|
Exhibit 10.49
LICENSE & ROYALTY AGREEMENT
THIS LICENSE & ROYALTY AGREEMENT (this “
Agreement ”), dated as of the 23
th day of
August, 2007 (the “ Effective Date
”), is made and entered into by and between
OLYMPUS-CYTORI, INC. , a Delaware corporation,
located at 3030 Callan Road, San Diego, CA 92121 (The "
JVCo ") and CYTORI
THERAPEUTICS, INC. ,
a
Delaware corporation, located at 3020 Callan Road, San Diego, CA
92121 ("
Cytori ")
.
(JVCo
and Cytori may each be individually referred to herein as a
“ Party ” and collectively
as the “ Parties
”).
RECITALS
A. Cytori,
JVCo and Olympus Corporation (“Olympus”) entered
into a series of agreements in November 2005 creating a joint
venture (collectively, the “Joint Venture
Agreements”) dedicated to the commercial development,
manufacture and sale of JVCo Licensed Products (as defined
below) according to the terms of such agreements.
B. Cytori
is desirous of commercializing and marketing an earlier
version of Cytori Licensed Product (as defined below) (e.g.,
CT-800) during the Term (as defined in Section 2.5 below) or
until JVCo starts to sell its comparable “Licensed
Product(s)” defined in the License/ Commercial Agreement
dated November 4, 2005 by Cytori and JVCo (“JVCo
Licensed Product(s)”). Each of the Parties hereto now
recognizes that it would be beneficial to all Parties for
Cytori to commercialize and market an earlier version of the
Licensed Product than had been anticipated under the Joint
Venture Agreements, and have determined that the appropriate
licenses for Cytori to conduct such early commercialization
should be granted to Cytori pursuant to all of the terms and
conditions provided below.
NOW,
THEREFORE, in consideration of the foregoing, the mutual
promises herein contained, and for other good and valuable
consideration, the receipt and adequacy of which are
acknowledged, the Parties agree as follows:
1. DEFINITIONS
|
1.1
|
Defined Terms . As used in this Agreement, the
capitalized terms set forth in this Section 1 shall have the
following meanings:
|
“
Affiliate ” means, as to any
Party, any Person that, directly or indirectly, controls, or
is controlled by, or is under common control with, such Party,
where “control” (including, with its correlative
meanings, “controlled by” and “under common
control with”) means (a) the beneficial ownership of
fifty percent (50%) or more of the outstanding voting
securities of a Party, or (b) the possession, directly or
indirectly, of the power to direct or cause the direction of
management or policies of a Party, whether through the
ownership of securities or partnership or other ownership
interests, by contract or otherwise.
“
Agreement ” shall have the
meaning set forth in the Preamble.
“
Business Day ” shall mean any
day on which banking institutions are open in the United
States, and excluding national holidays in Japan.
“
Cytori ” shall have the meaning
set forth in the Preamble.
“
Development Agreement ” shall
mean the License/ Joint Development Agreement dated November
4, 2005 by and among Cytori, Olympus and JVCo.
“ Distr
ibutor Sale
” shall mean
the last sale of Cytori Licensed Product by Cytori or an Affiliate
of Cytori to an unaffiliated third party who intends to resell the
Cytori Licensed Product.
“
Effective Date ” shall have the
meaning set forth in the Preamble.
" End-User Sale
” means the last sale of Cytori Licensed
Product within the control of Cytori, or an Affiliate of Cytori, to
a Hospital or physician for use in such Hospital or Physicians
facility.
" Fully Burdened Cost of Sales
” means all materials, labor and overhead
costs as determined by Cytori’s accounting policies and
procedures, including any costs associated with set-up and
installation of the Cytori Licensed Products.
“
JVCo IP ” or “Licensed
IP” shall mean all Intellectual Property Rights today or
hereafter owned by, licensed by or acquired by JVCo (other
than JVCO trademarks and service marks) and useable or useful
in the Licensed Field.
“ Licensed
Field ”
shall
mean the designing, developing, manufacturing, testing,
importing, exporting, marketing, offering to sell, selling and
servicing Cytori Licensed Products.
“
Cytori
Licensed
Product(s) ”
shall
mean any automated devices (and related component parts)
,
manufactured by Cytori (e.g., “ CT-800
)
***
***
***
***
***
***
***
***
***
The Cytori Celut ion System is a
current example of a Cytori
Licensed
Product. Cytori
Licensed
Products shall not
include: ***
***
***
***
***
***
***
***
***
“ Net Sales " means the
total of the gross invoice prices from the Sale of Cytori Licensed
Product by Cytori in the form of a Distributor Sale or
End –User Sale, 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, handling and
refrigeration charges, including insurance; and allowances or
credits to customers because of rejections or returns
(“Customary Deductions”). If Cytori or any
Affiliate of Cytori sells at a single price or rate a packaged
combination of products and/or services, not all of which if sold
individually would be Cytori Licensed Products, then “Net
Sales” with respect to such sales of packaged products shall
equal the number of units of each Cytori Licensed Product sold as
part of such packaged products multiplied by the
respective average adjusted net selling price for the same type of
Cytori Licensed Product sold individually, and in the
same market and distribution method, over the preceding six month
period , in each case excluding rejections, defects and
returns.
“
Person ” shall mean an
association, corporation, individual, partnership, trust or
any other entity or organization, including a governmental
entity, other than a Party.
_________________________
***Material has been omitted pursuant to a request for confidential
treatment filed separately with the Securities and Exchange
Commission
“
Term ” shall have the meaning
set forth in Section 2.5.
“
Three-Way NDA ” shall mean the
Three-Way Non-Disclosure Agreement, dated November 4, 2005,
entered into by and among Cytori, Olympus and
JVCo.
“ Intellectual Property
Rights ” shall mean “Intellectual Property
Rights” defined in the License/ Commercial Agreement dated
November 4, 2005 by Cytori and JVCo.
1.2
References . In this Agreement, a reference
to:
(a) A
Section, Sub-section, Preamble, Recital, Attachment, Schedule
or Exhibit is, unless the context otherwise requires, a
reference to a section or sub-section of, or a preamble,
recital, attachment, schedule or exhibit to, this
Agreement;
(b) “This
Agreement” (or any specific provision hereof) shall be
construed as references to this Agreement or that provision as
amended, varied or modified from time to time;
(c) “¥”
or “JPY” refers to Japanese Yen, the lawful
currency for the time being of
Japan. “$” or “USD” refers
to United States Dollars, the lawful currency for the time
being of the United States of America; and
(d) All
references in this Agreement to “days” will,
unless otherwise specified herein, mean calendar
days.
|
1.3
|
Headings . Headings in this Agreement are for ease
of reference only and shall not affect the interpretation or
construction of this Agreement.
|
2. THE
LICENSE GRANTED BY JVCO
|
2.1
|
License Grant .
|
Subject
to the terms, conditions and obligations set forth in this
Agreement including the royalty payments to be made by Cytori to
JVCo hereunder, JVCo hereby grants to Cytori a non-exclusive,
worldwide license to the JVCo IP (including any improvements
thereto) for use in the Licensed Field for the Term. In addition,
Cytori shall be entitled to sublicense sales rights to its
distributors during the Term, and to sublicense the manufacture of
certain component parts, but such rights shall not extend the third
party manufacture of all or substantially all of the any finished
Cytori
Licensed Product . For avoidance of doubt, the license
granted herein is intended to allow Cytori to develop, make, and
use Cytori Licensed Products for commercial sale during the Term,
and the exercise of the rights granted herein in accordance with
the terms in this Agreement, shall not be construed as competing
with any products of the Joint Venture or in any
way violating the Joint Venture
Agreements.
|
|
2.2
|
Royalty Payments . In consideration of the license granted by
JVCo to Cytori pursuant to Section 2.1 above (and subject to the
exceptions described in 2.2 (b)):
|
(a)
Cytori shall pay to JVCo a payment in the form of a royalty as
described in either of the following cases:
***
(b)
Cytori shall not be required to pay a royalty for its
distribution or provision of Cytori Licensed Products without
charge or cost to the receiving party (i.e. for clinical
trials, regulatory, reimbursement etc.).
______________ ___________
***Material has been omitted pursuant to a request for confidential
treatment filed separately with the Securities and Exchange
Commission
| 2.3 |
Reports . Effective upon the first commercial
sale of a Cytori Licensed Product, Cytori shall make quarterly
royalty reports to JVCo on or before each February 15 (for the
quarter ending December 31), May 15 (for the quarter ending March
31), August 15 (for the quarter ending June 30) and November 15
(for the quarter ending September 30) of each year. Each
royalty report will cover Cytori's most recently completed calendar
quarter and will show: |
| |
|
(a) all
Net Sales during the most recently completed calendar
quarter; |
| |
|
(b) the
Fully Burdened Cost of Sales associated with the Net Sales in 2.3
(a); |
| |
|
(c) the
number of each type of Cytori Licensed Product sold; |
| |
|
(d) the
royalties, in U.S. dollars, payable to JVCo hereunder; |
| |
|
(e)& |
|