Exhibit 10.1
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 of
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