EXHIBIT
10.36
LICENSE
AGREEMENT
between
CONRAD, Eastern Virginia
Medical School
and
Biosyn, Inc., a subsidiary
of Cellegy Pharmaceuticals, Inc.
THIS AGREEMENT (this “Agreement”),
effective as of the 30th day of January, 2006 by and between
Biosyn, Inc. (“Biosyn”), a corporation organized and
existing under the laws of the Commonwealth of Pennsylvania and a
wholly owned subsidiary of Cellegy Pharmaceuticals, Inc.
(“Cellegy”), and having its principal place of business
at1800 Byberry Road, Building 13, Huntingdon Valley, PA 19006, and
CONRAD, Eastern Virginia Medical School, (“CONRAD”),
organized and existing under the laws of the State of Virginia and
having its principal place of business at the address set forth in
Section 10.1.
WITNESSETH:
WHEREAS, Biosyn owns or controls certain United
States patents and patent applications and corresponding foreign
patents and patent applications and related technology relating to
compounds and formulations having microbicidal properties for
treating or preventing the contraction of sexually transmitted
diseases and/or inactivating pathogenic microbes;
WHEREAS, Biosyn wishes to grant to CONRAD a
non-exclusive license to its Technology related to such compounds
and formulations (as specifically defined herein) in the Developing
Countries to make, have made, use, research, develop, market and
sell, but only for the Public Sector; and
WHEREAS, CONRAD wishes to conduct research and
development activities with regard to Biosyn’s Technology and
to make, have made, use, research, develop, market and sell, in and
for the benefit of the Developing Countries and for the Public
Sector, products that incorporate the Technology and to share the
results of such research and development activities with
Biosyn.
NOW, THEREFORE, in consideration of the mutual
covenants and agreements of the parties contained herein, and
intending to be legally bound, the parties agree as
follows:
“C31G” means compounds, compositions
and processes covered under the C31G Patents in Schedule II, along
with associated trademarks and know-how, sometimes referred to as
Savvy, and for use in the prevention of transmission of sexually
transmitted diseases including HIV and for
contraception.
“C31G Permitted Field of Use” means
for the prevention of infection by HIV and other sexually
transmitted pathogens and for contraception, by topical, but not
systemic, administration.
“CV-N License” means the Patent
License Agreements between Biosyn and the National Institutes of
Health (“NIH”) by the Public Health Service
(“PHS”) dated February 27, 2003 and February 28, 2003,
a copy of which is appended hereto as Schedule V.
“CV-N Permitted Field of Use” means
compositions, devices and methods for the prevention of infection
by HIV and other sexually transmitted pathogens, by topical, but
not systemic, administration, utilizing cyanovirin-N, anti-HIV
mutants of cyanovirin-N, including glycosylation-resistant mutants
of cyanovirin-N, and anti-HIV fragments of both, including
conjugated forms of cyanovirin-N, mutants of cyanovirin-N, and
anti-HIV fragments of both, to increase the in vivo half-life, but
excluding pegylated cyanovirin-N, pegylated mutants of
cyanovirin-N, and pegylated anti-HIV fragments of both. For the
avoidance of doubt, such compositions shall include sustained
release formulations; devices shall include all drug delivery
systems, including but not limited to condoms, sponges, vaginal
rings, suppositories, IUDs and other solid matrices; and topical
administration shall include administration to mucosal membranes,
including vaginal, anal and oral membranes.
“Cyanovirin-N” or “CV-N”
means a naturally occurring protein originally isolated from the
cyanobacterium Nostoc ellipsosporum .
“Developing Countries” means
countries eligible for support from the Global Alliance for Vaccine
Initiatives (GAVI) or successor organization, or which at the
effective date of this Agreement are those countries with a Gross
National Product of less than US $1,000 per capita per year, and at
the effective date of this Agreement include those listed in
Schedule I.
“Patents” means any and all patent
applications (including provisional patent applications) and any
and all patents issuing therefrom together with any foreign
equivalents, patents of addition, divisions, continuations,
continuations-in-part, substitutions, extensions or renewals
therefore or re-issues, registrations and re-validations,
international applications under the Patent Cooperation Treaty, and
including supplementary protection certificates or other
governmental-granted exclusivity in the nature of a
patent.
“Products” means any product or
product candidate that incorporates or is covered by the
Technology.
“Public Sector” means the U.S.
government and/or the government of a Developing Country, or any
nonprofit entity empowered by the U.S. government and/or the
government of a Developing Country to act for said government in
matters applicable to this Agreement, organizations within the
United Nations system including the World Health Organization and
UNICEF, and other nonprofit organizations when they purchase drugs
or vaccines for delivery, manufacture and/or sale in the U.S. and
Developing Countries.
“Technology” means any technology,
compounds, formulations, pharmaceutical compositions and methods
and processes covered by a Valid Claim in Patents covering C31G,
CV-N, or UC-781, including those patents and patent applications
listed on Schedule II , Schedule III , and
Schedule IV , respectively, a product incorporating C31G,
CV-N, or UC-781 or the use or manufacture thereof, and/or other
proprietary technology and know-how (including manufacturing
process technology) related to C31G, CV-N, or UC-781 or any such
Patents.
“UC-781” is a non-nucleoside reverse
transcriptase inhibitor of the HIV-1 reverse transcriptase
enzyme.
“UC-781 License” means the License
Agreement between Biosyn, Inc., and Uniroyal Chemical Company,
Inc., dated May 22, 2001, a copy of which is appended hereto as
Schedule VI.
“UC-781 Permitted Field of Use”
means use as a human topical microbicide, alone or in combination
with other compounds, for application to the skin, mucosal and/or
epithelial tissue as an active ingredient in formulations such as
creams, foams, jellies, or other similar formulations, including
contraceptive and other vaginal delivery devices such as sponges,
intrauterine devices, diaphragms and condoms; but Permitted Field
of Use does not include, and specifically excludes:
(a) non-human uses;
(b) human application for both systemic therapeutic
uses and systemic post-exposure prophylactic uses; and
(c) uses when applied to or incorporated into any
surface (except for human surfaces consisting of skin, mucosal
and/or epithelial tissue) or device (except contraceptive and other
vaginal delivery devices as provided for above in this definition)
including, but not limited to, gloves, aprons, tubing and
filters.
“Valid Claim” means a claim of any
issued, unexpired Patent that has not been revoked or held
unenforceable or invalid by a decision of a court or governmental
agency of competent jurisdiction, from which no further appeal can
be taken or with respect to which an appeal is not taken within the
time allowed for appeal, and which has not been disclaimed, denied
or admitted to be invalid or unenforceable through reissue,
disclaimer or otherwise.
2.1 Biosyn hereby grants to CONRAD a non-exclusive
license in the Developing Countries under the Technology to make,
have made, use, conduct research, import, export, offer for sale,
sell and have sold Products, solely for the Public Sector in the
Developing Countries, and with respect to the Technology related to
UC-781, only in the UC-781 Permitted Field of Use, with respect to
the Technology related to CV-N, only in the CV-N Permitted Field of
Use and with respect to the Technology related to C31G, only in the
C31G Permitted Field of Use. CONRAD shall also have the right to
make, have made and conduct research on Products anywhere in the
world provided that CONRAD may only offer for sale, sell, and have
sold such Products solely for the Public Sector in the Developing
Countries. CONRAD shall have the right to grant sublicenses only
with Biosyn’s written approval, which approval shall not be
unreasonably withheld; except that CONRAD may, without
Biosyn’s written approval, grant sublicenses to affiliated
entities for the sole purpose of executing CONRAD’s
charitable mission; provided, however, that any sublicense shall
include all applicable restrictions and limitations of this
Agreement.
2.2 Biosyn shall provide CONRAD access to its
Investigational New Drug Applications for C31G and UC-781 and to
such other data relating to C31G, UC-781 and CV-N in Biosyn’s
possession as CONRAD shall reasonably request from time to time in
order to facilitate research and development activities conducted
by CONRAD. Any data or other information provided to CONRAD under
this Agreement shall be subject to Section 8 and CONRAD shall only
use the same for the sole purpose of conducting research and
developing Products in the respective Permitted Fields of Use and
for the purpose of providing the Products to the Public Sector in
the Developing World (collectively, the “Purpose”).
Disclosure of such data and other information can only be made to
those representatives and agents who need to know in order to
perform activities directed at the Purpose and to regulatory
authorities for the purpose of seeking approval of such Products
for the Purpose.
2.3 Notwithstanding the provisions of this Agreement
to the contrary, to the extent that the rights held by Biosyn to
the Technology are subject to or limited by (i) rights held by the
Public Health Service, the National Institutes of Health and the
U.S. Government under the CV-N License, (ii) rights held by
Uniroyal Chemical Company, Inc. under the UC-781 License, (iii)
rights held by a government agency, (iv) rights of Philanthropic
Ventures Holding Corporation (“PVHC”) granted or to be
granted under the Letter of Reaffirmation, dated October 7, 2004,
between Cellegy and PVHC, (v) rights granted or to be granted to
the International Partnership for Microbicides under the Sponsored
Development and Collaboration Agreement, dated as of January 1,
2003, or (vi) the rights of third party philanthropic organizations
such as The Global Microbicide Project (“GMP”), the
World Health Organization, USAID and the International Partnership
for Microbicides, the parties understand and agree that rights to
such intellectual property licensed to CONRAD hereunder are subject
to such limitations.
2.4 As consideration for the licenses and rights
granted to CONRAD under this Agreement, CONRAD shall pay a license
grant fee of one hundred dollars ($100.00). CONRAD shall pay the
license grant fee within thirty (30) days from the date of
execution of this Agreement by both Parties.
3.1 This Agreement shall commence effective as of
the date first above set forth and, unless earlier terminated
pursuant to the terms of this Agreement, shall remain in effect
until the expiration of the last-to-expire Valid Claim of Patents
included in the Technology.
3.2 CONRAD may terminate this Agreement at any time
and for any reason or no reason upon sixty (60) days prior written
notice. This Agreement may be terminated prior to expiration of the
term hereof by either party in the event of any material breach of
this Agreement by the other party that shall go uncorrected for a
period of sixty (60) days after notice of such breach, setting
forth the details thereof with reasonable particularity, has been
given to the other party. In the event of any termination under
this Section 3.2, the License shall immediately and automatically
revert back to Biosyn.
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4.
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Representations, Warranties and
Covenants
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4.1 Biosyn represents and warrants to CONRAD that
(a) Biosyn is a wholly owned subsidiary of Cellegy Pharmaceuticals,
Inc., has been duly incorporated and is a validly subsisting under
the laws of the Commonwealth of Pennsylvania; (b) Biosyn has taken
all actions necessary to authorize it to enter into and perform its
obligations under this Agreement and to consummate the transactions
contemplated hereby; and (c) this Agreement is a legal, valid and
binding obligation of Biosyn, enforceable in accordance with its
terms subject, as to enforcement, to bankruptcy, insolvency,
reorganization and other laws of general applicability relating to
creditors’ rights and to general equitable
principles.
4.2 CONRAD represents and warrants to Biosyn that
(a) CONRAD has all requisite power and authority to enter into and
perform all of its obligations under this Agreement and to carry
out the transactions contemplated hereby in accordance with the
terms and conditions set forth herein; and (b) this Agreement is a
legal valid and binding obligation of CONRAD, enforceable in
accordance with its terms subject, as to enforcement, to
bankruptcy, insolvency, reorganization and other laws of general
applicability relating to creditors’ rights and to general
equitable principles.
4.3 CONRAD covenants as follows:
(a) CONRAD shall use commercially reasonable efforts
to conduct research and/or development activities on
Products.
(b) CONRAD shall own all results and data CONRAD
creates, develops or collects in its research and development
activities related to Products. CONRAD hereby grants to Biosyn an
option to purchase some or all such results and data as Biosyn
elects, on terms that are no less favorable to Biosyn than
commercially reasonable terms for such results and data, and shall
negotiate in good faith the terms of such purchase with Biosyn, its
parent corporation, successor or permitted assignee, with such
terms taking into consideration, among other factors, all of the
benefits and burdens of CONRAD hereunder and relating to the
results or data sought to be acquired and amounts expended by
Biosyn before and after the date of this Agreement related to
research and development activities concerning the Technology to
which the results or data relate. In all events, the amount payable
by Biosyn (or its parent, successor or permitted assignee) shall
not exceed the amount of funds expended after the date of this
Agreement by CONRAD (excluding overhead) that are directly related
to the study or trial producing the results and data that Biosyn
desires to acquire; and the foregoing is intended to represent a
maximum limit on payment rather than an indicia of a commercially
reasonable amount. Except for sale to Biosyn as provided above,
CONRAD shall not sell, license or otherwise provide such results or
data to a third party for use other than in the Public Sector in
Developing Countries.
(c) CONRAD hereby grants to Biosyn an option to
purchase all such results and data and will discuss the terms of
such purchase with Biosyn, its parent corporation, successor or
permitted assignee in good faith, taking into consideration all of
the benefits and burdens hereunder.
(d) CONRAD shall keep Biosyn informed of (i) its
research and/or development activities, (ii) efforts to obtain
regulatory approvals with respect to any Products it develops and
the status of such efforts, and (iii) plans and achievements
relating to the sale or distribution of any such Products
throughout the Developing Countries. The parties shall meet at
times and places mutually agreeable or shall participate in
telephone conferences from time to time to enable CONRAD to report
to Biosyn on the foregoing matters. Such reporting, whether by
telephone or in meetings, shall take place not less frequently than
semiannually.
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5.
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Limitation of
Liability
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5.1 Biosyn makes no representations or
warr