CONFIDENTIAL TREATMENT REQUESTED EXHIBIT 10.10
CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24(B)(2) OF THE SECURITIES AND
EXCHANGE ACT OF 1934. CONFIDENTIAL TREATMENT REQUESTED 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.
PHENYLBUTYRATE CO-DEVELOPMENT AND
SUBLICENSE AGREEMENT
BY AND AMONG
BRIDGE THERAPEUTIC PRODUCTS, INC AND
BRIDGE ONCOLOGY PRODUCTS, INC.
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:
1. Grant of Sublicense
1.1 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.
1.2 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
CONFIDENTIAL TREATMENT REQUESTED
hereto (the "PHSP License Agreement"), together with all
rights, title and interests conveyed thereunder.
2. Consideration
2.1 In consideration of the Sublicensed Technology, BOP agrees to
pay BTP [CONFIDENTIAL TREATMENT REQUESTED] as soon as
commercially reasonable after the Effective Date.
2.2 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.
2.3 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).
3. Co-Development Plan
3.1 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.
3.2 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.
3.3 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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CONFIDENTIAL TREATMENT REQUESTED
4. Representations and Warranties
4.1 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.
4.2 BTP hereby represents, warrants and covenants to BOP that BTP
has full right, power and authority to enter into this
Agreement.
4.3 BOP represents that it has full power, authority to enter into
this Agreement.
4.4 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.
4.5 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.
5. Other Considerations; General Provisions
5.1 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.
5.2 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.
5.3 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.
5.4 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.
5.5 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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CONFIDENTIAL TREATMENT REQUESTED
5.6 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.
5.7 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.
IN WITNESS WHEREOF, the parties have executed this Agreement by their
duly authorized representatives as of February 16, 2005.
Bridge Therapeutic Products Inc. Bridge Oncology Products Inc.
Signature: /s/ JEFFREY B. DAVIS Signature: /s/ STEVEN H. ROUHANDEH
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Name: Jeffrey B. Davis Name: Steven H. Rouhandeh
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Position: Chairman Position: Chairman
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Date: 2/16/05 Date: 2/16/05
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