rights of The Regents under the
assigned Sublicenses will not be less than the rights of The
Regents under this Agreement, including all financial consideration
and other rights of The Regents.
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4. FEES
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4.1
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In partial
consideration for the License, Licensee will pay to The Regents a
license issue fee of Five thousand dollars ($5,000) within thirty
(30) days of the Effective Date. This fee is nonrefundable and is
not an advance against royalties.
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4.2
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Licensee must
pay to The Regents a license maintenance fee of Five thousand
dollars ($5,000) beginning on the one-year anniversary date of the
Effective Date of this Agreement and continuing annually on each
anniversary date of the Effective Date. The maintenance fee will
not be due and payable on any anniversary date of the Effective
Date if on that date Licensee is commercially selling a Licensed
Product and paying an earned royalty to The Regents on the sales of
that Licensed Product. The license maintenance fees are
non-refundable and are not an advance against royalties.
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5. ROYALTIES
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5.1
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Licensee must
pay to The Regents for sales by Licensee and sublicensees an earned
royalty of Six percent (6%) of Net Sales of Licensed Products or
Licensed Methods.
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5.2
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Licensee must
pay to The Regents a minimum annual royalty of Fifty thousand
dollars ($50,000) for the life of Regents' Patent Rights, beginning
one year after the First Commercial Sale of Licensed Product.
Licensee must pay the minimum annual royalty to The Regents by
February 28 of each year. The minimum annual royalty will be
credited against the earned royalty due and owing for the calendar
year in which the minimum payment was made.
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5.3
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Royalties are
payable on products covered by pending patent applications and
issued patents. Royalties accrue for the duration of this
Agreement.
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5.4
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Licensee must
pay royalties owed to The Regents on a quarterly basis. Licensee
must pay the royalties within two (2) months of the end of the
calendar quarter in which the royalties accrued.
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5.5
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All monies due
The Regents must be paid in United States funds. When Licensed
Products are sold for monies other than United States dollars, the
royalties will first be determined in the currency of the country
in which the Licensed Products were sold and, second, converted
into equivalent United States funds. Licensee will use the exchange
rate established by the Bank of America in San Francisco,
California on the last day of the calendar quarter.
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5.6
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Any tax for the
account of The Regents required to be withheld by Licensee under
the laws of any foreign country must be promptly paid by Licensee
for and on behalf of The Regents to the appropriate governmental
authority. Licensee will use its best efforts to furnish The
Regents with proof of payment of any tax. Licensee is responsible
for all bank transfer charges. All payments made by Licensee in
fulfillment of The Regents' tax liability in any particular country
will be credited against fees or royalties due The Regents for that
country.
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5.7
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If at any time
legal restrictions prevent the acquisition or prompt remittance of
United States Dollars by Licensee with respect to any country where
a Licensed Product is sold, the Licensee shall pay royalties due to
The Regents from Licensee’s other sources of United States
Dollars.
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5.8
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If any patent
or any claim included in Regents' Patent Rights is held invalid or
unenforceable in a final decision by a court of competent
jurisdiction from which no appeal has or can be taken, all
obligation to pay royalties based on that patent or claim or any
claim patentably indistinct from it will cease as of the date of
that final decision. Licensee will not, however, be relieved from
paying any royalties that accrued before that decision or that is
based on another patent or claim not involved in that
decision.
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6. DILIGENCE
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6.1
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Upon the
execution of this Agreement, Licensee must diligently proceed with
the development, manufacture and sale ("Commercialization") of
Licensed Products and must earnestly and diligently endeavor to
market them within a reasonable time after execution of this
Agreement and in quantities sufficient to meet the market demands
for them.
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6.2
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Licensee must
endeavor to obtain all necessary governmental approvals for the
Commercialization of Licensed Products.
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6.3
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The Regents has
the right and option to either terminate this Agreement or reduce
Licensee’s exclusive license to a nonexclusive license if
Licensee fails to perform any of the terms in this Paragraph 6.3.
This right, if exercised by The Regents, supersedes the rights
granted in Article 2 (Grant).
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6.3a
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Initiate a
study in humans to measure D-chiro-inositol (“DBI”)
throughout pregnancy and correlate DBI levels with conventional
gestational diabetes mellitus (“GDM”) assays to
determine value of DBI in predicting GDM by September 1,
2010.
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6.3b
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Complete a
study in humans to measure D-chiro-inositol (“DBI”)
throughout pregnancy and correlate DBI levels with conventional
gestational diabetes mellitus (“GDM”) assays to
determine value of DBI in predicting GDM by September 1,
2011.
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6.3c
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Complete a
study to measure plasma DBI levels in samples from the
Hyperglycemia and Adverse Pregnancy Outcomes (HAPO) study and
correlate these DBI levels to GDM incidence by June 1,
2012.
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6.3d
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Complete a
prospective human study on DBI and its value in predicting GDM by
June 1, 2013.
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6.3e
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Develop a
urine-based test for assaying DBI by September 1, 2015.
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6.3f
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First
Commercial Sale of a Licensed Product by September 1,
2017.
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6.4
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Licensee has
the sole discretion for making all decisions as to how to
commercialize any Licensed Product.
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7. PATENT FILING, PROSECUTION AND
MAINTENANCE
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7.1
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As long as
Licensee is current in reimbursing patent prosecution costs, The
Regents will file, prosecute and maintain the patents and
applications comprising Regents' Patent Rights. These patents will
be held in the name of The Regents and will be obtained with
counsel of The Regents' choice. The Regents must provide Licensee
with copies of each patent application, office action, response to
office action, request for terminal disclaimer, and request for
reissue or reexamination of any patent or patent application under
Regents' Patent Rights. The Regents will consider any comments or
suggestions by Licensee and will use reasonable efforts to amend
patent applications to include claims reasonably requested by the
License to protect the products and services contemplated under
this Agreement. The Regents is entitled to take action to preserve
rights and minimize costs whether or not Licensee has
commented.
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7.2
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Patent
Costs.
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7.2.1
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Licensee will
bear all costs incurred prior to this Agreement as well as during
the term of this Agreement for territories elected by Licensee
pursuant to Section 7.3 of this Agreement, and invoiced to The
Regents in the preparation, filing, prosecution and maintenance of
patent applications and patents in Regents' Patent Rights.
Prosecution includes interferences, oppositions and any other inter
partes matters originating in a patent office. Licensee must send
payment to The Regents within thirty (30) days after Licensee's
receipt of an invoice.
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7.2.2
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The Regents
will use reasonable efforts to give Licensee estimates in advance
for patent actions costing more than two thousand dollars ($2,000)
in order to get input from Licensee regarding the performance of
such activity and cost control. Reasonable efforts pursuant to this
Paragraph 7.2.2 shall include: (A) providing to Licensee, after
receipt by The Regents from The Regents’ outside counsel,
copies of all estimates for fees and expenses to the extent such
documents were not previously provided to Licensee by
Regents’ outside counsel and (B) instructing its outside
counsel to directly forward to Licensee, at the same time as its
outside counsel forwards to The Regents and using the same means
that The Regents’ outside counsel uses to forward to The
Regents, copies of all estimates for fees and expenses. No later
than (A) ten (10) weeks prior to the relevant patent action
deadline (for example a patent filing bar date or an office action
response deadline); or (B) within ten (10) business days of The
Regents supplying the relevant cost estimate, whichever is first,
Licensee will inform The Regents in writing whether or not it
elects to proceed with the relevant patent action. If, based on the
cost estimate, Licensee elects not to proceed with the relevant
patent action such patent applications or the patents to which the
office action applies, will then no longer
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