CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY
FILED HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST.
OMISSIONS ARE DESIGNATED AS * . A COMPLETE, UNREDACTED VERSION OF THIS EXHIBIT
HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
EXHIBIT 10.1
Agreement No. 02-0273
LICENSE AGREEMENT
This Agreement is made effective the 8th day of January, 2002, by and
between Wisconsin Alumni Research Foundation (hereinafter called "XXXX"), a
nonstock, nonprofit Wisconsin corporation, and Geron Corporation (hereinafter
called "Geron"), a corporation organized and existing under the laws of
Delaware;
WHEREAS, XXXX owns certain inventions that are described in the
"Licensed Patents" defined below;
WHEREAS, XXXX and Geron had previously entered into a license agreement,
Agreement No. 95-0208 dated January 1, 1996, as amended on March 19, 1997 and
March 1, 1998, (the "First License") and a license agreement, Agreement No.
99-0027 dated April 23, 1999, as amended on October 1, 1999, January 28, 2000,
January 30, 2001, February 21, 2001, May 29, 2001 and June 25, 2001 which
superseded the First License (the "Second License");
WHEREAS, XXXX and Xxxxx desire to enter into this Agreement to restate
and modify the agreement between the parties; and
WHEREAS, XXXX and Geron agree that this Agreement shall supersede in
their entirety all prior agreements between the parties relating to the subject
matter of this Agreement, except the Settlement Agreement of even date herewith.
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 purpose of this Agreement, the Appendix A definitions shall
apply.
Section 2. Grant.
A. Licenses.
(i) XXXX hereby grants to Geron an exclusive license,
limited to the Exclusive Field and the Licensed Territory, under the Licensed
Patents to make, have made, develop, have developed, use, sell, offer for sale,
and import Products.
(ii) XXXX hereby grants to Geron a nonexclusive license,
limited to the Nonexclusive Field and the Licensed Territory, under the Licensed
Patents to make, have made, develop, have developed, use, sell, offer for sale,
and import Products.
(iii) XXXX hereby grants to Geron a nonexclusive license,
limited to the Research Products Field and the Licensed Territory, under the
Licensed Patents to make, have made, develop, have developed, use, sell, offer
for sale, and import Research Products.
(iv) XXXX hereby grants to Geron a nonexclusive license,
without the right to grant sublicenses, limited to the Research-Related Field
and the Licensed Territory, under the Licensed Patents to make, have made,
develop, have developed, use, sell, offer for sale, and import Products and
Research Products.
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(v) XXXX hereby grants to Geron a nonexclusive license,
limited to the Licensed Territory, to use the Licensed Patents for Internal
Research Purposes.
B. Sublicenses.
(i) Geron may grant written sublicenses to third
parties under the exclusive licenses granted herein in the Exclusive Field. Any
agreement granting a sublicense shall state that the sublicense is subject to
the termination of this Agreement. Geron shall require that its sublicensee(s)
comply with all requirements of this Agreement (including without limitation
restrictions on the right to use and transfer Materials) and Geron shall have
the same responsibility for the activities of any sublicensee as if the
activities were directly those of Geron. Any conversion of Geron's exclusive
license to a nonexclusive license pursuant to Section 3A(iii)(d) below shall not
affect a sublicense existing prior to the date of such conversion.
(ii) Geron may grant written sublicenses to third
parties under the nonexclusive licenses granted herein in the Nonexclusive Field
and the Research Products Field, but only:
(a) To Contract Service Providers to enable the
Contract Service Provider to perform services in support of Geron's
commercialization of Products or Research Products, under a written
contract with Geron, at Geron's expense, and pursuant to protocols or
specifications developed by Geron. Such a sublicense may include a
license to make or use the Materials, Products, or Research Products
solely for the purpose of providing the services, or to sell Products or
Research Products as Geron's agent, but not to sell or transfer any of
them for any other purpose.
(b) To Collaborators to enable the Collaborator to
engage in a project of collaborative research with Geron on Materials
and cells derived from Materials and/or development of Products or
Research Products, provided that the project is described and directed
by Geron. Such a sublicense may include a license to make or use the
Materials, Products, or Research Products solely for the purpose of the
project, but not to sell or transfer any of them for any purpose.
(c) To Development Partners to enable the Development
Partner to develop Products or Research Products collaboratively with
Geron, provided XXXX does not disapprove as provided below. Such a
sublicense may include a license to make or use the Materials, and to
make, have made, use, sell, offer for sale, or import Products and/or
Research Products. At or before the time that Geron signs a term sheet
with a proposed Development Partner, Geron shall inform XXXX in writing,
in confidence, of the proposed non-economic terms, including Geron's
role in the collaborative development. XXXX shall have the right to
disapprove such subcontract with a Development Partner only if Geron is
not participating actively and substantively (e.g. by providing
research, manufacturing, co-marketing, etc.). If XXXX does not inform
Geron in writing of its disapproval and the reasons for it within ten
(10) days after Geron informs XXXX of the proposed terms, XXXX shall be
deemed to have approved them. If XXXX does inform Geron in writing of
its disapproval and the reasons for it within ten (10) days after Geron
informs XXXX of the proposed terms, and Geron believes XXXX'x
disapproval to be unreasonable, Geron may submit the matter to Truncated
Arbitration.
(iii) Any agreement granting a sublicense under this
Section 2B shall state that the sublicense is subject to the termination of this
Agreement; that the sublicensee is not authorized to transfer any Materials, or
use them for any purpose outside that permitted by the sublicense; and that the
sublicensee will not use Materials originally provided by XXXX, WiCell or the
University of Wisconsin to Geron or derived therefrom to perform any of the
following experiments: (a) intermixing of Materials with an intact embryo,
either human or nonhuman; (b) implanting Materials or products of Materials in a
uterus; or (c) attempting to make whole embryos by any method. Geron shall
require that its sublicensee(s) comply with all requirements of this Agreement
(to the extent applicable to the work under the sublicense) and Geron shall have
the same responsibility for the activities of any sublicensee as if the
activities were directly those of Geron. Geron shall provide to XXXX, in
confidence, a summary of any sublicense agreement under this Section 2B within
thirty (30) days after execution of such sublicense agreement subject to the
obligation, however, in the case of Development Partners to have earlier
provided the proposed terms as required above in Section 2B(ii)(c).
(iv) In respect to sublicenses granted by Geron under
this Section 2B, Geron shall pay to
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XXXX an amount equal to what Geron would have been required to pay to XXXX had
Xxxxx sold the amount of Products or Research Products sold by such sublicensee.
In addition, if Geron receives any fees, minimum royalties, or other payments in
consideration for any rights granted under a sublicense, except for payments
received by Geron upon achievement of the milestones set forth in Section 4D
(provided that Geron shall be responsible for payment upon achievement of such
milestones by a sublicensee as if Geron itself had achieved such milestones and
shall make payment directly to XXXX pursuant to Section 4D), and such payments
are not based directly upon the amount or value of Products or Research Products
sold by the sublicensee, then Geron shall pay XXXX * percent (* %) of such
payments in the case of sublicenses under Section 2B(i) and * percent (* %) of
such payments in the case of sublicenses under Section 2B(ii), in the manner
specified in Section 4E. XXXX recognizes that payments received from
sublicensees to fund research are not consideration for rights granted under the
sublicense and as such research funds are not subject to sharing with XXXX
hereunder. However, Geron shall not receive from sublicensees anything of value
in lieu of cash payments (other than equity in another company which can and
will be shared with XXXX) in consideration for any sublicense under this
Agreement without the express prior written permission of XXXX. Both parties
agree to act in good faith when negotiating the consideration to be paid for
sublicensing and when assessing whether such consideration is subject to sharing
with XXXX under this Section 2B(iv). Any disagreement between XXXX and Geron
over the consideration to be paid to XXXX on account of sublicenses shall be
submitted to Truncated Arbitration.
C. License to XXXX, WiCell and the University of Wisconsin.
To the extent permitted by applicable law, Geron hereby grants to XXXX,
WiCell and the University of Wisconsin - Madison a nonexclusive, royalty-free,
paid-up research license under any and all inventions made during the term of
the First License or Second License or hereafter made or acquired by Geron to
the extent any such inventions are Improvements. Such license shall be
nontransferable as long as Geron remains an existing and solvent entity but may
be transferable upon bankruptcy or dissolution of Geron other than in the event
of the sale of substantially all of Geron's assets pursuant to Section 8.
"Improvements" shall mean any modification of an invention described in Licensed
Patents which, if unlicensed, would infringe one or more claims of the Licensed
Patents. Geron shall provide XXXX with a written, enabling disclosure of each
such invention (such as a U.S. patent application), unambiguously identifying it
as an invention governed by this paragraph, within six (6) months of filing a
patent application thereon.
D. Provision of Cell Lines.
Pursuant to a Material Transfer Agreement dated October 12, 1998, XXXX
has provided to Geron certain human embryonic stem cell lines, which constitute
Materials. XXXX agrees to provide to Geron any and all additional human
embryonic stem cell lines derived or developed by XXXX, WiCell Research
Institute, or the University of Wisconsin-Madison and available for licensing by
XXXX or WiCell. XXXX will provide such cell lines to Geron with no fee, subject
to the restrictions provided in this Agreement with respect to the use and
transfer of Materials.
X. Xxxxx IP Licensing.
(i) If a third party to which XXXX has granted a
license for commercialization of Products under the Licensed Patents outside the
Exclusive Field wishes to obtain a license to Geron IP, Geron agrees to grant a
nonexclusive license under such Geron IP to such third party. Such a license
shall be restricted in scope to the scope of the XXXX license to such third
party, shall in no event include a license to make, use, or sell Research
Products, and shall be on commercially reasonable terms.
(a) With respect to the structure and
non-economic terms of the license, if Geron and the third party fail to
reach agreement, the third party may submit to Truncated Arbitration the
question of whether Geron's last offer was commercially reasonable. If
the arbitrator finds that the offer was not commercially reasonable,
Geron shall make another offer, which if the parties fail to agree shall
in turn be subject to Truncated Arbitration as provided in the preceding
sentence. If the arbitrator finds that the offer was commercially
reasonable, Geron may choose to re-offer the terms or decline to grant a
license, in Geron's sole discretion.
(b) With respect to the economic terms of the
license, if Geron and the third party fail to reach agreement, the third
party may submit to Truncated Arbitration the
3
question of what economic terms represent fair market value economic
terms for the license. Geron and the third party will then each make a
last offer, and the arbitrator will choose Geron's last offer or the
third party's last offer, whichever the arbitrator determines to be
closer to the fair market value ("baseball arbitration").
(c) Notwithstanding the above, if the third
party is a public company with a market capitalization greater than $200
million, or a private company with a comparable value, and the third
party wishes to develop a product for an indication for which Geron has
submitted a development plan, Geron may at its election propose that the
third party enter into a commercially reasonable collaboration or
development partnership rather than a license. The structure and
non-economic terms and the economic terms of such collaboration or
development partnership shall be subject to Truncated Arbitration as
provided above in Section 2E(i)(a) and (b).
(ii) If a governmental or academic or non-profit
research organization to which XXXX has granted a license for research (but not
commercialization or distribution of Products or Research Products) under the
Licensed Patents outside the Exclusive Field wishes to obtain a license to Geron
IP, Geron agrees to grant a nonexclusive license under such Geron IP to such
third party. Such a license shall be restricted in scope to the scope of the
XXXX license to such third party, shall in no event include a license to make,
use, or sell Products or Research Products, and shall be on commercially
reasonable terms without royalties or other fees (it being understood that Geron
shall not be obligated under this Agreement to accept the terms of the federal
government's CRADA form agreement).
Section 3. Development Plans and Reporting.
A. Development Plans for Exclusive Field.
(i) Geron has submitted, and XXXX has accepted,
specific development plans for Products based on each of the three cell types in
the Exclusive Field (the "Specific Exclusive Development Plans"). For purposes
of this Agreement, the milestones in Geron's specific development plans are
understood to be (1) new clinical entity candidate selection, (2) IND filing,
(3) BLA submission, and (4) BLA approval/product launch. A Specific Exclusive
Development Plan may be changed by agreement of the parties, as provided in
Section 3A(ii) below, or unilaterally by Geron because of a missed milestone or
in anticipation of a missed milestone, as provided in Section 3A(iii) below and
subject to the consequences specified in Section 3A(iii). Upon any such change,
the changed Specific Exclusive Development Plan shall supersede all previous
Specific Exclusive Development Plans for that cell type.
(ii) Should Geron desire to make changes to a Specific
Exclusive Development Plan for any reason (including, without limitation, in the
context of a sublicensing, partnership or development agreement), Geron shall
propose such changes to XXXX for XXXX'x written agreement, such agreement not to
be unreasonably withheld. If XXXX does not agree and Geron believes XXXX'x
disagreement with a change to be unreasonable, Geron may submit the matter to
Truncated Arbitration.
(iii) Should Geron miss, or conclude that it will miss, a
milestone set forth in a then-current Specific Exclusive Development Plan, then:
(a) As soon as Geron has missed, or concludes
that it will miss, a milestone, Geron shall inform XXXX and explain in
writing why the milestone was or may be missed.
(b) If the milestone is or will be missed by
more than *, then Geron shall revise the milestones in the Specific
Exclusive Development Plan to account for the delay and inform XXXX in
writing of the revised milestones.
(c) If (and only if) the milestone is or will be
missed by more than * for a reason within Geron's control, then the
consequences specified in (d) below shall apply, unless XXXX agrees in
writing to waive the consequences. Reasons "within Geron's control"
shall be limited exclusively to Resource Allocation (defined below in
Section 3B) decisions, wherein Geron allocates less than * percent (* %)
of the projected Resource Allocation set forth in the
4
Work Plans or assigns to a project personnel without appropriate
scientific expertise; except that if XXXX finds that either or both of
the 2002 Work Plans for the cardiomyocyte and pancreatic islet cell
areas are not reasonable, in XXXX'x reasonable judgment communicated to
Geron no later than * , then for the cell type(s) for which the Work
Plans are found not to be reasonable, reasons "within Geron's control"
shall thereafter primarily, but not exclusively, be limited to Resource
Allocation decisions. If the parties disagree as to whether the reason
was within Geron's control, the issue shall be resolved by Truncated
Arbitration, which must be requested by one of the parties within ninety
(90) days of Geron notifying XXXX of the missed milestone and the
reasons for missing it.
(d) For each cell type, the first milestone
missed for a reason within Geron's control shall result in a * penalty,
and the second shall result in a * penalty. Such penalties shall be
payable by Geron to XXXX within thirty (30) days after the milestone is
missed (or, if later, after the conclusion of a Truncated Arbitration
determining that the milestone was missed for reasons within Geron's
control). The third milestone missed for the same cell type for a reason
within Geron's control shall result, at XXXX'x election, in conversion
of Geron's license for that cell type from exclusive to non-exclusive.
If XXXX elects such conversion, XXXX will notify Geron in writing, and
the effective date of such conversion shall be thirty (30) days after
XXXX'x written notice (or, if later, thirty (30) days after the
conclusion of a Truncated Arbitration determining that the milestone was
missed for reasons within Geron's control). Upon such conversion, the
definitions of Exclusive Field and Nonexclusive Field shall be deemed
modified accordingly.
B. Work Plans for Exclusive Field.
Geron has submitted, and XXXX has found to be reasonable, a
specific work plan (a "Work Plan") for work on the neural cell type in the
calendar year 2002. By *, Geron will submit a Work Plan for work on the
cardiomyocyte and pancreatic islet cell types in the calendar year 2002. Each
Work Plan will detail activities to be taken towards accomplishing the goals set
forth in the Specific Exclusive Development Plan for that cell type, and will
include (a) budget projections, (b) headcount allocations, (c) facilities, and
(d) scientific expertise of personnel allocated to the cell type ((a) through
(d) are collectively defined as "Resource Allocation"). XXXX will notify Geron
in writing by * whether XXXX considers the 2002 Work Plans for the cardiomyocyte
and pancreatic islet cell types to be reasonable, in XXXX'x reasonable judgment.
Beginning in 2003 and in each year thereafter, Geron will provide a Work Plan
for that year for each cell type in the Exclusive Field by January 31 of each
year, to inform XXXX and to allow XXXX to understand the resources being
allocated to the work. Work Plans will not be subject to XXXX'x approval.
C. Development Plans for Nonexclusive Field.
(i) Geron has submitted, and XXXX has accepted,
specific development plans for Products based on each of the three cell types in
the Nonexclusive Field (the "Specific Nonexclusive Development Plans"). For
purposes of this Agreement, the milestones in Geron's specific development plans
are understood to be (1) new clinical entity candidate selection, (2) IND
filing, (3) BLA submission, and (4) BLA approval/product launch. A Specific
Nonexclusive Development Plan may be changed by agreement of the parties, as
provided in Section 3C(ii) below, or unilaterally by Geron because of a missed
milestone or in anticipation of a missed milestone, as provided in Section
3C(iii) below. Upon any such change, the changed Specific Nonexclusive
Development Plan shall supersede all previous Specific Nonexclusive Development
Plans for that cell type.
(ii) Should Geron desire to make changes to a Specific
Nonexclusive Development Plan for any reason (including, without limitation, in
the context of a sublicensing, partnership or development agreement), Geron
shall propose such changes to XXXX for XXXX'x written agreement, such agreement
not to be unreasonably withheld. If XXXX does not agree and Geron believes
XXXX'x disagreement with a change to be unreasonable, Geron may submit the
matter to Truncated Arbitration.
(iii) Should Geron miss, or anticipate missing, a
milestone set forth in a Specific Nonexclusive Development Plan, then:
5
(a) As soon as Geron has missed, or concludes that it
will miss, a milestone, Geron shall inform XXXX and explain in writing
why the milestone was or may be missed.
(b) If the milestone is or will be missed by more than
two calendar quarters, then Geron shall revise the milestones in the
Specific Nonexclusive Development Plan to account for the delay and
inform XXXX in writing of the revised milestones.
(c) Missing a milestone in a Specific Nonexclusive
Development Plan will not result in any penalty, although it will result
in an extension of the royalty period pursuant to Section 7A to the
extent provided in that section.
D. Development Reports.
Within one month following the end of each calendar quarter ending on
March 31, June 30, September 30 and December 31 and until commercial sales of
Products begin for the indications Geron for which Geron has supplied
Development Plans, Geron will supply XXXX with a written Development Report
showing Geron's progress toward bringing Products to market in the Exclusive
Field and the Nonexclusive Field.
X. Xxxxx'x Discretion.
Except as explicitly stated in this Agreement, all development
activities and strategies and all aspects of Product design and decisions to
market and the like are entirely at the discretion of Geron, and Geron shall
rely entirely on its own expertise with respect thereto.
F. Confidentiality of Development Information.
Geron's Development Plans, Work Plans and Development Reports shall be
considered confidential information subject to the obligations set forth in
Section 19 hereto.
G. Review of Development Documentation.
XXXX may, within thirty (30) days of its request, review all
documentation and records relating to Geron's development of Products and
Research Products in the Exclusive Field and the Nonexclusive Field. Geron shall
make such records available at a single United States location. Such review may
be performed by any employee of XXXX, or any agent designated by XXXX. XXXX
shall perform such review at its expense, and not more than once per calendar
year. In the event that XXXX'x audit reveals an unreported missed milestone, or
a cessation of active development of Products or Research Products in a
particular cell type or cell types for more than one year, the provisions of
Sections 3A(iii)(d), 7A and 7D shall apply.
Section 4. Consideration.
A. License Fee.
The parties acknowledge that Geron paid XXXX a license fee under the
Second License. No additional license fee is payable under this Agreement.
B. Patent Prosecution.
(i) Geron agrees to reimburse XXXX for a portion of the
costs associated with filing, prosecuting and maintaining the Licensed Patents.
Geron has paid such patent reimbursement for the Licensed Patents up to the date
of this Agreement. In the event that further patents are added to the Licensed
Patents, Geron shall reimburse XXXX * per United States patent application
within thirty (30) days after Geron's receipt of an invoice from XXXX. For each
such newly added U.S. patent application, Geron shall notify XXXX of whether it
desires a PCT application and/or foreign national application to be filed, and,
upon such filings being made by XXXX shall reimburse XXXX * per PCT application
and * per foreign national application.
6
(ii) XXXX will prosecute all applications until XXXX
determines that continued prosecution is unlikely to result in the issuance of a
patent in that country. XXXX will timely provide copies of all patent
communications with the U.S. Patent Office or its foreign counterpart to Geron
and allow Geron the opportunity to comment on the prosecution of the Licensed
Patents. If XXXX decides to abandon prosecution of an application in a
particular country (excluding abandonment of applications as part of patent
prosecution strategy in favor of continuing application(s) claiming the subject
matter claimed in the abandoned application), or to allow an issued patent
within the Licensed Patents to lapse, XXXX shall notify Geron in writing of such
decision at least thirty (30) days before any abandonment or lapse would occur
and Geron may, at its election, continue prosecution of the application or
maintenance of the patent. In the event that Geron does so elect, XXXX will
cooperate with Geron as reasonably requested by Geron to facilitate such
continued prosecution or maintenance.
(iii) Geron and XXXX hereby agree that they will make all
necessary filings and provide all necessary documentation to allow XXXX to apply
for an extension of the patent term for each of the Licensed Patents pursuant to
37 CFR 1.710 et seq.
C. Royalty.
(i) Geron agrees to pay to XXXX as "earned royalties" a
royalty calculated as a percentage of the Selling Price of Products in
accordance with the terms and conditions of this Agreement. The royalty is
deemed earned as of the earlier of the date the Product or Research Product is
actually sold and paid for, the date an invoice is sent by Geron, or the date a
Product or Research Product is transferred to a third party for any promotional
reasons. The royalty shall remain in effect until no Licensed Patent remains an
enforceable patent (except as extended for Therapeutic Products pursuant to
Section 7A) at the following rates:
(a) * percent (* %) of the Selling Price for
Therapeutic Products in the Exclusive Field;
(b) * percent (* %) of the Selling Price for Diagnostic
Products in the Exclusive Field;
(c) * percent (* %) of the Selling Price for
Therapeutic Products in the Nonexclusive Field;
(d) * percent (* %) of the Selling Price for Diagnostic
Products in the Nonexclusive Field;
(e) * percent (* %) of the Selling Price for Research
Products in the Research Products Field; and
(f) between * percent and * percent (* % - * %) of the
Selling Price of Products or Research Products in the Research-Related
Field as appropriate to the type of product and market for such product.
The parties agree to negotiate the royalty rate in good faith upon
identification or discovery of a Product or Research Product in the
Research-Related Field.
(ii) Royalties on sales by Geron or its sublicensee of
Products or Research Products that are neither made, used, nor sold in a country
within the Patent Territory shall be subject to reduction as follows:
(a) If Competing Products are sold in a country outside
the Patent Territory in which Geron or its sublicensees are also selling
Products or Research Products, and the total sales of the Competing
Products in that country are greater than or equal to * percent (* %) of
the total sales of Products or Research Products sold by Geron in that
country, the royalties otherwise payable by Geron or its sublicensees to
XXXX shall be reduced by * percent (* %).
(b) If Competing Products are sold in a country outside
the Patent Territory in which Geron or its sublicensees are also selling
Products or Research Products, and the total sales of the Competing
Products in that country are greater than or equal to * percent (* %) of
the
7
total sales of Products or Research Products sold by Geron in that
country, the royalties otherwise payable by Geron or its sublicensees to
XXXX shall be reduced by * percent (* %)
For purposes of this Section 4C(ii), "Patent Territory" means all the countries
in which the Licensed Patents are pending or enforceable at the time Products or
Research Products are sold. The reduction in royalties set forth herein shall be
subject to adjustment each quarter based on the relative amounts (as provided in
(a) and (b) above) of Competing Products and Products or Research Products sold
in a country during the quarter in which a royalty reduction in being applied.
"Competing Products" means products or services that (i) if sold by Geron, would
be Products or Research Products, and (ii) address the same indication as a
Therapeutic Product sold by Geron or its sublicensee, or the same application as
a Diagnostic Product or Research Product sold by Geron or its sublicensee, and
(iii) which are not sold under a royalty-bearing agreement between XXXX or
WiCell and the seller of the Competing Products.
(iii) If Geron must make payments to one or more third
parties, pursuant to an arms' length transaction with such third party (which
transaction, in the case of a third party which is a Collaborator, Contract
Service Provider, or Development Partner, is not part of the collaboration with
Geron), during any calendar year to obtain a license or similar right in the
absence of which Geron could not legally make, use or sell the Products or
Research Products, then Geron may deduct * percent (* %) of such third party
payments from royalties payable to XXXX with respect to that calendar year,
provided that such deduction does not exceed * percent (* %) of the royalties
payable to XXXX under this Agreement during such calendar year.
D. Minimum Royalty and Milestone Payment.
(i) Geron agrees to pay to XXXX a minimum royalty per
calendar year or part thereof during which this Agreement is in effect starting
in calendar year 2003, against which any earned royalty paid for the same
calendar year will be credited. The minimum royalty shall be * in 2003, * in
2004, * in 2005 and in each calendar year thereafter. The minimum royalty
payment for a given year shall be due at the time payments are due for the
calendar quarter ending on December 31. It is understood that the minimum
royalties will apply on a calendar year basis, and that sales of Products or
Research Products requiring the payment of earned royalties made during a prior
or subsequent calendar year shall have no effect on the annual minimum royalty
due XXXX for any given calendar year.
(ii) Geron further agrees to pay to XXXX milestone
payments as outlined below within thirty (30) days from the specified event set
forth below whether achieved by Geron or its sublicensee(s). These payments are
not creditable against running royalties or other payments due hereunder.
--------------------------------------------------------------------------------
EVENT CASH SHARES
--------------------------------------------------------------------------------
IND or comparable regulatory * * Geron Shares, plus an additional
filing for the first Product number of Geron Shares with a value
developed from each cell type equivalent to * Geron Options
in the Exclusive Field
--------------------------------------------------------------------------------
IND or comparable regulatory * * Geron Shares, plus an additional
filing for the first Product number of Geron Shares with a value
developed from each cell type equivalent to * Geron Options
in the Nonexclusive Field
--------------------------------------------------------------------------------
NDA, BLA or comparable regulatory * * Geron Shares, plus an additional
approval for the first Product number of Geron Shares with a value
developed from each cell type in equivalent to * Geron Options
the Exclusive Field
--------------------------------------------------------------------------------
NDA, BLA or comparable regulatory * * Geron Shares, plus an additional
approval for the first Product number of Geron Shares with a value
developed from each cell type in equivalent to * Geron Options
the Nonexclusive Field
--------------------------------------------------------------------------------
Geron shall file with the Securities and Exchange Commission a
registration statement for the Geron Shares to be issued to XXXX within thirty
(30) days after the date the milestone is achieved, and will use reasonable
diligence thereafter to obtain registration of the Geron Shares. In the event
that XXXX
8
desires to sell a substantial percentage of the Geron Shares in the public
market, XXXX agrees to appropriately manage the sale of such shares so as not to
detrimentally affect the price of the stock.
E. Accounting; Payments.
(i) Amounts owing to XXXX under Sections 2B and 4C
shall be paid on a quarterly basis, with such amounts due and received by XXXX
on or before the sixtieth (60th) 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 to XXXX at the address
provided in Section 16(a). All royalties owing with respect to Selling Prices
stated in currencies other than U.S. dollars shall be converted at the rate
published in the Wall Street Journal for the last day of the calendar quarter.
(iii) A full accounting showing how any amounts owing to
XXXX under Sections 2B and 4C 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 Geron or its sublicensees apply a
royalty reduction to the Selling Price of Products or Research Products as set
forth in Section 4C(ii), Geron or its sublicensees shall supply XXXX with
reasonable documentation evidencing the sales of Competing Products to support
such reduction in royalty rate. 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 except as otherwise provided under
Section 14 of this Agreement with respect to U.S. Government interests, it is
the owner of the Licensed Patents or otherwise has the right to grant the
licenses granted to Geron in this Agreement. However, nothing in this Agreement
shall be construed as:
(i) a warranty or representation by XXXX as to the
validity or scope of any of Licensed Patents;
(ii) a warranty or representation that anything made,
used, sold or otherwise disposed of under the license granted in this Agreement
will or will not infringe patents of third parties; or
(iii) an obligation to furnish any know-how not provided
in Licensed Patents or any services other than those specified in this
Agreement.
X. XXXX MAKES NO REPRESENTATIONS, EXTENDS NO WARRANTIES OF
ANY KIND, EITHER EXPRESS OR IMPLIED, AND ASSUMES NO RESPONSIBILITIES WHATSOEVER
WITH RESPECT TO USE, SALE, OR OTHER DISPOSITION BY GERON OR ITS VENDEES OR OTHER
TRANSFEREES OF PRODUCTS INCORPORATING OR MADE BY USE OF INVENTIONS LICENSED
UNDER THIS AGREEMENT.
X. Xxxxx warrants that it will not perform the following
three experiments with Materials provided by XXXX, WiCell or the University of
Wisconsin or derived therefrom: (a) intermixing of Materials with an intact
embryo, either human or nonhuman; (b) implanting Materials or products of
Materials in a uterus; and (c) attempting to make whole embryos by any method.
X. Xxxxx represents and warrants that it has, or will obtain,
the expertise necessary to develop and market Products and Research Products and
that it will actively and diligently pursue development of Products and Research
Products for sale in the commercial market. Notwithstanding the foregoing, the
exclusive remedies for Geron's breach of the warranty set forth in this Section
5D, are those provided in Sections 3A(iii)(d), 7A and 7D, and only to the extent
that a milestone for a Product in the Exclusive Field is missed by more than *
as specified in Section 3A(iii)(d), or commencement of clinical
9
trials or product launch for Therapeutic Products is delayed as specified in
Section 7A, or Geron ceases active development of a cell type for therapeutic
and diagnostic purposes for 12 months as specified in Section 7D.
Section 6. Recordkeeping.
A. Beginning when the first of the Products or Research
Products is sold, Geron and its sublicensee(s) shall keep books and records
sufficient to verify the accuracy and completeness of Geron's and its
sublicensee(s)'s accounting referred to above, including without limitation
inventory, purchase and invoice records relating to the Products or Research
Products or their manufacture. 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; however, XXXX shall initially have only the right to
audit the most recent three (3) years of books and records. If a discrepancy of
five percent (5%) or more of the royalties paid in any given year is found, XXXX
shall have the right to audit an additional three (3) years of books and
records.
X. Xxxxx and its sublicensee(s) shall take all steps
necessary so that XXXX may within thirty (30) days of its request review and
copy all the books and records at a single U.S. location to verify the accuracy
of Geron's and its sublicensee(s)'s accounting. Such review may be performed no
more than annually by any independent attorney or registered CPA designated by
XXXX, upon reasonable notice and during regular business hours.
C. If a royalty payment deficiency is determined, Geron and
its sublicensee(s) shall pay the royalty deficiency outstanding within thirty
(30) days of receiving written notice thereof, plus interest on outstanding
amounts as described in Section 4E(i).
D. If a royalty payment deficiency for a calendar year
exceeds five percent (5%) of the royalties paid for that year, then Geron or its
sublicensee shall be responsible for paying XXXX'x out-of-pocket expenses
incurred with respect to the audit that identified the deficiency.
Section 7. Term and Termination.
A. The term of this Agreement shall begin on the effective
date of this Agreement and continue until the earlier of (i) the date that no
Licensed Patent remains an enforceable patent or the date that the Extended
Royalty Period (defined below) ends, whichever is later, or (ii ) the date that
the payment of earned royalties under Section 4C, once begun, ceases for more
than eight (8) consecutive calendar quarters. In light of the long development
process before Geron will bring Therapeutic Products to market, in consideration
for XXXX'x having provided the Materials to Geron and XXXX'x agreement to
provide to Geron additional Materials under Section 2D, Geron agrees to pay to
XXXX royalties on Therapeutic Products, at a stepped-down royalty rate, for an
"Extended Royalty Period" after the expiration of the last Licensed Patent to
expire. Such stepped-down royalty rate shall be * percent (* %) of the royalty
rates specified for such Therapeutic Products in Section 4C of this Agreement.
The Extended Royalty Period shall begin on the date that none of the Licensed
Patents listed in Appendix B as of * remains an enforceable patent, and continue
for each cell type for whichever of the following two periods is longer for that
cell type:
(i) The number of months between * and the commencement
of the first human clinical trial on a Therapeutic Product for that cell type.
(ii) If the date of launch of the first Therapeutic
Product for that cell type is later than the launch milestone in the Specific
Development Plan for that cell type (as adjusted for changes made by agreement
under Section 3A(ii) or by Geron under Section 3A(iii) for delays outside
Geron's control, but not adjusted for changes made by Geron under Section
3A(iii)(c) for delays within Geron's control), the cumulative months of delay
attributable to reasons within Geron's control (as defined in Section
3A(iii)(c)) for which XXXX has not agreed in writing to waive the consequences.
X. Xxxxx may terminate this Agreement at any time by giving
at least ninety (90) days' written and unambiguous notice of such termination to
XXXX. Such a notice shall be accompanied by a statement of the reasons for
termination. The royalty provisions of Section 4C shall survive Geron's
termination of this Agreement prior to its expiration under this Section 7B with
respect to any Products or
10
Research Products sold by Geron or its sublicensees before the date this
Agreement would have expired under Section 7A.
C. If Geron at any time defaults in the timely payment of any
monies due to XXXX or the timely submission to XXXX of any Development Report,
or commits any breach of any other covenant herein contained, and Geron fails to
remedy any such breach or default within ninety (90) days after written notice
thereof by XXXX, XXXX may, at its option, terminate this Agreement by giving
written notice of termination to Geron. Notwithstanding the foregoing, XXXX
shall have no right to terminate, and no other remedy, for Geron's failure to
meet milestones in or otherwise adhere to Geron's Specific Development Plans,
Geron's failure to have or obtain necessary expertise, or Geron's failure to
develop Products or Research Products actively and diligently, except as
provided in Sections 3A(iii)(d), 7A and 7D.
D. On thirty (30) days written notice, XXXX may terminate
Geron's license under Section 2A(i) or 2A(ii) with respect to any particular
cell type if Geron ceases active development of such cell type for both
diagnostic and therapeutic purposes (i.e., Geron pursues neither one) for a
continuous period of * months. If XXXX asserts that Geron has ceased active
development and Geron disagrees, Geron may submit the issue to Truncated
Arbitration.
E. Upon the termination of this Agreement, Geron shall remain
obligated to provide an accounting for and to pay royalties earned up to the
date of the termination and any minimum royalties shall be prorated as of the
date of termination by the number of days elapsed in the applicable calendar
year.
Section 8. Assignability.
This Agreement may not be transferred or assigned by Geron except to a
company in which Geron owns at least fifty percent (50%) of the equity, upon
sale or transfer of substantially all the assets of Geron, or with the prior
written consent of XXXX.
Section 9. Enforcement.
X. XXXX intends to protect the Licensed Patents against
infringers or otherwise act to eliminate infringement, when, in XXXX'x sole
judgment, such action may be reasonably necessary, proper, and justified. In the
event that Geron believes there is infringement of any Licensed Patent under
this Agreement which is to Geron's substantial detriment, Geron shall provide
XXXX with written notice that such infringement is occurring including
reasonable evidence of the infringement. Within three (3) months of receiving
such written notice from Geron, XXXX shall either take action to xxxxx the
infringement or notify Geron in writing that it does not intend to take action
to xxxxx the infringement. In the event that XXXX notifies Geron that it elects
not to take action to xxxxx the infringement, XXXX shall at the same time notify
Geron as to whether XXXX consents to Geron taking action to xxxxx the
infringement. The decision to allow Geron to take action to enforce the Licensed
Patents shall be at XXXX'x sole discretion.
B. In the event that XXXX does take action to xxxxx the
infringement, it shall do so at its own expense. Upon reasonable request by
XXXX, and if the cause of action arose during the term of this agreement and
subject to XXXX reimbursing Geron for reasonable out-of-pocket expenses as
provided below, Geron shall take action, join in an action, and otherwise
provide XXXX with such assistance and information as may be useful to XXXX in
connection with XXXX'x taking such action. Geron shall have a right to review
and comment, in accordance with the confidentiality obligations set forth in
Section 19, on XXXX'x enforcement of the Licensed Patents in the Licensed Field,
including the right to review any proposed settlement of an infringement action
prior to XXXX'x entering into such an agreement. Any recovery or damages for
infringement derived through XXXX taking such action shall be applied as
follows: (a) first, to XXXX to reimburse XXXX for the expenses of the
litigation, including reasonable attorneys' fees, (b) second, to Geron to
reimburse Geron for its reasonable expenses in assisting with such litigation,
including reasonable attorneys' fees, and (c) the balance of any recovery or
damages, except enhanced damages, shall be divided * to Geron and * to XXXX.
C. If XXXX does not take action to xxxxx the infringement of
the Licensed Patents within three (3) months of receiving the notice described
above, Geron may reduce royalties as specified in
11
Section 9C(i) below or, with XXXX'x written consent, bring an action to enforce
the Licensed Patents as specified in Section 9C(ii) below.
(i) The royalties owed under Section 4C on sales of
Products or Research Products in a country in the Patent Territory (as
defined in Section 4C(ii)) in which Infringing Products (as defined
below) are sold shall be reduced by * percent (* %) in such country
until such infringement is abated. Additionally, in the event that the
total sales of Infringing Products (either by an individual infringer,
or collectively in the case of multiple infringers) exceed * percent (*
%) of the total sales of Products or Research Products sold by Geron and
its sublicensees with which the Infringing Products compete, then the
royalty owed by Geron and its sublicensees on sales of such Products or
Research Products in that country shall be reduced to zero until such
infringement is abated. "Infringing Products" means products or services
that infringe one or more claims of a Licensed Patent and which are not
sold under a license from XXXX or WiCell.
(ii) With XXXX'x written consent, which shall be at the
sole discretion of XXXX, Xxxxx may elect to enforce the Licensed Patents
at its own expense. Any recovery or damages for infringement derived
through Geron taking such action shall be applied as follows: (a) first,
to Geron to reimburse Geron for the expenses of the litigation,
including reasonable attorneys' fees, (b) second, to XXXX to reimburse
XXXX for its reasonable expenses in assisting with such litigation,
including reasonable attorneys' fees, and (c) the balance of any
recovery or damages, except enhanced damages, shall be divided * to XXXX
and * to Geron.
Section 10. Contest of Validity.
In the event Geron contests the validity of any Licensed Patent, Geron
shall continue to pay royalties 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 11. Patent Marking.
Geron shall insure that it and its sublicensee(s) apply patent markings
that meet all requirements of U.S. law, 35 U.S.C. 287, with respect to all
Products subject to this Agreement.
Section 12. Product Liability; Conduct of Business.
X. Xxxxx and its sublicensee(s) shall, at all times during
the term of this Agreement and thereafter, indemnify, defend and hold XXXX and
the inventors of the Licensed Patents harmless against all claims and expenses,
including legal expenses and reasonable attorneys fees, arising out of the death
of or injury to any person or persons or out of any damage to property and
against any other claim, proceeding, demand, expense and liability of any kind
whatsoever (other than patent infringement claims) resulting from the
production, manufacture, sale, use, lease, consumption or advertisement of
Products arising from any right or obligation of Geron or any sublicensee
hereunder. Notwithstanding the above, XXXX at all times reserves the right to
retain counsel of its own to defend XXXX'x interests.
X. Xxxxx warrants that it now maintains and will continue to
maintain liability insurance coverage appropriate to the risk involved in
marketing the products subject to this Agreement and that such insurance
coverage lists XXXX and the inventors of the Licensed Patents 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, Geron will
present evidence to XXXX that the coverage is being maintained with XXXX and its
inventors listed as additional insureds. In addition, Geron shall provide XXXX
with at least 30 days prior written notice of any change in or cancellation of
the insurance coverage.
Section 13. Use of Names.
Geron and its sublicensee(s) shall not use XXXX'x name, the name of any
inventor of inventions governed by this Agreement, or the name of the University
of Wisconsin in sales promotion, advertising, or any other form of publicity
without the prior written approval of the entity or person whose name is being
used; except that Geron may use the following statement:
12
Geron supported research by Dr. Xxxxx Xxxxxxx at the University of
Wisconsin-Madison which resulted in the successful derivation of human
embryonic stem cells. Geron has a license agreement with Wisconsin
Alumni Research Foundation under the patents on human embryonic stem
cells. Geron's license is exclusive for therapeutic and diagnostic
products based on neural cells, cardiomyocytes, and pancreatic islet
cells made from human embryonic stem cells; nonexclusive for therapeutic
and diagnostic products based on hematopoietic cells, osteoblasts, and
chondrocytes made from human embryonic stem cells; and nonexclusive for
research products based on hepatocytes, neural cells, myocytes,
pancreatic islet cells, hematopoietic cells, and osteoblasts made from
human embryonic stem cells.
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,
then:
A. The United States Government is entitled, as a right,
under the provisions of 35 U.S.C. Section 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
invention of such Licensed Patents for governmental purposes. Any license
granted to Geron in this Agreement shall be subject to such right. In the event
there is assertion by the Government of such rights, Geron may be entitled to
modification of the royalty and license fee provisions of the Agreement.
B. Any Products in the Exclusive Field embodying the
invention or produced through the use of the invention will be manufactured
substantially in the United States.
Section 15. Miscellaneous.
A. This Agreement shall be construed in accordance with the
internal laws of the State of Wisconsin.
B. If any dispute arising under this Agreement results in
litigation, both parties hereby waive and agree not to request a jury trial.
C. If 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. The parties further agree that they shall use good faith efforts to
reform the invalid and/or unenforceable clause(s) so as to render them valid and
enforceable and, to the extent possible, in conformance with the intent of the
parties. The Parties then shall execute a new agreement having the same
effective date as this Agreement.
D. The parties hereto are independent contractors and not
joint venturers or partners.
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
fax, 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) Wisconsin Alumni Research Foundation
Attn: Managing Director
13
000 Xxxxxx Xxxxxx
Xxxxxxx, Xxxxxxxxx 00000
Fax: (000) 000-0000
(b) Geron Corporation
Attn: Vice President, Corporate Development
000 Xxxxxxxxxxxx Xxxxx
Xxxxx Xxxx, XX 00000
Fax: (000)000-0000
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, acknowledgement, 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.
Section 18. Contract Formation and Authority.
The persons signing on behalf of XXXX and Xxxxx hereby warrant and
represent that they have authority to execute this Agreement on behalf of the
party for whom they have signed.
Section 19. Confidentiality.
"Confidential Information" shall mean any non-public and/or proprietary
information identified as confidential by the disclosing party, including
without limitation Geron's Development Plans, Work Plans and Development
Reports, the Licensed Patents and all information concerning them, and any other
information exchanged between the parties hereto that is marked confidential or
accompanied by correspondence indicating such information is confidential. In
the course of this Agreement, either or both of the parties may disclose
Confidential Information to the other. The recipient of the Confidential
Information will use it only for the purposes of this Agreement, and will not
disclose it except to its employees and designees for those purposes. Each of
the parties will ensure that its employees and designees who receive access to
the other party's Confidential Information are legally obligated to maintain the
confidentiality of such Confidential Information, and such party shall be
responsible for the compliance of its employees and designees. Neither party
will use any of the other party's Confidential Information to its advantage and
to the other party's detriment, and in particular neither party will use
Confidential Information to claim priority, in its own patent applications, to
the other party's patent applications. Each party represents to the other that
the terms of this Section 19 do not conflict with any of the representing
party's obligations to any other person or entity.
The restrictions on use and disclosure of Confidential Information shall
not apply to information to the extent any of the following is true:
(a) the information is now, or hereafter becomes, through no act
or failure to act on the part of the recipient, generally known
or available to the public;
(b) the information is known by the recipient before it receives
the information;
(c) the information is furnished to the recipient by a third
party who did not acquire the information directly or indirectly
from the disclosing party;
(d) the information is independently developed by the recipient
without use or knowledge of the Confidential Information;
(e) the information is required by law or by order of any court
or governmental authority to be disclosed by the recipient. In
the event of such compulsory disclosure, however, the recipient
shall give the disclosing part sufficient advance written notice
to enable it to seek a protective order or other remedy to
protect such Confidential Information. The
14
recipient may disclose only the minimum Confidential Information
required to be disclosed, whether or not a protective order or
other remedy is in place.
Section 20. Favored Licensee.
A. If XXXX hereafter grants to any third party a license
under one or more of the Licensed Patents to make, use and sell Products in the
Nonexclusive Field at earned royalty rates which are lower than those provided
in this Agreement for the applicable Licensed Patents, then XXXX will (i)
promptly notify Geron of the existence of such a license; and (ii) in such
notice, offer to Geron the lower royalty rate/structure, effective as of the
date on which they became effective in respect to the noticed license.
B. Such new royalty rates shall only be effective if, within
thirty (30) days after receipt of the notice provided in Section 20A(i), Geron
notifies XXXX that it accepts the new royalty rates as offered.
C. If the third party's license under the applicable Licensed
Patent expires or is terminated, the royalty rate to be paid by Geron shall, at
XXXX'x option, return to the rate specified in this Agreement, effective * after
the later of the date of such termination or expiration or the date XXXX
notifies Geron of such termination or expiration.
D. Any new royalty rates shall become effective only with
respect to those cell types that are licensed to the third party at the lower
rate and Geron shall continue to pay XXXX earned royalties at the rates
specified in this Agreement for any Products based on other cell types. In
addition, any new royalty rates shall be effective only with respect to Products
made, used and sold in an indication for which Geron has submitted, or submits a
development plan to XXXX and in the territory in which the third party may make,
use and sell Products under the lower royalty.
E. No settlement between XXXX and any third party of claims
for infringement occurring prior to the execution of such settlement shall be
considered the grant of a license under this Section 20; however, any license
granted to such third party by reason of the settlement shall be considered a
license, but only to the extent it permits the third party to make, use and sell
Products under a Licensed Patent in the Nonexclusive Field and the Licensed
Territory after the settlement agreement is executed.
Section 21. Cooperation.
The parties acknowledge that in the course of Geron's development of
Products and Research Products, issues may arise that were not anticipated or
adequately addressed in this Agreement. Both parties will work in good faith to
identify those issues, understand the other party's interests and concerns with
respect to those issues, and explore reasonable and fair ways of addressing
those issues. In particular, the parties acknowledge that it is possible that
some of the provisions of this Agreement will be objectionable to potential
Collaborators or Development Partners of Geron, and that it may be in the
interests of both parties to modify those provisions. XXXX agrees to discuss
with Geron the possibility of modifying those provisions if and when such
objections arise, but shall not be obligated to agree to any such modification.
Both parties also agree to work to maintain a spirit of cooperation,
collaboration, and open and clear communication between them on all matters.
IN WITNESS WHEREOF, the parties hereto have duly executed this Agreement
on the dates indicated below.
WISCONSIN ALUMNI RESEARCH FOUNDATION
By: /s/ Xxxx X. Xxxxxxxxxxx Date: 1/8/2002
----------------------------------------------- --------
Xxxx X. Xxxxxxxxxxx, Managing Director
GERON CORPORATION
By: /s/ Xxxxxx X. Xxxxxx Date: 1/8/02
----------------------------------------------- ------
Xxxxxx X. Xxxxxx, Ph.D. M.D., CEO
15
-----------------------------------------------------------------
Reviewed by XXXX'x General Counsel:
/s/ Xxxxxxxxx X.X. Xxxxxx
-------------------------
Xxxxxxxxx X.X. Xxxxxx, Esq.
1/8/02
(XXXX'x attorney shall not be deemed a signatory to this Agreement.)
XXXX Ref.: Xxxxxxx-P96014US
16
APPENDIX A
DEFINITIONS
A. "Licensed Patents" shall refer to and mean those patents and
patent applications listed on Appendix B attached hereto that are in countries
in the Licensed Territory and any subsequent patent application owned by XXXX,
including divisionals, continuations, continuations-in-part, reissues, and
reexaminations in a country in the Licensed Territory.
B. "Products" shall refer to and mean Therapeutic Products and
Diagnostic Products.
C. "Therapeutic Products" shall refer to and mean products or
services other than Diagnostic Products that (i) are used in the treatment of
disease in humans, and (ii) employ, are in any way produced by the practice of,
are identified using or arise out of any research involving the inventions
claimed in the Licensed Patents or that would otherwise constitute infringement
of any claims of the Licensed Patents. For avoidance of doubt, the parties agree
and acknowledge that (i) the use of a Research Product by a third party
purchaser, which purchased the Research Product in an arms' length transaction
(which transaction, in the case of a third party which is a Collaborator,
Contract Service Provider, or Development Partner, is not part of the
collaboration with Geron), to identify, create or otherwise produce a product
does not make that product a Therapeutic Product, and (ii) Geron's use of a
Research Product to screen or profile a known substance or library of known
substances from which a product is developed does not make that product a
Therapeutic Product.
D. "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) employ, are in any way produced by the practice
of, are identified using or arise out of any research involving the inventions
claimed in the Licensed Patents or that would otherwise constitute infringement
of any claims of the Licensed Patents. For avoidance of doubt, the parties agree
and acknowledge that (i) the use of a Research Product by a third party
purchaser, which purchased the Research Product in an arms' length transaction
(which transaction, in the case of a third party which is a Collaborator,
Contract Service Provider, or Development Partner, is not part of the
collaboration with Geron), to identify, create or otherwise produce a product
does not make that product a Diagnostic Product, and (ii) Geron's use of a
Research Product to screen or profile an known substance or library of known
substances from which a product is developed does not make that product a
Diagnostic Product.
E. "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 include any material that, but for this license,
would infringe one or more claims of the Licensed Patents or which are
manufactured by any method, or using as any material, that, but for this
license, would infringe one or more claims of the Licensed Patents. For
avoidance of doubt, the parties agree and acknowledge that the license in
Section 2A(iii) includes the right to use Materials in the production of
Research Products (including in services). However, Geron agrees that Research
Products does not include the Materials themselves nor shall Geron distribute
Materials to third parties other than sublicensees in the Exclusive Field,
Contract Service Providers, Collaborators and Development Partners. XXXX agrees
that Materials may be used in "services" within the definition of Research
Products by Geron and its Contract Service Providers, Collaborators, and
Development Partners, but that Contract Service Providers and Collaborators may
not sell such services to third parties other than as Geron's agent.
F. "Selling Price" shall mean, in the case of Products or Research
Products (including services) that are sold by Geron or Geron's sublicensee, the
price to the end user of Products (regardless of uncollectible accounts) less
any shipping costs, allowances because of returned Products or Research
Products, value added taxes (or comparable duties as required in each country)
or sales taxes. For purposes of this Agreement, the term "price to the end user"
shall mean the price paid to Geron or Geron's sublicensee for Products or
Research Products by its customer assuming an arm's length transaction. In the
event that Geron or Geron's sublicensee sells Products or Research Products to
an Affiliate, the price shall be deemed that amount that Geron would have
received if it had sold such Products or Research Products to an unaffiliated
third-party. The Selling Price for a Product or Research 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 or Research Product during the applicable calendar year, but only to the
extent the number of Products or Research Products so transferred exceeds *
percent (* %) of the annual
17
total of Products or Research Products sold. All taxes, assessments, or other
charges of any kind which may be imposed on sales of Products or Research
Products 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 shall be paid by Geron.
G. "Development Report" shall mean a written account of Geron's
progress in development having at least the information specified on Appendix D
to this Agreement, and shall be sent to the address specified on Appendix D.
H. "Materials" shall refer to and mean the primate, including human,
embryonic stem cells claimed in the Licensed Patents.
I. "Exclusive Field" shall mean the use in Therapeutic Products or
Diagnostic Products of the following cell types, and precursors of such cell
types, developed from and/or incorporating the Materials or derivatives of the
Materials: neural cells, cardiomyocytes, and pancreatic islet cells.
Notwithstanding Geron's exclusivity, to the extent a precursor of a cell type
within the Exclusive Field is also a precursor of a cell type outside the
Exclusive Field, XXXX is not restricted from granting licenses to third parties
for the use of such precursor.
J. "Nonexclusive Field" shall mean the use in Therapeutic Products
or Diagnostic Products of the following cell types, and precursors of such cell
types, developed from and/or incorporating the Materials or derivatives of the
Materials: hematopoietic cells, osteoblasts, and chondrocytes.
K. "Research Products Field" shall mean the use in Research Products
of the following cell types, and precursors of such cell types, developed from
and/or incorporating the Materials or derivatives of the Materials: hepatocytes,
neural cells, myocytes, pancreatic islet cells, hematopoietic cells, and
osteoblasts.
L. "Research-Related Field" shall mean any use of Therapeutic
Products, Diagnostic Products or Research Products that arise out of research
under the nonexclusive license for Internal Research granted in Section 2A(v)
that is outside the Exclusive Field, the Nonexclusive Field, and the Research
Products Field. However, in no event shall Products or Research Products in the
Research-Related Field comprise the Materials or cells derived from the
Materials.
M. "Licensed Territory" shall be worldwide.
N. "Contract Service Provider" shall mean a person or organization
with which Geron enters into a written contract for the provision of specific
services (e.g., testing, contract manufacturing, distribution, etc. to Geron) in
support of Geron's commercialization of Products or Research Products.
O. "Collaborator" shall mean a person or organization with which
Geron enters into a written agreement for a specific project or projects to be
directed by Geron involving research on and/or development of Materials and
cells derived from Materials in support of Geron's commercialization of Products
or Research Products.
P. "Development Partner" shall mean a person or organization with
which Geron enters into a specific written collaborative agreement (subject to
XXXX'x right to disapprove pursuant to Section 2B(ii)(c)) for research and
development, manufacturing, marketing, or other activities necessary for the
commercialization of Products or Research Products.
Q. "Truncated Arbitration" means an arbitration process meeting the
following criteria: (i) a specific issue or small group of related issues is
submitted to arbitration; (ii) a single neutral arbitrator (chosen by two
qualified arbitrators, of whom each party shall select one), with at least ten
(10) years of experience directly relevant to the issues in dispute, decides the
issue(s); (iii) each party submits concise written facts and arguments (not more
than 50 pages); (iv) the arbitrator holds a single hearing, with informal
procedures, of not more than one day; and (v) the arbitrator renders a written
decision within no more than 90 days after the request for arbitration. The
parties may agree on the informal procedures and the place for the arbitration,
but in the absence of agreement the arbitrator will establish them.
R. "Geron IP" means those claims of any patent or patent
application, together with any reissues, continuations or divisional
applications arising therefrom and those claims of any continuation-in-
18
part application that are fully supported by such filings, that are assigned to
Geron, that are in the field of embryonic stem cells, and:
(i) that have a filing date before the date of this
Agreement; or
(ii) if Geron's license with respect to a cell type is
converted from exclusive to nonexclusive pursuant to Section 3A(iii)(d), that
relate specifically to that cell type and have a filing date before the date of
XXXX'x notice of conversion; or
(iii) if Geron's license with respect to a cell type is
terminated pursuant to Section 7D, that relate specifically to that cell type
and have a filing date before the date of XXXX'x notice of termination.
A claim in a patent or patent application "relates specifically to" a cell type
to the extent the claim pertains to a composition of matter comprising, or a
method of making, or a method of using, the cell type.
S. "Geron Options" means stock options granted pursuant to Geron's
1994 Stock Option Plan, with an exercise period of ten years and a strike price
equal to the closing price of Geron Shares as of the day prior to the date of
the event triggering the milestone. Geron shall use the Black-Scholes model for
purposes of calculating the value of the Geron Options.
T. "Geron Shares" means shares of Geron common stock.
U. "Licensed Field" shall refer to and mean the Exclusive Field, the
Nonexclusive Field, and the Research Products Field.
V. "Affiliate" means an entity that controls, is controlled by, or
is under common control with Geron. For purposes of this definition, "control"
means greater than fifty percent (50%) of the voting shares or units of an
entity.
W. "Internal Research Purposes" means research conducted internally
at Geron but excludes human clinical trials and development work subsequent to
commencement of those clinical trials.
00
XXXXXXXX X
LICENSED PATENTS
------------------------------------------------------------------------------
REFERENCE PATENT ISSUE APPLICATION
NUMBER COUNTRY NUMBER DATE SERIAL NUMBER
*
==============================================================================
* UNITED STATES * *
==============================================================================
*
==============================================================================
* UNITED STATES * *
------------------------------------------------------------------------------
* PCT *
------------------------------------------------------------------------------
* CANADA *
------------------------------------------------------------------------------
* EPO *
==============================================================================
*
==============================================================================
* UNITED STATES *
------------------------------------------------------------------------------
* PCT *
------------------------------------------------------------------------------
* EPO *
==============================================================================
*
==============================================================================
* UNITED STATES *
------------------------------------------------------------------------------
* UNITED STATES *
==============================================================================
20
APPENDIX C
XXXX ROYALTY REPORT
AGREEMENT NO: INVENTOR: P#: P
--------- ------------------------------- ----
PERIOD COVERED: From: / / 199 Through: / / 199
----------------------- -------------------
PREPARED BY: DATE:
----------------------------- --------------------
APPROVED BY: DATE:
----------------------------- --------------------
If license covers several major product lines, please prepare
a separate report for each line. Then combine all product
lines into a summary report.
REPORT TYPE: [ ] SINGLE PRODUCT LINE REPORT:
[ ] MULTIPRODUCT SUMMARY REPORT. Page 1 of ______ Pages
[ ] PRODUCT LINE DETAIL. Line: _______ Tradename: ____ Page: ___
REPORT CURRENCY: [ ] U. S. DOLLARS [ ] OTHER
======================================================================================================
PERIOD ROYALTY AMOUNT
GROSS * LESS: NET ROYALTY ---------------------------
COUNTRY SALES ALLOWANCES SALES RATE THIS YEAR LAST YEAR
------------------------------------------------------------------------------------------------------
U.S.A.
------------------------------------------------------------------------------------------------------
Canada
------------------------------------------------------------------------------------------------------
Europe:
------------------------------------------------------------------------------------------------------
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------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------
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:____
21
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 product 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 Product that has become publicly available,
e.g., published articles, competing products, patents, etc.
2. Development work being performed by third parties other than Geron 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:
Wisconsin Alumni Research Foundation
Attn.: Contract Coordinator
000 Xxxxxx Xxxxxx
X.X. Xxx 0000
Xxxxxxx, XX 00000-0000
22
