FIRST AMENDED AND RESTATED EXCLUSIVE LICENSE AND DISTRIBUTION AGREEMENT FOR RECTOGESIC® Between STRAKAN INTERNATIONAL LIMITED And Cellegy Pharmaceuticals, Inc. Confidential
FIRST
AMENDED AND RESTATED EXCLUSIVE LICENSE AND DISTRIBUTION AGREEMENT FOR
RECTOGESIC®
Between
STRAKAN
INTERNATIONAL LIMITED
And
Cellegy
Pharmaceuticals, Inc.
Confidential
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[*]
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designates
portions of this document that have been omitted pursuant to a request
for
confidential treatment filed separately with the
Commission
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1
FIRST
AMENDED AND RESTATED
EXCLUSIVE
LICENSE AND
DISTRIBUTION AGREEMENT
THIS
FIRST AMENDED AND RESTATED EXCLUSIVE LICENSE AND
DISTRIBUTION LICENSE AGREEMENT
(this "Agreement")
is
made and entered into as of November
9, 2005 (the “Agreement
Date”),
by
and between Cellegy Pharmaceuticals, Inc., a Delaware
corporation having its principal place of business at 0000 Xxxxxxx Xxxx,
Xxxxxxxx 00, Xxxxxxxxxx Xxxxxx, XX, 00000-0000 XXX ("Cellegy"),
and
Strakan International Limited,
a
company organized and existing under the laws of Bermuda with a branch office
at
Xxxxxxxx Xxxx, Xxxxxxxxxx, XX0 0XX, XX ("Licensee”").
BACKGROUND
A. Cellegy
owns or possesses certain intellectual property rights with respect to the
Licensed Product (as hereinafter defined) and certain rights pertaining to
Cellegy’s Marks (as hereinafter defined).
B. The
Parties previously entered into an Exclusive License and Distribution Agreement
(“Prior
Agreement”)
dated
as of July 9, 2004 (the “Prior
Agreement Date”),
pursuant to which Licensee obtained an exclusive license to certain rights
to
the Licensed Product under such intellectual property rights, and to Cellegy’s
Marks within the Territory (as hereinafter defined).
C. The
Parties desire to amend the Prior Agreement in various respects, as reflected
in
this Agreement.
AGREEMENT
Commencing
with the Agreement Date, this Agreement shall amend, restate and supersede
in
its entirety the Prior Agreement. In consideration of the foregoing and of
the
mutual covenants hereinafter set forth and other good and valuable
consideration, the receipt of which is hereby acknowledged, the Parties (as
hereinafter defined) mutually agree as follows:
DEFINITIONS
As
used
in this Agreement, the following terms, whether used in the singular or the
plural, shall have the following meanings:
“Affiliates”
shall
mean, with respect to any party, any person, which, directly or indirectly,
is
controlled by, controls or is under common control with such party. For purposes
of this definition, the term control (including with correlative meanings,
the
terms controlled by and under common control with) means having the power,
whether held directly or indirectly and by whatever means (and whether or not
enforceable at law or in equity) to:
1
| (i) | exercise or control the right to vote attached to 50% or more of the issued shares in the party; | |
| (ii) |
dispose
of or exercise a right of disposal in respect of 50% or more of the
issued
voting shares in the party;
|
|
| (iii) |
appoint
one half or more of the number of directors to the board of the party;
or
|
|
| (iv) | determine substantially the conduct of the party’s business activities. |
“Agreement”
means
this First Amended and Restated Exclusive License and Distribution
Agreement.
“Approvals”
are
registration approvals, registrations or authorizations provided by the Relevant
Regulatory Authority in the Territory for the importation, storage, Development,
promotion, marketing, distribution or sale of the Licensed Product, but
excluding any pricing approvals that may be required by any Relevant Regulatory
Authority of a country within the Territory.
“Cellegy
Information”
means
the technical and clinical information concerning the Licensed Product that
is
developed by Cellegy and that is included in the new drug application filed
with
the Relevant Regulatory Authority in the
United Kingdom,
and
Cellegy’s European common technical document format, and which may include,
without limitation, data in support of indications, bioequivalency data and
information, clinical data, pharmaco-toxicological data, analytical methods,
stability and pharmaceutical data concerning the Licensed Product, and any
other
of Cellegy’s related supporting documentation or other information or
materials
of
Cellegy
in
Cellegy’s possession from time to time that Cellegy may in its discretion from
time to time develop before the date that all required Approvals are obtained
and that may be necessary for, or useful in connection with obtaining and
maintaining Approvals for the Licensed Product in the Territory.
“Cellegy
Marks”
means
the trademarks, service marks and/or trade names owned by Cellegy or that
Cellegy has the right to use in connection with the Licensed Product as set
forth on Exhibit
C hereto
and as further described in Section 13.1, that are used by Licensee, its
Affiliates or Sublicensees in connection with the importation, storage,
Development, promotion, marketing, distribution and sale of the Licensed
Product.
“Cellegy
Patents”
means
the patents identified on Exhibit
B
hereto.
“Cellegy
Supply Agreement” means
the
supply agreement between Cellegy and Manufacturer governing the supply of the
Licensed Product to Cellegy or Cellegy’s nominees or licensees outside the
Territory and incorporating the terms and conditions of a relevant Technical
Agreement.
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“Commercially
Reasonable and Diligent Efforts”
shall
mean with respect to Development and commercialization of the Licensed Product,
a Party’s reasonable efforts no less than those efforts used by the Party in its
other development, commercialization or marketing projects with other
technologies and products having comparable commercial potential.
“Competing
Licensed Products”
has
the
meaning set forth in Section 2.4.
“Development”
(including variations such as “Develop” and the like) shall mean all appropriate
measures, steps and the like that are necessary to prepare and compile dossiers
appropriate for obtaining Approvals for the Licensed Product in the Territory
and conducting clinical trials in the Territory (if required). As it relates
to
Cellegy, “Development” shall mean that Cellegy shall provide Licensee a copy of
the dossier concerning the Licensed Product filed by Cellegy with the Relevant
Regulatory Authority in the
United Kingdom,
and
such other materials relating thereto or to obtaining other Approvals for the
Licensed Product in the Territory as Cellegy may in its discretion from time
to
time develop before the date that all required Approvals are
obtained.
“Dollars”
or
“$”
means
United States dollars.
“Prior
Agreement Date”
means
the date set forth at the beginning of the Prior Agreement.
“Euros”
or
“€”
shall
mean currency denominated in Euros.
“Field”
shall
mean the use of the Licensed Product for the treatment of the pain associated
with chronic anal fissure, for the treatment of one (1) or more of the symptoms
associated with or related to hemorrhoids, and for any other additional
therapeutic and medicinal uses of the Licensed Product within the
Territory.
“GMP”
means
good manufacturing practices in conformity with the regulations and regulatory
interpretations of the Relevant Regulatory Authorities in each country in the
Territory, including without limitation EU cGMP such regulations covering good
manufacturing practices set forth in the relevant legislation or guidelines
and
applicable to the Territory, as such regulations may be amended and interpreted
by the Relevant Regulatory Authorities from time to time.
“Initial
Indication”
means
the treatment of the pain associated with chronic anal fissure.
“Intellectual
Property Rights”
means
all rights and interests, vested or arising out of any industrial or
intellectual property, whether protected at common law or under statute,
which
includes (without limitation) the Patent
Rights, Cellegy
Marks
and Know-How and any rights and interests in inventions (both patentable
and
unpatentable), patents, copyrights, moral rights, designs (whether registered
or
unregistered), trade marks (whether registered or unregistered), trade secrets,
goodwill, samples, materials, data, results and Confidential
Information.
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“Know-How”
means
all data, information, methods, procedures, processes and materials, which
is or
comes to be possessed, acquired, licensed or owned by Cellegy as of the Prior
Agreement Date and from time to time thereafter, to the extent that such data,
information, methods, procedures, processes and materials specifically relate
to
the manufacture, development, testing or use of the Licensed Product, including
but not limited to, biological, chemical, biochemical, toxicological,
pharmacological, metabolic, formulation, clinical, analytical and stability
information and data (other than such Know-How which is the subject of a patent
or of a provisional or filed patent application), and for which Cellegy has
the
right to license, disclose or provide to Licensee.
“Launch
Date”
means
following Approval the date upon which the Licensed Product is first
commercially offered for sale in a country in the Territory, determined on
a
country by country basis.
“Licensed
Product”
means
the pharmaceutical
product known as Rectogesic®
ointment,
a
nitroglycerin
ointment in any formulations or presentations for the treatment of pain
associated with chronic anal fissure and, if Approvals are obtained, for
the
treatment of one or more additional
indications.
“Licensee
Supply Agreement”
means
the
supply agreement between Licensee and Manufacturer governing the supply of
the
Licensed Product to Licensee by Manufacturer for the Territory and incorporating
the terms and conditions of a relevant Technical Agreement.
“Loss”
means
any and all loss, liability, damage, fee, cost, (including without limitation
actual reasonable court costs and reasonable attorneys’ fees regardless of
outcome) expense, suit, claim, demand, judgment and prosecution.
“Major
European Countries”
shall
mean France, Germany, Italy, Spain and the United Kingdom.
“Manufacturer”
means
the existing Third Party manufacturer of the Licensed Product or any other
manufacturer that may in the future enter into a Cellegy Supply Agreement or
a
Licensee Supply Agreement.
“Marketing
Authorization” means
any
approval (including any applicable pricing and governmental reimbursement
approvals) in Licensee’s name required to Develop, market and sell the
Licensed Product in a particular country in the Territory.
“M.R.P”
means
the mutual recognition procedure as defined in Article 28 of European Directive
2001/83/EC.
“Net
Sales”
means
the gross proceeds from sales of the Licensed Product that is due, or otherwise
received by, Licensee, or its Affiliates or its Sublicensees from Third Party
customers for such Licensed Product, less:
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| (i) | reasonable credited allowances actually granted to such Third Party customers for spoiled, damaged, rejected, recalled, outdated or returned Licensed Product, | |
| (ii) |
the
amounts of reasonable trade and cash discounts actually allowed,
to the
extent such trade and cash discounts are specifically allowed on
account
of the purchase of such Licensed Product,
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|
| (iii) |
sales
taxes, excise taxes, use taxes and import/export duties and any
other
government charges (other than taxes on income) actually due or
incurred
or paid by Licensee, or its Affiliates or Sublicensees, in connection
with
the sales of the Licensed Product to any Third Party, and
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|
| (iv) | reasonable allowances, adjustments, reimbursements, discounts, chargebacks and rebates actually granted to Third Parties, including, but not limited to, rebates given to health care organizations or other Third Parties, and any bona fide payment made in respect of any sales of Licensed Product to any governmental or quasi-governmental body or agency, whether during the actual Sales Period or not. |
“Party”
means
Cellegy or Licensee, and Parties shall mean both Cellegy and
Licensee.
“Patent
Rights”
means
(i) the patents and patent applications listed in Exhibit
B
hereto
and any patents and patent applications existing as of the Prior Agreement
Date;
(ii) any patent or patent application hereafter which is acquired by Cellegy
or
under which Cellegy becomes licensed and with the right to sublicense to
Licensee, during the term of this Agreement, in each case of (i) and (ii)
above
relating to the Licensed Product, its manufacture, use or sale, including
methods of use and screening or processes that use the Licensed Product;
(iii)
any divisionals,
continuations and continuations-in-part defined in (i) or (ii); (iv) any
extension, renewal or reissue or patent identified in any reissue or
re-examination of any patent or patent application identified in (i) through
(iv), in each case, to the extent that such items relate to the Licensed
Product. Such items set forth in sub-items (i) through (iv) will be identified
and added by the Parties to Exhibit
B
from
time to time during the term of this Agreement.
“Relevant
Regulatory Authority”,
in
relation to a country or region in the Territory, means the governmental
authority, regulating the use, importation, storage, Development, promotion,
marketing, distribution or sale of therapeutic substances and the grant of
Approvals in such country or region.
“Retained
Information”
means
any and all books and records prepared and maintained by Cellegy now or in
the
future in connection with the Licensed Product, including, without limitation,
in relation to any and all additional formulations, therapeutic and medicinal
uses and further including, without limitation, all regulatory files (including
correspondence with regulatory authorities), assays, test methods, batch
records, analytical methods including validation protocol and the drug master
file and stability studies in relation thereto in each case to the extent that
Cellegy is permitted by law and under its agreements to provide such information
to Licensee.
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“Sublicensee”
means
any person to whom Licensee sublicenses the rights, or any portion thereof,
granted by Cellegy to Licensee pursuant to Section 2.1 hereof.
“Technical
Agreements”
mean the
agreements between Cellegy and Manufacturer for Product supplied outside the
Territory, and between Strakan and Manufacturer for Licensed Product supplied
within the Territory, defining the roles and responsibilities for the parties
in
relation to, inter alia, (i) manufacture and supply of the Licensed Product
pursuant to GMP; and (ii) regarding regulatory, safety and pharmacovigilence
issues, the terms and conditions of which are incorporated into any supply
agreement for the Licensed Product.
“Territory”
means
the countries listed on Exhibit
A hereto.
“Third
Party”
means
any party other than Cellegy or Licensee, or Licensee’s Affiliates or
Sublicensees.
GRANT
OF LICENSE
2.1 Grant.
Cellegy
grants to Licensee an exclusive
fully
paid up license, with a right to sublicense as set forth herein, under all
of
Cellegy’s Intellectual Property Rights to manufacture or have manufactured
anywhere in the world, import, store, Develop, have Developed (through
agreements with contract research organizations or similar Third Parties,
performing work on behalf of and for the benefit of Licensee), promote, market,
distribute, offer for sale, and sell the Licensed Product in
the
Field within
the Territory, and to use Cellegy’s Intellectual Property Rights and the
Retained Information in connection with the manufacturing, importation, storage,
Development, promotion, marketing, distribution
and sale of Licensed Product
in the
Field within the Territory
and
obtaining any Approvals hereunder. Licensee’s rights to the Licensed Product and
the Intellectual Property Rights are limited to those expressly granted, and
all
others are reserved to Cellegy.
2.2 Right
to sub-license.
Licensee may freely sub-license any of its rights or obligations under this
Agreement, directly or indirectly, in whole or in part.
Any such
sublicense shall not relieve Licensee of any of its obligations hereunder,
and
Licensee shall remain responsible and liable for compliance by any such Third
Party, Affiliate or Sublicensee with this Agreement, all relevant laws,
regulations and requirements relating to the manufacturing, importation,
distribution, marketing, promotion and sale of the Licensed Product in the
Territory, and any acts or omissions by any such Third Party, Affiliate or
Sublicensee that would constitute a breach of this Agreement if such sublicense
had not been entered into and the actions or omissions were those of Licensee
rather than the Third Party, Affiliate or Sublicensee. Any sublicense agreement
shall contain terms and conditions that are not inconsistent with those of
this
Agreement.
2.3 Acceptance
of Appointment; Sales Outside Territory.
(a) Licensee
hereby accepts appointment as Cellegy's exclusive licensee
of Licensed Product in the Territory, as provided in Section 2.1
above.
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(b) Licensee
shall not, and Licensee shall use all Commercially Reasonable and Diligent
Efforts to ensure that its officers, directors, employees, Affiliates, agents
or
representatives (collectively, "Agents")
shall
not, without the prior written consent of Cellegy, directly or indirectly
promote, sell, distribute or otherwise make available (for remuneration or
gratuitously) Licensed Product outside the Territory or sell, distribute or
otherwise make available (for remuneration or gratuitously) Licensed Product
to
persons outside the Territory for the purpose of resale or distribution (whether
for remuneration or gratuitously) outside the Territory. Without limiting the
foregoing, Licensee agrees to use all Commercially Reasonable and Diligent
Efforts to ensure compliance with the preceding sentence, including without
limitation placing appropriate notices on the labels of Licensed Products;
provided, however, that Licensee shall not be obligated to include any notices
in a particular country in the Territory that would conflict with any relevant
requirements of the Relevant Regulatory Authority for such country, and
Licensee’s failure or refusal to include any such notices in such circumstances
shall not constitute a breach of any provision of this Agreement.
2.4 Competing
Products.
Until
June 30, 2007, or, if earlier, the maximum period of time permitted by
applicable European Union regulations, Licensee shall not, and shall use all
Commercially Reasonable and Diligent Efforts to ensure that its officers,
directors, employees, Affiliates, Sublicensees, agents or representatives
(collectively, "Agents")
shall
not, directly or indirectly, promote, sell or distribute products within the
Major European Countries that are directly competitive in the treatment of
anal
fissures (the
“Competing
Licensed Products”).
If
applicable law or applicable European Union regulations provide that the
foregoing covenant is unenforceable or require that the duration of the
foregoing covenant be shorter than the term of this Agreement, then such
provision shall be deemed automatically conformed in order to comply with
applicable law or regulations.
REPRESENTATIONS
AND WARRANTIES
3.1 Representations
and Warranties of Cellegy. Cellegy
hereby represents and warrants to Licensee that:
(a) Cellegy
is a corporation duly incorporated, validly existing and in good standing under
the laws of the State of Delaware,
with
the corporate power and authority to enter into this Agreement and to perform
its obligations hereunder. The execution and delivery of this Agreement and
the
consummation of the transactions contemplated hereby have been duly authorized
by all requisite corporate action on the part of Cellegy. This Agreement has
been duly executed and delivered by Cellegy and constitutes the valid, binding
and enforceable obligation of Cellegy, subject to applicable bankruptcy,
reorganization, insolvency, moratorium and other laws affecting creditors’
rights generally from time to time in effect and to general principles of
equity.
(b) Except
as
disclosed by Cellegy to Licensee in a writing prior to the Agreement Date
specifically referencing this Section 3.1(b), Cellegy is not subject to, or
bound by, any provision of: (i) its certificate of incorporation or by-laws,
(ii) any mortgage, deed of trust, lease, note, shareholders’ agreement, bond,
indenture, license, permit, trust, custodianship, or other instrument, agreement
or restriction, or (iii) any judgment, order, writ, injunction or decree of
any
court, governmental body, administrative agency or arbitrator, that would
prevent, or be violated by, or under which there would be a default as a result
of, nor is the consent of any person required for, the execution, delivery
and
performance by Cellegy of this Agreement and the obligations contained herein,
including without limitation, the grant to Licensee of the license described
in
Section 2.1 hereof.
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(c) Subject
to the final sentence of this Section 3.1(c): (i) Cellegy
is the exclusive owner of all right, title and interest in the Patent
Rights
in the
applicable countries in the Territory;
(ii) the
patent applications included in the Patent Rights have been duly filed and
contain no material errors;
and
(iii)
Cellegy
shall maintain all Patent Rights for the full duration of this Agreement
or
such
earlier time, if any, as Licensee forecloses on the Patent Rights pursuant
to
Article 9. Attached hereto as Exhibit
B is
a
complete and accurate list of all patents and patent applications included
in
the Patent Rights.
Notwithstanding the foregoing, as Cellegy has disclosed in its filings with
the
Securities and Exchange Commission, the Board of Opposition of the European
Patent Office rendered a verbal decision revoking Cellegy’s European patent
relating to the Licensed Product; and although Cellegy has appealed this
decision, Cellegy makes no representation or warranty regarding the outcome
of
the opposition and appeal process, the Cellegy Patent Rights may be held to
be
invalid or revoked, and any representation or warranty of Cellegy made herein
regarding Cellegy Patent Rights is qualified in its entirety by the foregoing
matters.
(d) Cellegy
is the exclusive owner of all right, title and interest in the Cellegy Marks
in
the
Territory. Cellegy shall maintain at its sole expense where applicable all
Cellegy Marks for the full duration of this Agreement or such earlier time,
if
any, as Licensee forecloses on the Cellegy Marks pursuant to Article 9. Attached
hereto as Exhibit
C
is a
complete and accurate list of all trade marks and trade xxxx applications
included in the Cellegy Marks.
(e) To
the
best of Cellegy’s knowledge, neither the development, use or sale of the
Licensed Product or the practice of any of the inventions included in the Patent
Rights or the use of the Cellegy Marks or the use of the Know-How by Licensee
as
contemplated by this Agreement infringes upon any Third Party’s know-how,
patent, trade xxxx or other intellectual property rights in the
Territory.
(f) To
the
best of Cellegy’s knowledge, there is no Third Party using or infringing any or
all of the Patent Rights or the Cellegy Marks in derogation of the rights
granted to Licensee in this Agreement.
(g) Cellegy
represents and warrants that, to the best of its knowledge, it has furnished
or
will furnish (in accordance with the terms of this Agreement) to Licensee all
of
the Know-How which Cellegy owns or possesses.
(h) CELLEGY
MAKES NO REPRESENTATION OR WARRANTY OTHER THAN THOSE EXPRESSLY PROVIDED
HEREUNDER, AND CELLEGY HEREBY DISCLAIMS ALL SUCH OTHER WARRANTIES, EXPRESS
OR
IMPLIED, INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF MERCHANTABILITY, OR
THE
FITNESS FOR A PARTICULAR PURPOSE, OF THE LICENSED PRODUCT OR THE KNOW-HOW.
EXCEPT AS MAY BE EXPRESSLY PROVIDED ELSEWHERE HEREIN, CELLEGY MAKES NO
REPRESENTATION OR WARRANTY THAT THE LICENSED PRODUCT IS OR WILL BE SHOWN TO
BE
SAFE OR EFFECTIVE FOR ANY INDICATION. THE FOREGOING SHALL NOT REDUCE THE SCOPE
OF ANY REPRESENTATION OR WARRANTY OF CELLEGY EXPRESSLY MADE TO LICENSEE
HEREIN.
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(i) Cellegy
will use all Commercially Reasonable and Diligent Efforts to ensure that Cellegy
will provide
reasonable notice to Licensee of any significant changes to
the
Cellegy Information supplied to Licensee or the materials or processes described
in that information in relation to any Licensed Product.
3.2 Representations
and Warranties of Licensee.
Licensee hereby represents and warrants to Cellegy as follows:
(a) Licensee
is a corporation duly incorporated, validly existing and in good standing under
the laws of Bermuda, having a branch office in the UK with the corporate power
and authority to enter into this Agreement and to perform its obligations
hereunder. The execution and delivery of this Agreement and the consummation
of
the transactions contemplated hereby have been duly authorized by all requisite
corporate action on the part of Licensee. This Agreement has been duly executed
and delivered by Licensee and constitutes the valid, binding and enforceable
obligation of Licensee, subject to applicable bankruptcy, reorganization,
insolvency, moratorium and other laws affecting creditors’ rights generally from
time to time in effect and to general principles of equity.
(b) Licensee’s
Affiliates shall not conduct themselves in such a way that Licensee will be
in
breach of any term or condition of this Agreement.
(c) To
the
best of Licensee’s knowledge, Licensee currently is in compliance in all
material respects with all applicable laws and has received, or will receive
where relevant, all applicable pharmaceutical product certifications and
registrations from appropriate governmental entities that are necessary to
perform its obligations under this Agreement. Licensee agrees that during the
term of this Agreement it will comply in all material respects with all
applicable laws and regulations regarding the export, sale and distribution
of
the Licensed Product in the Territory.
ARTICLE
4
APPROVAL
AND MARKETING PLANS
4.1 Approval
Plan; Marketing Plan. The
overall timetable to obtain Approvals for the Licensed Product in the Major
European Countries has been set forth in a written plan by Licensee which
Cellegy has approved (the “Approval
Plan”).
In
addition, Licensee has
prepared and Cellegy has approved a
marketing plan
in
connection with the promotion, marketing and distribution of the Licensed
Product in the Major European Countries (the “Marketing
Plan”).
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REGULATORY
MATTERS; APPROVALS
5.1 Regulatory
Matters; Approvals.
(a) Licensee
shall use Commercially Reasonable and Diligent Efforts, subject to this
Agreement, to
obtain
at its sole expense all Approvals that are necessary for the sale of the
Licensed Product within the Territory for the Initial Indication only, including
without limitation any additional clinical trials, studies or data in addition
to the Cellegy Information that may be required in order to obtain or maintain
Approvals for the Licensed Product in each country in the Territory for the
Initial Indication, and comply with any and all applicable statutory,
administrative or regulatory requirements of the Territory or any governmental
or political subdivisions thereof (collectively, "Laws")
in
relation to the manufacture, importation, storage, Development, promotion,
marketing, distribution or sale of the Licensed Product in the Territory under
this Agreement, including, without limitation, Licensed Product documentation
such as Licensed Product tracking, samples, Licensed Product complaints, adverse
event reporting requirements, post-marketing surveillance activities, and
documentation of recalls, which documentation shall be maintained by the
Licensee for the period required by the Relevant Regulatory Authorities in
the
Territory notwithstanding termination or expiration of this Agreement, any
Licensed Product registrations with any government agency or health authority,
or any registration, approvals, or filing of this Agreement. Licensee
shall inform Cellegy on at least a semi-annual basis (and more frequently if
Cellegy so reasonably requests) about the progress of such registration work,
and will promptly provide Cellegy with a copy of all presentations and documents
submitted by Licensee to any Relevant Regulatory Authority with respect to
the
Licensed Product. Cellegy shall, upon Licensee’s written request, provide
reasonable assistance to Licensee, at Licensee’s sole cost, regarding obtaining
such Approvals in the Territory, including allowing Licensee reasonable access
to relevant experts in relation to the Cellegy Information for the purpose
of
obtaining Approvals.
(b) With
respect to indications other than the Initial Indication, Licensee shall be
responsible for the conduct of such clinical trials or studies as Licensee
may
in its discretion undertake.
(c) Utilizing
the United Kingdom Marketing Authorization for the Licensed
Product
Licensee
will
make
filings that are required to seek and obtain Approvals for the Licensed Product
in each other Major European Country through the M.R.P provided that the
dossier
used in the United Kingdom is acceptable for use in an MRP application. If
the
Relevant Regulatory Authority in a country other than the
United Kingdom
determines that such dossier is not complete or acceptable for the initiation
of
an M.R.P. application in such country, then the parties shall meet and attempt
to agree on an appropriate course of action. If Licensee desires to not seek
Approvals in one or more Major European Countries because Licensee concludes
in
good faith that for regulatory or marketing reasons it would not be in the
parties’ best interests to pursue Approvals in such countries, it shall notify
Cellegy and if Cellegy disagrees, the parties shall meet in good faith to
attempt to agree whether Approvals will be sought in such country or countries.
If alteration by Cellegy of the Cellegy Information after the date of this
Agreement requires additional time to submit or revise regulatory filings
relating to Approvals, then the time periods set forth above for making filings
and obtaining Approvals shall be extended by the additional period of time
required to submit or revise such filings. Licensee
shall have no liability nor shall it be deemed to be in breach of this Agreement
in the event that Approvals are not obtained in any or all other Major European
Countries or in any other country in the Territory.
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(d) With
the
exception of the assignment
of the Approval
that Cellegy has obtained in the
United Kingdom and
such
other materials as Cellegy in its discretion may provide to Licensee pursuant
to
this Agreement, Licensee shall pay all costs in connection with the filing,
prosecution, meetings, communications, and review by Relevant Regulatory
Authorities of Approval applications and Approvals relating to the Licensed
Product in the Territory and complying with applicable laws and
regulations.
5.2 Cooperation
Regarding Material Events.
Each
Party will immediately notify the other Party of any material events relating
to
the Development of the Licensed Product in the Territory, including, without
limitation, any material comments or concerns raised by any Relevant Regulatory
Authority.
To the
extent either Party receives written or material oral communication from any
Relevant Regulatory Authority relating to the Licensed Product in the Territory,
the party receiving such communication shall notify the other parties and
provide a copy of any written communication as soon as reasonably practicable.
5.3 Copies
of Documents.
Each
Party agrees to provide to the other Party a copy of (i) any documents or
reports relating to the Licensed Product that are filed with any Relevant
Regulatory Authority in the Territory under this Agreement, including any
Approval applications; and (ii) all data, database information and safety
reports from clinical trials conducted by or on behalf of Licensee. In
particular, Licensee acknowledges that Cellegy has provided to Licensee a copy
of the dossier concerning the Licensed Product filed in the
United Kingdom.
All
such documents and reports shall be centralized and held at Licensee or by
a
Third Party selected by Licensee and agreed to by Cellegy, provided however,
that Cellegy shall be entitled to obtain and keep copies of any such documents
and records but only for the uses specifically set forth in this
Agreement.
5.4 Meetings
With Regulatory Authorities. Licensee
shall be responsible for conducting all meetings and discussions and routine
telephone communications with any Relevant
Regulatory Authority, related to clinical studies, Approval applications and
Approvals for the Licensed Product in the Territory. Licensee will keep Cellegy
apprised of all material communications with such Relevant Regulatory
Authorities.
5.5 Clinical
Trials.
Licensee shall at its own cost be responsible for the conduct of all studies
and
clinical trials that may be necessary or appropriate to obtain all required
Approvals (with
the
exception of the Approval for the United Kingdom that has been
obtained)
and any
post-Approval Clinical Trials and for the grant of all necessary approvals
and
maintaining in effect all appropriate policies of insurance for clinical trials
for the use of the Licensed Product in the Territory. Licensee agrees to provide
such data and materials regarding any such studies or trials as Cellegy may
reasonably request, and Cellegy may use such materials for its own business
purposes in connection with obtaining or maintaining Approvals for the Licensed
Product in other jurisdictions outside the Territory. Licensee may enter into
one or more manufacturing and supply agreement(s) (or similar arrangements)
with
Third Party contract manufacturer(s) for such clinical supplies.
11
5.6 Cellegy
Obligations.
Promptly following entering into this Agreement Cellegy shall, to the extent
it
has not already done so pursuant to the Prior Agreement:
(a) provide
Licensee with a complete copy of the Cellegy Information
as well
as copies of clinical data, analysis and reports of Cellegy or its other
licensees of the Licensed Product in other countries (to the extent in Cellegy’s
possession and that Cellegy is permitted to provide such information under
the
terms of its agreements with such licensees, with Cellegy agreeing to use
commercially reasonable efforts after the date of this Agreement to include
provisions in agreements with other licensees of the Licensed Product to permit
the sharing of such data, analysis and reports from licensees);
(b) provide
Licensee with any information in its possession that is reasonably likely to
jeopardize or otherwise have a material adverse impact on the application,
or
any grant, maintenance, variation or renewal of the Approvals;
(c) use
commercially reasonable efforts to assist Licensee to enter into Licensee Supply
Agreement and Technical Agreement with the Manufacturer; and
(d) notify
Licensee and promptly provide all relevant assistance and supporting
documentation to Licensee and Manufacturer, where relevant, should Cellegy
make
any alteration to the Licensed Product, or the manufacture, or packing of the
Licensed Product that requires notification to a Relevant Regulatory
Authority.
5.7 Approvals.
(a) All
Approvals by any Relevant Regulatory Authority which are necessary to sell
the
Licensed Product within the Territory shall be issued to, owned by
and held
in the name of Licensee.
(b) Licensee
shall promptly provide to Cellegy, upon Cellegy's request, such evidence that
Cellegy shall reasonably require, confirming that all Approvals necessary to
import, store, Develop, promote, market, distribute and sell the Licensed
Product in the Territory have been obtained.
(c) Cellegy
hereby acknowledges that, except as may otherwise be required by law, Licensee
has no obligation to verify the Cellegy Information.
12
ARTICLE
6
POST-
APPROVAL RESPONSIBILITIES
6.1 Responsibility.
Each
Party acknowledges that Licensee or the Affiliate or Sublicensee named by
Licensee as the holder of the Approvals bears the ultimate responsibility
vis-à-vis
the
Relevant Regulatory Authorities for complying with the regulatory requirements
applicable to the manufacture, importation, storage, Development, promotion,
marketing, distribution and sale of the Licensed Product in the Territory.
6.2 Collaboration.
The
Parties shall collaborate with each other and each Party agrees to provide
the
other Party with any reasonable assistance it may require to ensure compliance
with the Approvals.
6.3 Insurance.
To the
extent commercially available, both Parties shall maintain in full force and
effect for the term of this Agreement and for five (5) years thereafter product
liability insurance and property damage insurance on its operations naming
the
other Party as an additional insured, with terms reasonably satisfactory to
the
other Party. The amount and extent of coverage of the insurance required
hereunder, if any, shall be not less than a single limit liability of not less
than U.S. $5 million in one claim and in the aggregate, and each Party shall
furnish to the other Party copies of policies of insurance or certificates
evidencing the existence and amounts of such insurance within thirty (30) days
of the other Party’s request for such copies. Each Party shall provide the other
Party with written notice of any cancellation of any insurance hereunder at
least thirty (30) days prior to such cancellation.
ARTICLE
7
INFORMATION;
DATA; PHARMACOVIGILENCE
7.1 Clinical
Data.
(a) All
clinical
data and
reports related to clinical trials for the Licensed Product in the Territory
shall be owned by the Party funding such clinical trial(s). Other than to a
Sublicensee in connection with the transactions contemplated by this Agreement,
Licensee shall not sell, disclose to or share with any Third Party, or grant
any
Third Party right to use, any clinical data arising owned by Licensee as a
result of the preceding sentence. Each Party shall have access to, and copies
of, all such data and reports related to clinical trials for the Licensed
Product in the Territory, and each Party may use such data without any
additional payments to the other Party. Each Party shall treat such data and
reports as Confidential Information of the other Party, and neither Party shall
disclose or use such data or reports for any purpose other than performing
its
obligations under this Agreement or as otherwise expressly authorized in writing
by the other party except to the extent that data or reports are required by
the
voluntary or compulsory prior registration of a clinical trial, and except
for
such disclosures as a Party reasonably believes is required by securities or
regulatory laws or regulations. If a Party itself obtains data from a clinical
trial hereunder, it shall promptly transfer all of the clean, final data for
such trial to Licensee or to Cellegy, as the case may be. The parties shall
coordinate the transfers of any such data.
7.2 Safety
Data Base.
The
Parties will, as soon as practical, organize a serious adverse event data base
(the “SAE
Data Base”).
Cellegy and Licensee shall jointly own the SAE Data Base and all data contained
therein, and the data from the SAE Data Base shall be made
available to both Parties. Licensee shall be responsible for, and bear the
costs
of, data for the SAE Data Base related to the Territory. Cellegy shall be
responsible for, and bear the costs of, data for the SAE Data Base related
to
territories outside the Territory. The provisions governing the management
of
such SAE Data Base shall be agreed separately by the
Parties.
13
[*]
designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the
Commission
7.3 Adverse
Events.
The
Parties recognize that as the holder of the Approvals, Licensee will be required
to submit information and file reports to various governmental agencies on
compounds under clinical investigation, compounds proposed for marketing, or
marketed drugs. The process and responsibilities for such reports will be
governed by the Adverse Event Reporting Addendum separately agreed to by the
Parties.
7.4 Product
Complaints.
Each
Party will maintain a record of all non-medical and medical Licensed
Product-related complaints and will notify the other Party of any complaint
in a
sufficient time to allow the other Party to comply with any regulatory
requirements it may have with respect to such complaint.
The
details and responsibilities governing the management of such Licensed
Product-related complaints shall be agreed separately by the
Parties.
7.5 Further
Development.
For the
avoidance of doubt, Licensee shall be free and clear to conduct further
development (including conducting clinical trials), formulation work for any
and
all additional therapeutic and medicinal uses of the Licensed Product within
the
Territory and to sub-license its rights obtained hereunder within the Territory
without the need for consent or any further payment or compensation due to
Cellegy whatsoever. Licensee shall provide information relating to such
development, work and uses as provided above.
7.6 Access
and Use of Retained Information, Future Information and
Personnel.
At any
time on or after the Agreement Date at no cost to Licensee: (i) Cellegy shall
cooperate with Licensee in making Retained Information available; (ii) Cellegy
shall use reasonable efforts to make available to Licensee for a minimum period
of [*]
certain
Cellegy personnel identified separately in writing, to assist, inter alia,
Licensee in relation to the MRP; and (iii) Cellegy shall furnish copies of
such
Retained Information for review by Licensee, to the extent practicable, at
the
reasonable request of Licensee. At any time on or after the Agreement Date
at no
cost to Cellegy, Licensee shall cooperate with Cellegy in making any information
developed by or on behalf of Licensee or its licensees relating to any further
development (including conducting clinical trials and any related technical
or
clinical data, analysis and reports), formulation work and clinical trials
for
any and all additional therapeutic and medicinal uses of the Licensed Product
within the Territory.
MILESTONE
PAYMENTS
8.1 Milestone
Payments.
After
the Agreement Date, Licensee shall pay Cellegy milestone payments in the
particular amounts specified below
(with
all payments to be made in U.S. Dollars):
Licensee
shall pay to Cellegy three (3) milestone payments, each milestone
being
14
[*]
designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the
Commission
the
amount of [*]
for each
Approval obtained in the first of [*]
up to a
maximum total amount payable of [*].
Such
payments shall be due no later than [*]
after
achievement of the milestone.
8.2 Sales
Milestones.
In
addition, Licensee shall pay Cellegy the following amounts, within [*] after
the
end of the month in which the relevant milestone is achieved:
(a) [*]
(b) [*]
(c) Licensee
shall provide to Cellegy sufficient information from time to time regarding
Licensed Product sales to enable Cellegy to determine whether one or more
of the
above milestones have been satisfied.
(d) Licensee’s
obligations to pay sales milestones under this Section shall terminate and
be of
no further force or effect on June 30, 2007 and Licensee shall not be deemed
to
be in breach of this Article 8.2 if it fails to achieve such Net Sales referred
to above prior to June 30, 2007.
8.3 Fee
Conditions. Each
and
every payment made under this Article shall be independent,
non-refundable, and shall not be considered an advance or credit on any
royalties or other obligation received or owed
ARTICLE
9
SECURITY
INTEREST IN CELLEGY PATENTS AND CELLEGY MARKS
9.1 Definitions.
For
purposes of this Article, the following terms shall have the following
meanings:
“Obligations”
means
the performance in all material respects of Cellegy’s obligations to Licensee
under this Agreement.
“Collateral”
means
the Cellegy Patents and the Cellegy Marks.
“UCC”
means
the Uniform Commercial Code as in effect from time to time in the State of
California or any other state (including without limitation Delaware) the laws
of which are required to be applied in connection with the perfection of
security interests.
9.2 Security
Interest.
In
consideration of and as security for the full and complete performance of the
Obligations, Cellegy hereby grants to Licensee a security interest in the
Collateral, subject to the rights of any Third Party separately identified
in
writing by Cellegy to Licensee before the date of this Agreement expressly
referencing this Section.
15
9.3 Default.
(a) If
Licensee
terminates this Agreement pursuant to Section 16.2 (an “Event
of Default”),
then
Licensee shall have the rights and remedies of a secured party under the UCC.
In
addition to exercising any other rights or remedies that Licensee may have
at
law or in equity, Licensee may, at its option, and without demand first made,
exercise any one or all of the following rights and remedies: (i) collect the
Collateral and its proceeds; (ii) take possession of the Collateral wherever
it
may be found, using all reasonable means to do so, or require Cellegy to
assemble the Collateral and make it available to Licensee at a place designated
by Licensee which is reasonably convenient to Cellegy; (iii) proceed with the
foreclosure of the security interest in the Collateral granted herein and the
sale or endorsement and collection of the proceeds of the Collateral in any
manner permitted by law or provided for herein; and (iv) sell, lease or
otherwise dispose of the Collateral at public or private sale, with or without
having the Collateral at the place of sale, subject to the notice requirement
below.
(b) No
Election of Remedies.
The
election by Licensee of any right or remedy will not prevent Licensee from
exercising any other right or remedy against Cellegy.
(c) Sales
of Collateral.
Any
item of Collateral may be sold for cash or other value at public or private
sale
or other disposition and the proceeds thereof collected by or for Licensee.
Cellegy agrees to promptly execute and deliver, or promptly cause to be executed
and delivered, such instruments, documents, assignments, waivers, certificates
and affidavits and supply or cause to be supplied such further information
and
take such further action as Licensee may require in connection with any such
sale or disposition. Licensee will have the right upon any such public sale
or
sales, and, to the extent permitted by law, upon any such private sale or sales,
to purchase the whole or any part of the Collateral so sold, free of any right
or equity of redemption in Cellegy, which right or equity is hereby waived
or
released. If any notice of a proposed sale, lease, license or other disposition
of Collateral shall be required by law, such notice shall be deemed reasonable
and proper if given at least ten (10) days before such sale, lease, license
or
other disposition. Licensee agrees to give Cellegy thirty (30) days prior
written notice of any sale, lease, license or other disposition of Collateral
(or any part thereof) by Licensee.
(d) Application
of Proceeds.
The
proceeds of all sales and collections in respect of the Collateral, the
application of which is not otherwise specifically herein provided for, will
be
applied as follows: (i) first, to the payment of the costs and expenses of
such
sale or sales and collections and the attorneys' fees and out-of-pocket expenses
incurred by Licensee relating to costs of collection; (ii) second, to
satisfaction of the Obligations; and (iii) third, any surplus then remaining
will be paid to Cellegy.
(e) Cooperation.
Upon
the occurrence of an Event of Default and foreclosure on the Collateral by
Licensee, Cellegy will cooperate with Licensee and execute such instruments
of
assignment and transfer as Licensee may reasonably request in order to vest
Licensee with ownership of the Collateral.
16
[*]
designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the
Commission
ARTICLE
10
MARKETING
10.1 General
Promotional Duties. Licensee
shall: (i) not make false or misleading representations to customers or other
persons with regard to the Licensed Product, and (ii) subject to sub-clause
(i),
shall not make any representations with respect to the specifications, features
or capabilities of the Licensed Product which are not consistent with the
relevant Approvals.
10.2 Marketing
Effort; Minimum Expenditures for Commercialization.
At all
times prior to June 30, 2007, Licensee agrees to exert its Commercially
Reasonable and Diligent Efforts to introduce, promote and, sell the Licensed
Product within the Major European Countries following receipt of Marketing
Authorization in such Major European Countries and minimum satisfactory (in
Licensee’s sole opinion) reimbursement price.
10.3 Minimum
Sales.
At all
times prior to June 30, 2007, Licensee shall use Commercially Reasonable and
Diligent Efforts to achieve agreed annual minimum unit sales of Licensed Product
in each Major European Country and commencing in each such country upon the
[*]
from
launch and representing [*]
of the
sales forecasts of the Licensed Product in each Major European Country as set
forth in the Marketing Plan (“Minimum
Sales”).
MANUFACTURING;
SUPPLY OF LICENSED PRODUCT
11.1 Production
and Supply of Product.
(a) During
the term of this Agreement or thereafter, Cellegy reserves the right, without
obligation or liability to Licensee, to manufacture, have manufactured, produce,
assemble, warehouse or source the Licensed Product
for sale outside of the Territory at any worldwide location, including Canada
or
the United States of America and locations within or outside the Territory.
(b) Cellegy
agrees to use all Commercially Reasonable and Diligent Efforts
to
(i)
maintain
its existing Cellegy Supply Agreement with the existing Manufacturer until
at
least Xxxxx
00,
0000, (xx)
cooperate with Licensee with the goal that, prior to the establishment of
the
Licensee Supply Agreement, Licensee may purchase Licensed Product directly
from
the Manufacturer,
and
(iii) until Licensee enters into a Licensee Supply Agreement, cooperate with
Licensee to involve Licensee in discussions between Cellegy and Manufacturer
concerning product pricing or other material terms of the Cellegy Supply
Agreement.
11.2 Forecasts.
Until
such time as Licensee enters into a Licensee Supply Agreement,
Licensee
shall be responsible for combining (if practicable in Licensee’s sole opinion)
its forecast for Licensed Product in the Territory and Cellegy’s forecast for
Licensed Product outside the Territory and for delivering all combined forecasts
for the Parties to the Manufacturer providing that both Cellegy and Licensee
are
utilizing the same Manufacturer. Should the Parties decide to utilize separate
manufacturers, each Party will be responsible for providing their Manufacturer
with its own forecasts. Additional details concerning relating to orders from
the Manufacturer shall be mutually agreed upon and set forth on Exhibit
E.
17
11.3 Additional
Manufacturing Location.
Either
Cellegy or Licensee may initiate activities relating to the establishment of
a
Manufacturer within the Territory.
11.4 Payment.
In
consideration of the amendments to the Prior Agreement and the execution of
this
Agreement concerning the purchase by Licensee of Licensed Products, at the
Agreement Date Licensee shall deliver to Cellegy the amount of [*]
by
electronic funds transfer to the bank account designated by Cellegy in writing.
Cellegy agrees that after the Agreement Date, Licensee shall have no further
obligation to pay Cellegy any amounts with respect to the purchase of Licensed
Products from the Manufacturer or other manufacturers, including with respect
to
purchase order no. 05-1180 dated October 31, 2005.
11.5 Warranty
Limitation, Disclaimer.
Except as expressly set forth in this Agreement, the sole warranty, if any,
given by Cellegy regarding any Licensed Product shall be that written limited
warranty, if any, which shall accompany such Licensed Product or which shall
otherwise be designated in writing by Cellegy as applicable to such Licensed
Product, as the same may be revised by Cellegy from time to time. After the
initial commercial launch of the Licensed Product, subsequent changes to the
written limited warranty must be approved by Licensee, which approval shall
not
be unreasonably withheld. THE WRITTEN LIMITED WARRANTY, IF ANY, APPLICABLE
TO
ANY PARTICULAR PRODUCT SHALL STATE THE FULL EXTENT OF CELLEGY’S LIABILITY
WHETHER DIRECT OR INDIRECT, SPECIAL OR CONSEQUENTIAL, RESULTING FROM ANY BREACH
OF SUCH WARRANTY. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT WITH RESPECT
TO WARRANTIES MADE TO LICENSEE, CELLEGY FURTHER DISCLAIMS ALL EXPRESS, STATUTORY
AND IMPLIED WARRANTIES APPLICABLE TO THE LICENSED PRODUCT.
11.6 Recalls.
(a) Licensee
may
recall
any quantity of Licensed Product at any time, and Licensee will administer
any
such recall in the Territory.
(b) If
the
Relevant Regulatory Authority requires or otherwise initiates a recall of the
Licensed Product for any reason whatsoever, Licensee will immediately administer
the recall.
18
ARTICLE
12
PATENT
RIGHTS
12.1 No
Ownership By Licensee.
Except
as provided in Article 9, Licensee shall not be deemed by anything contained
in
this Agreement or done pursuant to it to acquire any right, title or interest
in
or to the Cellegy Patent Rights or any patent owned by or licensed to Cellegy
now or hereafter covering or applicable to any Licensed Product, nor in or
to
any invention or improvement, owned by Cellegy, now or hereafter embodied in
the
Licensed Product, whether or not such invention or improvement is patentable
under the laws of any country.
12.2 New
Cellegy Inventions/Improvements to the Licensed Product.
If
Cellegy develops and commercially offers:
(a) any
improvements in terms of dosage, route of administration or formulation of
the
Licensed Product for the same indication; or
(b) any
improvement in terms of dosage, route of administration or formulation of any
product derived from the Licensed Product for the same indication;
then
such
improvements shall be included within the definition of Licensed Product herein
at no additional costs to Licensee.
12.3 Improvements
by Licensee.
If,
during the term of this Agreement other than where Cellegy is in material breach
or if Article 9 applies in which case this article 12.3 shall not apply ,
Licensee or any Sublicensee invents or designs any improved Licensed Product
or
any associated method, apparatus, equipment or process related to or having
application to the Licensed Product, or makes an improvement thereon, whether
or
not patented or patentable in any jurisdiction, Licensee shall make or cause
a
prompt and full disclosure to Cellegy of such invention, design or improvement
(“Licensee
Improvement”),
and
hereby irrevocably transfers, conveys and assigns to Cellegy all of its right,
title and interest therein. Licensee shall execute such documents, render such
assistance, and take such other action as Cellegy may reasonably request, at
Cellegy’s expense, to apply for, register, perfect, confirm, and protect
Cellegy’s rights therein. Cellegy shall have the exclusive right to apply for or
register any patents or other proprietary protections with respect thereto.
Such
Licensee Improvements shall be licensed back from Cellegy to Licensee as, and
shall be deemed part of, the Licensed Product, at no additional cost to
Licensee.
CELLEGY
MARKS
13.1 Use
of
Cellegy Marks by Licensee.
Licensee, its Affiliates and Sublicensees will have the exclusive right to
use
Cellegy’s Xxxx Rectogesic™
in the Territory in connection with the importation, storage, Development,
promotion, marketing, distribution and sale of Licensed Product. In such event,
Licensee and its Affiliates (and Sublicensees) shall use Cellegy’s Marks only in
the form and manner prescribed by Cellegy. In no event shall Licensee use any
of
Cellegy’s Marks or any similar xxxx or term as part of its business name. Should
Rectogesic™
not be
registered or registerable by Cellegy in all countries of the Territory, then
Cellegy may notify Licensee that another
Cellegy
trademark
will be
used; and if no such marks are registered or registerable by Cellegy in all
countries of the Territory, then Licensee may propose an alternative trade
xxxx/s for Cellegy’s approval, such approval not to be unreasonably withheld or
delayed.
Cellegy
shall apply for and maintain such alternative trade xxxx at Cellegy’s sole
expense and such alternate trade xxxx shall become a Cellegy Xxxx under the
terms of this Agreement. For
the
avoidance of doubt the Licensee shall be free to choose, use and own a different
trademark to the Cellegy Marks in relation to the Licensed Product.
19
13.2 Acknowledgment
of Ownership.
Except
as provided in Article 9 Licensee acknowledges that
(a) Cellegy
owns Cellegy’s Marks and all goodwill associated with or symbolized by Cellegy’s
Marks;
(b) Licensee
has no ownership right in or to any of Cellegy’s Marks; and
(c) Licensee
shall acquire no ownership interest in or to any of Cellegy’s Marks by virtue of
this Agreement. Licensee shall do nothing inconsistent with Cellegy's ownership
of Cellegy’s Marks and related goodwill, shall not directly or indirectly
contest the validity of or Cellegy’s rights in the Cellegy Marks, and agrees
that all use of Cellegy’s Marks by Licensee shall inure to the benefit of
Cellegy. Nothing in this Agreement shall be deemed to constitute or result
in an
assignment of any of Cellegy’s Marks to Licensee or the creation of any
equitable or other interests therein. Licensee shall not use any of Cellegy’s
Marks in any manner as a part of its business, corporate or trade
name.
13.3 Marking.
Licensee shall xxxx all advertising, promotional or other materials created
by
it and bearing any of Cellegy’s Marks (the “Licensee
Material”)
with
such notices as Cellegy may reasonably require, including, but not limited
to,
notices that Cellegy’s Marks are trademarks of Cellegy and are being used with
the permission of Cellegy.
13.4 Registration.
Cellegy
shall have the sole right to take such action as it deems appropriate to obtain
trademark registration in the Territory for any of Cellegy’s Marks. If it shall
be necessary for Licensee to be the applicant to effect any such registrations,
Licensee shall cooperate with Cellegy to effect any such registrations, and
hereby does assign all of its right, title and interest in and to each such
application, and any resulting registration, to Cellegy, and shall execute
all
papers and documents necessary to effectuate or confirm any such assignment.
Licensee shall perform all reasonable and necessary acts and execute all
necessary documents to affect the registration of Cellegy’s Marks as Cellegy may
request, all at Cellegy's sole expense. Licensee shall not obtain or attempt
to
obtain in the Territory, or elsewhere, any right, title or interest,
registration, or otherwise, in or to Cellegy’s Marks, or any of them. In the
event that any such right, title or interest should be obtained by Licensee
in
contravention hereof, Licensee shall hold the same on behalf of Cellegy and
shall transfer the same to Cellegy upon request and without expense to
Cellegy.
20
13.5 Trademarks.
Licensee further agrees not to use any Cellegy marks in connection with any
products other than the Licensed Product. Licensee also will include the
appropriate trademark notices when referring to any Licensed Product in
advertising and promotional materials. Licensee covenants and warrants that
Licensee's use of Cellegy’s Marks or other trademarks, trade names, logos and
designations of Cellegy on any Licensed Product, Licensed Product packaging
or
labels, or related materials that Licensee or its Agents prepare or use will
be
in accordance with Cellegy’s reasonable intellectual property policies in effect
from time to time, including but not limited to trademark usage and cooperative
advertising policies. Licensee agrees not to attach any additional trademarks,
trade names, logos or designations to any Licensed Product except in compliance
with such policies or otherwise with Cellegy’s prior written consent, which
shall not be unreasonably delayed or withheld. Licensee will include on each
Licensed Product that it distributes, and on all containers and storage media
therefor, all trademark, copyright and other notices of proprietary rights
included by Cellegy on such Licensed Product. Licensee agrees not to alter,
erase, deface or overprint any such notice on anything provided by Cellegy.
Licensee also will include the appropriate trademark notices when referring
to
any Licensed Product in advertising and promotional materials. Licensee shall
submit to Cellegy for its prior written approval (which shall not be
unreasonably delayed or withheld) and before any use is made thereof,
representative samples of the initial Licensed Product, packages, containers,
and advertising or promotional materials bearing any of Cellegy’s Marks which
Licensee or its Sublicensees prepare, but need not seek prior approval for
subsequent uses of such materials that are in compliance with Cellegy’s
policies. Licensee shall also submit to Cellegy for its prior written approval
(which shall not be unreasonably delayed or withheld) any such materials that
may not be consistent with Cellegy’s intellectual property policies in effect
from time to time, and Cellegy shall use all reasonable efforts to respond
promptly to give its approval or indicate the respects in which changes are
required in light of Cellegy’s policies. Cellegy and Licensee shall cooperate
with each other and use reasonable efforts to protect the Cellegy Marks from
infringement by Third Parties.
INFRINGEMENT;
INDEMNIFICATION AND OTHER CLAIMS
14.1 Infringement
of Intellectual Property Rights.
In the
event Cellegy or Licensee have reason to believe that a Third Party may be
infringing or diluting, as the case may be, Intellectual Property Rights or
misappropriating the Licensed Product, such Party shall promptly notify the
other Party. Cellegy may, in its discretion, elect to enforce the Intellectual
Property Rights through legal action or otherwise, and Licensee agrees to
reasonably cooperate with Cellegy in such enforcement subject to reimbursement
of its reasonable out-of-pocket expenses together with any reasonable attorneys
fees incurred in connection therewith. In the event Cellegy elects not to
enforce the Patent Rights relating to the Licensed Product within sixty (60)
days after notice of the possible infringement or dilution, and Licensee can
demonstrate that the potential infringement or dilution is reasonably likely
to
result in material lost sales of the Licensed Product within the applicable
country, then Licensee may institute a lawsuit or other such actions at its
expense to prevent continuation of such potential infringement or dilution,
and
then
Licensee
will retain all award, damages or compensation obtained by Licensee in such
suit. Cellegy will provide reasonable cooperation with respect to any lawsuit
which Licensee may bring pursuant to this Article, subject to reimbursement
of
its reasonable out-of-pocket expenses and reasonable attorneys fees in
connection therewith. Licensee shall not enter into any settlement or compromise
of any such claim without the prior written consent of Cellegy, which shall
not
be unreasonably delayed or withheld.
21
14.2 Alleged
Infringement of Third Party Intellectual Property Rights.
(a) If
a
claim or lawsuit is brought against Licensee alleging infringment of any patent
or infringement or dilution of any trademark owned by a Third Party arising
from
Licensee’s importation, storage, Development, promotion, marketing, distribution
and sale of
the
Licensed Product or use of proprietory rights, Licensee shall provide to Cellegy
all information in Licensee’s possession regarding such claim or lawsuit. Within
a reasonable time after receiving notice of such claim or lawsuit, but in any
event within sixty (60) days after receiving such notice, Cellegy shall advise
Licensee of Cellegy’s decision as what action it plans to take to dispose of
such claim or defend such lawsuit.
(b) If
Cellegy elects not to dispose of such claim or defend such lawsuit, Licensee
may
defend the claim or lawsuit. Licensee shall not enter into any settlement or
compromise of any such claim or lawsuit without the prior written consent of
Cellegy, which shall not be unreasonably delayed or withheld. For the purpose
of
Licensee’s conduct of the claim or defense, Cellegy shall furnish to Licensee
such reasonable assistance as Licensee may need and from time to time reasonably
request.
14.3 Notice
from Licensee.
Licensee shall promptly notify Cellegy of any potential or actual litigation
or
governmental activity in the Territory relating to the Licensed Product or
the
business operations of Licensee or Cellegy. Licensee shall provide such notice
within ten (10) days from the time that Licensee learns of such litigation
or
activity.
14.4 Indemnification.
(a) Cellegy
assumes all risk of loss and indemnifies and holds harmless Licensee, its
Affiliates, Sublicensees and their respective directors, officers and employees
from and against any and all Loss arising from or incidental to or relating
to
any claim, demand, lawsuit, action or proceeding (a “Claim”)
arising from or relating to:
(i) any
claim
or lawsuit which relates to or arises out of the alleged infringement by
Licensee of any patent or trademark owned by a Third Party to the extent that
the alleged infringement relates to actions covered by the Exclusive License
granted to Licensee under Section 2.1 of this Agreement;
(ii) the
importation, storage, Development, promotion, marketing, distribution or sale
of
the Licensed Product based on action or inaction of Cellegy;
22
(iii) a
Product
Liability Claim based on action or inaction of Cellegy; or
(iv) any
negligence or willful default of Cellegy relating to the Licensed Product
or
this Agreement; or any
material
breach
by Cellegy of any representation or warranty given in this Agreement;
or
(v) any
claim
by a Third Party against Cellegy or Licensee that entering into this Agreement
is a material breach of, or is prohibited by, any agreement between Cellegy
and
such Third Party.
(b) Any
indemnification by, Cellegy pursuant to a claim made under this Section shall
be
subject to the following limitations:
(i) no
indemnification shall be payable unless the aggregate of all Losses for which
Cellegy would be liable exceeds on a cumulative basis an amount equal to
$50,000, and then in such circumstances Licensee shall be entitled to demand
an
indemnity for the total aggregate of all Losses;
(ii) no
indemnification shall be payable for any individual items (or series of related
individual items) where the Loss relating thereto is less than $10,000, in
which
case such items shall not be aggregated;
(iii) no
indemnification shall be payable in excess of an aggregate amount equal to
the
sum of $2,000,000 and any additional payments made under Section 8.2; and
(iv) no
indemnification shall be payable to the extent the liability or obligation
is
directly caused by any action taken or omitted to be taken by Licensee or any
of
its Affiliates or Sublicensees.
(c) Licensee
assumes all risk of loss and indemnifies and holds harmless Cellegy from all
Loss arising from or incidental to or relating to any claim, action or
proceeding arising from or relating to:
(i) the
importation, storage, Development, promotion, marketing, distribution, or sale,
of the Licensed Product based on action or inaction of Licensee, Affiliates,
Sublicensees or their respective directors, officers and employees (Licensee
and
such other Persons sometimes referred to as “Licensee
Indemnified Persons”);
(ii) any
Product Liability claim based on action or inaction of any Licensee Indemnified
Person;
(iii) any
breach by any Licensee Indemnified Person of any representation or warranty
given in this Agreement; any negligence or willful default of any Licensee
Indemnified Person relating to the Licensed Product or this Agreement;
or
23
(iv) any
material
breach
by Licensee of any representation or warranty given in this
Agreement.
(e) Subject
to the provisions of Section 14.1 and 14.2, if a Third Party Claim is made
against an Indemnified Party, the Indemnifying Party shall be entitled to
participate in the defense thereof and, if it so chooses, to assume the defense
thereof with counsel selected by the Indemnifying Party. Should the Indemnifying
Party so elect to assume the defense of a Third Party Claim, the Indemnifying
Party shall not be liable to the Indemnified Party for any legal expenses
subsequently incurred by the Indemnified Party in connection with the defense
thereof. If the Indemnifying Party assumes such defense, the Indemnified Party
shall have the right to participate in the defense thereof and to employ
counsel, at its own expense, separate from the counsel employed by the
Indemnifying Party, it being understood that the Indemnifying Party shall
control such defense. The Indemnifying Party shall be liable for the fees and
expenses of counsel employed by the Indemnified Party for any period during
which the Indemnifying Party has not assumed the defense thereof (other than
during any period in which the Indemnified Party shall have failed to give
notice of the Third Party Claim as provided above). If the Indemnifying Party
chooses to defend or prosecute a Third Party Claim, all the indemnified parties
shall cooperate in the defense or prosecution thereof. Such cooperation shall
include the retention and (upon the Indemnifying Party's request) the provision
to the Indemnifying Party of records and information that are reasonably
relevant to such Third Party Claim, and making employees available on a mutually
convenient basis to provide additional information and explanation of any
material provided hereunder. Whether or not the Indemnifying Party assumes
the
defense of a Third Party Claim, the Indemnified Party shall not admit any
liability with respect to, or settle, compromise or discharge, such Third Party
Claim without the Indemnifying Party's prior written consent (which consent
shall not be unreasonably withheld). If the Indemnifying Party assumes the
defense of a Third Party Claim, the Indemnified Party shall agree to any
settlement, compromise or discharge of a Third Party Claim that the Indemnifying
Party may recommend and that by its terms obligates the Indemnifying Party
to
pay the full amount of the liability in connection with such Third Party Claim,
which releases the Indemnified Party completely in connection with such Third
Party Claim and that would not otherwise materially adversely affect the
Indemnified Party.
24
(f) Other
Claims.
In the
event any Indemnified Party should have a claim against any Indemnifying Party
that does not involve a Third Party Claim being asserted against or sought
to be
collected from such Indemnified Party, the Indemnified Party shall deliver
notice of such claim with reasonable promptness to the Indemnifying Party.
The
failure by any Indemnified Party so to notify the Indemnifying Party shall
not
relieve the Indemnifying Party from any liability that it may have to such
Indemnified Party hereunder, except to the extent that the Indemnifying Party
demonstrates that it has been materially prejudiced by such failure. If the
Indemnifying Party disputes its liability with respect to such claim, the
Indemnifying Party and the Indemnified Party shall proceed in good faith to
negotiate a resolution of such dispute and, if not resolved through
negotiations, such dispute shall be resolved as provided in Section 18.14.
ARTICLE
15
CONFIDENTIALITY
15.1 Treatment
of Confidential Information.
Except
as otherwise provided in this Article 15, during the term of this Agreement
and
for a period of five (5) years thereafter, Licensee and its Affiliates will
retain in confidence and use only for purposes of this Agreement any
information, data, and materials supplied by Cellegy or on behalf of Cellegy
to
Licensee and its Affiliates under this Agreement, and Cellegy will retain in
confidence and use only for purposes of this Agreement any information, data,
and materials supplied by Licensee or on behalf of Licensee to Cellegy under
this Agreement. For purposes of this Agreement, all such information and data
which a party is obligated to retain in confidence shall be called “Confidential
Information.”
For
the avoidance of doubt, Cellegy Information shall constitute Confidential
Information of Cellegy.
15.2 Right
to Disclose.
To the
extent it is reasonably necessary or appropriate to fulfill its obligations
or
exercise its rights under this Agreement or any rights which survive termination
or expiration hereof, Licensee may disclose Confidential Information to its
Affiliates, Sublicensees, consultants, outside contractors, clinical
investigators or other Third Parties on condition that such entities or persons
agree in writing (a) to keep the Confidential Information confidential for
the
same time periods and to the same extent as Licensee is required to keep the
Confidential Information confidential and (b) to use the Confidential
Information only for such purposes as Licensee is entitled to use the
Confidential Information. Each Party or its Affiliates or sublicensees may
disclose such Confidential Information to government or other regulatory
authorities to the extent that such disclosure (i) is reasonably necessary
to
obtain Approvals; or (ii) is otherwise legally required.
15.3 Release
From Restrictions.
The
foregoing obligations in respect of disclosure and use of Confidential
Information shall not apply to any part of such Confidential Information that
the non-disclosing party, or its Affiliates (all collectively referred to as
the
“Receiving
Party”)
can
demonstrate by contemporaneously prepared written evidence:
(a) is
or
becomes part of the public domain other than by acts of the Receiving Party
in
contravention of this Agreement;
25
(b) is
disclosed to the Receiving Party or its Affiliates or Sublicensees by a Third
Party, provided such Confidential Information was not obtained by such Third
Party directly or indirectly from the other party under this
Agreement;
(c) prior
to
disclosure under this Agreement, was already in the possession of the Receiving
Party or its Affiliates or Sublicensees, provided such Confidential Information
was not obtained, directly or indirectly, from the other party under this
Agreement; or
(d) results
from research and development by persons who have not had access to the
disclosures made to Receiving Party under this Agreement, including any
information obtained through the testing, manufacturing regulatory approval,
or
distribution of the Licensed Product, or other activities undertaken in
connection with this Agreement by the Receiving Party.
15.4 Confidentiality
of Agreement.
Except
as otherwise required by law or the terms of this Agreement or mutually agreed
upon by the Parties, each Party shall treat as confidential the terms,
conditions and existence of this Agreement, except that each Party may disclose
such terms and conditions and the existence of this Agreement to its Affiliates,
sublicensees, and shareholders to the extent required by the any corporate
laws,
and provided, that each Party shall seek confidential treatment of the key
business terms contained in this Agreement, including but not limited to all
payments owed hereunder. Notwithstanding
the foregoing, the
Parties
may make such public announcements as they determine including any required
by
law or applicable stock exchange requirements.
15.5 Return
of Confidential Information.
Upon
termination of this Agreement with respect to the entire Territory, the Parties
and Affiliates and sublicensees shall return all Confidential Information of
the
other Party, in their possession along with a certification that they no longer
possess any such Confidential Information.
15.6 Previous
Confidentiality Agreements.
Confidential information disclosed by either Party to the other Party or its
Affiliates prior to the Prior Agreement Date under any written agreement
executed by Cellegy and Licensee shall be treated as Confidential Information
under Section 15.1 notwithstanding expiration of such prior Confidentiality
Agreement.
TERM;
TERMINATION
16.1 Term.
Unless
terminated sooner pursuant to this Article 16, this Agreement shall become
effective as of the Agreement Date and shall continue in full force and effect
without term;
provided, however, that the license to the Cellegy Patent Rights shall expire
with respect to a particular country upon the later of (i) the date of
expiration of the last to expire of the Cellegy Patent Rights in the particular
country, or (ii) if earlier, the latest date permitted by applicable law,
determined on a country-by-country basis.
16.2 Termination
Rights.
26
[*]
designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the
Commission
16.2.1
Licensee
may terminate this Agreement in whole or in part upon the occurrence of any
of
the following:
(a) Cellegy
becomes the subject of voluntary bankruptcy or insolvency case; or
(b) Cellegy
becomes the subject of an involuntary bankruptcy or insolvency case that is
not
dismissed within ninety (90) days; or
(c) Upon
or
after the material breach of any provision of this Agreement by Cellegy, if
such
material breach is not cured (if such default is capable of cure) within thirty
(30) days after written notice thereof.
16.2.2 Cellegy
may terminate this Agreement:
(a) If
Licensee becomes the subject of a voluntary bankruptcy or insolvency case up
until June 30, 2007; or
(b) If
Licensee becomes the subject of an involuntary bankruptcy or insolvency case
that is not dismissed within ninety (90) days up until June 30, 2007
;or
(c) If
Licensee is in breach of its payment obligations under Sections 8.1 or 11.4
and
in no other circumstance and only if payment is not then made within thirty
(30)
days of receiving notice of such breach.
16.3 Licensee’s
Right to Terminate.
Licensee
may terminate this Agreement; (i) immediately on written notice on health or
safety grounds in relation to the Licensed Product; (ii) immediately on written
notice if Approvals
is not obtained, through no fault of Licensee, in all Major European Countries
[*]
of MRP
being initiated; (iii)
on
[*]
written
notice to Cellegy should it no longer be economically viable to market the
Licensed Product, based on Licensee’s reasonable opinion and determined on a
country by country basis; or (iv)
[*]
if a
claim by any Third Party that the Intellectual Property Rights infringe such
Third Party’s patent, trade xxxx, protected know-how or other intellectual
property right is made against Licensee and which either (A) prevents use of
the
Licensed Product in any country of the Territory for a period of [*],
or (B)
is not being challenged by either Party pursuant to Article 14 in relation
to
such country.
16.4 Cellegy’s
Rights Upon Termination under Section 16.2.2 .
Termination of this Agreement shall not extinguish debts and other obligations
created or arising between the Parties by virtue of contracts or arrangements
entered into hereunder before the effective date of termination of this
Agreement (the "Termination
Date").
Without limiting the generality of the foregoing, in the circumstance where
Cellegy terminates in the circumstances set out in Section 16.2.2 upon and
following the Termination Date:
27
(a) Licensee
shall be permitted to store, promote, sell and distribute such Licensed Product
as well as any Licensed Product in Licensee's inventory within the Territory,
subject to the provisions of paragraph (h) below and provided that Licensee
shall not sell or otherwise dispose any of the Licensed Product in bulk, in
any
non-customary manner or otherwise circumvent its regular customers.
(b) Licensee
shall cooperate with Cellegy to allow for the orderly transfer of Approvals
within the Territory to Cellegy or its designee upon request and without expense
to Cellegy. Licensee shall provide Cellegy with (i) full and immediate access
to
and copies of all marketing and sales information and other materials pertaining
to the Licensed Product, including, without limitation, customer lists, past
sales history and Licensed Product pricing information, and (ii) any inventions
or other materials or rights required to be assigned to Cellegy pursuant to
this
Agreement. Notwithstanding any other term or provision of this Agreement,
effective upon the Termination Date, Licensee shall execute any documents that
are necessary to transfer to Cellegy, or Cellegy’s designee, all Approvals or
intellectual property which are then in the name of and/or held by Licensee
and
which relate to the marketing or sale of the Licensed Product (the “Relevant
Documents”).
In
the event that full Approvals for any Licensed Product in the Territory are
not
completed before any transfer of operations pursuant to this Article, Licensee
shall also transfer to Cellegy or Cellegy’s designee, free of any charge, the
Cellegy Information and all the data submitted to the Relevant Regulatory
Authorities therefor. At Cellegy’s request, Licensee shall authorize Cellegy’s
nominee, without any delay, to perform all the required activities in order
to
obtain the transfer of such permits and registration rights. If Licensee fails
to execute the Relevant Documents, it hereby appoints Cellegy as its agent
and
authorizes Cellegy to act on its behalf, in order to execute all Relevant
Documents. Licensee, its Affiliates and Sublicensees shall terminate any use
of
the Cellegy Marks and shall, at Cellegy’s option, either destroy or return to
Cellegy at Licensee’s cost all literature, labels, or other materials,
incorporation or bearing same.
(c) Each
party shall cease to use any of the other party’s Confidential Information
relating to or in connection with its continued business operations and shall
promptly return or assign to the other party any and all physical, written
and
descriptive matter (including all reproductions and copies thereof) containing
that party’s Confidential Information, provided that each party
may:
(i) provide
one copy of the other party’s Confidential Information to its legal advisers to
be held by them solely for the purpose of determining the scope of that party’s
obligations under this clause;
(ii) retain
one copy of such of the other party’s Confidential Information that is required
by the Relevant Regulatory Authorities in the Territory, to be retained by
that
party; and
(iii) retain
any documents confidential to it (including board papers, strategic plans and
operational reviews) in which the other party’s Confidential Information is
incorporated, provided that such confidential information shall continue to
be
treated as Confidential Information hereunder.
28
(d) Upon
expiration or termination for any reason, the obligations of confidentiality
and
use of Confidential Information under Article 15 shall survive for the period
provided therein;
(e) Upon
expiration or termination for any reason, Articles 14 and 16 of this Agreement
shall survive for the maximum duration permitted by law; and
(f) Articles
5, 8 and 9 shall survive until all outstanding payment obligations and reporting
obligations of Licensee and its Affiliates and Sublicensees have been fulfilled,
and Sections 9.3 and 9.4 shall survive for two years following the year in
which
such or expiration became effective.
16.5 Licensee’s
Rights upon Termination.
Where
Licensee terminates this Agreement in accordance with the terms hereof Licensee
shall have an irrevocable fully paid up exclusive license under the Intellectual
Property Rights and Retained Information and, where Licensee terminates this
Agreement pursuant to the provisions of Section 16.2.1(c) above, Licensee shall
have no obligation to Cellegy to make any further milestone under Section 8.1
or
sales milestones under Section 8.2 or other payments or compensation of any
kind
that may have fallen due after the Termination Date.
REGISTRATION
OF LICENSE; LIMITATION OF LIABILITY
17.1 Registration.
Licensee may, at its expense, register the exclusive license granted under
this
Agreement in any country of the Territory where the government of such country
would require one for use, sale or distribution of the Licensed Product in
such
country and Cellegy shall reasonably cooperate in such registration at
Licensee’s expense. Upon request by Licensee, Cellegy agrees promptly to execute
any “short form” licenses developed in a form reasonably acceptable to both
Licensee and Cellegy and reasonably submitted to it by Licensee from time to
time in order to effect the foregoing registration in such country at no cost
to
Licensee.
17.2 Limitation
of Liability.
NEITHER
PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, INDIRECT, OR CONSEQUENTIAL
DAMAGES, WHETHER BASED ON BREACH OF CONTRACT, WARRANTY, TORT (INCLUDING
NEGLIGENCE) OR OTHERWISE, AND WHETHER OR NOT SUCH PARTY HAS BEEN ADVISED OF
THE
POSSIBILITY OF SUCH DAMAGE. NOTWITHSTANDING ANYTHING TO THE CONTRARY, NEITHER
PARTY SHALL BE LIABLE TO THE OTHER PARTY WITH RESPECT TO ANY SUBJECT MATTER
OF
THIS AGREEMENT UNDER ANY CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL
OR EQUITABLE THEORY FOR ANY AMOUNTS IN EXCESS OF THE AMOUNTS RECEIVED BY CELLEGY
FROM LICENSEE HEREUNDER. THIS LIMITATION WILL APPLY NOTWITHSTANDING ANY FAILURE
OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY PROVIDED HEREIN.
29
GENERAL
PROVISIONS
18.1 Force
Majeure.
Neither
Party shall be held liable or responsible to the other Party nor be deemed
to
have defaulted under or breached this Agreement for failure or delay in
fulfilling or performing any term of this Agreement, other than an obligation
to
make payments hereunder, when such failure or delay is caused by or results
from
fire, floods, embargoes, government regulations, prohibitions or interventions,
war, acts of war (whether war be declared or not), insurrections, riots, civil
commotions, strikes, lockouts, acts of God or any other cause beyond the
reasonable control of the affected party to anticipate, prevent, avoid or
mitigate (a “Force
Majeure Event”);
provided, however, that any failure or delay in fulfilling a term of this
Agreement shall not be considered a result of a Force Majeure Event if it arises
from a failure of Licensee or Cellegy to comply with applicable laws and
regulations. In the event of force majeure lasting more than sixty days (60)
days, the Parties agree to meet and discuss how this Agreement can be justly
and
fairly implemented under the circumstances prevailing in such Country or
Countries and if the Parties are unable to agree upon how the Agreement can
be
implemented then either Party may terminate the Agreement in relation to such
country or countries upon sixty (60) days written notice.
18.2 Further
Assurances.
Each
Party to agrees to perform such acts, execute such further instruments,
documents or certificates, and provide such cooperation in proceedings and
actions as may be reasonably requested by the other Party in order to carry
out
the intent and purpose of this Agreement, including without limitation the
registration or recordation of the rights granted hereunder.
18.3 Severability.
Both
Parties hereby expressly acknowledge and agree that it is the intention of
neither party to violate any public policy, statutory or common law, rules,
regulations, treaty or decision of any government agency or executive body
thereof of any country or community or association of countries and specifically
agree that if any word, sentence, paragraph, clause or combination thereof
in
this Agreement is found by a court or executive body with judicial powers having
jurisdiction over this Agreement or any of the parties hereto in a final
unappealed order, to be in violation of any such provisions in any country
or
community or association of countries, then in such event such words, sentences,
paragraphs, clauses or combination shall be inoperative in such country or
community or association of countries and the remainder of this Agreement shall
remain binding upon the parties hereto.
18.4 Notices.
Any
notice required or permitted to be given hereunder shall be in writing and
shall
be deemed to have been properly given if delivered in person, or by an
internationally recognized overnight courier, or by facsimile (and promptly
confirmed by overnight courier), to the addresses given below or such other
addresses as may be designated in writing by the parties from time to time
during the term of this Agreement. Any notice sent by overnight courier as
aforesaid shall be deemed to have been given two (2) working days after
sending.
30
|
In
the case of Cellegy:
Cellegy
Pharmaceuticals, Inc.
0000
Xxxxxx Xxxxxxxxx, Xxx. 000
Xxxxxxxx,
Xxxxxxxxxx 00000
Attention:
Xxxx Xxxxxxxx
Telephone
No.: (000)
000-0000
Facsimile
No.: (000)000-0000,
and
Cellegy
Pharmaceuticals, Inc.
0000
Xxxxxxx Xxxx, Xxxxxxxx 00
Xxxxxxxxxx
Xxxxxx, XX 00000-0000
Attention:
Chief Financial Officer
Telephone
No.: (000) 000-0000
Facsimile
No.: (000) 000-0000
|
With
a required copy to:
Xxxxxxxxx
Genshlea Chediak
000
Xxxxxxx Xxxx, 00xx
xxxxx
Xxxxxxxxxx,
XX 00000
Attention:
Xxxxx Xxxxx, Esq.
Telephone
No.: (000)
000-0000
Facsimile
No.: (000)
000-0000
|
|
In
the case of Licensee:
Strakan
International Limited
Buckholm
Mill
Galashiels
TD
1 2HB, UK
Attention:
Mr. Xxxxxx XxXxxx,
Corporate
Director
Telephone
No.: 00-0000-000000
Facsimile
No.: 00-0000-000000
|
|
18.5 Assignment.
This
Agreement may not be assigned or otherwise transferred by either Party without
the written consent of the other Party such consent not to be unreasonably
withheld or delayed; provided,
however,
that
either Party may, without such consent, assign this Agreement (i) in connection
with the transfer or sale of all or substantially all of its business related
to
this Agreement; or (ii) in the event of the merger or consolidation of such
Party with another corporation; or (iii) to an Affiliate. Any permitted assignee
shall assume all obligations of its assignor under this Agreement.
18.6 Amendment.
The
parties hereto may amend, modify or alter any of the provisions of this
Agreement, but only by a written instrument duly executed by both parties
hereto.
18.7 Entire
Agreement.
This
Agreement contains the entire understanding of the parties with respect to
the
subject matter hereof and supersedes and replaces all previous negotiations,
understandings and representations whether written or oral including, but not
limited to, the Heads of Agreement dated November
12,
2004
between the Parties
and the
Prior Agreement.
This
Agreement shall not be modified, altered or amended except by a written document
signed on behalf of and delivered by both Parties.
18.8 Waiver.
The
failure of a party to enforce, at any time or for any period, any of the
provisions hereof shall not be construed as a waiver of such provisions or
of
the rights of such party thereafter to enforce each such provision.
31
18.9 No
Implied Licenses.
Except
as expressly and specifically provided under this Agreement, the parties agree
that neither party is granted any implied rights to or under any of the other
party’s current or future patents, trade secrets, copyrights, moral rights,
trade or service marks, trade dress, or any other intellectual property
rights.
18.10 Injunctions.
The
parties agree that any breach or threatened breach by one party of the
confidentiality provisions contained in this Agreement may cause substantial
harm to the other party that cannot be remedied by monetary damages, and
therefore each party agrees that either party shall have the right to apply
for
equitable remedies, without bond, including injunctions and repossession of
Confidential Information, to xxxxx actual or threatened breaches of this
Agreement.
18.11 Independent
Contractors.
The
parties agree that the relationship of Cellegy and Licensee established by
this
Agreement is that of independent licensee and licensor. Furthermore, the parties
agree that this Agreement does not, is not intended to, and shall not be
construed to, establish a partnership or joint venture, and nor shall this
Agreement create or establish an employment, agency or any other relationship.
Except as may be specifically provided herein, neither party shall have any
right, power or authority, nor shall they represent themselves as having any
authority to assume, create or incur any expense, liability or obligation,
express or implied, on behalf of the other party, or otherwise act as an agent
for the other party for any purpose.
18.12 No
Third Party Beneficiaries.
All
rights, benefits and remedies under this Agreement are solely intended for
the
benefit of Cellegy and Licensee or permitted assignees, and no Third Party
shall
have any rights whatsoever to (i) enforce any obligation contained in this
Agreement (ii) seek a benefit or remedy for any breach of this Agreement, or
(iii) take any other action relating to this Agreement under any legal theory,
including but not limited to, actions in contract, tort (including but not
limited to negligence, gross negligence and strict liability), or as a defense,
setoff or counterclaim to any action or claim brought or made by the
parties.
18.13 Governing
Law.
This
Agreement shall be governed by and construed in accordance with the laws of
the
State of California, exclusive of its choice-of-law rules.
18.14 Resolution
of Disputes.
All
disputes arising out of or related to the terms and conditions of this
Agreement, or the breach thereof, will be settled as follows.
(a) If
a
dispute arises under this Agreement, a representative of each party must,
following whatever investigation each considers appropriate, promptly discuss
the dispute.
(b) If
the
dispute is not resolved as a result of the discussions in paragraph (a), either
party may give
written notice to the other party requesting the commencement of negotiations
in
good faith. The notice shall:
32
(i) set
out
the issues in dispute and any other relevant circumstances; and
(ii) designate
a senior representative with the appropriate authority to negotiate the
dispute.
(c) Within
ten (10) business days of receipt of the notice referred to in paragraph (b)
the
recipient shall notify the other party of a senior representative with similar
authority to negotiate the dispute and specify a reasonable time and place
to
meet within the following fourteen business days.
(d) The
representatives must meet in accordance with the notice referred to in paragraph
(b) and, using all reasonable endeavors, commence negotiations in good faith
to
resolve the dispute.
(e) If
the
dispute is not resolved within thirty (30) days of notification under paragraph
(b), then the dispute shall be settled by binding arbitration in Philadelphia,
Pennsylvania, in accordance with the then existing rules of International
Chamber of Commerce. In any arbitration pursuant to this Section the award
shall
be rendered by a single arbiter if the Parties agree to one or a majority of
three (3) arbiters, one (1) of whom shall be appointed by each Party and the
third of whom shall be appointed by mutual agreement of the two Party-appointed
arbitrators. Either Party may initiate such an arbitration by giving written
notice to the other Party of such arbitration, specifying, in reasonable detail,
the dispute to be resolved thereby. The determination of the arbitrators with
respect to any dispute will be conclusive and binding on the Parties, and the
arbitrators will have right to award attorneys’ fees and costs, including but
not limited to the costs of the arbitration, to the prevailing Party. Judgment
upon the award rendered in any arbitration may be entered in any court of
competent jurisdiction in any country. The Parties agree to the exclusive
jurisdiction and venue of any state or federal court located in Philadelphia,
Pennsylvania for purposes of any action arising out of or relating to this
Agreement that is not subject to mandatory arbitration, and agree that service
of process in any such action may be made in the manner provided for in this
Agreement for the delivery of notices.
(f) Neither
Party shall be prevented from applying to a court at any stage for urgent
injunctive or other relief.
18.15 Headings.
The
Article and section headings contained in this Agreement are for reference
purposes only and shall not affect in any way the meaning or interpretation
of
this Agreement.
18.16 Counterparts.
This
Agreement may be executed in any number of counterparts, each of which shall
be
deemed an original but all of which together shall constitute one and the same
document.
18.17 Late
Payment.
If
Licensee fails to pay to Cellegy any amount when due, Licensee agrees to pay
interest on the overdue balance at the rate of the LIBOR rate (as quoted in
the
33
[*]
designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the
Commission
London
edition of the Financial Times and in effect from time to time) plus
[*]
or, if
such rate exceeds the maximum rate permitted by law, the maximum rate permitted
by law. Payments received from Licensee when any overdue balance exists shall
be
applied first against accrued interest. Licensee shall pay all collection
charges and expenses, and including, but not limited to, attorneys’ fees, which
are incurred by Cellegy in connection with Cellegy’s collection of any amounts
under or relating to this Agreement, or otherwise in connection with the
enforcement of this Agreement.
18.18 ProStrakan
Group plc Guarantee.
ProStrakan Group plc, of which Licensee is a wholly-owned subsidiary, hereby
guarantees the performance of Licensee under this Agreement to the extent,
and
pursuant to the terms of, the Guarantee attached hereto as Exhibit
D.
IN
WITNESS HEREOF, the parties have executed this Agreement as of the Agreement
Date.
| STRAKAN INTERNATIONAL LIMITED | CELLEGY PHARMACEUTICALS, INC. | |||
| By: | By: | |||
| Its: | Its: | |||
|
PROSTRAKAN
GROUP plc, only as to
Section
18.18 and the Guarantee
|
||||
| By | ||||
| Its: | ||||
34
EXHIBIT
A
COUNTRIES
IN THE TERRITORY
TERRITORIES
|
1.
Europe
|
1.
Europe (continued)
|
|
Andorra
|
Slovak
Republic
|
|
Albania
|
Slovenia
|
|
Austria
|
Spain
|
|
Belgium
|
Sweden
|
|
Bosnia-Herzegovina
|
Switzerland
|
|
Bulgaria
|
United
Kingdom
|
|
Croatia
|
Republic
of Yugoslavia
|
|
Cyprus
|
|
|
Czech
Republic
|
|
|
Denmark
|
|
|
Estonia
|
|
|
Finland
|
|
|
France
|
|
|
Germany
|
|
|
Gibraltar
|
|
|
Greece
|
|
|
Hungary
|
|
|
Ireland
|
|
|
Italy
|
|
|
Latvia
|
|
|
Liechtenstein
|
|
|
Lithuania
|
|
|
Luxembourg
|
|
|
Republic
of Macedonia
|
|
|
Malta
|
|
|
Monaco
|
|
|
Netherlands
|
|
|
Norway
|
|
|
Poland
|
|
|
Portugal
|
|
|
Romania
|
A
EXHIBIT
B
PATENTS
PATENTS
“Cellegy
Patents”
|
Cellegy
Ref No
|
Description
or Title
|
Country
|
Application
No.
|
Filing
Date
|
Patent
or Publication No.
|
Issue/Pub
Date
|
Status
|
Summary
|
|
|
C045-4510-
|
AT
|
Nitric
oxide donor composition for treatment of anal disorders
|
Austria
|
95916264.5
|
04/10/95
|
AT
0719145
|
9/6/00
|
On
Appeal
|
National
Phase of European application 95916264.5
|
|
C045-4510-
|
BE
|
Nitric
oxide donor composition for treatment of anal disorders
|
Belgium
|
95916264.5
|
04/10/95
|
BE
0719145
|
9/6/00
|
On
Appeal
|
National
Phase of European application 95916264.5
|
|
C045-4510-
|
CH
|
Nitric
oxide donor composition for treatment of anal disorders
|
Switzerland
|
95916264.5
|
04/10/95
|
CH
0719145
|
9/6/00
|
On
Appeal
|
National
Phase of European application 95916264.5
|
|
C045-4510-
|
DE
|
Nitric
oxide donor composition for treatment of anal disorders
|
Germany
|
95916264.5
|
04/10/95
|
DE 0719145
|
9/6/00
|
On Appeal
|
German
translation filed 11/9/00. National Phase of European application
95916264.5
|
|
C045-4510-
|
DK
|
Nitric
oxide donor composition for treatment of anal disorders
|
Denmark
|
95916264.5
|
04/10/95
|
DK
0719145
|
9/6/00
|
On
Appeal
|
Danish
translation filed 11/00. National Phase of European application
95916264.5
|
|
C045-4510-
|
EP
|
Nitric
oxide donor composition and method for treatment of anal
disorders
|
Europe
|
95916264.5
|
04/10/95
|
0719145
|
9/6/00
|
On
Appeal
|
On
Appeal
|
|
C045-4510-
|
ES
|
Nitric
oxide donor composition for treatment of anal disorders
|
Spain
|
95916264.5
|
04/10/95
|
ES
0719145
|
0/0/00
|
Xx
Xxxxxx
|
Xxxxxxxx
Xxxxx xx Xxxxxxxx application
95916264.5
|
A
|
C045-4510-
|
FR
|
Nitric
oxide donor composition for treatment of anal disorders
|
France
|
95916264.5
|
04/10/95
|
FR
0719145
|
9/6/00
|
On
Appeal
|
National
Phase of European application 95916264.5
|
|
C045-4510-
|
GB
|
Nitric
oxide donor composition for treatment of anal disorders
|
United
Kingdom
|
95916264.5
|
04/10/95
|
GB
0719145
|
0/0/00
|
Xx
Xxxxxx
|
Xxxxxxxx
Xxxxx xx Xxxxxxxx application 95916264.5.
|
|
C045-4510-
|
GR
|
Nitric
oxide donor composition for treatment of anal disorders
|
Greece
|
95916264.5
|
04/10/95
|
GR
0719145
|
9/6/00
|
On
Appeal
|
National
Phase of European application 95916264.5
|
|
C045-4510-
|
IE
|
Nitric
oxide donor composition for treatment of anal disorders
|
Ireland
|
95916264.5
|
04/10/95
|
IE
0719145
|
9/6/00
|
On
Appeal
|
National
Phase of European application 95916264.5
|
|
C045-4510-
|
IT
|
Nitric
oxide donor composition for treatment of anal disorders
|
Italy
|
95916264.5
|
04/10/95
|
51262BE/2000
|
9/6/00
|
On
Appeal
|
National
Phase of European application 95916264.5
|
|
C045-4510-
|
LU
|
Nitric
oxide donor composition for treatment of anal disorders
|
Luxembourg
|
95916264.5
|
04/10/95
|
LU
0719145
|
9/6/00
|
On
Appeal
|
National
Phase of European application 95916264.5
|
|
C045-4510-
|
MC
|
Nitric
oxide donor composition for treatment of anal disorders
|
Monaco
|
95916264.5
|
04/10/95
|
MC
0719145
|
9/6/00
|
On
Appeal
|
National
Phase of European application 95916264.5
|
|
C045-4510-
|
NL
|
Nitric
oxide donor composition for treatment of anal disorders
|
Netherlands
|
95916264.5
|
04/10/95
|
NL
0719145
|
9/6/00
|
On
Appeal
|
National
Phase of European application 95916264.5
|
|
C045-4510-
|
PT
|
Nitric
oxide donor composition for treatment of anal disorders
|
Portugal
|
95916264.5
|
04/10/95
|
PT
0719145
|
9/6/00
|
On
Appeal
|
Portuguese
translation filed 10/27/00. National Phase of European application
95916264.5
|
|
C045-4510-
|
SE
|
Nitric
oxide donor composition for treatment of anal disorders
|
Sweden
|
95916264.5
|
04/10/95
|
SE
0719145
|
9/6/00
|
On
Appeal
|
National
Phase of European application
95916264.5
|
B
|
Microdose
Cases
|
||||||||||
|
V003-310-
|
PC
|
Microdose
Therapy
|
PCT
|
PCT/CA98/00603
|
06/22/98
|
WO
98/58633
|
12/30/98
|
National
Phase
|
PCT
claiming priority from first and second provisionals.
|
|
|
V003-310-
|
EP
|
Microdose
Therapy
|
Europe
|
98
930577.6
|
06/22/98
|
Pending
|
National
Phase of PCT/CA98/00603.
|
Allowable
Claim 1 on file: The use of NO or a NO-donor selected from glyceryl
trinitrate (GTN) and sodium nitroprusside in the manufacture of a
medicament for the treatment of female sexual dysfunction associated
with
a vascular condition, wherein the medicament does not appreicably
alter
normal systemic vascular tone, said medicament providing a dose of
NO or
NO-donor that is 1/2 to about 1/20 of that required to induce vasodilation
in an anatomical site lacking said vascular condition.
|
||
|
V003-311-
|
EP
|
Microdose
Therapy
|
Europe
|
04
029432.4
|
12/13/04
|
Pub.
No. 1535611
|
Pub.
6/1/05
|
Pending
|
DIV
of the 310 EP case.
|
|
|
Remodeling
Cases
|
||||||||||
|
V004-410-
|
PC
|
Methods
for Remodelling Neuronal and Cardiovascular Pathways
|
PCT
|
PCT/CA99/00787
|
08/25/99
|
WO
00/12110
|
3/9/00
|
National
Phase
|
PCT
claiming priority to provisional application.
|
|
|
V004-410-
|
EP
|
Methods
for Remodelling Neuronal and Cardiovascular Pathways
|
Europe
|
99
939874.6
|
08/25/99
|
Pending
|
National
Phase of PCT/CA99/00787.
|
Pending
Claim 1: The use of one or more phosphodiesterase inhibitors which
lower
blood pressure for the manufacture of a medicament for chronic
administration in the management of sexual dysfunction by remodeling
an
ilio-hypogastric-pudendal arterial bed and genetalia, the medicament
being
adapted for administration at a dose that is from about one twentieth
to
about one hald the dose required to evoke vasodilation in a human
patient
exhibiting normal circulation.
|
||
|
Urogenital
Disorders Cases
|
||||||||||
|
C081-8120-
|
PC
|
Use
of Nitric Oxide donors and other agents for the treatment of urogenital
disorders
|
PCT
|
PCT/US02/07026
|
03/06/02
|
WO
02/069906
|
9/12/02
|
National
Phase
|
PCT
claiming priority to provisional application.
|
|
|
C081-8120-
|
EP
|
Use
of Nitric Oxide donors and other agents for the treatment of urogenital
disorders
|
Europe
|
2723359.2
|
03/06/02
|
Pending
|
National
Phase of PCT/US02/07026.
|
Allowed
Claim 1 from equivalent US case: A method for relieving the vulvar
pain of
vulvodynia in a patient, the method comprising topically administering
to
the affected vulvar area of the patient a NO donor in a therapeutically
effective amount, wherein the vulvar pain which is not caused by
dyspareunia is relieved.
|
||
C
EXHIBIT
C
CELLEGY MARKS
CELLEGY MARKS
|
Name
|
Status
|
Country
|
Registration
Date
|
Renewal
|
|
Rectogesic
|
Registered
|
European
Union
|
10/25/02
|
9/13/10
|
|
Rectogesic
|
Registered
|
Switzerland
|
3/8/01
|
9/8/10
|
|
Rectogesic
|
no
filing
|
Andorra
|
||
|
Rectogesic
|
no
filing
|
Albania
|
||
|
Rectogesic
|
no
filing
|
Bosnia-Herzegovina
|
||
|
Rectogesic
|
no
filing
|
Bulgaria
|
||
|
Rectogesic
|
no
filing
|
Croatia
|
||
|
Rectogesic
|
no
filing
|
Gibraltar
|
||
|
Rectogesic
|
no
filing
|
Republic
of Yugoslavia
|
||
|
Rectogesic
|
no
filing
|
Republic
of Macedonia
|
||
|
Rectogesic
|
no
filing
|
Monaco
|
C
EXHIBIT
D
PROSTRAKAN GROUP plc GUARANTEE
PROSTRAKAN GROUP plc GUARANTEE
ProStrakan
Group plc (“Group”)
hereby
unconditionally guarantees and undertakes to Cellegy that Licensee will duly
and
punctually observe and perform all the undertakings, covenants and obligations
of Licensee under this Agreement (including the payment of any damages becoming
due to Cellegy as a result of any breach by Licensee of such undertakings,
covenants and obligations) and under any agreements between the Parties (or
any
of them) which are expressly supplemental to this Agreement or which this
Agreement requires to be executed (the “Obligations”)
to the
intent that if Licensee shall fail for whatever reason so to observe and perform
any Obligations, Group shall be liable to perform the same in all respects
as if
Group was the party principally bound thereby in place of Licensee on demand
from Cellegy.
D
EXHIBIT
E
FLOW
DIAGRAM SHOWING
ORDERING
AND COMMUNICATION PATHWAYS
