EXHIBIT 10(mm)
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
MARKETING, DISTRIBUTION AND SUPPLY AGREEMENT
AMONG
DUSA PHARMACEUTICALS, INC.,
DAEWOONG PHARMACEUTICAL CO., LTD.,
AND
DNC
DAEWOONG DERMA & PLASTIC SURGERY NETWORK COMPANY
DATED
January 4, 2007
EXHIBIT 10(mm)
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
MARKETING, DISTRIBUTION AND
SUPPLY AGREEMENT (the “Agreement”) made as of the
4th day of January, 2007 (the “Effective Date” )
among DUSA PHARMACEUTICALS, INC. , a New Jersey corporation
having a principal office and place of business at 25 Upton Drive,
Wilmington, Massachusetts, USA 01887 (hereinafter called “
DUSA” ), and DAEWOONG PHARMACEUTICAL CO., LTD ,
a Korean corporation having a principal office and place of
business at 163-3 Samsung-dong Gangnam-gu, Seoul, Korea,
(hereinafter called “ DAEWOONG ”) and DNC
DAEWOONG DERMA & PLASTIC SURGERY NETWORK COMPANY , a
wholly-owned Korean subsidiary of DAEWOONG PHARMACEUTICAL CO.,
LTD having a prinicipal office and place of business at 163-3
Samsung-dong Gangnam-gu, Seoul, Korea (hereinafter called “
DNC ” and collectively with DAEWOONG
hereinafter called “D&D” ).
WHEREAS, DUSA is engaged in
the development, manufacture and sale of pharmaceutical products
and wishes to market certain of its products in the Territory (as
such term is defined below);
WHEREAS, D&D is a
pharmaceutical company that distributes and sells pharmaceutical
products in the Territory and desires to obtain an exclusive right
to, distribute, promote, and sell in the Territory the Products as
such term is defined manufactured by DUSA;
WHEREAS, DUSA has agreed,
subject to the terms and conditions of the Agreement, to grant
D&D an exclusive right to distribute, promote, and sell such
Product in the Territory and to manufacture and supply to D&D
on an exclusive basis in the Territory all of D&D’s
reasonable requirements of the Product;
WHEREAS, D&D has agreed
to undertake the distribution, promotion, and sale of such Products
in the Territory, and will purchase the Product exclusively from
DUSA in accordance with the terms and conditions of this Agreement;
and
WHEREAS, the Parties also
wish to memorialize the understanding between them with respect to
DUSA’s grant to D&D of a license to use the DUSA
Trademarks on the DUSA labeled Products in connection with the
marketing and sale of the Product in the Territory under the terms
and conditions of the Agreement.
NOW, THEREFORE, the Parties
agree as follows:
1.
DEFINITIONS.
For the purposes of this Agreement,
capitalized terms used but not otherwise defined in this Agreement
shall have the meanings set forth in this Section 1:
1.1 “Affiliates”
shall mean any Person (defined below) which directly or indirectly
controls, is controlled by, or under common control with a Party to
this Agreement. For purposes
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been requested for this confidential information. The confidential
portions have been omitted and filed separately with the Securities
and Exchange Commission.
of the
foregoing definition, the term “control” (including
with correlative meaning, the terms “controlling”,
“controlled by”, and “under common control
with”) as used with respect to any Person, shall mean
(i) in the case of corporate entities, direct or indirect
ownership of at least [C.I.] of the stock or shares entitled
to vote for the election of directors; and (ii) in the case of
non-corporate entities, direct or indirect ownership of
[C.I.] of the equity interest or the possession, directly or
indirectly, of the power to direct or cause the direction of the
management and policies of such Person, whether through ownership
of voting securities, by contract, or otherwise.
1.2 “Applicable
Laws” shall mean all applicable laws, statutes, rules,
regulations and guidelines that may apply to the sale of the
Product in the Territory or the promotion, marketing, packaging,
labeling, importation, exportation, warehousing or distribution of
a Product that is to be sold in the Territory or the performance of
any Party’s obligations under this Agreement, and including
all good manufacturing practices and all applicable standards or
guidelines promulgated by the appropriate Regulatory
Authority.
1.3 “Approved
Product” shall mean any Product that shall have been
granted all necessary approvals by the required Regulatory
Authorities to allow DUSA and/or D&D, as the case may be, the
right to sell and distribute, promote, and sell the Product in any
country in the Territory.
1.4 “Batch” , with
respect to any of the Product, shall mean a separate and distinct
quantity of such Product processed under continuous and identical
conditions and designated by a batch number.
1.5 “Certificate of
Conformance” shall mean a document, which is dated and
signed by a duly authorized representative of the Quality Control
or Quality Assurance Department of DUSA, certifying that a Batch of
any Product meets all Specifications.
1.6 “ Commercially
Reasonable Efforts ” means the channels, methods and
diligence that a Party employs with respect to other products sold
by it (including its own products) of the same or similar
commercial potential.
1.7 “ Competing Products
” shall mean the products identified on
Schedule A attached hereto as Competing Products.
1.8 “ Confidential
Information ” means with respect to a Party, all
information of any kind whatsoever (including without limitation,
data, compilations, formulae, models, patent disclosures,
procedures, processes, projections, protocols, results of
experimentation and testing, specifications, strategies,
techniques, business and financial information, projections,
customer lists, and all non-public intellectual property rights,
and all tangible and intangible embodiments thereof of any kind
whatsoever (including without limitation, apparatus, compositions,
documents, drawings, machinery, patent applications, records and
reports)), and all business information, financial data,
projections, customer lists which is disclosed by such Party to the
other Parties.
1.9 “ Domain Names and
Websites ” shall mean those domain names and website
agreed upon by the Parties through which the Products shall be
marketed by D&D hereunder.
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been requested for this confidential information. The confidential
portions have been omitted and filed separately with the Securities
and Exchange Commission.
1.10 “DUSA
Trademarks” shall mean the DUSA Trademarks set forth on
Schedule A hereto, as such Schedule may be amended from
time to time by mutual agreement of the Parties.
1.11 “FDA” shall
mean the U.S. Food and Drug Administration, or any successor
body.
1.12 “Field” shall
mean all current and future uses of the Products for dermatology
indications.
1.13 “First Approval
Date” shall mean the date on which DUSA, or D&D, as
the case may be, first obtains approval to market a Product from a
Regulatory Authority in the Territory.
1.14 “GMP” shall
mean good manufacturing practices as required by the rules and
regulations of the applicable Regulatory Authority.
1.15 “Indemnified
Party” shall have the meaning set forth in
Section 14.3(a).
1.16 “Indemnifying
Party” shall have the meaning set forth in
Section 14.3 (a).
1.17 “Independent
Laboratory” shall have the meaning set forth in
Section 9.4.
1.18 “Launch Date”
, as to each Approved Product, shall mean that date on which
marketing and distribution of such Approved Product shall commence
in a given country in the Territory.
1.19 “Launch
Notice” shall have the meaning set forth in
Section 7.3(a).
1.20 “Minimum Purchase
Obligations” shall have the meaning set forth in
Section 7.2(a).
1.21 “Objection
Notice” shall have the meaning set forth in
Section 9.4.
1.22 “Party” means
DAEWOONG, DNC, and DUSA, individually, and
“Parties” means DAEWOONG, DNC and DUSA,
collectively.
1.23 “ Person ”
shall mean an individual, corporation, partnership, limited
liability company, firm, association, joint venture, estate, trust,
governmental or administrative body or agency, or any other
entity.
1.24 “Product”
shall mean the product set forth on Schedule A .
1.25 “Product Alliance
Manager” shall have the meaning set forth in
Section 5.1.
1.26 “Purchase Price Per
Unit” shall have the meaning set forth on
Schedule C attached hereto.
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[c.i.] ” to indicate that confidential treatment has
been requested for this confidential information. The confidential
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and Exchange Commission.
1.27
“Registration” shall mean the regulatory
approvals of any applicable Regulatory Authorities issued in
DUSA’s name (or in either DAEWOONG’s or DNC’s
name, if DUSA agrees in writing) and necessary to permit the
commencement of the marketing and sale of the Product in any
country in the Territory.
1.28 “Regulatory
Authority” means any and all bodies and organizations
regulating the manufacture, importation, distribution, use and sale
of the Product in any country in the Territory.
1.29 “Report”
shall have the meaning set forth in Section 9.4.
1.30
“Specifications” of Product means the
specifications for the Product as approved by the FDA. The
Specifications may be amended from time to time by written
agreement between the Parties and as specifically requested by
applicable Regulatory Authorities.
1.31 “Technical
Information” shall mean the manufacturing process and any
and all technical knowledge, trade secrets, analytical methodology,
processes, manufacturing and toxicological information, and any and
all other technical information or experience related to the
manufacturing of the Product.
1.32 “Term” shall
have the meaning set forth in Section 18.1.
1.33 “Territory”
shall mean Korea, Taiwan, China, including without limitation Hong
Kong, India, Indonesia, Malaysia, Philippines, Singapore, Thailand
and Vietnam.
1.34 “Third Party”
means any party other than DUSA, DAEWOONG, or DNC, or their
respective Affiliates.
1.35 “Third Party
Loss” shall have the meaning set forth in
Section 14.1.
1.36 “Trademark Infringement
Claims” shall have the meaning set forth in
Section 3.3(a).
2.
DISTRIBUTION, MARKETING AND PROMOTION.
2.1 Appointment . During the
Term and subject to the terms and conditions of this Agreement,
DUSA hereby appoints D&D as its exclusive distributor for the
Product in the Field in the Territory and D&D hereby accepts
such appointment. Pursuant to this appointment, D&D shall have
the exclusive right to import in finished package form, distribute,
promote and sell the Product in the Field in the Territory subject
to the terms and conditions of this Agreement.
2.2 Marketing and Promotion
Efforts .
(a) D&D
shall use its best efforts to vigorously distribute, sell and
promote the sale of the Product in the Field within and throughout
the Territory at its own expense, so as to maximize sales in each
country in the Territory, beginning as soon as feasible after the
date of this Agreement, using generally, [C.I.] channels and
methods, exercising [C.I.] and adhering to [C.I.]
that it employs with respect to [C.I.] (including its own
products), provided that in the event that
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[c.i.] ” to indicate that confidential treatment has
been requested for this confidential information. The confidential
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and Exchange Commission.
D&D
is legally prohibited from selling the Product until Registration
for the Product is obtained, then D&D shall begin distribution
and promotion of the Product [C.I.] after Registration for
the Product is obtained.
(b) D&D
shall be deemed to have commenced the marketing of the Product in a
country within the Territory [C.I.] . If D&D does not
begin marketing and promotion of the Product in a country within
the Territory [C.I.] after receipt of all necessary
government approvals to market the Product in such country, in
addition to any other remedies available to DUSA hereunder or under
law or in equity, DUSA may, [C.I.] .
(c) D&D
shall provide DUSA as reasonably requested by DUSA: (1)
[C.I.] for purposes of [C.I.] regarding [C.I.]
in the market within the Territory, (2) a summary of
[C.I.] of the Product held by D&D at [C.I.] and
(3) [C.I.] report of each lot and serial number records of
the Product, [C.I.] including to comply with Applicable
Laws. The Parties will mutually agree on the form(s) of reports,
information to be contained therein and the timing of such reports
[C.I.] of the Effective Date, and such agreed upon items
shall be attached to this Agreement as a Schedule D
.
(d) D&D
shall, [C.I.] use [C.I.] to distribute, promote, and
sell the Product for use [C.I.] as appropriate in the
Territory, in compliance with Applicable Laws and good commercial
practice (including, but not limited to proper shipping and
storage). Without limiting the foregoing obligations, D&D shall
[C.I.] consistent with good business practice, use
[C.I.] to: (i) place the Product in D&D’s
literature [C.I.] ; (ii) use its sales force to provide
[C.I.] contact with existing and potential customers within
the Territory [C.I.] ; (iii) advertise the Product in
trade publications within and throughout the Territory, participate
in appropriate trade shows, (iv) directly solicit orders from
customers within and throughout the Territory for the Product, and
(v) use [C.I.] inventory control systems by it and its
sub-distributors, if any, [C.I.] sales of Product to Third
Parties within or outside of the Territory.
(e) D&D
will not (and will ensure that its sub-distributors, if any, do
not) enter into any sales contracts for the Product with its
customers, [C.I.] that contain terms that exceed or are
otherwise inconsistent with the terms of this Agreement (including
but not limited to sales contracts that [C.I.] of this
Agreement), without receiving DUSA’s written approval,
[C.I.] before entering into such agreement.
(f) D&D
shall purchase all Product needed in pre-marketing efforts from
DUSA at the Purchase Price Per Unit, except that DUSA shall
[C.I.] pursuant to Section 7.3(g), [C.I.]
labeled [C.I.] of the Product during the [C.I.] and
[C.I.] of the Product during [C.I.] .
(g) Prior
to D&D marketing, promoting, distributing or selling a Product
in the Territory, DUSA shall conduct Product related training
programs for the Product for D&D’s trainers, at
[C.I.] . The training program shall use training materials
[C.I.] and be [C.I.] regarding the safety and
efficacy of the Product in question and shall not in any way
[C.I.] the Products should be marketed, promoted,
distributed or sold in the Territory. Ongoing training of D&D
and its personnel, sales force or sub-distributors, if any,
regarding [C.I.] and all other training, [C.I.]
compliance training, shall be the responsibility [C.I.] .
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[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.
2.3 Restrictions .
(a) D&D
undertakes and agrees that it will [C.I.] of the Territory
[C.I.] for the Product [C.I.] such orders are
intended [C.I.] the Territory.
(b) Except
as permitted pursuant to Section 2.5 below, during the Term of
this Agreement, D&D shall [C.I.] to, market, promote,
sell, offer for sale, distribute or otherwise make the Product
available (nor contract [C.I.] to do any of the foregoing),
except as [C.I.] to any Third Party in the Territory.
(c) D&D
warrants to DUSA that D&D [C.I.] . During the Term of
this Agreement, D&D shall [C.I.] market, promote, sell,
offer for sale, distribute or otherwise make available (nor
contract [C.I.] to do any of the foregoing), any
[C.I.] to any Person in the Territory.
2.4 Milestone Payments .
(a)
Milestone Payments on Signing and Approval . The milestone
payments to be paid herein, are being paid [C.I.] and DUSA
hereby does grant to D&D the [C.I.] with DUSA
[C.I.] in any, [C.I.] . Within [C.I.] of this
Agreement by the Parties, D&D shall make a [C.I.]
payment of [C.I.] to DUSA; provided however, (i) if
[C.I.] for the Product to the [C.I.] of the
[C.I.] and if the [C.I.] the Product [C.I.]
and [C.I.] of the [C.I.] or (ii) if the
[C.I.] or (iii) if [C.I.] the Product
[C.I.] , then [C.I.] [C.I.] . In the event that the
circumstance under Section 2.4(a)(ii) occurs, D&D may,
[C.I.] and DUSA shall [C.I.] if (x) D&D
[C.I.] (y) [C.I.] and (z) [C.I.] of written
notification from [C.I.] that [C.I.] . In such case,
if [C.I.] D&D shall [C.I.] to DUSA. In addition,
[C.I.] of receipt by D&D, on behalf of DUSA, or DUSA, as
the case may be, of [C.I.] Product for sale by the Korean
Regulatory Authority, D&D shall pay a second [C.I.]
milestone payment to DUSA in the amount of [C.I.] .
(b)
First Units Shipped Milestone Payment . Within [C.I.]
following the total cumulative number of units of Product ordered
hereunder by D&D and shipped by DUSA to D&D [C.I.]
units, D&D shall make [C.I.] payment of [C.I.] to
DUSA.
(c)
Second Units Shipped Milestone Payment . Within
[C.I.] following the total cumulative number of units of
Product ordered hereunder by D&D and shipped by DUSA to D&D
[C.I.] units, D&D shall make a [C.I.] payment of
[C.I.] to DUSA.
2.5 Sub-Distributors .
(a) D&D
shall have the right to appoint [C.I.] sub-distributor to
distribute, market, promote and/or sell the Product within the
Territory, subject to [C.I.] and [C.I.] . The
appointment of any sub-distributor shall be in writing and on such
terms and conditions as [C.I.] provided such terms and
conditions are not inconsistent with the terms and conditions of
this Agreement. D&D shall provide DUSA with [C.I.]
copies of each agreement appointing a sub-distributor
hereunder.
(b) D&D
acknowledges and agrees that [C.I.] a sub-distributor
hereunder shall [C.I.] of [C.I.] . D&D further
agrees that it shall, [C.I.] be solely responsible:
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been requested for this confidential information. The confidential
portions have been omitted and filed separately with the Securities
and Exchange Commission.
(i) for
the [C.I.] sub-distributor appointed pursuant to this
Section 2.5; and
(ii) for
[C.I.] or for [C.I.] to any such sub-distributors or
representatives, [C.I.] ;
(c) Sales
made by such sub-distributors shall be subject to [C.I.] and
such sub-distribution arrangements shall [C.I.] to DUSA in
respect of such sales (that is, [C.I.] to DUSA in respect of
such Product sales shall be [C.I.] ).
(d) Each
sub-distributor shall [C.I.] of D&D hereunder with
respect to the activities undertaken by such sub-distributor in the
distribution, marketing and sale of the Product, including without
limitation [C.I.] and [C.I.] .
3.
TRADEMARKS; PRODUCT MARKING.
3.1 DUSA Trademarks .
(a)
Ownership of DUSA Trademarks . D&D shall use the DUSA
Trademarks set forth on Schedule A for the Product and
the Domain Names and Websites to distribute, market, promote, sell,
package and label such Product during the Term in accordance with
the Applicable Laws of the relevant Regulatory Authority. D&D
acknowledges and agrees that [C.I.] all right, title and
interest in and to each of the DUSA Trademarks and the Domain Names
and Websites. During the Term: (i) D&D and its Affiliates
shall [C.I.] the DUSA Trademarks or the Domain Names and
Websites, and agree that [C.I.] or [C.I.] any of the
DUSA Trademarks or the Domain Names and Websites by virtue of
[C.I.] to D&D under this Agreement; and (ii) all
use of the DUSA Trademarks or the Domain Names and Websites in the
Territory during the Term, whether in combination with or apart
from any Party’s corporate name, including any goodwill
generated in connection therewith, [C.I.] and DUSA may
[C.I.] thereof.
(b)
Use of DUSA Trademarks . Each Party shall [C.I.]
during the Term not to do any act which endangers, destroys or
similarly affects, in any material respect, the value of the
goodwill pertaining to the DUSA Trademarks. Further, except when
used in accordance with any usage guidelines agreed to by DUSA or
except when a use is otherwise approved in accordance with other
provisions of this Agreement, D&D shall submit to DUSA any
materials bearing the DUSA Trademarks [C.I.] the use
thereof.
(c)
Costs . All costs of prosecuting and maintaining the DUSA
Trademarks [C.I.] .
3.2 Other Proprietary
Trademarks .
(a)
Ownership of Corporate Names . Each Party shall retain all
right, title and interest in and to its corporate names, and agrees
that it shall [C.I.] such other Party’s corporate
names, or any registrations issued or issuing with respect thereto.
Each Party expressly acknowledges and agrees that [C.I.] the
limited rights of use granted under this Agreement, and that all
use of the corporate names in accordance therewith, including any
goodwill generated in
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been requested for this confidential information. The confidential
portions have been omitted and filed separately with the Securities
and Exchange Commission.
connection therewith, [C.I.] of the corporate names and the
owner of such corporate names [C.I.] thereof.
(b)
Use of Corporate Names . With respect to any corporate names
[C.I.] under or in connection with this Agreement, such
Party agrees to conform to the customary guidelines of the
[C.I.] with respect to manner of use (as provided
[C.I.] of the corporate name), and to maintain the quality
standards [C.I.] with respect to the goods sold and services
provided in connection with such Party’s corporate names.
Each Party shall use [C.I.] not to do any act which
endangers, destroys or similarly affects the value of the goodwill
pertaining to any other Party’s corporate names. Further,
except when used in accordance with any usage guidelines
[C.I.] of a corporate name or a use is otherwise
[C.I.] in accordance with other provisions of this
Agreement, each Party shall submit to the other Parties any
materials bearing any other Party’s corporate name for
[C.I.] prior to the use thereof and shall make no use of
such corporate name of another Party [C.I.] . No Party shall
use, or allow any of their Affiliates to use, in connection with
the Product any other trademark that is similar to or substantially
similar to or so nearly resembles another Party’s corporate
names as to be likely to cause deception or confusion.
(c)
Cooperation . Each Party shall execute any documents
required in the reasonable opinion of the other Parties to be
entered as a “registered user” or recorded licensee of
the other Parties’ corporate names, or to be removed as
registered user or licensee thereof.
3.3 DUSA Trademarks
Infringement .
(a)
Trademark Infringement Asserted by Third Parties in the
Territory . Each Party shall notify the other Parties
[C.I.] of any actual or alleged infringement of any
trademark or of any unfair trade practices, trade dress imitation,
passing off of counterfeit goods, or like offenses, or any such
claims (hereinafter “Trademark Infringement
Claims” ) [C.I.] in connection with the Product in
the Territory.
(i) Upon
learning of such Trademark Infringement Claim, [C.I.] shall
take [C.I.] steps to resolve the Trademark Infringement
Claim with the [C.I.] provided however [C.I.]
may not settle any such alleged infringement [C.I.] .
(ii)
[C.I.] shall have the [C.I.] and [C.I.]
.
(b)
DUSA Trademarks Infringement by Third Parties in the
Territory . Each Party shall notify the other Parties
[C.I.] of any actual or alleged infringement by a Third
Party of any DUSA Trademarks in the Territory of which they become
aware.
(i) Upon
learning of such infringement under this Section 3.3(b),
[C.I.] shall, [C.I.] take [C.I.] steps to
resolve such infringement with the [C.I.] provided
however [C.I.] may not settle any such alleged
infringement [C.I.] .
(ii)
[C.I.] shall have the [C.I.] and [C.I.]
.
3.4 Product Marking . Any
Product marketed and sold hereunder shall be marked with
appropriate patent numbers and trademarks, as approved by
DUSA.
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[c.i.] ” to indicate that confidential treatment has
been requested for this confidential information. The confidential
portions have been omitted and filed separately with the Securities
and Exchange Commission.
3.5 Alternative Trademarks .
If one or more the DUSA Trademarks cannot be used or registered in
any country within the Territory for reasons beyond DUSA’s
control (e.g., due to objections by Third Parties or local
trademark offices) or cannot otherwise be legally used to
commercialize the Product in a country within the Territory (e.g.,
due to rejection by Regulatory Authorities), and if the Parties
have determined that an alternative worldwide trademark is not
practicable for the Product, then each Party shall have
[C.I.] trademarks. [C.I.] shall then select one
[C.I.] trademarks for the Product in each country in the
Territory. [C.I.] will undertake the [C.I.] of
conducting appropriate trademark clearance of any such selected
alternative trademark for use in each such country in the
Territory, and filing applications for the cleared trademark. If
(a) an alternative trademark is cleared successfully for use
and registration, (b) trademark applications are filed for the
additional alternative trademark, and (c) such additional
alternative trademark receives regulatory approval, then all terms
and conditions of this Agreement shall apply, mutatis
mutandis , to the use and registration of such alternative
trademark [C.I.] and, thereafter the term “DUSA
Trademarks” shall include such alternative trademark.
4.
REGISTRATIONS.
4.1 Approval and Maintenance
.
(a) D&D
shall, [C.I.] use [C.I.] to prepare and file the
documents necessary for submission to the Regulatory Authorities in
each country in the Territory, if required, to seek approval for
the treatment of Actinic Keratoses and/or other indications in the
Field. D&D shall meet the regulatory milestones listed on
Schedule E in order to retain its rights to market and
sell the Product in each country of the Territory.
(b) With
regard to the application for Registration for the treatment of
Actinic Keratoses, DUSA will provide D&D with copies of
existing clinical and chemistry, manufacturing and controls data to
support of this application. D&D shall [C.I.] for
[C.I.] including but not limited to, [C.I.] and
[C.I.] in connection with seeking these approvals, but DUSA
shall [C.I.] . D&D shall, develop and implement
documented standard operating procedures, such as, but not limited
to, adverse event reporting, storage and handling, etc., required
to support the Registration in all countries in the
Territory.
(c) For
clarity, regulatory costs shall mean [C.I.] and
[C.I.] incurred by a Party or any of its Affiliates in
accordance with [C.I.] during the Term and pursuant to this
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, including ICSR recordation and
reporting, regulatory affairs activities, and recalls and
withdrawals of the Product in the Territory. [C.I.] shall
[C.I.] after the end of [C.I.] with regard to
regulatory costs incurred during [C.I.] . Such report shall
(i) specify [C.I.] expenses incurred [C.I.] or
(ii) be accompanied by invoices or other appropriate
supporting documentation for [C.I.] that individually
[C.I.] as may be determined by the Parties. The Parties
shall seek to resolve any questions related to [C.I.] within
[C.I.] following receipt [C.I.] hereunder and
[C.I.] within [C.I.] thereafter.
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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.
4.2 Adverse Event Reporting .
D&D shall notify DUSA, in writing, of any adverse drug
experience within seventy-two (72) hours of such adverse drug
experience becoming known to D&D. As provided in
Section 4.5, and except as required by any Applicable Laws,
DUSA shall [C.I.] and [C.I.] determine whether any
adverse drug experience must be reported to the applicable
Regulatory Authority, and following making a determination to
report, to report such events to the applicable Governmental
Authority.
4.3 Ownership of Product
Registration . All Registrations and regulatory filings for the
Product in the Territory, including marketing and pricing filings
and authorizations, in connection with the Product, shall be filed
by D&D on DUSA’s behalf, registered and owned exclusively
by DUSA, unless otherwise explicitly agreed in writing by DUSA.
Should any Registration be filed in the name of D&D, or any
Affiliate or sub-distributor of D&D, as may be required by a
Regulatory Authority, then on termination of this Agreement
for
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