COMMERCIAL LICENSE AND OPTION AGREEMENT
Exhibit
10.1
Agreement
08-0155
This
Agreement is made effective the
3rd day of January 2008 (“Effective Date”), by and between the Wisconsin Alumni
Research Foundation (hereinafter called “XXXX”), a nonprofit Wisconsin
corporation, and BioTime, Inc. (hereinafter called “Licensee”), a corporation
organized and existing under the laws of California.
WHEREAS,
XXXX owns or holds
certain intellectual property rights to the inventions described in the Licensed
Patents defined below;
WHEREAS,
XXXX has granted to
Geron Corporation (“Geron”) an exclusive license under the Licensed Patents in
certain fields covering Therapeutic Products and Diagnostic Products, as well
as
a non-exclusive license for Research Products (all defined below), which may
prohibit XXXX from granting Licensee any rights outside those granted in this
Agreement; and
WHEREAS,
Licensee desires to
obtain a license under the Licensed Patents and certain Licensed Materials
(defined below) to make, use and sell Products, and XXXX is willing to grant
to
Licensee such a license under the terms and conditions set forth
herein.
NOW,
THEREFORE, in
consideration of the mutual covenants and agreements set forth below, the
parties covenant and agree as follows:
Section
1. Definitions.
For
the purposes of this Agreement, the
Appendix A definitions shall apply.
Section
2. Grant.
A.
License.
(i)
XXXX hereby grants Licensee a world-wide, nonexclusive license under the
Licensed Patents to make, use and receive Licensed Materials for use in Internal
Research.
(ii)
XXXX hereby grants Licensee a world-wide, nonexclusive license under the
Licensed Patents and the Licensed Materials to make, use and sell Products
in
the Licensed Field.
B.
Limited
Sublicenses.
(i)
XXXX hereby grants Licensee the right to transfer, as applicable, Licensed
Materials and Derivative Materials to Collaborators, Development Partners,
Contract Service Providers, subsidiaries, and Affiliates and to receive and
use
Licensed Materials and Derivative Materials from its Collaborators, Development
Partners, Contract Service Providers, subsidiaries, and Affiliates, in each
case
only to conduct research to develop and commercialize Products on behalf of
or
cooperatively with Licensee. Licensee may grant only written sublicenses only
to
Collaborators, Development Partners, Contract Service Providers, subsidiaries
and Affiliates as follows:
(a)
Such a sublicense may be granted, in the case of a Collaborator, to enable
the
Collaborator to engage in a project of collaborative research with Licensee
on
Licensed Materials and Derivative Materials and/or the development of Products.
Such a sublicense may include a license to make or use the Licensed Materials,
Derivative Materials, or Products solely for the purpose of the project, but
not
to sell or transfer any of them to any party other than to
Licensee.
(b) Such
a sublicense may be granted, in the case of a Contract Service Provider, to
enable the Contract Service Provider to perform specific services in support
of
Licensee’s sale or distribution of Products (e.g. testing, contract
manufacturing, distribution), under a written contract with Licensee, at
Licensee’s expense, and pursuant to protocols or specifications developed or
approved by Licensee. Such a sublicense may include a license to make
or use the Licensed Materials and Derivative Materials solely for the purpose
of
providing such services, or to sell Products as Licensee’s agent or authorized
distributor, but not to sell or transfer any of them for any other
purpose.
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(c) Such
a sublicense may be granted, in the case of a Development Partner, to enable
the
Development Partner to collaboratively research, develop, manufacture, market,
or perform other activities necessary for the commercialization of Products
with
Licensee, pursuant to a collaborative agreement. Such a sublicense may include
a
license to make or use the Licensed Materials, Derivative Materials, or
Products, and to make, have made, use, sell, offer for sale or import
Products.
(ii)
Unless otherwise agreed to in writing by XXXX, any sublicense agreement entered
into under this Section 2B shall terminate upon the termination of this
Agreement, and each sublicense shall so state. Licensee shall require that
its
sublicensee(s) comply with all relevant requirements of this Agreement
(including without limitation restrictions on the right to use and transfer
Licensed Materials) and Licensee shall have the same responsibility for the
activities of any sublicensee as if the activities were directly those of
Licensee. Licensee shall provide to XXXX, in confidence, a summary of any
sublicense agreement with a Collaborator, Development Partner or a Contract
Service Provider, under this Section 2B within thirty (30) days after execution
of such sublicense agreement.
C.
Restrictions and
Limitations.
Licensee
acknowledges and agrees that the licenses granted under this Agreement do not
provide any right or license to: (i) grant any sublicenses
under this Agreement to any third parties other than as permitted by Section
2B,
(ii) use the inventions of the Licensed Patents, Licensed Materials or any
Derivative Materials in the manufacture or distribution of Products in fields
outside of the Licensed Field for any commercial purpose or in human clinical
trials, or (iii) make, have made, use, sell, offer for sale, import or otherwise
transfer any Licensed Materials to third parties, except to Affiliates of
Licensee, without the express written consent of XXXX.
D.
License to
XXXX.
Licensee
hereby grants to XXXX a nonexclusive, royalty-free, irrevocable, paid-up
license, with the right to grant sublicenses to the University of Wisconsin,
the
WiCell Research Institute and the Xxxxxxxxx Institute for Research, to practice
and use Developments for Non-Commercial Research Purposes, if XXXX does not
otherwise have rights to or in such Developments.
E.
Option to a
License.
(i)
XXXX hereby grants to Licensee an option, for the period of time during which
this Agreement is in effect, to negotiate a commercial license under the
Licensed Patents to make, use and sell Therapeutic Products in the Option Field
and Option Territory. Said option shall terminate simultaneously with the
termination of this Agreement.
(ii)
In order to exercise the option granted hereunder, Licensee must, prior to
the
termination of the option, both notify XXXX in writing that it is exercising
its
rights and provide to XXXX an acceptable development plan similar in scope
to
that outlined on Appendix E.
(iii)
Upon XXXX’x receipt of notice and a development plan reasonably acceptable to
XXXX, XXXX and Licensee shall enter into good faith negotiations regarding
the
terms of a license. XXXX and Licensee shall have ninety (90) days
from the date that XXXX receives notice pursuant to Section 2E(ii) to negotiate
such a license. If XXXX and Licensee fail to enter a license within
such time period, the option granted in this Section 2E shall terminate, unless
extended by a written agreement signed by both parties. The terms of
the license shall include, without limitation, a license fee, royalties, patent
reimbursement fees and other commercially reasonable terms as negotiated by
the
parties, and shall be substantially the same in format as those generally used
in XXXX’x agreements with companies concerning similar
technology.
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Section
3. Reporting.
A.
Licensee shall diligently develop, manufacture, market and sell Products in
the
Licensed Field throughout the term of this Agreement. Such activities shall
include, without limitation, those activities listed in the Development Plan
attached hereto as Appendix E. Licensee agrees that said Development Plan is
reasonable and that it shall take all reasonable steps to meet the development
program as set forth therein.
B.
Beginning in January 2008 and until the date of first commercial sale, Licensee
shall provide XXXX with a written Development Report similar in scope to the
form attached as Appendix D, summarizing Licensee’s development activities since
the last Development Report and any necessary adjustments to the Development
Plan. Licensee agrees to provide each Development Report to XXXX on
or before thirty (30) days from the end of each semi-annual period ending June
30 and December 31 for which a report is due, and shall set forth in each
Development Report sufficient detail to enable XXXX to ascertain Licensee’s
progress toward the requirements of the Development Plan. XXXX reserves the
right to audit Licensee’s records relating to the development activities
required hereunder. Such record keeping and audit procedures shall be
subject to the procedures and restrictions set forth in Section 6 for auditing
the financial records of Licensee.
C.
Licensee acknowledges that any failure by Licensee to reasonably implement
the
Development Plan, or to make timely submission to XXXX of any Development
Report, or the providing of any false information to XXXX regarding Licensee’s
development activities hereunder, shall be a material breach of the terms of
this Agreement, subject to the right to cure under Section 7.
Section
4. Consideration.
A.
License and
Maintenance Fees.
Licensee
agrees to pay to XXXX a
license fee of $225,000 due and payable as follows: the first
installment of $10,000 shall be due within thirty (30) days of the Effective
Date of this Agreement, and the remaining $215,000 shall be due on the earlier
of: (i) thirty (30) days after Licensee raises $5,000,000 or more of new equity
financing or (ii) the first anniversary of the Effective Date of this
Agreement. A maintenance fee of $25,000 shall be due annually on each
anniversary of the Effective Date of this Agreement beginning on the first
anniversary and continuing thereafter for the term of this
Agreement.
B.
Royalty.
(i)
In addition to the Section 4A license and maintenance fees, Licensee agrees
to
pay to XXXX as “earned royalties” a royalty calculated as a percentage of the
Net Selling Price of Research Products in accordance with the terms and
conditions of this Agreement. The royalty is deemed earned as of the
earlier of the date the Research Product is actually sold or otherwise performed
for consideration, the date an invoice is sent by Licensee, or the date a
Research Product is transferred to a third party for any promotional reasons.
The royalty shall remain fixed while this Agreement is in effect at a rate
of
four percent (4%) of the Net Selling Price of Research Products.
(ii)
Licensee also agrees to pay to XXXX as “earned royalties” a royalty calculated
as a percentage of the Net Selling Price of Related Products in accordance
with
the terms and conditions of this Agreement. The royalty is deemed
earned as of the earlier of the date the Related Product is actually sold or
otherwise performed for consideration, the date an invoice is sent by Licensee,
or the date a Related Product is transferred to a third party for any
promotional reasons. The royalty shall remain fixed while this
Agreement is in effect at a rate of two percent (2%) of the Net Selling Price
of
Related Products.
(iii)
If Licensee grants any sublicenses
under Section 2B of this Agreement to a sublicensee that markets, distributes,
or sells Products, XXXX shall receive a royalty in amount of four percent (4%)
of the Net Selling Price of Research Products, and two percent (2%) of the
Net
Selling Price of Related Products sold by the sublicensee under such
sublicense.
(iv)
If Licensee or any permitted sublicensee is required to make payments to an
unaffiliated third party for a license or similar right to such third party’s
patents, in the absence of which right or license Licensee or any permitted
sublicensee could not legally make, use or sell Research Products, or Related
Products, then the royalty payable under this Section 4B shall be reduced by
one-quarter of one percent (0.25%) for each additional one-half percent (0.5%)
of royalties payable to such third parties on that Product; provided, however, that the
adjusted royalty rate to XXXX will be no less than fifty percent (50%) of the
applicable royalty rate payable to XXXX under this Agreement for such Research
Products or Related Products.
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(v)
In the event that the sale, lease, or other transfer by Licensee of Research
Products or Related Products under this Agreement also requires payment to
XXXX
of royalties under any other agreement between XXXX and Licensee, the cumulative
earned royalties owed to XXXX for that Product under all such agreements shall
not exceed the single highest royalty as set forth in those agreements. Licensee
shall pay to XXXX royalties under all such agreements individually and on a
pro rata
basis. (For example, if Licensee owes to XXXX a one and one-half
percent (1.5%) earned royalty under this Agreement and a three percent (3%)
earned royalty under a separate agreement, the cumulative royalties owed to
XXXX
shall be three percent (3%), but shall be paid proportionately under each
agreement in payments of one percent (1%) under this Agreement and two percent
(2%) on the other.)
C.
Patent Fees and
Costs.
Licensee
also agrees to pay to XXXX
$25,000 toward reimbursement of the costs associated with preparing, filing
and
maintaining the Licensed Patents, which shall be due and payable as
follows: the first installment of $5,000 shall be due within thirty
(30) days of the Effective Date of this Agreement, and the remaining $20,000
shall be due on the earlier of (i) thirty (30) days after Licensee raises
$5,000,000 or more of new equity financing or (ii) the first anniversary of
the
Effective Date of this Agreement.
D.
Accounting;
Payments.
(i)
Amounts owing to XXXX under Section 4B of this Agreement shall be paid on a
quarterly basis, with such amounts due and received by XXXX on or before the
forty-fifth (45th)
day
following the end of the calendar quarter ending on March 31, June 30, September
30 or December 31 in which such amounts were earned. The balance of
any amounts which remain unpaid more than thirty (30) days after they are due
to
XXXX shall accrue interest until paid at the rate of the lesser of one percent
(1%) per month or the maximum amount allowed under applicable
law. However, in no event shall this interest provision be construed
as a grant of permission for any payment delays.
(ii)
Except as otherwise directed, all amounts owing to XXXX under this Agreement
shall be paid in U.S. dollars. All royalties owing with respect to Net Selling
Prices stated in currencies other than U.S. dollars shall be converted at the
rate shown in the Federal Reserve Noon Valuation - Value of Foreign Currencies
on the day preceding the payment. XXXX is exempt from paying income taxes under
U.S. law. Therefore, all payments due under this Agreement shall be made without
deduction for taxes, assessments, or other charges of any kind which may be
imposed on XXXX by any government outside of the United States or any political
subdivision of such government with respect to any amounts payable to XXXX
pursuant to this Agreement. All such taxes, assessments, or other charges shall
be assumed by Licensee.
(iii)
A full accounting showing how any amounts owing to XXXX under Section 4B have
been calculated shall be submitted to XXXX on the date of each such payment.
Such accounting shall be on a per-country and Product line, model or tradename
basis and shall be summarized on the form shown in Appendix C of this Agreement.
In the event no payment is owed to XXXX, a statement setting forth that fact
shall be supplied to XXXX.
Section
5. Certain
Warranties.
X.
XXXX warrants that it has the right to grant the licenses granted to Licensee
in
this Agreement. Nothing in this Agreement shall, however, be construed as:
(i) a
warranty or representation by XXXX or Licensee as to the validity or scope
of
any of the Licensed Patents; (ii) a warranty or representation that anything
made, used or transferred under the license granted in this Agreement will
or
will not infringe patents of third parties; (iii) an obligation to furnish
any
assistance, or know-how not provided in the Licensed Patents or any materials
or
services other than those specified in this Agreement; or (iv) an obligation
to
file any patent application or secure or maintain any patent
right.
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X.
XXXX AND ITS LICENSORS MAKE NO REPRESENTATIONS, EXTEND NO WARRANTIES OF ANY
KIND, EITHER EXPRESS OR IMPLIED, AND ASSUME NO RESPONSIBILITIES WHATSOEVER
WITH
RESPECT TO THE MERCHANTIBILITY OR FITNESS FOR ANY PARTICULAR PURPOSE OR THE
NON-INFRINGEMENT OR USE OF ANY SERVICE UNDER THIS AGREEMENT.
C.
TO THE MAXIMUM EXTENT PERMITTED BY LAW, IN NO EVENT SHALL WARF, WICELL, OR
THEIR
RESPECTIVE TRUSTEES, DIRECTORS, OFFICERS AND EMPLOYEES (INCLUDING WITHOUT
LIMITATION ANY INVENTORS OF THE LICENSED PATENTS) BE LIABLE FOR ANY INDIRECT,
INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND, INCLUDING ECONOMIC DAMAGES
OR
INJURY TO PROPERTY AND LOST PROFITS, REGARDLESS OF WHETHER SUCH PARTY HAS BEEN
ADVISED OF THE POSSIBILITY OF SUCH DAMAGES AND NOTWITHSTANDING THE FAILURE
OF
THE ESSENTIAL PURPOSE OF ANY LIMITED REMEDY.
Section
6.
Recordkeeping.
A.
Licensee shall keep books and records sufficient to verify the accuracy and
completeness of Licensee’s accounting referred to above, including without
limitation inventory, purchase and invoice records relating to any Products
sold
under this Agreement. In addition, Licensee shall keep books and
records sufficient to verify the accuracy and completeness of Licensee’s
Development Reports. Such documentation may include, but is not
limited to, invoices for studies, laboratory notebooks, internal job cost
records, and filings made to the Internal Revenue Department to obtain tax
credit, if available, for research and development. All such books
and records shall be preserved for a period not less than six (6) years after
they are created during and after the term of this Agreement.
B.
Licensee shall take all steps reasonably necessary so that XXXX may, within
thirty (30) days of its request, review Licensee’s books and records to allow
XXXX to verify the accuracy of Licensee’s Development Reports and the payments
made to XXXX. Such review will be performed no more than annual and
by an attorney or registered CPA and scientific expert designated by XXXX and
mutually agreeable to Licensee, at XXXX’x expense upon reasonable notice and
during regular business hours.
C.
If a royalty payment deficiency is determined, Licensee shall pay the royalty
deficiency outstanding within thirty (30) days of receiving written notice
thereof, plus interest on outstanding amounts as described in Section 4D(i).
If
a royalty payment deficiency for a calendar year exceeds the lesser of five
percent (5%) of the royalties paid for that year or $50,000, then Licensee
shall
be responsible for paying XXXX’x out-of-pocket expenses incurred with respect to
such review.
Section
7. Term and
Termination.
A.
The term of this license shall begin on the Effective Date and continue until
the expiration of the last to expire Licensed Patents, unless otherwise earlier
terminated as provided herein.
B.
Licensee may terminate this Agreement at any time by giving at least ninety
(90)
days written and unambiguous notice of such termination to XXXX.
C.
If Licensee at any time defaults in the timely payment of any monies due to
XXXX, or the timely submission to XXXX of any report, or commits any breach
of
any other covenant herein contained, and Licensee fails to remedy any such
breach or default within ninety (90) days after written notice thereof by XXXX,
or if Licensee commits any act of bankruptcy, becomes insolvent, is unable
to
pay its debts as they become due, files a petition under any bankruptcy or
insolvency act, or has any such petition filed against it which is not dismissed
within sixty (60) days, or offers any component of the Licensed Patents or
Licensed Materials to its creditors, XXXX may, at its option, terminate this
Agreement by giving notice of termination to Licensee.
D.
Upon termination of this Agreement, the licenses granted herein shall
immediately terminate. In the event of termination under Section 7B or 7C above,
Licensee shall have ninety (90) days to cease all activities involving the
use
of the Licensed Materials and any Derivative Materials for any purpose, and
shall destroy all Licensed Materials and Derivative Materials in its possession.
Licensee shall remain obligated to pay any maintenance fees prorated as of
the
date of termination by the number of days elapsed in the applicable calendar
year, as well as any yet unpaid License Fees described in Section 4A and Patent
Fees and Costs described in Section 4C.
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E.
The confidentiality obligations of Section 13 below shall survive any
termination of this Agreement. Licensee acknowledges and agrees that damages
may
not be an adequate remedy in the event of a breach of this Agreement by
Licensee. Licensee therefore agrees that XXXX and/or XXXX shall be entitled
to
seek immediate and permanent injunctive relief from a court of competent
jurisdiction in addition to any other rights or remedies otherwise available
to
XXXX and/or XXXX.
Section
8. Assignability; Change
of
Control.
Licensee
may not assign or transfer
this Agreement, nor any of the rights granted herein, except pursuant to a
Change of Control Event, without the prior written consent of
XXXX. Licensee shall notify XXXX in writing promptly in the event of
any Change of Control Event and, with respect to a transfer to any non-Affiliate
pay to XXXX a fee of $300,000 to allow the transfer of the license granted
herein to that non-Affiliate to whom control has been transferred.
Section
9. Contest of
Validity.
In
the event Licensee contests the
validity of any Licensed Patent, Licensee shall continue to pay all amounts
owed
under this Agreement with respect to that patent as if such contest were not
underway until the patent is adjudicated invalid or unenforceable by a court
of
last resort.
Section
10. Enforcement.
XXXX
intends to protect the Licensed
Patents against infringers, or otherwise act to eliminate infringement when,
in
XXXX'x sole judgment and discretion, such action may be reasonably necessary,
proper and justified. In the event that Licensee believes there is
infringement of any Licensed Patents, Licensee shall provide XXXX with
notification and reasonable evidence of such infringement. If XXXX
takes action to remedy the infringement, Licensee agrees to provide reasonable
assistance to XXXX as requested by XXXX and at XXXX’x expense.
Section
11. Indemnification
and
Insurance.
A.
Licensee shall, at all times during the term of this Agreement and thereafter,
indemnify, defend and hold WARF, WiCell, the University of Wisconsin (the
“University”), and their respective trustees, directors, officers, shareholders
and employees (including without limitation any inventors of the Licensed
Patents) (each, an “Indemnitee”) harmless against all liabilities, demands,
damages, settlements, suits, claims, proceedings, costs and expenses, including
legal expenses and reasonable attorneys fees, arising out of or relating to
the
death of or injury to any person or persons or any damage to property, due
to
the use of the Licensed Materials or any Derivative Materials or Developments
or
the production, manufacture, sale, use, lease, consumption or advertisement
of
Products arising from any right or obligation of Licensee
hereunder. XXXX at all times reserves the right to select and retain
counsel of its own to defend XXXX’x interests in any such
proceeding.
B.
Licensee warrants that it now maintains and will continue to maintain liability
insurance coverage reasonably appropriate to the risk involved in using and
marketing the Licensed Materials, any Derivative Materials, and Products under
this Agreement, and that such insurance coverage is sufficient to cover XXXX
and
the inventors of the Licensed Patents and Licensed Materials as additional
insureds. Within ninety (90) days after the execution of this Agreement and
thereafter annually between January 1 and January 31 of each year, Licensee
will
present evidence to XXXX that such coverage is being maintained. In addition,
Licensee shall provide XXXX with notice of any change in or cancellation of
the
insurance coverage.
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Section
12. Use of
Names.
Neither
party shall use the other’s
name, the name of any inventor of the Licensed Patents, or the name of XXXX,
WiCell or the University in any other form of publicity without the prior
written approval of the entity or person whose name is being used, except where
a disclosure is required by any applicable law or regulation or the rules of
any
securities exchange or electronic securities trading
system. Notwithstanding the foregoing, both parties shall have the
right to disclose the fact that XXXX has entered into this Agreement with
Licensee.
Section
13. Confidentiality.
Both
parties agree to keep any
information identified as confidential by the disclosing party, confidential
using methods at least as stringent as each party uses to protect its own
confidential information. Confidential information shall include,
without limitation, any information provided to XXXX under Section 3 and Section
4B or 4D, until such information is publicly disclosed by
Licensee. The confidentiality and use obligations set forth above
apply to all or any part of information disclosed hereunder except to the extent
that:
(i)
Licensee or XXXX can show by written record that they
possessed the information prior to its receipt from the other
party;
(ii)
the information was already available to the public or became so through no
fault of Licensee or XXXX;
(iii)
the information is subsequently disclosed to Licensee or XXXX by a third party
that has the right to disclose it free of any obligations of confidentiality;
or
(iv)
five (5) years have elapsed from the expiration of this Agreement.
Licensee
acknowledges and agrees that nothing contained in this Section 13 shall be
construed to limit or preclude XXXX from negotiating or entering into any
agreements with third parties under terms and conditions similar to that set
forth in this Agreement.
Section
14. United States Government
Interests.
It
is understood that if the United
States Government (through any of its agencies or otherwise) has funded
research, during the course of or under which any of the inventions of the
Licensed Patents were conceived or made, the United States Government is
entitled, as a right, under the provisions of 35 U.S.C. § 200-212 and applicable
regulations of Chapter 37 of the Code of Federal Regulations, to a nonexclusive,
nontransferable, irrevocable, paid-up license to practice or have practiced
the
inventions of the Licensed Patents for governmental purposes. Any
license granted to Licensee in this Agreement shall be subject to such
right.
Section
15. Miscellaneous.
A.
This Agreement shall be governed by and construed in all respects in accordance
with the laws of the State of Wisconsin, without reference to its conflicts
of
laws principles.
B.
The parties hereto are independent contractors
and not joint venturers or partners.
C.
If the enforcement of any provisions of this
Agreement are or shall come into conflict with the laws or regulations of any
jurisdiction or any governmental entity having jurisdiction over the parties
or
this Agreement, those provisions shall be deemed automatically deleted, if
such
deletion is allowed by relevant law, and the remaining terms and conditions
of
this Agreement shall remain in full force and effect. If such a deletion is
not
so allowed or if such a deletion leaves terms thereby made clearly illogical
or
inappropriate in effect, the parties agree to substitute new terms as similar
in
effect to the present terms of this Agreement as may be allowed under the
applicable laws and regulations.
X.
XXXX and Licensee have each been represented by counsel who participated in
the
preparation of this Agreement. This Agreement reflects a negotiated compromise
between the parties. Neither party shall be considered to be the drafter of
this
Agreement or any of its provisions for the purpose of any statute, case law
or
rule of interpretation or construction that would or might cause any provision
to be construed against the drafter of this Agreement. The Section headings
contained in this Agreement are for reference purposes only and shall not in
any
way affect the meaning or interpretation of this Agreement.
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E.
This Agreement is not intended to be for the benefit of and shall not be
enforceable by any third party. Nothing in this Agreement, express or implied,
is intended to or shall confer on any third party any rights (including
third-party beneficiary rights), remedies, obligations or liabilities under
or
by reason of this Agreement. This Agreement shall not provide third parties
with
any remedy, claim, reimbursement, cause of action or other right in excess
of
those existing without reference to the terms of this Agreement. No third party
shall have any right, independent of any right that exists irrespective of
this
Agreement, to bring any suit at law or equity for any matter governed by or
subject to the provisions of this Agreement.
Section
16. Notices.
Any
notice required to be given
pursuant to the provisions of this Agreement shall be in writing and shall
be
deemed to have been given at the earlier of the time when actually received
as a
consequence of any effective method of delivery, including but not limited
to
hand delivery, transmission by telecopier, or delivery by a professional courier
service or the time when sent by certified or registered mail addressed to
the
party for whom intended at the address below or at such changed address as
the
party shall have specified by written notice, provided that any notice of change
of address shall be effective only upon actual receipt.
(a)
WARF Research Institute,
Inc.
Attn: Director
of
Licensing
000
Xxxxxx Xxxxxx
Xxxxxxx,
Xxxxxxxxx 00000
(b)
BioTime, Inc.
0000
Xxxxxx Xxxxxx
Xxxxxxxxxx,
Xxxxxxxxxx 00000
Section
17. Integration.
This
Agreement constitutes the full
understanding between the parties with reference to the subject matter hereof,
and no statements or agreements by or between the parties, whether orally or
in
writing, except as provided for elsewhere in this Section 17, made prior to
or
at the signing hereof, shall vary or modify the written terms of this
Agreement. Neither party shall claim any amendment, modification, or
release from any provisions of this Agreement by mutual agreement,
acknowledgment, or otherwise, unless such mutual agreement is in writing, signed
by the other party, and specifically states that it is an amendment to this
Agreement.
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Section
18. Authority.
The
persons signing on behalf of XXXX
and Licensee hereby warrant and represent that they have authority to execute
this Agreement on behalf of the party for whom they have signed.
IN
WITNESS WHEREOF, the parties hereto
have duly executed this Agreement on the dates indicated below.
WISCONSIN
ALUMNI RESEARCH
FOUNDATION
By:
|
s/Xxxxx
X. Xxxxxxxxxxxx
|
Date:
December 31, 2007
|
|
Xxxxx
X. Xxxxxxxxxxxx, Director of Licensing
|
BIOTIME,
INC.
By:
|
s/Xxxxxxx
X. Xxxx
|
Date:
:December 14, 2007
|
|
Chief
Executive Officer
|
|||
(insert
name) Xxxxxxx Xxxx
|
XXXX
Ref.: Thomson – P96014US
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APPENDIX
A
A.
“Affiliate” and “Affiliates” shall refer to and mean any entity controlled by or
under common control of Licensee. As used herein, “control” shall
refer to and mean ownership of greater than fifty percent (>50%) or more of
the outstanding voting equity of an entity.
B.
“Change of Control Event” shall mean (i) the sale or disposition of all or
substantially all the assets of the Company or its direct or indirect parent
corporation; (ii) the
reorganization, merger, consolidation, or similar transaction involving the
Company or its direct or indirect parent corporation which results in the
voting securities of such entity outstanding immediately prior to that
transaction ceasing to represent at least 50% of the combined voting power
of
the surviving entity immediately after such transaction; (iii) the acquisition
in one or more related transactions by any “person”, as that term is used in
Sections 13(d) and 14(d) of the Securities Exchange Act of 1934, as amended
(the
“Exchange Act”), together with any of such person's “affiliates” or
“associates”, as such terms are used in the Exchange Act, of 40% or more of the
outstanding shares of the voting capital stock of the Company or its direct
or
indirect parent corporation (excluding any employee benefit plan or related
trust sponsored or maintained by that entity); or (iv) any event or series
of
related events in which the individuals who are the directors of the Company
or
its direct or indirect parent corporation as of the effective date of this
Agreement (“Incumbent Directors”) cease for any reason to constitute at least
fifty percent (50%) of the board of directors of that entity; provided, however,
that if any
new director is approved by a vote of at least fifty percent (50%) of the
Incumbent Directors or by a nominating committee the majority of whom are
Incumbent Directors, such new director shall be considered an Incumbent
Director.
C.
“Collaborator” shall mean a person or organization with which Licensee enters
into a written agreement for a specific project or projects to be directed
by
Licensee involving research on and/or development of Products.
D.
“Contract Service Provider” shall mean a third party person or organization with
which Licensee enters into a written contract for the provision of specific
services (e.g., testing, contract manufacturing, distribution, etc. to Licensee)
in support of Licensee’s sale or distribution of Products.
E.
“Derivative Materials” shall refer to and mean any compositions or materials
derived from the use of the Licensed Materials, or produced by the use of the
Licensed Materials, or which incorporate wholly or partially the Licensed
Materials, including without limitation, fully or partially differentiated
cells
or cell lines derived from the Licensed Materials.
F.
“Development Partner” shall mean a person or organization with which Licensee
enters into a specific written collaborative agreement for research and
development, manufacturing, marketing, or other activities necessary for the
commercialization of Products.
G.
“Development” and “Developments” shall mean Derivative Materials, and any
inventions, discoveries or developments, patentable or not, that are conceived,
reduced to practice, discovered, tested or developed through the use of the
inventions of the Licensed Patents, Licensed Materials or Derivative Materials,
and any compositions, products or other materials in which the Licensed
Materials or Derivative Materials were used in any way in their discovery or
testing.
H.
“Development Report” shall mean the written report provided under Section 3
describing each Development to be patented or commercialized by
Licensee.
I.
“Diagnostic Products” shall refer to and mean products or services that
(i) are used in the diagnosis, prognosis, screening or detection of disease
in
humans, and (ii) which employ, or are in any way produced or manufactured by,
or
discovered, identified, developed or otherwise arise out of any research
involving, the practice or use of the inventions of the Licensed Patents, or
that would otherwise constitute infringement of any claims of the Licensed
Patents.
J.
“Internal Research” shall refer to and mean research conducted
internally by Licensee at Licensee’s facilities.
Page
10 of 29
K.
“Licensed Field” shall be limited to the field of Research Products, sold solely for an end user’s internal
research purposes, and Related Products.
L.
“Licensed Materials” means primate (including human) embryonic stem cells
covered by the Licensed Patents and which meet the following
conditions:
(i)
For embryonic stem cells created prior to April 26, 2005, the embryonic stem
cell must be either: (1) listed on the NIH Human Embryonic Stem Cell Registry
at
xxxx://xxxx.xxx.xxx; or (2) derived from excess embryos created for the purpose
of in vitro fertilization with appropriate consent of the donor couple and
not
for the purpose of creating embryonic stem cells; or (3) derived from embryos
created specifically for research purposes either by in vitro fertilization
or by somatic cell nuclear transfer, for which the following additional
conditions apply: (a) the embryo may not have been maintained in vitro for
more than 14 days; (b) the gamete donor(s) and somatic cell donor (if any)
made
the donation without payment beyond reimbursement for reasonable expenses
associated with donation; (c) in the case of egg donation, the donor was fully
informed of the risks to herself; (d) the gamete donor(s) and somatic cell
donor
(if any) were fully informed of the purposes to which their donated
materials would be put; (e) the research could not be done equally well
using surplus IVF embryos originally created for reproductive purposes;
(f) the research protocol, including gamete collection, somatic cell
collection, embryo management and stem cell derivation is approved by an
appropriate Institutional Review Board; and (g) protections are in place
to prevent misappropriation of embryos created specifically for
research.
(ii)
For embryonic stem cells created from embryos created after April 26, 2005,
the
embryonic stem cells must be derived from embryos and under conditions in
compliance with the “Guidelines for Human Embryonic Stem Cell Research”
established by the National Research Council Institute of Medicine of the
National Academies (the “NAS Guidelines”).
(iii)
For embryonic stem cells created after April 26, 2005 from embryos generated
prior to April 26, 2005, and which do not meet the NAS Guidelines, the embryonic
stem cells must meet one of the conditions set forth in paragraph (i) above
and
be created using protocols substantially in compliance with the requirements
of
the NAS Guidelines.
M.
“Licensed Patents” shall refer to and mean those patents and patent applications
listed on Appendix B attached hereto, all foreign equivalents and any subsequent
patent application owned by or licensed to XXXX, but only to the extent it
claims priority to and is an invention claimed in a patent application or patent
listed on Appendix B.
N.
“Non-Commercial Research Purposes” shall mean the use for internal academic
research purposes or other internal not-for-profit or scholarly purposes not
involving the use of the technology: (1) to perform services for a fee; or
(2)
for the production or manufacture of products for sale to third parties; or
(3)
to conduct research wherein the sponsor receives a right, whether actual or
contingent, to use the results of the research for purposes other than
non-commercial research purposes.
O.
“Option Field” shall be limited to the field of Therapeutic Products excluding
Therapeutic Products that use neural cells, cardiomyocytes, or pancreatic islet
cells, or their precursors, developed from and/or incorporating the Licensed
Materials or derivatives of the Licensed Materials.
P.
“Option Territory” shall be worldwide.
Q.
“Products” shall refer to and mean any Research Products and Related
Products.
R.
“Related Products” shall refer to
and mean products that are
discovered or developed by Licensee through its internal research, using the Licensed Patents,
Licensed Materials, Derivative
Materials and/or Wisconsin Materials. Related Products
specifically excludes Research Products, Diagnostic Products,
Therapeutic Products,
Wisconsin Materials and Licensed Materials.
Page
11 of 29
S.
“Research Products” shall refer to and mean products or services that are (i)
used as research tools, including in drug discovery and development, and (ii)
which employ, or are in any way produced or manufactured by, or discovered,
identified, developed or otherwise arise out of any research involving, the
practice or use of the inventions of the Licensed Patents, or that would
otherwise constitute infringement of any claims of the Licensed
Patents. For clarity,
Research Products may consist of or incorporate Licensed Materials and/or
Wisconsin
Materials.
T.
“Net Selling Price” shall
mean the invoice price to the end user of Products (regardless of uncollectible
accounts) less any shipping costs, allowances because of returned Products,
or
sales taxes. The “Net Selling Price” for a Product that is
transferred to a third party for promotional purposes without charge or at
a
discount shall be the average invoice price to the end user of that type of
Product during the applicable calendar quarter. Non-monetary
consideration may not be accepted
by
Licensee for any Product without the prior written consent of XXXX, such consent
not to be unreasonably withheld if the parties agree on the value of such
consideration.
U.
“Therapeutic Products” shall refer to and mean products or services that (i) are
used in the treatment of disease in humans, and (ii) which employ, or are in
any
way produced or manufactured by, or discovered, identified, developed or
otherwise arise out of any research involving, the practice or use of the
inventions of the Licensed Patents, or that would otherwise constitute
infringement of any claims of the Licensed Patents.
Page
12 of 00
XXXXXXXX
X
LICENSED
PATENTS
REFERENCE
NUMBER
|
COUNTRY
|
PATENT
NUMBER
|
ISSUE
DATE
|
APPLICATION
SERIAL
NUMBER
|
PRIMATE
EMBRYONIC STEM CELLS
(XXXXXXX Xxxxx A)
P02115US
|
XXXXXX
XXXXXX
|
0000000
|
4/18/06
|
09/982637
|
P05205US
|
XXXXXX
XXXXXX
|
|
00/000000
|
|
X00000XX
|
XXXXXX
XXXXXX
|
11/036245
|
||
P06228EP
|
EUROPE
|
05024871.5
|
||
P96014US
|
XXXXXX
XXXXXX
|
0000000
|
12/1/98
|
08/591246
|
P98222US
|
XXXXXX
XXXXXX
|
0000000
|
3/13/01
|
09/106390
|
SERUM
FREE CULTIVATION OF
PRIMATE EMBRYONIC STEM CELLS (XXXXXXX Xxxxx A, XXXX
Xxxxxx)
P03122US
|
XXXXXX
XXXXXX
|
0000000
|
5/15/07
|
10/430497
|
P06075US
|
UNITED
STATES
|
|
11/257704
|
|
P07322AU
|
AUSTRALIA
|
|
|
2007200575
|
P99275US
|
XXXXXX
XXXXXX
|
0000000
|
2/28/06
|
09/522030
|
P99275AU
|
AUSTRALIA
|
2001241973
|
2/22/07
|
2001241973
|
P99275BR
|
BRAZIL
|
PI0108507-7
|
||
P99275CA
|
CANADA
|
2402299
|
||
P99275CN
|
CHINA
|
01806235.0
|
||
P99275EP
|
EUROPE
|
|
01913296.8
|
Page
13 of 29
P99275HK
|
HONG
KONG
|
03106031.5
|
||
P99275IL
|
ISRAEL
|
151270
|
||
P99275IN
|
INDIA
|
198604
|
3/10/06
|
2002/01134
|
P99275IS
|
ICELAND
|
|
6515/2002
|
|
P99275JP
|
JAPAN
|
2001-565854
|
||
P99275KR
|
KOREA
|
2002-7011681
|
||
P99275MX
|
MEXICO
|
2002/008698
|
||
P99275NO
|
NORWAY
|
20024200
|
||
P99275NZ
|
NEW
ZEALAND
|
520701
|
7/4/04
|
520701
|
P99275SG
|
SINGAPORE
|
9095
|
7/29/05
|
200204677-9
|
P99275WO
|
W.I.P.O.
|
|
ENDOTHELIAL
CELLS DERIVED
FROM PRIMATE EMBRYONIC STEM CELLS (XXXXXXX
Xxx S, XXXXX
Xxxxxx, XXXXXXXX Xxxxxx)
P02004US
|
XXXXXX
XXXXXX
|
0000000
|
2/13/07
|
10/287334
|
P02004AU
|
AUSTRALIA
|
2002356896
|
||
P02004CA
|
CANADA
|
2465173
|
||
P02004CN
|
CHINA
|
02821970.8
|
||
P02004EP
|
EUROPE
|
02802833.0
|
||
P02004HK
|
HONG
KONG
|
04106593.4
|
||
P02004IL
|
ISRAEL
|
161461
|
||
P02004IN
|
INDIA
|
KOLNP/2004
|
||
P02004IS
|
ICELAND
|
7242/2004
|
||
P02004JP
|
JAPAN
|
2003-542566
|
||
P02004KR
|
KOREA
|
2004-7006549
|
||
P02004LU
|
LUXEMBOURG
|
|
||
P02004MX
|
MEXICO
|
2004/004067
|
Page
14 of 29
P02004NZ
|
NEW
ZEALAND
|
532170
|
||
P02004SE
|
SWEDEN
|
529427
|
8/7/07
|
0401132-6
|
P02004SG
|
XXXXXXXXX
|
000000
|
6/30/06
|
200402813-0
|
P02004WO
|
W.I.P.O.
|
HEMATOPOIETIC
DIFFERENTIATION OF HUMAN EMBRYONIC STEM CELLS (XXXXXXX
Xxx X, XXXXXXX
Xxxxx X)
X00000XX
|
XXXXXX
XXXXXX
|
6280718
|
8/28/01
|
09/435578
|
P00032AU
|
AUSTRALIA
|
784928
|
11/9/06
|
784928
|
P00032BR
|
BRAZIL
|
XX0000000.5
|
||
P00032CA
|
CANADA
|
2390281
|
10/25/05
|
2390281
|
P00032CN
|
CHINA
|
00815326.4
|
11/23/05
|
00815326.4
|
P00032EP
|
EUROPE
|
00957842.8
|
||
P00032IL
|
ISRAEL
|
149387
|
||
P00032IN
|
INDIA
|
2002/00548
|
||
P00032IS
|
ICELAND
|
2002/00548
|
||
P00032JP
|
JAPAN
|
2001-537473
|
||
P00032KR
|
KOREA
|
|
2002-7005890
|
|
P00032LU
|
LUXEMBOURG
|
90918
|
7/9/02
|
90918
|
P00032MX
|
MEXICO
|
2002/004551
|
||
P00032NO
|
NORWAY
|
20022180
|
||
P00032NZ
|
NEW
ZEALAND
|
518683
|
5/10/04
|
518683
|
P00032SE
|
SWEDEN
|
526490
|
9/27/05
|
0201328-2
|
P00032SG
|
XXXXXXXXX
|
00000[XX
01/34]
|
1/31/05
|
200203064-1
|
P00032WO
|
X.X.X.X.
|
|
|
|
X00000XX
|
XXXXXX
XXXXXX
|
0000000
|
9/2/03
|
09/940175
|
Page
15 of 29
P07426KR
|
KOREA
|
2007-7008013
|
METHOD
OF FORMING
MESENCHYMAL STEM CELLS FROM EMBRYONIC STEM CELLS (PIKE
J Xxxxxx, XXXXXX
Xxxxxxxx K)
P04247US
|
UNITED
STATES
|
11/123794
|
||
P04247AU
|
AUSTRALIA
|
2005243158
|
||
P04247CA
|
CANADA
|
2563872
|
||
P04247EP
|
EUROPE
|
05748314.1
|
||
P04247GB
|
GREAT
BRITAIN
|
0621960.4
|
||
P04247IL
|
ISRAEL
|
178662
|
||
P04247JP
|
JAPAN
|
2007-511701
|
||
P04247KR
|
KOREA
|
2006-7924376
|
||
P04247SG
|
SINGAPORE
|
|||
P04247W0
|
W.I.P.O.
|
METHOD
OF FORMING
MESENCHYMAL STEM CELLS FROM EMBRYONIC STEM CELLS (TIKE
J Xxxxxx, XXXXXX
Xxxxxxxx K)
P03410US
|
XXXXXX
XXXXXX
|
0000000
|
5/22/07
|
10/632399
|
METHOD
OF MAKING EMBRYOID
BODIES FROM PRIMATE EMBRYONIC STEM CELLS (XXXXXXX Xxxxx A, XXXXXXXX Xxxxxxxx
S,
XXXXXXXXX Xxxxxxxx J)
P07100AU
|
AUSTRALIA
|
2006203588
|
||
P99276US
|
XXXXXX
XXXXXX
|
0000000
|
8/5/03
|
09/5100444
|
P99276AU
|
AUSTRALIA
|
2001238491
|
||
P99276BR
|
BRAZIL
|
PI0108436.4
|
||
P99276CA
|
CANADA
|
2400158
|
4/4/06
|
2400158
|
Page
16 of 29
P99276CN
|
CHINA
|
61805291.6
|
||
P99276EP
|
EUROPE
|
01910936.2
|
||
P99276HK
|
HONG
KONG
|
03105106.3
|
||
P99276IL
|
ISRAEL
|
151270
|
||
P99276IN
|
INDIA
|
2002/01133
|
||
P99276IS
|
ICELAND
|
6514/2002
|
||
P99276JP
|
JAPAN
|
2001-562673
|
||
P99276KR
|
KOREA
|
2002-7010830
|
||
P99276MX
|
MEXICO
|
2002/008054
|
||
P99276NO
|
NORWAY
|
20023949
|
||
P99276NZ
|
NEW
ZEALAND
|
520700
|
8/12/04
|
520700
|
P99276SG
|
XXXXXXXXX
|
00000
|
11/30/04
|
200204676-1
|
METHODS
OF MAKING
DIFFERENTIATED CELLS FROM PRIMATE EMBRYONIC STEM CELLS (XXXXXXX
Xxxxx
A)
P02348US
|
UNITED
STATES
|
10/430496
|
DIFFERENTIATION
OF STEM
CELLS TO ENDODERM AND PANCREATIC LINEAGE XXXXXXX
Xxx, XXXXX Xxxxxx W,
XXXXX Xxxxxx R)
P04361US
|
XXXXXX
XXXXXX
|
00/000000
|
||
X00000XX
|
X.X.X.X.
|
|||
X00000XX
|
XXXXXX
XXXXXX
|
11/799659
|
||
P06310WO
|
W.I.P.O
|
Page
17 of 29
CRYOPRESERVATION
OF
PLURIPOTENT STEM CELLS (XXXXXXX Xxxx P, XXXXXXX Xxxx J,
XX Xxx , XXXXXXX
Xxxxx A)
P03369US
|
UNITED
STATES
|
10/993468
|
CULTIVATION
OF PRIMATE
EMBRYONIC STEM CELLS (XXXXXXX Xxxxx X, XXXXXXXXXX
Xxxx
X)
X00000XX
|
XXXXXX
XXXXXX
|
11/078737
|
||
W05007AU
|
AUSTRALIA
|
2005282510
|
||
W05007CA
|
CANADA
|
|||
W05007CN
|
CHINA
|
|||
W05007EP
|
EUROPE
|
05801117.2
|
||
W05007GB
|
GREAT
BRITAIN
|
0707395.0
|
||
W05007IL
|
ISRAEL
|
182143
|
||
W05007JP
|
JAPAN
|
2007-534698
|
||
W05007KR
|
KOREA
|
2007-7009550
|
||
W05007SG
|
SINGAPORE
|
0000000000-2
|
||
W05007WO
|
W.I.P.O.
|
DEFINED
SURFACES OF
SELF-ASSEMBLED MONOLAYERS AND STEM CELLS (XXXXXXXXX Xxxxx L, XXXXXXX Xxxxx
A,
XXXXX Xxxxxx, XXXXX Xxxxxxx X)
X00000XX
|
XXXXXX
XXXXXX
|
11/504573
|
FEEDER
INDEPENDENT EXTENDED
CULTURE OF EMBRYONIC STEM CELLS (XXXXXXX
Xxxxx X, XX
Xxx-Xx)
X00000XX
|
XXXXXX
XXXXXX
|
11/134564
|
||
W04001AU
|
AUSTRALIA
|
2005245965
|
||
W04001CA
|
CANADA
|
2566177
|
Page
18 of 29
W04001CN
|
CHINA
|
580016446.2
|
||
W04001EP
|
EUROPE
|
05754462.9
|
||
W04001GB
|
GREAT
BRITAIN
|
0623883.6
|
||
W04001IL
|
ISRAEL
|
179022
|
||
W04001IN
|
INDIA
|
KOLNP/2006
|
||
W04001IS
|
ICELAND
|
0000/0000
|
||
X00000XX
|
XXXXX
|
2007-527574
|
||
W04001KR
|
KOREA
|
2006-7026488
|
||
W04001NZ
|
NEW
ZEALAND
|
5511176
|
||
W04001SE
|
XXXXXX
|
|||
X00000XX
|
XXXXXXXXX
|
200608063-4
|
||
W04001WO
|
W.I.P.O.
|
METHOD OF REDUCING CELL DIFFERENTIATION (XXXXXXX Xxxx P, XXXXXXX Xxxx J, XX Xxx)
P03370US
|
UNITED
STATES
|
10/717677
|
PHYSIOCHEMICAL
CULTURE CONDITIONS FOR EMBRYONIC STEM
CELLS
(XXXXXXX Xxxxx X, XXXXXX Xxxxxxxxx
X)
X00000XX
|
XXXXXX
XXXXXX
|
10/811423
|
DIRECTED
GENETIC MODIFICATIONS OF HUMAN STEM
CELLS
(XXXXX
Xxxxxx P,
XXXXXXX Xxxxx
X)
X00000XX
|
XXXXXX
XXXXXX
|
10/744122
|
||
P02339AU
|
AUSTRALIA
|
0000000000
|
||
P02339CA
|
CANADA
|
2515108
|
Page
19 of 29
P02339EP
|
EUROPE
|
04709064.2
|
||
P02339GB
|
GREAT
BRITAIN
|
2414480
|
6/27/07
|
0517919.7
|
P02339IL
|
ISRAEL
|
|||
P02339KR
|
KOREA
|
2005-7014427
|
||
P02339SG
|
SINGAPORE
|
2005504747-7
|
||
P02339WO
|
W.I.P.0
|
|||
P07134GB
|
GREAT
BRITAIN
|
DIRECTED
GENETIC MODIFICATIONS OF HUMAN STEM
CELLS
(XXXXX
Xxxxxx P,
XXXXXXX Xxxxx
X
X00000XX
|
XXXXXX
XXXXXX
|
|
10/744122
|
|
P02339AU
|
AUSTRALIA
|
0000000000
|
||
P02339CA
|
CANADA
|
2515108
|
||
P02339EP
|
EUROPE
|
04709064.2
|
||
P02339GB
|
GREAT
BRITAIN
|
2414480
|
6/27/07
|
0517919.7
|
P02339IL
|
ISRAEL
|
|||
P02339KR
|
KOREA
|
2005-7014427
|
||
P02339SG
|
SINGAPORE
|
2005504747-7
|
||
P02339WO
|
W.I.P.0
|
|||
P07134GB
|
GREAT
BRITAIN
|
METHOD
FOR
GENERATING PRIMATE TROPHOBLASTS (XU Ren-He,
XXXXXXX Xxxxx
Xx)
X00000XX
|
XXXXXX
XXXXXX
|
7148062
|
12/12/06
|
10/389484
|
W03002AU
|
AUSTRALIA
|
2003225835
|
||
W03002CA
|
CANADA
|
2478987
|
||
W03002CN
|
CHINA
|
03805960.6
|
Page
20 of 29
W03002EP
|
EUROPE
|
|
03744695.2
|
|
W03002HK
|
HONG
KONG
|
05100288.6
|
||
W03002IL
|
ISRAEL
|
163948
|
||
W03002IN
|
INDIA
|
KOLNP/2004
|
||
W03002IS
|
ICELAND
|
0000/0000
|
||
X00000XX
|
XXXXX
|
2003-576593
|
||
W03002KR
|
KOREA
|
2004-7014409
|
||
W03002LU
|
LUXEMBOURG
|
|||
W03002MX
|
MEXICO
|
2004-008824
|
||
W03002NZ
|
NEW
ZEALAND
|
535243
|
||
W03002SE
|
SWEDEN
|
|||
W03002SG
|
XXXXXXXXX
|
000000
|
1/31/07
|
200406131-3
|
X00000XX
|
X.X.X.X
|
|
||
X00000XX
|
XXXXXX
XXXXXX
|
11/582773
|
METHOD
OF
IDENTIFYING GENES
CONTROLLING
DIFFERENTIATION (XXXXXXX
Xxxxx A)
P00092US
|
UNITED
STATES
|
10/389120
|
METHOD
OF FORMING DENDRITIC CELLS FROM EMBRYONIC STEM
CELLS
(XXXXXXX Xxxx I, XXXXXXX Xxxxx A, XXXXXXXX Xxxxxx X, XXXXXXXX
Xxxxxx
X)
X00000XX
|
XXXXXX
XXXXXX
|
11/443608
|
||
P04434WO
|
W.I.P.O.
|
METHOD
OF IN VITRO DIFFERENTIATION OF TRANSPLANTABLE NEURAL PRECURSOR CELLS FROM
PRIMATE EMBRYONIC STEM
CELLS
(XXXXX Xx-Xxxx, XXXXXXX Xxxxx A,
XXXXXX Xxx E)
P01258US
|
XXXXXX
XXXXXX
|
0000000
|
5/3/05
|
09/970382
|
Page
21 of 29
METHOD
OF IN
VITRO DIFFERENTIATION OF NEURAL STEMCELLS,
MOTOR
NEURONS AND
DOPAMINE
NEURONS FROM PRIMATE EMBRYONIC STEM
CELLS
(XXXXX
Xx-Xxxx, XXXXXXX Xxxxx A, XXXXXX Xxx D, XX Xxx-jun)
P04277US
|
XXXXXX
XXXXXX
|
00/000000
|
||
X00000XX
|
X.X.X.X.
|
|||
X00000XX
|
XXXXXX
XXXXXX
|
11/594455
|
||
P07445US
|
UNITED
STATES
|
11/932582
|
DIFFERENTIATION
OF PLURIPOTENT EMBRYONIC STEMCELLS
(XXXXX
Xxxxxx
P,
XXXXXXX Xxxxx
X)
X00000XX
|
XXXXXX
XXXXXX
|
11/395657
|
Page
22 of 29
APPENDIX
C
XXXX
ROYALTY
REPORT
Licensee:
|
|
Agreement No:
|
|
|||||||||||
Inventor:
|
|
XXXX
Ref. #:
|
P
|
|||||||||||
Period Covered:
|
From:
|
|
/
|
|
/
|
|
Through:
|
|
/
|
|
/
|
|
||
Prepared
By:
|
|
Date:
|
|
|||||||||||
Approved
By:
|
|
|
Date:
|
|
If
license covers several major Service lines, please prepare a separate report
for
each line, and combine all Service lines into a summary report.
Report
Type:
|
q Single
Service Line Report:
|
|
||||
q Multiproduct
Summary Report: Page 1 of ______ Pages
|
||||||
q Service
Line
Detail. Line:
|
|
Tradename:
|
|
Page:
|
|
|
Report Currency:
|
q U.
S.
Dollars q Other
|
|
Gross
|
*
Less:
|
Net
|
Royalty
|
Period
Royalty Amount
|
||
Country
|
Sales
|
Allowances
|
Sales
|
Rate
|
This
Year
|
Last
Year
|
U.S.A.
|
||||||
Canada
|
||||||
Europe:
|
||||||
Japan
|
||||||
Other:
|
||||||
TOTAL:
|
Total
Royalty: _______________ Conversion Rate: _______________Royalty in
U.S. Dollars: $
The
following royalty forecast is non-binding and for XXXX’x internal planning
purposes only:
Royalty
Forecast Under This Agreement: Next Quarter:__________
Q2:__________ Q3:__________ Q4:__________
*
On a separate page, please indicate the reasons for returns or
other
adjustments if significant.
Also
note any unusual occurrences that affected royalty amounts during
this
period.
To
assist XXXX’x forecasting, please comment on any significant expected
trends in sales volume.
|
Page
23 of 29
APPENDIX
D
DEVELOPMENT
REPORT
A.
|
Date
development plan initiated
and time period covered by this
report.
|
B.
Development Report (4-8
paragraphs).
1. Activities
completed since last report
including the object and parameters of the development, when initiated, when
completed and the results.
2. Activities
currently under
investigation, i.e., ongoing activities including object and parameters of
such
activities, when initiated, and projected date of
completion.
C.
|
Future
Development Activities (4-8
paragraphs).
|
1. Activities
to be undertaken before next
report including, but not limited to, the type and object of any studies
conducted and their projected starting and completion
dates.
2. Estimated
total development time
remaining before a Service will be commercialized.
D.
|
Changes
to initial development
plan (2-4 paragraphs).
|
1. Reasons
for
change.
2. Variables
that may
cause additional changes.
E.
|
Items
to be provided if
applicable:
|
1. Information
relating to Service that has
become publicly available, e.g., published articles, competing Services,
patents, etc.
2. Development
work being performed by
third parties other than Licensee to include name of third party, reasons
for
use of third party, planned future uses of third parties including reasons
why
and type of work.
3. Update
of competitive information trends
in industry, government compliance (if applicable) and market
plan.
PLEASE
SEND DEVELOPMENT REPORTS
TO:
XXXX
Research Institute,
Inc.
Attn.: Contract
Coordinator
000
Xxxxxx Xxxxxx
X.X.
Xxx 0000
Xxxxxxx,
XX 00000-0000
Page
24 of 29
APPENDIX
E
DEVELOPMENT
PLAN
(To
be provided by Licensee prior to
execution)
BioTime,
Inc. will be developing products using XXXX technology for the research products
market (i.e. products such as cell lines, materials such as cell culture media,
monoclonal antibodies, and online databases that provide researchers information
on molecular markers of embryonic progenitor cells that are derived from hES
cells. BioTime’s initial development plan is summarized below:
I.
Product Categories
A. Launch
of an online database named
“Xxxxxxxx.xxx” that displays murine and human cellular ontology and molecular
markers associated with said cell types and facilitates the marketing of
hES
cell-derived products such as cell lines, media, antibodies, and growth and
differentiation factors.
Estimated
|
|||
Start
Date
|
Finish
Date
|
||
1.
Launch Phase I of Xxxxxxxx.xxx (murine)
|
January
2008
|
||
2.
Launch Phase II of Xxxxxxxx.xxx (human)
|
June
2008
|
B. Launch
growth and differentiation
factors that are free of pathogens and are useful in the propagation and
differentiation of hES cells and hES-derived cells.
Estimated
|
|||
Start
Date
|
Finish
Date
|
||
1.
Launch EScalate TM factors
|
March
2008 -
|
December
2009
|
C. Launch
ESpyTMcell
lines (murine and human embryonic
progenitors with fluorescent or luminescent markers) useful in basic research,
drug discovery, and toxicology.
Estimated
|
|||
Start
Date
|
Finish
Date
|
||
1.
Launch murine ESpyTM
cell lines
|
August
2008 -
|
March
2009
|
|
2.
Launch human ESpyTM
cell lines
|
October
2008 -
|
June
2009
|
D. Launch
monoclonal antibodies useful in
the identification and purification of hES-derived embryonic progenitor cell
types.
Page
25 of 29
Estimated
|
|||
Start
Date
|
Finish
Date
|
||
1.
Launch monoclonal antibodies
|
April
2009 -
|
December
2010
|
II.
Governmental Approval
A.
No known governmental approval required.
III.
The proposed marketing approach will be to market the products through an online
database designated “Xxxxxxxx.xxx”.
IV.
Competitors include such companies as Invitrogen, Chemicon, and
Millipore.
Page
26 of 29
XXXX Agreement
No.
08-0155
WISCONSIN
MATERIALS ADDENDUM
This
Addendum is made effective the 10th day of December, 2007, by and between
Wisconsin Alumni Research Foundation (hereinafter called “XXXX”), a nonprofit
Wisconsin corporation, and BioTime, Inc.. (hereinafter called “Licensee”), a
corporation organized and existing under the laws of Wisconsin.
WHEREAS,
XXXX and Licensee
have entered into License Agreement No. 08-0155, effective December 10, 2007
(the “Patent Rights Agreement”), granting Licensee the right under certain
Licensed Patents to make, use and receive Licensed Materials for use in Internal
Research;
WHEREAS,
XXXX also holds
certain rights in human embryonic stem cell lines developed by Xxxxx X. Xxxxxxx
of the University of Wisconsin – Madison, working either alone or with other
researchers at the University (the “Wisconsin Materials” as defined below);
and
WHEREAS,
Licensee desires to
obtain from XXXX the Wisconsin Materials to maintain and use in accordance
with
the Patent Rights Agreement and the terms and conditions set forth
below.
NOW,
THEREFORE, in
consideration of the above premises and the mutual covenants contained herein,
the parties further agree as follows:
1.
Except as otherwise provided in this Addendum, all terms and conditions
previously set forth in the Patent Rights Agreement shall remain in effect
as
set forth therein. In the event that this Addendum and the Patent Rights
Agreement are inconsistent with respect to any terms and conditions pertaining
to the Wisconsin Materials, the terms and provisions of this Addendum shall
supersede the terms and provisions of the Patent Rights Agreement.
2.
“Wisconsin Materials” shall mean any and all embryonic stem cells and cell lines
provided to Licensee by XXXX or a third party authorized by XXXX, including
any
progeny, unmodified derivatives, genetically modified embryonic stem cells
or
clones of those cells or cell lines. Within thirty (30) days of the
Effective
Date of the Patent Rights Agreement, XXXX shall provide Licensee, without
additional charge, two aliquots each of the following embryonic stem cell
lines: X0, X0, X0, X00x and H14.
3.
As used in the Patent Rights Agreement, “Licensed Materials” shall further
include the Wisconsin Materials; provided, however, that Licensee shall not
have
the right to:
(a)
|
intermix
the Wisconsin Materials
with an intact embryo, either human or
nonhuman;
|
(b)
|
implant
the Wisconsin Materials or
any products of the Wisconsin Materials in a uterus, including Derivative
Materials derived from the Wisconsin
Materials;
|
(c)
|
attempting
to make whole embryos
by any method using the Wisconsin
Materials.
|
(d)
|
use
the Wisconsin Materials for therapeutic purposes.
|
4.
Licensee agrees that on or before June 30th of each year in which this Addendum
is in effect, License will submit to XXXX a signed Annual Certification
Statement as set forth on Exhibit A confirming compliance with the above
restrictions. Licensee agrees that it will comply with all applicable laws,
regulations and government orders with respect to any use of the Wisconsin
Materials, and shall, as appropriate, seek and comply with the decisions and
recommendations of any applicable Institutional Review Board or similar
body.
Page
27 of 29
5.
Wisconsin Materials are the property of XXXX and are being made available to
Licensee as a service by XXXX. Ownership of all Wisconsin Materials, including
any progeny or modified versions thereof, shall remain with XXXX, regardless
of
whether such Wisconsin Materials are received from XXXX or an authorized third
party. Any Wisconsin Materials provided hereunder will be returned to XXXX
or
destroyed upon a material breach of any terms of this Addendum or the Patent
Rights Agreement.
6.
Licensee agrees to communicate to XXXX all publications
and/or research results made public by Licensee based on research using the
Wisconsin Materials. In addition, any reports, publications, or other disclosure
of results obtained with the Wisconsin Materials will acknowledge XXXX as the
original source of the Wisconsin Materials and, in the event that the Wisconsin
Materials were received from an authorized third party, the conditions in which
such Wisconsin Materials were maintained prior to their transfer.
7.
Licensee may not assign or transfer this Addendum, nor any of the rights
granted herein, except pursuant to a Change of Control Event, without the prior
written consent of XXXX, such consent not to be unreasonably withheld. This
Addendum shall be governed by and construed in all respects in accordance with
the laws of the State of Wisconsin.
The
persons signing on behalf of XXXX
and Licensee hereby warrant and represent that they have authority to execute
this Agreement on behalf of the party for whom they have signed.
IN
WITNESS WHEREOF, the parties hereto
have duly executed this Agreement on the dates indicated below.
WISCONSIN
ALUMNI RESEARCH
FOUNDATION
By:
|
|
Date:
|
|
,
|
|
||
Xxxxx
X. Xxxxxxxxxxxx, Director of
Licensing
|
BIOTIME,
INCORPORATED
By:
|
s/Xxxxxxx
Xxxx
|
Date:
December 17, 2007
|
|
(insert
name) Xxxxxxx Xxxx
|
XXXX
Ref.: Thomson P96014US
Page
28 of 29
EXHIBIT
A
ANNUAL
CERTIFICATION
BIOTIME,
INC. (“Licensee”) hereby warrants that it is in compliance with all aspects of
Agreement Nos. 08-0155and 08-0155A between the Wisconsin Alumni Research
Foundation (“XXXX”) and Licensee, including but not limited to the restrictions
on the use, sale or transfer of the Licensed Materials, including the Wisconsin
Materials. Licensee further warrants and certifies that it is not
engaged in, and has not been engaged in, any of the following:
(a) | mixing of Wisconsin Materials with an intact embryo, either human or non-human; |
(b) | implanting Wisconsin Materials or products of the Wisconsin Materials in a uterus; or |
(c)
|
attempting
to make whole embryos with Wisconsin Materials by any method.
|
The
individual signing for the Licensee, hereby warrants that he or she is a
representative legally authorized to sign on behalf of that entity.
BIOTIME,
INCORPORATED
By:
|
|
Date:
|
|
,
|
|
Page
29 of 29