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CONFIDENTIAL
TREATMENT REQUESTED
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EXHIBIT 10.10
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CONFIDENTIAL TREATMENT REQUESTED
UNDER RULE 406 THE SECURITIES ACT OF 1933 CONFIDENTIAL TREATMENT IS
REQUESTED AND IS NOTED WITH “[CONFIDENTIAL TREATMENT
REQUESTED].” AN UNREDACTED VERSION OF THIS DOCUMENT HAS BEEN
PREVIOUSLY FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION.
P HENYLBUTYRATE C O -D EVELOPMENT AND
S UBLICENSE A GREEMENT
BY AND AMONG
B RIDGE T HERAPEUTIC P RODUCTS , I NC AND
B RIDGE O NCOLOGY P RODUCTS , I NC .
CONFIDENTIAL TREATMENT
REQUESTED
PHENYLBUTYRATE CO-DEVELOPMENT AND
SUBLICENSE
AGREEMENT
BY AND BETWEEN
BRIDGE THERAPEUTIC PRODUCTS INC.
AND BRIDGE
ONCOLOGY PRODUCTS
INC.
DATED AND EFFECTIVE: FEBRUARY 16,
2005
CONFIDENTIAL TREATMENT
REQUESTED
Strictly Confidential
SUBLICENSE
AGREEMENT
THIS AGREEMENT (the
“Agreement”), is made and effective as of
February 16, 2005 (the “Effective Date”), by and
between Bridge Therapeutic Products Inc. (“BTP”) and
Bridge Oncology Products Inc. (“BOP” and, together with
BTP, the “Parties”).
RECITALS:
WHEREAS BTP, Inc. (“BTP”) has worldwide
rights to intellectual property, commercialization rights and know
how pertaining to phenylbutyrate (“PB” or the “PB
Technology”), and
WHEREAS Bridge Oncology Inc. (“BOP”) wishes
to enter into an exclusive sublicense to all of BTP’s PB
Technology in the Territory (defined as worldwide with the
exception of the United States of America and Canada), including,
without limitation, any and all patents, patent applications,
continuations, continuations-in-part, inventions, improvements,
know how, trademarks, trade secrets, and any and all other
intellectual property or proprietary information related thereto,
in each case, together with any and all commercialization rights
pertaining to the PB technology (collectively, the
“Sublicensed Technology”).
NOW, THEREFORE,
in consideration of the mutual
premises, covenants and agreements set forth in this Sublicense
Agreement, and other good and valuable consideration the receipt
and sufficiency of which is hereby acknowledged, BTP and BOP hereby
agree as follows:
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1.1
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The intention
and purpose of the Sublicense Agreement is to continue to promote
the on-going development programs already instituted by BTP and
outside clinical investigators for PB, to maximize the potential
therapeutic benefit of PB for the treatment of certain cancers,
autoimmune diseases and other clinical indications, and to expedite
a global strategy for the development, regulatory approval and
commercial development of PB.
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1.2
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BTP hereby grants to BOP an
exclusive sub-license to all of BTP’s intellectual property
rights, including without limitation, any and all patents, patent
applications, continuations, continuations-in-part, inventions,
improvements, trademarks, trade secrets, and any and all other
intellectual property or proprietary information related thereto,
in each case, together with any and all commercialization rights
and all know how to PB (collectively, the “Sublicense”)
in the Territory (defined as worldwide with the exception of the
United States of America and Canada). For purposes of this
Sublicense Agreement, the parties hereto acknowledge and agree that
the Sublicense shall include, without limitation, all rights, title
and interest to the Public Health Service Patent License Agreement,
dated May 25, 1995, between the Public Health Service and the
National Institute of Health and BTP, in the form attached as
Exhibit 1 hereto (the
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CONFIDENTIAL TREATMENT
REQUESTED
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“PHSP License
Agreement”), together with all rights, title and interests
conveyed thereunder.
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2.1
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In
consideration of the Sublicensed Technology, BOP agrees to pay BTP
US$50,000.00 as soon as commercially reasonable after the Effective
Date.
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2.2
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BOP will pay
royalties to BTP on all direct sales of PB or any product
incorporating the PB Technology within the Territory of
[CONFIDENTIAL TREATMENT REQUESTED] . In any country with the
Territory where PB or any product incorporating the PB Technology
is sold by a third party, such as distributor, wholesaler or
marketing company, any payments made by their third party as part
of the acquisition of rights to sell or distribute PB or any
product incorporating the PB Technology shall be shared equally
between BOP and BTP.
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2.3
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BOP agrees to
pay all costs and expenses of prosecuting, filing and maintaining
Patents and defending revocation proceedings on patent and patent
applications on PB in all other countries within the Territory
(which specifically excludes the United States of America and
Canada).
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3.1
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The parties to
this Agreement hereby agree to cooperate in the development and
commercialization of PB. BTP will be responsible for conducting all
clinical trials and the filing and prosecution of all applications
with applicable USA and Canadian regulatory authorities, and all
regulatory filings in the USA and Canada will be in the name of
BTP. BOP will be responsible for conducting all clinical trials and
the filing and prosecution of all applications with applicable
regulatory authorities other than in the USA and Canada and all
such filings shall be in the name of BOP.
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3.2
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The parties
will promptly share all information generated under this
co-development program pursuant to confidentiality including,
without limitation, all information with respect to market
analysis, competitor position, pre-clinical and clinical trials,
the filing of any applications with the US Food and Drug
Administration or similar Canadian authority and the manufacture
and testing of different formulations and preparations of PB or any
product incorporating the PB Technology.
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3.3
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BTP shall pay
all costs and expenses of any work deemed necessary for the
development of PB in the USA and Canada. BOP shall pay all costs
and expenses of any work deemed necessary for the development of PB
in any other countries within the Territory (other than USA or
Canada).
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2
CONFIDENTIAL TREATMENT
REQUESTED
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4.
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Representations and Warranties
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4.1
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The parties
agree that this Agreement shall constitute a binding and
enforceable agreement between the parties. In this regard, the
parties agree to use commercially reasonable efforts to work
together in good faith to obtain all necessary consents and
approvals required from the National Institute of Health’s
Public Health Service and any other third party or governmental
authority reasonably required to provide a consent, if any, as soon
as reasonably practicable after the date hereof.
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4.2
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BTP hereby
represents, warrants and covenants to BOP that BTP has full right,
power and authority to enter into this Agreement.
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4.3
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BOP represents
that it has full power, authority to enter into this
Agreement.
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4.4
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BTP is unaware
of any claims asserted against BTP by any third parties with
respect to patent infringement or any other type of liability
relevant to licensing or sub-licensing of the Sublicensed
Technology.
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4.5
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The execution
of this Agreement by BTP shall not contravene any provision of law
or any contract to which BTP is a party. The execution of this
Agreement by BOP shall not contravene any provision of law or any
contract to which BOP is a party.
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5.
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Other
Considerations; General Provisions
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5.1
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Confidentiality: In fulfilling their obligations
under this Sublicense Agreement, it may be desirable or necessary
for BTP and BOP to disclose to one another certain confidential
information. In the event of receipt of such confidential
information, the receiving party agrees to preserve such
information as confidential and not disclose it to third parties or
to use it except where legally or commercially required to do so,
in the reasonable opinion of counsel to the disclosing
party.
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5.2
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Governing law:
This Agreement shall be construed and enforced in accordance with
the substantive laws of the State of New York, without regard to
the principles thereof regarding the choice of law.
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5.3
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Severability:
If any provision(s) of this Sublicense Agreement shall be
determined to be invalid or unenforceable, the validity and effect
of the other provisions of this Sublicense Agreement shall not be
affected thereby.
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5.4
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Waiver: The
waiver by either party or the failure by either party to claim a
breach of any provision of this Sublicense Agreement shall not be
deemed to constitute a waiver or estoppel with respect to any
subsequent breach or with respect to any provision
thereof.
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5.5
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Successors and
Assigns: This Sublicense Agreement shall be binding upon and shall
inure to the benefit of the Parties and their respective successors
and assigns.
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3
CONFIDENTIAL TREATMENT
REQUESTED
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5.6
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Further
Assurances: Each Party covenants and agrees to use commercially
reasonable efforts to take, or cause to be taken, all actions and
to do, or cause to be done, all things reasonably required,
necessary or appropriate, in good faith, to make effective the
transactions contemplated by this Sublicense Agreement, including,
without limitation, the conveyance of the Sublicensed
Technology.
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5.7
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Counterparts:
This Sublicense Agreement may be executed in any number of
counterparts, each of which shall be deemed an original but all of
which together shall constitute a single instrument.
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IN WITNESS WHEREOF, the parties
have executed this Agreement by their duly authorized
representatives as of February 16, 2005.
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Bridge
Therapeutic Products Inc.
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Bridge
Oncology Products Inc.
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Signature:
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/s/ Jeffrey B.
Davis
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Signature:
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/s/ Steven H.
Rouhandeh
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Name:
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Jeffrey B.
Davis
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Name:
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Steven H.
Rouhandeh
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Position:
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Chairman
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Position:
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Chairman
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Date:
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2/16/05
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Date:
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2/16/05
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4
CONFIDENTIAL TREATMENT
REQUESTED
EXHIBIT 1
PHS P ATENT L ICENSE
A GREEMENT B ETWEEN
THE U NITED S TATES P UBLIC H EALTH S ERVICE AND
N ATIONAL I NSTITUTE OF H
EALTH ,
ON THE ONE HAND ,
AND
E LAN P HARMACEUTICAL R ESEARCH C ORPORATION ,
ON THE OTHER HAND
(A SSIGNED AND N OVATED TO V
ECTRA M ED
, I NC .
ON J
UNE 27, 2003 AND
A SSIGNED AND N OVATED TO
V IRIUM P HARMACEUTICALS , I NC .
ON J
ANUARY 5, 2005)
1
CONFIDENTIAL TREATMENT
REQUESTED
PHS PATENT LICENSE AGREEMENT
— EXCLUSIVE
PHS and LICENSEE agreement as
follows:
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1.1
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In the course
of conducting biomedical and behavioral research funded by
LICENSEE, Dr. Dvorit Samid, a PHS employee, previously an
investigator with the Uniformed Services University of the Health
Services (“USUHS”), made inventions that may have
commercial applicability.
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1.2
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By assignment
of rights from Dr. Samid and the Department of the Army
(“DOA”), DHHS, on behalf of the United States
Government, owns the intellectual property rights claimed in any
United States and foreign patent applications or patents
corresponding to the assigned inventions. DHHS also owns any
tangible embodiments of these inventions actually reduced to
practice by DOA or PHS.
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1.3
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The Assistant
Secretary for Health of DHHS has delegated to PHS the authority to
enter into this Agreement for licensing of rights to these
inventions under 35 U.S.C. §§ 200-212, the Federal
Technology Transfer Act of 1986, 15 U.S.C. § 3710a, and/or the
regulations governing the licensing of Government-owned inventions,
37 C.F.R. Part 404.
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1.4
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PHS desires to
transfer these inventions to the private sector through
commercialization licenses to facilitate the commercial development
of products and processes for public use and benefit.
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1.5
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LICENSEE
desires to acquire commercialization rights to certain of these
inventions in order to develop processes, methods or marketable
products for public use and benefit.
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2.1
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“Licensed
Patent Rights” shall mean:
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2.1.1 U.S. patent applications and
patents listed in Appendix A, all divisions and continuations of
these applications, all patents issuing from such applications,
divisions, and continuations, and any reissues, re-examinations,
and extensions of all such patents;
2.1.2 to the extent that the
following contain one or more claims directed to the invention or
inventions claimed in a) above: 1) continuations-in-part of a)
above; 2) all divisions and continuations of these
continuations-in-part; 3) all patents issuing from such
continuations-in-part, divisions, and continuations; and 4) any
reissues, re-examinations, and extensions of all such
patents;
2
CONFIDENTIAL TREATMENT
REQUESTED
2.1.3 to the extent that the
following contain one or more claims directed to the invention or
inventions claimed in a) above: all counterpart foreign
applications and patents to a) and b) above, including those listed
in Appendix A.
Licensed Patent Rights shall
not include b) or c) above to the extent that they contain
one or more claims directed to new matter which is not the subject
matter of a claim in a) above.
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2.2
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“Licensed
Product(s)” means tangible materials which, in the course of
manufacture, use or sale would, in the absence of this Agreement,
infringe one or more claims of the Licensed Patent Rights that have
not been held invalid or unenforceable by an unappealed or
unappealable judgment of a court of competent
jurisdiction.
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2.3
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“Licensed
Process(es)” means processes which, in the course of being
practiced would, in the absence of this Agreement, infringe one or
more claims of the Licensed Patent Rights that have not been held
invalid or unenforceable by an unappealed or unappealable judgment
of a court of competent jurisdiction.
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2.4
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“Licensed
Territory” means the geographical area identified in Appendix
B.
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2.5
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“Net
Sales” means the total gross receipts for sales of Licensed
Products or practice of Licensed Processes by or on behalf of
LICENSEE or its sublicensees, and from leasing, renting, or
otherwise making Licensed Products available to others without sale
or other dispositions, whether invoiced or not, less returns and
allowances actually granted, packing costs, insurance costs,
freight out, taxes or excise duties imposed on the transaction (if
separately invoiced), and wholesaler and cash discounts in amounts
customary in the trade. No deductions shall be made for commissions
paid to individuals, whether they be with independent sales
agencies or regularly employed by LICENSEE, or sublicensees, and on
its payroll, or for the cost of collections.
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2.6
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“First
Commercial Sale” means the initial transfer by or on behalf
of LICENSEE or its sublicensees, of Licensed Products or the
initial practice of a Licensed Process by or on behalf of LICENSEE
or its sublicensees in exchange for cash or some equivalent to
which value can be assigned for the purpose of determining Net
Sales.
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2.7
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“Government” means the government of
the United States of America.
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2.8
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“Licensed
Fields of Use” means the fields of use identified in Appendix
B.
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3.1
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PHS hereby grants and LICENSEE
accepts, subject to the terms and conditions of this Agreement, an
exclusive license to LICENSEE under the Licensed Patent Rights in
the Licensed Territory to make and have made, to use and have used
and
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3
CONFIDENTIAL TREATMENT
REQUESTED
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to sell and have sold any
Licensed Products in the Licensed Fields of Use and to practice and
have practicedany Licensed Processes in the Licensed Fields of
Use.
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3.2
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This Agreement
confers no license or rights by implication, estoppel or otherwise
under any patent applications or patents of PHS other than Licensed
Patent Rights regardless of whether such patents are dominant or
subordinate to Licensed Patent Rights.
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4.1
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Upon written
approval by PHS, which approval will not be unreasonably withheld,
LICENSEE may enter into sublicensing agreements under the Licensed
Patent Rights.
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4.2
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LICENSEE agrees
that any sublicenses granted by it shall provide that the
obligations to PHS of Paragraphs 5.01-5.05, 8.01, 10.01, 10.02,
12.05 and 13.08-13.11 of this Agreement shall be binding upon the
sublicensee as if it were a party to this Agreement. LICENSEE
further agrees to attach copies of these Paragraphs to all
sublicense agreements.
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4.3
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Any sublicenses
granted by LICENSEE shall provide for the termination of the
sublicense, or the conversion to a license directly between such
sublicensees and PHS, at the option of the sublicensee, upon
termination of this Agreement under Article 13. Such conversion is
subject to PHS approval and contingent upon acceptance by the
sublicensee of the remaining provisions of this
Agreement.
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4.4
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LICENSEE agrees
to forward to PHS a copy of each fully executed sublicense
agreement postmarked within sixty (60) days of the execution
of such agreement.
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5.
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STATUTORY
AND PHS REQUIREMENTS AND RESERVED GOVERNMENT RIGHTS
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5.1
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PHS reserves on
behalf of the Government an irrevocable, nonexclusive,
nontransferable, royalty-free license for the practice of all
inventions licensed under the Licensed Patent Rights throughout the
world by or on behalf of the Government and on behalf of any
foreign government or international organization pursuant to any
existing or future treaty or agreement to which the Government is a
signatory.
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5.2
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LICENSEE agrees
that products used or sold in the United States embodying Licensed
Products or produced through use of Licensed Processes shall be
manufactured substantially in the United States, unless a written
waiver is obtained in advance from PHS.
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5.3
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LICENSEE acknowledges that PHS
may enter into a future Cooperative Research and Development
Agreements (“CRADAs”) under the Federal Technology
Transfer Act of 1986 that relate to the subject matter of this
Agreement. LICENSEE agrees not to unreasonably deny requests for
sublicense or cross
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4
CONFIDENTIAL TREATMENT
REQUESTED
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license rights from such future
collaborators with PHS when acquiring such derivative rights is
necessary in order to make a CRADA project feasible. PHS will
endeavor to give LICENSEE a reasonable opportunity to join as a
party to the proposed CRADA prior to its initiation and to obtain
reciprocal patent rights in any resultant inventions.
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5.4
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In addition to
the reserved license of Paragraph 5.01 above, PHS reserves the
right to grant nonexclusive licenses to make and to use the
inventions defined by the Licensed Patent Rights for purposes of
research involving the inventions themselves, and not for purposes
of commercial manufacture or in lieu of purchase if the inventions
are available as commercial products for research purposes. The
purpose of this research license is to encourage basic research,
whether conducted at an academic or corporate facility. In order to
safeguard the Licensed Patent Rights, however, PHS shall obtain the
consent of LICENSEE before granting to commercial entities a
research license or providing to them research samples of the
materials claimed in the Licensed Patent Rights, which consent
shall not be unreasonably withheld.
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6.
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ROYALTIES
AND REIMBURSEMENT
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6.1
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LICENSEE agrees
to pay to PHS a noncreditable, nonrefundable license issue royalty
as set forth in Appendix C within thirty (30) days from the
date that this Agreement becomes effective.
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6.2
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LICENSEE agrees
to pay to PHS a nonrefundable minimum annual royalty as set forth
in Appendix C. The minimum annual royalty is due and payable on
January 1 of each calendar year and may be credited against
any earned royalties due for sales made in that year. The minimum
annual royalty due the first calendar year of this Agreement may be
prorated according to the fraction of the calendar year remaining
between the effective date of this Agreement and the next
subsequent January 1.
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6.3
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LICENSEE agrees
to pay PHS Earned Royalties as set forth in Appendix C.
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6.4
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LICENSEE agrees
to pay PHS Benchmark Royalties as set forth in Appendix
C.
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6.5
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A claim of a
patent or patent application licensed under this Agreement shall
cease to fall within the Licensed Patent Rights for the purpose of
computing the minimum annual royalty and earned royalty payments in
any given country on the earliest of the dates that (a) the
claim has been abandoned but not continued, (b) the patent
expires, (c) the patent is no longer maintained by the
Government, or (d) all claims of the Licensed Patent Rights
have been held to be invalid or unenforceable by an unappealed or
unappealable decision of a court of competent jurisdiction or
administrative agency.
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6.6
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No multiple
royalties shall be payable because any Licensed Products or
Licensed Processes are covered by more than one of the Licensed
Patent Rights.
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5
CONFIDENTIAL TREATMENT
REQUESTED
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6.7
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On sales of
Licensed Products by LICENSEE to sublicensees or affiliated parties
or on sales made in other than an arm’s length transaction,
the value of the Net Sales attributed under this Article 6 to such
a transaction shall be that which would have been received in an
arm’s length transaction, based on sales of like quantity and
quality products on or about the time of such
transaction.
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6.8
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As an
additional royalty, LICENSEE agrees to pay PHS, within sixty
(60) days of PHS’s submission of a statement and request
for payment, an amount equivalent to all reasonable expenses
previously incurred by PHS in the preparation,
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