EXHIBIT 10.1
CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT
PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIALS HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
AMENDED AND RESTATED COLLABORATION AGREEMENT
This AMENDED AND RESTATED COLLABORATION AGREEMENT (the "Agreement") dated
as of October 15, 2004 (the "Effective Date"), is entered into between CancerVax
Corporation's wholly owned subsidiary, Cell-Matrix, Inc., a Nevada corporation,
along with its Affiliates, successors and assigns (collectively herein
"Cell-Matrix"), having a place of business at 0000 Xxxxxxxxxx Xxxx, Xxxxxxxx, XX
00000, and Applied Molecular Evolution having its principal offices at 0000
Xxxxxxx Xxxxxx, Xxx Xxxxx, XX 00000, along with its Affiliates, successors and
assigns, including but not limited to Xxx Lilly and Company (collectively herein
"AME"). This Agreement supersedes and replaces that certain collaboration
Agreement, dated as of November 29, 1999 ("Effective Date of Prior Agreement"),
by and between Cell-Matrix (f/k/a Bio-Management) and Applied Molecular
Evolution (f/k/a Ixsys) together with the Amendments dated June 5, 2000 and July
3, 2000 (the "Prior Agreement").
NOW THEREFORE, in consideration of the promises and mutual covenants
contained herein, the parties agree as follows:
ARTICLE 1
DEFINITIONS
For purposes of this Agreement, the terms defined in the Article 1 shall
have the respective meanings set forth below:
1.1. "Affiliate" shall mean, with respect to any Person, any other Person
which directly or indirectly controls, is controlled by, or is under
common control with, such Person. A Person shall be regarded as in
control of another Person if it owns, or directly or indirectly
controls, at least forty percent (40%) of the voting stock or other
ownership interest of the other Person, or if it directly or
indirectly possesses the power to direct or cause the direction of
the management and policies of the other Person by any means
whatsoever.
1.2. "BLA" shall mean a Biologics License Application, Product License
Application, New Drug Application, or other application for
marketing approval of a product for use in any human or veterinary
therapeutic application submitted to the applicable governing health
authority of any country.
1.3. "Candidate Molecules" shall mean, collectively, monoclonal antibody
("mAb") HUIV26 and mAb HUI77 as provided by Cell-Matrix to AME
hereunder.
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1.4. "Confidential Information" shall mean, with respect to a party, all
information of any kind whatsoever (including without limitation,
data, compilations, formulae, models, patent disclosures,
procedures, processes, projections, protocols, results of
experimentation and testing, specifications, strategies and
techniques), and all tangible and intangible embodiments thereof of
any kind whatsoever (including without limitation, apparatus,
compositions, documents, drawings, machinery, patent applications,
records, reports), which is disclosed by such party to the other
party and is marked, identified as or otherwise acknowledged to be
confidential at the time of disclosure to the other party.
Notwithstanding the foregoing, Confidential Information of a party
shall not include information which the other party can establish by
written documentation (a) to have been publicly known prior to
disclosure of such information by the disclosing party to the other
party, (b) to have become publicly known, without fault on the part
of the other party, subsequent to disclosure of such information by
the disclosing party to the other party, (c) to have been received
by the other party at any time from a source, other than the
disclosing party, rightfully having possession of and the right to
disclose such information, (d) to have been otherwise known by the
other party prior to disclosure of such information by the
disclosing party to the other party, or (e) to have been
independently developed by employees or agents of the other party
without access to or use of such information disclosed by the
disclosing party to the other party.
1.5. "Derived" or "derived" shall mean obtained, developed, created,
synthesized, designed, derived or resulting from, based upon or
otherwise generated (whether directly or indirectly, or in whole or
in part).
1.6. "Field" shall mean human and veterinary therapeutic and diagnostic
applications.
1.7. "First Commercial Sale" shall mean, with respect to any Product, the
first sale of such Product by a party, its Affiliates or
sublicensees to customers who are not Affiliates in any country
after all applicable marketing and pricing approvals (if any) have
been granted by the applicable governing health authority of such
country.
1.8. "FDA" shall mean the United States Food and Drug Administration, or
the successor thereto.
1.9. "IND" shall mean an Investigational New Drug application, or any
other filing with the governing regulatory of any country to
commence clinical testing of a product for use in any human or
veterinary therapeutic application submitted to the applicable
governing health authority of any country.
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1.10. "Intellectual Property" shall mean trade secrets, Patents,
trademarks, trade names, copyrights, know-how and similar rights of
any type under the laws of any governmental authority, domestic or
foreign, including all applications and registrations relating to
any of the foregoing.
1.11. "Materials" shall mean the Candidate Molecules, DNA sequence
information and the cDNA to encode Candidate Molecules and the
hybridoma cell lines expressing the Candidate Molecules.
1.12. "Net Sales" shall mean, with respect to a Product, the gross amount
invoiced by Cell-Matrix, its Affiliates and sublicensees thereof or
AME, its Affiliates and sublicensees for sales of such Product to
unrelated Third Parties, excluding any sublicensee, for the Product
in the Territory, less:
(a) Trade, quantity and cash discounts allowed;
(b) Commissions, discounts, refunds, rebates, chargebacks,
retroactive price adjustments, and any other allowances which
effectively reduce the net selling price;
(c) Actual Product returns and allowances;
(d) Sales taxes, duties and other governmental charges (including
value added tax), but excluding what is commonly known as income
taxes.
Such amounts shall be determined from the books and records of
Cell-Matrix or sublicensee or AME, its Affiliates and sublicensees,
maintained in accordance with U. S. Generally Accepted Accounting
Principles or, in the case of sublicensees, such similar accounting
principles, consistently applied. Cell-Matrix and AME further agree
in determining such amounts, they will use their then current
standard procedures and methodology, including their then current
standard exchange rate methodology for the translation of foreign
currency sales into U.S. Dollars or, in the case of sublicensees,
such similar methodology, consistently applied.
1.13. "Patents" shall mean (i) all patents worldwide including without
limitation, all substitutions, reissues, renewals, reexaminations,
patents of addition, and inventor's certificates thereof; (ii) all
term extensions or other government action which provides exclusive
rights to an invention beyond the original patent expiration date;
and (iii) all pending patent applications (including provisional
applications, divisions, continuations, continued prosecutions and
continuations-in-part).
1.14. "Person" shall mean an individual, corporation, partnership, limited
liability company, trust, business trust, association, joint stock
company, joint venture, pool, syndicate, sole proprietorship,
unincorporated organization, governmental authority or any other
form of entity not specifically listed herein.
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1.15. "Phase II Clinical Trial" shall mean a human clinical trial in any
country that is intended to initially evaluate the effectiveness of
a product for a particular indication or indications in patients
with the disease or indication under study, or that would otherwise
satisfy requirements of 21 CFR 312.21(b), or its foreign equivalent.
1.16. "Phase III Study Initiation" means a pivotal human clinical trial
conducted in patients and designed to establish Product safety and
efficacy and required to obtain clinical registration of a product
with health regulatory authorities such as the FDA.
1.17. "PMA" shall mean a Product Marketing Application, 510(k) application
or other application for marketing approval of a product for use in
any human or veterinary diagnostic application submitted to the
applicable governing health authority of any country.
1.18. "Product" shall mean any product for use in the Field, which is a
composition that incorporates one or more Program Antibodies or is
derived from one or more Program Antibodies.
1.19. "Program" shall mean the collaborative research program described in
Section 3.1 below to optimize and humanize the Candidate Molecules,
and to use the Program Antibodies (as defined below) to evaluate
their diagnostic and therapeutic potential.
1.20. "Program Antibody" shall mean the optimized and humanized
compositions of matter developed under the Program, and the cDNA
encoding such compositions of matter, delivered to Cell-Matrix
hereunder.
1.21. "Program Invention" shall mean any invention, discovery,
composition, technology, data or information (whether or not
patentable), made or conceived by employees or others on behalf of
AME, Cell-Matrix or both in the performance of the Program during
the term of the Program, excluding Program Antibodies.
1.22. "Research Plan" shall mean the written research work plan
established by the parties pursuant to Section 3.2 below, as
modified from time to time pursuant to Section 3.2.
1.23. "Third Party" shall mean any Person other than AME, Cell-Matrix and
their respective Affiliates.
ARTICLE 2
REPRESENTATIONS AND WARRANTIES
2. Each party hereby represents and warrants to the other party as follows:
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2.1. Corporate Existence. Such party is a corporation duly organized,
validly existing and in good standing under the laws of the state in
which it is incorporated.
2.2. Authorization and Enforcement of Obligations. Such party (a) has the
corporate power and authority and the legal right to enter into this
Agreement and to perform its obligations hereunder, and (b) has
taken all necessary corporate action on its part to authorize the
execution and delivery of this Agreement and the performance of its
obligations hereunder. This Agreement has been duly executed and
delivered on behalf of such party, and constitutes a legal, valid,
binding obligation, enforceable against such party in accordance
with its terms.
2.3. Consents. All necessary consents, approvals and authorizations of
all governmental authorities and other Persons required to be
obtained by such party in connection with this Agreement have been
obtained.
2.4. No Conflict. The execution and delivery of this Agreement and the
performance of such party's obligations hereunder (a) do not
conflict with or violate any requirement of applicable laws or
regulations and (b) do not conflict with, or constitute a default
under, any contractual obligation of such party.
2.5. DISCLAIMER OF WARRANTIES. NEITHER PARTY MAKES ANY REPRESENTATIONS OR
WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE MATERIALS
(INCLUDING BUT NOT LIMITED TO THE CANDIDATE MOLECULES), INCLUDING
WITHOUT LIMITATION ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE OR NONINFRINGEMENT OF THE PATENT RIGHTS OR OTHER
INTELLECTUAL PROPERTY RIGHTS OF ANY OTHER PERSON.
ARTICLE 3
THE PROGRAM
3.1 Collaborative Research. The goal of the Program is to humanize and
optimize Candidate Molecules as detailed in Schedule A attached
hereto.
3.2 Conduct of Program. An initial Research Plan is attached as Schedule
A. Either party may recommend changes to the Research Plan at any
time during the Program Term. Such change shall only be effective if
in a written amendment duly executed by the parties.
3.3 Specific Obligations of Cell-Matrix. Cell-Matrix shall provide AME
with sufficient quantities of the Materials, sufficient quantities
of a single soluble antigen per Candidate Molecule for purposes of
screening and affinity determination (such single soluble antigen
per Candidate molecule shall be
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specified in writing prior to the transfer of the Materials to AME),
antigens to which the Materials are directed, and any Cell-Matrix
technology necessary or useful for the humanization and optimization
in accordance with the Program, and any information known and
available to Cell-Matrix concerning the storage of the Materials
that may be unique or peculiar to the Materials. Cell-Matrix shall
use its commercially reasonable efforts to perform its obligations
under the Program in accordance with the Research Plan. Cell-Matrix
shall perform its obligations under the Program in accordance with
high scientific and professional standards, and in compliance with
all material respects within the requirements of applicable laws and
regulations and shall provide all reasonable assistance to AME in
connection with AME's performance of the Program.
3.4 Specific Obligations of AME. AME shall optimize and humanize the
Candidate Molecules as set forth in the Research Plan. AME shall use
its commercially reasonable efforts to perform its obligations under
the Program in accordance with the Research Plan. AME shall provide
the personnel, materials, equipment and other resources required to
conduct its obligations under the Program. AME shall perform its
obligations under the Program in accordance with high scientific and
professional standards, and in compliance in all material respects
with the requirements of applicable laws and regulations.
3.5 Materials. AME shall use the Materials solely for purposes of
conducting the Program, at its address listed above, under
commercially and scientifically reasonable containment conditions,
and not for any commercial, business or other use or purpose,
without the prior express written consent of Cell-Matrix.
Notwithstanding anything to the contrary in this Agreement, AME
shall not transfer or provide access to the Materials to any Third
Party, without the prior express written consent of Cell-Matrix. AME
shall not transfer or transport the Materials from its address
identified above to any other location. AME shall limit access to
the Materials to those of its employees working on its premises, to
the extent such access is reasonably necessary in connection with
its activities as expressly authorized by this Agreement; provided,
however that each such employee shall be bound by confidentiality
obligations at least as stringent as those in Section 5.1.
3.6 Funding of the Program. In consideration of AME's performance of its
obligations under the Research Plan or the identification of a
Program Antibody demonstrating an affinity equal to or greater than
[***] times the initial affinity of the Candidate Molecule from
which that Program Antibody was derived as determined by an in vitro
assay to be agreed upon by the parties, Cell-Matrix shall pay to AME
the amounts set forth in Schedule B.
3.7 Term of the Program. Unless earlier terminated as provided herein,
the term of the Program shall begin on November 29, 1999, and
continue for the subsequent nineteen (19) months (the "Program
Term"). Cell-Matrix shall have the right (in its sole discretion),
exercisable by giving AME express written notice of
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the Commission. Confidential treatment has been requested with respect to the
omitted portions.
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such exercise not less than thirty (30) days prior to the expiration
of the Program Term, to extend the Program Term with respect to the
following Candidate Molecules: mAb XL313 and mAb FM155, for the
period commencing on the date ninety (90) days following the date
AME timely receives such notice of exercise from Cell-Matrix and
continuing for the subsequent seven (7) months.
3.8 Results.
3.8.1 Reports. Within thirty (30) days following the end of the
initial seven (7) month period of the Program, within thirty
(30) days following the expiration or termination of the
Program (if extended), and within thirty (30) days after the
end of each twelve (12) month period thereafter for the
following ten (10) years, each Party shall prepare, and
provide to the other party, a reasonably detailed written
report which shall describe the work performed by such party
during that period, and the results achieved, to date under
this Agreement, together with copies of all data resulting
from the tests and evaluation performed by such party to date
under the Agreement. Such reports shall include, without
limitation, summaries of pre-clinical animal studies of
efficacy, toxicity and immunogenicity, and regulatory filings
such as Investigational New Drug ("IND") applications, and
Phase I, Phase II and Phase III FDA reports.
3.8.2 Records. Each party shall maintain records, in sufficient
detail and in good scientific manner appropriate for patent
purposes, which shall be complete and accurate and shall
fully and properly reflect all work done and results achieved
in the performance of the Program.
3.8.3 Inspection of Records. Each party shall have the right,
during normal business hours and on reasonable written
notice, to inspect and copy such records of the other party
regarding the work done and results achieved in the
performance of the Program, to the extent reasonably
necessary to enable such party to conduct its obligations
under the Program or to exercise its rights hereunder. Each
party shall maintain such records of the other party
(together with the information contained therein) in
confidence in accordance with Article 5 below and shall not
use such records (or information) except to the extent
otherwise permitted by this Agreement.
3.9 Program Leaders. Each party shall appoint a person (a "Program
Leader") to coordinate its part of the Program. The Program Leaders
shall be the primary contacts between the parties with respect to
the Program. Each party shall notify the other within thirty (30)
days after the date of this Agreement of the appointment of its
Program Leader and shall notify the other party as soon as
practicable upon changing this appointment.
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3.10 Subcontracts. AME may not subcontract portions of the Program to be
performed by it in the normal course of its business without the
prior written consent of Cell-Matrix.
3.11 Sale of Program Antibodies. Subject to the terms and conditions
herein, AME xxxxx xxxxx, assigns, transfers and conveys to
Cell-Matrix all right title and interest in and to the Program
Antibodies and all Patent rights and other Intellectual Property
rights therein. AME shall not use the Program Antibodies, or the
suboptimized and humanized compositions of matter derived by AME
from the Candidate Molecules under the Program (or the cDNA encoding
such compositions of matter), for any purpose other than the
performance of its obligations under this Agreement.
3.12 Materials and Program Antibodies. The parties hereby acknowledge
that the Materials and the Program Antibodies are experimental in
nature and that they are provided "AS IS" AND WITHOUT ANY
REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, INCLUDING WITHOUT
LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR
ANY PARTICULAR PURPOSE OR ANY WARRANTY THAT THE USE OF THE MATERIALS
OR THE PROGRAM ANTIBODIES WILL NOT INFRINGE OR VIOLATE ANY PATENT OR
OTHER PROPRIETARY RIGHTS OF ANY THIRD PARTY.
3.13 Each party hereby represents that all employees and other persons
acting on its behalf in performing its obligations under the program
shall be obligated under a binding written agreement to assign to
it, or as it shall direct, all inventions made or conceived by such
employees or other persons.
3.14 Prosecution, Maintenance and Enforcement.
3.14.1 Cell-Matrix shall have the right, at its sole discretion, to
control the preparation, filing, prosecution, maintenance
and enforcement of all Patents which claim Program
Antibodies, with the exception that Xxxxxx Xxxxxxx Xxxxxxxx
& Xxxxxx, or another intellectual property counsel with
biotechnology expertise specifically in the field of human
antibodies, shall be appointed by mutual agreement between
the parties and retained as the intellectual property
counsel for the prosecution and maintenance of all Patents
which claim Program Antibodies.
3.14.2 The Parties hereby acknowledge that, as of the Effective
Date, all claims of the Patents are directed solely to
Program Antibodies ("Pending Applications"). As such,
Cell-Matrix will, at its sole discretion, control and pay
for the preparation, filing, prosecution,
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maintenance and enforcement of all Pending Applications. If
at some time in the future, AME requests Cell-Matrix to file
Program Invention claims, prosecution and assignment
obligations will be in accordance with Paragraph 3.14.3 and
3.14.4 herein or as otherwise agreed to by the parties.
3.14.3 In the event that Cell-Matrix desires to file a patent
application after the Effective Date which claims Program
Antibodies or Products or Program Inventions, Cell-Matrix
shall provide AME with a copy of any such patent application
prior to filing the first of such applications in any
jurisdiction, for review and comment by AME. Cell-Matrix
shall keep AME informed as to the status of patent matters
described in this Article 3 by providing AME copies of any
substantive documents that Cell-Matrix receives from any
patent office after receipt, and by providing the
opportunity, as far in advance of filing dates as reasonably
possible, to review and comment on any documents which will
be filed in any patent office. The Parties agree to
cooperate with and assist the other Party in connection with
such activities.
3.14.4 Cessation of Prosecution or Maintenance. Cell-Matrix shall
give notice to AME of any decision by Cell-Matrix to cease
the prosecution and maintenance of Pending Applications and
Patents which claim Program Antibodies, and, in such case,
AME shall have the right at its sole discretion and expense
to continue such prosecution or maintenance. If AME
continues prosecution or maintenance, Cell-Matrix shall
execute such documents and perform such acts as may be
reasonably necessary for AME to continue such prosecution or
maintenance. The prosecution by AME of any patent pursuant
to this section 3.14.4 shall not create any ownership
interest in such Patents or in such patentable subject
matter by AME that AME would not otherwise have hereunder.
3.14.5 Reports. Cell-Matrix shall provide AME with a written report
within sixty (60) days after the end of each calendar year
describing the status of Pending Applications and Patents
which claim Program Antibodies or Products. Such report
shall include at a minimum, the country names, patent
numbers, application numbers, filing dates, issuance dates,
expiration dates and any other relevant information.
3.14.6 Third Party Infringement. Cell-Matrix and AME each agrees to
take reasonable actions to protect Patents claiming Program
Antibodies or Products from a claim of infringement. In the
event that either party becomes aware that any such Patents
are being or have been infringed by any third party or are
subject to a declaratory action, such party shall promptly
notify the other party hereto in writing. AME further
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agrees that it will not notify any such third party of a
potential infringement without first obtaining the consent
of Cell-Matrix.
3.14.7 Enforcement: Cell-Matrix shall have the right, but not the
obligation, to bring suit in its own name to prosecute and
defend any action or proceeding which it deems necessary to
protect the Patents claiming Program Antibodies or Products,
including but not limited to actions or proceedings
involving infringement of such Patents. Cell-Matrix shall
have the sole right to control the conduct and disposition
of any such action or proceedings, and to retain any
compensation derived therefrom, whether by settlement or
otherwise. AME agrees to cooperate fully with Cell-Matrix in
any such actions or proceedings, including producing
documents, and making AME employees available for
consultation and testimony. If Cell-Matrix has not
instituted an action for infringement or has not commenced
negotiations for discontinuance of said infringement within
[***] after the notice provided for in 3.14.6 then AME shall
have the right to pursue such action in its own name, or
alternatively, the right to pursue such action in
Cell-Matrix's name but only if it has received Cell-Matrix's
consent to such action, such consent not to be unreasonably
withheld. If Cell-Matrix has commenced negotiations for
discontinuance of said infringement within such [***]
period, then the time period before AME may bring its own
suit or a suit in the name of Cell-Matrix shall be [***].
Any such actions initiated by AME shall be at AME's sole
expense. In any action where Cell-Matrix is a party,
Cell-Matrix shall have the right to control the conduct and
disposition of any such action or proceedings.
Notwithstanding the forgoing, in the event that the parties
enter into a commercialization agreement pursuant to
paragraph 7.5 of this Agreement, AME shall have the right to
control the action initiated by AME. In no event shall AME
enter into any settlement, consent judgment or other
voluntary final disposition of such suit which would
adversely affect validity and enforceability of the Patents
claiming Program Antibodies or Products or Cell-Matrix's
rights without first obtaining Cell-Matrix's written consent
thereto. [***]
3.14.8 Cell-Matrix hereby assigns to AME all right, title and
interest in the Program Inventions and all patent rights and
other Intellectual Property rights therein. AME shall have
the right, at its sole discretion,
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the Commission. Confidential treatment has been requested with respect to the
omitted portions.
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to control and pay for the preparation, filing, prosecution,
maintenance and enforcement of all Patent Applications and
Patents which claim Program Inventions. Nothing in this
Section 3.14.4 shall relieve AME from its confidentiality
obligations set forth in Article 5 below.
3.14.9 With regard to any assignments of Intellectual Property,
including all the rights in Intellectual Property thereof,
made or to be made by each Party to the other Party pursuant
to this Agreement, each Party agrees to take all acts deemed
necessary or desirable to the other Party to permit and
assist it, at the other Party's expense, in evidencing,
obtaining, maintaining, defending and enforcing the
assignment of all right, title, and interest to all such
inventions, including all patent and patent applications and
intellectual property thereof. Such acts may include, but
are not limited to execution of documents, and assistance or
cooperation in legal proceedings.
3.14.10 Retained Rights; No Further Rights. No right or license of
either Party is granted hereunder, other than the expressly
granted herein. No other license or rights, including
without limitation any license or rights in Materials,
Candidate Molecules or Program Antibodies, shall be granted
or created by implication, estoppel or otherwise.
3.14.11 Patent Enforcement. Each Party retains the right to control,
and, at its option and expense, to enforce and defend any
Intellectual Property owned solely by it.
ARTICLE 4
CONSIDERATION
4.1 Financial Terms.
4.1.1 Notice of First Commercial Sale. Within thirty (30) days
following the First Commercial Sale for each Product in each
country, and within thirty (30) days after the occurrence of
each of the milestone events described in Section 4.1.4
below, Cell-Matrix shall give written notice to AME thereof.
4.1.2 Royalties. In consideration for the sale of Program
Antibodies to Cell-Matrix, pursuant to Section 3.11 above,
Cell-Matrix shall pay to AME royalty equal to [***] of Net
Sales of Products sold by Cell-Matrix, its Affiliates and
sublicensees; provided, however, in the event that a Program
Antibody demonstrates an affinity equal to or greater than
[***] times the initial affinity of the Candidate Molecule
from which that Program Antibody was derived, Cell-Matrix
shall pay to AME a royalty equal to [***] of Net Sales of
Products sold by Cell-Matrix, its Affiliates and
sublicensees.
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omitted portions.
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4.1.3 [***]
4.1.4 Length of Royalty Obligations. Cell-Matrix's obligation to
pay royalties with respect to each Product in such country
shall commence on the First Commercial Sale for such Product
in such country, and shall continue for such Product in such
country until the date ten (10) years from the First
Commercial Sale.
4.1.5 Milestone Payments.
a. Cell-Matrix shall pay to AME [***] by November 29, 2004;
b. Within thirty (30) days after the first occurrence of each
of the following milestone events with respect to each
Product for use in any human or veterinary therapeutic
application, Cell-Matrix shall pay to AME the applicable
non-refundable, non-creditable milestone payment set forth
below:
[***] [***]
[***] [***]
[***] [***]
If any milestone event listed in this Section 4.1.5(b) is
achieved with respect to a Product for use in any human or
veterinary therapeutic application, and at such time any one
or more of the milestone events previously listed in this
Section 4.1.5(b) has not been achieved with respect to such
Product, then at the time of the payment of the milestone
payment for such achieved milestone event, Cell-Matrix shall
pay to AME the previously listed and unpaid payments for
such unmet milestone events. At the time of the First
Commercial Sale of a Product for use in any human or
veterinary therapeutic application, if any one or more of
the milestone events listed in this Section 4.1.5(b) has not
been achieved with respect to such Product, then within
thirty (30) days after the First Commercial Sale of such
Product, Cell-Matrix shall pay to AME all payments for such
unmet milestone events for such Product.
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omitted portions.
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c. Within thirty (30) days after the first occurrence of each
of the following milestone events with respect to each
Product for use in any human or veterinary diagnostic
application, Cell-Matrix shall pay to AME the applicable
non-refundable, non-creditable milestone payment set forth
below:
[***] [***]
[***] [***]
If any milestone event listed in this Section 4.1.5(c) is
achieved with respect to a Product for use in any human or
veterinary diagnostic application, and at such time any one
or more of the milestone events previously listed in this
Section 4.1.5(c) has not been achieved with respect to such
Product, then at the time of the payment of the milestone
payment for such achieved milestone event, Cell-Matrix shall
pay to AME the previously listed and unpaid payments for
such unmet milestone events. At the time of the First
Commercial Sale of a Product for use in any human or
veterinary diagnostic application, if any one or more of the
milestone events listed in this Section 4.1.5(c) has not
been achieved with respect to such Product, then within
thirty (30) days after the First Commercial Sale of such
Product, Cell-Matrix shall pay to AME all payments for such
unmet milestone events for such Product.
d. Within thirty (30) days after Cell-Matrix first grants or
transfers to, or authorizes, any other Person any license or
other right to conduct research (other than basic research
conducted at academic or non-profit institutions), develop
or commercialize any Product, Cell-Matrix shall pay to AME
[***] per Product.
e. Notwithstanding anything to the contrary in this Agreement,
Cell-Matrix shall not be obligated to pay each milestone
payment set forth above more than once with respect to each
milestone event described above, beyond one series of
milestone payments as encompassed by the provisions of this
Section 4.1.5, for all such Products derived from the same
Candidate Molecule.
4.2 Royalty Reports and Payment Terms.
4.2.1 Royalty Reports. Within thirty (30) days after the end of
each calendar quarter during the term of this Agreement
following the First Commercial Sale of a Product by
Cell-Matrix, its Affiliate, licensees or sublicensee,
Cell-Matrix shall furnish to AME a written report
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the Commission. Confidential treatment has been requested with respect to the
omitted portions.
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showing in reasonably specific detail, on a
Product-by-Product and country-by-country basis, (a) the
gross sales of all Products sold by Cell-Matrix, its
Affiliates, licensees, and sublicensees during such calendar
quarter and the calculation of Net Sales from such gross
sales; (b) the calculation of the royalties, if any, which
shall have accrued based upon such Net Sales; (c) the
withholding taxes, if any, required by law to be deducted
with respect to such sales; and (d) the exchange rates, if
any, used in determining the amount of United States
dollars.
4.2.2 With respect to sales of Products invoiced in United States
dollars, all such amounts shall be expressed in United
States dollars. With respect to sales of Products invoiced
in a currency other than United States dollars, all such
amounts shall be expressed both in the currency in which the
distribution is invoiced and in the United States dollar
equivalent. The United States dollar equivalent shall be
calculated using the exchange rate (local currency per US$1)
published in The Wall Street Journal, Western Edition, under
the heading "Currency Trading," on each of the last business
day of each month during the applicable calendar quarter.
4.2.3 Cell-Matrix shall keep complete and accurate records in
sufficient detail to properly reflect all gross sales and
Net Sales and to enable the royalties payable to be
determined.
4.3 Audits.
4.3.1 Upon the written request of AME and not more than once in
each calendar year, Cell-Matrix shall permit an independent
certified public accounting firm of nationally recognized
standing, selected by AME and reasonably acceptable to
Cell-Matrix, at AME's expense, to have access during normal
business hours to such of the records of Cell-Matrix as may
be reasonably necessary to verify the accuracy of the
royalty reports hereunder for any year ending not more than
[***] prior to the date of such request. The accounting firm
shall disclose to AME only whether the reports are correct
or not and the specific details concerning any
discrepancies. No other information shall be shared.
4.3.2 If such accounting firm concludes that additional royalties
were owed during the audited period, Cell-Matrix shall pay
the additional royalties within thirty (30) days of the date
AME delivers to Cell-Matrix such accounting firm's written
report so concluding. The fees charged by such accounting
firm shall be paid by AME; provided, however, if the audit
discloses that the royalties payable by Cell-Matrix for such
period are more than [***]
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14
of the royalties actually paid for such period, then
Cell-Matrix shall pay the reasonable fees and expenses
charged by such accounting firm.
4.3.3 AME shall treat all financial information subject to review
under this Section 4.3 as confidential, and shall cause its
accounting firm to retain all such financial information in
confidence.
4.3.4 Payment Terms. All royalties shown to have accrued by each
royalty report provided for under Section 4.1 above shall be
payable on the date such royalty report is due. Payment of
royalties in whole or in part may be made in advance of such
due date.
4.3.5 Payment Method. All payments by Cell-Matrix to AME under
this Agreement shall be paid in United States dollars, and
all such payments shall be originated from a United States
bank located in the United States and made by bank wire
transfer in immediately available funds to such account as
AME shall designate before such payment is due.
4.3.6 Exchange Control. If at any time legal restrictions prevent
the prompt remittance of part or all royalties with respect
to any country where the Product is sold, Cell-Matrix shall
have the right, at its option, to make such payments by
depositing the amount thereof in local currency to AME's
account in a bank or other depository in such country. If
the royalty rate specified in this Agreement should exceed
the permissible rate established in any country, the royalty
rate for sales in such country shall be adjusted to the
highest legally permissible or government-approved rate.
4.3.7 Withholding Taxes. Cell-Matrix shall be entitled to deduct
the amount of any withholding taxes, value-added taxes or
other taxes, levies or charges with respect to such amounts,
other than United States taxes, payable by Cell-Matrix, or
any taxes required to be withheld by Cell-Matrix, to the
extent Cell-Matrix pays to the appropriate governmental
authority on behalf of AME such taxes, levies or charges.
Cell-Matrix shall use reasonable efforts to minimize any
such taxes, levies or charges required to be withheld on
behalf of AME by Cell-Matrix. Cell-Matrix promptly shall
deliver to AME proof of payment of all such taxes, levies
and other charges, together with copies of all
communications from or with such governmental authority with
respect thereto.
ARTICLE 5
CONFIDENTIALITY
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5.1 Confidential Information. During the term of this Agreement, and for
a period of five (5) years following the expiration or earlier
termination hereof, each party shall maintain in confidence all
Confidential Information disclosed by the other party, and shall not
use, disclose or grant the use of the Confidential Information
except on a need-to-know basis to those directors, officers,
employees, consultants, clinical investigators, contractors,
sublicensees, distributors or permitted assignees, to the extent
such disclosure is reasonably necessary in connection with such
party's activities as expressly authorized by this Agreement. To the
extent that disclosure is authorized by this Agreement, prior to
disclosure, each party hereto shall obtain agreement of any such
Person to hold in confidence and not make use of the Confidential
Information for any purpose other than those permitted by this
Agreement. Each party shall notify the other promptly upon discovery
of any unauthorized use or disclosure of the other party's
Confidential Information.
5.2 Terms of this Agreement. Except as otherwise provided in Section 5.1
above, neither party shall disclose any terms or conditions of this
Agreement to any Third Party without the prior written consent of
the other party. Notwithstanding the foregoing, prior to execution
of this Agreement, the parties shall agree upon the substance of
information that can be used to describe the terms of this
transaction, and each party may disclose such information, as
modified by mutual agreement from time to time, without the other
party's consent.
5.3 Permitted Disclosures. The confidentiality obligations contained in
this Article 5 shall not apply to the extent that the receiving
party (the "Recipient") is required (a) to disclose information by
law, order or regulation of a governmental agency or a court of
competent jurisdiction, or (b) to disclose information to any
governmental agency for purposes of obtaining approval to test or
market a Product, provided in either case that the Recipient shall
provide written notice thereof to the other party and sufficient
opportunity to object to any such disclosure or to request
confidential treatment thereof.
5.4 Notice of Publication. During the term of the Agreement, AME and
Cell-Matrix each acknowledge the other party's interest in
publishing certain of its results to obtain recognition within the
scientific community and to advance the state of scientific
knowledge. Each party also recognizes the mutual interest in
obtaining valid patent protection and protecting business interests.
Consequently, either party, its employees or consultants wishing to
make a publication (including any oral disclosure made without
obligation of confidentiality) relating to work performed by such
party, which in the case of Cell-Matrix includes Program Inventions
and in the case of AME includes Program Antibodies, (the "Publishing
Party") shall transmit to the other party (the "Reviewing Party") a
copy of the proposed written publication [***] prior to the
presentation. The Reviewing Party shall have the right (a) to
propose modifications to the publication for patent reasons, (b) to
request a reasonable
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delay in publication in order to protect patentable information and
(c) to edit the publication in a manner reasonably acceptable to the
Publishing Party to protect its Confidential Information.
ARTICLE 6
DILIGENCE
Cell-Matrix shall use its best efforts to actively research, develop
and obtain regulatory approvals to market in major markets
throughout the world at least one Product hereunder as expeditiously
as possible, and following such approval to maximize sales of such
Product. Without limiting the foregoing, Cell-Matrix shall meet the
following diligence milestones by the dates set forth below:
6.1 Filing of IND. Cell-Matrix, its licensees or sublicensees shall file
an IND with the U.S. FDA for one or more Products under this
Agreement no later than February 28, 2006. Cell-Matrix shall use its
best efforts to obtain FDA approval of the IND within [***]. Within
[***] after the non-conditional approval of the IND for a Product,
Cell-Matrix, its licensees or sublicensees, shall be required to
have an active IND and to be actively and diligently conducting
clinical trials in pursuit of regulatory approval for such Product
in the U. S. until such Product may be sold commercially in the U.S.
6.2 Conduct of Clinical Trials. Cell-Matrix, its licensees or
sublicensees shall use its best efforts to conduct, as soon as
commercially practicable, such human clinical trials as are
necessary or desirable to obtain all regulatory approvals to develop
and commercialize in the U.S. each Product for which an IND has been
filed.
6.3 Obtain Regulatory Approvals. Cell-Matrix, its licensees or
sublicensees shall use its best efforts to obtain, as soon as
commercially practicable, regulatory approval to market in the U.S.
at least one Product, and obtain regulatory approval to market in
the United States at least one Product no later than [***].
ARTICLE 7
TERM AND TERMINATION
7.1 Expiration. Unless terminated earlier pursuant to Section 7.2 below,
this Agreement shall expire on the expiration of Cell-Matrix's
obligations to pay royalties under this Agreement.
7.2 Termination for Cause. A party may terminate this Agreement upon or
after the breach of any material provision of this Agreement by the
other party, if the breaching party has not cured such breach within
[***] after notice
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17
thereof from the other party; provided, however, that if the breach
is due to Cell-Matrix's failure to pay under Article 4 or Section
3.6, AME shall provide an additional notice of failure to pay and
allow Cell-Matrix a second [***] period to cure such breach. If
Cell-Matrix fails to cure such breach during the second [***]
period, AME shall provide a third and final notice of failure to pay
and allow Cell-Matrix a third and final [***] period to cure such
breach prior to any termination hereunder.
7.3 Effect of Expiration and Termination. Expiration or termination of
this Agreement shall not relieve the parties of any obligation
accruing prior to such expiration or termination. The provisions of
Articles 2, 5, 8, and Sections 3.8.1, 3.12, 7.4 and 9.11 shall
survive the expiration or termination of this Agreement.
7.4 Effect of Certain Breaches. In addition to all other rights and
remedies available by law or otherwise, in the event of a breach of
the provisions of Section 3.6 or Article 4 or 6 above, AME shall
have the right to terminate the Agreement pursuant to Section 7.2
thereof. In the event of such termination, Cell-Matrix shall grant
an exclusive license to AME under all Cell-Matrix's patent rights
relating to Program Antibodies, Products and the use thereof in the
Field. In addition, Cell-Matrix shall deliver to AME copies of all
data and information in Cell-Matrix's control resulting from
research related to the Program Antibodies and Products, and shall
assign and deliver to AME all copies of any and all regulatory
filings related to Program Antibodies and Products. In consideration
of the foregoing, AME shall pay to Cell-Matrix the following: (a)
[***] of cash consideration received by AME or its Affiliates in
consideration for licenses (including modified or renegotiated
sublicenses) granted thereunder (excluding royalties on sales) and
(b) with respect to sales, [***] received on Net Sales of Products
covered by Cell-Matrix's patents on Program Antibodies or Products
except for [***] of which shall be retained by AME; provided,
however, that in the event that AME sells Products directly, AME
shall only pay to Cell-Matrix a royalty equal to [***] of Net Sales
on Products sold by AME. In the event that such termination occurs
and an exclusive license to AME is granted pursuant to this Section
7.4 and Cell-Matrix previously has granted license or sublicense
rights to any third party, AME shall enter into a license or
sublicense, as the case may be, on substantially the same terms
provided that such third party agrees in writing to be bound by all
of the terms and conditions therein.
7.5 AME's Right of First Negotiation. Cell-Matrix hereby grants to AME a
right of first negotiation (hereinafter "the AME Right of First
Negotiation") to obtain from Cell-Matrix an exclusive, worldwide,
license under the Cell-Matrix Intellectual Property Rights related
to the making, using, and selling of Products should Cell-Matrix
intend to negotiate with or seek a collaborator for the
commercialization (other than the 3rd party manufacturing of a
Product for sale exclusively by Cell-Matrix). The AME Right of First
Negotiation shall be
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exercisable by AME in accordance with Section 7.5(g), below, and
shall operate as follows:
a) Cell-Matrix shall promptly notify AME in writing (the
"Cell-Matrix Notification") of its intention to negotiate with
or seek a collaborator for commercialization (other than the
3rd party manufacturing of a Product for Sale exclusively by
Cell-Matrix or any activity under the Development and
Sublicensing Agreement between Eyetech Pharmaceuticals, Inc
and Cell-Matrix dated March 5, 2001) of any Product. [***]
b) AME shall notify Cell-Matrix within [***] after receipt of
the Cell-Matrix Notification (the "AME Response Period"),
indicating its interest, if any, in initiating discussions
regarding an agreement with Cell-Matrix with respect to the
commercialization of such Cell-Matrix Product.
c) In the event that AME notifies Cell-Matrix prior to the
termination of the AME Response Period that it has an interest
in collaborating with Cell-Matrix in the commercialization of
such Cell-Matrix Product (an "AME Expression of Interest"),
then the Parties shall negotiate exclusively in good faith
reasonable terms that are intended to form the basis of a
final agreement for a period no longer than [***] from the
Cell-Matrix Notification.
d) In the event that (i) AME fails to notify Cell-Matrix prior
to the termination of the AME Response Period, or (ii) AME
notifies Cell-Matrix prior to the termination of the AME
Response Period that it has no interest in collaborating with
Cell-Matrix in the commercialization of a Product, or (iii)
the Parties fail to reach agreement on the terms that are
intended to form the basis of a final agreement within [***]
of the Cell-Matrix Notification, or (iv) the Parties fail to
reach a final agreement within [***] following the date on
which the Parties reach agreement on the terms that are
intended to form the basis of a final agreement, then
Cell-Matrix shall thereafter be free to develop such Product
on its own or to initiate discussions with potential
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omitted portions.
19
alternative partners with respect to the commercialization of
such Product; [***]
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the Commission. Confidential treatment has been requested with respect to the
omitted portions.
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ARTICLE 8
INDEMNITY
8.1 Indemnity.
8.1.1 By AME. AME shall indemnify and hold Cell-Matrix harmless,
and hereby forever releases and discharges Cell-Matrix, from
and against all losses, liabilities, damages and expenses
(including reasonable attorneys' fees and costs) resulting
from all claims, demands, actions and other proceedings by
any Third Party to the extent arising from (a) the breach of
any representation, warranty or covenant of AME under this
Agreement, (b) the use of the Materials by or, its
Affiliates, or (c) the gross negligence or willful
misconduct of AME, its Affiliates or licensees in the
performance of its obligations, and its permitted
activities, under this Agreement.
8.1.2 By Cell-Matrix. Cell-Matrix shall indemnify and hold AME
harmless, and hereby forever releases and discharges AME,
from and against all losses, liabilities, damages and
expenses (including reasonable attorneys' fees and costs)
resulting from all claims, demands, actions and other
proceedings by any Third Party to the extent arising from
(a) the breach of any representation, warranty or covenant
of Cell-Matrix under this Agreement, (b) the use of the
Materials by Cell-Matrix, its Affiliates or licensees (other
than AME), (c) the making, using or selling of Products
(including claims, demands, actions or other proceedings
based on strict liability), or (d) the gross negligence or
willful misconduct of Cell-Matrix, its Affiliates or
licensees (other than AME) in the performance of its
obligations, and its permitted activities, under this
Agreement.
8.2 Procedure. A party (the "Indemnitee") that intends to claim
indemnification under this Article 8 shall promptly notify the other
party (the "Indemnitor") of any claim, demand, action or other
proceeding for which the Indemnitee intends to claim such
indemnification. The Indemnitor shall have the right to participate
in, and to the extent the Indemnitor so desires jointly with any
other indemnitor similarly noticed, to assume the defense thereof
with counsel selected by the Indemnitor; provided, however, that the
Indemnitee shall have the right to retain its own counsel, with the
fees and expenses to be paid by the Indemnitor, if
21
representation of the Indemnitee by the counsel retained by the
Indemnitor would be inappropriate due to actual or potential
differing interests between the Indemnitee and any other party
represented by such counsel in such proceedings. The indemnity
obligations under this Article 8 shall not apply to amounts paid in
settlement of any claim, demand, action or other proceeding if such
settlement is effected without the prior express written consent of
the Indemnitor, which consent shall not be unreasonably withheld or
delayed. The failure to deliver notice to the Indemnitor within a
reasonable time after notice of any such claim or demand, or the
commencement of any such action or other proceeding, if prejudicial
to its ability to defend such claim, demand, action or other
proceeding, shall relieve such Indemnitor of any liability to the
Indemnitee under this Article 8 with respect thereto, but the
omission so to deliver notice to the Indemnitor shall not relieve it
of any liability that it may have to the Indemnitee otherwise than
under this Article 8. The Indemnitor may not settle or otherwise
consent to an adverse judgment in any such claim, demand, action or
other proceeding, that diminishes the rights or interests of the
Indemnitee without the prior express written consent of the
Indemnitee, which consent shall not be unreasonably withheld or
delayed. The Indemnitee, its employees and agents, shall reasonably
cooperate with the Indemnitor and its legal representatives in the
investigation of any claim, demand, action or other proceeding
covered by this Article 8.
8.3 Insurance. Each party shall maintain insurance with respect to the
development, manufacture and sales of Products by such party, its
Affiliates or sublicensees in such amounts as such party customarily
maintains with respect to the development, manufacture and sales of
its other products. Each party shall maintain such insurance for so
long as it continues to develop, manufacture or sell Products, and
thereafter for so long as it customarily maintains insurance for
itself covering the development, manufacture and sales of its other
products.
ARTICLE 9
MISCELLANEOUS
9.1 Notices. Any consent, notice or report required or permitted to be
given or made under this Agreement by one of the parties to the
other shall be in writing and addressed to such other party at its
address indicated below, or to such other address as the addressee
shall have last furnished in writing to the addressor, and shall be
effective upon receipt by the addressee.
If to AME: Xxx Xxxxx & Company
Lilly Xxxxxxxxx Xxxxxx
Xxxxxxxxxxxx, Xxxxxxx 00000
Attn: General Patent Counsel
22
If to Cell-Matrix: Cell-Matrix Inc.
0000 Xxxxxxxxxx Xxxx
Xxxxxxxx, XX 00000
Attn: General Counsel
9.2 Assignment. Except as otherwise expressly provided under this
Agreement neither this Agreement nor any right or obligation
hereunder may be assigned or otherwise transferred (whether
voluntarily, by operation of law or otherwise), without the prior
express written consent of the other party; provided, however, that
either party may, without such consent, assign this Agreement and
its rights and obligations hereunder in connection with the transfer
or sale of all or substantially all of its business related to this
Agreement or in the event of its merger, consolidation, change in
control or similar transaction. Any permitted assignee shall assume
all obligations of its assignor under this Agreement. Any purported
assignment or transfer in violation of this Section 9.2 shall be
void.
9.3 Applicable Law. This Agreement shall be governed by and construed in
accordance with the laws of the State of California, without regard
to the conflicts of law principles thereof.
9.4 Entire Agreement. This Agreement contains the entire understanding
of the parties with respect to the subject matter hereof. All
express or implied representations, agreements and understandings,
either oral or written, heretofore made are expressly superseded by
this Agreement. This Agreement may be amended, or any term hereof
modified, only by a written instrument duly executed by both
parties.
9.5 Headings. The captions to the several Articles and Sections hereof
are not a part of this Agreement, but are merely guides or labels to
assist in locating and reading the several Articles and Sections
hereof.
9.6 Independent Contractors. Each party hereby acknowledges that the
parties shall be independent contractors and that the relationship
between the parties shall not constitute a partnership, joint
venture or agency. Neither party shall have the authority to make
any statements, representations or commitments of any kind, or to
take any action, which shall be binding on the other party, without
the prior consent of the other party to do so.
9.7 Waiver. The waiver by a party of any right hereunder, or of any
failure to perform or breach by the other party hereunder, shall not
be deemed a waiver of any other right hereunder or of any other
breach or failure by the other party hereunder whether of a similar
nature or otherwise.
9.8 Force Majeure. A party shall neither be held liable or responsible
to the other party, nor be deemed to have defaulted under or
breached this Agreement, for failure or delay in fulfilling or
performing any obligation under this Agreement
23
(other than an obligation for the payment of money) to the extent,
and for so long as, such failure or delay is caused by or results
from causes beyond the reasonable control of such party including
but not limited to fire, floods, embargoes, war, acts of war
(whether war be declared or not), insurrections, riots, civil
commotions, strikes, lockouts or other labor disturbances, acts of
God or acts, omissions or delays in acting by any governmental
authority or the other party.
9.9 Other Activities. Except as otherwise expressly provided in this
Agreement, nothing in this Agreement shall preclude either party
from conducting other programs (either for its own benefit or with
or for the benefit of any other Person) to conduct research, or to
develop or commercialize products or services, for use in any field.
9.10 Counterparts. This Agreement may be executed in two or more
counterparts, each of which shall be deemed an original, but all of
which together shall constitute one and the same instrument.
9.11 Arbitration. All controversies or claims under this Agreement, the
enforcement or interpretation hereof, or because of an alleged
breach, default or misrepresentation under the provisions hereof,
shall be settled by final and binding arbitration in San Diego,
California in accordance with the then-existing commercial
arbitration rules (the "Rules") of the American Arbitration
Association ("AAA"), and judgment upon the award rendered by the
arbitrators be entered in any court having jurisdiction thereof;
provided, however, that the law applicable to any controversy shall
be the law of the State of California, regardless of its or any
other jurisdiction's choice of law principles. In any arbitration
pursuant to this Agreement, the award or decision shall be rendered
by the majority of the members of a Board of Arbitration consisting
of three (3) members, one of whom shall be appointed by each party
and the third of whom shall be the chairman of the panel and shall
be appointed be mutual agreement of said two party-appointed
arbitrators. In the event of a failure of said two arbitrators to
agree within sixty (60) days after the commencement of the
arbitration proceeding upon the appointment of the third arbitrator,
the third arbitrator shall be appointed by the AAA in accordance
with the Rules. In the event that either party shall fail to appoint
an arbitrator within thirty (30) days after the commencement of the
arbitration proceedings, such arbitrator shall be appointed by the
AAA in accordance with the Rules. Notwithstanding the foregoing, the
parties may apply to any court of competent jurisdiction for a
temporary restraining order, as necessary, without breach of this
arbitration agreement and without abridgement of the powers of the
arbitrator. In no event shall the demand for arbitration be made
after the date when institution of a legal or equitable proceeding
based on such claim, dispute or other matter in question would be
barred by the applicable statute of limitation.
24
IN WITNESS WHEREOF, the parties hereto have executed this Agreement the day and
year first above written.
Cell-Matrix, Inc. AME
Signature: /s/ Xxxxxxx X. Xx Xxx Signature: /s/ Xxxxxx X. Xxxxx
-------------------------- ----------------------------
Name: Xxxxxxx X. Xx Xxx Name: Xxxxxx X. Xxxxx
Title: President and Chief Financial Officer Title: Chairman of the Board
Cell-Matrix, Inc. Applied Molecular Evolution
25
Schedule A
[***]
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SCHEDULE B
PROJECT FUNDING
1. Fixed Fee. Cell-Matrix shall pay to AME Five Hundred Thousand Dollar
($500,000) each for the humanization and optimization of each of the two (2)
Candidate Molecules, to be paid in equal quarterly installments over the six (6)
months starting from the Effective Date of the Prior Agreement. Payments shall
be due within thirty (30) days.
2. Milestone Payments. Cell-Matrix shall pay to AME milestone payments
equal to [***] per Program Antibody demonstrating an affinity equal to or
greater than [***] times the initial affinity of the Candidate Molecule from
which that Program Antibody was derived as determined by an in vitro assay to be
agreed upon by the parties. These milestone payments shall be paid within sixty
(60) days following the demonstration of the Program Antibody demonstrating an
affinity equal to or greater than [***] times the initial affinity of the
Candidate Molecule from which that Program Antibody was derived. In the event
that a Program Antibody fails to demonstrate an affinity equal to or greater
than [***] times the initial affinity of that Candidate Molecule from which that
Program Antibody was derived, no milestone payment shall be payable for that
Program Antibody.
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omitted portions.
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