AMENDED AND RESTATED EXCLUSIVE LICENSE AGREEMENT for ADIPOSE-DERIVED STEM CELLS
Exhibit
10.39
AMENDED
AND RESTATED
for
ADIPOSE-DERIVED
STEM CELLS
This
amended and restated exclusive license agreement ("Agreement") is made effective
this 6th
day
of
September, 2006 ("Effective Date"), between The Regents of the University
of
California, a California corporation, having its statewide administrative
offices at ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇
("The Regents"), and Cytori Therapeutics, Inc., a Delaware corporation, having
a
principal place of business at ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇
("Licensee").
BACKGROUND
IN CONNECTION WITH THE AMENDMENT AND RESTATEMENT
A.
The
Regents and StemSource, Inc. entered into that certain Exclusive License
Agreement for Adipose-Derived Stem Cells (U.C. Agreement Control Number
2002-03-0194) effective October 16, 2001 (the “License Agreement”), as amended
by the Amendment to Exclusive License Agreement between The Regents and
StemSource, Inc. dated January 23, 2002, and by the Consent Of Substitution
Of
Party dated November 8, 2002 pursuant to which Cytori Therapeutics, Inc
(formerly MacroPore Biosurgery, Inc.) was substituted in as the exclusive
licensee to The Regents interest in certain Inventions (as described below),
under terms and conditions set forth in the License Agreement.
B.
The
Regents and Licensee have recently reached a mutual understanding that the
License Agreement drafted in 2001 no longer accurately reflected the business
model of the Licensee, and that it contained certain restrictions and milestones
that were not optimal for the commercialization of the Invention
portfolio.
C.
In
light of these issues, the parties have agreed to amend and restate the License
Agreement to maximize the commercial potential for the Inventions, the interests
of the parties and the public good.
BACKGROUND
OF THE INVENTIONS
A.
Certain inventions, generally characterized as "Adipose-Derived Stem Cells
and
Lattices" ("Inventions"), were made in the course of research at the University
of California, Los Angeles by Drs. ▇▇▇▇ ▇. ▇▇▇▇▇▇▇, H. ▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇
▇▇▇▇▇▇▇ and ▇▇▇ ▇▇▇ ("Regents' Inventors") and as of the Effective Date named
inventors at the University of Pittsburgh ("Pittsburgh") include Drs. ▇▇▇▇
▇.
▇▇▇▇, J. ▇▇▇▇▇ ▇▇▇▇▇ and J. ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ("Pittsburgh's Inventors")
(collectively, the "Inventors"). The Inventions are disclosed in ▇▇ ▇▇▇▇
▇▇.
▇▇▇▇-▇▇▇ and are covered by Patent Rights as defined below.
B.
Licensee acknowledges that The Regents and Pittsburgh have not entered into
any
agreement that sets out the rights of each in regards to patent prosecution
matters, inventorship, or licensing of the Inventions.
C.
Licensee acknowledges that Pittsburgh has filed and taken the lead in
prosecuting PCT/US00/06232 (filed 03/10/2000 and designating the US) and
The
Regents has filed and taken the lead in prosecuting a Continuation-in-Part
application (filed 09/10/2001). No decisions have been made by the parties
concerning Patent Rights.
D.
Licensee acknowledges that certain of the Inventions may be jointly owned
by The
Regents and Pittsburgh and that each party is licensing its interest in Patent
Rights independently of the other.
E.
Licensee acknowledges and agrees that the rights granted under this Agreement
may be limited by Pittsburgh's joint ownership or sole ownership in certain
claims under Patent Rights, and the licenses granted under this Agreement
are
granted solely under The Regents undivided interest in Patent Rights, whatever
those rights might be.
F.
Licensee wishes to obtain rights from The Regents for the exclusive commercial
development, use and sale of products from The Regents' interest in the
Inventions, and The Regents is willing to grant those rights so that the
Inventions may be developed to their fullest and the benefits enjoyed by
the
general public.
G.
Licensee is "a small business firm" as defined in 15 U.S.C. § 632.
H.
Licensee and The Regents recognize and agree that (subject to Sections 2.2
and
2.3 below) royalties due under this Agreement on products and methods will
be
paid by Licensee on both pending patent applications and issued
patents.
In
view
of the foregoing, the parties agree:
| 1. |
DEFINITIONS
|
"Affiliate"
means any corporation or other business entity: (i) 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; or
(ii)
which owns, directly or indirectly, at least fifty percent (50%) of the
outstanding stock or other voting rights entitled to elect directors of the
Licensee; or (iii) which is under common ownership or control with Licensee
to
the extent of at least fifty percent (50%) of the outstanding stock or other
voting rights entitled to elect directors. Notwithstanding the foregoing,
in any
country where the local law does not permit foreign equity participation
of at
least fifty percent (50%), then an "Affiliate" includes any company in which
Licensee owns or controls, or is owned or controlled by, or is under common
ownership or control with, directly or indirectly, the maximum percentage
of
outstanding stock or voting rights permitted by local law.
"Licensed
Method"
means any method that is covered by or claimed in Patent Rights, or the use
of
which would constitute, but for the license granted to Licensee under this
Agreement, an infringement of any unexpired claim of a patent or pending
claim
of a patent application included in Patent Rights.
"Licensed
Product"
means any product that is covered by or claimed in Patent Rights; that is
used
in a manner requiring the performance of the Licensed Method; that is produced
by the Licensed Method or that the manufacture, use or sale of which would
be an
infringement, but for the license granted to Licensee pursuant to this
Agreement, of an unexpired claim of a patent or pending claim of a patent
application included in Patent Rights. This definition of Licensed Product
also
includes a service either used by Licensee or an Affiliate or sublicensee
or
provided by Licensee an Affiliate or sublicensee to its customers when such
service requires the use of Licensed Product or performance of Licensed
Method.
“Research
Product”
means a Licensed Product that is not a Clinical Product and is sold for research
purposes or drug discovery purposes, i.e. an assay for identifying or validating
human therapeutic drugs.
“Clinical
Product”
means a Licensed Product which, were it sold in the United States, would
require
regulatory approval from the United States Food and Drug
Administration.
“Product”
means Research Product and Clinical Product.
1.7 “Field”
means
any and all products and/or services for the research, diagnosis, and/or
therapy
of disease and/or dissorders in humans and for cosmetic applications in humans.
1.8 "Net
Sales"
means
the total of the gross invoice prices from the Final Sale of Product, or
Licensed Method performed by Licensee or an Affiliate, less the sum of the
following actual and customary deductions where applicable: cash, trade or
quantity discounts; sales, use, tariff, import/export duties or other excise
taxes imposed on particular sales (excepting value added taxes or income
taxes);
transportation charges, including insurance; and allowances or credits to
customers because of rejections or returns. Final Sale means the last sale
within the control of Licensee or an Affiliate to an independent third party
(including without limitation to distributors and agents). If the Licensee
or an
Affiliate sells Licensed Products to a sublicense, an Affiliate or the Licensee
for the recipient’s end use (and not for resale, clinical studies, clinical
trials, or other research to promote commercialization), then such sales
will be
considered a Final sale at the price normally charged to independent,
unaffiliated third parties at the time of such end use sale or, if there
is no
such price, at the fair market value thereof at the time of such end use
sale.
Any sale of a Product by Licensee or an Affiliate to an Affiliate, the Licensee,
or a sublicensee will not be considered a Final Sale where such sale is not
for
end use by Licensee, an Affiliate or a sublicensee. If Licensee
or
an
Affiliate
sells at
a single price or rate a packaged combination of products (or “Kit”), not all of
which if sold individually would be Licensed Products, then “Net Sales” with
respect to such sales of such Kit or packaged products shall equal the number
of
units of Licensed Products sold as part of such Kit (less rejections, defects
and returns) multiplied by either (i) the respective average net selling
price
during such period of the same type of Licensed Product sold individually,
or
(ii) the average net selling price during such period for a comparable product
(if the same type of Product is not sold individually), in either case excluding
sales, use or excise tax, freight, duty or insurance included therein.
***.
Additionally,
for the avoidance of doubt, if such product is an indivisible component of
a
larger product, composition of matter or combination product (the components
of
which cannot be sold separately), then such composition of matter or combination
product is deemed in its entirety to be a Licensed Product for purposes of
this
definition.
1.9 "Patent
Rights"
means The Regents' undivided interest in the following United States patents
and
patent applications, corresponding foreign patents and patent applications,
and
any reissues, extensions, substitutions, continuations, divisions, and
continuation-in-part applications but excluding continuation-in-part
applications (to the extent that claims are not supported in the
parent);
1.9.1 United
States Patent Application No. 60/123,711 entitled “Isolation of Stromal Cells
from Adipose Tissue,” filed March 10, 1999, by ▇▇. ▇▇▇▇ ▇▇▇▇▇▇▇ et al (UC Case
2000-310-1) - inactive;
1.9.2. United
States Patent Application No. 60,162,462 entitled “Isolation of Mesenchymal Stem
Cells from Adipose Tissue,” filed October 29, 1999, by ▇▇. ▇▇▇▇ ▇▇▇▇▇▇▇ et al.
(UC Case No. 2000-301-2) - converted;
1.9.3 United
States Patent Application No. 09/947,985 entitled “Adipose-Derived Stem Cells
and Lattices,” filed Sept. 6, 2001, by ▇▇▇▇ ▇▇▇▇ et al (UC Case No. 2000-310-3),
abandoned;
1.9.4 United
States Patent Serial No. 6,777,231 entitled “Adipose-Derived Stem Cells and
Lattices,” issued August 17, 2004 by ▇▇. ▇▇▇▇ ▇▇▇▇▇▇▇ et al (UC Case
2000-310-4).;
1.9.5 United
States Patent Application No. 09/952,522 entitled “Adipose-Derived Stem Cells
and Lattices,” filed September 10, 2001, by ▇▇. ▇▇▇▇ ▇▇▇▇▇▇▇ et al.; (UC Case
No. 2000-310-5) now abandoned;
1.9.6 United
States Patent Application No.10/651,564 entitled ‘Adipose-Derived Stem Cells and
Lattices,” filed August 29, 2003, by ▇▇. ▇▇▇▇ ▇. ▇▇▇▇ et al.; (UC Case No.
2000-310-6);
1.9.7 United
States Patent Application No. 10/740,315 entitled “Adipose-Derived Stem Cells
and Lattices,” filed December 17, 2003, by Dr. ▇▇. ▇▇▇▇ ▇▇▇▇▇▇▇ et al.; (UC Case
No. 2000-310-7);
1.9.8 United
States Patent Application No. 10/797,371 entitled “Adipose-Derived Stem Cells
and Lattices,” filed March 9, 2004, by Dr. ▇▇▇▇ ▇▇▇▇ et al.; (UC Case No.
2000-310-8);
1.9.9 United
States Patent Application No. 10/845,315 entitled “Adipose-Derived Stem Cells
and Lattices,” filed May 12, 2004, by Dr. ▇▇▇▇ ▇▇▇▇ et al.; (UC Case No.
2000-310-9);
1.9.10 United
States Patent Application No. 11/211,114 entitled “Adipose-Derived Stem Cells
and Lattices,” filed August 24, 2005, by ▇▇. ▇▇▇▇ ▇▇▇▇▇▇▇ et al.; (UC Case No.
2000-310-A).
__________
***Material
has been omitted pursuant to a request for confidential treatment filed
separately with the Securities and Exchange Commission.
2. LIFE
OF PATENT EXCLUSIVE GRANT
2.1 Subject
to the limitations set forth in this Agreement, The Regents grants to Licensee
a
world-wide license under The Regents' undivided interest in Patent Rights
to
make, have made, use, sell, offer to sell and import Product and to practice
Licensed Method in the Field to the extent permitted by
law.
2.2 The
Regents acknowledge Licensee is currently commercializing an automated device
called “Celution”, which when operated in conjunction with various disposable
component parts is capable of producing a heterogeneous isolate of the material
naturally occurring in adipose tissue including unmodified amounts of stem
cells
and other regenerative cells ( hereafter “PLA”), intended for human therapeutic,
diagnostic, cosmetic and other uses;
2.3
Licensee
and the Regents acknowledge and agree that (except as provided below in this
Paragraph 2.3) Licensee’s Celution device and PLA shall be deemed not to be
included in or covered by the Patent Rights for purposes of this License,
and
that such exclusion shall not constitute an admission by The Regents that
the
Celution device or the PLA are not encompassed, either in whole or in part,
within the Regents Patent Rights. Nor shall the Regents be barred from later
requiring that the Celution device and PLA be governed by the terms of this
Agreement in the event (and to the extent) of any subsequent issuance of
claims
under prosecution in the Patent Rights that would cause either Licensees
Celution device or PLA to fall within the category of “Licensed Products” or
“Licensed Methods”. In no event shall any subsequent royalty associated with
Licensees Celution device or the PLA exceed ***.
2.4 Licensee
acknowledges that Pittsburgh has the right to grant licenses to its undivided
interest in Patent Rights.
2.5 Except
as otherwise provided in this Agreement, the license granted in Paragraph
2.1
is exclusive for the life of the Agreement.
2.6 The
Regents reserves the right to practice, and for other educational and non-profit
institutions to practice, the Inventions and associated technology for
educational and research purposes, including publication and other communication
of research results.
3. SUBLICENSES
3.1 The
Regents also grants to Licensee the right to issue sublicenses to third parties
to make, have made, use, sell, and offer to sell and import Products and
to
practice Licensed Method, as long as Licensee has current exclusive rights
thereto under this Agreement, except that the sublicensee may not be granted
the
right to further sublicense the technology without the prior approval by
The
Regents, which approval shall be granted only upon Licensees provision of
substantial assurances that the Regents interests in the technology will
at all
times be maintained. To the extent applicable, sublicenses must include all
of
the rights of and obligations due to The Regents contained in this Agreement.
The Licensee will not issue additional paid-up sublicenses without prior
written
approval of The Regents. For the avoidance of doubt, Licensee’s Affiliates are
not licensed under this Agreement, except by a written sublicense agreement
under this Article 3. And furthermore, The Regents hereby acknowledges and
approves the sublicense issued by Licensee to Olympus-Cytori, Inc, entitled
License/Commercial Agreement dated November 4, 2005, and acknowledges
additionally that such sublicense is fully paid-up with respect to the Regents
for the life thereof.
3.2 The
Licensee will pay to The Regents *** under each sublicense agreement issued
for
the purpose of development or commercialization of Products (the “Purpose”)
after the Effective Date (“Sublicensing Revenue”). Sublicensing Revenue will be
the sole form of compensation payable to the Regents by Licensee with respect
to
any and all sublicenses granted hereunder. Sublicensing Revenue will not
include
the following: *** The
operations of all sublicensees will be deemed to be the operations of the
Licensee, for which the Licensee will be responsible. The Licensee will notify
The Regents of each sublicense granted hereunder and provide The Regents
with a
complete copy
__________
***Material
has been omitted pursuant to a request for confidential treatment filed
separately with the Securities and Exchange Commission.
of
each sublicense within thirty (30) days of issuance of the sublicense. The
Licensee will pay to The Regents all Sublicensing Revenue due in accordance
with
Article 4 (Sublicenses) below on or before the due date of the royalty report
applicable to the quarter in which the Sublicensing Revenue is due to The
Regents, in accordance with Section 4.1. The Licensee will require the
sublicensees to provide it with Progress Reports and royalty reports in
accordance with the provisions herein, and the Licensee will collect and
deliver
to The Regents all such reports due from the sublicensees. For avoidance
of
doubt, ***.
3.3 In
the
event that The Regents rights to United States Patent Serial No. 6,777,231
are
finally determined not to be solely owned and assigned to The Regents in
connection with the pending Complaint for Correction of Inventorship by the
University of Pittsburgh vs. ▇▇▇▇▇▇▇ et al. (U.S. Disc. Ct., C.D. Cal, Case
No.
CV 04-9014 CBM (AJWX)) (the “Complaint”), or ***.
3.4 Upon
termination of this Agreement for any reason, The Regents, will enter into
written agreements with all sublicensees then in compliance with their
obligations under this Agreement and who are willing to enter into direct
agreements with The Regents on terms no less favorable to such sublicensees
than
set forth in their respective sublicense agreements. In no case, however,
will
The Regents be bound by duties and obligations contained in any sublicense
that
extend beyond the duties and obligations of The Regents set forth in this
Agreement.
| 4. |
PAYMENT
TERMS
|
4.1 Paragraphs
1.9, 1.2 and 1.3 define Patent Rights, Licensed Method, and Licensed Product
so
that royalties are payable on products and methods covered by both pending
patent applications and issued patents (subject to Paragraphs 2.1 and 2.3).
Royalties will accrue in each country for the duration of Patent Rights in
that
country and are payable to The Regents thirty (30) days after the Product
is
invoiced or if not invoiced, when delivered to a third party. Sublicensing
Revenue will accrue in each country for the duration of Patent Rights in
that
country and are payable to The Regents thirty (30) days after payment is
due to
the Licensee under the sublicense agreement.
4.2 Licensee
will pay to The Regents earned royalties and Sublicensing Revenue quarterly
on
or before February 28, May 31, August 31 and November 30 of each calendar
year.
Each payment will be for earned royalties and Sublicensing Revenue accrued
within Licensee's most recently completed calendar
quarter.
4.3 All
monies due The Regents are payable in U.S. dollars. Licensee is responsible
for
all bank transfer charges. When Product is sold for monies other than U.S.
dollars, Licensee will first determine the earned royalty in the currency
of the
country in which Product was sold and then convert the amount into equivalent
U.S. funds, using the exchange rate quoted in The Wall Street Journal on
the
last business day of the reporting period.
4.4 Sublicensing
Revenue and royalties earned on sales occurring in any country outside the
U.S.
may not be reduced by any taxes, fees or other charges imposed by the government
of such country on the payment of royalty income. Notwithstanding the foregoing,
all payments made by Licensee in fulfillment of The Regents' tax liability
in
any particular country will be credited against earned royalties or fees
due The
Regents for that country.
4.5 If
at any time legal restrictions prevent the prompt remittance of royalties
by
Licensee from any country where a Product is sold or Sublicensing Revenue
accrued, then Licensee will deposit the amount owed to The Regents into an
interest bearing account and will pay The Regents directly from this account
or
from its U.S. source of funds within a year of the due
date.
4.6 If
any patent or patent claim within Patent Rights is abandoned or held invalid
in
a final decision by a court of competent jurisdiction and last resort and
from
which no appeal has or can be taken, then all obligation to pay royalties
or
Sublicensing Revenue based on that patent or claim or any claim patentably
indistinct there from will cease as of the date of final decision. Licensee
will
not, however, be relieved from paying any royalties that accrued before the
final decision or that are based on another patent or claim not involved
in the
final decision or that are based on The Regents' property
rights.
__________
***Material
has been omitted pursuant to a request for confidential treatment filed
separately with the Securities and Exchange Commission.
4.7 In
the event payments, rebillings or fees are not received by The Regents when
due,
Licensee will pay to The Regents interest charges at a rate of ten percent
(10%)
per annum. Interest is calculated from the date payment was due until actually
received by The Regents.
5. LICENSE
AMENDMENT CONSIDERATION
5.1 As
consideration for this amendment and restating of the Agreement, the Licensee
will issue to The Regents one hundred thousand (100,000) shares of common
stock
(“the Stock”) of Cytori Therapeutics, Inc, within seven (7) days of the
Effective Date of this Agreement or of the date Licensee receives notice
from
The Regents that The Regents’ Office of the President has approved acceptance of
Stock, whichever is later. Licensee will use reasonable efforts to, within
sixty
(60) business days after such issuance, prepare and file with the US Securities
and Exchange Commission (the "Commission") a Registration Statement covering
the
resale of the Shares for an offering to be made on a continuous basis pursuant
to Rule 415. The Registration Statement will be on Form S-3 (except if Licensee
is not then eligible to register for resale the Shares on Form S-3, in which
case such registration will be on another appropriate form in accordance
with
the US Securities Act and the rules promulgated there under). Licensee will
use
its reasonable efforts to cause the Registration Statement to be declared
effective under the US Securities Act within ninety (90) business days after
such filing. Licensee will keep such Registration Statement continuously
effective under the Securities Act for a period of two (2) years (the
“Effectiveness Period”). The Regents represents that they would acquire the
Shares for their own account for investment, and not with a view to any
distribution, which would violate any applicable securities laws. The Regents
acknowledges that they have not received and are not relying upon any advice,
representations or assurances made by or on behalf of the Licensee or any
Licensee affiliate or any employee of or counsel to Licensee regarding the
Shares. The Regents may transfer, or direct Licensee to transfer, to Regents’
Inventors an inventor share portion of the Stock under Regent’s Patent
Policy.
6. LICENSE
MAINTENANCE FEE AND MILESTONE PAYMENTS
6.1 Licensee
will also pay to The Regents a royalty in the form of a license maintenance
fee
as follows:
6.1.1 Fifty
Thousand Dollars ($50,000) on or before June 30, 2008;
6.1.2 Fifty
Thousand Dollars ($50,000), on or before June 30, 2009;
6.1.3 Seventy-Five
Thousand Dollars ($75,000) on or before June 30, 2010;
| 6.1.4 |
One
Hundred Thousand Dollars ($100,000) on or before June 30,
2011;
|
| 6.1.5 |
One
Hundred Thousand Dollars ($100,000) on or before June 30, 2012;
and,
|
| 6.1.6 |
One
Hundred Thousand Dollars ($100,000) on or before June 30,
2013.
|
| 6.2 |
The
license maintenance fee is not due on any anniversary of the Effective
Date if Licenseeis commercially selling Product on that date and
paying an
earned royalty to The Regents on the sales of that Licensed Product.
License maintenance fees are non-refundable and not an advance against
earned royalties.
|
7. EARNED
ROYALTIES AND MINIMUM ANNUAL ROYALTIES
7.1 Licensee
will also pay to The Regents an earned royalty of *** based on the Net Sales
of
Product sold by the Licensee.
__________
***Material
has been omitted pursuant to a request for confidential treatment filed
separately with the Securities and Exchange Commission.
7.2 In
the event that it becomes necessary for Licensee to license patent rights
owned
by third parties to make, have made, use or sell Clinical Product, then the
Licensee will have the right to obtain the patent rights from such third
party
***.
7.3 Licensee
will pay to The Regents a minimum annual royalty for the life of Regents'
Patent
Rights beginning in the year of the first commercial sale of Product or Licensed
Method but no later than ***. Minimum annual royalties will be as
follows:
7.3.1. ***;
7.3.2 ***;
7.3.3 ***.
7.4 The
minimum annual royalty will be paid semi-annually to The Regents on February
28
and July 31 of each year and will be credited against the earned royalty
due for
the calendar year in which the minimum payment was
made.
8. DUE
DILIGENCE
8.1 Licensee,
upon execution of this Agreement, will diligently proceed with the development,
manufacture and sale of Product and will earnestly and diligently endeavor
to
market the same within a reasonable time after execution of this Agreement
and
in quantities sufficient to meet market demands.
8.2 Licensee
will endeavor to obtain all necessary governmental approvals for the
manufacture, use and sale of Licensed Product.
8.3 Licensee,
or its sublicense(s), will develop and commercialize a Research Product and
will
develop and commercialize a Clinical Product in the diagnostic field and/or
in
the therapeutic or cosmetic field as follows:
8.3.1 ***;
and will fill the market demand for such Research Product following commencement
of marketing at any time during the exclusive period of this
Agreement;
8.3.2 Licensee
will complete the following for a Clinical Product in the diagnostic field
(i.e.
a Clinical Product intended to diagnosis, prognosis or monitoring of disease
in
humans):
(i) ***,
and
market such Clinical Product in the United States within six (6) months of
receiving marketing approval;
(ii) Fill
the
market demand for such Clinical Product following commencement of marketing
at
any time during the exclusive period of this Agreement; and/or,
8.3.3 Licensee
will complete the following for a Clinical Product in the therapeutic field
(i.e. intended to treat or ameliorate disease in humans or intended for cosmetic
applications);
(i) ***;
(ii) ***;
and
(iii) ***;
__________
***Material
has been omitted pursuant to a request for confidential treatment filed
separately with the Securities and Exchange Commission.
(iv) ***;
(v) ***;
(vi) ***;
and
(vii)
Fill
the
market demand for such Clinical Products following commencement of marketing
at
any time during the exclusive period of this Agreement.
Licensee’s
completion of Paragraph 8.3.2 or 8.3.3 above will be considered fulfillment
of
Licensee’s obligation to develop a Clinical Product
hereunder.
8.4 If
Licensee (or a sublicense) is unable to perform any of the above diligence
provisions, then The Regents may terminate this Agreement and its licenses
or
reduce the licenses hereunder to non-exclusive licenses. Notwithstanding
the
foregoing, if the Licensee is in compliance with diligence provisions for
the
Research Product and fails to meet a diligence provision for the Clinical
Product, or vice-versa, under Paragraph 8.3 above, then The Regents’ may
terminate or reduce the exclusivity for the Product for which the diligence
provision is unmet but not for the Product for which diligence is met. Moreover,
if the Licensee can demonstrate to The Regents’ reasonable satisfaction that a
milestone at issue for Clinical Product has been determined to be impracticable
for commercialization, then The Licensee and The Regents will negotiate revised
due diligence for Clinical Products. If the Licensee fails to meet a diligence
provision for Clinical Product and cannot demonstrate that the milestone
at
issue for has been determined impractical for commercialization, then the
Regents has the right to terminate the licenses granted hereunder or reduce
such
licenses for Clinical Products to non-exclusive licenses. The right, if
exercised by The Regents, supersedes the rights granted for such Products
in
Article 2 (Life of Patent Exclusive Grant).
8.5 Licensee
will endeavor to develop Products through research performed at the University
of California, Los Angeles in the amount of fifty thousand dollars ($50,000)
in
research funding by Licensee per year for six (6) years, beginning in the
year
2007. Both parties will endeavor to combine the research funding provided
by
Licensee with UC Discovery grants and/or the BioStar research programs (or
any
similar research fund matching programs then in effect), and Licensee will
have
sole discretion with respect to the development and design of such research.
In
accordance with the disclosure and licensing terms of the research agreement(s)
executed by The Regents and the License, The Regents will disclose, and offer
to
license The Regents’ interest in patent rights claiming, inventions made and
reduced to practice under such research agreements. Licensee will be released
from the requirement to provide research funding in the event that this
Agreement is terminated for any reason.
8.6 The
due diligence provisions of this Article 8 (Earned Royalties and Minimum
Annual
Royalties) shall not apply to, or effect Licensee’s rights to Celution Product
and/or PLA., if any such rights are later deemed to be covered by this License
pursuant to Paragraph 2.3.
9. PROGRESS
AND ROYALTY REPORTS
9.1 During
the life of this Agreement Licensee will submit to The Regents a written
progress report covering Licensee's (and any Affiliate's or sublicensee's)
activities related to the development and testing of all Products and the
obtaining of the governmental approvals necessary for marketing. Progress
reports are due on August 15 and on February 15 of each year and will cover
the
Licensee’s activities for the preceding January 1 through June 30 and July 1
through December 31, respectively. Progress reports are required for each
Product until the first commercial sale of that Product occurs in the U.S.
and
will be again required if commercial sales of such Product are suspended
or
discontinued.
__________
***Material
has been omitted pursuant to a request for confidential treatment filed
separately with the Securities and Exchange Commission.
9.2 Progress
reports submitted under Paragraph 9.1 will include, but are not limited to,
the
following topics:
9.2.1 Summary
of work completed;
9.2.2 Key
scientific discoveries;
9.2.3 Summary
of work in progress;
9.2.4 Current
schedule of anticipated events or milestones;
9.2.5 Market
plans for introduction of Licensed Product; and
9.2.6 A
summary of resources (dollar value) spent in the reporting
period.
9.3 Licensee
has a continuing responsibility to keep The Regents informed of the large
and
small business entity status as defined by the U.S. Patent and Trademark
Office
of itself and its sublicensees and Affiliates.
9.4 Licensee
will report to The Regents in its immediately subsequent progress and royalty
report the date of first commercial sale of a Product in each
country.
9.5 After
the first commercial sale of a Product anywhere in the world, Licensee will
make
quarterly royalty reports to The Regents on or before each February 28 (for
the
quarter ending December 31), May 31 (for the quarter ending March 31), August
31
(for the quarter ending June 30) and November 30 (for the quarter ending
September 30) of each year. Each royalty report will cover Licensee's most
recently completed calendar quarter and will show:
9.5.1 The
gross sales and Net Sales of Product sold during the most recently completed
calendar quarter;
9.5.2 The
number of Product and sold;
9.5.3 The
royalties, in U.S. dollars, payable with respect to sales of
Product;
9.5.4 The
method used to calculate the royalty;
9.5.5 The
exchange rates used;
9.5.6 Sublicensing
Revenue accrued during the previous quarter;
9.5.7If
no sales of Product are made during any reporting period, then the Licensee
will
so state in the subsequent royalty report.
10. BOOKS
AND RECORDS
10.1 Licensee
will keep accurate books and records showing all
Product,
developed,
manufactured, used and/or sold under the terms of this Agreement, as well
as all
Sublicensing Revenue owed to The Regents under the terms of this Agreement.
Books and records must be preserved for at least five (5) years from the
date of
the royalty payment to which they pertain.
10.2 Books
and records must be open to inspection by representatives or agents of The
Regents at reasonable times. The Regents will bear the fees and expenses
of
examination but if an error in royalties of more than five percent (5%) of
the
total royalties or Sublicensing Revenue due for any year is discovered in
any
examination, then Licensee will bear the fees and expenses of that
examination.
11. LIFE
OF THE AGREEMENT
11.1 Unless
otherwise terminated by operation of law, Paragraph 11.2, or by acts of the
parties in accordance with the terms of this Agreement, this Agreement will
remain in effect from the Effective Date until the expiration or abandonment
of
the last of the Patent Rights licensed hereunder.
11.2 This
Agreement will become immediately terminable by either party upon the insolvency
of the Licensee.
11.3 Any
termination or expiration of this Agreement will not affect the rights and
obligations set forth in the following Articles:
Article
1 Definitions
Article
5 Payment
Terms
Article
10 Books
and
Records
Article
14 Disposition
of Product on Hand upon Termination
Article
15 Use
of
Names
Article
16 Limitation
of Liability
Paragraphs
17.5 and 17.6 Patent
Prosecution and Maintenance
Article
20 Indemnification
Article
21 Notices
Article
25 Governing
Laws; Venue; Attorneys’ Fees
Article
29 Secrecy
11.4 The
termination or expiration of this Agreement will not relieve the Licensee
of its
obligation to pay any fees, royalties, reimbursements for Patent Prosecution
Costs, or other payments owed to the Regents at the time of such termination
or
expiration and will not impair any accrued right of The Regents, including
the
right to receive earned royalties and other consideration in accordance with
Articles 3, 4, 8, and 15.
12. TERMINATION
BY THE REGENTS
12.1 Subject
to Paragraph 8.4, if Licensee fails to perform or violates any term of this
Agreement, then The Regents may give written notice of default ("Notice of
Default") to Licensee. If a Notice of Default is issued for non-payment of
a fee
or patent prosecution cost reimbursement owed hereunder, the Licensee must
cure
the default within sixty (60) days of the effective date of Notice of Default.
If a Notice of Default is issued for something other than a payment of monies
owed hereunder then the Licensee must cure the default within ninety (90)
days
of effective date of Notice of Default. If the Licensee fails to cure the
material default within the time required above, The Regents may terminate
this
Agreement and its licenses by a second written notice ("Notice of Termination").
If a Notice of Termination is sent to Licensee, then this Agreement will
automatically terminate on the effective date of that notice. Such termination
will not relieve Licensee of its obligation to pay any fees owing at the
time of
termination and will not impair any accrued right of The Regents. These notices
are subject to Article 21 (Notices). These notices will be subject to Article
21
(Notices).
13. TERMINATION
BY LICENSEE
13.1 Licensee
has the right at any time to terminate this Agreement in whole or as to any
portion of Patent Rights by giving notice in writing to The Regents. Such
notice
of termination will be subject to Article 20 (Notices) and termination of
this
Agreement will be effective sixty (60) days from the effective date of such
notice.
13.2 Any
termination under the above Paragraph 13.1 does not relieve Licensee of any
obligation or liability accrued under this Agreement prior to termination
or
rescind any payment made to The Regents or anything done by Licensee prior
to
the time termination becomes effective. Termination does not affect in any
manner any rights of The Regents arising under this Agreement prior to
termination.
14. DISPOSITION
OF PRODUCT ON HAND UPON TERMINATION
14.1 Upon
termination of this Agreement, Licensee is entitled to dispose of all previously
made or partially made Product, but no more, within a period of one hundred
and
twenty (120) days provided that the sale of Product is subject to the terms
of
this Agreement, including, but not limited to, the rendering of reports and
payment of royalties required under this Agreement.
15. USE
OF NAMES AND TRADEMARKS
15.1 Nothing
contained in this Agreement confers any right to use in advertising, publicity
or other promotional activities any name, trade name, trademark or other
designation of either party hereto (including contraction, abbreviation or
simulation of any of the foregoing). Unless required by law, the use by Licensee
of the name "The Regents of the University of California" or the name of
any
campus of the University of California is prohibited.
15.2 The
Regents is free to release to the inventors and senior administrators employed
by The Regents the terms and conditions of this Agreement. If such release
is
made, then The Regents will give notice of the confidential nature and will
request that the recipient does not disclose such terms and conditions to
others. If a third party inquires whether a license to Patent Rights is
available, then The Regents may disclose the existence of this Agreement
and the
extent of the grant in Article 2 (Life of Patent Exclusive Grant) to such
third
party, but will not disclose the name of Licensee or any other terms or
conditions of this Agreement, except where The Regents is required to release
information under either the California Public Records Act, a governmental
audit
requirement or other applicable law.
16. LIMITED
WARRANTY
16.1 The
Regents warrants to Licensee that it has the lawful right to grant this
license.
16.2 This
license and the associated Inventions are provided WITHOUT WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY,
EXPRESS OR IMPLIED. THE REGENTS MAKES NO REPRESENTATION OR WARRANTY THAT
PRODUCT
OR LICENSED METHOD WILL NOT INFRINGE ANY PATENT OR OTHER PROPRIETARY
RIGHT.
16.3 IN
NO EVENT MAY THE REGENTS BE LIABLE FOR ANY INCIDENTAL, SPECIAL OR CONSEQUENTIAL
DAMAGES RESULTING FROM EXERCISE OF THIS LICENSE OR THE USE OF THE INVENTIONS
OR
PRODUCT.
16.4 This
Agreement does not:
16.4.1 Express
or imply a warranty or representation as to the validity or scope of any
of
Patent Rights;
16.4.2 Express
or imply a warranty or representation that anything made, used, sold, offered
for sale or imported or otherwise disposed of under any license granted in
this
Agreement is or will be free from infringement of patents of third
parties;
16.4.3 Obligate
The Regents to bring or prosecute actions or suits against third parties
for
patent infringement except as provided in Article 19 (Patent
Infringement);
16.4.4 Confer
by implication, estoppel or otherwise any license or rights under any patents
of
The Regents other than Patent Rights as defined in this Agreement, regardless
of
whether those patents are dominant or subordinate to Patent Rights;
or,
16.4.5 Obligate
The Regents to furnish any know-how not provided in Patent
Rights.
17. PATENT
PROSECUTION AND MAINTENANCE
17.1 In
regard to PCT/US00/06232, filed by Pittsburgh, The Regents does not control
patent prosecution and there is no agreement in place between The Regents
and
Pittsburgh regarding patent prosecution matters. This Agreement may need
to be
amended to take into account the provisions of any agreement reached between
Pittsburgh and The Regents in regard to patent prosecution matters and the
payment of patent costs by The Regents.
17.2 In
regard to Patent Rights filed by and assigned solely to The Regents, as long
as
Licensee has paid patent costs as provided for in this Article 17 (Patent
Prosecution and Maintenance), The Regents will diligently endeavor to prosecute
and maintain the U.S. and foreign patents using counsel of its choice. The
Regents will provide Licensee with copies of all relevant documentation so
that
Licensee may be informed of the continuing prosecution. Licensee agrees to
keep
this documentation confidential. The Regents' counsel will take instructions
only from The Regents, but The Regents will consider input from the Licensee
in
its choice of patent counsel and, if the Licensee so requests, The Regents
will
suggest three patent attorneys from which the Licensee may choose one to
prosecute and maintain Patent Rights, provided The Regents concur that a
change
of prosecution counsel is warranted.
17.3 The
Regents will use reasonable effort to amend any patent application to include
claims reasonably requested by Licensee to protect the products contemplated
to
be sold under this Agreement.
17.4 Licensee
may request that The Regents obtain patent protection on the Inventions in
foreign countries if available and if it so desires. Licensee will notify
The
Regents of its decision to obtain or maintain foreign patents not less than
sixty (60) days prior to the deadline for any payment, filing or action to
be
taken in connection therewith. This notice concerning foreign filing must
be in
writing, must identify the countries desired and must reaffirm Licensee's
obligation to underwrite the costs thereof. The absence of such a notice
from
Licensee to The Regents will be considered an election not to obtain or maintain
foreign rights.
17.5 Licensee
will bear The Regents' costs of preparing, filing, prosecuting and maintaining
all U.S. and foreign patent applications contemplated by this Agreement.
Costs
billed by The Regents' counsel will be rebilled to Licensee and are due within
thirty (30) days of rebilling by The Regents. These costs include patent
prosecution costs for the Inventions incurred by The Regents prior to the
execution of this Agreement and any patent prosecution costs that may be
incurred for patentability opinions, re-examination, re-issue, interferences,
oppositions and inventorship determinations, as well as the existing Complaint
for Correction of Inventorship by the University of Pittsburgh vs. ▇▇▇▇▇▇▇
et
al. (U.S. Disc. Ct., C.D. Cal, Case No. CV 04-9014 CBM
(AJWX)
and any
other filings in this case, including counterclaims and appeals.
Prior prosecution costs will be due upon execution of this Agreement and
billing
by The Regents.
17.6 Licensee's
obligation to underwrite and to pay patent prosecution costs will continue
for
so long as this Agreement remains in effect, but Licensee may terminate its
obligations with respect to any given patent application or patent upon three
(3) months' written notice to The Regents. The Regents will use its best
efforts
to curtail patent costs when a notice of termination is received from Licensee.
The Regents may prosecute and maintain such application(s) or patent(s) at
its
sole discretion and expense, but Licensee will have no further right or licenses
hereunder. Non-payment of patent costs may be deemed by The Regents as an
election by Licensee not to maintain application(s) or
patent(s).
17.7 The
Regents may file, prosecute or maintain patent applications at its own expense
in any country in which Licensee has not elected to file, prosecute or maintain
patent applications in accordance with this Article 17 (Patent Prosecution
and
Maintenance) and those applications and resultant patents will not be subject
to
this Agreement.
17.8 Licensee
will apply for an extension of the term of any patent included within Patent
Rights under the Drug Price Competition and Patent Term Restoration Act of
1984
and/or European, Japanese and other foreign counterparts of this Law. Licensee
will prepare all documents and The Regents agrees to execute the documents
and
to take additional action as Licensee reasonably requests in connection
therewith.
17.9 If
either party (in the case of The Regents: the Licensing Officer responsible
for
administration of this Agreement) receives notice pertaining to infringement
or
potential infringement of any issued patent included within Patent Rights
under
the Drug Price Competition and Patent Term Restoration Act of 1984 and/or
foreign counterparts of this Law, then that party will notify the other party
within ten (10) days after receipt of notice of
infringement.
18. PATENT
MARKING
18.1 Licensee
will ▇▇▇▇ all Products made, used or sold under the terms of this Agreement,
or
their containers, in accordance with the applicable patent marking
laws.
19. PATENT
INFRINGEMENT
19.1 If
Licensee learns of the substantial infringement of any patent licensed under
this Agreement, then Licensee will call The Regents' attention thereto in
writing and provide The Regents with reasonable evidence of infringement.
Neither party will notify a third party of the infringement of any of Patent
Rights without first obtaining consent of the other party, which consent
will
not be unreasonably denied. Both parties will use their best efforts in
cooperation with each other to terminate infringement without
litigation.
19.2 Licensee
may request that The Regents take legal action against the infringement of
Patent Rights. Such request must be in writing and must include reasonable
evidence of infringement and damages to Licensee. If the infringing activity
has
not abated within ninety (90) days following the effective date of request,
then
The Regents has the right to:
19.2.1 Commence
suit on its own account; or,
19.2.2 Refuse
to participate in the suit, and,
The
Regents will give notice of its election in writing to Licensee by the end
of
the one-hundredth (100th) day after receiving notice of written request from
Licensee. Licensee may thereafter bring suit for patent infringement, at
its own
expense, if and only if The Regents elects not to commence suit and if the
infringement occurred during the period and in a jurisdiction where Licensee
had
exclusive rights under this Agreement. If, however, Licensee elects to bring
suit in accordance with this Paragraph 19.2, then The Regents may thereafter
join that suit at its own expense. Licensee agrees not to bring suit for
patent
infringement without following the procedures of this Paragraph 19.2, and
both
parties agree to be bound by an order of a court for patent infringement,
patent
infringement issues and patent infringement defenses raised through the pendency
of such a suit under this Paragraph 19.2.
19.3 Legal
action, as is decided on, will be at the expense of the party bringing suit
and
all damages recovered thereby will belong to the party bringing suit, but
legal
action brought jointly by The Regents and Licensee and fully participated
in by
both will be at the joint expense of the parties and all recoveries will
be
shared jointly by them in proportion to the share of expense paid by each
party.
19.4 Each
party will cooperate with the other in litigation proceedings instituted
hereunder but at the expense of the party bringing suit. Litigation will
be
controlled by the party bringing the suit, except that The Regents may be
represented by counsel of its choice in any suit brought by
Licensee.
20. INDEMNIFICATION
20.1 Licensee
will indemnify, hold harmless and defend The Regents, its officers, employees
and agents, the sponsors of the research that led to the Inventions and the
inventors of the patents and patent applications in Patent Rights and their
employers against any and all claims, suits, losses, liabilities, damages,
costs, fees and expenses resulting from or arising out of exercise of this
license or any sublicense. This indemnification includes, but is not limited
to,
any product liability.
20.2 Licensee,
at its sole cost and expense, will insure its activities in connection with
the
work under this Agreement and obtain, keep in force and maintain
insurance.
20.3 Licensee
will maintain the following or an equivalent program of self-insurance while
Products are not being tested or used in-vivo in
humans:
Comprehensive
or commercial form general liability insurance (contractual liability included)
with limits as follows:
-
Each
Occurrence $ 2,000,000 ($7MI Umbrella
policy)
-
Products/Completed Operations Aggregate $5,000,000
-
Personal and Advertising Injury $1,000,000 ($7MI Umbrella
policy)
-
General
Aggregate (commercial form only) $2,000,000 ($7MI Umbrella
policy)
The
Licensee increasing the required insurance levels as follows, prior to using
or
testing Products in-vivo in humans:
-
Each
Occurrence $5,000,000
-
Products/Completed Operations Aggregate $10,000,000
-
Personal and Advertising Injury $5,000,000
-
General
Aggregate (commercial form only) $10,000,000
The
coverage and limits referred to in this Paragraph 20.3 do not in any way
limit
the liability of Licensee. Licensee will furnish The Regents with certificates
of insurance showing compliance with all requirements. Certificates
must:
|
-
|
Provide
for thirty (30) days' advance written notice to The Regents of
any
modification.
|
|
-
|
Indicate
that The Regents has been endorsed as an additional Insured under
the
coverage referred to under the
above.
|
|
-
|
Include
a provision that the coverage will be primary and will not participate
with nor will be excess over any valid and collectable insurance
or
program of self-insurance carried or maintained by The
Regents.
|
20.4 The
Regents will notify Licensee in writing of any claim or suit brought against
The
Regents in respect of which The Regents intends to invoke the provisions
of this
Article 20 (Indemnification). Licensee will keep The Regents informed on
a
current basis of its defense of any claims under this Article 20
(Indemnification).
21. NOTICES
21.1 Any
notice or payment required to be given to either party will be deemed to
have
been properly given and to be effective as of the date specified below if
delivered to the respective address given below or to another address as
designated by written notice given to the other
party:
on
the
date of delivery if delivered in person;
on
the
date of mailing if mailed by first-class certified mail, postage paid;
or
on
the
date of mailing if mailed by any global express carrier service that requires
recipient to sign the documents demonstrating the delivery of such notice
or
payment.
In
the
case of Licensee: Cytori
Therapeutics, Inc.
▇▇▇▇
▇▇▇▇▇▇ ▇▇.
▇▇▇
▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attention: ▇▇▇▇
▇▇▇▇
Chief
Financial Officer
In
the
case of The Regents: The
Regents of the University of California
Office
of
Intellectual Property Administration
▇▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇., ▇▇▇. #▇▇▇▇
▇▇▇▇▇▇▇▇,
▇▇ ▇▇▇▇▇
Attention:
Director
22. ASSIGNABILITY
22.1 This
Agreement may be assigned by The Regents, but is personal to Licensee and
assignable by Licensee only with the written consent of The Regents, which
consent will not be unreasonably withheld.
23. NO
WAIVER
23.1 No
waiver by either party of any default of this Agreement may be deemed a waiver
of any subsequent or similar default. A suspension of duty under this Agreement
due to force majeure will not be for a period longer than one (1)
year.
24. FAILURE
TO PERFORM
24.1 If
either party finds it necessary to undertake legal action against the other
on
account of failure of performance due under this Agreement, then the prevailing
party is entitled to reasonable attorney's fees in addition to costs and
necessary disbursements.
25. GOVERNING
LAWS
25.1 THIS
AGREEMENT WILL BE INTERPRETED AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF
THE
STATE OF CALIFORNIA WITHOUT REGARD TO CONFLICT OF LAWS OR TO WHICH PARTY
DRAFTED
PARTICULAR PROVISIONS OF THIS AGREEMENT, but the scope and validity of any
patent or patent application will be governed by the applicable laws of the
country of the patent or patent application. Disputes between the parties
regarding this Agreement will utilize only trial courts within California
for
disputes that go to court.
26. PREFERENCE
FOR U.S. INDUSTRY
26.1 Because
this Agreement grants the exclusive right to use or sell the Inventions in
the
U.S., Licensee agrees that any products sold in the U.S. embodying this
Invention or produced through the use thereof will be manufactured substantially
in the U.S.
27. GOVERNMENT
APPROVAL OR REGISTRATION
27.1 Licensee
will notify The Regents if it becomes aware that this Agreement is subject
to
any U.S. or foreign government reporting or approval requirement. Licensee
will
make all necessary filings and pay all costs including fees, penalties and
all
other out-of-pocket costs associated with such reporting or approval
process.
28. EXPORT
CONTROL LAWS
28.1 Licensee
will observe all applicable U.S. and foreign laws with respect to the transfer
of Product and related technical data to foreign countries, including, without
limitation, the International Traffic in Arms Regulations (ITAR) and the
Export
Administration Regulations.
29
SECRECY
29.1 With
regard to confidential information (“Data”), which can be oral or written or
both, received from The Regents regarding this Inventions, Licensee
agrees:
29.1.1
Not to use the Data except for the sole purpose of performing under the terms
of
this Agreement;
29.1.2 To
safeguard Data against disclosure to others with the same degree of care
as it
exercises with its own data of a similar nature;
29.1.3 Not
to disclose Data to others (except to its employees, agents or consultants
who
are bound to Licensee by a like obligation of confidentiality) without the
express written permission of The Regents, except that Licensee is not prevented
from using or disclosing any of the Data that:
(i)
Licensee
can demonstrate by written records was previously known to it;
|
(ii)
|
is
now or becomes in the future, public knowledge other than through
acts or
omissions of Licensee; or
|
(iii) is
lawfully obtained by Licensee from sources independent of The Regents;
|
(iv)
|
is
required to be disclosed to a governmental entity or agency in
connection
with seeking any governmental or regulatory approval, or pursuant
to the
lawful requirement or request of a governmental entity or agency;
and
|
29.1.4 that
the secrecy obligations of Licensee with respect to Data will continue for
a
period ending five (5) years from the termination date of this
Agreement.
29.2 Upon
the termination of this Agreement, Licensee must destroy or return to The
Regents any Data in its possession within thirty (30) days following the
effective date of termination. However, Licensee may retain one copy of Data
solely for archival purposes, provided that such Data is subject to the
confidentiality provisions set forth in this Paragraph 29.2 (Secrecy). Within
sixty (60) days following termination, Licensee must provide The Regents
with a
written notice that Data has been returned or
destroyed.
29.3 With
regard to biological material received by Licensee from The Regents, if any,
including any cell lines, vectors, genetic material, derivatives, products
progeny or material derived there from (“Biological Material”), Licensee
agrees:
29.3.1 Not
to use Biological Material except for the sole purpose of performing under
the
terms of this Agreement;
29.3.2 Not
to transfer Biological Material to others (except to its employees, agents
or
consultants who are bound to Licensee by like obligations conditioning and
restricting access, use and continued use of Biological Material) without
the
express written permission of The Regents, except that Licensee is not prevented
from transferring Biological Material that:
(i) becomes
publicly available other than through acts or omissions of Licensee;
or
(ii) is
lawfully obtained by Licensee from sources independent of The Regents;
and
29.3.3 To
safeguard Biological Material against disclosure and transmission to others
with
the same degree of care as it exercises with its own biological materials
of a
similar nature; and,
29.3.4 to
destroy all copies of Biological Material at the termination of this
Agreement.
30. MISCELLANEOUS
30.1 The
headings of the several sections are inserted for convenience of reference
only
and are not intended to be a part of or to affect the meaning or interpretation
of this Agreement.
30.2 This
Agreement is not binding on the parties until it has been signed below on
behalf
of each party. It is then effective as of the Effective
Date.
30.3 No
amendment or modification of this Agreement is valid or binding on the parties
unless made in writing and signed on behalf of each
party.
30.4 This
Agreement embodies the entire understanding of the parties and will supersede
all previous communications, representations, or understandings, either oral
or
written, between the parties relating to the subject matter
hereof.
30.5 In
case any of the provisions contained in this Agreement is held to be invalid,
illegal or unenforceable in any respect, that invalidity, illegality or
unenforceability will not affect any other provisions of this Agreement and
this
Agreement will be construed as if the invalid, illegal or unenforceable
provisions had never been contained in it.
30.6 None
of the provisions of this Agreement is intended to create any form of joint
venture
between the parties, rights in third parties or rights that are enforceable
by
any third party.
IN
WITNESS WHEREOF, both The Regents and Licensee have executed this Agreement,
in
duplicate originals, by their respective and duly authorized officers on
the day
and year written.
CYTORI
THERAPEUTICS, INC THE
REGENTS OF THE UNIVERSITY
OF
CALIFORNIA
By: /s/
▇▇▇▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ By: /s/
▇▇▇▇▇
▇▇▇▇▇▇▇▇
Name: ▇▇▇▇▇▇▇▇▇▇▇
▇. ▇▇▇▇▇▇▇ Name:
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Title: CEO Title: Director
of Licensing
Date: September
18, 2006 Date: September
26, 2006