<PAGE>
EXHIBIT 10(A)
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.
EXECUTION COPY
AMENDMENT NO. 1
TO THE
MARKETING, DISTRIBUTION AND SUPPLY AGREEMENT
This
Amendment No. 1 ("Amendment") is made as of September 26, 2007, to
the
Marketing, Distribution and Supply Agreement ("Agreement") dated as
of January
12, 2006 by and 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 referred to as "DUSA") and
Stiefel
Laboratories, Inc., a Delaware corporation having a principal
office and place
of business at 255 Alhambra Circle, Site 1000, Coral Gables,
Florida, USA 33134
(hereinafter referred to as "STIEFEL")
WHEREAS, the Parties wish to amend the Agreement as more fully set
forth
below;
NOW,
THEREFORE, in consideration of the premises and mutual agreements
set
forth in the Lease and this Amendment, and for good and valuable
consideration,
the receipt and sufficiency of which the Parties hereby
acknowledge, the Parties
hereby agree as follows:
1. All capitalized terms used herein, unless otherwise defined
herein, are
defined in the Agreement.
2. The fifth "WHEREAS" clause shall be amended to read as
follows:
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 Products in connection with the marketing and
sale of the
Product in the Territory under the terms and conditions of the
Agreement.
3. Paragraph 1.3 of the Agreement (definition of "Approved Price")
shall be
deleted in its entirety and replaced with the following:
1.3
INTENTIONALLY OMITTED.
4. The definition of "Approved Product" as set forth in Section 1.4
shall be
revised to read as follows:
1.4 "Approved Product"
shall mean any Product that shall have been granted
all
necessary approvals by the required Regulatory Authorities to
allow
STIEFEL, the exclusive right to distribute, promote and sell the
Product in
any
country in the Territory pursuant to the terms of this
Agreement.
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<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.
5. Paragraph 1.13 of the Agreement shall be amended to read as
follows:
1.13
FIELD" shall mean [C.I.] uses of the Products for [C.I.]
dermatology
indications.
6. Paragraph 1.15 of the Agreement (definition of "Fiscal Year")
shall be
deleted in its entirety and replaced with the following:
1.15
INTENTIONALLY OMITTED.
7. Paragraph 1.28 shall be amended to read as follows:
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.] per unit which price is [C.I.]
of
the [C.I.] government taxes to be paid [C.I.].
8. Paragraph 1.32 shall be amended to read as follows:
1.32
"REGISTRATION" means the regulatory approvals of any applicable
Regulatory Authorities issued in STIEFEL's name, and necessary
to
permit the commencement of the marketing and sale of the Product
in
any country in the Territory pursuant to the terms and conditions
of
this Agreement.
9. Paragraph 1.35 shall be amended to read as follows:
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 the applicable
Regulatory
Authorities.
10. Paragraph 1.39 shall be amended as follows:
1.39
"TERRITORY" shall mean the following countries: Argentina,
Brazil,
Bolivia, Chile, Colombia, Costa Rica, Ecuador, El Salvador,
Guatemala,
Honduras, Mexico, Nicaragua, Panama, Peru, Dominican Republic,
Venezuela,
Jamaica (including the Cayman Islands), Barbados (including all
surrounding
islands including, but not limited to St. Lucia, Tortola, St.
Vincent,
Granada, Bahamas, Aruba, Bonaire, Curacao, Trinidad, Tobago,
Bermuda,
Belize), Paraguay, and Uruguay.
11. Paragraph 2.1 shall be amended to delete reference to
"7.1(a)(i)" and
replace with "7.2(a)."
12. Paragraph 2.2(a) shall be amended to read as follows:
Subject to Section 7.1, STIEFEL shall use its Commercially
Reasonable
Efforts to
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<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.
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 in
each
country in the Territory no later than [C.I.] days after obtaining
the
Registration (and in the case of Brazil, also the Pricing Approval)
from
the
appropriate Regulatory Authority in each of the respective
countries in
the
Territory.
13. Paragraph 2.2(f) shall be deleted in its entirety and replaced
with the
following:
DUSA
shall provide to STIEFEL, [C.I.], the number of samples and
demonstration units (Kerastick units without active ingredient) in
the
quantity of Products more fully set forth on Schedule B, a copy of
which is
attached hereto and made a part hereof. STIEFEL shall purchase from
DUSA
all
samples [C.I.] at the transfer price of [C.I.] per unit. STIEFEL
shall
purchase from DUSA all demonstration units [C.I.] at a price of
[C.I.] per
box
of six (6) units.
14. Paragraph 2.4 (and its sub-parts) shall be deleted in its
entirety and
replaced with the following:
2.4
Milestone Payments; Rights of Termination Relating to Pricing
Approval.
2.4.1 Milestone Payment for all countries in the Territory
except
Brazil.
(a)
STIEFEL shall pay DUSA
within [C.I.] days of the Launch Date of the
Product in Mexico or Argentina, whichever occurs first, a
non-refundable, non-creditable payment of Three Hundred
Seventy-Five
Thousand U.S. Dollars (U.S. $375,000).
Within [C.I.] days after the total cumulative number of units of
Product
ordered hereunder by STIEFEL and shipped by DUSA to STIEFEL exceeds
One
Hundred Fifty Thousand (150,000) units, STIEFEL shall make a
non-refundable,
non-creditable payment of Three Hundred Seventy-Five U.S.
Dollars (US $375,000).[C.I.]
(b)
Within [C.I.] days
after the total cumulative number of units of
Product ordered hereunder by STIEFEL and shipped by DUSA to
STIEFEL
exceeds Three Hundred Thousand (300,000) units, STIEFEL shall make
a
non-refundable, non-creditable payment of Three Hundred
Seventy-Five
Thousand U.S. Dollars (US $375,000).
2.4.2 Milestone Payment for Brazil.
(a)
Within [C.I.] days of
STIEFEL's receipt of the Pricing Approval,
STIEFEL shall pay a non-refundable, non-creditable payment of
Three
Hundred Seventy-Five Thousand Dollars (US $375,000).
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<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.
(b)
Within [C.I.] days
after the total cumulative number of units of
Product sold in Brazil by STIEFEL exceeds One Hundred Fifty
Thousand
(150,000) units, STIEFEL shall make a non-refundable,
non-creditable
payment of Three Hundred Seventy-Five Thousand U.S. Dollars
(U.S.$375,000) to DUSA.
(c)
Within [C.I.] days
following the total cumulative number of units of
Product sold in Brazil by STIEFEL exceeds Three Hundred
Thousand
(300,000) units, STIEFEL shall make a non-refundable,
non-creditable
payment of Three Hundred Seventy-Five Thousand Dollars (US$375,000)
to
DUSA.
2.4.3 Rights of Termination Relating to Pricing Approval
(a)
If STIEFEL (i) does
not receive appropriate Pricing Approval for
Brazil, or (ii) fails to receive approval with [C.I.] days of
Registration and negotiations with CMED, a CMED appeal and/or
other
legal processes relating to Pricing Approval are not ongoing,
STIEFEL
shall have the right to terminate this Agreement as it relates
to
Brazil only, and its obligation under Section 2.4.2 above shall
also
immediately terminate. STIEFEL's exercise of its right under
this
Section 2.4.3 shall not by itself give rise to any claim by DUSA.
In
the event STIEFEL elects to terminate pursuant to this Section
2.4.3
or otherwise, STIEFEL shall maintain any Registration for the
Product,
for Brazil or any other country in the Territory, until DUSA is
able
to transfer or assign such Registration to another Third Party or
to
itself. DUSA shall be responsible [C.I.] involved with
STIEFEL's
maintaining of the Registration and [C.I.]. It is understood
and
agreed that DUSA shall be responsible [C.I.] in connection with
the
CMED Pricing Approval process to date and STIEFEL shall be
responsible
[C.I.]. On an on-going basis, with respect to the effort to
receive
acceptable Pricing Approval, the Parties agree that DUSA shall
be
responsible for [C.I.] and STIEFEL shall [C.I.]. Should the
current
process not be successful as determined by the Parties, acting in
good
faith, then the executives of the Parties named in Section 4.5 of
this
Amendment shall meet promptly to discuss whether to proceed to
the
judiciary process and [C.I.] incurred for such judiciary process.
If
STIEFEL elects not to proceed with the judiciary process, then it
may
exercise its rights under this Section 2.4.3.
(b)
If STIEFEL fails to
receive Pricing Approval from CMED within [C.I.]
days of Registration and negotiations with CMED, a CMED appeal
and/or
other legal processes relating to Pricing Approval are not
ongoing,
DUSA may elect to terminate this Agreement as to Brazil only. In
such
event, (i) STIEFEL shall maintain any Registration for the
Product
until DUSA is able to transfer or assign such Registration to
another
Third Party or to itself [C.I.]; and STIEFEL shall cooperate with
DUSA
to effect such transfer or assignment, and (ii) STIEFEL shall
[C.I.]
to DUSA for any Product and [C.I.] on purchase orders submitted
to
DUSA [C.I.].
PAGE 4
<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.
15. The heading of Section 4. shall be amended to read as
follows:
4.
REGISTRATIONS, PHARMACOVIGILANCE AND RECALL.
16. Section 4.1 (and its sub-parts) and Section 4.2 shall be
deleted in their
entirety and replaced with the following:
4.1
Approval and Maintenance.
(a)
DUSA shall, [C.I.],
use Commercially Reasonable Efforts to prepare the
documents necessary for STIEFEL's submission to the Regulatory
Authorities in Brazil for Registration of the Product 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.
Subject to Section 7.1 and the terms and conditions of the Safety
Data
Exchange Agreement defined below, [C.I.] shall be responsible
for
[C.I.] relating to such Registration. [C.I.] shall be responsible
for
[C.I.] incurred prior to the Effective Date in connection with
seeking
Registration in Brazil. Should DUSA receive FDA approval for
the
Product for an indication other than Actinic Keratoses, or wish
to
sell a new indication in the Territory, DUSA shall provide to
STIEFEL
copies of the relevant portions of the new drug application, in
English, so that STIEFEL can translate and convert such
information
into the appropriate format for submission to the Regulatory
Authorities in the Territory. Nothing herein shall be deemed to
require DUSA to conduct any clinical development activities
relating
to use of the Product for Actinic Keratoses or any other
indication,
nor permit STIEFEL to undertake any such activities without the
prior
written consent of DUSA.
(b)
STIEFEL shall, [C.I.]
following the Effective Date, prepare, file,
seek and maintain Registration in Brazil, which shall include, but
not
be limited to, the naming of [C.I.] and developing and
implementing
document standard operating procedures required to support the
Product's Registration.
(c)
For other countries in
the Territory with respect to Actinic Keratoses
and/or other indications in the Field in all countries in the
Territory, STIEFEL shall, [C.I.], use [C.I.] to prepare, file,
seek
and maintain applications for Registration, by translating and
converting DUSA's clinical, scientific and manufacturing
proprietary
information into the appropriate format required for submission
to
Regulatory Authorities in the Territory for Registration of the
Product. DUSA shall provide STIEFEL, with copies of existing
clinical
and
chemistry, manufacturing and controls data to support any
Registration. STIEFEL shall [C.I.], on or after the Effective Date
in
connection with seeking these approvals.
(d)
For clarity, [C.I.]
shall mean all [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
PAGE 5
<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.
Agreement in
connection with the preparation of regulatory submissions
for the Product, the obtaining and maintenance of Registrations,
and
compliance with Registrations and requirements of such
Regulatory
Authorities needed to effect such Registration. [C.I.] shall report
to
[C.I.] within [C.I.] days after the end of each calendar [C.I.]
with
regard to Regulatory Costs incurred during such calendar [C.I.]
(except for [C.I.] after the Effective Date relating to
Registration
in Brazil which have [C.I.]). Such report shall specify in
reasonable
detail to allow STIEFEL to verify same all expenses incurred
during
such [C.I.], and such report shall be accompanied by invoices or
other
appropriate supporting documentation for any payments to Third
Parties. The Parties shall seek to resolve any questions related
to
such accounting statements within [C.I.] days following receipt
by
STIEFEL of DUSA's report hereunder and payment shall be made
within
[C.I.] days of STIEFEL's receipt of such report.
(e)
The Parties shall
execute a pharmacovigilance agreement, i.e., the
Safety Data Exchange Agreement ("SDEA") in the form attached hereto
as
Schedule E and made a part hereof, concurrent with the signing of
this
Amendment by both Parties,.
4.2
Pharmacovigilance and
Recall. The Parties agree to be abide by and be
bound to the terms of the SDEA, as stated in Section 4.1 (e)
above.
17. Paragraph 4.3 of the Agreement shall be deleted in its entirety
and replaced
with the following:
4.3
INTENTIONALLY OMITTED.
18. Sections 4.4 and Section 4.5 shall be deleted in their entirety
and replaced
with the following:
4.4
Cooperation
(a)
The Parties shall
assist each other and cooperate in determining the
optimal form of, and the necessary information to be included
in
applications for Registration of the Product in the Territory so
that
the preparation, filing, submission and maintenance of
Registrations
in the Territory are handled timely and as efficiently as
reasonably
possible. STIEFEL shall not submit any Registration to a
Regulatory
Authority without the prior written approval of DUSA, which shall
not
be unreasonably withheld, conditioned or delayed.
(b)
From time to time,
each party shall provide the other Party with a
status of its efforts in attempting to obtain Registration for
the
Product in each country in the Territory.
4.5
Communications;
Regulatory Inspections and Notifications. The Parties
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<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.
recognize that due to the rules and regulations of the
Regulatory
Authorities in the Territory, the certificates of registration
will,
in most, if not all, countries of the Territory, be issued in
STIEFEL's name. STIEFEL acknowledges and agrees that substantially
all
of the information, including without limitation, the
scientific,
clinical, chemistry, manufacturing and control information is
proprietary information of DUSA's. STIEFEL shall not submit any
non-routine response to an inquiry from a Regulatory Authority in
the
Territory, or any amendments or supplements to the
Registrations
without the prior written consent of DUSA which shall not be
unreasonably withheld. The Parties agree to cooperate with each
other
in order to comply with all laws, rules and regulations of the
Regulatory Authorities in the Territory, however if they disagree
on a
response to any inquiry from a Regulatory Authority in a
particular
country, the [C.I.] for Latin America for STIEFEL and the
Executive
[C.I.] for DUSA, or their respective successors, shall meet
promptly
in order to try to resolve their differences regarding the
regulatory
matter. If such officers are unable to resolve the regulatory issue
at
hand, DUSA shall have the final decision-making authority with
respect
to such matter, however, [C.I.] shall have the right, without
being
deemed [C.I.] the Agreement, to then [C.I.] in such country,
provided
that [C.I.] by its obligations hereunder with respect to [C.I.] of
any
[C.I.] Registration or Registration in such country, and the
Parties
shall meet in good faith to consider modifications [C.I.] under
the
Agreement which may be impacted as a result of [C.I.], including,
but
not limited to, [C.I.]. DUSA and STIEFEL each shall notify the
other
within [C.I.] (or, if such [C.I.] period ends on a non-business
day,
then prior to noon on the next following business day) of receipt
of
any notice of any governmental agency inspection, investigation
or
other inquiry, or other material governmental notice or
communication,
in each case which relates to the marketing, promotion,
distribution
and/or detailing of the Product during the term of this
Agreement.
STIEFEL and DUSA shall discuss any response to observations or
notifications received in connection with any such inspection,
investigation or other inquiry and each shall give the other an
opportunity to comment upon any proposed response before it is
made.
In the event of disagreement concerning the form or content of
such
response, however, the executive officers of each Party named
above
shall meet promptly in order to try to resolve their differences.
If
such officers are unable to resolve the regulatory issue at hand,
DUSA
shall be responsible for deciding the appropriate form and content
of
any response with respect to any of its cited activities and
STIEFEL
shall be responsible for deciding the appropriate form and content
of
any response with respect to any of its cited activities. Each
Party
will provide the other Party with copies of all correspondence
received by it from, or filed by it with any Regulatory Authority
to
the extent pertaining to the Product or its marketing, promotion
or
detailing.
19. The following shall be added to the end of Section 7.1 - "In
the event that
DUSA effects any change in the manufacturing of the Product
(whether that be
internal or with a Third-Party) which necessitates a regulatory
submission to
any Regulatory Authority in the Territory, the
PAGE 7
<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.
[C.I.] (as defined in Section 4.1(d)) associated with such
regulatory submission
shall [C.I.]:
(a)
if the change is
initiated [C.I.] shall [C.I.] of such regulatory
submissions;
(b)
if the change is i)
initiated [C.I.], ii) made upon the [C.I.] of the
Parties, or iii) is initiated [C.I.], then [C.I.] shall [C.I.] of
such
regulatory submission [C.I.] and [C.I.] shall [C.I.] of such
regulatory submissions [C.I.]."
20. Section 7.2(a) shall be revised by replacing all references to
Section
7.1(a)(ii) with Section 7.2(a)(ii) and shall revise the first
phrase of Section
7.2(a) to read as follows:
STIEFEL shall purchase, no less than the Minimum Number of Units of
the
Product at the Purchase Price Per Unit during the applicable Time
Period
(as
such terms are defined on Schedule B) (the "MINIMUM PURCHASE
OBLIGATIONS"). For purposes of clarity, the [C.I.] royalty used
in
calculating the Purchase Price Per Unit shall be based on Net
Selling Price
for
the preceding quarter.
21. The first sentence of Section 7.3(a) shall be amended to read
as follows:
Within [C.I.] prior to any Registration relating to the Product,
STIEFEL
shall provide DUSA with a forecast of STIEFEL's quantity
requirements for
the
applicable commercial launch of the Product and the [C.I.]
period
following such launch.
22. The first sentence of Section 7.3(b) shall be revised to delete
reference to
"[C.I.]" and to replace with "[C.I.]"; and to add the following as
the last
sentence - "All orders shall be placed in [C.I.]."
23. Section 7.3(e) shall be revised to include the following
sentence at the end
of such section:
However, DUSA shall use Commercially Reasonable Efforts to meet an
increase
in
demand by STIEFEL, but any DUSA failure to meet such increase shall
not
be
deemed a breach of this Agreement.
24. Section 7.3(g) shall be revised to delete reference to "FOB"
and to replace
with "EX-WORKS".
25. Section 7.3(i) shall be added as follows: "As part of placing
each order for
the Product, and due to differing label requirements in the various
countries in
the Territory, STIEFEL shall indicate in writing the country in the
Territory
where such ordered Product is intended to be sold. Product
purchased as being
indicated for sale in a given country shall not be sold in any
other country."
26. Section 8.1 shall be deleted in its entirety and replaced with
the
following:
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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.
(a)
Payment of Transfer
Price. Subject to Section 7.3(a), STIEFEL shall
pay the transfer price portion of the Purchase Price Per Unit (as
set
forth on Schedule C hereto) for the quantities of Product
ordered
within [C.I.] days of the date of invoice submitted by DUSA,
provided
that DUSA [C.I.] the Product has been delivered to STIEFEL pursuant
to
Section 7.3(g).
(b)
Royalty Reports and
Payments. Within [C.I.] after the end of each
[C.I.] (or portion thereof) beginning with the first [C.I.]
ending
after the Launch Date, STIEFEL shall deliver to DUSA a report,
giving
such particulars of the Product sold by STIEFEL and its Affiliates
and
subdistributors under this Agreement during such [C.I.]. This
report
shall set forth in reasonable detail sufficient to perform an
accounting of royalties due to DUSA under this Agreement.
Within
[C.I.] days after the end of each [C.I.] (or portion thereof)
beginning with the first [C.I.] after the Launch Date (i.e.,
[C.I.]) a
copy of the report shall be accompanied by payment of the royalty
for
[C.I.]. Following the end of each calendar year, the Parties
shall
reconcile (true-up) any adjustments in the last payment of each
year.
These shall include at least the following, separately stated as
to
the Product:
(i) the quantity of the Product invoiced by STIEFEL and its
Affiliates, and subdistributors during [C.I.] and the billings
therefor by country in the Territory;
(ii) the calculation of royalties thereon; and
(iii) STIEFEL's then current inventory of the Product.
(c)
Records and
Audits.
(i) Records. STIEFEL shall keep or cause to be kept, and shall
cause its Affiliates and subdistributors to keep, such records
as
are necessary to determine accurately, in a manner consistent
with GAAP and this Agreement, the royalties due to DUSA under
this Agreement.
(ii) Audit. Such records shall be retained by STIEFEL, and
STIEFEL shall
cause its Affiliates and subdistributors to retain
(in such capacity, the "Recording Party") for three (3)
calendar
years and, once during any applicable calendar year (unless
otherwise required by securities law or regulations) upon ten
(10) business days prior written notice from DUSA, such records
shall be made available for inspection, review, and audit, and
during normal business hours, by an independent public
accounting
firm appointed by DUSA for the sole purpose of verifying the
Recording Party's accounting reports and payments made or to be
made pursuant to this Agreement. Such independent public
accounting firm shall execute a Confidential Disclosure
Agreement, which is deemed acceptable to STIEFEL, substantially
in the form attached hereto as Exhibit A, and
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<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.
made a part hereof, to protect STIEFEL's, or its Affiliates',
or
subdistributors' respective Confidential Information. The
results
of each inspection, if any, shall be binding upon both Parties.
Any underpayment or overpayment determined by such inspection
shall be paid [C.I.] after the delivery of the accountant's
report to the Parties.
(d)
Confidential. Such
independent accounting firm shall not reveal to the
Party seeking verification the details of its review, except for
such
information as is required to be disclosed under this Agreement,
and
such details shall be treated as Confidential Information. Each
Party
agrees to hold in strict confidence all information concerning
payments and reports, and all information learned in the course of
any
audit or inspection (and not to make copies of such reports and
information), except to the extent necessary for such Party to
reveal
such information in order to enforce its rights under this
Agreement
or if disclosure is required by law, regulation or judicial
order.
(e)
Costs of Audits. The
results of each inspection, if any, shall be
binding on both Parties. DUSA shall [C.I.] that in the event where
the
[C.I.] to the detriment [C.I.] of more than [C.I.] of the amount
of
any such payment, then STIEFEL shall [C.I.].
(f)
Foreign Exchange. The
rate of exchange to be used in computing the
royalty amounts of currency equivalent in United States dollars
due
DUSA shall be made at the Wall Street Journal published rate as of
the
last business day of the relevant calendar quarter.
(g)
Tax Withholding. In
the event that any country in the Territory
assesses a withholding tax, tariff, duty, levy, or other
similar
charge against any payments to be made by STIEFEL to DUSA pursuant
to
this Agreement("Taxes") such Taxes shall be paid in the first
instance
[C.I.] the [C.I.] under this Agreement. If for any reason [C.I.]
has
not [C.I.] such Taxes, and DUSA becomes obligated [C.I.], then
DUSA
shall [C.I.] for such Taxes [C.I.] in accordance with Section
8.1(a)
above. DUSA shall secure and promptly send to STIEFEL [C.I.] or
[C.I.]
by DUSA for the benefit of STIEFEL. The Parties shall cooperate
reasonably with each other to ensure that any amounts required to
be
[C.I.] are reduced in amount to the fullest extent permitted by
law.
[C.I.] shall be made, or a [C.I.] shall be [C.I.], if STIEFEL
furnishes a document from the appropriate tax authorities to
DUSA
certifying that the payments are exempt from withholding Taxes
or
subject to reduced tax rates, according to the applicable
convention
for the avoidance of double taxation.
(h)
Method of Payment. All
payments shall be made in United States
dollars, by wire transfer, preferably Automated Clearing House
("ACH"), of immediately available funds [C.I.].
27. Section 8.4 shall be deleted in its entirety and not
replaced.
PAGE 10
<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.
28. Section 9.4(d) - the last sentence shall be revised to read as
follows:
In
the event that [C.I.] Product is required, it shall be [C.I.]
unless
otherwise agreed to in writing by STIEFEL.
29. Section 11.2 shall be revised to add the following language to
the end of
such section:
but
all such improvements, to the extent they relate to the Product,
shall
be
considered part of the grant made to STIEFEL herein pursuant to
Sections
2
and 3.1; provided, however, that if the [C.I.] such improved
Product is
[C.I.] the Product [C.I.] improved Technical Information, the grant
shall
be
[C.I.].
30. Section 18.2(d) shall be revised to delete references to
Sections 7.1(a)(ii)
and 2.4(c) and replace them with Sections 4.5 (but only as it
relates to a
particular country in the Territory in which STIEFEL will be
assigning or
transferring a Registration to DUSA or its designee), 7.2(a)(ii)
and 2.4.3(a),
respectively.
31. Section 18.2(e) shall be revised to delete reference to Section
2.4(b) and
replace with Section 2.4.3(b).
32. Section 18.2(g) shall be deleted in its entirety and replaced
with the
following:
(g)
INTENTIONALLY OMITTED.
33. Section 25 shall be revised to read as follows "The Agreement,
as may be
amended by the written agreement of the Parties, from time to time,
together
with all Schedules and Exhibits, incorporates the entire
understanding of the
Parties and revokes and supersedes any and all agreements,
contracts,
understandings or arrangements that might have existed heretofore
between the
Parties regarding the subject matter hereof.
34. Schedule B attached to the Agreement shall be deleted and
replaced with the
attached Schedule B.
35. Schedule C attached to the Agreement shall be deleted and
replaced with the
attached Schedule C.
PAGE 11
<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.
IN WITNESS WHEREOF, each of the Parties has caused this Amendment
to be executed
in multiple counterparts by its duly authorized representative.
STIEFEL LABORATORIES, INC.
By: /s/ William Humphries
---------------------------------
William
Humphries
Chief
Commercial Officer
DUSA PHARMACEUTICALS, INC.
By: /s/ William F. O'Dell
---------------------------------
William F.
O'Dell
Executive
Vice President,
Sales and
Marketing
PAGE 12
<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.
SCHEDULE B
MINIMUM PURCHASE OBLIGATIONS AND PRODUCT FREE OF CHARGE
The Minimum Purchase Obligations for Levulan(R) Kerastick(R) shall
be as
follows:
1 - All countries in the territory, except Brazil
<TABLE>
<CAPTION>
TIME
PERIOD MINIMUM
NUMBER OF UNITS
-----------
-----------------------
<S>
<C>
First Time Period
[C.I.]
Second Time Period
[C.I.]
Third Time Period
[C.I.]
Fourth Time Period
[C.I.]
Fifth Time Period
[C.I.]
</TABLE>
DUSA shall supply Stiefel with [C.I.] units of Levulan Kerastick in
U.S
packaging, [C.I.]. The products must be delivered to Stiefel when
the product is
launched in Mexico, or otherwise, agreed between the parties.
2 - Only Brazil
<TABLE>
<CAPTION>
TIME
PERIOD MINIMUM
NUMBER OF UNITS
-----------
-----------------------
<S>
<C>
First Time Period
[C.I.]
Second Time Period
[C.I.]
Third Time Period
[C.I.]
Fourth Time Period
[C.I.]
Fifth Time Period
[C.I.]
</TABLE>
Obligations for Levulan(R) Kerastick(R) shall be determined by
[C.I.] no later
than [C.I.] months prior to the end of calendar year 2011.
DUSA shall supply Stiefel with [C.I.] units of Levulan Kerastick in
U.S.
packaging, [C.I.]. The products must be delivered to Stiefel when
the product is
launched in Brazil, or otherwise, agreed between the parties.
Additionally to the [C.I.] products to support the product
launching, DUSA will
also provide Stiefel with:
a.
[C.I.] products
for any Clinical Study with approved protocol;
b.
[C.I.] products
with U.S. labeling (Kerastick units [C.I.].
PAGE 13
<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.
SCHEDULE C
SUPPLY PRICE AND [C.I.] OF SUPPLY - ALL COUNTRIES IN THE
TERRITORY
"PURCHASE PRICE PER UNIT", with respect to units of the Product
that are
purchased for sales in a country in the Territory, shall mean
[C.I.] plus [C.I.]
based on the Net Selling Price received by STIEFEL for the
Products. For
purposes hereof, the Net Selling Price shall mean the price charged
[C.I.], to
end-users (i.e., physician or hospital customers, or the like) in
the [C.I.]
after [C.I.] on units of the Product sold.
In the event at any time the Net Selling Price Per Unit for sales
in a country
in the Territory in a given calendar quarter, as expressed in U.S.
Dollars using
the current average daily applicable local currency / U.S. Dollar
exchange rate,
is [C.I.] U.S. Dollars ([C.I.] USD) (the "Event"), then STIEFEL
shall [C.I.] Net
Selling Price in the applicable local currency [C.I.] of such
Purchase Price Per
Unit [C.I.] U.S. Dollars ([C.I.] USD)provided that [C.I.] prior
written notice
from STIEFEL given after such the Event, STIEFEL [C.I.]; provided
further that
upon giving such notice to DUSA, [C.I.]. beginning [C.I.] and
continuing until
the [C.I.] U.S. Dollars ([C.I.] USD) for a period of not less than
[C.I.] weeks.
PAGE 14
<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.
EXHIBIT A
CONFIDENTIAL
DISCLOSURE AGREEMENT
This Agreement is entered into as of the __ day of ________, 200_,
by and
between Stiefel Laboratories, Inc. ("Stiefel"), a Delaware
corporation with an
office and place of business at 255 Alhambra Circle, Coral Gables,
Florida 33134
and _________________ ("Company"), with an office and place of
business at
_____________________________. Stiefel and Company are also jointly
referred to
herein as "Parties," and individually as a "Party."
1. Company shall be conducting an audit of Stiefel's accounting
reports and
payment records solely as it relates to Stiefel's obligations under
the
Marketing, Distribution and Supply Agreement, as amended between
Stiefel and
DUSA Pharmaceuticals, Inc.. The Parties anticipate that in the
course of such
activities, Stiefel may disclose to Company certain of Stiefel's
inventions,
trade secrets, know how, data, materials, or other information
(together,
"Information") that Stiefel considers confidential and/or
proprietary.
2. As used in this Agreement, "Confidential Information" means all
Information
disclosed by Stiefel to Company, whether by oral or written
communication,
delivery, demonstration or access.
3. Company shall use Confidential Information only in the course of
the
activities described above or as otherwise directed in writing by
Stiefel.
Company agrees that, for a period of [C.I.] following Stiefel's
disclosure of
Confidential Information to Company, Company shall:
(i)
Not disclose such
Confidential Information to any other person or
entity other than DUSA without Stiefel's prior written consent;
and
(ii)
protect such Confidential Information from further disclosure in
the
same manner as it protects its own information of a similar
nature
(but in no event with
less than a reasonable standard of care).
4. Stiefel grants no present or future rights or license, under any
of its
inventions, patents, copyrights, trade secrets, trademarks or other
property, to
Company with respect to Confidential Information.
5. Company's obligations specified in Section 3 shall not apply to
any
Information that Company can demonstrate:
(i)
is or becomes known or
generally available to the public, through no
act or omission of Company and without any wrongful act of any
third
party;
(ii)
is or becomes known to Company through disclosure by any third
party,
without any wrongful act of Company or such third party;
(iii) is subsequently disclosed by Company pursuant to the
requirement of a
statute, regulation, or judicial or administrative order
requiring
disclosure thereof, provided that Company first provides Stiefel
with
written notice of any such
PAGE 15
<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.
requirement, promptly upon learning of the requirement; or
(iv)
has been or is subsequently developed independently by Company,
without any use of Confidential Information.
6. Company shall, upon Stiefel's written request, return to Stiefel
its
Confidential Information (to include all copies and reproductions
thereof and
all information prepared by Company which incorporates
Confidential
Information).
7. The Parties agree that if Company breaches any of its
obligations hereunder,
money damages will not afford Stiefel an adequate remedy.
Therefore, if any such
breach occurs, in addition to any other remedies as may be provided
by law,
Stiefel shall have the right to seek such equitable relief as it
deems
reasonably necessary to enforce its rights hereunder (whether
temporary or
permanent injunctive relief, or otherwise). Notwithstanding the
foregoing, the
Parties expressly agree that neither Party shall be liable to the
other Party
for incidental, consequential, punitive, special or exemplary
damages with
respect to any breach of this Agreement.
8. Neither Party may assign all or any part of its rights or
obligations
hereunder without the other Party's prior wri