Exhibit 10.2
* INDICATES A PORTION OF THIS EXHIBIT THAT WAS OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT. THIS EXHIBIT INCLUDING SUCH OMITTED INFORMATION WAS
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION ON A CONFIDENTIAL
BASIS.
EXCLUSIVE LICENSE AGREEMENT
BETWEEN
UNIVERSITY OF LOUISVILLE RESEARCH FOUNDATION, INC.
AND
STEM CELL TECHNOLOGIES, INC.
This exclusive license agreement (the "Agreement") is entered into this
12 day of November 2007 (the "Effective Date") by and between the University of
Louisville Research Foundation, Inc. ("ULRF"), a Kentucky 501 (c) 3 non-profit
corporation having an office at Med Center Three, 000 X. Xxxxxxxxx Xxxxxx, Xxxxx
000, Xxxxxxxxxx, XX 00000 as the agent of the University of Louisville ( "UofL")
and Stem Cell Technologies, Inc. ("LICENSEE"), a Florida corporation with a
principal place of business located at 0000 X. Xxxx Xxxxxx, Xxxxx, XX 00000.
RECITALS
1. ULRF was established by UofL to enter into and administer research
agreements with external funding sources in order to benefit the public
by the transfer of technology from UofL to the private sector for
development and commercialization;
2. ULRF owns the exclusive rights in certain Licensed Technology (as
defined below) including rights in any patent applications filed on,
and patents that issue on, such Licensed Technology;
3. The Inventors are employees of UofL and are obligated to assign all of
their right, interest and title in the Licensed Technology to ULRF;
4. Intentionally Omitted;
5. Intentionally Omitted;
6. ULRF desires to have the Licensed Technology perfected and marketed at
the earliest possible time to insure that products resulting therefrom
may be available for public use and benefit;
7. LICENSEE desires to obtain from ULRF certain rights for the commercial
development, use and sale of the Licensed Technology, and ULRF is
willing to grant such rights;
8. In consideration of the mutual promises contained herein and other good
and valuable consideration, the receipt and sufficiency thereof is
hereby acknowledged;
NOW, THEREFORE, ULRF and LICENSEE hereby agree as follows:
ARTICLE 1
DEFINITIONS AND INTERPRETATION
------------------------------
1.1 Definitions. Unless the context otherwise requires, the capitalized terms
used herein shall have the respective meanings specified or referred to in this
Section 1.1, or elsewhere in this Agreement.
1.1.1 "Affiliate" shall mean any corporation or other legal
entity which directly or indirectly controls, is
controlled by, or is under common control with
LICENSEE as of the Effective Date of this Agreement.
For the purpose of this Agreement, "control" shall
mean the direct or indirect ownership of greater than
fifty percent (50%) of the outstanding shares on a
fully diluted basis or other voting rights of the
subject entity to elect directors, or if not meeting
the preceding, any entity owned or controlled by or
owning or controlling at the maximum control or
ownership right permitted in the country where such
entity exists. For clarity, a party's status as an
Affiliate of LICENSEE shall terminate if and when
such control ceases to exist.
1.1.2 "Change of Control" shall mean: (a) the acquisition,
either directly or indirectly, by any third party of
more than fifty percent (50%) of the voting stock of
LICENSEE; (b) any merger or consolidation involving
LICENSEE that requires a vote of the stockholders of
LICENSEE; or (c) the transfer to any third party of
all or substantially all the assets of LICENSEE
relating to the subject matter of this Agreement.
1.1.3 "Field of Use" shall mean the field for which
Licensed Products may be designed, manufactured, used
or sold and shall be limited to the following field:
all fields, unless further restricted under Section
3.3 and excluding education, academic research,
teaching and public service.
1.1.4 "Net Sales" shall mean the gross sum which is
invoiced (and any revenues received but not billed)
to customers by LICENSEE or its Affiliates or
sublicensees for the use, sale or other transfer of
Licensed Products, less sales and/or use taxes
actually paid, import and/or export duties actually
paid, outbound transportation prepaid or allowed,
insurance agents' commissions and amounts allowed or
credited due to returns, rebates, discounts and the
like (not to exceed the original billing or invoice
amount). In the event Licensed Products are put into
use or otherwise disposed of, or if sales are made
other than by an arms-length transaction, or if
LICENSEE or its Affiliates or sublicensees receive
consideration other than cash for Licensed Products,
then the gross selling price shall not be less than
fair market value.
1.1.5 "Inventors" shall mean Drs. Xxxxxxx X. Xxxxxxxxx,
Xxxxxxxxxx Xxxxx, and Xxxxxx Xxxxxxxxx.
1.1.6 "License Year" shall mean a year in which this
Agreement is in effect. The first License Year shall
begin on the Effective Date of this Agreement and run
until December 31 of the same calendar year.
Thereafter, each subsequent License Year shall mean
each subsequent calendar year, beginning January 1
and ending December 31, provided that the final
License Year shall end on the date of expiration or
termination of this Agreement.
2
1.1.7 "Licensed Patents" shall mean ULRF's United States
patents and patent applications identified in Exhibit
A, including any divisions, continuations (but not
continuations-in-part), and reissues and extensions
thereof, and any foreign counterparts and equivalents
thereof.
1.1.8 "Licensed Products" shall mean any product or service
in the Field of Use (i) that is covered by, or is
made by a process covered by, any Valid Claim, (ii)
for which the use, manufacture, import or sale would,
absent this license, infringe, induce infringement or
contribute to infringement of a Valid Claim, or (iii)
which is made with, uses or incorporates any Licensed
Technology. A Licensed Product may be marketed as a
separate single component or may be marketed as a
component of a more complex system or apparatus into
which it has been incorporated.
1.1.9 "Licensed Technology" shall mean collectively the
Licensed Patents identified in Exhibit A and any
unpatented inventions, discoveries or know-how as
further identified in Exhibit B.
1.1.10 "Licensed Territory" shall mean the world.
1.1.11 "Party" shall mean either LICENSEE or ULRF, and
"Parties" shall mean both LICENSEE and ULRF.
1.1.12 "Royalty Periods" shall mean the four (4) three month
periods during a License Year, the first beginning
January 1 and ending March 31, the second beginning
April 1 and ending June 30, the third beginning July
1 and ending September 30, the fourth beginning
October 1 and ending December 31; provided that the
first Royalty Period of this Agreement shall begin on
the Effective Date and end December 31 of that same
calendar year.
1.1.13 "Term" shall mean the term of this Agreement, which
shall begin on the Effective Date and continue until
the later of: (i) the latest date that a Valid Claim
exists; or (ii) twenty (20) years after the Effective
Date; or (iii) the date this Agreement is terminated
in accordance with the terms hereof.
1.1.14 "Valid Claim" shall mean:
(a) a claim of an issued patent within the Licensed
Patents that has not:
(i) expired or been canceled,
(ii) been finally adjudicated to be invalid
or unenforceable by a decision of a court or other
appropriate body of competent jurisdiction (and from
which no appeal is or can be taken),
(iii) been admitted to be invalid or
unenforceable through reissue, disclaimer or
otherwise, or
3
(iv) been abandoned in accordance with or as
permitted by the terms of this Agreement or by mutual
written agreement; or
(b) a claim included in a pending patent application
within the Licensed Patents, which claim is being
actively prosecuted in accordance with this Agreement
and which has not been:
(i) canceled,
(ii) withdrawn from consideration,
(iii) finally determined to be unallowable
by the applicable governmental authority (and from
which no appeal is or can be taken), or
(iv) abandoned in accordance with or as
permitted by the terms of this Agreement or by mutual
written agreement.
1.2 Interpretation. Each definition in this Agreement includes the singular
and the plural, and reference to the neuter gender includes the masculine and
feminine where appropriate. References to any statutes or regulations mean such
statutes or regulations as amended at the time of interpretation and include any
successor legislation or regulations. The headings to the Articles and Sections
hereof are for convenience of reference and shall not affect the meaning or
interpretation of this Agreement. Except as otherwise stated, reference to
Articles, Sections, and Exhibits mean the Articles, Sections and Exhibits of
this Agreement. Any Exhibits are hereby incorporated by reference into and shall
be deemed a part of this Agreement. Unless the context clearly indicates
otherwise, the word "including" means "including but not limited to." Any words
that are not defined within this Agreement shall have their ordinary dictionary
meaning.
ARTICLE 2
LICENSE GRANT AND RESERVATION OF RIGHTS
---------------------------------------
2.1 Exclusive License. Subject to LICENSEE's compliance with the terms and
conditions of this Agreement, ULRF hereby grants and LICENSEE hereby accepts an
exclusive, worldwide license under the Licensed Technology for the Term to make,
have made, develop, use, sell, offer to sell import and export Licensed Products
in the Fields of Use throughout the Licensed Territory.
2.2 Reservation of Rights.
2.2.1 ULRF and UofL reserve the right to license and
practice the Licensed Technology for noncommercial
purposes only, such as education, academic research,
teaching, and public service. Any transfer of
materials covered under the Licensed Patents shall be
accompanied by a material transfer agreement that
notifies the recipient of this License. The terms of
the material transfer agreement to be used by ULRF
for such transfers is attached to this Agreement as
Exhibit C; the terms of which may be modified upon
mutual agreement of the Parties. Upon request, ULRF
will provide LICENSEE with a list of its academic or
nonprofit recipients which have executed any such
material transfer agreement.
4
2.2.2 The Inventors of the Licensed Technology reserve the
right to practice the technology solely as provided
in Section 2.2.1 above, for their own noncommercial
educational and research purposes.
2.2.3 Nothing in this Agreement shall be construed as
granting any license, title or any interest, by
assumption, implication, estoppel or otherwise, to
any patent or other rights not specifically listed as
Licensed Technology.
2.2.4 LICENSEE understands and agrees that ULRF may publish
or otherwise disseminate information concerning the
Licensed Technology at any time in accordance with
the provisions of confidentiality set forth in
Article 11.
ARTICLE 3
DUE DILIGENCE BY LICENSEE
-------------------------
3.1 Due Diligence by LICENSEE. LICENSEE represents to ULRF, to induce ULRF
to enter into this Agreement for the licensing of Licensed Technology, that
LICENSEE will engage in a diligent program as herein set forth exploiting the
Licensed Technology with the goal of public utilization resulting therefrom.
LICENSEE represents and warrants that it will use reasonable commercial efforts
to obtain the expertise necessary to develop the Licensed Technology with the
goal of developing the Licensed Products in accordance with the terms of this
Agreement. If the Licensed Products are subject to United States regulatory
approval prior to marketing, LICENSEE shall use reasonable commercial efforts to
market the Licensed Products in the United States within * of receiving
regulatory approval to market such Licensed Products, subject to reasonable
extension as may be requested by Licensee. Following the first commercial sale
of the Licensed Products, LICENSEE shall use reasonable commercial efforts to
reasonably fill the market demand for Licensed Products at all times during the
Term.
3.2 Development Records. LICENSEE shall maintain documentation evidencing
that LICENSEE (including Affiliates and sublicensees) is pursuing development of
Licensed Products as required herein. Such documentation may include, but is not
limited to, invoices for studies advancing development of Licensed Products,
laboratory notebooks, internal job cost records, and filing made to the Internal
Revenue Service to obtain tax credits, if available, for research and
development of Licensed Products.
3.3 Development Plan. Upon execution of this Agreement, LICENSEE shall
submit an initial Development Plan outlining work to be completed during the
first * of the Research Period (as defined in the Sponsored Research Agreement
described in Section 3.6 herein), which shall also serve as the research plan of
the Sponsored Research Agreement. Within a reasonable time, but in no event
later than * from the commencement of the Research Period, LICENSEE shall
provide ULRF with a list of its desired, specific fields of use of the Licensed
Technology and the definition of Field of Use set forth in 1.1.3 shall be deemed
amended accordingly. In addition, within * from the commencement of the Research
Period, LICENSEE will provide ULRF with a draft Development Plan written in the
format set forth in Exhibit D for each specific field of use of the Licensed
Technology included on the aforementioned list, satisfactory to ULRF, in its
reasonable discretion and describing the steps it intends to take which it
believes in good faith will result in allowing the inventions of the Licensed
Patents to be utilized to provide Licensed Products for sale in the commercial
market, which shall further include those steps taken, or to be taken, by
Affiliates and sublicensees, as it may have been advised by Affiliates and
sublicensees. For each specified field of use included on the aforementioned
list for which ULRF does not receive a timely Development Plan from LICENSEE
satisfactory to ULRF in its reasonable discretion, ULRF may withdraw that field
of use from this Agreement the definition of Field of Use in 1.1.3 shall again
be deemed amended to reflect the narrowed fields of use and ULRF may license
such use to a third party, subject to prior notice to Licensee and an
opportunity to cure as set forth in Section 12.1.1.1. For each new field of use
desired by LICENSEE but not included on the list submitted to ULRF by LICENSEE
at the end of * from the commencement of the Research Period, LICENSEE may
request the addition of the new field(s) of use and its corresponding
Development Plan to this Agreement in accordance with Section 13.3 of this
Agreement.
5
3.4 Development Report. Annually, commencing on January 1, 2009, LICENSEE
shall provide ULRF with a written Development Report in order to keep ULRF
informed of its progress. Such report shall contain substantially the
information set forth in Exhibit E, including any relevant considerations
involving any Affiliates and sublicensees as well as any necessary adjustments
to the Development Plan. ULRF's review of LICENSEE's Development Report is
solely to verify the existence of LICENSEE's commitment to the development
activity and to assure compliance with LICENSEE's obligations to utilize the
Licensed Technology to commercialize the Licensed Products for the marketplace,
as set forth above.
3.5 Auditing and Review of Development Records. ULRF reserves the right to
audit LICENSEE's records relating to the development of Licensed Products as
required hereunder. Such requirements for LICENSEE's record keeping and ULRF's
audit thereof shall be subject to the same procedures and restrictions set forth
for audit of financial records of LICENSEE in Section 5.7.
3.6 Sponsored Research; Collection Center Agreement. LICENSEE recognizes
the expertise of the Inventors in the Licensed Technology. ULRF and LICENSEE
acknowledge that ULRF and NeoStem, Inc. ("NeoStem") shall execute a Sponsored
Research Agreement ("SRA") which will serve as a basis for LICENSEE's diligence
obligations hereunder. Furthermore, NeoStem and ULRF intend to enter into a
collection center agreement soon after the execution of this Agreement,
including making all filings and receiving all necessary approvals with respect
to an investigational new drug application and institutional review board for
the collection of stem cells as contemplated in the collection center agreement.
3.7 Conversion of License. If LICENSEE fails to perform in any material
respect its obligations specified in Article 3, then ULRF shall have the right
and option to either terminate this Agreement as provided in Section 12.1.1.1 or
convert LICENSEE's exclusive license to a non-exclusive license, subject to the
non-binding mediation and dispute resolution procedures provided in Section
13.10, subject to prior notice to Licensee and an opportunity to cure as set
forth in Section 12.1.1.1.
ARTICLE 4
SUBLICENSING BY LICENSEE
------------------------
4.1 Sublicenses. LICENSEE may not grant any sublicenses without the prior
written approval of ULRF which shall not be unreasonably witheld, unless the
following conditions are met: LICENSEE provides thirty (30) days advance written
notice to ULRF; LICENSEE has used good faith efforts to assure itself of the
integrity and financial responsibility of the sublicensee; the sublicensee has
received and executed a license agreement binding it to all of the obligations,
terms and conditions that obligate, bind or affect LICENSEE under this Agreement
to the extent that such obligations, terms and conditions are relevant given the
nature of the right to be granted by LICENSEE to the sublicensee; LICENSEE
remits to ULRF all royalties that become payable, under Sections 5.3 and 5.4;
and sublicensee is a publicly traded company, or if not a publicly traded
company, has annual sales exceeding One Million Dollars ($1,000,000). LICENSEE
agrees to provide ULRF with (i) the identity of any proposed sublicensee, and
(ii) a true, correct and complete copy of the terms of any proposed sublicense
at the time that LICENSEE seeks approval or provides notice. In the event that
the original license with ULRF is terminated, all sublicenses would survive
termination of the original license, and ULRF shall have the option to convert
sublicenses to nonexclusive licenses.
6
ARTICLE 5
CONSIDERATION
-------------
5.1 License Issue Fee. LICENSEE shall pay to ULRF a non-creditable,
non-refundable License Issue Fee of * . Said License Issue Fee shall be payable
by LICENSEE to ULRF upon the commencement of the Research Period as described in
Section 3.3.
5.2 License Maintenance Fee. LICENSEE shall pay ULRF a License Maintenance
Fee of * due by January 31 of each calendar year upon issuance of the Licensed
Patent in the United States. This annual maintenance fee payment will be
nonrefundable and will not be creditable against any other payments due to ULRF
under this Agreement.
5.3 Earned Royalty.
5.3.1 For any use or sale of Licensed Products, including
the Licensed Products used and/or sold in connection
with quantitating VSEL Stem Cells, LICENSEE shall pay
to ULRF a royalty of * of Net Sales. Royalties due
under this Section 5.3 shall be payable on a
country-by-country and Licensed Product-by-Licensed
Product basis until the expiration or termination of
this Agreement. Royalties shall accrue when the
Licensed Product is invoiced, or if not invoiced,
when delivered to a third party. For purposes of
clarity, ULRF is not entitled to a royalty payment on
NeoStem's current collection and processing services.
5.3.2 Stacking. In the event during any Royalty Period,
LICENSEE's total combined royalty burden for Licensed
Patents and Enabling Technology (the "Total Royalty
Stack") exceeds * of Net Sales (the "Royalty Stack
Cap") the Earned Royalty payable by LICENSEE to ULRF
for that Royalty Period shall be reduced such that
for every * paid for Enabling Technology, * may be
deducted from Earned Royalties owed to ULRF; provided
however, that under no circumstance shall the Earned
Royalty be less than * . For purposes of this Section
5.3.2, "Enabling Technology" means any and all
additional third party licenses and rights which are
required by LICENSEE for the practice of Licensed
Patents or the manufacture of Licensed Products
hereunder.
5.4 Sublicensing Consideration. In the event a sublicense is granted by
LICENSEE hereunder, LICENSEE shall pay to ULRF * of all consideration (other
than on Net Sales owed under Section 5.3) received by LICENSEE from the
sublicensing of any rights granted under Section 2.1 of the Agreement. Such
amounts shall be paid along with the earned royalties under Section 5.3.
5.5 Milestone Payments. For the specific fields of use identified on the
list due to ULRF by LICENSEE at the end of * from the commencement of the
Research Period as described in Section 3.3, LICENSEE shall pay to ULRF the
following milestone payments within thirty days of the event set forth below:
7
o *
o *
o *
5.6 Royalty Payment and Report. Within thirty (30) days after the end of
each Royalty Period, commencing with the date of the first commercial sale of
Licensed Products including the Licensed Products used and/or sold in connection
with quantitating VSEL Stem Cells, LICENSEE shall provide to ULRF a written
report (even if there are no sales) detailing LICENSEE's (and each Affiliate's
and sublicensee's) sales activities during such Royalty Period. Each report
shall contain the information specified in the form attached hereto as Exhibit
F. Concurrent with the making of each such report, LICENSEE shall include
payment due ULRF of royalties for the Royalty Period covered by such report. If
no payment is due for any such period, LICENSEE shall so state.
5.7 Accounting. LICENSEE shall keep and maintain records for a period of
six (6) years from the date of creation, which show the manufacture, sale,
lease, use, and other disposition of Licensed Products sold or otherwise
disposed of under the licenses herein granted. Such records will include general
ledger records showing cash receipts and expenses, and records which include
production records, customers, and related information, in sufficient detail to
enable the royalties payable hereunder by LICENSEE to be determined. LICENSEE
will permit an independent certified public accountant as well as an internal
ULRF auditor to have reasonable access annually upon reasonable notice and
within six (6) months after termination of this Agreement, to audit, during
ordinary business hours, such records as may be necessary to verify or determine
royalties or other payments paid or payable under this Agreement. Such auditor
or other person shall be instructed to report to ULRF only information related
to determining the amount of royalties or other payments due and payable.
LICENSEE shall reimburse ULRF all unpaid royalties, plus interest as set forth
in Section 5.8, within thirty (30) days after receiving a written audit report.
ULRF shall pay the cost of the audit unless the results of the audit reveal an
under-reporting or an underpayment of royalties due ULRF of five percent (5%) or
more, in which case LICENSEE shall pay the audit costs.
5.8 Interest. The royalty and other payments set forth in this Agreement
shall, if overdue, bear interest until payment at the monthly rate of [(P+2)/12]
%, where P is the prime rate quoted in the Wall Street Journal on the day such
royalty becomes due. The payment of such interest shall not foreclose ULRF from
exercising any other rights it may have as a consequence of the lateness of any
payment.
5.9 Payment Procedures. All payments due from LICENSEE to ULRF hereunder
shall be in U.S. currency by check or money order payable to the "University of
Louisville Research Foundation, Inc." With respect to sales in countries outside
the United States, royalties shall be payable in US dollars at the rate of
exchange published in the Wall Street Journal on the close of business on the
last banking day of each Royalty Period in which the royalty accrues. Royalties
shall be paid to the ULRF free and clear of all foreign taxes. Such payments
shall reference the UofL tax identification number #00-0000000 and shall be
remitted to the address for ULRF specified in Section 13.1 of this Agreement.
5.10 Non-U.S. Taxes. LICENSEE will pay all non-U.S. taxes related to
royalty payments. These payments are not deductible from any payments due to
ULRF.
8
ARTICLE 6
PATENT PROSECUTION
------------------
6.1 Prosecution and Maintenance of Licensed Patents and Payment of Patent
Costs. Upon execution of this Agreement, LICENSEE will assume responsibility of
taking the lead on patent drafting and prosecution activities for the Licensed
Patents as described below in this Article 6. Provided that LICENSEE timely
makes all of its payments under this ARTICLE, subject in each case to notice and
forty-five days to cure any nontimely payment as provided in Section 12.1, the
following shall apply:
6.1.1 Reimbursement of Prior Patent Expenses. Upon execution of this
Agreement, LICENSEE shall reimburse ULRF in the amount of *
for all expenses related to patent filing and prosecution
incurred prior to the Effective Date.
6.1.2 Future Patent Office Expenses. Future patent expenses
shall be borne as follows:
6.1.2.1 LICENSEE will bear all costs, including ULRF's
counsel fees (for reviewing and approving of filing
and prosecution as described below) incurred in
connection with such preparation, filing, prosecution
and maintenance of Licensed Patents. Any necessary
reimbursement by LICENSEE to ULRF for such costs
shall occur within thirty (30) days after receipt of
each invoice sent by ULRF to LICENSEE. ULRF shall use
reasonable efforts to minimize reimbursable expenses
by only utilizing external counsel on actions for
which ULRF requires expert advice.
6.1.2.2 Prepayment of Future Patent Office Expenses. Upon the
commencement of the Research Period, LICENSEE shall
pay a non-refundable * , which shall be creditable
against the first * of patent expenses incurred after
the Effective Date of this Agreement.
6.1.3 Counsel and Joint Representation. LICENSEE may choose counsel
from ULRF's pre-approved list of counsel, or any other counsel
subject to ULRF's final approval, such approval not to be
unreasonably withheld. Counsel shall provide concurrently to
both Parties copies of all drafts, prosecution documents and
correspondence for pending U.S. and foreign patent
applications.
6.1.4 Patent Prosecution. LICENSEE shall formally direct patent
prosecution and shall concurrently copy ULRF on all
communication with counsel related to the Licensed Patents.
LICENSEE will provide ULRF with ample opportunity to review
and approve patent drafts and prosecution activities (either
internally or with assistance from ULRF retained counsel, as
appropriate), and shall incorporate any suggestions or changes
made by ULRF.
6.1.5 Timing for Notice of Non-Election. In the event that LICENSEE
shall elect not to continue prosecution or pay for the
maintenance of any Licensed Patents, or for the filing,
prosecution and maintenance of patent applications and patents
which issue thereunder in accordance with this Agreement,
LICENSEE shall provide ULRF with written notice of
non-election at least thirty (30) days before the date patent
related actions or fees are due or such other period of time
as may be reasonable under the circumstances, and shall turn
over patent prosecution toULRF. In the event LICENSEE does not
provide sufficient notice, LICENSEE shall be responsible for
reasonable expenses incurred by ULRF as related to the
above-mentioned actions or fees that are due less than thirty
(30) days from the date LICENSEE's notice of non-election is
provided.
9
6.1.6 Recovery of Patents. In the event that LICENSEE shall elect
not to pay for the maintenance of any Licensed Patent, or for
the filing, prosecution and maintenance of patent applications
and patents which issue thereunder, then such Patent(s) and
patent applications shall cease to be considered Licensed
Technology and shall no longer be subject to the exclusive
license provisions of Article 2. LICENSEE shall cease
utilizing technology covered by such recovered patents and
ULRF shall be free to seek out a new licensee for the same
recovered patents in any field, including the Field of Use.
Non-payment of any material portion of patent expenses with
respect to the maintenance of any Licensed Patent, or for the
filing, prosecution and maintenance of patent applications and
patents which issue thereunder, shall be deemed by ULRF as an
election by LICENSEE to terminate its reimbursement
obligations regarding such patent or application and its
license rights thereto. LICENSEE shall cooperate with ULRF as
reasonably requested to facilitate ULRF's filing, prosecution
and maintenance of recovered patents.
6.2 Patent Term Extensions. If requested by LICENSEE, ULRF shall cooperate
with LICENSEE to apply for an extension of the term of any patent in the
Licensed Patents if appropriate under the Drug Price Competition and Patent Term
Restoration Act of 1984 and/or European, Japanese and other foreign counterparts
of this law. ULRF shall assist LICENSEE, if so requested, in preparing all
documents for such application, and ULRF shall execute such documents and take
any other additional action as LICENSEE reasonably requests in connection
therewith. LICENSEE shall pay expenses incurred by the foregoing.
ARTICLE 7
EXCLUSIONS AND NEGATIONS OF WARRANTIES; LIMITATION OF LIABILITY;
----------------------------------------------------------------
REPRESENTATIONS
---------------
7.1 Negation of Warranties. ULRF provides LICENSEE the rights
granted in this Agreement AS IS and WITH ALL FAULTS. ULRF
makes no representations other than as set forth herein and
extends no warranties of any kind, either express or implied.
Among other things, ULRF disclaims any express or implied
warranty:
7.1.1 of merchantability, of fitness for a particular
purpose;
7.1.2 of non-infringement; or
7.1.3 arising out of any course of dealing.
7.2 No Representation of Licensed Patent. LICENSEE also acknowledges that
ULRF does not represent or warrant:
7.2.1 the validity or scope of any Licensed Patent; or
7.2.2 that the exploitation of Licensed Patent will be
successful.
7.3 Representations of ULRF and LICENSEE.
10
7.3.1 Representations of the Parties: The Parties represent
to the best of their knowledge that:
(a) the execution and delivery of this Agreement
and the performance of the transactions
contemplated hereby have been duly
authorized by all appropriate corporate
action of such party; and
(b) this Agreement is a legal and valid
obligation binding upon such Party and
enforceable in accordance with its terms,
and the execution, delivery and performance
of this Agreement by the Parties does not
conflict with any agreement, instrument or
understanding to which such Party is a party
or by which it is bound.
7.3.2 Additional Representations of ULRF. ULRF represents
to the best of its knowledge that:
(a) ULRF is the sole owner of the entire right,
title and interest in and to the Licensed
Patents and Licensed Technology;
(b) ULRF has the full right and legal capacity
to grant the rights granted to LICENSEE
hereunder without violating the rights of
any third party and there are no rights in
the Licensed Technology or Licensed Patents
held by any governmental authority; and
(c) to the best of ULRF's knowledge, Licensed
Patents have been properly filed and
prosecuted.
7.4 No Warranties to Third Parties. LICENSEE shall not make any
statements, representations or warranties or accept any liabilities or
responsibilities whatsoever to or with regard to any person or entity that are
inconsistent with any disclaimer or limitation included in this Article 7.
7.5 Limitation of Liability. THE ENTIRE RISK AS TO PERFORMANCE OF
LICENSED PRODUCTS IS ASSUMED BY LICENSEE. IN NO EVENT SHALL ULRF, INCLUDING ITS
TRUSTEES, FELLOWS, OFFICERS, EMPLOYEES, STUDENTS AND AGENTS, BE RESPONSIBLE OR
LIABLE FOR ANY DIRECT, INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL OR OTHER
DAMAGES WHATSOEVER, OR LOST PROFITS OR OTHER ECONOMIC LOSS OR DAMAGE WITH
RESPECT TO LICENSED PRODUCTS, WHETHER GROUNDED IN TORT (INCLUDING NEGLIGENCE AND
PRODUCT LIABILITY), STRICT LIABILITY, CONTRACT OR OTHERWISE. THE ABOVE
LIMITATIONS ON LIABILITY APPLY EVEN THOUGH ULRF, ITS TRUSTEES, FELLOWS,
OFFICERS, EMPLOYEES, STUDENTS OR AGENTS, MAY HAVE BEEN ADVISED OF THE
POSSIBILITY OF SUCH DAMAGE.
ARTICLE 8
INDEMNITY & INSURANCE
---------------------
8.1 Indemnity.
8.1.1 LICENSEE shall indemnify, hold harmless, and defend ULRF and its
trustees, fellows, officers, employees, students, and agents, from and against
any and all claims, suits, losses, damage, costs, fees, and expenses (including
attorneys' fees) resulting from or arising out of the exercise of the licenses
granted hereunder, or any sublicense thereof, by LICENSEE or its Affiliates or
sublicensees except to the extent such losses arise from ULRF's gross negligence
or willful misconduct. This indemnification shall include, but not be limited
to, any product liability.
11
8.1.2 To the extent allowed by applicable Kentucky law (Kentucky
Revised Statutes 44.070 et seq.), ULRF will defend, indemnify and hold harmless
LICENSEE, its officers, directors employees, agents and assigns from and against
any and all claims, suits, losses, damage, costs, fees and expenses (including
attorneys' fees) which may result from any error or omission arising out of
ULRF's performance under this Agreement.
8.2 Insurance. During the Term and for one year thereafter, LICENSEE shall
obtain and maintain at all times and shall require its Affiliates and
sublicensees, and any subcontractors of any of the foregoing, to obtain and
maintain (i) insurance for all statutory workers' compensation and employers'
liability requirements covering any and all employees with respect to activities
performed under this Agreement; and (ii) comprehensive general liability
insurance, including products liability insurance, with reputable and
financially secure insurance carriers to cover their respective activities. Such
insurance shall provide minimum limits of liability of $5,000,000 (which the
Parties believe to currently be an appropriate level of coverage for the
activities contemplated by this Agreement and which shall be reviewed from time
to time by Licensee to assess its continued appropriateness and increase such
levels should it consider it to be warranted) and shall include ULRF, its
trustees, fellows, officers, employees, students, and agents as additional
insureds. Such insurance shall be written to cover claims incurred, discovered,
manifested, or made at any time during or after the expiration or termination of
this Agreement. At ULRF's request, LICENSEE shall furnish a certificate of
insurance evidencing primary coverage, indicating that ULRF has been endorsed as
an additional insured under coverage referred to above, and requiring thirty
(30) days prior written notice to ULRF of cancellation or material change. All
such insurance of LICENSEE shall be primary coverage; the insurance of ULRF
shall be deemed to be excess and noncontributory. ULRF shall notify LICENSEE in
writing of any claim brought against ULRF in respect to which ULRF intends to
invoke the provisions of this Section. LICENSEE shall keep ULRF informed in
writing and on a current basis of LICENSEE's defense(s) of any known claim under
this Section.
ARTICLE 9
MARKING; USE OF NAMES AND TRADEMARKS
------------------------------------
9.1 Marking. Prior to the issuance of a Licensed Patent, LICENSEE shall
xxxx Licensed Products (or their containers or labels if the Licensed Products
are not capable of being marked) made, sold, or otherwise disposed of by
LICENSEE under the license granted in this Agreement with the words "Patent
Pending" if a patent application is pending. Following the issuance of Licensed
Patent(s), LICENSEE shall xxxx Licensed Products (or their containers or labels
if the Licensed Products are not capable of being marked) with the serial
numbers of the Licensed Patents. All Licensed Products shipped to or sold in
other countries shall be marked in such a manner as to conform with the patent
laws and best practices of the country of manufacture or sale.
9.2 Use of Names and Trademarks. Neither Party shall, without the prior
written consent of the other Party (which consent shall not be unreasonably
withheld), identify the other Party in any advertising or other promotional
materials to be disseminated to the public or use the name of any faculty member
(with the exception of any ULRF Inventors who are employed by, partners in, or
consultants of the LICENSEE), employee, or student of ULRF or UofL, or any
trademark, service xxxx, trade name, or symbol owned by or associated with the
other Party ULRF or UofL. The restrictions imposed by this Section shall not
prohibit either Party from making any disclosure identifying the other Party
that is required by applicable law or the requirements of a national securities
exchange or another similar regulatory body.
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9.3 Notwithstanding the foregoing, either Party may state that LICENSEE is
licensed by ULRF under one or more of the patents or applications comprising the
Licensed Patents.
ARTICLE 10
INFRINGEMENT
------------
10.1 Infringement.
10.1.1 LICENSEE shall promptly notify ULRF of any suspected
infringement of any Licensed Patent by a third party and
furnish ULRF with any available evidence thereof.
10.1.2 ULRF shall have the right, but shall not be obligated, to
prosecute at its own expense all infringements of the Licensed
Patents, and, in furtherance of such right, LICENSEE hereby
agrees that ULRF may include LICENSEE as a party plaintiff in
any such suit, without expense to LICENSEE. ULRF shall notify
LICENSEE in writing in the event that ULRF decides to initiate
suit. The total cost of any such infringement action commenced
or defended solely by ULRF shall be borne by ULRF and from any
recovery or damages for past infringement derived therefrom,
ULRF shall be reimbursed its out-of-pocket costs and attorney
fees, then ULRF shall receive any sums of money that would
have been paid to ULRF if said infringement had not occurred,
then LICENSEE shall be reimbursed for any awards characterized
as lost profits to LICENSEE if said infringement had not
occurred, and then any remaining balance shall be retained by
ULRF. In the event that a non-cash cross license is awarded or
a non-cash settlement is reached, both Parties agree to
negotiate appropriate compensation in good faith.
10.1.3 If, four (4) months after having been notified of any alleged
infringement, ULRF is unsuccessful in persuading the alleged
infringer to desist and ULRF has not brought suit against the
alleged infringer, or if ULRF has notified LICENSEE at any
time prior thereto of its intention not to bring suit against
any alleged infringer, then, and in those events only,
LICENSEE shall have the right, but shall not be obligated, to
prosecute at its own expense any infringement of the Licensed
Patent. If LICENSEE chooses to prosecute such a suit, LICENSEE
shall notify ULRF in writing within forty-five (45) days after
the date ULRF notifies LICENSEE of ULRF's intention not to
bring suit. LICENSEE may, for such purposes, withhold up to
thirty percent (30%) of royalties otherwise payable to ULRF to
offset up to thirty percent (30%) of its infringement
litigation expenses. LICENSEE may use the name of ULRF as
party plaintiff; provided, however, that such right to bring
such an infringement action shall remain in effect only for so
long as the license granted herein remains in effect. No
settlement, consent judgment or other voluntary final
disposition of the suit may be entered into without the
consent of ULRF, which consent shall not be unreasonably
withheld. LICENSEE shall indemnify ULRF against any order for
costs that may be made against ULRF in such proceedings. Any
recovery of damages for past infringement delivered therefrom
shall first reimburse LICENSEE for any of its out-of-pocket
costs and attorney fees, then reimburse ULRF for the thirty
percent (30%) of royalties that LICENSEE withheld from ULRF,
then reimburse LICENSEE for its lost profits, then reimburse
ULRF for any sums of money that would have been paid to ULRF
if said infringement had not occurred, and then any balance
shall be equally divided between the Parties.
13
10.1.4 Both Parties shall use reasonable efforts and cooperation to
terminate infringement without litigation.
ARTICLE 11
CONFIDENTIALITY AND PUBLICATION
-------------------------------
11.1 Confidentiality. Each Party agrees to keep confidential any
Confidential Information disclosed by the other Party hereunder using methods at
least as stringent as such Party uses to protect its own confidential
information, and understands that this Section shall survive any termination of
this Agreement. "Confidential Information" means confidential or proprietary
information of a Party that shall be designated confidential at the time of
disclosure by the disclosing Party either orally or in writing. If designated
confidential orally, the disclosing Party shall within thirty (30) days of the
date of disclosure confirm in writing the confidential nature of such
information. In the case of LICENSEE, Confidential Information shall include
LICENSEE's Development Plan and Development Reports, Licensed Products and all
information concerning them. The receiving Party shall use reasonable efforts to
ensure said Confidential Information is kept confidential and shall promptly
return or destroy all originals and copies of Confidential Information at the
written request of the disclosing Party. Except as otherwise provided herein,
for a period of five (5) years following the date of such disclosure, the
receiving Party will not disclose the Confidential Information without the
consent of the disclosing Party and shall use such Confidential Information only
for the purposes of this Agreement. Not withstanding the foregoing and except as
may be authorized in advance in writing by the disclosing Party, the receiving
Party may transfer the disclosing Party's Confidential Information to those of
receiving Party's employees, students, officers, directors and agents as may be
reasonably necessary to carry out the performance of this Agreement. Each Party
agrees not to use any Confidential Information other than as provided hereunder.
The confidentiality and use obligations set forth above apply to all or any part
of the Confidential Information disclosed hereunder except to the extent that:
11.1.1 the receiving Party can show by written records that it
possessed the information prior to its receipt from the other
Party;
11.1.2 the information was already in the public domain or became so
through no fault of the receiving Party;
11.1.3 the information is subsequently disclosed to the receiving
Party by a third Party that has the right to disclose it free
of any obligations of confidentiality;
11.1.4 the information is required to be disclosed by law or court
order; or
14
11.1.5 five (5) years have elapsed from the expiration of this
Agreement.
Notwithstanding the foregoing, each Party shall have the right to disclose the
Confidential Information of the other Party to any actual or prospective
investors, acquirers, lenders and other potential financing sources who are
obligated to keep such information confidential.
ARTICLE 12
TERMINATION
-----------
12.1.1 Termination.
12.1.1.1 Either Party may terminate this Agreement immediately
upon notice to the other if the other Party is in
material breach of any provision of this Agreement,
including, but not limited to, failure to perform in
any material respect the due diligence obligations
specified in Article 3, failure to make any material
payments under any section of Articles 5 and 6,
failure to maintain levels of insurance specified
herein, and failures to maintain confidentiality and
representations and warranties and such breach is not
cured by such breaching Party within thirty (30) days
after written notice thereof by the non-breaching
Party.
12.1.1.2 Either Party may terminate this Agreement immediately
upon written notice to the other Party in the event
the other Party (i) files a petition under any
bankruptcy or insolvency act or has any such petition
filed against it which is not discharged within sixty
(60) days of the filing thereof; (ii) makes an
assignment for the benefit of its creditors or an
offer of settlement, extension, or composition to its
unsecured creditors generally; or (iii) appoints or
suffers an appointment of a trustee, conservator,
receiver, or similar fiduciary for substantially all
of the assets of such Party.
12.1.1.3 LICENSEE may terminate this Agreement for any reason
within sixty (60) days after written notice thereof
by LICENSEE.
12.2 Consequences of Termination. Upon termination of this Agreement for
any reason, nothing herein shall be construed to release either Party from any
obligation that matured prior to the effective date of such termination. ULRF
shall negotiate such license in good faith under reasonable terms and
conditions. Upon termination, LICENSEE shall remain obligated to provide, in the
form specified in Article 5 of this Agreement, an accounting for and pay
royalties earned up to the date of termination. Any such payments or reports due
to ULRF shall be sent to ULRF within thirty (30) days of termination. In the
event of such termination, ULRF shall have no obligation to refund any license
or royalty fees or other amounts paid by LICENSEE to ULRF under this Agreement
or any other agreement between the Parties. Additionally, in the event of
termination by ULRF for any reason provided herein or by LICENSEE pursuant to
Section 12.1.1.3, LICENSEE may for one (1) year following the date of
termination, sell inventoried Licensed Products, provided that LICENSEE shall
pay to ULRF the royalties thereon as required by Article 5 of this Agreement and
shall submit the related reports as required by Article 5 of this Agreement.
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12.3 Survival upon termination. The following provisions shall survive any
termination or expiration of this Agreement: Articles 1, 7, 8, 11, and 13 and
Sections 5.6, 5.7, 5.8, 5.9, 5.10, 12.2 and 12.3.
ARTICLE 13
MISCELLANEOUS PROVISIONS
------------------------
13.1 Notices. All notices required or permitted to be given under this
Agreement shall be effective when given in writing, with reference to this
Agreement and when (a) delivered personally; (b) sent by confirmed facsimile;
(c) five (5) days after having been sent by United States mail, registered or
certified, return receipt requested, postage prepaid; or (d) two (2) days after
deposit with a commercial overnight carrier, with written verification of
receipt. All communications shall be sent to the applicable Party's address set
forth below or to such other address as may be designated by written notice.
To ULRF: If by Regular Postal Service:
University of Louisville
Office of Technology Transfer
Attn.: Director
000 X. Xxxxxxxxx Xxxxxx
Xxxxxxxxxx, XX 00000
Phone (000) 000-0000
Fax (000) 000 0000
To LICENSEE:
Stem Cell Technologies, Inc.
0000 X. Xxxx Xxxxxx
Xxxxx, XX 00000
Attention: Xxxxxxxx Xxxxxx, President
13.2 Assignment. While this Agreement is freely assignable by ULRF, this
Agreement is personal to LICENSEE and may not be assigned or delegated accept as
further described below, in whole or in part, by LICENSEE without the prior
written consent of ULRF, which shall not be unreasonably withheld. A Change in
Control shall not be considered an assignment for purposes of this Section 13.2
unless such Change in Control causes LICENSEE or its Affiliates to engage in any
morally objectionable activities including: activities designed to defame,
embarrass, harm, abuse, threaten, slander or harass third parties; activities
prohibited by the laws of the United States and/or foreign territories in which
LICENSEE conducts business; activities designed to encourage unlawful behavior
by others, such as hate crimes, terrorism and child pornography; activities that
are tortuous, vulgar, obscene, invasive of the privacy of a third party,
racially, ethnically, or otherwise objectionable; activities designed to harm
minors in any way Any attempted assignment in violation of this Section 13.2
shall be void and of no effect. It is understood that upon execution of this
Agreement, LICENSEE shall be acquired by NeoStem, Inc. and all rights and
responsibilities provided for in this Agreement shall be binding upon and inure
to the benefit of NeoStem, Inc.
13.3 Entire Agreement; Amendments. This Agreement contains the entire
understanding of the Parties with respect to the matter contained herein. The
Parties may, from time to time during the continuance of this Agreement, modify,
vary or alter any of the provisions of this Agreement, but only by an instrument
duly executed by authorized officials of both Parties hereto and only if such
instrument specifically states that it is an amendment to this Agreement.
16
13.4 Invalidity. In the event that any provision of this Agreement shall be
determined by a court of competent jurisdiction to be invalid, illegal or
unenforceable, that provision will be curtailed, limited or deleted, but only to
the extent necessary to remove such invalidity, illegality or unenforceability,
and the remaining provisions shall not in any way be affected or impaired
thereby. In the event that such curtailment, limitation or deletion is not
allowed by relevant law or if such curtailment, limitation or deletion changes
any essential basis of the bargain set forth in this Agreement, the Parties
agree to substitute a new provision as similar in effect to the deleted
provision as may be allowed by relevant law.
13.5 Force Majeure. Neither Party hereto shall be deemed to be in default
of any provision of this Agreement, or for any failure in performance, resulting
from acts or events beyond the reasonable control of such Party, such as Acts of
God, acts of civil or military authority, including denial or cancellation of
any export or other necessary license, civil disturbance, war, strikes, fires,
power failures, natural catastrophes or other "force majeure" events.
13.6 Waiver. No waiver by either Party of any breach of this Agreement, no
matter how long continuing or how often repeated, shall be deemed a waiver of
any subsequent breach thereof, nor shall any delay or omission on the part of
either Party to exercise any right, power, or privilege hereunder be deemed a
waiver of such right, power or privilege. All waivers must be in writing and
signed by the Party to be charged with such waiver.
13.7 No Agency. The relationship between the Parties is that of independent
contractors. Neither Party shall be deemed to be an agent of the other in
connection with the exercise of any rights hereunder, and neither shall have any
right or authority to assume or create any obligation or responsibility on
behalf of the other.
13.8 Jurisdiction and Forum. The state and federal courts located in the
Commonwealth of Kentucky shall have exclusive jurisdiction over any claim or
dispute concerning or arising out of this Agreement and shall apply the laws of
the Commonwealth of Kentucky (excluding its body of law controlling conflicts of
law) in construing and interpreting this Agreement. The Parties hereby
irrevocably consent to the exclusive jurisdiction of such courts and irrevocably
waive any claim of inconvenient forum; provided that, notwithstanding the
foregoing, either Party shall have the right to seek injunctive relief and the
enforcement of judgments in any court of competent jurisdiction, no matter where
located.
13.9 Laws and Regulations of the United States and Export. This Agreement
shall be subject to all United States laws and regulations now or hereafter
applicable to the subject matter of this Agreement. Each Party shall comply with
all provisions of any applicable laws, regulations, rules and orders relating to
the license herein granted and to the testing, production, transportation,
export, packaging, labeling, sale or use of Licensed Products, or otherwise
applicable to such Party's activities hereunder. LICENSEE hereby gives written
assurance that it will comply with, and will make reasonable commercial efforts
to cause its sublicensees to comply with, all United States export control laws
and regulations.
13.10 Dispute Resolution. In the event the Parties cannot resolve a
dispute, which arises under this Agreement, the Parties agree to submit the
dispute to non-binding mediation. Either Party may request mediation by sending
a written notice to the other Party, and the mediation shall be held in a
mutually agreeable place in Louisville, Kentucky, at a mutually agreeable time,
within thirty (30) days of the date of request for mediation. The Parties shall
select a mediator who is acceptable to both of them, and if they cannot agree on
a mediator, then each shall select their own mediator, and the two mediators
shall serve in tandem to mediate the dispute. If as a result of the mediation
the Parties do not resolve their dispute, then either Party shall have the right
to pursue any other legal or equitable remedies it may have. Should dispute
resolution be unsuccessful, the Parties agree that no written or oral
representation made during the course of the settlement shall constitute a party
admission.
17
THEREFORE, the Parties have executed this Agreement in duplicate
originals by their duly authorized officers or representatives.
UNIVERSITY OF LOUISVILLE Stem Cell Technologies Inc.
RESEARCH FOUNDATION, INC.
/s/ Xxxxxx Xxxxxxxx-Xxxxxxxxx /s/ Xxxxxxxx Xxxxxx
Xxxxxx Xxxxxxxx-Xxxxxxxxx, EVPR Xxxxxxxx Xxxxxx, President
Date November 12, 2007 Date November 12, 2007
----------------- -----------------
Attachments:
Exhibit A: Licensed Patents
Exhibit B: Licensed Technology
Exhibit C: Material Transfer Agreement
Exhibit D: Development Plan
Exhibit E: Development Report
Exhibit F: ULRF Royalty Report
18
