First Amended and Restated Exclusive License Agreement For Tostrex® Between STRAKAN INTERNATIONAL LIMITED And Cellegy Pharmaceuticals, Inc. Confidential
First
Amended and Restated Exclusive License Agreement For
Tostrex®
Between
STRAKAN
INTERNATIONAL LIMITED
And
Cellegy
Pharmaceuticals, Inc.
Confidential
________________________________
[*]
|
designates
portions of this document that have been omitted pursuant to a
request for
confidential treatment filed separately with the
Commission.
|
TABLE
OF
CONTENTS
PAGE | |||
ARTICLE
1 DEFINITIONS
|
1
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||
Affiliates
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1
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||
Agreement
|
2
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||
Approvals
|
2
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||
Cellegy
Information
|
2
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||
Cellegy
Marks
|
2
|
||
Cellegy
Patents
|
2
|
||
Cellegy
Supply Agreement
|
2
|
||
Cellegy
Surcharge
|
2
|
||
Commercially
Reasonable and Diligent Efforts
|
3
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||
Competing
Licensed Products
|
3
|
||
Current
SmPC”
|
3
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||
Development”
|
3
|
||
Dollars”
or “$”
|
3
|
||
Effective
Date”
|
3
|
||
Euros”
or “€
|
3
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||
GMP”
|
3
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||
Intellectual
Property Rights”
|
3
|
||
Know-How
|
3
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||
Launch
Date
|
5
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||
Licensed
Product”
|
5
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||
Licensee
Product
|
5
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||
Licensee
Supply Agreement
|
5
|
||
Loss
|
5
|
||
Major
European Countries
|
5
|
||
Manufacturer
|
5
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||
Minimum
Sales
|
5
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||
M.R.P
|
5
|
||
Net
Sales
|
5
|
||
Party
|
6
|
||
Patent
Rights
|
6
|
||
Relevant
Regulatory Authority
|
6
|
||
Steering
Committee
|
6
|
||
Sublicensee
|
6
|
||
Technical
Agreement
|
6
|
||
Territory
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6
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||
Third
Party
|
6
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||
ARTICLE
2 GRANT OF LICENSE
|
7
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||
2.1
|
Grant
|
7
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|
2.2
|
Right
to sub-license
|
7
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|
2.3
|
Acceptance
of Appointment; Sales Outside Territory
|
8
|
|
|
i
2.4
|
Competing
Products
|
8
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|
2.5
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Right
of First Negotiation Regarding Licensee Product in North
America
|
9
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ARTICLE
3 REPRESENTATIONS AND WARRANTIES
|
9
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||
3.1
|
Representations
and Warranties of Cellegy
|
9
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3.2
|
Representations
and Warranties of Licensee
|
13
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|
ARTICLE
4 MANAGEMENT OF THE COLLABORATION
|
13
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||
4.1
|
Steering
Committee.
|
13
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4.2
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Responsibilities
of the Steering Committee
|
14
|
|
4.3
|
Voting;
Deadlocks
|
16
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4.4
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Approval
Plan; Marketing Plan.
|
16
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ARTICLE
5 REGULATORY MATTERS; APPROVALS
|
17
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||
5.1
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Regulatory
Matters; Approvals
|
17
|
|
5.2
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Reversion
of Product Rights in Certain Circumstances
|
19
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|
5.3
|
Cooperation
Regarding Material Events
|
19
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|
5.4
|
Copies
of Documents
|
19
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5.5
|
Approval
Application in Sweden
|
19
|
|
5.6
|
Meetings
With Regulatory Authorities
|
20
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5.7
|
Inspection
|
20
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|
5.8
|
Clinical
Trials
|
20
|
|
5.9
|
Cellegy
Obligations
|
21
|
|
5.10
|
Approvals
|
22
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|
ARTICLE
6 POST- APPROVAL RESPONSIBILITIES
|
22
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||
6.1
|
Responsibility
|
22
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|
6.2
|
Collaboration
|
23
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6.3
|
Insurance
|
23
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|
ARTICLE
7 INFORMATION; DATA; PHARMACOVIGILENCE
|
23
|
||
7.1
|
Clinical
Data
|
23
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|
7.2
|
Safety
Data Base
|
23
|
|
7.3
|
Adverse
Events
|
25
|
|
7.4
|
Product
Complaints
|
25
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|
ARTICLE
8 MILESTONE PAYMENTS; ROYALTIES AND RELATED PAYMENTS
|
25
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||
8.1
|
Milestone
Payments
|
25
|
|
8.2
|
Sales
Milestones
|
25
|
|
8.3
|
Fee
Conditions.
|
25
|
|
8.4
|
Royalties
in General
|
26
|
|
8.5
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Period
for Royalty Payments; Residual Payments
|
26
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ARTICLE
9 ROYALTY REPORTS AND ACCOUNTING
|
26
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9.1
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Quarterly
Royalty Reports; Records
|
26
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|
9.2
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Payment
Due Dates
|
27
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|
9.3
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Right
to Audit Licensee
|
27
|
|
|
ii
ARTICLE
10 MARKETING
|
30
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||
10.1
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General
Promotional Duties
|
30
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|
10.2
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Marketing
Effort; Minimum Expenditures for Commercialization
|
30
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|
10.3
|
Licensee’s
Failure to Commercialize in the Territory
|
30
|
|
10.4
|
Minimum
Sales
|
31
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|
ARTICLE
11 MANUFACTURING; SUPPLY OF LICENSED PRODUCT
|
33
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||
11.1
|
Production
and Supply of Product
|
33
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11.2
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Forecasts
|
33
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|
11.3
|
[*]
|
33
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|
11.4
|
Pricing
|
33
|
|
11.5
|
Warranty
Limitiation; Disclaimer
|
24
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11.6
|
Recalls
|
24
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|
ARTICLE
12 PATENT RIGHTS
|
35
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||
12.1
|
No
Ownership By Licensee
|
35
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|
12.2
|
New
Cellegy Inventions/Improvements to the Licensed Product
|
35
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|
12.3
|
Improvements
by Licensee
|
35
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ARTICLE
13 CELLEGY MARKS
|
36
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||
13.1
|
Use
of Cellegy Marks by Licensee
|
36
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|
13.2
|
Acknowledgment
of Ownership
|
36
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|
13.3
|
Marking
|
36
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|
13.4
|
Registration
|
36
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|
13.5
|
Termination
of Use
|
38
|
|
13.6
|
Trademarks
|
38
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|
ARTICLE
14 INFRINGEMENT; INDEMNIFICATION AND OTHER CLAIMS
|
38
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||
14.1
|
Infringement
of Intellectual Property Rights
|
38
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|
14.2
|
Alleged
Infringement of Third Party Intellectual Property Rights
|
40
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|
14.3
|
Product
Liability Claims
|
40
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|
14.4
|
Notice
from Licensee
|
41
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|
14.5
|
Indemnification
|
41
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ARTICLE
15 CONFIDENTIALITY
|
42
|
||
15.1
|
Treatment
of Confidential Information
|
42
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|
15.2
|
Right
to Disclose
|
42
|
|
15.3
|
Release
From Restrictions
|
44
|
|
15.4
|
Confidentiality
of Agreement
|
44
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|
15.5
|
Return
of Confidential Information
|
44
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|
15.6
|
Previous
Confidentiality Agreements
|
44
|
|
ARTICLE
16 TERM; TERMINATION
|
45
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||
|
iii
16.1
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Term
|
45
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|
16.2
|
Bilateral
Termination Rights
|
45
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|
16.3
|
Cellegy’s
Right to Terminate
|
45
|
|
16.4
|
Licensee’s
Right to Terminate
|
47
|
|
16.5
|
Rights
Upon Termination or Expiration
|
47
|
|
ARTICLE
17 REGISTRATION OF LICENSE; LIMITATION OF LIABILITY
|
50
|
||
17.1
|
Registration
|
50
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|
17.2
|
Limitation
of Liability
|
50
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|
ARTICLE
18 GENERAL PROVISIONS
|
50
|
||
18.1
|
Force
Majeure
|
50
|
|
18.2
|
Further
Assurances
|
52
|
|
18.3
|
Severability
|
52
|
|
18.4
|
Notices
|
52
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|
18.5
|
Assignment
|
53
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|
18.6
|
Amendment
|
53
|
|
18.7
|
Entire
Agreement
|
53
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18.8
|
Waiver
|
53
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18.9
|
No
Implied Licenses
|
53
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|
18.10
|
Injunctions
|
54
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|
18.11
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Independent
Contractors
|
54
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18.12
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No
Third Party Beneficiaries
|
54
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|
18.13
|
Governing
Law
|
54
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|
18.14
|
Resolution
of Disputes
|
54
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|
18.15
|
Headings
|
55
|
|
18.16
|
Counterparts
|
55
|
|
18.17
|
Late
Payment
|
56
|
|
18.18
|
Strakan
Group Limited Guarantee
|
56
|
SIGNATURES
EXHIBIT
A
LICENSED PRODUCT
EXHIBIT
B
COUNTRIES IN THE TERRITORY
EXHIBIT
C
MINIMUM SALES REQUIREMENTS
EXHIBIT
D
PATENT RIGHTS
EXHIBIT
E
CELLEGY MARKS
EXHIBIT
F
STRAKAN GROUP GUARANTEE
EXHIBIT
G
ADVERSE EVENT REPORTING ADDENDUM
iv
FIRST
AMENDED AND RESTATED EXCLUSIVE LICENSE AGREEMENT
THIS
FIRST AMENDED AND RESTATED EXCLUSIVE LICENSE AGREEMENT (this "Agreement")
is
made and entered into as of January 16, 2006 (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 “Effective
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
ARTICLE
1
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:
(i) exercise
or control the right to vote attached to 50% or more of the issued shares
in the
party;
1
(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 Agreement.
“Approvals”
are
registration approvals, registrations or authorizations provided by the
Relevant
Regulatory Authority in the Territory for the [manufacture,]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 Sweden, 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 related supporting
documentation or other information or materials 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
E
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
D
hereto.
“Cellegy
Supply Agreement”
means
the supply agreement between Cellegy and Manufacturer to Licensee 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.
“Cellegy
Surcharge”
means
10% of the per unit cost.
2
“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.
“Current
SmPC”
has
the
meaning set forth in Section 11.4.
“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 Sweden, 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.
“Effective
Date”
means
the date set forth at the beginning of the Prior Agreement.
“Euros”
or
“€”
shall
mean currency denominated in Euros.
“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.
“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, Trade 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.
“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
Effective Date and from time to time thereafter of this Agreement, 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.
3
“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 Tostrex® (testosterone) 2% topical
testosterone gel for the treatment of male hypogonadism, in the pharmaceutical
presentation described in Exhibit
A.
“Licensee
Product”
has
the
meaning set forth in Section 2.4.
“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 United Kingdom.
“Manufacturer”
means
Cellegy’s nominated Third Party manufacturer of the Licensed Product or any
other manufacturer nominated by Cellegy or by Licensee.
“Minimum
Sales”
means
agreed targets for unit sales of Licensed Product in the Territory, as
set forth
on Exhibit
C
hereto.
“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:
(i) reasonable
credited allowances actually granted to such Third Party customers,
(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,
(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
4
(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 royalty 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
D
hereto
and any patents and patent applications existing as of the Effective 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
D
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.
“Steering
Committee”
means
the Steering Committee, as described in Article 4 of this
Agreement.
“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
Agreement”
means
the agreements between Cellegy and Manufacturer for Licensed Product supplied
outside the Territory, and between Licensee and Manufacturer for Licensed
Product supplied within the Territory, defining the roles and responsibilities
for the parties to the Technical Agreements 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
B
hereto.
“Third
Party”
means
any party other than Cellegy or Licensee, or Licensee’s Affiliates or
Sublicensees.
5
GRANT
OF
LICENSE
2.1 Grant.
Cellegy
hereby grants to Licensee an exclusive, royalty-bearing, 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 within the Territory, and to use Cellegy’s Intellectual Property Rights
in connection with the importation, storage, Development, promotion, marketing,
distribution and sale of Licensed Product and obtaining any Approvals hereunder,
in each of the above cases only in relation to promotion, marketing,
distribution, offer for sale and sale of the Licensed Product within the
Territory. 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.
Subject
to Section 2.5 below, Licensee may sub-license any of its rights or obligations
under this Agreement, directly or indirectly, in whole or in part:
(a) to
Third
Parties approved by Cellegy in writing, which approval will not be unreasonably
withheld or delayed; and
(b) to
a
Cellegy approved Third Party Manufacturer in the case of Licensee sub-licensing
the rights to manufacture the Licensed Product and subject to appropriate
confidential disclosure by Cellegy of the Cellegy Information and Know-How
which
Cellegy shall disclose to allow the manufacture of the Licensed Product
by such
Manufacturer; and
[*]
designates portions of this document that have been omitted pursuant to
a
request for confidential treatment filed separately with the
Commission
(c) to
any of
its Affiliates that are engaged primarily in the business of manufacture,
importation, storage, Development, promotion, marketing, distribution and
sale
of pharmaceutical products, as Licensee sees fit.
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 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.
6
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.
(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.
During
the term of this Agreement, 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
Territory that are directly competitive in the treatment of male hypogonadism
or
such other indications for the Licensed Product as may be added to this
Agreement (the “Competing
Licensed Products”),
excluding Licensee’s [*] (the “Licensee
Product”).
For
the avoidance of doubt, this shall not preclude Licensee from conducting
research and development in relation to projects or products
[*]
designates portions of this document that have been omitted pursuant to
a
request for confidential treatment filed separately with the
Commission
that
may
be associated with the treatment of male hypogonadism or such other indication
for the Licensed Product added to this Agreement. 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 if at any time during the term of
this
Agreement when such covenant is not effective Licensee or its Agents directly
or
indirectly promote, sell or distribute Competing Licensed Products, Cellegy
may
terminate this Agreement with respect to any country where such Competing
Licensed Products are being promoted, sold or distributed by delivery of
written
notice to Licensee.
7
2.5 Right
of First Negotiation Regarding Licensee Product in North America.
Before
Licensee enters into any agreement with any Third Party which includes
the right
to develop, promote, distribute or sell the Licensee Product for use in
males in
territories that include the United States of America or Canada (“North
America”),
or
any agreement with any Third Party which includes worldwide rights to develop,
promote, distribute or sell the Licensee Product, Licensee shall first
offer to
Cellegy in writing (the “Negotiation
Notice”)
a
one-time right of exclusive first negotiation to negotiate with Licensee
concerning exclusive development, marketing and/or distribution rights
in North
America (or worldwide, as the case may be) for such Licensee Product, for
a
negotiation period not to exceed [*] (the “Negotiation
Period”).
Cellegy shall exercise the Right of First Negotiation granted herein by
providing written notice of
its
election (the “Exercise
Notice”)
to
Licensee within [*] after the date of delivery of the Negotiation Notice
to
Cellegy. The Negotiation Period shall commence upon delivery to Licensee
of the
Exercise Notice. During the Negotiation Period, Licensee shall not enter
into
any agreement with any person other than Cellegy with respect to the
development, promotion, distribution or sale of the Licensee Product within
any
country in North America (or worldwide, as the case may be). During the
Negotiation Period, the Parties shall negotiate in good faith; provided,
however, that nothing in this Article shall be deemed to create a legal
obligation on the part of Licensee to enter into any such agreement. This
Right
of First Negotiation shall terminate upon the first to occur of (i) Cellegy’s
failure to timely deliver its Exercise Notice following receipt of the
Negotiation Notice; (ii) the expiration of the Negotiation Period; (iii)
the
mutual termination of negotiations by the Parties conducted under this
Article;
or (iv) the effective date of termination of this Agreement by either Party
as
provided elsewhere in this Agreement.
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) Cellegy
is not subject to, or bound by, any provision of: (i) its articles 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.
8
(c) Cellegy
is the exclusive owner of all right, title and interest in the Patent Rights
in
the applicable countries in the Territory, and the patent applications
included
in the Patent Rights have been duly filed and contain no material errors.
Cellegy shall maintain all Patent Rights for the full duration of this
Agreement. Attached hereto as Exhibit
D
is a
complete and accurate list of all patents and patent applications included
in
the Patent Rights.
(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. Attached hereto
as
Exhibit
E
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) To
the
best of Cellegy’s knowledge, there is no interference or opposition actions or
litigations pending or any communication, which threatens interference
or
opposition actions or litigation before any patent and trade xxxx office,
court
or any other governmental entity in any jurisdiction in regard to the Patent
Rights or the Cellegy Marks.
(h) 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.
(i) 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.
(j) Cellegy
will use all Commercially Reasonable and Diligent Efforts to ensure that
Cellegy
will not alter the Cellegy Information supplied to Licensee or the materials
or
processes described in that information in relation to any of the Licensed
Product without the prior written notification to Licensee.
9
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) 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.
ARTICLE
4
MANAGEMENT
OF THE COLLABORATION
4.1 Steering
Committee.
(a) Upon
execution of the Prior Agreement, Cellegy and Licensee established a Steering
Committee (the “Steering
Committee”)
which
shall have the responsibilities described in this Article 4. The Steering
Committee shall be initially comprised of a total of six (6) members, of
which
three (3) members shall be appointed by Licensee and three (3) members
[*]
designates portions of this document that have been omitted pursuant to
a
request for confidential treatment filed separately with the
Commission
shall
be
appointed by Cellegy. The total number of Steering Committee members may
be
changed by the Steering Committee from time to time as appropriate, but
in all
cases it will be comprised of an equal number of members designated by
each of
Cellegy and Licensee, and in no event shall the Steering Committee be comprised
of an aggregate of less than six (6) members. Each of Cellegy and Licensee
may
substitute its representatives from time to time and the substitution shall
be
effective upon notice to the other Party. The Steering Committee shall
meet once
every quarter during the first year of the term of this Agreement and thereafter
at such other times as the Steering Committee may agree (but at least one
time
each year), on such dates and at such places as to be agreed upon between
the
Parties. Each representative on the Steering Committee will have one vote
in
decisions submitted to the Steering Committee. The meetings of the Steering
Committee may be held in person or in any other reasonable manner, including,
without limitation, by telephone, video conference or e-mail.
10
(b)
[*]
shall designate a Chairperson who will serve as such. The Chairperson shall
send
notices (not less than 15 business days in advance of such meetings) and
agendas
for all regular Steering Committee meetings to all Steering Committee members.
The location of regularly scheduled Steering Committee meetings shall alternate
among the offices of the Parties, unless otherwise agreed. Meetings may
be held
telephonically or by video conference, but each member shall attend at
least one
meeting in person each year. The Party hosting any Steering Committee meeting
shall appoint one person (who need not be a member of the Steering Committee)
to
attend the meeting and record the minutes of the meeting. Such minutes
shall be
circulated to the Parties promptly following the meeting for review, comment
and
approval.
4.2 Responsibilities
of the Steering Committee.
The
Steering Committee will be primarily responsible for activities relating
to
implementation of the activities contemplated by this Agreement. The Steering
Committee shall, subject to the provisions set forth in this Agreement
(including the dispute resolution procedures hereof), be the primary vehicle
for
interaction between the Parties with respect to the Development and
commercialization of the Licensed Product in the Territory. In particular,
the
Steering Committee shall perform the following functions:
(a) exchange
of information and facilitation of cooperation and coordination between
the
Parties as they exercise their respective rights and meet their respective
obligations under this Agreement;
(b) perform
such other functions as appropriate to further the purposes of this Agreement,
as determined by the mutual agreement of the Parties;
(c) with
the
exception of the Approval application that Cellegy has already submitted
in
Sweden, prior to submitting any Approval application, the Steering Committee
shall discuss the scope and content of such Approval application. The Steering
Committee may
[*]
designates portions of this document that have been omitted pursuant to
a
request for confidential treatment filed separately with the
Commission
review
and comment on all Approval applications, and such comments will be considered
by the Parties as long as such comments are provided in a timely manner.
In the
event of a dispute within the Steering Committee or between the Parties
directly
or indirectly relating to the choice of countries within the Territory
where
Approval applications shall be filed and Approvals shall be obtained then
clause
4.3 shall not apply. Licensee shall have final decision-making authority
with
respect to such Approval application issues; however, any such decisions
shall
be based on Licensee’s good faith belief that such decision is consistent with
commercialization requirements of the Territory; and
(d) In
the
event that the Current SmPC requires substantial and significant changes
as
described in Section 11.4(b), then the Steering Committee shall review
the
timetable and the Approval Plan, and if it so determines to revise and
modify
such timetable and Approval Plan, then the time periods for obtaining Approvals
(as set out in Section 5.1(b)) and consequently commercializing the Licensed
Product (as set out in Sections 10.3(i) and (ii)) shall be extended by
the
amount of time determined by the Steering Committee.
11
(e) at
the
end of [*] review and attempt to agree on the Minimum Sales for
[*].
4.3 Voting;
Deadlocks.
Each
member of the Steering Committee shall have one vote, and all the decisions
of
the Steering Committee shall be made by a simple majority of the members
of such
committee; provided,
however,
that in
the event the members of the Steering Committee are deadlocked and cannot
reach
a decision within three (3) days after notice of a deadlock with regard
to any
decision required to be made by such committee (each, a “Dispute”),
then
the Dispute shall be referred to the Chief Executive Officer of each Party..
If
such Dispute is not resolved by the Chief Executive Officers within five
(5)
working days of such referral, then (i) Cellegy’s Chief Executive Officer (or
such other officer as Cellegy determines) will have the authority to cast
the
tie-breaking vote with regard to such Dispute if, and only if, the Dispute
relates to clinical studies or trials where, in Cellegy’s good faith opinion,
the conduct or results of the studies or activities could have a detrimental
effect on the commercial viability of the Licensed Product outside of the
Territory, and (ii) for other kinds of Disputes, if the Chief Executive
Officers
cannot agree within such time period, then the Dispute shall be resolved
by
means of the dispute resolution procedures set forth in Section 18.14 of
this
Agreement.
4.4 Approval
Plan; Marketing Plan. The
overall timetable to obtain Approvals for the Licensed Product in the Territory
shall be set forth in a written plan (the “Approval Plan”). In addition,
Licensee shall prepare a marketing plan, including details of promotional
effort, size of sales force, associated budget in connection with the promotion,
marketing and distribution of the Licensed Product in the Major European
Countries (the “Marketing Plan”). The initial Marketing Plan for Sweden shall be
submitted no later than six (6) weeks after the Effective Date of this
Agreement. The initial Marketing Plans for the Major European Countries
shall be
[*]
designates portions of this document that have been omitted pursuant to
a
request for confidential treatment filed separately with the
Commission
submitted
no later than three (3) months after the Effective Date, and the initial
Marketing Plans for the other countries in the Territory shall be submitted
no
later than one (1) year after the Effective Date. Such initial Marketing
Plans
shall be subject to review and approval by Cellegy, such approval not to
be
unreasonably withheld or delayed. The Marketing Plans shall be consistent
in all
material respects with the provisions of this Agreement. Subsequent revisions
and updates to the Marketing Plan shall be delivered annually and no later
than
the end of the first week in January (or, if Licensee makes interim revisions
or
updates, then as soon as reasonably practicable after Licensee prepares
such
revisions or updates).
12
REGULATORY
MATTERS; APPROVALS
5.1 Regulatory
Matters; Approvals.
(a) Licensee
shall use Commercially Reasonable and Diligent Efforts, subject to this
Agreement, and with the exception of the Approval application that Cellegy
has
already submitted in Sweden, to obtain at its sole expense obtain all Approvals
that are necessary for the sale of the Licensed Product within the Territory
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 Licensed Product in each country in the Territory,
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 do all that is necessary to assign the
Approval
in Sweden to Licensee, including notifying the Swedish Relevant Regulatory
Authority of such a change. 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) Licensee
agrees that it will make all filings that are required to seek and obtain
Approvals for the Licensed Product in each Major European Country by initiating
the M.R.P. no later than [*] after the date of Approval of the variation
dealing
with impurities in the
[*]
designates portions of this document that have been omitted pursuant to
a
request for confidential treatment filed separately with the
Commission
Licensed
Product which variation was filed 18 May 2005 with the Relevant Regulatory
Authority in Sweden, provided that the dossier used in Sweden is acceptable
for
use in an M.R.P. application.
If the
Relevant Regulatory Authority in a country other than Sweden determines
that
such dossier is not complete or acceptable for the initiation of an M.R.P.
application in such country, then the Steering Committee shall promptly
meet and
attempt to agree on an appropriate course of action, and recommend an
appropriate modification to the above deadline as applied to such country.
Licensee agrees that it will make all filings that are required to seek
and
obtain Approvals for the Licensed Product in other countries in the Territory
no
later than [*] after the completion of the M.R.P. and to use Commercially
Reasonable and Diligent Efforts to take such actions as may be required
to
promptly obtain Approvals in all of the foregoing countries. If Licensee
desires
to not seek Approvals in one or more countries in the Territory 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 the Steering Committee and the Steering Committee shall decide 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.
13
(c) With
the
exception of the Approval application that Cellegy has already submitted
in
Sweden 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 Reversion
of Product Rights in Certain Circumstances.
If
further clinical development is required for Approval in a given country
(or
countries) within the Territory and Licensee elects not to conduct any
required
clinical studies within twenty-four (24) months after the need for further
clinical studies is identified, then the rights in the Licensed Product
in any
such country shall revert to Cellegy at no further cost to
Licensee.
5.3 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.
5.4 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 Sweden. 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.
5.5 Approval
Application in Sweden. Cellegy
agrees to continue the ongoing Approval process in Sweden; provided, however,
that the foregoing shall not obligate Cellegy to conduct any additional
studies
or trials. Cellegy shall provide Licensee with a copy of such other reports,
analysis and clinical data relating to the Licensed Product in a timely
manner
as Cellegy may from time to time develop before the date that all required
Approvals are obtained.
14
5.6 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; provided that Licensee shall use Commercially Reasonable
and
Diligent Efforts to conduct such meetings and discussions to facilitate
the
Approval of the Licensed Product in the Territory. Licensee will inform
Cellegy
and the Steering Committee early in advance of all meetings with such Relevant
Regulatory Authorities and will keep Cellegy and the Steering Committee
apprised
of all material communications with such Relevant Regulatory Authorities.
Cellegy or its designee shall be entitled to attend all meetings with Relevant
Regulatory Authorities. If appropriate Cellegy, or Cellegy’s designee, will
provide reasonable assistance and technical support for the preparation
of and
attendance at any relevant meeting with a Relevant Regulatory Authority.
5.7 Inspection.
Licensee and Cellegy shall use all Commercially Reasonable and Diligent
efforts
to procure that Manufacturer, shall cooperate in good faith with respect
to the
conduct of any inspections by any Relevant Regulatory Authority of Licensee’s or
Manufacturer's site and facilities related to the manufacture of the Licensed
Product for the Territory, and each Party shall be given the opportunity
to
attend such site inspection and the summary, or wrap up, meeting related
to the
Licensed Product with such Relevant Regulatory Authority at the conclusion
of
such site inspection. 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.
5.8 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 (excluding Sweden) 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 Licensed Product in the
Territory. All clinical trials for the Licensed Product in the Territory
that
are initiated after the date of this Agreement shall be performed in compliance
with and in conformity to ICH and E.U. good clinical practice guidelines.
Licensee shall provide Cellegy with the study plans and/or protocols relating
to
any such clinical trial before the trial is started, and Cellegy shall
have the
right to review and comment on such trial plans or protocols. It will be
the
responsibility of the Party conducting the trial to register such trial,
unless
by law Cellegy as the originator of the Licensed Product is required to
register
it in which circumstance if Licensee is conducting the trial it shall supply
Cellegy with the appropriate information to enable the trial to be registered.
At the completion of each clinical trial initiated after the Effective
Date,
Licensee shall prepare a written report, in compliance with the relevant
ICH
guidelines summarizing the results of such clinical trial, and containing
an
analysis of the clinical significance of such results, which reports shall
be
submitted to Cellegy as soon as is reasonably practicable after completion
of
the relevant clinical trial. 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, providing that use of the Third
Party contract manufacturer(s) has been approved by Cellegy .
5.9 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;
15
(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) except
as
provided in Section 5.8 above, at its cost promptly provide to Licensee
a
sufficient quantity of the Licensed Product reasonably necessary for Licensee
to
prepare and submit the application, and the grant, maintenance, variation
or
renewal of Approvals;
(d) use
Commercially Reasonable and Diligent Efforts to assist Licensee and Manufacturer
to procure the assistance of any Third Party supplier of raw materials
, in
meeting the demands of the Relevant Regulatory Authority relating to any
application and any grant, maintenance, variation or renewal of Approvals;
(e) use
commercially reasonable efforts to assist Licensee to enter into Licensee
Supply
Agreement and Technical Agreement with the Manufacturer; and
(f) 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.
5.10 Approvals.
(a) All
Approvals by any Relevant Regulatory Authority which are necessary to sell
the
Licensed Product within the Territory shall be issued to, and held in the
name
of Licensee for the benefit of Cellegy; provided, however, that all such
Approvals shall constitute the sole property of Cellegy.
(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.
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.
16
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.
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 Steering Committee 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
[*]
designates portions of this document that have been omitted pursuant to
a
request for confidential treatment filed separately with the
Commission
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 Steering Committee 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. As soon as practicable, the Parties shall attach a policy governing
the formation and administration of the SAE Data Base to this Agreement
as part
of Exhibit
G.
17
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 detailed in Exhibit
G.
ARTICLE
8
MILESTONE
PAYMENTS; ROYALTIES AND RELATED PAYMENTS
8.1 Milestone
Payments.
Licensee shall pay Cellegy a milestone payment in the particular amounts
specified below:
(a) Five
Hundred Thousand Dollars ($500,000), within five (5) business days after
the
date the Prior Agreement was executed and delivered by both parties hereto,
receipt of which amount is hereby acknowledged by Cellegy.
(b) With
respect to [*], the amounts set forth below, payable on the earlier to
occur of
(i) [*], or (ii) [*]:
[*]
8.2 [*]
[*]
designates portions of this document that have been omitted pursuant to
a
request for confidential treatment filed separately with the
Commission
(a) [*]
(b) [*]
(c) [*]
(d) [*]
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.
18
8.4 Royalties
in General.
In
consideration of the exclusive license granted to Licensee hereunder, Licensee
shall pay or cause to be paid to Cellegy the Royalty set forth herein.
The
“Royalty”
shall
be equal to the following amounts:
(a) For
aggregate, annual Net Sales of the Product in the Territory up to [*] Million
Euros [*], the Royalty shall be equal to [*] Percent [*] of Net
Sales.
(b) For
aggregate, annual Net Sales of the Licensed Product in the Territory in
excess
of [*] Million Euros [*], the Royalty shall be equal to [*] Percent [*]
of Net
Sales. (For example, Net Sales of [*] would accrue Royalties equal to [*]
of [*]
and [*] of [*], which is equal to [*].)
8.5 Period
for Royalty Payments; Residual Payments.
Royalty
payments will continue as set forth above, on a country by country basis,
until
the later of (i) ten years from the
Launch
Date for the Licensed Product in such country, or (ii) expiration, lapse
or
invalidation by a final, non appealable order or judgment of a court or
other
governmental authority of competent jurisdiction, of the last valid claim
included within any of the Cellegy Patents covering such country in the
Territory relating to the Licensed Product. Thereafter, following the period
of
time described in the preceding sentence, Licensee will pay Cellegy a [*]
royalty with respect to Net Sales in such country for ongoing use of Cellegy’s
trademark Tostrex® and know-how relating to the Licensed Product.
ARTICLE
9
ROYALTY
REPORTS AND ACCOUNTING
9.1 Quarterly
Royalty Reports; Records.
During
the term of this Agreement after the first Launch Date, Licensee shall
furnish
or cause to be furnished to Cellegy a written report within sixty (60)
days
following the end of each preceding calendar quarter (the “Royalty
Report”)
covering such preceding calendar quarter (the “Royalty
Period”)
showing:
(a) the
Net
Sales of the Licensed Product in each country of the Territory during the
royalty period;
(b) the
Royalties, payable in Dollars, which shall have accrued hereunder in respect
to
such Net Sales; and
(c) the
exchange rates used in determining the amount of Dollars, using the exchange
rates normally used by Licensee in its management and financial reporting,
provided,
however,
that
the exchange rates used by Licensee in preparation of the Royalty Report
shall
not be materially different from the exchange rates posted in the London
edition
of the Financial
Times published
on the last day of such Royalty Period.
19
With
respect to sales of Licensed Product invoiced in Dollars, the Net Sales
and
royalty payable shall be expressed in Dollars. With respect to sales of
Licensed
Product invoiced in a currency other than Dollars, the Net Sales and royalty
payable shall be expressed in the domestic currency of the country where
such
sale was made together with the Dollar equivalent of the royalty payable,
calculated using the exchange rates as described in clause (c) above. Licensee,
and its Affiliates and Sublicensees shall keep contemporaneous, legible,
verifiable and accurate records in sufficient detail to enable the royalties
payable hereunder to be determined and substantiated. A final Royalty Report
shall be due upon the expiration or termination of this Agreement. Any
income or
other tax which Licensee is requested to pay or withhold on behalf of Cellegy
with respect to any upfront or milestone payment and Royalties shall be
deducted
from the amount of such upfront and milestone payments and Royalties due,
provided, however, that in regard to any such deduction Licensee shall
give
Cellegy such assistance as may reasonably be necessary to enable or assist
Cellegy to claim appropriate tax credits or exemptions threrefrom and shall
upon
request give Cellegy proper evidence from time to time as to the withholding
and
payment of the tax. If Cellegy is unable to claim such an exemption or
recover
such amounts that have been
deducted
or withheld, or if any restrictions are imposed by a governmental entity
in a
particular country in the Territory regarding the payment of milestones
or
Royalties to companies outside of such countries, then the Steering Committee
shall promptly meet to agree upon a suitable response. If the Steering
Committee
is unable to agree on a suitable response, then Cellegy may, in its discretion,
discontinue the supply of the Licensed Product to Licensee for sale in
such
country.
9.2 Payment
Due Dates.
Royalties shown to have accrued by each Royalty Report provided for hereunder
shall be due and payable on the date such Royalty Report is due. Payment
of
royalties in whole or in part may be made in advance of such due date.
All
royalty and other payments due to Cellegy hereunder, shall be made in Dollars,
delivered to the account(s) specified by Cellegy from time to time.
9.3 Right
to Audit Licensee.
(a) Upon
the
written request of Cellegy, at Cellegy’s expense and not more than once in each
year, Licensee and its Affiliates shall permit an independent public accountant
and auditor bound to strict secrecy (the “Auditor”),
selected by Cellegy to have access during normal business hours to those
records
of Licensee and its Affiliates as may be reasonably
[*]
designates portions of this document that have been omitted pursuant to
a
request for confidential treatment filed separately with the
Commission
necessary
to verify the accuracy of the Royalty Reports furnished by Licensee hereunder
in
respect of any year ending not more than twenty four (24) months prior
to the
date of such request. Cellegy acknowledges that the Auditor shall conduct
its
audit in such a manner so as to not unreasonably interfere with Licensee’s, its
Affiliates’, or Sublicensees’ business.
(b) Licensee
shall include in each written sublicense granted by it pursuant to this
Agreement a provision requiring the Sublicensee to keep and maintain records
of
sales made pursuant to such Sublicense and to grant access to such records
by
Cellegy’s independent accountant bound to strict secrecy subject to the same
terms and conditions as stated herein.
20
(c) If
the
Auditor’s report shows any underpayment of royalties, Licensee shall remit, or
shall cause its Affiliates or Sublicensees to remit, to Cellegy the amount
of
such underpayment within thirty (30) days after Licensee’s receipt of the
Auditor’s report assuming there is no disagreement as to the Auditor’s
calculation; if there is such a disagreement, the result shall be resolved
under
Section 18.14 of this Agreement. In the event that the amount of any
underpayment of royalties is in excess of [*] percent [*] of the total
royalties
due to Cellegy with respect to the period covered by the Auditor’s report,
Licensee shall reimburse Cellegy for the reasonable cost of the audit in
which
the underpayment was discovered. In addition, in the event that the amount
of
any underpayment of royalties is in excess of [*] percent [*] of the total
royalties due to Cellegy with respect to the period covered by the Auditor’s
report, Licensee shall reimburse Cellegy for the reasonable cost of the
next
subsequent audit.
21
[*]
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.
(a) Licensee
shall: (i) at all times display, demonstrate and otherwise represent the
Licensed Product fairly in comparison with other competitive products or
therapies, (ii) shall not make false or misleading representations to customers
or other persons with regard to the Licensed Product or Cellegy, and (iii)
subject to sub-clause (ii), 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. Licensee, its Affiliates and
Sublicensees shall promote, market and sell the Licensed Product only for
the
therapeutic indications for which Approvals are granted in the
Territory.
10.2 Marketing
Effort; Minimum Expenditures for Commercialization.
(a) Licensee
agrees to exert its Commercially Reasonable and Diligent Efforts to introduce,
promote and, sell the Licensed Product within the Territory, including,
without
limitation, the attainment of the Minimum Sales,
and to
commence sales of the Licensed Product in all Major European Countries
within
[*] months following Approval in such countries, subject to Section 10.3
below.
(b) Licensee
shall detail commercialization expenditures relating to the Development
and
marketing of the Licensed Product in the Territory in the Marketing Report
as
described at Section 4.4 of this Agreement.
10.3 Licensee’s
Failure to Commercialize in the Territory.
(a) If
Licensee fails to make commercial sales of the Product in a particular
country
within the Territory within (i) [*] in Major European Countries, and (ii)
[*]
for other countries in the Territory, after Approval has been obtained
(including price reimbursement approval where applicable) for commercial
sale in
such country, other than failures caused by (i) the Relevant Regulatory
Authority approving a minimum reimbursement price for sale of the Product
in
such country that does not permit the Licensed Product to be economically
sold
in such country; or (ii) Cellegy’s inability to supply Licensed Product in a
timely manner, or (iii) Cellegy’s material breach of any relevant obligation
under this Agreement; (iv) health or safety reasons relating to the Licensed
Product, or (v) the assertion of a proceeding or lawsuit brought against
Licensee 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 that prevents sales of the Licensed Product in a particular
country of the Territory, then Cellegy may, upon notice to Licensee, terminate
all of Licensee’s rights under this Agreement with respect to the Licensed
Product in such country and recapture all rights granted to Licensee with
respect to the
22
[*]
designates portions of this document that have been omitted pursuant to
a
request for confidential treatment filed separately with the
Commission
Licensed
Product in such country hereunder. In
the
event that rights to the Licensed Product are returned to Cellegy due to
a
failure to launch within a particular country within the time frames specified
above, a minimum royalty for [*] will be due with respect to the Major
European
Countries, and a minimum royalty for [*] will be due in any other country
in the
Territory. Should price reimbursement approval for the Licensed Product
not be
achieved in any country of the Territory the Parties shall meet to discuss
how
to proceed.
(b) If
Licensee decides in good faith for commercial reasons not to file an application
for Approval in a particular country within the Territory or to pursue
commercial launch in that country following Approval, it shall notify Cellegy
and the Parties shall discuss in good faith the termination of the license
granted in Section 2.1 and the return of all rights to the Licensed Product
to
Cellegy within such country.
10.4 Minimum
Sales.
(a) Exhibit
C
hereto
sets forth certain targets for the agreed minimum unit sales of Licensed
Product
in the Territory (“Minimum
Sales”)
for a
period of [*]. It is acknowledged by the Parties that all Approvals pursuant
to
the MRP will not be obtained within [*] following the Launch Date in the
first
country of the Territory through no fault of Licensee and the Parties have
agreed to vary the Minimum Sales accordingly.
(b) If
Licensee fails to achieve the Minimum Sales in a given year then Licensee
shall
pay to Cellegy the Royalties that would have been due to Cellegy had the
Minimum
Sales for that particular year been achieved, such shortfall in the Royalties
to
be paid within sixty (60) days following the end of the relevant year.
For the
avoidance of doubt this shall be Cellegy’s sole remedy for Licensee’s failure to
achieve the Minimum Sales in any year, except as provided in paragraph
(d)
below. However in the event Licensee fails to pay the relevant shortfall
within
sixty (60) days following the end of the relevant year this shall constitute
material breach and Cellegy shall be entitled to terminate this Agreement
in
accordance with Section 16.2(c).
(c) The
Minimum Sales amounts set forth on Exhibit
C
are
subject to review and revision as described in Section 11.4 below.
(d) At
any
time commencing with “Year 3” Minimum Sales as set forth on Exhibit
C,
if
Licensee fails to achieve, in any particular country, the annual Minimum
Sales
amounts for such country as set forth on Exhibit
C
for any
[*] consecutive years, and if the Relevant Regulatory Authority for such
country
has not required any substantial and significant changes to the Current
SmPC
that can reasonably be expected to materially and adversely affect Licensee’s
competitive position and ability to market and sell the Licensed Product
in such
country, then if the Steering Committee cannot agree (without the occurrence
of
a deadlock) on mutually satisfactory modifications to the Minimum Sales
amounts
for such country, then Cellegy may, at its option, make the exclusive license
granted pursuant to Sections 2.1 and 2.2
23
[*]
designates portions of this document that have been omitted pursuant to
a
request for confidential treatment filed separately with the
Commission
herein
a
nonexclusive license for the remainder of the term of this Agreement as
it
relates to such country in the Territory, except for the right to use Cellegy
Marks granted to Licensee hereunder, which shall continue to be exclusive
for
Cellegy’s Xxxx actually being used in connection with the Licensed Product, and
without limiting the above may import, store, Develop, have Developed,
promote,
market, distribute, offer for sale, and sell the Licensed Product in such
country on its own or through a Third Party licensee.
ARTICLE
11
MANUFACTURING;
SUPPLY OF LICENSED PRODUCT
11.1 Production
and Supply of Product.
(a) Without
limitation on Cellegy’s other rights, during the term of this Agreement and
thereafter, Cellegy may, without obligation or liability to Licensee,
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 Reasnoable 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 produt pricing
or other
material terms of the Cellegy Supply Agreement.
11.2 Forecasts.
Until
such time as Licensee enters into a Licensee Supply Agrement, 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.
11.3 [*]
11.4 Pricing.
For
each
order of Licensed Product delivered to Licensee by Manufacturer, Licensee
will
pay Cellegy the Cellegy Surcharge (plus, if applicable, the additional
percentage of total Licensed Product cost and Cellegy Surcharge as set
forth
below) within forty-five (45) days of the receipt of the invoice for such
order
from Manufacturer. Licensee
will pay Cellegy the Cellegy Surcharge multiplied by the number of Licensed
Product units on the relevant Manufacturer invoice for supply of the Licensed
Product to Licensee.
24
[*]
designates portions of this document that have been omitted pursuant to
a
request for confidential treatment filed separately with the
Commission
(a) If
the
royalty paid to Cellegy for each unit of Licensed Product sold is equal
to or
greater than [*], Licensee shall pay Cellegy the Cellegy Surcharge multiplied
by
the number of Licensed Product units.
(b) If
the
royalty paid to Cellegy for each unit of Licensed Product sold is between
[*],
Licensee shall pay Cellegy the Cellegy Surcharge multiplied by the number
of
Licensed Product units, plus [*] of the total of the invoiced purchase
price
from the Manufacturer and the Cellegy Surcharge.
(c) If
the
royalty paid to Cellegy for each unit of Licensed Product sold is less
than [*],
Licensee shall pay Cellegy the Cellegy Surcharge multiplied by the number
of
Licensed Product units, plus [*] of the total of the invoiced purchase
price
from the Manufacturer and the Cellegy Surcharge..
(d) Both
Parties agree to work in mutual cooperation and in collaboration with
Manufacturer to manage the purchase price, production, packaging, delivery
and
availability of the Licensed Product for sale in the Territory. The Parties
agree to explore arrangements for Cellegy to contract with a secondary
Manufacturer as a back-up manufacturer of Licensed Product as soon as reasonably
possible. Cellegy agrees to inform Licensee of any amendments to any
Manufacturer contract that may have any material effect on the purchase
price of
the Licensed Product.
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.
25
(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.
ARTICLE
12
PATENT
RIGHTS
12.1 No
Ownership By Licensee.
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 the Prior Agreement or this Agreement or within one
(1) year
after the date of its termination, 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.
26
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 Tostrex 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 Tostrex not be registered or registerable by
Cellegy
in all countries of the Territory, then Cellegy may notify Licensee that
one of
the other “Cellegy’s Marks” 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.
13.2 Acknowledgment
of Ownership.
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.
27
13.5 Termination
of Use.
Upon
expiration or earlier termination of this Agreement, Licensee shall cease
using
Cellegy’s Marks in any manner, either similar or dissimilar to the use
enumerated above.
13.6 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 (i) during the pendency of such action, Licensee shall be entitled
to defer
the payment of 50% of the royalties due to Cellegy on Net Sales under Section
8.4 in the relevant country or countries, with such deferred amount being
paid
to Cellegy at the successful conclusion of such action, and (ii) Licensee
will
retain all award, damages or compensation obtained by Licensee in such
suit,
except that Cellegy shall receive a portion equivalent to the royalties
it would
have received in accordance with the terms of this Agreement as if such
amount
were Net Sales of Licensee. 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.
28
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 Product
Liability Claims.
Licensee shall immediately notify Cellegy in writing of any product liability
claim or product liability action brought against Licensee with respect
to the
Licensed Product based on any reason other than (i) alleged defects in
the
manufacture or supply of the Licensed Product or (ii) any action or inaction
in
relation to the manufacture or supply of the Licensed Product on the part
of
Licensee or any of its employees, affiliates or sublicensees (a “Product
Liability Claim”).
Upon
receiving such written notice, Cellegy shall assume and have sole control
of the
defense of any such claim or action, including the power to conduct and
conclude
any and all negotiations, compromises or settlements. Licensee may participate
in (but not control) the defense of any such Product Liability Claim, but
at its
own expense. Licensee shall comply with all reasonable requests from Cellegy
for
information, materials or assistance, with respect to the conduct of such
defense at Cellegy's expense. Cellegy shall be responsible for payment
of all
Product Liability Claims. Nothing in this Article shall be construed as
requiring Cellegy to conduct and/or assume Licensee's independent defense
against any claim or action, if such claim or action involves the independent
conduct, acts or omissions of Licensee for Product Liability Claims or
actions
brought with respect to the manufacture or supply of the Licensed
Product.
29
14.4 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.
14.5 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
manufacture, importation, storage, Development, promotion, marketing,
distribution or sale of the Licensed Product based on action or inaction
of
Cellegy;
(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 breach by Cellegy of any representation or warranty
given
in this Agreement.
(b) 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
manufacture, 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
30
(iv) any
breach by Licensee of any representation or warranty given in this
Agreement.
(c) Licensee
shall give Cellegy written notice (a “Notice
of Claim”)
promptly after Licensee becomes aware of the assertion, whether orally
or in
writing, of a Claim brought by a Third Party (in each such case, a “Third-Party
Claim”)
that
may require indemnification pursuant to this Agreement. Each Notice of
Claim by
a party hereunder will contain the following information:
(i) that
the
Person has incurred, paid or accrued or, in good faith, believes it will
have to
incur, pay or accrue, Losses and, if reasonably determinable at the time,
a good
faith estimate of the aggregate amount of Losses arising from such Claim
(which
amount may be the amount of damages claimed by a third party in the Claim);
and
(ii) A
BRIEF
DESCRIPTION, IN REASONABLE DETAIL (TO THE EXTENT REASONABLY AVAILABLE TO
THE
PARTY), OF THE FACTS, CIRCUMSTANCES OR EVENTS GIVING RISE TO THE ALLEGED
LOSSES
BASED ON THE PARTY’S GOOD FAITH BELIEF THEREOF, INCLUDING THE IDENTITY AND
ADDRESS OF ANY THIRD-PARTY CLAIMANT AND COPIES OF ANY FORMAL DEMAND OR
COMPLAINT, THE AMOUNT OF LOSSES, THE DATE EACH SUCH ITEM WAS INCURRED,
PAID OR
ACCRUED, OR THE BASIS FOR SUCH ANTICIPATED LIABILITY, AND THE SPECIFIC
NATURE OF
THE BREACH TO WHICH SUCH ITEM IS RELATED.
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.
31
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;
(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. Upon the execution of this Agreement, the Parties
shall
draft a joint press release, the text of such shall be mutually agreeable
to
each Party, announcing the execution of the Agreement.
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 Effective Date of this Agreement 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.
32
TERM;
TERMINATION
16.1 Term.
Unless
terminated sooner pursuant to this Article 16, this Agreement shall become
effective as of the Effective Date and shall continue in full force and
effect
in each country until the later of (i) the date of expiration of the last
to
expire of Licensee’s obligation to make royalty payments in a particular
country, or (ii) ten years from the Launch Date. For countries in which
none of
Cellegy’s Patents are filed, the Agreement shall terminate upon the date of the
last to expire of Cellegy’s Patents in the last applicable country. Such
termination may be made with respect to one or more countries of the Territory
without affecting the rest of this Agreement or the Exclusive License granted
hereunder in any other country of the Territory.
16.2 Bilateral
Termination Rights.
Either
Party may terminate this Agreement in whole or in part upon the occurrence
of
any of the following:
(a)
The
other Party becomes the subject of voluntary bankruptcy or insolvency case;
or
(b)
The
other Party 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 the other
Party,
if such material breach is not cured (if such default is capable of cure)
within
thirty (30) days after written notice thereof to the Party in
default.
16.3 Cellegy’s
Right to Terminate.
Cellegy
may terminate this Agreement with immediate effect upon written notice
to
Licensee if a Change in Control of Licensee shall occur, PROVIDED THAT
this
shall not apply in the case whereby Licensee or its Affiliates undergoes
an
initial public offering of its stock on a recognized stock exchange. Subject
to
the aforesaid provision, for purposes of this Article, a “Change
in Control”
means
(i) any reorganization, consolidation, merger, tender offer, purchase of
stock
or similar transaction or series of related transactions (each, a "combination
transaction")
in
which Licensee (or any direct or indirect parent entity of Licensee (a
“Parent”))
is a
constituent corporation or is a party if, as a result of such combination
transaction, the voting securities of Licensee (or any Parent) that are
outstanding immediately before the consummation of such combination transaction
(other than
any such
securities that are held by an "Acquiring Stockholder", as defined below)
do
not
represent, or are not converted into, securities of the surviving corporation
of
such combination transaction (or such surviving corporation’s parent or other
Affiliate) that, immediately after the consummation of such combination
transaction, together possess at least a majority of the total voting power
of
all outstanding securities of such surviving corporation (or its parent
or other
Affiliate, if applicable) that are outstanding immediately after the
consummation of such
combination transaction, including securities of such surviving corporation
(or
its parent or other Affiliate, if applicable) that are held by the Acquiring
Stockholder; or (ii) a sale of all or substantially all of the assets or
the
business of the Licensee (or any Parent), if, and only if, in each of the
above
cases, the acquiring entity (or its parent or other Affiliate) engages
in the
33
[*]
designates portions of this document that have been omitted pursuant to
a
request for confidential treatment filed separately with the
Commission
development,
distribution, or sale of Competing Licensed Products. For purposes of this
Article, an "Acquiring
Stockholder"
means a
stockholder or stockholders of the Licensee (or any Parent) that (i) merges
or
combines with the Licensee (or any Parent) in such combination transaction
or
(ii) owns or controls a majority of another corporation that merges or
combines with the Licensee (or Parent) in such combination transaction.
Licensee
agrees to use its Commercially Reasonable and Diligent Efforts to notify
Cellegy
at least thirty (30) days before any such Change in Control.
16.4 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 Approval is not obtained by Cellegy in Sweden; (iii) immediately
on
written notice if Approvals is not obtained, through no fault of Licensee,
in
all Major European Countries within [*] of MRP being initiated; (iv) on
one (1)
year’s 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 (v) immediately upon written
notice
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 sixty
(60)
consecutive days, or (B) is not being challenged by either Party pursuant
to
Article 14 in relation to such country.
16.5 Rights
Upon Termination or Expiration.
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, upon and following the
Termination Date:
(a) Licensee
shall not be relieved of its obligation to (i) pay for Licensed Product
delivered by Cellegy prior to the Termination Date, or (ii) accept and
pay for
all Licensed Product covered by orders received and accepted by Cellegy
prior to
the Termination Date. Cellegy shall be obligated to complete all orders
received
and accepted prior to the Termination Date, provided that Cellegy receives
reasonable assurance of payment. In each such case, 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.
34
(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.
(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;
35
(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; and
(g) Cellegy
shall have the right to repurchase all then-current inventory of the Licensed
Product then in Licensee’s possession, at the landed cost paid by Licensee for
such inventory (including delivery, insurance and any applicable import/export
taxes paid thereon).
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. NOTHWITHSTANDING 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.
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.
36
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.
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
|
37
[*]
designates portions of this document that have been omitted pursuant to
a
request for confidential treatment filed separately with the
Commission
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; 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 [*], the Agreement dated [*],
and the
Addendum dated [*] between the Parties and the Confidentiality Agreement
described at Section 15.6. 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.
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.
38
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, 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 Pennsylvania, 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:
(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.
39
(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.
40
[*]
designates portions of this document that have been omitted pursuant to
a
request for confidential treatment filed separately with the
Commission
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
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 Limited 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
F.
[Remainder
of this page intentionally left blank]
41
IN
WITNESS HEREOF, the parties have executed this Agreement as of the Agreement
Date.
STRAKAN
INTERNATIONAL LIMITED
By:
Its: ____________________________
ProStrakan
Group plc, only as to
Section
18.18 and the Guarantee
By_____________________________
Its:
_____________________________
|
CELLEGY
PHARMACEUTICALS, INC.
By:
Its: _____________________________
|
42
[*]
designates portions of this document that have been omitted pursuant to
a
request for confidential treatment filed separately with the
Commission
EXHIBIT
A
LICENSED
PRODUCT
[*]
gram
metered dosing canister.
[*]
gram
metered dosing canister.
A
EXHIBIT
B
COUNTRIES
IN THE TERRITORY
TERRITORIES
1.
Europe
|
1.
Europe (continued)
|
Andorra
|
Slovak
Republic
|
Albania
|
Slovenia
|
Austria
|
Spain
|
Belgium
|
Sweden
|
Bosnia-Herzegovina
|
Switzerland
|
Bulgaria
|
Turkey
|
Croatia
|
United
Kingdom
|
Cyprus
|
Republic
of Yugoslavia
|
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
|
B
[*]
designates portions of this document that have been omitted pursuant to
a
request for confidential treatment filed separately with the
Commission
EXHIBIT
C
MINIMUM
SALES REQUIREMENTS
[*]
C
EXHIBIT
D
PATENTS
RIGHTS
“Cellegy
Patents”
WO
99/24041 - Entitled ‘Penetration enhancing and irritation reducing systems,
including improvements thereto, relating to the Licensed Product in the
Field
and Territory.
Country
|
Application
No.
|
Filing
Date
|
Patent
or
Publication No.
|
Issue/Pub
Date
|
Status
|
Europe:
AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, IT, LU, MC, NL,
PT,
SE*
|
98956663.3
|
11/09/98
|
Pub.
No. EP 1030668A1
|
Pub.
8/30/00
|
Pending
|
Norway
|
20002422
|
11/09/98
|
XXX
|
XXX
|
Xxxxxxx
|
XXX
|
XXX/XX00/00000
|
11/09/98
|
WO
99/24041
|
5/20/99
|
National
Phase
|
D
EXHIBIT
E
CELLEGY
MARKS
Name
|
Status
|
Country
|
Registration
Date
|
Renewal
|
Tostrex
|
Registered
as EU community xxxx
|
Austria
|
6/20/2003
|
1/21/2012
|
Tostrex
|
Registered
as EU community xxxx
|
Belgium
|
6/20/2003
|
1/21/2012
|
Tostrex
|
Registered
as EU community xxxx
|
Cyprus
|
6/20/2003
|
1/21/2012
|
Tostrex
|
Registered
as EU community xxxx
|
Czech
Republic
|
6/20/2003
|
1/21/2012
|
Tostrex
|
Registered
as EU community xxxx
|
Denmark
|
6/20/2003
|
1/21/2012
|
Tostrex
|
Registered
as EU community xxxx
|
Estonia
|
6/20/2003
|
1/21/2012
|
Tostrex
|
Registered
as EU community xxxx
|
Finland
|
6/20/2003
|
1/21/2012
|
Tostrex
|
Registered
as EU community xxxx
|
France
|
6/20/2003
|
1/21/2012
|
Tostrex
|
Registered
as EU community xxxx
|
Germany
|
6/20/2003
|
1/21/2012
|
Tostrex
|
Registered
as EU community xxxx
|
Greece
|
6/20/2003
|
1/21/2012
|
Tostrex
|
Registered
as EU community xxxx
|
Hungary
|
6/20/2003
|
1/21/2012
|
Tostrex
|
Registered
as EU community xxxx
|
Xxxxxxx
|
6/20/2003
|
1/21/2012
|
Tostrex
|
Registered
as EU community xxxx
|
Italy
|
6/20/2003
|
1/21/2012
|
Tostrex
|
Registered
as EU community xxxx
|
Latvia
|
6/20/2003
|
1/21/2012
|
Tostrex
|
Registered
as EU community xxxx
|
Liechtenstein
|
6/20/2003
|
1/21/2012
|
Tostrex
|
Registered
as EU community xxxx
|
Lithuania
|
6/20/2003
|
1/21/2012
|
Tostrex
|
Registered
as EU community xxxx
|
Xxxxxxxxx
|
6/20/2003
|
1/21/2012
|
Tostrex
|
Registered
as EU community xxxx
|
Malta
|
6/20/2003
|
1/21/2012
|
Tostrex
|
Registered
as EU community xxxx
|
Netherlands
|
6/20/2003
|
1/21/2012
|
Tostrex
|
Registered
as EU community xxxx
|
Norway
|
6/20/2003
|
1/21/2012
|
E-1
Name
|
Status
|
Country
|
Registration
Date
|
Renewal
|
Tostrex
|
Registered
as EU community xxxx
|
Xxxxxx
|
6/20/2003
|
1/21/2012
|
Tostrex
|
Registered
as EU community xxxx
|
Xxxxxxxx
|
6/20/2003
|
1/21/2012
|
Tostrex
|
Registered
as EU community xxxx
|
Romania
|
6/20/2003
|
1/21/2012
|
Tostrex
|
Registered
as EU community xxxx
|
Slovak
Republic
|
6/20/2003
|
1/21/2012
|
Tostrex
|
Registered
as EU community xxxx
|
Slovenia
|
6/20/2003
|
1/21/2012
|
Tostrex
|
Registered
as EU community xxxx
|
Xxxxx
|
6/20/2003
|
1/21/2012
|
Tostrex
|
Registered
as EU community xxxx
|
Sweden
|
6/20/2003
|
1/21/2012
|
Tostrex
|
Registered
as EU community xxxx
|
United
Kingdom
|
6/20/2003
|
1/21/2012
|
Tostrex
|
Registered
|
Switzerland
|
1/22/2002
|
1/22/2012
|
Tostrex
|
No
application pending
|
Andorra
|
-
|
-
|
Tostrex
|
No
application pending
|
Albania
|
-
|
-
|
Tostrex
|
No
application pending
|
Bosnia-Herzegovina
|
-
|
-
|
Tostrex
|
No
application pending
|
Bulgaria
|
-
|
-
|
Tostrex
|
No
application pending
|
Croatia
|
-
|
-
|
Tostrex
|
No
application pending
|
Gibraltar
|
-
|
-
|
Tostrex
|
No
application pending
|
Republic
of Yugoslavia
|
-
|
-
|
Tostrex
|
No
application pending
|
Republic
of Macedonia
|
-
|
-
|
Tostrex
|
No
application pending
|
Monaco
|
-
|
-
|
Name
|
Status
|
Country
|
Registration
Date
|
Renewal
|
Tostran
|
Registered
as EU community xxxx
|
Austria
|
2/4/2004
|
5/102012
|
Tostran
|
Registered
as EU community xxxx
|
Belgium
|
2/4/2004
|
5/102012
|
E-2
Name
|
Status
|
Country
|
Registration
Date
|
Renewal
|
Tostran
|
Registered
as EU community xxxx
|
Cyprus
|
2/4/2004
|
5/102012
|
Tostran
|
Registered
as EU community xxxx
|
Czech
Republic
|
2/4/2004
|
5/102012
|
Tostran
|
Registered
as EU community xxxx
|
Denmark
|
2/4/2004
|
5/102012
|
Tostran
|
Registered
as EU community xxxx
|
Estonia
|
2/4/2004
|
5/102012
|
Tostran
|
Registered
as EU community xxxx
|
Finland
|
2/4/2004
|
5/102012
|
Tostran
|
Registered
as EU community xxxx
|
France
|
2/4/2004
|
5/102012
|
Tostran
|
Registered
as EU community xxxx
|
Germany
|
2/4/2004
|
5/102012
|
Tostran
|
Registered
as EU community xxxx
|
Greece
|
2/4/2004
|
5/102012
|
Tostran
|
Registered
as EU community xxxx
|
Hungary
|
2/4/2004
|
5/102012
|
Tostran
|
Registered
as EU community xxxx
|
Xxxxxxx
|
2/4/2004
|
5/102012
|
Tostran
|
Registered
as EU community xxxx
|
Italy
|
2/4/2004
|
5/102012
|
Tostran
|
Registered
as EU community xxxx
|
Latvia
|
2/4/2004
|
5/102012
|
Tostran
|
Registered
as EU community xxxx
|
Liechtenstein
|
2/4/2004
|
5/102012
|
Tostran
|
Registered
as EU community xxxx
|
Lithuania
|
2/4/2004
|
5/102012
|
Tostran
|
Registered
as EU community xxxx
|
Xxxxxxxxx
|
2/4/2004
|
5/102012
|
Tostran
|
Registered
as EU community xxxx
|
Malta
|
2/4/2004
|
5/102012
|
Tostran
|
Registered
as EU community xxxx
|
Netherlands
|
2/4/2004
|
5/102012
|
Tostran
|
Registered
as EU community xxxx
|
Norway
|
2/4/2004
|
5/102012
|
Tostran
|
Registered
as EU community xxxx
|
Xxxxxx
|
2/4/2004
|
5/102012
|
Tostran
|
Registered
as EU community xxxx
|
Xxxxxxxx
|
2/4/2004
|
5/102012
|
Tostran
|
Registered
as EU community xxxx
|
Romania
|
2/4/2004
|
5/102012
|
Tostran
|
Registered
as EU community xxxx
|
Slovak
Republic
|
2/4/2004
|
5/102012
|
Tostran
|
Registered
as EU community xxxx
|
Slovenia
|
2/4/2004
|
5/102012
|
E-3
Name
|
Status
|
Country
|
Registration
Date
|
Renewal
|
Tostran
|
Registered
as EU community xxxx
|
Xxxxx
|
2/4/2004
|
5/102012
|
Tostran
|
Registered
as EU community xxxx
|
Sweden
|
2/4/2004
|
5/102012
|
Tostran
|
Registered
as EU community xxxx
|
United
Kingdom
|
2/4/2004
|
5/102012
|
Tostran
|
Registered
|
Switzerland
|
9/3/2002
|
5/3/2012
|
Tostran
|
No
application pending
|
Andorra
|
-
|
-
|
Tostran
|
No
application pending
|
Albania
|
-
|
-
|
Tostran
|
No
application pending
|
Bosnia-Herzegovina
|
-
|
-
|
Tostran
|
No
application pending
|
Bulgaria
|
-
|
-
|
Tostran
|
No
application pending
|
Croatia
|
-
|
-
|
Tostran
|
No
application pending
|
Gibraltar
|
-
|
-
|
Tostran
|
No
application pending
|
Republic
of Yugoslavia
|
-
|
-
|
Tostran
|
No
application pending
|
Republic
of Macedonia
|
-
|
-
|
Tostran
|
No
application pending
|
Monaco
|
-
|
-
|
Name
|
Status
|
Country
|
Registration
Date
|
Renewal
|
Fortigel
|
Pending
approval
|
Austria
|
4/28/2003
|
Unknown
|
Fortigel
|
Pending
approval
|
Belgium
|
4/28/2003
|
Unknown
|
Fortigel
|
Pending
approval
|
Cyprus
|
4/28/2003
|
Unknown
|
Fortigel
|
Pending
approval
|
Czech
Republic
|
4/28/2003
|
Unknown
|
Fortigel
|
Pending
approval
|
Denmark
|
4/28/2003
|
Unknown
|
Fortigel
|
Pending
approval
|
Estonia
|
4/28/2003
|
Unknown
|
Fortigel
|
Pending
approval
|
Finland
|
4/28/2003
|
Unknown
|
Fortigel
|
Pending
approval
|
France
|
4/28/2003
|
Unknown
|
Fortigel
|
Pending
approval
|
Germany
|
4/28/2003
|
Unknown
|
E-4
Name
|
Status
|
Country
|
Registration
Date
|
Renewal
|
Fortigel
|
Pending
approval
|
Greece
|
4/28/2003
|
Unknown
|
Fortigel
|
Pending
approval
|
Hungary
|
4/28/2003
|
Unknown
|
Fortigel
|
Pending
approval
|
Ireland
|
4/28/2003
|
Unknown
|
Fortigel
|
Pending
approval
|
Italy
|
4/28/2003
|
Unknown
|
Fortigel
|
Pending
approval
|
Latvia
|
4/28/2003
|
Unknown
|
Fortigel
|
Pending
approval
|
Liechtenstein
|
4/28/2003
|
Unknown
|
Fortigel
|
Pending
approval
|
Lithuania
|
4/28/2003
|
Unknown
|
Fortigel
|
Pending
approval
|
Luxemburg
|
4/28/2003
|
Unknown
|
Fortigel
|
Pending
approval
|
Malta
|
4/28/2003
|
Unknown
|
Fortigel
|
Pending
approval
|
Netherlands
|
4/28/2003
|
Unknown
|
Fortigel
|
Pending
approval
|
Norway
|
4/28/2003
|
Unknown
|
Fortigel
|
Pending
approval
|
Poland
|
4/28/2003
|
Unknown
|
Fortigel
|
Pending
approval
|
Portugal
|
4/28/2003
|
Unknown
|
Fortigel
|
Pending
approval
|
Romania
|
4/28/2003
|
Unknown
|
Fortigel
|
Pending
approval
|
Slovak
Republic
|
4/28/2003
|
Unknown
|
Fortigel
|
Pending
approval
|
Slovenia
|
4/28/2003
|
Unknown
|
Fortigel
|
Pending
approval
|
Spain
|
4/28/2003
|
Unknown
|
Fortigel
|
Pending
approval
|
Sweden
|
4/28/2003
|
Unknown
|
Fortigel
|
Pending
approval
|
United
Kingdom
|
4/28/2003
|
Unknown
|
Fortigel
|
No
application pending
|
Switzerland
|
-
|
-
|
Fortigel
|
No
application pending
|
Andorra
|
-
|
-
|
Fortigel
|
No
application pending
|
Albania
|
-
|
-
|
Fortigel
|
No
application pending
|
Bosnia-Herzegovina
|
-
|
-
|
Fortigel
|
No
application pending
|
Bulgaria
|
-
|
-
|
E-5
Name
|
Status
|
Country
|
Registration
Date
|
Renewal
|
Fortigel
|
No
application pending
|
Croatia
|
-
|
-
|
Fortigel
|
No
application pending
|
Gibraltar
|
-
|
-
|
Fortigel
|
No
application pending
|
Republic
of Yugoslavia
|
-
|
-
|
Fortigel
|
No
application pending
|
Republic
of Macedonia
|
-
|
-
|
Fortigel
|
No
application pending
|
Monaco
|
-
|
-
|
E-6
EXHIBIT
F
STRAKAN
GROUP LIMITED 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.
F
EXHIBIT
G
ADVERSE
EVENT REPORTING
G