Exhibit 10.1
EXCLUSIVE LICENSE
AGREEMENT
THIS
AGREEMENT is made and entered into this
21 st day of May, 2008, by and
between: SYNTHETIC BLOOD INTERNATIONAL, INC. (hereinafter
referred to as the “LICENSEE”) with its principal place
of business at 3189 Airway Avenue Bldg. C, Costa Mesa, CA 92626,
and VIRGINIA COMMONWEALTH UNIVERSITY INTELLECTUAL PROPERTY
FOUNDATION (hereinafter referred to as the
“LICENSOR”), and with its principal place of operation
at Virginia Commonwealth University, 800 E. Leigh Street, Suite
113, Richmond, Virginia 23298-0568, United States of
America.
WHEREAS, LICENSOR is charged with management and
licensing of intellectual properties developed at Virginia
Commonwealth University (“VCU”) and, under VCU
intellectual property policy, inventions made by employees of VCU
or made using the facilities of VCU are required to be assigned to
VCU and managed by LICENSOR;
WHEREAS, VCU is the owner of all right, title, and
interest in patent applications associated with the VCU invention
disclosure 06-31 “Novel Means to Provide Non pulmonary
Oxygenation,” VCU invention disclosure 07-080 “Novel
Combinatorial Approaches to Enhancing Oxygen Transport to
Tissue”, and VCU Invention disclosure 08-008 “Gas Based
Wound and Tissue Therapeutics” invented by Dr. Kevin
Ward, Bruce Speiss, Robert Diegelman, Gary Bowlin, et al, employees
at Virginia Commonwealth University; and
WHEREAS, LICENSEE is desirous of acquiring from LICENSOR
certain rights set forth below;
NOW, THEREFORE,
in consideration of the promises and
the covenants set forth herein, LICENSOR and LICENSEE agree as
follows:
I. DEFINITIONS
The following definitions shall
apply in the interpretation of this AGREEMENT.
1.1 “AFFILIATE” of any
LICENSEE means any corporation which, directly or indirectly,
controls or is controlled by, or is under direct or indirect common
control with, such LICENSEE; and for the purposes of this
definition “control” (including “control
by” and “under common control with”) as used with
respect to any corporation or LICENSEE, shall mean the possession,
directly or indirectly, of the power to direct or cause the
direction of the management and policies of such corporation or
LICENSEE, through the ownership of more than 50% of the voting
shares.
1.2 “CALENDAR QUARTER”
means the three-month period ending
March 31, June 30, September 30, or
December 31 in any year.
1.3 “LICENSED PATENTS”
shall mean the VALID CLAIMS of to, the extent controlled by
LICENSOR, the United States patents and patent applications,
corresponding foreign patents and patent applications as listed in
Appendix A, attached hereto and incorporated herein by reference,
and any reissues, re-examinations, renewals, extensions,
substitutions, continuations, divisions, and continuation-in-part
applications (but only those VALID CLAIMS in the
continuation-in-part applications that are entirely supported in
the specification and entitled to the priority date of the parent
application).
1.4 “LICENSED PRODUCTS”
shall mean any product in the FIELD OF USE that incorporates, is
covered by (in whole or in part), or is made, uses or is used by a
process covered by (in whole or in part), one or more VALID CLAIMS
in one or more of the LICENSED PATENTS (including reissues and
re-examinations) and without a license from VCU, would infringe one
or more of the VALID CLAIMS in a Licensed Patent.
1
1.5 “FIELD OF USE” shall mean all
therapeutic and diagnostic applications in humans and
animals.
1.6 “IMPROVEMENT
INVENTIONS” shall mean inventions in the FIELD OF USE which
improvement arose from research sponsored by LICENSEE and/or arose
out of research in the FIELD OF USE in the area of oxygen
therapeutics conducted (i) solely by Dr. Bruce Spiess, or
(ii) under the direction or control of Dr. Bruce Spiess
(e.g., arising from Dr. Spiess’ laboratory or research
group).
1.7 “EFFECTIVE DATE”
shall mean the date of the AGREEMENT set forth above.
1.8 “NET SALES” shall
mean the amounts received by LICENSEE from the use of LICENSED
PRODUCTS, or the sale of LICENSED PRODUCTS, less (i) discounts
or rebates actually allowed from the billed amount,
(ii) credits or allowances actually allowed upon claims or
returns, (iii) shipping and insurance charges, and
(iv) taxes, customs, or other government charges and
surcharges included in the amounts billed. For non-cash and
partial-cash sales, NET SALES shall include the fair market value
of non-cash consideration received for such sale of the same
quantity of LICENSED PRODUCTS. For sales not at arms-length, NET
SALES shall be equal to the fair market price of such LICENSED
PRODUCTS as when transferred in comparable arms-length
transactions. In the event that LICENSED PRODUCTS are used by
LICENSEE rather than sold, the parties shall agree upon an
appropriate NET SALES price for each such use on which to base a
royalty calculation. The distribution of reasonable quantities of
free promotional samples of LICENSED PRODUCT or LICENSED PRODUCTS
provided without charge for clinical trials or research purposes
shall not be considered a sale of a LICENSED PRODUCT for royalty
purposes.
1.9 “SUBLICENSEE” shall
mean any non-affiliated third party to whom LICENSEE has granted a
SUBLICENSE. “SUBLICENSE” shall mean an agreement in
which LICENSEE (i) grants or otherwise transfers any of the
rights licensed to LICENSEE hereunder, (ii) agrees not to
assert such rights or to sue, prevent or seek a legal remedy for
the practice of same, or (iii) is under an obligation to
grant, assign or transfer any such rights or non-assertion, or to
forebear from granting or transferring such rights to any other
entity, including licenses, option agreements, right of first
refusal agreements, or other agreements.
1.10 “SUBLICENSING
REVENUE” shall mean the fair market cash value of any and all
consideration received by LICENSEE from SUBLICENSEE under its
SUBLICENSE, including without limitation running royalties paid for
NET SALES of LICENSED PRODUCTS by SUBLICENSEE, license issue fees
and other licensing fees, option fees, milestone payments, minimum
annual royalties, equity or other payments of any kind whatsoever,
irrespective of whether such revenues are received in the form of
cash, barter, credit, stock, warrants, release from debt, goods or
services, licenses back, or any other form whatever.
Notwithstanding the foregoing, “SUBLICENSING REVENUE”
shall not include the following payments, in cash or equity,
received by LICENSEE: (i) payments for research and
development activities, as documented in development plans and/or
budgets under research or development agreements with third
parties, (ii) amounts received in consideration for
LICENSEE’s equity, and (iii) amounts received in
consideration for the sale of all or substantially all of the
business or assets of LICENSEE relating to this license, whether by
merger, acquisition, sale of assets, stock, or
otherwise.
2
1.11 “VALID CLAIM” means a claim of
a patent or patent application in any country that (i) has not
expired, (ii) has not been disclaimed, (iii) has not been
cancelled or superseded, or if cancelled or superseded, has been
reinstated; (iv) has not been revoked, held invalid, held
unpatentable, or otherwise declared unenforceable or not allowable
by a tribunal or patent authority of competent jurisdiction over
such claim in such country from which no further appeal has or may
be taken, and (v) has not been admitted to be invalid or
unenforceable through reissue, re-examination, disclaimer, or
otherwise.
II. GRANT
2.1 LICENSOR grants to LICENSEE an
exclusive, royalty bearing, worldwide license under the LICENSED
PATENTS to make, have made, use, offer to sell, sell, have sold,
and import LICENSED PRODUCTS, with the right to SUBLICENSE under
the terms of Article VIII, throughout the term hereof in the FIELD
OF USE. This grant shall be subject to the payment by LICENSEE to
LICENSOR of all consideration as provided in this AGREEMENT, and
shall be further subject to the rights retained by LICENSOR and VCU
to:
|
|
a.
|
publish the
scientific findings from research related to LICENSED PATENTS;
provided, however, LICENSOR shall provide LICENSEE any proposed
publication at least thirty (30) days prior to any proposed
publication thereof to review any such publication for the purpose
of identifying any patentable inventions and, in the event that
LICENSEE identifies any such information, LICENSOR will delay any
publication for up to forty-five (45) days for the purpose of
filing a patent application; and
|
|
|
b.
|
practice under
the LICENSED PATENTS for educational, research, non-commercial
patient care and treatment, and other non-commercial internal
purposes. Such reservation shall include the right to extend such
right to practice under the LICENSED PATENTS for non-commercial
educational and academic research purposes (but not for patient
care and treatment, or any other internal purpose) to subsequent
employers of any of the Inventors, but only to the extent that such
employers are not-for-profit organizations. Such reservation shall
further include the right to provide technical information, and to
grant non-transferable licenses, without the right to sublicense,
under the LICENSED PATENTS, to not-for-profit and governmental
institutions for their internal non-commercial research and
scholarly use only, in accordance with the NIH Guidelines for
Obtaining and Disseminating Biomedical Research Resources (as
published in the U.S. Federal Register / vol. 64, No. 246 -
12/23/99).
|
2.2 LICENSOR grants to LICENSEE, and
LICENSEE accepts, an exclusive first option to include IMPROVEMENT
INVENTIONS in this AGREEMENT. Subject to any third party
obligations, LICENSOR grants to LICENSEE, and LICENSEE accepts, an
exclusive first option to enter into good faith negotiations for a
license in the FIELD OF USE to include any inventions with respect
to oxygen therapeutics invented by Dr. Bruce Spiess together
with other inventors (if no inventor objects in writing) in this
AGREEMENT upon payment of $25,000 fee. Subject to any third party
obligations and if no inventor objects in writing, LICENSEE shall
have an option to negotiate an exclusive license on inventions
based on oxygen delivery to tissue developed by other inventors at
VCU after the EFFECTIVE DATE under commercially reasonable terms.
The exclusive option granted to LICENSEE under this
Section 2.2 must be exercised in writing within forty-five
(45) days after LICENSEE’S receipt of written
information of LICENSOR’S decision to file a patent
application concerning an IMPROVEMENT INVENTION or other invention
from LICENSOR. Upon expiration of the option period, LICENSOR may
seek other licensees.
3
2.3 Notwithstanding anything herein to the
contrary, any and all licenses and other rights granted hereunder
are limited by and subject to the rights and requirements of the
United States Government which may attach as a result of United
States Government sponsorship of research at VCU, in which the
invention covered by the LICENSED PATENTS was conceived or reduced
to practice, as set forth in 35 U.S.C. §§200-206, 37
C.F.R. Part 401 and in the relevant United States Government
research contracts with VCU, and as such rights and requirements
may be amended or modified by law. To the extent applicable, such
rights and requirements include without limitation (i) the
grant of a nonexclusive, nontransferable, irrevocable, paid-up
license to practice or have practiced for or on behalf of the
Government any of the LICENSED PATENTS throughout the world (as set
forth in 35 U.S.C. §202(c)(4)), and (ii) the requirement
that LICENSED PRODUCTS used or sold in the United States will be
manufactured substantially in the United States (as set forth in 35
U.S.C. §204).
III. PAYMENT
PROVISIONS
3.1 In consideration for the rights,
privileges and license granted under this AGREEMENT, the LICENSEE
must pay to LICENSOR the fees and royalties specified in Appendix
B, attached hereto and incorporated herein by reference.
3.2 With each report submitted under
Section 5.1 of this AGREEMENT, LICENSEE shall make all
payments to LICENSOR in US dollars due and payable under this
Article III. If no royalties are due, LICENSEE shall so
report.
3.3 LICENSEE shall be obligated to
pay royalties as provided in this AGREEMENT on all LICENSED
PRODUCTS that are either sold or produced under this license,
regardless of whether such LICENSED PRODUCTS are produced prior to
the EFFECTIVE DATE of this AGREEMENT or sold after the termination
of this AGREEMENT. LICENSEE also agrees to make a written report to
LICENSOR within ninety (90) days after the termination of this
AGREEMENT pursuant to Article VII. LICENSEE shall continue to make
reports concerning royalties on the sale of LICENSED PRODUCTS
payable in accordance with this Article III after termination of
this AGREEMENT, until such time as all such LICENSED PRODUCTS
produced under the license have been sold or destroyed. Concurrent
with the submittal of each post-termination report, LICENSEE shall
pay LICENSOR all applicable royalties.
3.4 All payments due
the LICENSOR must be paid in U.S. currency to the LICENSOR. The
LICENSEE must convert NET SALES invoiced in foreign currency into
equivalent U.S. currency at the exchange rate for the foreign
currency prevailing as of the last day of the reporting period, as
reported in the Wall Street Journal
®
.
Royalty payments
shall be based on NET SALES in any country where a valid patent
covering LICENSED PATENTS or LICENSED PRODUCTS is in effect, and on
NET SALES of export PRODUCTS when the PRODUCTS were produced in a
country where a valid patent covering LICENSED PATENTS is in
effect. LICENSEE agrees to pay interest of 1.5% per month, the
interest being compounded monthly, or two hundred fifty dollars
($250.00), whichever is greater, on any delinquent payments to
LICENSOR. LICENSEE shall calculate the correct late payment charge,
and shall add it to each such late payment. LICENSEE shall pay for
all costs and reasonable attorneys fees incurred by LICENSOR in
collecting payments due to LICENSOR.
3.5 In the case of a buyout or other
change in majority ownership of LICENSEE, or a buyout of LICENSED
PRODUCTS, all payment provisions arc passed through,
non-negotiable, and remain in effect for LICENSEE. SUBLICENSEE, or
purchaser, as applicable. LICENSEE shall inform any potential
purchaser of this clause and present evidence of such notification
to LICENSOR.
4
IV. DILIGENCE AND PATENT
PROSECUTION
4.1 The LICENSEE will use its
reasonable best efforts to bring one or more LICENSED PRODUCT(S) to
market through a thorough, vigorous and diligent program for
exploitation of the PATENT RIGHTS and to continue active, diligent
marketing efforts for LICENSED PRODUCTS throughout the life of this
AGREEMENT.
4.2 LICENSEE agrees
to present to LICENSOR a development plan for each LICENSED PRODUCT
within two (2) months of acquiring the relevant LICENSED
PATENT. The diligence milestones outlined in the development plans
for each LICENSED PRODUCT will be attached to this AGREEMENT as a
new Appendix C 1.2.3 etc., no later than two months
after LICENSEE acquires the the relevant LICENSED PATENT. To be in
compliance with Section 4.1, the LICENSEE must meet the
diligence milestones set out in Appendix C, which shall be attached
hereto and incorporated herein by reference.
4.3 Article IV is a material term of
this AGREEMENT, without which the license grant under Article II
would not have been made, and the LICENSEE’S failure to
perform in accordance with Sections 4.1 and 4.2 is grounds for the
LICENSOR to terminate this AGREEMENT pursuant to Article
VII.
4.4 LICENSEE shall be responsible
for the cost of prosecution and maintenance of patents and
copyrights during the term of this AGREEMENT. LICENSEE shall have
the right to appoint and engage patent counsel to prosecute and
maintain the LICENSED PATENTS, subject to the approval of LICENSOR,
such approval not to be unreasonably or untimely withheld. LICENSOR
shall fully cooperate and assist LICENSEE in all related matters.
LICENSEE shall provide LICENSOR with copies of all papers received
from and to be filed in the U.S. Patent and Trademark Office, U.S.
Copyright Office, and corresponding foreign patent and copyright
offices.
4.5 All patents, patent
applications, and copyrights on the LICENSED PATENTS shall be,
assigned to LICENSOR, and LICENSOR’S interest therein shall
be recorded in the U.S. Patent and Trademark Office, U.S. Copyright
Office, and corresponding foreign patent and copyright
offices.
4.6 LICENSOR shall provide LICENSEE
with copies of all papers, including without limitation, all papers
existing prior to the EFFECTIVE DATE, received from and to be filed
in the U.S. Patent and Trademark Office, U.S. Copyright Office, and
corresponding foreign patent and copyright offices.
4.7 LICENSEE shall be entitled, in
its discretion, to abandon any application or granted patent or
copyright if it considers that the ongoing costs of the same are
not justified, provided that LICENSEE notifies LICENSOR prior to
such abandonment and allows LICENSOR opportunity to avoid such
abandonment. In no event shall such reasonable opportunity be less
than three (3) months prior to abandonment. If LICENSEE
chooses to abandon an application or granted patent or copyright
under this provision and LICENSOR, at its sole expense, continues
pursuing the application, granted patent or copyright, LICENSEE
shall retain no right to use or exploit the LICENSED PATENTS or any
related copyright in the country, territory or jurisdiction which
granted the patent or copyright.
4.8 LICENSOR shall have the right to
immediately terminate this AGREEMENT, without requirement of
notification of default, in the event that LICENSEE challenges,
directly or indirectly or at written urging of a third party on
behalf of LICENSEE, whether as a claim, a cross-claim,
counterclaim, or defense, the validity or enforceability of any of
the LICENSED PATENTS before any court, arbitrator, or other
tribunal or administrative agency in any jurisdiction. The parties
acknowledge that re-examination proceedings shall not be considered
a challenge of the LICENSED PATENTS.
5
V. REPORTING
OBLIGATIONS
5.1 LICENSEE, within sixty
(60) days after each CALENDAR QUARTER of each year, shall
deliver to LICENSOR true and accurate reports, pertaining to NET
SALES of LICENSED PRODUCTS, which shall include at least the
following information:
|
|
a)
|
the identity of
each of the LICENSED PRODUCTS being developed, manufactured,
marketed and/or sold;
|
|
|
b)
|
the stage of
development of each LICENSED PRODUCT;
|
|
|
c)
|
the number of
each LICENSED PRODUCT manufactured and/or sold in each
country;
|
|
|
d)
|
NET SALES of
LICENSED PRODUCTS sold by the LICENSEE and all SUBLICENSEES,
prepared in accordance with generally accepted accounting
principles, on a country by country basis, for each LICENSED
PRODUCT;
|
|
|
e)
|
any and all
allowable deductions from NET SALES;
|
|
|
f)
|
names and
addresses of all SUBLICENSEES; and
|
|
|
g)
|
total fees,
royalties, and SUBLICENSING REVENUE due.
|
5.2 Progress Report. On or before
January 1 and July 1 of each year until LICENSEE markets
LICENSED PRODUCTS, LICENSEE shall make a written semi-annual report
to LICENSOR covering the preceding six (6) months regarding
the progress of LICENSEE toward commercial use of LICENSED
PRODUCTS. Such report shall include, as a minimum, information
sufficient to enable LICENSOR to satisfy reporting requirements of
the U.S. Government and for LICENSOR to ascertain progress by
LICENSEE toward meeting the diligence requirements of Sections 4.1
and 4.2.
5.3 LICENSEE shall keep full, true
and accurate books of account containing all particulars that may
be necessary for the purpose of showing the amounts payable to
LICENSOR hereunder. Said books of account shall be kept at
LICENSEE’S principal place of business. Said books and
supporting data, subject to reasonable obligations of
confidentiality, shall be open at all reasonable times for five
(5) years following the end of the calendar year to which they
pertain, to the inspection of LICENSOR or its agents for the
purpose of verifying LICENSEE’s royalty statement or
compliance in other respects with this AGREEMENT. Said records will
include general ledger records showing cash receipts and expenses,
and records which include production records, customers, serial
numbers, and related information, as applicable, in sufficient
detail to enable the royalties payable hereunder by LICENSEE to be
determined. Such examination is to be made by LICENSOR or its
designee, at the expense of LICENSOR. Should such inspection,
however, lead to the discovery of a greater than five percent
(5%) discrepancy in reporting to LICENSOR’S detriment,
LICENSEE shall pay the full cost of such inspection. LICENSEE shall
pay any amounts such inspection reveals to be due and owing within
thirty (30) days of the receipt of an invoice for
same.
VI. INFRINGEMENT
6.1 LICENSOR represents that, to the
best of its knowledge, as of the EFFECTIVE DATE, the entire right,
title, and interest in the patent applications or patents
comprising the LICENSED PATENTS have been assigned to it (or VCU)
free and clear of all liens, claims and encumbrances of any
inventor or any non-governmental third party and that it (or VCU)
has all requisite power and authority to grant the
6
license contained in this AGREEMENT. LICENSOR
also represents that it has received no notification (i) that
the LICENSED PATENTS are invalid or (ii) that the exercise by
LICENSEE of the rights granted hereunder will infringe on any
patent or other proprietary right of any third party. LICENSEE
acknowledges and agrees that all rights licensed by the LICENSOR
hereunder are licensed “as is” and without any
representation, indemnification or warranty with respect to
possible infringement of third party rights. In the event of a
third party infringement action against either party with respect
to any LICENSED PATENTS, LICENSEE will defend LICENSOR and VCU at
LICENSEE’s expense, with the understanding that breaching
such obligation may result in a default judgment against LICENSEE,
its AFFILIATES, SUBLICENSEEs, and/or LICENSOR (however,
LICENSEE’S failure to defend sha