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 ▇▇ ▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇,
▇▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇ (hereinafter referred to as "DUSA") and ▇▇▇▇▇▇▇
Laboratories, Inc., a Delaware corporation having a principal office and place
of business at ▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, Site 1000, ▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇
(hereinafter referred to as "▇▇▇▇▇▇▇")
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 ▇▇▇▇'▇ ▇▇▇▇▇ to ▇▇▇▇▇▇▇ 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
▇▇▇▇▇▇▇, 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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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 ▇▇▇▇▇▇▇'▇ 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 ▇▇▇▇▇▇▇'▇ 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. ▇▇▇▇▇▇▇,
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, ▇▇▇▇▇▇▇ shall use its Commercially Reasonable
Efforts to
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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.
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 ▇▇▇▇▇▇▇ is legally prohibited
from selling the Product until Registration for the Product is obtained,
then ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇, [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. ▇▇▇▇▇▇▇ shall purchase from DUSA
all samples [C.I.] at the transfer price of [C.I.] per unit. ▇▇▇▇▇▇▇ 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) ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇ and shipped by DUSA to ▇▇▇▇▇▇▇ exceeds One
Hundred Fifty Thousand (150,000) units, ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇ and shipped by DUSA to ▇▇▇▇▇▇▇
exceeds Three Hundred Thousand (300,000) units, ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇'▇ receipt of the Pricing Approval,
▇▇▇▇▇▇▇ shall pay a non-refundable, non-creditable payment of Three
Hundred Seventy-Five Thousand Dollars (US $375,000).
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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.
(b) Within [C.I.] days after the total cumulative number of units of
Product sold in Brazil by ▇▇▇▇▇▇▇ exceeds One Hundred Fifty Thousand
(150,000) units, ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇ exceeds Three Hundred Thousand
(300,000) units, ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇ (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, ▇▇▇▇▇▇▇
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. ▇▇▇▇▇▇▇'▇ exercise of its right under this
Section 2.4.3 shall not by itself give rise to any claim by DUSA. In
the event ▇▇▇▇▇▇▇ elects to terminate pursuant to this Section 2.4.3
or otherwise, ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇'▇
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 ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇ 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
▇▇▇▇▇▇▇ elects not to proceed with the judiciary process, then it may
exercise its rights under this Section 2.4.3.
(b) If ▇▇▇▇▇▇▇ 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) ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇ shall cooperate with DUSA
to effect such transfer or assignment, and (ii) ▇▇▇▇▇▇▇ shall [C.I.]
to DUSA for any Product and [C.I.] on purchase orders submitted to
DUSA [C.I.].
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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.
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 ▇▇▇▇▇▇▇'▇ 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 ▇▇▇▇▇▇▇
copies of the relevant portions of the new drug application, in
English, so that ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇ to undertake any such activities without the prior
written consent of DUSA.
(b) ▇▇▇▇▇▇▇ 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, ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇, with copies of existing clinical
and chemistry, manufacturing and controls data to support any
Registration. ▇▇▇▇▇▇▇ 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
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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.
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 ▇▇▇▇▇▇▇ 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
▇▇▇▇▇▇▇ of DUSA's report hereunder and payment shall be made within
[C.I.] days of ▇▇▇▇▇▇▇'▇ 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. ▇▇▇▇▇▇▇ 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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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
▇▇▇▇▇▇▇'▇ name. ▇▇▇▇▇▇▇ 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. ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇ 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.
▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇
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
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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.
[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:
▇▇▇▇▇▇▇ 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, ▇▇▇▇▇▇▇
shall provide DUSA with a forecast of ▇▇▇▇▇▇▇'▇ 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 ▇▇▇▇▇▇▇, 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, ▇▇▇▇▇▇▇ 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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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), ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇ 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, ▇▇▇▇▇▇▇ shall deliver to DUSA a report, giving
such particulars of the Product sold by ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇ and its
Affiliates, and subdistributors during [C.I.] and the ▇▇▇▇▇▇▇▇
therefor by country in the Territory;
(ii) the calculation of royalties thereon; and
(iii) ▇▇▇▇▇▇▇'▇ then current inventory of the Product.
(c) Records and Audits.
(i) Records. ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇, and
▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇, substantially
in the form attached hereto as Exhibit A, and
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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 ▇▇▇▇▇▇▇'▇, 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 ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇ to ▇▇▇▇ 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 ▇▇▇▇▇▇▇ [C.I.] or [C.I.]
by DUSA for the benefit of ▇▇▇▇▇▇▇. 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 ▇▇▇▇▇▇▇
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
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 ▇▇▇▇▇▇▇.
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 ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇ 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
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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.
▇▇▇▇▇▇▇ LABORATORIES, INC.
By: /s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇
---------------------------------
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇
Chief Commercial Officer
DUSA PHARMACEUTICALS, INC.
By: /s/ ▇▇▇▇▇▇▇ ▇. O'Dell
---------------------------------
▇▇▇▇▇▇▇ ▇. O'Dell
Executive Vice President,
Sales and Marketing
PAGE 12
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
TIME PERIOD MINIMUM NUMBER OF UNITS
----------- -----------------------
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.]
DUSA shall supply ▇▇▇▇▇▇▇ with [C.I.] units of Levulan Kerastick in U.S
packaging, [C.I.]. The products must be delivered to ▇▇▇▇▇▇▇ when the product is
launched in Mexico, or otherwise, agreed between the parties.
2 - Only Brazil
TIME PERIOD MINIMUM NUMBER OF UNITS
----------- -----------------------
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.]
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 ▇▇▇▇▇▇▇ with [C.I.] units of Levulan Kerastick in U.S.
packaging, [C.I.]. The products must be delivered to ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇ 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
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 ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇ given after such the Event, ▇▇▇▇▇▇▇ [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
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 ▇▇▇▇▇▇▇ Laboratories, Inc. ("▇▇▇▇▇▇▇"), a Delaware corporation with an
office and place of business at ▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇
and _________________ ("Company"), with an office and place of business at
_____________________________. ▇▇▇▇▇▇▇ and Company are also jointly referred to
herein as "Parties," and individually as a "Party."
1. Company shall be conducting an audit of ▇▇▇▇▇▇▇'▇ accounting reports and
payment records solely as it relates to ▇▇▇▇▇▇▇'▇ obligations under the
Marketing, Distribution and Supply Agreement, as amended between ▇▇▇▇▇▇▇ and
DUSA Pharmaceuticals, Inc.. The Parties anticipate that in the course of such
activities, ▇▇▇▇▇▇▇ may disclose to Company certain of ▇▇▇▇▇▇▇'▇ inventions,
trade secrets, know how, data, materials, or other information (together,
"Information") that ▇▇▇▇▇▇▇ considers confidential and/or proprietary.
2. As used in this Agreement, "Confidential Information" means all Information
disclosed by ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇.
Company agrees that, for a period of [C.I.] following ▇▇▇▇▇▇▇'▇ disclosure of
Confidential Information to Company, Company shall:
(i) Not disclose such Confidential Information to any other person or
entity other than DUSA without ▇▇▇▇▇▇▇'▇ 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. ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇ with
written notice of any such
PAGE 15
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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 ▇▇▇▇▇▇▇'▇ written request, return to ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇ an adequate remedy. Therefore, if any such
breach occurs, in addition to any other remedies as may be provided by law,
▇▇▇▇▇▇▇ 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 written consent. This Agreement will
be binding upon and inure to the benefit of the Parties and their respective
successors and (permitted) assigns.
9. Nothing in this Agreement shall be construed to (i) create a joint venture,
partnership or other shared enterprise between the Parties, or (ii) authorize
either Party to act as an agent for or otherwise on behalf of the other Party.
Nothing in this Agreement shall be construed to obligate the Parties to enter
into any further agreement between them.
10. This Agreement contains the parties' entire understanding as to its subject
matter supersedes all prior agreements, written or oral, between ▇▇▇▇▇▇▇ and
Company relating thereto. This Agreement may not be modified, changed or
discharged, in whole or in part, except by a writing signed by ▇▇▇▇▇▇▇ and
Company.
This Agreement shall be construed and interpreted in accordance with the laws of
the State of New York, without reference to such State's conflicts of laws
principles.
EXECUTED as of the day and year first set forth above.
▇▇▇▇▇▇▇ LABORATORIES, INC.
By:
---------------------------------
Title:
------------------------------
COMPANY
By:
---------------------------------
Title:
------------------------------
PAGE 16
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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 E
SAFETY DATA EXCHANGE AGREEMENT
BETWEEN
▇▇▇▇▇▇▇ LABORATORIES, INC.
AND
DUSA PHARMACEUTICALS, INC.
REGARDING
LEVULAN(R) KERASTICK(R)
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.
TABLE OF CONTENTS
PAGE
----
I. General............................................................ 3
A. Background...................................................... 3
B. Terminology and Definitions..................................... 3
C. Purpose......................................................... 3
D. Scope........................................................... 4
E. Language........................................................ 4
F. Reporting Contacts.............................................. 4
II. Communications with Regulatory Authorities......................... 4
A. Regulatory Reporting............................................ 4
B. Regulatory Inquiries............................................ 5
C. Confidentiality of Information.................................. 5
III. Individual Case Safety Report Processing........................... 6
A. Sales Representative Reporting & Other Personnel................ 6
B. Translations.................................................... 6
C. Individual Case Safety Reports, Pregnancy Reports, Study
Findings and Aggregate Data..................................... 6
D. Causality Assessments........................................... 7
E. Follow-up Reports............................................... 7
F. Literature Reports.............................................. 7
G. Product Complaints Associated with an ICSR or Pregnancy
Report.......................................................... 8
H. Internet........................................................ 8
I. Regulatory Authority Sourced Reports............................ 8
J. Measures Taken to Protect Public Health; Product Recalls........ 8
K. Product Recall.................................................. 9
L. Line Listings................................................... 10
IV. Product Complaint Management....................................... 10
V. Retained Samples................................................... 10
A. Product Retained Samples........................................ 10
VI. Reporting Timeframes............................................... 10
A. Overview........................................................ 11
B. Reporting Requirements.......................................... 11
C. Record Keeping.................................................. 11
VII. Safety Database.................................................... 11
VIII. Written Procedures................................................. 12
IX. QA Audit........................................................... 12
X. Terms of this Agreement............................................ 12
APPENDIX I: TERMINOLOGY AND DEFINITIONS.................................. 15
APPENDIX II: ABBREVIATIONS............................................... 17
APPENDIX III: CONTACTS................................................... 17
APPENDIX IV: TIMEFRAMES FOR THE EXCHANGE OF SAFETY INFORMATION
BETWEEN PARTIES ...................................................... 19
EXHIBIT I.C.: PRODUCT COMPLAINT MANAGEMENT AGREEMENT..................... 21
2
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.
I. General
A. Background
▇▇▇▇▇▇▇ Laboratories, Inc. (hereinafter referred to as "▇▇▇▇▇▇▇") and DUSA
Pharmaceuticals, Inc. (hereinafter referred to as "DUSA") entered into a
Marketing, Distribution and Supply Agreement as of the 12th day of January
2006, as amended September 26, 2007 (collectively the "Agreement"). This
Safety Data Exchange Agreement ("SDEA") forms an addendum to the Agreement.
▇▇▇▇▇▇▇ and ▇▇▇▇ may hereinafter be individually referred to as "the Party"
and collectively as "the Parties".
B. Terminology and Definitions
Relevant definitions and terminology relating to this SDEA are included in
Appendix I of this document.
A list of abbreviations used in this SDEA, and their meaning, may be found
in Appendix II.
Any capitalized terms used herein, not otherwise defined, shall have the
meaning set forth in the Agreement.
C. Purpose
As stipulated under Article 4.2 of the Agreement , the Pharmacovigilance
Departments (or their equivalent thereof) of ▇▇▇▇▇▇▇ and DUSA hereby agree,
via the implementation of this SDEA, to use mutually agreed-upon guidelines
and procedures for the receipt, evaluation and communication of adverse
event reports, i.e. Individual Case Safety Reports (ICSRs), pregnancy
information, and new safety information associated with DUSA's product, the
Levulan(R) Kerastick(R) and Territories covered by the Agreement.
In addition, in order to comply with Applicable Laws regarding the
investigation and evaluation of Product Complaints (defined below), ▇▇▇▇▇▇▇
and DUSA hereby agree to use mutually agreed-upon guidelines and procedures
to receive, evaluate, investigate and resolve all Product Complaints coming
to the attention of the Parties relating to any Product distributed in
countries for which they are responsible in accordance with the Product
Complaint Management Agreement, substantially in the form attached hereto
and made a part hereof as Exhibit I.C. For purposes of this SDEA, a Product
Complaint ("Product Complaint") is defined as any inquiry from a Third
Party that questions the purity, identity, potency, or quality of the
Product.
3
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.
The Parties further understand that the purpose of this SDEA is not to add
to, reduce, or otherwise modify the rights or obligations of either Party
under the Agreement, but to further define their respective roles, in
respect of the subject matter hereof. Each Party shall be responsible for
the costs and expenses associated with its respective obligations under
this SDEA.
D. Scope
This SDEA describes procedures and time frames, and defines
responsibilities that the Parties shall employ to protect patients, promote
their well-being and ensure, to the greatest extent possible, appropriate
and safe use of the Levulan(R) Kerastick(R). The requirements set forth in
this SDEA will also:
- Facilitate global compliance with worldwide regulatory safety
reporting requirements and guidelines
- Aid in the timely detection and investigation of potential safety
signals
- Help ensure the completeness and accuracy of the safety
information as found in the product labeling (e.g. "Local
Prescribing Information")
- Ensure global harmonization and consistency of safety information
- Prevent premature dissemination of safety information
- Optimize the decision making process in the event that an adverse
event is likely to have an impact on the benefit/risk balance of
the product
- Facilitate pharmacovigilance/risk management programs, as defined
as necessary by ▇▇▇▇▇▇▇ and ▇▇▇▇
E. Language
The Parties hereby agree that all communications shall be in English.
F. Reporting Contacts
All communications shall occur between the defined pharmacovigilance
contacts of each Party, or their documented delegates thereof.
For ▇▇▇▇▇▇▇ and DUSA contact information, refer to Appendix III.
Each Party is responsible for notifying the other Party regarding changes
in contact information within three (3) working days of the change.
II. Communications with Regulatory Authorities
A. Regulatory Reporting
All regulatory filings associated with Levulan(R) Kerastick(R) (for
example, without limitation, investigational new drug applications ("IND"),
clinical trial applications ("CTA"), new drug applications ("NDA"),
abbreviated new drug applications ("ANDA"), marketing authorizations
("MA"), and related amendments or supplements, or comparable
4
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.
filings with any relevant Regulatory Authority are the property of DUSA and
held in the name of DUSA or its designated Affiliate, except to the extent
such filings are held in the name of ▇▇▇▇▇▇▇ as provided in the Agreement.
DUSA is therefore responsible for fulfilling all safety reporting
obligations to Regulatory Authorities throughout the world. This includes
submissions of all individual adverse experience reports, aggregate
reports, e.g. US periodic adverse experience reports ("USPAERs"); periodic
safety update reports ("PSURs"), and other required reports to each IND,
CTA, NDA, ANDA, MA or supplements, thereto.
However, ▇▇▇▇▇▇▇ will be responsible for fulfilling all safety reporting
obligations to Regulatory Authorities within the specified Territory
according to the terms of the Agreement. DUSA shall generate the CIOMS line
listings, data summary tables, and other data required to prepare and
submit PSUR's from information provided by ▇▇▇▇▇▇▇, as necessary, and
▇▇▇▇▇▇▇ shall prepare and submit the PSURs in the Territory for submission
within the Territory.
If DUSA determines to conduct any clinical trial in the Territory with the
Levulan(R) Kerastick(R), the Parties will identify whether DUSA or ▇▇▇▇▇▇▇
will be the study sponsor who will then be responsible for reporting to
relevant ethics committees, Regulatory Authorities, the other Party, and
the investigators associated with the study, as well as preparation of
annual safety reports.
DUSA is responsible for maintaining the company core safety information
("CCSI"). The Parties agree to cooperate with each other by providing
safety information to fulfill their regulatory obligations in connection
with the marketing and sale of the Levulan(R) Kerastick(R).
The timeframe for these communications are detailed in Appendix IV.
B. Regulatory Inquiries
The Parties will notify each other in accordance with Section 4.5 of the
Agreement if either Party receives an inquiry from a Regulatory Authority
in the Territory concerning the manufacturing, marketing, promotion,
distribution, and/or detailing of the Product.
The timeframe for safety communications are detailed in Appendix IV.
C. Confidentiality of Information
DUSA and ▇▇▇▇▇▇▇ shall implement all reasonable physical, technical and
administrative safeguards to protect adverse event ("AE") information from
loss, misuse, and unauthorized access, disclosure, alteration or
destruction.
In addition, DUSA and ▇▇▇▇▇▇▇ shall collect, use and disclose AE
information solely for regulatory reporting purposes as described in this
procedure, and in compliance with Applicable Laws, including without
limitation, all applicable privacy and data protection laws, rules, and
regulations. Each Party shall promptly notify the other of any unauthorized
uses or disclosures of such information of which they become aware.
5
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.
III. Individual Case Safety Report Processing
A. Sales Representative Reporting & Other Personnel
▇▇▇▇▇▇▇ and DUSA agree to implement the necessary training, procedures and
mechanisms for the timely reporting of any ICSR or pregnancy report to a
Party that becomes known to the other Party, whether by their sales
representatives or other personnel, and which is associated with the
Levulan(R) Kerastick(R).
The timeframe for these communications are detailed in Appendix IV.
B. Translations
▇▇▇▇▇▇▇ shall be responsible for English translations of ICSRs, pregnancy
reports, or other data, information, or documents that fall within the
scope of this SDEA and within the Territory. DUSA shall be responsible for
English translations of ICSRs, pregnancy reports, or other data,
information, or documents that are reportable as part of an ICSR outside of
the Territory.
C. Individual Case Safety Reports, Pregnancy Reports, Study Findings and
Aggregate Data
ICSRs and pregnancy reports may originate from any source, such as for
example, healthcare professionals, Regulatory Authorities, literature,
consumers and patients, lawyers, clinical studies (including postmarketing
surveillance and epidemiological studies), non-interventional studies,
patient support programs, registries, internet, preclinical studies (e.g.
toxicological studies).
ICSRs include the following types of reports:
- Adverse Events/Adverse Reactions
- Product quality complaints, whether or not associated with an
Adverse Event
- Lack of efficacy (postmarketing only)
- Overdose (symptomatic or not)
- Misuse or abuse
- Cancer
- Medication errors, including potential errors due to trade name,
packaging or labeling issues
- Unintended beneficial effect
- Preclinical (i.e., nonhuman) findings
In addition to ICSRs, significant unexpected in vitro, animal or human
(clinical; epidemiological) study safety findings or aggregate data from
studies suggesting significant risk to humans (e.g., mutagenicity,
teratogenicity or carcinogenicity) of which either Party becomes aware
shall be provided to the other Party.
6
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.
All relevant safety information must be included in each ICSR, report of
study safety findings or aggregate safety data. ICSR reports shall conform
to all applicable regulatory requirements and shall, at a minimum, include
the following information: an identifiable reporter; patient identifier;
Adverse Event(s) and the product(s) involved. All reasonable efforts will
be expended by ▇▇▇▇▇▇▇ in the Territory and by DUSA outside of the
Territory in attempting to obtain this minimum information on ICSRs.
Full information on all reports of pregnancy (and experience during
lactation), even if not associated with an Adverse Event, shall be
collected and exchanged between the Parties as provided in Section E below.
DUSA and ▇▇▇▇▇▇▇ shall make all reasonable attempts to cooperate with each
other should clarification of any information be required, but DUSA, the
database holder, is responsible for maintaining and updating the database
with complete information.
The ICSRs will be provided in a format approved by DUSA for reporting in
the applicable Territories. If additional formats are required (e.g.,
MedWatch, or CIOMS) ▇▇▇▇▇▇▇ shall give DUSA one month's notice of this
requirement.
The timeframe for these communications are detailed in Appendix IV.
D. Causality Assessments
All ICSRs arising from spontaneous sources are considered to have an
implied association to Levulan(R) Kerastick(R) and will be managed within
the scope of this SDEA.
E. Follow-up Reports
DUSA shall request specific follow-up information as it may need to fulfill
its regulatory obligations. ▇▇▇▇▇▇▇ shall be responsible for acting on this
request and for obtaining follow-up information on all ICSRs and pregnancy
reports for Levulan(R) Kerastick(R) in the Territory according to its
internal practices and procedures. ▇▇▇▇▇▇▇ shall be responsible for
collecting good quality data from the reporter in the Territory.
F. Literature Reports
DUSA shall be responsible for regularly screening (i.e., bimonthly (every
two months)) the worldwide published scientific and medical literature by
accessing widely used systematic literature reviews or reference
database(s). Reports of ICSRs or pregnancy reports that appear either as
case reports or as the result of a formal clinical trial, or significant
unexpected in vitro, animal or human (clinical; epidemiological) study
safety findings or aggregate data from studies suggesting significant risk
to humans (e.g., mutagenicity, teratogenicity or carcinogenicity) and which
are associated with the use of Levulan(R) Kerastick(R) or of its active
constituent(s) qualify for processing. ▇▇▇▇▇▇▇ shall also conduct this
screening on a weekly basis and provide any relevant literature to DUSA.
DUSA shall include such literature in its database.
7
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.
Each Party is responsible for notifying the other Party, in accordance with
the time frames stipulated in Section IV.B., of any relevant ICSR,
pregnancy report, study safety finding or aggregate data that may come to
its attention via an unpublished scientific or conference paper. A copy of
the unpublished paper shall also be provided, and an English translation
(if the article is in a non English language), if available.
G. Product Complaints Associated with an ICSR or Pregnancy Report
The Parties shall cooperate in the investigation and resolution of any ICSR
or pregnancy report that questions the safety, purity, identity, potency,
or quality of the Levulan(R) Kerastick(R). Every effort should be made to
identify the lot and/or batch number for the product in question.
Each Party shall provide the other Party with all Product Complaints
associated with an ICSR or pregnancy in accordance with the same timeframes
as stipulated in Appendix IV.
H. Internet
DUSA shall regularly screen any web sites under its management or
responsibility for potential ICSRs or reports of pregnancy; however, DUSA
is not expected to proactively screen for ICSRs or pregnancy reports on any
external web site that it does not manage or for which it does not have
responsibility. Should DUSA become aware of an ICSR or a pregnancy report
on a web site that it does not manage or have responsibility for, the
report should be processed in accordance with the requirements set forth in
this SDEA.
I. Regulatory Authority Sourced Reports
ICSRs or pregnancy reports originating from any Regulatory Authority that
come to the attention of either Party must be submitted to the other Party
in accordance with the timeframes stipulated in this SDEA for ICSR.
J. Measures Taken to Protect Public Health; Product Recalls
Each Party shall immediately inform the other Party of any newly identified
safety issue or signal on Levulan(R) Kerastick(R), or any circumstance in
its Territory where an action may be required to protect public health.
Resultant actions by ▇▇▇▇▇▇▇ in the Territory may include, but are not
limited to, the issuance of "Dear Health Professional" letters, revisions
to the product label, or public statements regarding such actions; provided
however, that no such actions shall be taken by ▇▇▇▇▇▇▇ without the prior
written consent of DUSA which consent shall not be unreasonably withheld,
conditioned or delayed. In the event that such safety issue or signal
causes ▇▇▇▇▇▇▇ to discontinue marketing of the Product, then Section 4.5 of
the Agreement shall govern the actions of the Parties; provided, however,
that if ▇▇▇▇▇▇▇ believes in good faith that there is an immediate need to
discontinue marketing of the Product and to provide a public statement
announcing such discontinuance such that it is not feasible for the Parties
to confer, then ▇▇▇▇▇▇▇ may do so. DUSA is responsible for distribution of
notifications to Healthcare Professionals (e.g.
8
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.
Dear Doctor letter), the public or media on safety issues, except within
the Territory where the responsibility lies with ▇▇▇▇▇▇▇.
K. Product Recall.
(a) In the event the FDA, or other Regulatory Authority in the Territory
shall order (or appear reasonably likely to order) any Recall with respect
to the Product, and the cause of such Recall is due to (i) a breach by DUSA
of any of its representations, warranties, obligations, covenants or other
agreements contained in the Agreement or this SDEA, or its negligence or
willful misconduct then DUSA shall be liable, and shall reimburse ▇▇▇▇▇▇▇
for the reasonable out-of-pocket costs and expenses relating to or arising
out of such Recall including, but not limited to, replacing all of
▇▇▇▇▇▇▇'▇ effected inventory, or (ii) a breach by ▇▇▇▇▇▇▇ of any of its
representations, warranties, obligations, covenants or other agreements
contained herein, or its negligence or willful misconduct, then ▇▇▇▇▇▇▇
shall be liable and shall reimburse DUSA for its reasonable out-of-pocket
costs and expenses relating to or arising out of such Recall, including but
not limited to any Product not yet invoiced that must be destroyed;
provided that if both Parties share responsibility with respect to such
Recall, the costs shall be shared in the ratio of the Parties' contributory
responsibility.
(b) Either DUSA or ▇▇▇▇▇▇▇, after consultation by the executive officers
named in Section 4.5 of the Agreement, as amended, to discuss whether a
Recall is necessary, shall have the right to undertake any Recall of the
Product supplied hereunder for any reason that would cause (or appear
reasonably likely to cause) the FDA or other Regulatory Authority in the
Territory to order a Recall; provided however, if either Party believes in
good faith that there is need for an immediate Recall (as well as a public
statement announcing such Recall), such that it is not reasonable feasible
for the Parties to confer, then such Recall may be initiated without
consultation in advance of the initiation of such Recall, and if the cause
of such Recall is due to (i) a breach by DUSA of any of its warranties,
representations, obligations, covenants or other agreements contained in
the Agreement or herein, or its negligence or willful misconduct then DUSA
shall be liable, and shall reimburse ▇▇▇▇▇▇▇ for the reasonable
out-of-pocket costs and expenses relating to or arising out of such Recall,
including, but not limited to, replacing all of ▇▇▇▇▇▇▇'▇ effected
inventory or (ii) a breach by ▇▇▇▇▇▇▇ of any of its representations,
warranties, obligations, covenants or other agreements contained in the
Agreement or herein, or its negligence or willful misconduct, then ▇▇▇▇▇▇▇
shall be liable, and shall reimburse DUSA for its reasonable out-of-pocket
costs and expenses relating to or arising out of such Recall, including but
not limited to any Product not yet invoiced that must be destroyed;
provided that if both Parties share responsibility with respect to such
recall, the costs shall be shared in the ratio of the Parties' contributory
responsibility.
(c) ▇▇▇▇▇▇▇ and ▇▇▇▇ shall each maintain traceability records as are
sufficient and as may be necessary to permit a Recall of any Product.
▇▇▇▇▇▇▇ and DUSA agree that if either Party shall discover or become aware
of any fact, condition, circumstance or event (whether actual or potential)
concerning or related to the Product which may reasonably
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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.
require a Recall of the Product, such Party shall promptly communicate such
fact, condition, circumstance or event to the other Party as soon as
possible but in all instances within forty-eight (48) hours. In the event
(i) any Regulatory Authority or other governmental body requests that the
Product be Recalled, (ii) a court of competent jurisdiction orders such a
Recall, or (iii) ▇▇▇▇▇▇▇ or ▇▇▇▇ determines that the Product should be
Recalled from the market, the Parties shall take all appropriate remedial
actions with respect to such Recall of the Product. To the extent that it
is necessary to communicate with any third party, including but not limited
to any Regulatory Authority or other governmental body, the media, or any
customer of ▇▇▇▇▇▇▇, concerning any such fact, condition, circumstance or
event, a ▇▇▇▇▇▇▇ official shall be the primary contact person concerning
the Recall and remedial action. The obligations under this Section shall
survive the complete or partial termination of this Agreement.
Each Party shall make every reasonable effort to mitigate any costs or
expenses to be reimbursed by the other Party pursuant to this Section ▇.
▇. Line Listings
▇▇▇▇▇▇▇ shall provide DUSA with monthly line listings of Levulan(R)
Kerastick(R) Safety Data received during the previous month in the
Territory. A line listing shall be in CIOMS format.
DUSA shall generate CIOMS line listings and data summary tables from their
own data and information provided by ▇▇▇▇▇▇▇, as necessary, and ▇▇▇▇▇▇▇
shall prepare and submit the PSURs for submission in the Territory. In
addition, ▇▇▇▇▇▇▇ may request a confirmation from DUSA of its receipt of a
particular line listing. Such reports shall be requested no more often than
once a month. DUSA may also send these line listings unprompted to ▇▇▇▇▇▇▇.
In accordance with internal ▇▇▇▇▇▇▇ procedure, ▇▇▇▇▇▇▇ shall promptly
review this report, and take appropriate action, as necessary, to help
ensure compliance with the forwarding of future reports to DUSA.
DUSA may request line listing from ▇▇▇▇▇▇▇ on the same terms and conditions
stated above.
IV. Product Complaint Management
The Parties will cooperate to develop procedures to facilitate management,
investigation and reporting of Product Complaint Issues.
V. Retained Samples
A. Product Retained Samples
Product samples will be retained as specified in the Product Complaint
Management Agreement.
VI. Reporting Timeframes
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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. Overview
A table summarizing the reporting time frames for exchanging information
pertaining to ICSRs, pregnancy reports, and other information, as
stipulated in the various sections of this agreement, may be found in
Appendix IV.
B. Reporting Requirements
The regulatory reporting time clock for submitting ICSR, pregnancy reports,
and all other stipulated safety information to DUSA or ▇▇▇▇▇▇▇, as the case
may be, shall begin on the date when notice is first received by ▇▇▇▇▇▇▇ or
DUSA of a case report that fulfills the minimum criteria for a case report
as defined in Section IIIC. The date of first receipt must be recorded on
each report by the receiving Party and sent to the other Party, or in the
case of a follow up report, the date of receipt of the follow up
information must be recorded on each report by the Party following-up on
the information and then it shall be submitted to the other Party. For
regulatory reporting purposes, the date of receipt of the initial notice is
considered to be Calendar Day zero (0).
Upon notification of an initial ICSR, pregnancy report, study safety
findings or aggregate data or upon receipt of new follow-up information,
regardless of source, the receiving Party shall report to the other Party
within the time frames outlined in Appendix IV.
To ensure compliance with the timeframes required by this SDEA, and in
emergency situations, the receiving Party shall contact the other Party by
telephone, followed by the required written correspondence.
C. Record Keeping
Both Parties agree to maintain a record of each ICSR in the Territory and
communications associated with each such ICSR, which shall at least
include:
1. A copy of each Adverse Event or other safety report
2. The date the report was received by the receiving Party
3. The date the report was submitted to the other Party
4. The name and address of the Party recipient and a copy of the confirmation
sent by receiving Party to the other Party
5. Record log of any and all attempts by the receiving Party to follow-up for
additional ICSR information
DUSA and ▇▇▇▇▇▇▇ shall keep records for a minimum of 10 years and will not
discard any applicable safety documents without prior agreement of the
other Party.
VII. Safety Database
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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.
DUSA is responsible for maintaining a worldwide electronic safety database,
which will include records of:
- Serious ICSRs from clinical trials;
- All ICSRs from spontaneous and literature sources
- Pregnancy reports originating from either clinical trial,
spontaneous, or literature sources.
Direct access to this database shall not be granted to ▇▇▇▇▇▇▇, but all
reasonable assistance shall be provided by DUSA to ▇▇▇▇▇▇▇, as required,
for ▇▇▇▇▇▇▇'▇ reporting obligations.
VIII. Written Procedures
Both Parties shall keep on file in its own manner, and in accordance with
required regulatory practice, written standard operating procedures
("SOP"s), working practices, and all correspondence, documents, and other
information pertaining to the Levulan(R) Kerastick(R). These written
procedures shall designate the responsibilities and obligations that each
Party undertakes in its part of the world. DUSA and ▇▇▇▇▇▇▇ shall ensure
that their SOPs and working practices enable compliance with the
requirements of this document.
Further, in case either Party makes any request concerning the other
Party's SOPs, working practices, and all correspondence, documents, and
other information pertaining to Levulan(R) Kerastick(R), the Parties' shall
cooperate with each other, within reason, by complying with the request.
Each Party also agrees to conduct business in accordance with its own SOPs
and working practices for pharmacovigilance activities.
IX. QA Audit
The Parties will conduct periodic quality assurance auditing in accordance
with Section 17 of the Agreement.
X. Terms of this Agreement
If applicable regulatory requirements change, or there is disagreement
regarding the interpretation of any aspect of this SDEA, or either Party
requests a review of this SDEA due to issues or conflicts involving legal
or regulatory requirements, the Parties agree to review, and negotiate
amendment(s) in good faith, as appropriate, the terms of this contract.
Otherwise, the Parties also agree to review and revise this SDEA, if
necessary, for other mutually agreeable reasons every two years.
Renegotiation/review shall be considered complete when ▇▇▇▇▇▇▇ and DUSA
have mutually agreed to a written SDEA or addendum, and both Parties sign
it.
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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.
This SDEA supersedes any previous versions, and is effective upon
signatures by authorized representatives of both Parties. Each Party is
bound by its requirements, and it is in effect until both Parties agree to
terminate the SDEA or the Agreement is terminated. In the event the
Agreement is terminated, the Parties agree to implement the necessary
procedures and practices to ensure adverse event reporting obligations are
fulfilled for Levulan(R) Kerastick(R) that remains in the marketplace.
Neither Party shall be required to adhere to any requirement set forth in
this SDEA, or take or refrain from taking any action whatsoever that is
inconsistent with any applicable national or international regulatory
requirement.
There can be no use of any information covered by this SDEA for any purpose
not contemplated by this SDEA.
******
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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, the Parties have executed this Agreement by their duly
authorized representatives as of the date last written below.
▇▇▇▇▇▇▇ LABORATORIES, INC. DUSA PHARMACEUTICALS, INC.
By: /s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ By: /s/ ▇▇▇▇▇▇▇ ▇. O'Dell
--------------------------------- ------------------------------------
Name and Title: ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ Name and Title: ▇▇▇▇▇▇▇ ▇. O'Dell
Chief Commercial Executive Vice President, Sales and
Officer Marketing
Date: September 26, 2007 Date: September 26, 2007
[Signature Page to SDEA]
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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.
APPENDIX I: TERMINOLOGY AND DEFINITIONS
TERM ICH
------------------------------ ---------------------------------------------------------
ADVERSE EVENT (OR ADVERSE Post Marketing: An adverse event is any untoward medical
EXPERIENCE) (AE) occurrence in a patient administered a medicinal product
and which does not necessarily have to have a causal
relationship with this treatment. An adverse event can
therefore be any unfavorable and unintended sign (for
example, an abnormal laboratory finding), symptom, or
disease temporally associated with the use of a medicinal
product, whether or not considered related to this
medicinal product. (E2D)
ADVERSE REACTION Post Marketing: Adverse drug reactions, as established by
regional regulations, guidance, and practices, concern
noxious and unintended responses to a medicinal product.
The phrase "responses to a medicinal product" means that
a causal relationship between a medicinal product and an
adverse event is at least a reasonable possibility (refer
to the ICH E2A guideline).
A reaction, in contrast to an event, is characterized by
the fact that a causal relationship between the drug and
the occurrence is suspected. For regulatory reporting
purposes, if an event is spontaneously reported, even if
the relationship is unknown or unstated, it meets the
definition of an adverse drug reaction. (E2D)
ASSOCIATED WITH THE USE OF THE Post Marketing: For purposes of reporting, adverse event
DRUG/CAUSALITY ASSESSMENT reports associated with marketed drugs (spontaneous
reports) usually imply causality. (E2A)
DISABILITY Postmarketing: Results in persistent or significant
disability/incapacity (E2D)
LIFE-THREATENING Post Marketing: The term "life-threatening" in the
definition of "serious" refers to an event/reaction in
which the patient was at risk of death at the time of the
event/reaction; it does not refer to an event/ reaction
which hypothetically might have caused death if it were
more severe. (E2D)
RECALL Any recall, market withdrawal or general corrective
action procedures relating to the Product, whether
voluntary or involuntary.
REPORTABLE ADVERSE REACTION - Post Marketing: The minimum data elements for an ADR case
MINIMUM INFORMATION are: an identifiable reporter, an identifiable patient,
an adverse reaction, and a suspect product. (E2D)
SPONTANEOUS REPORT An unsolicited communication to a company, regulatory
authority, or other organization that describes an
adverse reaction in a patient given one or more medicinal
PRODUCTS and which does not derive from a study or any
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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.
organized data collection scheme. (E2C)
An unsolicited communication by a healthcare
professional or consumer to a company, regulatory
authority or other organization (e.g. WHO, Regional
Center, Poison Control Center) that describes one or more
adverse drug reactions in a patient who was given one or
more medicinal PRODUCTS and that does not derive from a
study or any organized data collection scheme.
Stimulated reporting can occur in certain situations,
such as notification by a "Dear Healthcare Professional"
letter, publication in the press, or questioning of
healthcare professionals by company representatives.
These reports should be considered spontaneous. Consumer
adverse reaction reports should be handled as spontaneous
reports irrespective of any subsequent "medical
confirmation". Regulatory Authorities might require
medical confirmation for the purpose of expedited
reporting. Emphasis should be placed on the quality of
the report and not on its source. Even if reports
received from consumers do not qualify for regulatory
reporting, the cases should be retained. (E2D)
TERRITORY 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. ▇▇▇▇▇▇▇, Granada,
Bahamas, Aruba, Bonaire, Curacao, Trinidad, Tobago,
Bermuda, and Belize), Paraguay and Uruguay.
UNEXPECTED Post Marketing: An ADR whose nature, severity,
specificity, or outcome is not consistent with the term
or description used in the local/regional product
labeling (e.g. Package Insert or Summary of Product
Characteristics) should be considered unexpected. (E2D)
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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.
APPENDIX II: ABBREVIATIONS
AE Adverse Event
ANDA Abbreviated New Drug Application
CIOMS Council for International Organizations of Medical Sciences
CFR Code of Federal Regulations
CTA Clinical Trials Applications
EEA European Economic Area
FDA Food and Drug Administration
ICH International Conference on Harmonization
ICH E2A ICH Guideline on Clinical Safety Data Management
ICH E2C ICH Guideline on Clinical Safety Data Management:
Periodic Safety Update Reports for Marketed Drugs
ICH E2D ICH Guideline on Post-Approval Safety Data Management:
Definitions and Standards for Expedited Reporting
ICSR Individual Case Safety Report
IND Investigational New Drug
MA Marketing Authorization
NDA New Drug Application
PSURS Periodic Safety Update Reports
US PERIOD REPORT United States Periodic Adverse Experience Reports
SDEA Safety Data Exchange Agreement
SOP Standard Operating Procedure
US United States
WHO World Health Organization
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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.
APPENDIX III: CONTACTS
▇▇▇▇▇▇▇ LABORATORIES, INC DDUSA PHARMACEUTICALS, INC.
------------------------- ---------------------------
ADVERSE EVENT REPORTING/PROCESSING
ALL ADVERSE INFORMATION MUST BE ALL ADVERSE INFORMATION MUST BE E-MAILED
E-MAILED DIRECTLY TO THE FOLLOWING DIRECTLY TO THE FOLLOWING E-MAIL ADDRESS
E-MAIL ADDRESS OR CAN BE FAXED TO A OR CAN BE FAXED TO A NUMBER PROVIDED TO
NUMBER PROVIDED TO YOU BY THE YOU BY THE PHARMACOVIGILANCE CONTACT:
PHARMACOVIGILANCE CONTACT:
▇▇▇▇▇▇▇.▇▇▇▇▇@▇▇▇▇▇▇▇.▇▇▇ [C.I.]
[C.I.]
BRAZIL PHARMACOVIGILANCE CONTACT: DIRECTOR, REGULATORY AFFAIRS
[C.I.] ▇▇ ▇▇▇▇▇ ▇▇▇▇▇
TEL: [C.I.] ▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇, ▇▇▇
PHONE (▇▇▇) ▇▇▇-▇▇▇▇ [C.I.]
UK Pharmacovigilance contact: FAX: (978) [C.I.]
[C.I.]
Tel: [C.I.]
US Pharmacovigilance contact:
[C.I.]
Tel: [C.I.]
[C.I.]
QP Pharmacovigilance in Europe:
[C.I.]
Tel [C.I.]
[C.I.]
MEDICAL OVERSIGHT/MANAGEMENT
GLOBAL DIRECTOR PHARMACOVIGILANCE: [C.I.]
[C.I.] DIRECTOR, REGULATORY AFFAIRS
Tel [C.I.] ▇▇ ▇▇▇▇▇ ▇▇▇▇▇
[C.I.] ▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇, ▇▇▇
PHONE (▇▇▇) ▇▇▇-▇▇▇▇ [C.I.]
FAX: (978) [C.I.]
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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.
SAFETY DATA EXCHANGE AGREEMENT ISSUES
[C.I.] [C.I.]
Associate Director, Drug Safety VICE PRESIDENT REGULATORY AFFAIRS AND
Tel: [C.I.] INTELLECTUAL PROPERTY
Email: [C.I.] ▇▇ ▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇, ▇▇▇
PHONE (▇▇▇) ▇▇▇-▇▇▇▇ [C.I.]
FAX: (978) [C.I.]
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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.
APPENDIX IV: TIMEFRAMES FOR THE EXCHANGE OF SAFETY INFORMATION BETWEEN PARTIES
ICSRS (AND PREGNANCY REPORTS)
REPORT TYPE RESPONSIBLE PARTY TIMEFRAME FORMAT METHOD
----------- ----------------- ---------------------- ------------- -------------------------
All serious ICSRs ▇▇▇▇ - ▇▇▇▇▇▇▇ Three (3) working days Source e-mail to:
documentation ▇▇▇▇▇▇▇.▇▇▇▇▇@▇▇▇▇▇▇▇.▇▇▇
e-mail to:
▇▇▇▇▇▇▇ - ▇▇▇▇ ▇▇▇▇▇▇▇▇@▇▇▇▇▇▇▇▇▇▇.▇▇▇
Non-serious ICSRs and pregnancies* ▇▇▇▇ - ▇▇▇▇▇▇▇ Five (5) working days Source e-mail to:
documentation ▇▇▇▇▇▇▇.▇▇▇▇▇@▇▇▇▇▇▇▇.▇▇▇
▇▇▇▇▇▇▇ - ▇▇▇▇
e-mail to:
▇▇▇▇▇▇▇▇@▇▇▇▇▇▇▇▇▇▇.▇▇▇
* If follow-up data changes a report status from non-serious to serious, the
timeframe for reporting serious ICSRs should be observed.
REPORTS AND ACTIONS ON A REGULAR BASIS
ITEM RESPONSIBLE PARTY FORMAT INTERVAL ETC.
---- ----------------- ------------------ --------------------------------
Monthly Report ▇▇▇▇▇▇▇ - ▇▇▇▇ Line listing Monthly
▇▇▇▇ - ▇▇▇▇▇▇▇
Ad Hoc Report Line listing Five (5) working days
▇▇▇▇▇▇▇ - ▇▇▇▇
Acknowledgments of ICSRs submitted
to DUSA/▇▇▇▇▇▇▇ ▇▇▇▇ - ▇▇▇▇▇▇▇ Individual receipt On a case by case basis
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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.
ICSRs and pregnancy reports ▇▇▇▇ - ▇▇▇▇▇▇▇
submitted to ▇▇▇▇▇▇▇/DUSA Line listing Monthly
outside of agreed time frames ▇▇▇▇▇▇▇ - ▇▇▇▇
▇▇▇▇ - ▇▇▇▇▇▇▇
Review of this agreement Renewed agreement For the period of this Agreement
▇▇▇▇▇▇▇ - ▇▇▇▇
NOTIFICATIONS AND ACTIONS ON AN AS-NEEDED/AD HOC BASIS
EVENTS TO BE NOTIFIED RESPONSIBLE PARTY TIMEFRAME
--------------------- ----------------- ------------------------------------
Changes in reporting contacts ▇▇▇▇ - ▇▇▇▇▇▇▇ Within 3 working days of the change.
▇▇▇▇▇▇▇ - ▇▇▇▇
Submissions to regulatory authorities ▇▇▇▇▇▇▇/DUSA Per regulations
▇▇▇▇ - ▇▇▇▇▇▇▇
Notification of a regulatory authority Three (3) working days
request for safety information ▇▇▇▇▇▇▇ - ▇▇▇▇
Response to regulatory authority ▇▇▇▇▇▇▇ As finalized
request for safety information
▇▇▇▇ - ▇▇▇▇▇▇▇
Regulatory inspection of the Immediately (within 24 hours)
Pharmacovigilance Dept. ▇▇▇▇▇▇▇ - ▇▇▇▇
▇▇▇▇ - ▇▇▇▇▇▇▇
Newly identified safety signals Immediately (within 24 hours)
▇▇▇▇▇▇▇ - ▇▇▇▇
-21-
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.
EXHIBIT I.C.
PRODUCT COMPLAINT MANAGEMENT AGREEMENT
BETWEEN
▇▇▇▇▇▇▇ LABORATORIES, INC.
AND
DUSA PHARMACEUTICALS, INC.
REGARDING
LEVULAN(R) KERASTICK(R)
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. GENERAL
1.1. Background.
▇▇▇▇▇▇▇ Laboratories, Inc. (hereinafter referred to as "▇▇▇▇▇▇▇") and
DUSA Pharmaceuticals, Inc. (hereinafter referred to as "DUSA") entered into a
Marketing, Distribution and Supply Agreement as of the 12th day of January 2006,
as amended September 26, 2007 (the "Agreement"). This Product Complaint
Management Agreement ("PCMA") shall, when signed by all Parties, be an addendum
to the Agreement and Exhibit I.C. to the Safety Data Exchange Agreement dated
September 26, 2007, between the Parties (the "SDEA").
▇▇▇▇▇▇▇ and ▇▇▇▇ may hereinafter be individually referred to as "the
Party" and collectively as "the Parties".
1.2. Terminology and Definitions.
The Parties agree that the purpose of this PCMA is not to add to,
reduce, or otherwise modify, the rights or obligations of either Party under the
Agreement, but to further define their respective roles, in respect of the
subject matter hereof.
Any capitalized terms used herein, not otherwise defined, shall have
the meaning set forth in the Agreement, or SDEA. In the event that a discrepancy
arises between the terms of this PCMA, the SDEA and/or the Agreement, the terms
of the Agreement shall control.
1.3. Purpose.
In order to comply with Applicable Laws regarding the investigation
and evaluation of Product Complaints (defined below), ▇▇▇▇▇▇▇ and DUSA hereby
agree, through the implementation of this PCMA, to use mutually agreed-upon
guidelines and procedures to receive, evaluate, investigate and resolve all
Product Complaints coming to the attention of the Parties relating to any
Product distributed in the Territories. For purposes of this PCMA, a Product
Complaint ("Product Complaint") is defined as any inquiry from a Third Party
that questions the purity, identity, potency, or quality of the Product.
1.4. Language.
The Parties hereby agree that all communications shall be in English.
-1-
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. PRODUCT COMPLAINT MANAGEMENT PROCEDURE
2.1. Product Complaint Notification.
2.1.1. ▇▇▇▇▇▇▇ shall have primary responsibility for fielding Product
Complaint calls from customers in the Territory and for
responding to the customers with the final resolution of the
Product Complaint. Product Complaint calls received directly by
DUSA from ▇▇▇▇▇▇▇'▇ customers regarding the Products will be
forwarded to ▇▇▇▇▇▇▇'▇ compliance contact designated in Appendix
III of the SDEA. Every effort should be made to identify the lot
and/or batch number and quantity of Product involved, under what
conditions the Product was being administered, the name, model
and serial number of the light source used, and the treatment
protocol followed, for each Product Complaint in question.
2.1.2. Any Party receiving a Product Complaint shall notify the other
Party by contacting the person(s) listed on the contact list
attached hereto as Attachment 1, no later than three (3) working
days after receipt of any Product Complaint.
2.1.3. ▇▇▇▇▇▇▇ shall send and cause its sub-distributors to send to
DUSA any returned Product Complaint field specimens of the
Product for its investigation within ten (10) calendar days of
receipt of the Product Complaint with the exception of Product
exposed to blood borne pathogens which should not be returned to
DUSA.
2.2. Reporting Contacts.
2.2.1. Each Party shall report Product Complaint information to the
other Party in accordance with the Notices provisions of the
Agreement; provided however, that the Parties may establish
Product Complaint specific contacts upon mutual, written
agreement.
2.2.2. Each Party shall notify the other Party regarding changes in
Product Complaint specific contact information within three (3)
working days of the change.
2.3. Product Complaint Investigation Procedure.
2.3.1. DUSA shall have primary responsibility for investigating the
alleged Product defect or failure that is the cause of the
Product Complaint, and report the results to ▇▇▇▇▇▇▇ within
thirty (30) calendar days of the Product being returned. Such
investigations shall attempt to: (1) identify any root causes for
the Product Complaint, if any; and (2) identify any corrective
and preventative actions, if necessary.
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 the event that DUSA, either independently or in consultation
with ▇▇▇▇▇▇▇, determines that additional physical, chemical,
microbial or other evaluation should be conducted by DUSA in
relation to an Adverse Event or Product Complaint, DUSA will
conduct the necessary evaluation and report the results to
▇▇▇▇▇▇▇ within thirty (30) calendar days of receipt of the
Product being returned or from the date a decision to investigate
is made, which ever is later, based on anticipated standard
laboratory turn-around time.
2.4. Follow-up Reports.
In the event that DUSA is required under Applicable Laws to report
Product Complaints to any Regulatory Authority in the Territories, DUSA shall
have the right to request specific follow-up information from ▇▇▇▇▇▇▇, and
▇▇▇▇▇▇▇ shall the obligation to provide to DUSA such information as necessary
and as reasonably available.
2.5. Recalls.
Recalls shall be conducted pursuant to the terms of the SDEA.
3. RETAINED SAMPLES
3.1. Product Retain Samples.
DUSA or its approved designee will retain sufficient samples as
required by Applicable Laws, or if no such Applicable Law exists, in accordance
with best industry practices, from each batch of Product manufactured and
supplied to ▇▇▇▇▇▇▇ to conduct two (2) complete testings (excluding Microbiology
and sterility testing, if applicable) in accordance with the approved
specifications for the finished dosage form. These retained samples will be
maintained for at least one (1) year beyond the expiry date of the Product.
3.2. API Retain Samples.
DUSA will retain sufficient samples of the active pharmaceutical
ingredient (the "API") as required by Applicable Laws, or if no such Applicable
Law exists, in accordance with best industry practices, from each lot of raw
material used in the manufacture of the Products to conduct two (2) complete
testings of the material. Retained chemical samples will be maintained for at
least one (1) year beyond the expiry date of any Product manufactured from that
lot.
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.
4. REGULATORY INQUIRIES
The Parties will notify each other in accordance with Section 2.2 of
this PCMA if either Party receives an inquiry from any Regulatory Authority in
the Territory concerning any Product Complaint for the Product.
5. CONFIDENTIALITY OF INFORMATION
DUSA and ▇▇▇▇▇▇▇ shall implement all reasonable physical, technical
and administrative safeguards to protect Product Complaint information from
loss, misuse, and unauthorized access, disclosure, alteration or destruction.
In addition, DUSA and ▇▇▇▇▇▇▇ shall collect, use and disclose Product
Complaint information solely for regulatory reporting purposes as required under
Applicable Laws, including all applicable privacy and data protection laws,
rules, and regulations. Each Party agrees to promptly notify the other of any
unauthorized uses or disclosures of such information of which they become aware.
6. RECORD KEEPING
DUSA and ▇▇▇▇▇▇▇ shall both keep all records associated with the
receipt, investigation, evaluation and resolution of any Product Complaint for
five (5) years.
7. QA AUDITS
The Parties agree that ▇▇▇▇▇▇▇ shall have the right to conduct an
audit of DUSA's facilities, documentation and systems relating to: (1) DUSA's
Product Complaint investigational systems; and/or (2) DUSA's Adverse Event
reporting responsibilities as described in the Safety Data Exchange Agreement
between ▇▇▇▇▇▇▇ and ▇▇▇▇. All audits shall be conducted in accordance with the
rights and limitations provided in Section 17 of the Agreement.
▇▇▇▇▇▇▇ will comply with any audit request of DUSA to make available
all documents, electronic or paper, and completely answer questions relating to
the activities as defined in this PCMA on reasonable advance notice to ▇▇▇▇▇▇▇,
and in accordance with Section 17 of the Agreement.
8. INTERPRETATION; MISCELLANEOUS TERMS
8.1. Interpretative Rules.
If applicable regulatory requirements change, or there is disagreement
regarding the interpretation of any aspect of this PCMA, or either Party
requests a review of this PCMA due to issues or conflicts involving legal or
regulatory requirements, the Parties agree to review, and
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.
renegotiate, as appropriate, the terms of this contract. Otherwise, the Parties
also agree to review and revise this PCMA, if necessary, for other mutually
agreeable reasons every two years. Renegotiation/review shall be considered
complete when ▇▇▇▇▇▇▇ and DUSA have mutually agreed to a written PCMA or
addendum, and both Parties sign it. There can be no use of any information
covered by this PCMA for any purpose not contemplated by this PCMA.
8.2. Entire Agreement.
This PCMA supersedes any previous versions, and is effective upon
signatures by authorized representatives of both Parties. This PCMA shall remain
in effect unless the Parties agree to terminate the PCMA or the Agreement
terminates. In the event the PCMA or the Agreement is terminated, the Parties
agree to implement the necessary procedures and practices to ensure that any
Product Complaint received following the date of such termination is properly
investigated.
8.3. Compliance with Applicable Laws.
Neither Party shall be required to adhere to any requirement set forth
in this PCMA, or take or refrain from taking any action whatsoever that is
inconsistent with Applicable Laws, or any international regulatory requirement.
****
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, the Parties have executed this Agreement by their duly
authorized representatives as of the date last written below.
▇▇▇▇▇▇▇ LABORATORIES, INC. DUSA PHARMACEUTICALS, INC.
By: /s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ By: /s/ ▇▇▇▇▇▇▇ ▇. O'Dell
--------------------------------- ------------------------------------
Name and Title: ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ Name and Title: ▇▇▇▇▇▇▇ ▇. O'Dell
Chief Commercial Executive Vice
Officer President, Sales and
Marketing
Date: September 26, 2007 Date: September 26, 2007
[Signature Page to the Product Complaint Management Agreement]
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.
Attachment 1
Contact List
Customer: ▇▇▇▇▇▇▇ LABORATORIES, INC. Contractor: DUSA PHARMACEUTICALS, INC.
------------------------------------------------- ---------------------------------------
Responsibility Address Responsibility Address
----------------------- ----------------------- -------------- ----------------------
Manufacturing Quality - Name: [c.i.] All Matters [c.i.]
Brazil - SBL Phone: [c.i.] Phone:
978.657.7500 Ext. [c.i.]
Manufacturing Quality - Name: [c.i.]
Mexico - SMX Phone: [c.i.]
Quality - others Name: [c.i.]
Latin America Phone: [c.i.]
Sites ext [c.i.]