LICENSE AGREEMENT between CONRAD, Eastern Virginia Medical School and Biosyn, Inc., a subsidiary of Cellegy Pharmaceuticals, Inc.
EXHIBIT
10.36
between
▇▇▇▇▇▇,
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 ▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇, and
▇▇▇▇▇▇, Eastern Virginia Medical School, (“▇▇▇▇▇▇”), 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 ▇▇▇▇▇▇ 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,
▇▇▇▇▇▇ 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:
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1.
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Definitions
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“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.
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2.
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License
Grant
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2.1 Biosyn
hereby grants to ▇▇▇▇▇▇ 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. ▇▇▇▇▇▇ shall also
have
the right to make, have made and conduct research on Products anywhere in
the
world provided that ▇▇▇▇▇▇ may only offer for sale, sell, and have sold such
Products solely for the Public Sector in the Developing Countries. ▇▇▇▇▇▇
shall
have the right to grant sublicenses only with Biosyn’s written approval, which
approval shall not be unreasonably withheld; except that ▇▇▇▇▇▇ may, without
Biosyn’s written approval, grant sublicenses to affiliated entities for the sole
purpose of executing ▇▇▇▇▇▇’▇ charitable mission; provided, however, that any
sublicense shall include all applicable restrictions and limitations of this
Agreement.
2.2 Biosyn
shall provide ▇▇▇▇▇▇ 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 ▇▇▇▇▇▇ shall reasonably request from time to time in
order to facilitate research and development activities conducted by ▇▇▇▇▇▇.
Any
data or other information provided to ▇▇▇▇▇▇ under this Agreement shall be
subject to Section 8 and ▇▇▇▇▇▇ 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 ▇▇▇▇▇▇ hereunder are subject to such
limitations.
2.4 As
consideration for the licenses and rights granted to ▇▇▇▇▇▇ under this
Agreement, ▇▇▇▇▇▇ shall pay a license grant fee of one hundred dollars
($100.00). ▇▇▇▇▇▇ shall pay the license grant fee within thirty (30) days
from
the date of execution of this Agreement by both Parties.
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3.
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Term
and Termination
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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 ▇▇▇▇▇▇
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.
| 4. |
Representations,
Warranties and Covenants
|
4.1 Biosyn
represents and warrants to ▇▇▇▇▇▇ 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 ▇▇▇▇▇▇
represents and warrants to Biosyn that (a) ▇▇▇▇▇▇ 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 ▇▇▇▇▇▇, 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 ▇▇▇▇▇▇
covenants as follows:
(a) ▇▇▇▇▇▇
shall use commercially reasonable efforts to conduct research and/or development
activities on Products.
(b) ▇▇▇▇▇▇
shall own all results and data ▇▇▇▇▇▇ creates, develops or collects in its
research and development activities related to Products. ▇▇▇▇▇▇ 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 ▇▇▇▇▇▇ 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 ▇▇▇▇▇▇
(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,
▇▇▇▇▇▇ 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)
▇▇▇▇▇▇
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) ▇▇▇▇▇▇
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 ▇▇▇▇▇▇ 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 warranties other than those specified in Section
4.1. Without limiting the generality of the foregoing, Biosyn makes no
representation or warranty that any Patents are validly issued, that patent
applications will issue, that the Technology does not infringe on any third
party’s technology or patents, nor that persons other than Biosyn do not own or
control technology and know-how substantially similar to technology and know-how
comprising part of the Technology.
5.2 Biosyn
shall not have any liability for damages, whether direct, indirect, special
or
consequential, including without limitation damages for economic loss, death
or
injury to persons or damage to property, in respect of any Patent, the
Technology or any Product, whether or not Biosyn shall be advised, shall
have
reason to know or in fact shall know of the possibility of such damages,
except
that Biosyn shall have liability for damages arising out of Biosyn’s gross
negligence and/or willful misconduct.
5.3 BIOSYN
MAKES NO WARRANTIES, EXPRESS OR IMPLIED, OF MERCHANTABILITY OR FITNESS FOR
A
PARTICULAR PURPOSE OF ANY SUBJECT MATTER DEFINED BY THE TECHNOLOGY OR ANY
TANGIBLE MATERIALS RELATED THERETO.
5.4 Biosyn
has no obligation to prosecute or maintain the C31G Patents, the CV-N Patents
or
the UC-781 Patents. Biosyn shall keep ▇▇▇▇▇▇ reasonably informed of the status
of such Patents and patent applications. In
the
event that Biosyn, and any successors, licensors, collaborative partners,
licensees, or other parties, that have or are granted the right to prosecute
such Patents elect not to proceed with the filing of any of such Patents
or to
cease prosecution or maintenance of any of such Patents, Biosyn shall promptly
so advise ▇▇▇▇▇▇ who may, but is not obligated to, assume responsibility
for
such filing, prosecution or maintenance of any such Patents at ▇▇▇▇▇▇’▇ own
expense, to the extent Biosyn has the power or authority to grant such right
to
▇▇▇▇▇▇ under the CV-N License and UC-781 License, as applicable. Biosyn shall
promptly assign to ▇▇▇▇▇▇ Biosyn’s entire right, title and interest in and to
any such Patents as to which ▇▇▇▇▇▇ assumes responsibility under this Section
5
to the extent that Biosyn has any such right, title and interest.
Notwithstanding the foregoing, any rights that might be granted to ▇▇▇▇▇▇
under
this Section 5.4 are limited by those rights described in Section
2.3.
5.5 The
selection of the Technology for the development, making, use, testing,
distribution or sale of Products is solely ▇▇▇▇▇▇’▇, and Biosyn does not assume
any responsibility whatsoever for such development, making, use, testing,
distribution, or sale.
| 6. |
Indemnification
|
6.1 ▇▇▇▇▇▇
shall indemnify and hold harmless Biosyn and its parent, subsidiaries,
affiliates, directors, officers, employees and agents from and against any
and
all loss, cost, claim, damage, liability or expense (including reasonable
attorneys’ fees, costs of suit and costs of appeal) incurred by any of them
arising out of or in connection with any claim, action, suit, proceeding
or
investigation ("Claim") filed or threatened including, without limitation,
any
Claim alleging death or injury to any person, with respect to (a) the
production, manufacture, testing, sale, marketing, distribution, shipment,
transportation, handling, cleanup, use or disposal of any Product developed,
manufactured, tested, distributed or sold by or on behalf of ▇▇▇▇▇▇, and
(b) the
negligence or willful misconduct of ▇▇▇▇▇▇ and/or its subsidiaries, affiliates,
directors, officers, agents, contract manufacturers, distributors, sublicensees
and other representatives, except when such Claim arises out of Biosyn’s gross
negligence or willful misconduct.
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7.
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Compliance
with Law
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7.1 ▇▇▇▇▇▇,
its subsidiaries, affiliates, directors and officers shall, and ▇▇▇▇▇▇ shall
use
commercially reasonable efforts to cause its agents, contract manufacturers,
distributors, permitted sublicensees and other representatives to, comply
with
all United States federal, state and local laws, rules and regulations and
all
foreign laws, rules and regulations applicable to the development, testing,
production, transportation, packaging, labeling, export, import, marketing,
distribution, sale and use of any Products.
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8.
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Confidentiality
|
8.1 Except
as
provided in Section 4.3(b), the recipient of information supplied pursuant
to
this Agreement shall treat the same as confidential. For purposes of this
Section 8.1, the terms "recipient" and "recipient party" shall mean the party
receiving information pursuant to this Agreement, its officers, directors,
employees and agents. The foregoing obligations as to confidentiality shall
not
extend to any transmitted information that is publicly available at the date
of
its disclosure to the recipient party or which is, at that date, already
properly in the possession of the recipient party (evidenced by writing)
or
which may thereafter become publicly available from sources other than the
recipient party and its employees or which may properly thereafter become
available to the recipient party on a non-confidential basis from a source
other
than the disclosing party and that is not known by the recipient party to
be
under an obligation of confidentiality to the disclosing party with respect
thereto. The obligations set forth in this Section 8 shall survive for a
period
of five years after the expiration or termination of this
Agreement.
8.2 If
either
party becomes or believes that it will become legally compelled to disclose
any
confidential information of the other party, the party subject to such
disclosure requirement shall give prompt written notice of such requirement
to
the other party prior to any such disclosure so that such other party may
seek a
protective order or other appropriate remedy and/or waive compliance with
the
provisions of Section 8.1 of this Agreement. The party subject to such
disclosure requirement shall disclose only the portion of the confidential
information that, in the reasonable judgment of its counsel, it is legally
required to disclose and shall use
reasonable
efforts to obtain an appropriate protective order or other reasonable assurance
that the confidential information being disclosed will be given confidential
treatment.
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9.
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Publication
|
9.1 ▇▇▇▇▇▇
may publish manuscripts, abstracts or the like related to its research and
development efforts of the Products provided confidential information of
Biosyn
is not included, or if confidential information of Biosyn is included, after
first obtaining approval from Biosyn to include such confidential information.
Prior to any publication related to the Technology or the Products, ▇▇▇▇▇▇
shall
provide a copy of the proposed manuscript, abstract or other to Biosyn and
allow
Biosyn a period of thirty (30) days to identify any confidential information
of
Biosyn contained therein. Upon written request by Biosyn prior to expiration
of
the thirty (30) day period, ▇▇▇▇▇▇ shall redact such confidential information
from the proposed publication. In the event that Biosyn identifies material
of a
patentable nature in the proposed publication, the submission of the publication
will be delayed for thirty (30) days in order to allow a patent application
to
be filed. Notwithstanding the foregoing, ▇▇▇▇▇▇ may publish any information
required of it by any law or regulation governing the manufacture, marketing,
sale or distribution of Products.
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10.
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Notice
|
10.1 All
notices, requests, demands and other communications which are required or
permitted to be given under this Agreement shall be in writing and shall
be
deemed to be duly given upon the delivery or mailing thereof, as the case
may
be, if hand delivered or sent by registered or certified mail, return receipt
requested, postage prepaid, or upon delivery to an express courier service,
addressed in any such case:
if
to
Biosyn:
Biosyn,
Inc.
▇▇▇▇
▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇
▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attn:
President
if
to
▇▇▇▇▇▇:
▇▇▇▇▇▇,
Eastern Virginia
Medical
School
▇▇▇▇
▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇
▇▇▇
▇▇▇▇▇▇▇▇▇,
▇▇ ▇▇▇▇▇
Attn:
▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇, Ph.D., Executive Director
or
to
such other address as either party shall have specified for itself by notice
to
the other given in accordance with this Section 10.1.
| 11. |
Use
of Name
|
11.1 Except
as
otherwise provided herein, neither party shall have any right, express or
implied, to use in any manner the name of the other party or any other trade
name or trademark or other identifying ▇▇▇▇ or symbol of the other party
for any
purpose in connection with the performance of this Agreement.
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12.
|
Assignment;
Successors
|
12.1 Assignment.
Neither
Biosyn nor ▇▇▇▇▇▇ may assign this Agreement without the prior written consent
of
the other party, except that (a) Biosyn may assign this Agreement in whole
or in
part to an affiliated entity, to a successor, or to the purchaser of the
related
assets and (b) ▇▇▇▇▇▇ may assign this Agreement to affiliated entities for
the
sole purpose of executing ▇▇▇▇▇▇’▇ charitable mission; provided in each case
that the assigning party provides prior written notice thereof to the
non-assigning party confirming that the assignee has agreed in writing to
be
bound by the terms hereof.
12.2 Binding
Upon Successors and Assigns.
Subject
to the limitations on assignment herein, this Agreement shall be binding
upon
and inure to the benefit of any successors in interest and assigns of Biosyn
and
▇▇▇▇▇▇. Any such successor or assignee of either party’s interest shall
expressly assume in writing the performance of all the terms and conditions
of
this Agreement to be performed by such party.
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13.
|
Applicable
Law
|
13.1 This
Agreement shall be construed in accordance with the laws of the Commonwealth
of
Virginia without giving effect to any conflict of law principles.
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14.
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Announcements
|
14.1 All
press
releases and other public announcements related to the subject matter hereof
shall be made only with the mutual written agreement of the parties hereto
(which shall not be unreasonably withheld or delayed), except that any such
public announcement required by law (including regulations of the FDA or
Securities and Exchange Commission) may be made without such written
agreement.
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15.
|
General
|
15.1 This
Agreement shall be binding upon and inure to the benefit of the parties hereto
and their respective successors.
15.2 This
Agreement sets forth and constitutes the entire agreement between the parties
hereto with respect to the subject matter hereof, and supersedes any and
all
prior agreements, understandings, promises and representations made by either
party to the other concerning the subject matter hereof and the terms applicable
hereto. No other terms and conditions shall be binding on either party including
terms that may be additional to or at variance with the terms hereof, unless
such provision is expressly agreed to in writing signed by both parties
hereto.
15.3 If
any
provision of this Agreement is or becomes or is deemed invalid, illegal or
unenforceable in any jurisdiction to which the Agreement is sought to be
enforced, (a) such provision shall be deemed amended to conform to applicable
laws of such jurisdiction so as to be valid and enforceable or, if it cannot
be
so amended without materially altering the intention of the parties, it shall
be
stricken; (b) the validity, legality and enforceability of such provision
shall
not in any way be affected or impaired thereby in any other jurisdiction;
and
(c) the remainder of this Agreement shall remain in full force and
effect.
15.4 Dispute
Resolution.
All
disputes arising in connection with this Agreement which cannot be settled
in an
amicable way between ▇▇▇▇▇▇ or EVMS and Biosyn within sixty (60) days shall
be
mediated in good faith. The Party raising such dispute shall promptly advise
the
other Party of such claim, dispute or controversy in a writing which describes
in reasonable detail the nature of such dispute. By not later than fifteen
(15)
business days after the recipient has received such notice of dispute, each
Party shall have selected for itself a representative who shall have the
authority to bind such Party, and shall additionally have advised the other
Party in writing of the name and title of such representative. By not later
than
fifteen (15) business days after the date of such notice of dispute, the
Party
against whom the dispute shall be raised shall select a mediation firm in
Richmond, Virginia, if it is initiated by Biosyn and in Huntingdon Valley,
Pennsylvania if it is initiated by ▇▇▇▇▇▇ or EVMS. Such representatives shall
schedule a date with such firm for a mediation hearing. The Parties shall
enter
into a good faith mediation. The mediation shall be non-binding and shall
constitute a binding and final resolution upon mutual agreement of the parties.
The prevailing Party shall be entitled to an award of reasonable attorney
fees
incurred in connection with the mediation in such amount as may be determined
by
the mediators.
15.5 Sovereign
Immunity.
Nothing
in this Agreement shall be construed to waive the sovereign immunity of Eastern
Virginia Medical School.
15.6 Force
Majeure.
Neither
Party will be liable for any failure or delay in its performance under this
Agreement due to any cause beyond its reasonable control, including acts
of war,
acts of God, earthquake, flood, fire, embargo, riot, sabotage, labor shortage
or
dispute, governmental act, or failure of third party power or telecommunications
networks, provided that the delayed Party: (a) gives the other Party prompt
notice of such cause, and (b) uses its reasonable commercial efforts to promptly
correct such failure or delay in performance. Notwithstanding the foregoing,
if
such event causes a delay in performance of more than ninety (90) days, the
unaffected Party shall have the right to terminate this Agreement without
penalty upon written notice at any time prior to the affected Party’s resumption
of performance.
[signature
page to follow]
IN
WITNESS WHEREOF, the parties hereto have caused this License Agreement to
be
executed by their respective authorized representatives on the dates indicated
below.
BIOSYN,
INC.
Date:
January 31, 2006
By:
/s/
▇▇▇▇-▇▇▇▇▇ Corner
Name:
▇▇▇▇-▇▇▇▇▇ Corner
Title:
Senior Vice President
▇▇▇▇▇▇
Eastern
Virginia Medical School
Date:
January 31, 2006
By:
/s/
▇▇▇▇▇
▇. ▇▇▇▇▇▇▇▇▇
Name:
▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇, Ph.D.
Title:
Executive Director
Eastern
Virginia Medical School
Date:
January 31, 2006
By:
/s/
▇▇▇▇
▇▇▇▇▇▇▇▇▇▇▇
Name:
▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇
Title:
Vice President of Administration & Finance
Acknowledged
and Agreed to:
CELLEGY
PHARMACEUTICALS, INC.,
parent
corporation to Biosyn, Inc.
Date:
January 31, 2006
By:
/s/
▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
Name:▇▇▇▇▇▇▇
▇. ▇▇▇▇▇▇▇▇
Title:
Chairman/Interim CEO
SCHEDULE
I
Initial
List of Developing Countries
|
Afghanistan
Albania
Angola
Armenia
Azerbaijan
Bahamas
Belize
Bangladesh
Barbados
Benin
Bhutan
Bolivia
Bosnia
and Herzegovina
Botswana
Burkina
Faso
Burundi
Cambodia
Cameroon
Central
African
Republic
Chad
China
Comoros
Congo
Dominican
Republic
Republic
oldie Congo
Cote
d'Ivoirc
Cuba
Djibouti
Eritrea
Ethiopia
Gambia
Georgia
Ghana
Guinea
Guinea
Bissau
Guatemala
Guyana
Haiti
Honduras
India
Indonesia
Kenya
Korea
DPR
Kyrgyz
Republic
|
Lao
PDR
Lesotho
Liberia
Madagascar
Malawi
Mali
Mauritania
Moldova
Mongolia
Mozambique
Myanamar
Namibia
Nepal
Nicaragua
Niger
Nigeria
Pakistan
Panama
Papua
New Guinea
Rwanda
Sao
Tome
Senegal
Sierra
▇▇▇▇▇
▇▇▇▇▇▇▇
Islands
Somalia
South
Africa
Sri
Lanka
Sudan
Suriname
Swaziland
Thailand
Tajikistan
Tanzania
Togo
Trinidad
Tobago
Turkmenistan
Ukraine
Uganda
Uzbekistan
Vietnam
Yemen
Zambia
Zimbabwe
|
SCHEDULE
II
C3IG
Patent Listing
| I) |
U.S.
Filings
|
|
Parent
Number
|
Inventor
|
Date
Issued
|
Title
|
|
|
4,839,158
|
▇▇▇▇▇
▇. ▇▇▇▇▇▇▇▇
|
6/13/89
|
Process
and composition for oral hygiene
|
|
|
5,314,917
|
Michaels
and ▇▇▇▇▇▇▇
|
5/24/94
|
Method
for Inactivating Enveloped Viruses and Sperm
|
|
|
6,297,278
|
Michaels
and ▇▇▇▇▇▇▇
|
10/2/01
|
Method
for Inactivating Sexually Transmitted. Enveloped Viruses
|
|
|
5,389,676
|
▇▇▇▇▇
▇. ▇▇▇▇▇▇▇▇
|
2/14/95
|
Viscous
Surfactant Emulsion Compositions
|
|
|
5.275,804
|
▇▇▇▇▇
▇. ▇▇▇▇▇▇▇▇
|
¼
/194
|
Process
and Composition for Oral Hygiene
|
|
|
5,403,579
|
▇▇▇▇▇
▇. ▇▇▇▇▇▇▇▇
|
4/4/95
|
Process
and Composition for Oral Hygiene
|
|
|
5.244,652
|
▇▇▇▇▇
▇. ▇▇▇▇▇▇▇▇
|
9/14/93
|
Viscous
Surface Active Composition
|
|
|
6,281,176* }
|
▇.▇.
▇▇▇▇▇▇▇ 8/28/0I
|
8/28/01
|
Process
for producing betainc/amine oxide
mixtures
|
|
| • |
This
patent is held by Albemarle Corp. and protects the single process
production method for C31G. Biosyn has an exclusive license option
for
this protected process.
|
| ii) |
International
Filings
|
Equivalents
for USPN
4,839,158; 5,275,804; 5,403,579
|
Patent
Number
|
Country
|
Issued
|
Status
|
|
606861
|
Australia
|
7/9/1991
|
Issued
|
|
1315693
|
Canada
|
4/6/1993
|
Issued
|
|
EP0294391
|
Switzerland
|
2/2/1994
|
Issued
|
|
3789020.4
|
Germany
|
2/2/1994
|
Issued
|
|
EP0294391
|
France
|
2/2/1994
|
Issued
|
|
EP0294391
|
United
Kingdom
|
2/2/1994
|
Issued
|
|
2/2/1994
|
Issued
|
||
|
EP0294391
|
Italy
|
||
|
▇▇▇▇▇▇▇
|
▇▇▇▇▇
|
8/8/1996
|
Issued
|
|
EP0294391
|
Netherlands
|
2/2/1994
|
Issued
|
|
EP0294391
|
Sweden
|
2/2/1994
|
Issued
|
[X]
Designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with this
commission.
Equivalents
for USPN 5,244,652
|
Patent
Number
|
Country
|
Issued
|
Status
|
|
663506
|
Australia
|
2/6/1996
|
Issued
|
|
[X]
|
[X]
|
[X]
|
[X]
|
|
EP0576585
|
Switzerland
|
12/20/1995
|
Issued
|
|
69206976.6
|
Germany
|
12/20/1995
|
Issued
|
|
EP0576585
|
France
|
12/20/1995
|
Issued
|
|
EP0576585
|
United
Kingdom
|
12/20/1995
|
Issued
|
|
EP0576585
|
Italy
|
12/20/1995
|
Issued
|
|
[X]
|
[X]
|
[X]
|
[X]
|
|
202057
|
South
Korea
|
3/17/1999
|
Issued
|
|
EP0576585
|
Netherlands
|
12/20/1995
|
Issued
|
|
▇▇▇▇/▇▇
|
▇▇▇▇▇
▇▇▇▇▇▇
|
6/28/1995
|
Issued
|
Equivalents
for USPN 5,314,917; 6,297,278
|
Patent
Number
|
Country
|
Issued
|
Status
|
|
AP327
|
Aripo
|
3/21/1994
|
Issued
|
|
661968
|
Australia
|
12/12/1995
|
Issued
|
|
2106683
|
Canada
|
9/24/2002
|
Issued
|
|
E0733361
|
Switzerland
|
5/30/2001
|
Issued
|
|
E0576425
|
Switzerland
|
2/3/1999
|
Issued
|
|
69130871
|
Germany
|
2/3/1999
|
Issued
|
|
69132621.2
|
Germany
|
5/30/2001
|
Issued
|
|
EP0576425
|
France
|
2/3/1999
|
Issued
|
|
EP0733361
|
France
|
5/30/2001
|
Issued
|
|
EP0576425
|
United
Kingdom
|
2/3/1999
|
Issued
|
|
EP0733361
|
United
Kingdom
|
5/30/2001
|
Issued
|
|
EP0576425
|
Italy
|
2/3/1999
|
Issued
|
|
EP0733361
|
Italy
|
5/30/2001
|
Issued
|
|
[X]
|
[X]
|
[X]
|
[X]
|
|
▇▇▇▇▇▇▇
|
▇▇▇▇▇
|
9/7/2001
|
Issued
|
|
227773
|
South
Korea
|
8/5/1999
|
Issued
|
|
221486
|
South
Korea
|
6/28/1999
|
Issued
|
|
92/0017
|
Namibia
|
11/25/1992
|
Issued
|
|
EP0576425
|
Netherlands
|
2/3/1999
|
Issued
|
|
EP0733361
|
Netherlands
|
5/30/2001
|
Issued
|
|
9911
|
African
Union
|
9/15/1994
|
Issued
|
|
2110256
|
Russian
Fed.
|
7/17/1991
|
Issued
|
|
EP0733361
|
Sweden
|
5/30/2001
|
Issued
|
|
EP0576425
|
Sweden
|
2/3/1999
|
Issued
|
|
▇▇/▇▇▇▇
|
▇▇▇▇▇
▇▇▇▇▇▇
|
11/25/1992
|
Issued
|
Equivalents
for USPN 5,389,676
|
Patent
Number
|
Country '
Issued
|
Status
|
|
|
685507
|
Australia
|
9/9/1997
|
Issued
|
|
2171294
|
Canada
|
9/9/1994
|
Issued
|
|
EP0719137
|
Switzerland
|
2/20/2002
2/20/2002
|
Issued
|
|
69429922.7
|
Germany
|
2/20/2002
|
Issued
|
|
EP0719137
|
European
Patent
|
2/20/2002
|
Issued
|
|
EP0719137
|
Spain
|
2/20/2002
|
Issued
|
|
EP0719137
|
France
|
2/20/2002
|
Issued
|
|
EP07137
|
United
Kingdom
|
2/20/2002
|
Issued
|
|
EP071937
|
|||
|
Italy
|
2/20/2002
|
Issued
|
|
|
▇▇▇▇▇▇/▇▇
|
▇▇▇▇▇
|
9/9/1994
|
|
|
178857
|
South
Korea
|
11/25/1998
|
Issued
|
|
▇▇▇▇▇▇
|
▇▇▇▇▇▇
|
4/23/1997
|
Issued
|
|
▇▇-▇▇▇▇▇▇-
|
▇▇▇▇▇▇▇▇
|
6/30/2401
|
Issued
|
|
EP0719137
|
Netherlands
|
2/20/2002
|
Issued
|
|
EP0719137
|
Sweden
|
2/20/2002
|
Issued
|
SCHEDULE
III
CV-N
Patent Listing
| i) |
U.S.
Filings
|
| Patent Number |
Inventor
|
Date
Issued
|
Title
|
|
|
5,843,882
|
▇▇▇▇,
et al.
|
12/1/98
|
Antiviral
Proteins and Peptides, DNA, DNA-
coding
Sequences Thereof, and Uses thereof
|
|
|
5,821,081
|
▇▇▇▇,
et al.
|
10/13/98
|
Nucleic
Acids Encoding Antiviral Proteins and
Peptides,
Vectors and Host Cells Comprising
Same,
and Methods of Producing the Antiviral Proteins and
Peptides
|
|
|
5,962,653
|
▇▇▇▇,
et a].
|
10/5/99
|
Methods
of Obtaining Antiviral Proteins and Antiviral Peptides from Nostoc
Ellipsosporum
|
|
|
5,962,668
|
▇▇▇▇,
et al.
|
10/5/99
|
Nucleic
Acids Encoding Antiviral
Proteins
and Peptides Fused to
Effector
Proteins
|
|
|
6,015,876
|
▇▇▇▇▇▇▇
▇.
▇▇▇▇
|
1/18/00
|
Method
of Using Cyanovirins
|
|
|
5,998,587
|
▇▇▇▇,
et al,
|
12/7/.99
|
Anti-cyanovirin
Antibody
|
|
|
6,245,737
|
▇▇▇▇▇▇▇
▇.
|
6/12/01
|
Conjugates
of antiviral proteins or peptides and
|
|
|
▇▇▇▇
___.-_.
|
virus rviral-envelope
glycoproteins
|
|||
|
6,420,
336 B1
|
▇▇▇▇▇▇▇
▇.
|
7/16/02
|
Methods
of Using Cyanovirins Topically to
|
|
|
▇▇▇▇
|
Inhibit
Viral Infection
|
|||
|
6,428,790
B1
|
▇▇▇▇▇▇▇
▇.
|
8/6/02
|
Cyanovirin
Conjugates and Matrix-Anchored
|
|
|
▇▇▇▇
|
Cyanovirin
and Related Compositions and
Methods
of Use
|
|||
|
U.S.
Patent Appl.
|
▇▇▇▇▇▇▇
▇.
|
10/27/99
|
Methods
of Using Cyanovirins to Inhibit Viral
|
|
|
No.
|
▇▇▇▇
|
Infection
|
||
|
09/427,873
|
||||
|
U.S.
Patent Appl
No.
09/815,079
|
▇▇▇▇▇▇▇
▇. ▇▇▇▇
|
03/22/01
|
Glycosylation-Resistant
Cyanovirins and Related Conjugates, Compositions, Nucleic Acids,
Vectors,
Host Cells, Methods of Production and Methods of Using Nonglycosylated
Cyanovirins
|
|
|
U.S_
Patent Appl.
|
▇▇▇▇▇▇▇ ▇. | 9/12/01 |
Cyanovirin
Conjugates and Matrix-Anchored
|
|
|
No.
09/951,189
|
▇▇▇▇ |
Cyanovirin
and Related Compositions and
Methods
of Use
|
||
Other
Biosyn Patents Pending
|
[X]
|
[X]
|
[X]
|
[X]
|
[X]
Designates portions of this document that have been omitted pursuant to
a
request for confidential treatment filed separately with this
commission.
Schedule
IV
UC-781
Patent Listing
| i) |
U.S.
Filings
|
|
Patent
Number
|
Inventor
|
Date
Issued
|
Title
|
|
5,268,389
|
▇▇▇▇▇▇▇▇,
et al.
|
12/7/93
|
Thiocarboxylate
ester compositions containing the same
|
|
5,693,827
|
▇▇▇▇▇▇▇▇,
et al.
|
12/2/97
|
Treatment
of HIV infections and compounds useful therein
|
|
5,696,151
|
▇▇▇▇▇▇▇,
et al.
|
12/9/97
|
Compounds
useful for the inhibition of the replication of HIV-1 and HIV-1
mutants
|
|
6,017,947
|
▇▇▇▇▇▇▇,
et al.
|
1/25/00
|
Heterocyclic
carbodithioperoxyimidic compounds useful for the inhibition of
the
replication of HIV
|
|
PCT
WO
97/45116
|
Borkow
et al.
|
5/23/97
|
Use
of Thiocarboxanilide derivatives for the preparation of a medicament
for
preventing the transmission of HIV to uninfected cells and contraceptive
compositions comprising the said
derivatives
|
| ii) |
International
Filings
|
|
o
|
Filings
equivalent to USPNs 5,268,389 and
5,693,827
|
|
Patent
Number
|
Country
|
Application
Number
|
|
0497816
|
Austria
|
90915588.9
|
|
616409
|
Australia
|
66035/90
|
|
0497816
|
Belgium
|
90915588.9
|
|
[X]
|
[X]
|
[X]
|
|
[X]
|
[X]
|
[X]
|
|
▇▇▇▇▇▇▇
|
▇▇▇▇▇▇▇▇▇▇▇
|
90915588.9
|
|
69019533.8
|
Germany
|
90915588.9
|
|
0497816
|
Denmark
|
90915588.9
|
|
▇▇▇▇▇▇▇
|
▇▇▇▇▇▇
|
90915588.9
|
|
0497816
|
Great
Britain
|
90915588.9
|
|
3017128
|
Greece
|
90915588.9
|
|
198/5
|
Haiti
|
|
|
Published
|
Hungary
|
P9201258
|
|
▇▇▇▇▇
|
▇▇▇▇▇▇
|
95956
|
|
0497816
|
Italy
|
▇▇▇▇▇▇▇▇.9
|
|
▇▇▇▇▇▇▇
|
▇▇▇▇▇
|
514569/90
|
|
▇▇▇▇▇▇▇
|
South
Korea
|
700831/92
|
|
0497816
|
Luxembourg
|
90915588.9
|
|
▇▇▇▇▇▇
|
▇▇▇▇▇▇
|
22844
|
|
▇▇▇▇.▇.▇
|
▇▇▇▇▇▇▇▇▇
|
91-009
|
|
0497816
|
Netherlands
|
90915588.9
|
|
235653
|
▇▇▇
▇▇▇▇▇▇▇
|
▇▇▇▇▇▇
|
|
[X]
|
[X]
|
[X]
|
|
2108785
|
Russian
Fed.
|
5011885.04
|
|
▇▇▇▇▇▇▇
|
▇▇▇▇▇▇
|
90915588.9
|
|
NI-58187
|
Taiwan
|
79108696
|
|
90/8094
|
South
Africa
|
90/8094
|
| o |
Filings
equivalent to USPN 5,696,151
|
|
Patent
Number
|
Country
|
Application
Number
|
|
AP902
|
Kenya
|
AP/P/98/01245
|
|
AP902
|
Gambia
|
AP/P/98/01245
|
|
AP902
|
Ghana
|
AP/P/98/01245
|
|
AP902
|
Africa
(ARIPO)
|
AP/P/98/01245
|
|
AP902
|
Lesotho
|
AP/P/98/01245
|
|
AP902
|
Malawi
|
AP/P/98/01245
|
|
AP902
|
Sudan
|
AP/P/98/01245
|
|
AP902
|
Swaziland
|
AP/P/98/01245
|
|
AP902
|
Uganda
|
AP/P/98/01245
|
|
704086
|
Australia
|
11199/97
|
|
[X]
|
[X]
|
[X]
|
|
[X]
|
[X]
|
[X]
|
|
[X]
|
[X]
|
[X]
|
|
[X]
|
[X]
|
[X]
|
|
[X]
|
[X]
|
[X]
|
|
[X]
|
[X]
|
[X]
|
|
229-REG.5
|
Haiti
|
|
|
[X]
|
[X]
|
[X]
|
|
▇▇▇▇▇▇▇
|
▇▇▇▇▇
|
520533/97
|
|
[X]
|
[X]
|
[X]
|
|
[X]
|
[X]
|
[X]
|
|
[X]
|
[X]
|
[X]
|
|
324118
|
▇▇▇
▇▇▇▇▇▇▇
|
▇▇▇▇▇▇
|
|
[X]
|
[X]
|
[X]
|
|
[X]
|
[X]
|
[X]
|
|
[X]
|
[X]
|
[X]
|
|
[X]
|
[X]
|
[X]
|
|
▇▇/▇▇▇▇
|
▇▇▇▇▇
▇▇▇▇▇▇
|
96/9490
|
|
o
|
Filings
equivalent to PCT WO 97/45116
|
|
Patent
Number
|
Country
|
Application
Number
|
|
[X]
|
[X]
|
[X]
|
|
[X]
|
[X]
|
[X]
|
|
[X]
|
[X]
|
[X]
|
SCHEDULE
V
Public
Health Service Patent License Agreement - Exclusive, between
Public
Health Service agencies and Biosyn, Inc.
Incorporated
by reference to Exhibit 10.22 to the Registrant’s Annual Report on Form 10-K for
the year ended December 31, 2004, filed with the Commission.
SCHEDULE
VI
License
Agreement dated May 22, 2001, between
Biosyn,
Inc. and Crompton Corporation.
Incorporated
by reference to Exhibit 10.23 to the Registrant’s Annual Report on Form 10-K for
the year ended December 31, 2004, filed with the Commission.