<PAGE>
Exhibit 10(aa)
Note: Certain portions of this document have been marked "[C.I.]"
to indicate
that confidential treatment has been requested for this
confidential
information. The confidential portions have been omitted and filed
separately
with the Securities and Exchange Commission.
MARKETING, DISTRIBUTION AND SUPPLY AGREEMENT
BETWEEN
DUSA PHARMACEUTICALS, INC.
AND
STIEFEL LABORATORIES, INC.
DATED
JANUARY 12, 2006
<PAGE>
Note: Certain portions of this document have been marked "[C.I.]"
to indicate
that confidential treatment has been requested for this
confidential
information. The confidential portions have been omitted and filed
separately
with the Securities and Exchange Commission.
MARKETING, DISTRIBUTION AND SUPPLY AGREEMENT made as of the 12th
day of
January 2006 (the "EFFECTIVE DATE") between DUSA PHARMACEUTICALS,
INC., a New
Jersey corporation having a principal office and place of business
at 25 Upton
Drive, Wilmington, Massachusetts, USA 01887 (hereinafter called
"DUSA") and
STIEFEL LABORATORIES, INC., a Delaware corporation having a
principal office and
place of business at 255 Alhambra Circle, Suite 1000, Coral Gables,
Florida, USA
33134 (hereinafter called "STIEFEL").
WHEREAS, DUSA is engaged in the development, manufacture and sale
of
pharmaceutical products and wishes to market certain of its
products in the
Territory (as such term is defined below);
WHEREAS, STIEFEL is a pharmaceutical company that distributes and
sells
pharmaceutical products in the Territory and desires to obtain an
exclusive
right to, distribute, promote, and sell in the Territory the
Products as such
term is defined manufactured by DUSA;
WHEREAS, DUSA has agreed, subject to the terms and conditions of
the
Agreement, to grant STIEFEL an exclusive right to distribute,
promote, and sell
such Product in the Territory and to manufacture and supply to
STIEFEL on an
exclusive basis in the Territory all of STIEFEL's reasonable
requirements of the
Product;
WHEREAS, STIEFEL has agreed to undertake the distribution,
promotion, and
sale of such Products in the Territory, and will purchase the
Product
exclusively from DUSA in accordance with the terms and conditions
of this
Agreement; and
WHEREAS, the Parties also wish to memorialize the understanding
between
them with respect to DUSA's grant to STIEFEL of a license to use
the DUSA
Trademarks on the DUSA labeled Products in connection with the
marketing and
sale of the Product in the Territory under the terms and conditions
of the
Agreement.
NOW,
THEREFORE, the Parties agree as follows:
1.
DEFINITIONS.
For
the purposes of this Agreement, capitalized terms used but not
otherwise defined in this Agreement shall have the meanings set
forth in this
Section 1:
1.1
"AFFILIATES" shall mean any Person (defined below) which directly
or
indirectly controls, is controlled by, or under common control with
a Party to
this Agreement. For purposes of the foregoing definition, the term
"control"
(including with correlative meaning, the terms "controlling",
"controlled by",
and "under common control with") as used with respect to any
Person, shall mean
(i) in the case of corporate entities, direct or indirect ownership
of at least
[C.I.] percent ([C.I.]%) of the stock or shares entitled to vote
for the
election of directors; and (ii) in the case of non-corporate
entities, direct or
indirect ownership of at least [C.I.] percent ([C.I.]%) of the
equity interest
or the possession, directly or indirectly, of the power to direct
or cause the
<PAGE>
Note: Certain portions of this document have been marked "[C.I.]"
to indicate
that confidential treatment has been requested for this
confidential
information. The confidential portions have been omitted and filed
separately
with the Securities and Exchange Commission.
direction of the management and policies of such Person, whether
through
ownership of voting securities, by contract, or otherwise.
1.2
"APPLICABLE LAWS" shall mean all applicable laws, statutes,
rules,
regulations and guidelines that may apply to the sale of the
Product in the
Territory or the promotion, marketing, packaging, labeling,
importation,
exportation, warehousing or distribution of a Product that is to be
sold in the
Territory or the performance of either Party's obligations under
this Agreement,
and including all good manufacturing practices and all applicable
standards or
guidelines promulgated by the appropriate Regulatory Authority.
1.3
"APPROVED PRICE" shall mean the [C.I.] price per unit to STIEFEL
[C.I.]
for the sale of the Product in Brazil excluding up to [C.I.]
Percent ([C.I.]%)
in government sales taxes actually paid by STIEFEL on units of the
Product sold.
1.4
"APPROVED PRODUCT" shall mean any Product that shall have been
granted
all necessary approvals by the required Regulatory Authorities to
allow DUSA
and/or Stiefel, as the case may be, the right to sell and
distribute, promote,
and sell the Product in any country in the Territory.
1.5
"BATCH", with respect to any of the Product, shall mean a separate
and
distinct quantity of such Product processed under continuous and
identical
conditions and designated by a batch number.
1.6
"CERTIFICATE OF CONFORMANCE" shall mean a document, which is dated
and
signed by a duly authorized representative of the Quality Control
or Quality
Assurance Department of DUSA, certifying that a Batch of any
Product meets all
Specifications.
1.7
"COMMERCIALLY REASONABLE EFFORTS" mean the channels, methods
and
diligence that a Party employs with respect to other products sold
by it
(including its own products) of the same or similar commercial
potential.
1.8
"COMPETING PRODUCTS" means the products identified on Schedule
A
attached hereto as Competing Products.
1.9
"CONFIDENTIAL INFORMATION" means with respect to a Party, all
information of any kind whatsoever (including without limitation,
data,
compilations, formulae, models, patent disclosures, procedures,
processes,
projections, protocols, results of experimentation and testing,
specifications,
strategies, techniques, business and financial information,
projections,
customer lists, and all non-public intellectual property rights,
and all
tangible and intangible embodiments thereof of any kind whatsoever
(including
without limitation, apparatus, compositions, documents, drawings,
machinery,
patent applications, records and reports), and all business
information,
financial data, projections, customer lists which is disclosed by
such Party to
the other Party.
1.10
"DOMAIN NAMES AND WEBSITES" shall mean those domain names and
website
agreed upon by the Parties through which the Products shall be
marketed by
STIEFEL hereunder.
<PAGE>
Note: Certain portions of this document have been marked "[C.I.]"
to indicate
that confidential treatment has been requested for this
confidential
information. The confidential portions have been omitted and filed
separately
with the Securities and Exchange Commission.
1.11
"FDA" shall mean the U.S. Food and Drug Administration, or any
successor body.
1.12
"FD&C ACT" means the Federal Food, Drug and Cosmetic Act of
1938, as
amended and the regulations thereunder, as the same may be amended
or revised.
1.13
"FIELD" shall mean [C.I.] uses of the Products for dermatology
indications.
1.14
"FIRST APPROVAL DATE" shall mean the date on which DUSA first
obtains
approval to market a Product from a Regulatory Authority in the
Territory.
1.15
"FISCAL YEAR" shall mean the twelve-month period commencing on
January
1st of each year and ending on December 31st, or any other
twelve-month period
designated as the fiscal year of STIEFEL.
1.16
"GMP" shall mean good manufacturing practices as required by the
rules
and regulations of the applicable Regulatory Authority.
1.17 "GROSS-UP" shall
have the meaning set forth in Section 7.2(a).
1.18
"INDEMNIFIED PARTY" shall have the meaning set forth in Section
14.3(a).
1.19
"INDEMNIFYING PARTY" shall have the meaning set forth in Section
14.3
(a).
1.20
"INDEPENDENT LABORATORY" shall have the meaning set forth in
Section
9.4.
1.21
"LAUNCH DATE", as to each Approved Product, shall mean that date
on
which marketing and distribution of such Approved Product shall
commence in a
given country in the Territory.
1.22
"LAUNCH NOTICE" shall have the meaning set forth in Section
7.3(a).
1.23
"MINIMUM PURCHASE OBLIGATIONS" shall have the meaning set forth
in
Section 7.2(a).
1.24
"OBJECTION NOTICE" shall have the meaning set forth in Section
9.4.
1.25
"PARTY" means STIEFEL and DUSA, individually, and "PARTIES"
means
STIEFEL and DUSA, collectively.
1.26
[C.I.] shall have the meaning set forth on Schedule C attached
hereto.
1.27
"PERSON" shall mean an individual, corporation, partnership,
limited
liability company, firm, association, joint venture, estate, trust,
governmental
or administrative body or agency, or any other entity.
1.28
"PRICING APPROVAL" shall mean STIEFEL's receipt from CMED of
Registration of the [C.I.] price allowed to market and sell the
Product in
Brazil within the time period stated in Section 2.4 below, at a
price of not
less than [C.I.] Brazilian Reals (Brazilian Reals [C.I.]) per
unit
<PAGE>
Note: Certain portions of this document have been marked "[C.I.]"
to indicate
that confidential treatment has been requested for this
confidential
information. The confidential portions have been omitted and filed
separately
with the Securities and Exchange Commission.
including [C.I.] ([C.I.]%) government taxes (i.e.Net per unit to
STIEFEL is
[C.I.] Brazilian Reals (Brazilian Reals [C.I.])).
1.29
"PRODUCT" shall mean the product set forth on Schedule A.
1.30
"PRODUCT ALLIANCE MANAGER" shall have the meaning set forth in
Section
5.1.
1.31
"PURCHASE PRICE PER UNIT" shall have the meaning set forth on
Schedule
C attached hereto.
1.32
"REGISTRATION" means the regulatory approvals of any applicable
Regulatory Authorities issued in DUSA's name and necessary to
permit the
commencement of the marketing and sale of the Product in any
country in the
Territory.
1.33
"REGULATORY AUTHORITY" means any and all bodies and
organizations
regulating the manufacture, importation, distribution, use and sale
of the
Product in any country in the Territory.
1.34 "REPORT" shall
have the meaning set forth in Section 9.4.
1.35
"SPECIFICATIONS" of Product means the specifications for the
Product
as approved by the FDA. The Specifications may be amended from time
to time by
[C.I.] and as specifically requested by applicable Regulatory
Authorities.
1.36
"DUSA'S TRADEMARKS" shall mean the DUSA Trademarks set forth on
Schedule A hereto, as such Schedule may be amended from time to
time by mutual
agreement of the parties.
1.37
"TECHNICAL INFORMATION" shall mean the manufacturing process and
any
and all technical knowledge, trade secrets, analytical methodology,
processes,
manufacturing and toxicological information, and any and all other
technical
information or experience related to the manufacturing of the
Product.
1.38
"TERM" shall have the meaning set forth in Section 18.1.
1.39
"TERRITORY" shall mean all countries of the Western Hemisphere
from
south of and including Mexico, and all other countries located in
the Caribbean
excluding US territories.
1.40
"THIRD PARTY" means any party other than DUSA, STIEFEL or their
respective Affiliates.
1.41
"THIRD PARTY LOSS" shall have the meaning set forth in Section
14.1.
1.42
"TRADEMARK INFRINGEMENT CLAIMS" shall have the meaning set forth
in
Section 3.3(a).
<PAGE>
Note: Certain portions of this document have been marked "[C.I.]"
to indicate
that confidential treatment has been requested for this
confidential
information. The confidential portions have been omitted and filed
separately
with the Securities and Exchange Commission.
2. DISTRIBUTION,
MARKETING AND PROMOTION.
2.1
Appointment. During the Term and subject to Sections 2.2(b) and
7.1(a)(i), DUSA hereby appoints STIEFEL as its exclusive
distributor for the
Product in the Field in the Territory and STIEFEL hereby accepts
such
appointment. Pursuant to this appointment, STIEFEL shall have the
exclusive
right to import in finished package form, distribute, promote and
sell the
Product in the Field in the Territory subject to the terms and
conditions of
this Agreement.
2.2
Marketing and Promotion Efforts.
(a) STIEFEL shall use its Commercially Reasonable Efforts to
vigorously distribute, sell and promote the sale of the Product in
the Field
within and throughout the Territory [C.I.], so as to maximize sales
in each
country in the Territory, beginning [C.I.] after the date of this
Agreement,
provided that in the event that STIEFEL is legally prohibited from
selling the
Product until Registration for the Product is obtained, then
STIEFEL shall begin
distribution and promotion of the Product no later than [C.I.]
([C.I.]) days
after Pricing Approval for the Product is obtained.
(b) STIEFEL shall be deemed to have commenced the marketing of
the
Product in a country within the Territory [C.I.] when it shall have
offered such
Product [C.I.]. If STIEFEL does not begin marketing and promotion
of the Product
in a country within the Territory within [C.I.] ([C.I.]) days after
receipt of
all necessary government approvals to market the Product in such
country, in
addition to any other remedies available to DUSA hereunder or under
law or in
equity, DUSA may, in its sole discretion [C.I.] of such Product in
such country.
(c) STIEFEL shall provide DUSA as reasonably requested by DUSA on
a
[C.I.] basis: (1) [C.I.], as reasonably requested by DUSA for
purposes of DUSA's
[C.I.] within the Territory, (2) a summary of the [C.I.] of the
Product held by
STIEFEL at the end of such [C.I.] and (3) a report of [C.I.] of the
Product sold
by STIEFEL as requested by DUSA, including to comply with
applicable laws. The
Parties will mutually agree on the form(s) of reports, information
to be
contained therein and the timing of such reports regarding [C.I.]
within [C.I.]
([C.I.]) days of the Effective Date, and such agreed upon items
shall be
attached to this Agreement as a Schedule D.
(d) STIEFEL shall, [C.I.], use its Commercially Reasonable Efforts
to
distribute, promote, and sell the Product for use [C.I.], as
appropriate in the
Territory, in compliance with Applicable Laws and good commercial
practice
(including, but not limited to proper shipping and storage).
(e) STIEFEL will not (and will ensure that its subdistributors,
if
any, do not) enter into any [C.I.] for the Product with its
customers, including
but not limited to [C.I.], that contain terms that exceed or are
otherwise
inconsistent with the terms of this Agreement (including but not
limited to
[C.I.] that exceed the term of this Agreement), without receiving
DUSA's written
approval, which may be withheld in its sole discretion, before
entering into
such agreement.
<PAGE>
Note: Certain portions of this document have been marked "[C.I.]"
to indicate
that confidential treatment has been requested for this
confidential
information. The confidential portions have been omitted and filed
separately
with the Securities and Exchange Commission.
(f) STIEFEL shall purchase all Product needed in pre-marketing
efforts
from DUSA at the Purchase Price Per Unit; provided with respect to
pre-marketing
in Brazil, during the time that the Pricing Approval has not yet
been received,
STIEFEL shall purchase Product needed in pre-marketing efforts in
Brazil from
DUSA at [C.I.] U.S. Dollars (U.S. $[C.I.]) per unit.
(g) Prior to STIEFEL marketing, promoting, distributing or selling
a
Product in the Territory, DUSA shall [C.I.] for the Product for
STIEFEL's
trainers, at [C.I.]. The [C.I.] shall use [C.I.] provided by DUSA
and be limited
only to provide medical information regarding the safety and
efficacy of the
Product in question [c.i.] the Products should be marketed,
promoted,
distributed or sold in the Territory. [C.I.] STIEFEL and its
personnel, sales
force or subdistributors, if any, regarding such medical
information regarding
the safety and efficacy and [C.I.], including without limitation
marketing and
promotion [C.I.], shall be the responsibility of [C.I.].
2.3
Restrictions.
(a) STIEFEL undertakes and agrees that it will not [C.I.] directly
or
indirectly [C.I.] the Product [C.I.] nor [C.I.] for the Product
knowing that
such [C.I.].
(b) Except as permitted pursuant to Section 2.5 below, during the
term
of this Agreement, STIEFEL shall not, nor shall it aid or
facilitate [C.I.] to,
market, promote, sell, offer for sale, distribute or otherwise make
the Product
available [C.I.], except as supplied to STIEFEL by DUSA, [C.I.] in
the
Territory.
(c) STIEFEL warrants to DUSA that STIEFEL does not currently
represent
or promote [C.I.]. During the term of this Agreement, STIEFEL shall
not, nor
shall it aid or facilitate any Third Party to, market, promote,
sell, offer for
sale, distribute or otherwise make available [C.I.] to any person
in the
Territory.
2.4
Milestone Payments; Rights of Termination Relating to Pricing
Approval.
(a) Pricing Approval Milestone Payment. Within [C.I.] ([C.I.]) days
of
STIEFEL's receipt of the Pricing Approval, STIEFEL shall make a
[C.I.], [C.I.]
payment of [C.I.] U.S. Dollars (U.S. $[C.I.]) to DUSA.
(b) First Units Shipped Milestone Payment. Within [C.I.] ([C.I.])
days
following the total cumulative number of units of Product ordered
hereunder by
STIEFEL and shipped by DUSA to STIEFEL exceeding [C.I.] ([c.i.])
units, STIEFEL
shall make a [C.I.], [C.I.] payment of [C.I.] U.S. Dollars (U.S.
$[C.I.]) to
DUSA.
(c) Second Units Shipped Milestone Payment. Within [C.I.]
([C.I.])
days following the total cumulative number of units of Product
ordered hereunder
by STIEFEL and shipped by DUSA to STIEFEL exceeding [C.I.] ([c.i.])
units,
STIEFEL shall make a [C.I.], [C.I.] payment of [C.I.] U.S. Dollars
(U.S.
$[C.I.]) to DUSA.
(d) STIEFEL Right of Termination. If STIEFEL does not receive
the
Pricing Approval and STIEFEL wishes to terminate the Agreement,
STIEFEL must
give DUSA notice
<PAGE>
Note: Certain portions of this document have been marked "[C.I.]"
to indicate
that confidential treatment has been requested for this
confidential
information. The confidential portions have been omitted and filed
separately
with the Securities and Exchange Commission.
of such termination within [C.I.] ([C.I.]) days of either (i)
receiving a
pricing approval not meeting the conditions of the Pricing Approval
(as defined
in Section 1.21), or (ii) failing to receive any approval within
[C.I.] ([C.I.])
days of Registration; provided, however that STIEFEL shall not have
such right
to terminate if negotiations with CMED are on-going and DUSA and
STIEFEL
mutually agree, in writing, to extend such [C.I.] ([C.I.]) day
period. In the
event STIEFEL elects to terminate this Agreement, in addition to
other effects
of termination set forth herein, STIEFEL shall maintain any
Registration for the
Product, [C.I.], until DUSA is able to [C.I.].
(e) DUSA Right of Termination. If STIEFEL fails receive any
approval
from CMED within [C.I.] ([C.I.]) days of Registration, DUSA may
elect to
terminate this Agreement provided, however that DUSA shall not have
such right
to terminate if negotiations with CMED are on-going and DUSA and
STIEFEL
mutually agree, in writing, to extend such [C.I.] ([C.I.]) day
period. In such
event, in addition to other effects of termination set forth
herein, (i) STIEFEL
shall maintain any Registration for the Product, [C.I.], until DUSA
is able to
[C.I.], and (ii) STIEFEL shall be [C.I.] for any Product and [C.I.]
ordered from
DUSA on purchase orders submitted to DUSA prior to the date of
termination.
2.5
Sub-Distributor.
(a) Upon prior written notice to DUSA, STIEFEL shall have the right
to
appoint any sub-distributor to distribute, market, promote and/or
sell the
Product within the Territory. The appointment of any
sub-distributor shall be in
writing and on such terms and conditions as STIEFEL may reasonably
require in
writing provided such terms and conditions are not inconsistent
with the terms
and conditions of this Agreement. STIEFEL shall provide DUSA with
complete,
unredacted copies of each agreement appointing a sub-distributor
hereunder.
(b) STIEFEL acknowledges and agrees that the appointment of a
sub-distributor hereunder shall not relieve STIEFEL of any of
STIEFEL's
obligations hereunder. STIEFEL further agrees that it shall, at all
times, be
solely responsible:
(i) for the acts, deeds or omissions of any sub-distributor
appointed pursuant to this Section 2.5; and
(ii) for the compensation or for the wages, salaries and
remunerations to any such sub-distributors or representatives,
without any cost
or liability to DUSA;
(c) Sales made by such sub-distributors shall be [C.I.] by STIEFEL
to
DUSA and such sub-distribution arrangements shall not [C.I.] to
DUSA in respect
of such sales (that is, the [C.I.] to DUSA in respect of such
Product sales
shall be [C.I.] if STIEFEL had made the sale itself).
(d) Each sub-distributor shall meet all obligations of STIEFEL
hereunder with respect to the activities undertaken by such
sub-distributor in
the distribution, marketing and sale of the Product, including
without
limitation adverse event reporting and use of trademarks.
<PAGE>
Note: Certain portions of this document have been marked "[C.I.]"
to indicate
that confidential treatment has been requested for this
confidential
information. The confidential portions have been omitted and filed
separately
with the Securities and Exchange Commission.
3. TRADEMARKS;
PRODUCT MARKING.
3.1
DUSA Trademarks.
(a) Ownership of DUSA Trademarks. STIEFEL shall use the DUSA
Trademarks set forth on Schedule A for the Product and the Domain
Names and
Websites to distribute, market, promote, sell, package and label
such Product
during the Term in accordance with the Applicable Laws of the
relevant
Regulatory Authority. STIEFEL acknowledges and agrees that DUSA
shall own all
right, title and interest in and to each of the DUSA Trademarks and
the Domain
Names and Websites. During the Term: (i) STIEFEL and its Affiliates
shall not
[c.i.] of the DUSA Trademarks or the Domain Names and Websites, and
agree that
no ownership rights are vested or created in any of the DUSA
Trademarks or the
Domain Names and Websites by virtue of any licenses and other
rights granted to
STIEFEL under this Agreement; and (ii) all use of the DUSA
Trademarks or the
Domain Names and Websites in the Territory during the Term, whether
in
combination with or apart from any Party's corporate name,
including any
goodwill generated in connection therewith, inures to the benefit
of DUSA, and
DUSA may call for a confirmatory assignment thereof.
(b) Use of DUSA Trademarks. Each Party shall use Commercially
Reasonable Efforts during the Term not to do any act which
endangers, destroys
or similarly affects, in any material respect, the value of the
goodwill
pertaining to the DUSA Trademarks. Further, except when used in
accordance with
any usage guidelines agreed to by DUSA or except when a use is
otherwise
approved in accordance with other provisions of this Agreement,
STIEFEL shall
submit to DUSA any materials bearing the DUSA Trademarks for review
and approval
prior to the use thereof.
(c) Costs. All costs of prosecuting and maintaining the DUSA
Trademarks shall be paid by [C.I.].
3.2
Other Proprietary Trademarks.
(a) Ownership of Corporate Names. Each Party shall retain all
right,
title and interest in and to its corporate names, and agrees that
it shall not
[C.I.] of such other Party's corporate names, or any registrations
issued or
issuing with respect thereto. Each Party expressly acknowledges and
agrees that
no ownership rights are vested or created by the limited rights of
use granted
under this Agreement, and that all use of the corporate names in
accordance
therewith, including any goodwill generated in connection
therewith, inures to
the benefit of the respective owner of the corporate names and the
owner of such
corporate names may call for a confirmatory assignment thereof.
(b) Use of Corporate Names. With respect to any corporate names
licensed to a Party under or in connection with this Agreement,
such Party
agrees to conform to the customary guidelines of the granting Party
with respect
to manner of use (as provided in writing by the owner of the
corporate name),
and to maintain the quality standards of such granting Party with
respect to the
goods sold and services provided in connection with such Party's
corporate
names. Each Party shall [C.I.] not to do any act which endangers,
destroys or
similarly affects the
<PAGE>
Note: Certain portions of this document have been marked "[C.I.]"
to indicate
that confidential treatment has been requested for this
confidential
information. The confidential portions have been omitted and filed
separately
with the Securities and Exchange Commission.
value of the goodwill pertaining to the other Party's corporate
names. Further,
except when used in accordance with any usage guidelines provided
by the owner
of a corporate name or a use is otherwise approved in accordance
with other
provisions of this Agreement, each Party shall submit to the other
Party any
materials bearing the other Party's corporate name for review and
approval prior
to the use thereof and shall make no use of such corporate name of
the other
Party without the other Party's written consent. Neither Party
shall use, or
allow any of their Affiliates to use, in connection with the
Product any other
trademark that is similar to or substantially similar to or so
nearly resembles
the other Party's corporate names as to be likely to cause
deception or
confusion.
(c) Cooperation. Each Party shall execute any documents required
in
the reasonable opinion of the other Party to be entered as a
"registered user"
or recorded licensee of the other Party's corporate names, or to be
removed as
registered user or licensee thereof.
3.3
DUSA Trademarks Infringement.
(a) Trademark Infringement Asserted by Third Parties in the
Territory.
Each Party shall notify the other Party promptly upon learning of
any actual or
alleged infringement of any trademark or of any unfair trade
practices, trade
dress imitation, passing off of counterfeit goods, or like
offenses, or any such
claims (hereinafter "TRADEMARK INFRINGEMENT CLAIMS") brought by a
Third Party
against a Party in connection with the Product in the
Territory.
(i) Upon learning of such Trademark Infringement Claim, DUSA,
[C.I.], shall take reasonable and appropriate steps to resolve the
Trademark
Infringement Claim with the reasonable cooperation and assistance
of STIEFEL;
provided however DUSA [C.I.] such alleged infringement on behalf of
STIEFEL
[C.I.] of STIEFEL, [C.I.].
(ii) DUSA shall have the right to [C.I.].
(b) DUSA Trademarks Infringement by Third Parties in the
Territory.
Each Party shall notify the other Parties in writing promptly upon
learning of
any actual or alleged infringement by a Third Party of any DUSA
Trademarks in
the Territory of which they become aware.
(i) Upon learning of such infringement under this Section
3.3(b),
DUSA shall, [C.I.], take reasonable and appropriate steps to
resolve such
infringement with the reasonable cooperation and assistance of
STIEFEL; provided
however DUSA [C.I.] such alleged infringement on behalf of STIEFEL
[C.I.]
STIEFEL, [C.I.].
(ii) DUSA shall
have the right to [C.I.].
3.4
Product Marking. Any Product marketed and sold hereunder shall
be
marked with appropriate patent numbers and Trademarks, as approved
by DUSA.
3.5
Alternative Trademarks. If one or more the DUSA Trademarks cannot
be
used or registered in any country within the Territory for reasons
beyond DUSA's
control (e.g., due to objections by Third Parties or local
trademark offices) or
cannot otherwise be legally used to
<PAGE>
Note: Certain portions of this document have been marked "[C.I.]"
to indicate
that confidential treatment has been requested for this
confidential
information. The confidential portions have been omitted and filed
separately
with the Securities and Exchange Commission.
commercialize the Product in a country within the Territory (e.g.,
due to
rejection by regulatory authorities), and if the Parties have
determined that an
alternative worldwide trademark is not practicable for the Product,
then [C.I.]
shall have the right to propose one or more alternative trademarks.
[C.I.] shall
then select one of the alternative trademarks for the Product in
each country in
the Territory. [C.I.] will undertake the obligation and expense of
conducting
appropriate trademark clearance of any such selected alternative
trademark for
use in each such country in the Territory, and filing applications
for the
cleared trademark. If (a) an alternative trademark is cleared
successfully for
use and registration, (b) trademark applications are filed for the
additional
alternative trademark, and (c) such additional alternative
trademark receives
regulatory approval, then all terms and conditions of this
Agreement shall
apply, mutatis mutandis, to the use and registration of such
alternative
trademark approved [C.I.] and, thereafter the term "DUSA
Trademarks" shall
include such alternative trademark.
4.
REGISTRATIONS.
4.1
Approval and Maintenance.
(a) DUSA shall, [C.I.], use Commercially Reasonable Efforts to
prepare
the documents necessary for submission to the Regulatory
Authorities in Brazil
to seek approval for the treatment of Actinic Keratoses. [C.I.]
shall [C.I.] for
[C.I.] incurred on or after the Effective Date, including but not
limited to,
[C.I.], and [C.I.] in connection with seeking Registration in
Brazil. [C.I.]
shall be responsible for [C.I.] prior to the Effective Date,
including but not
limited to, [C.I.], and [C.I.] in connection with seeking
Registration in
Brazil.
(b) STIEFEL shall, [C.I.], provide [C.I.] with reasonable
assistance
and cooperation in [C.I.] preparing, filing, seeking and
maintaining
Registration in Brazil, which shall include, but not be limited to,
the naming
of a [C.I.] and developing and implementing documented standard
operating
procedures required to support the Product Registration. If the
Pricing Approval
is not obtained and STIEFEL wishes to terminate the Agreement,
STIEFEL shall
continue to perform all necessary activities to maintain DUSA's
regulatory
approval for the Product, [C.I.], until DUSA is able to [C.I.].
(c) For other countries in the Territory and/or other indications
in
the Field, STIEFEL shall, [C.I.], use [C.I.] to prepare the
application for
Registration, on [C.I.] behalf, to seek approval to market. With
regard to the
application for Registration for the treatment of Actinic
Keratoses, DUSA will
provide STIEFEL with copies of existing clinical and chemistry,
manufacturing
and controls data to support of this application. STIEFEL shall
[C.I.] for
[C.I.], including but not limited to, [C.I.], and [C.I.] in
connection with
seeking these approvals. STIEFEL shall, [C.I.], provide DUSA with
reasonable
assistance with the development and implementation of mutual
documented standard
operating procedures, such as, but not limited to, adverse event
reporting,
storage and handling, etc., required to support the Registration in
other
countries in the Territory.
(d) For clarity, regulatory [C.I.] shall mean all [C.I.] and
[C.I.]
(including [C.I.]) incurred by a Party or any of its Affiliates in
accordance
with GAAP during the term and pursuant to this Agreement in
connection with the
preparation of regulatory submissions for the
<PAGE>
Note: Certain portions of this document have been marked "[C.I.]"
to indicate
that confidential treatment has been requested for this
confidential
information. The confidential portions have been omitted and filed
separately
with the Securities and Exchange Commission.
Product, the obtaining and maintenance of Registrations, and
compliance with
Registrations and requirements of such Regulatory Authorities,
including ICSR
recordation and reporting, regulatory affairs activities, and
recalls and
withdrawals of the Product in the Territory. [C.I.] shall report to
[C.I.]
within [C.I.] ([C.I.]) days after the end of each calendar [c.i.]
with regard to
regulatory costs incurred during such calendar [C.I.]. Such report
shall (i)
specify in reasonable detail all expenses incurred during such
[C.I.], or (ii)
be accompanied by invoices or other appropriate supporting
documentation for any
payments to Third Parties that individually exceed $[C.I.] or such
[C.I.] as may
be determined by the Parties. The Parties shall seek to resolve any
questions
related to such accounting statements within [C.I.] ([C.I.]) days
following
receipt by STIEFEL of DUSA's report hereunder and payment shall be
made within
[C.I.] ([C.I.]) days of such report.
4.2
Adverse Event Reporting. STIEFEL shall notify DUSA, in writing, of
any
adverse drug experience within [C.I.] ([C.I.]) hours of such
adverse drug
experience becoming known to STIEFEL. As provided in Section 4.5,
and except as
required by any Applicable Laws, DUSA shall have the sole
discretion and
responsibility to determine whether any adverse drug experience
must be reported
to the applicable Regulatory Authority, and following making a
determination to
report, to report such events to the applicable Governmental
Authority.
4.3
Ownership of Product Registration. All Registrations and
regulatory
filings for the Product in the Territory, including marketing and
pricing
filings and authorizations, in connection with the Product, shall
be filed,
registered and owned exclusively by DUSA, unless otherwise
explicitly agreed in
writing by DUSA.
4.4
Cooperation.
(a)
STIEFEL shall, [C.I.], provide DUSA with reasonable assistance
and
timely cooperation in the preparation, filing, submission and
maintenance of
Registrations, which shall include naming of a [C.I.] in Brazil,
and in any
country in the Territory which requires it.
(b) At DUSA's reasonable request, STIEFEL will assist DUSA, in
determining the optimal form of, and the necessary information to
be included
in, such filings to meet the applicable requirements of the
Regulatory Authority
in the Territory.
(c) Fro
