License Agreement Between DUSA Pharmaceuticals INC. and River’s Edge Pharmaceuticals, LLC Effective as of July 3, 2008
EXHIBIT 10(a)
EXECUTION COPY
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.
Between
and
River’s Edge Pharmaceuticals, LLC
Effective as of July 3, 2008
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 | ||||
1. Definitions |
1 | |||
2. Grant of Rights |
4 | |||
3. Consideration |
5 | |||
4. Payments And Reports |
5 | |||
5. Manufacturing And Supply |
7 | |||
6. Ownership; Patents |
7 | |||
7. Regulatory Matters |
9 | |||
8. Representations, Warranties and other Acknowledgements |
10 | |||
9. Publication; Confidentiality |
11 | |||
10. Indemnification; Insurance |
13 | |||
11. Term; Termination |
15 | |||
12. Force Majeure |
17 | |||
13. Miscellaneous |
17 | |||
Exhibit 1: Patent Rights |
i
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.
This License Agreement, effective as of July 3, 2008 (the “Effective
Date”), is entered into by and between DUSA Pharmaceuticals, Inc. having offices at 00 Xxxxx
Xxxxx, Xxxxxxxxxx, Xxxxxxxxxxxxx 00000 (“DUSA”) and River’s Edge Pharmaceuticals, LLC, having its
principal offices at 0000 Xxxxxx Xxxxxxx Xxxxxxx, Xxxxxxxx 000, Xxxxxxx, Xxxxxxx 00000 (“River’s
Edge”).
Preliminary Statements
WHEREAS, DUSA, together with its Affiliates (as defined below), owns and has all right, title
and interest in, the Licensed Product (as defined below).
WHEREAS, DUSA and River’s Edge were parties in that certain lawsuit styled DUSA
Pharmaceuticals, Inc., et. al. v. River’s Edge Pharmaceuticals, LLC, Civil Action No. 06-1843, in
the United States District Court for the District of New Jersey, alleging, among other things, that
River’s Edge infringed DUSA’s Patent No. 6,979,468;
WHEREAS, DUSA and River’s Edge settled their dispute by entering into a Settlement Agreement
and Mutual Release dated October 28, 2007 (the “Settlement Agreement”), a License Agreement for
certain AVAR products and exhibits thereto shall be referred to collectively as the “Settlement
Documents”; and
WHEREAS, the Parties (as defined below) believe it is in their mutual interests to amend the
Settlement Agreement and to enter into the First Amendment to the Settlement Agreement (attached
hereto) and to this License Agreement and bind themselves as set forth herein;
Now, Therefore, in consideration of the foregoing preliminary statements and the
mutual agreements and covenants set forth herein, the Parties hereby agree as follows:
1. Definitions.
As used in this Agreement, the following terms shall have the meanings set forth in this
Section 1 unless context clearly and unambiguously dictates otherwise. Unless the context requires
otherwise, references to the singular include the plural and vice versa, and references to
Sections, Exhibits and Schedules are references to the sections, exhibits and schedules of this
Agreement.
1.1 “Affiliate” shall mean, with respect to a Party, any entity controlling,
controlled by, or under common control with, such Party, for only so long as such control exists.
For these purposes, “control” shall refer to: (i) the possession, directly or indirectly,
of the power to direct the management or policies of an entity, whether through the ownership of
voting securities, by contract or otherwise, (ii) the ownership, directly or indirectly, [C.I.] or
more of the voting securities or other voting ownership interest of an entity or (iii) the right to
appoint or nominate [C.I.] or more of the directors or managers of such entity.
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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.
1.2 “Agreement” shall mean this license agreement together with the preliminary
statements and all exhibits, schedules and attachments hereto.
1.3 “Bankruptcy Code” shall have the meaning assigned to such term in Section 11.7.
1.4 “Breaching Party” shall have the meaning assigned to such term in Section 11.2.
1.5 “Confidential Information” shall have the meaning assigned to such term in Section
9.2.
1.6 “Cost of Goods” shall mean the actual cost to purchase the Licensed Product from a
Third Party, or to manufacture the Licensed Product in its own or in an Affiliate’s facility, in
finished form ready for sale. For clarity, Cost of Goods does not include [C.I.], including,
without limitation, [C.I.] or [C.I.].
1.7 “Cover”, “Covered” or “Covering” shall mean, in connection with a
Patent Right, claiming any idea, Know-How or Invention or describing same in the specifications or
the drawings of such Patent Right in a manner that it can be made the subject matter of the patent
claims of such Patent Right.
1.8 “DUSA Know-How” shall mean all Know-How owned or controlled by DUSA or its
Affiliates as of the Effective Date which is reasonably necessary for the manufacture, use, offer
for sale, sale or importation of Licensed Product in the Field. Notwithstanding anything herein to
the contrary, DUSA Know-How shall exclude: (i) DUSA patent rights relating to any product other
than the Licensed Product; and (ii) Know-How owned or controlled by DUSA or its Affiliates relating
to any product other than the Licensed Product.
1.9 “DUSA Technology” shall mean, collectively, the Patent Rights and DUSA Know-How.
1.10 “Effective Date” shall have the meaning assigned to such term in the introductory
paragraph of this Agreement.
1.11 “Execution Date” shall mean, as it relates to a party’s obligations,
representations, warranties or other undertakings under this Agreement, the date of receipt of a
final executed copy of this Agreement, designated as an execution copy, by the other party.
1.12 “Field” shall mean the sale of the Licensed Product dispensed pursuant to a
prescription written by a licensed physician.
1.13 “First Commercial Sale” means the first arms-length commercial sale by River’s
Edge or its Affiliates or Sublicensees of a Licensed Product to a Third Party in any country in the
Territory before or after the Effective Date (except for sales of NIC 750 which are covered under
the Settlement 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.
1.14 “Indemnitee” shall have the meaning assigned to such term in Section 10.3.
1.15 “Infringement” shall have the meaning assigned to such term in Section 6.3.1.
1.16 “Know-How” shall mean any and all formulae, processes, trade secrets,
technologies, know-how, inventions, improvements, discoveries and claims (including confidential
data and Confidential Information), whether patentable or unpatentable, including, without
limitation, synthesis, preparation, recovery and purification processes and techniques, control
methods and assays, chemical data, toxicological and pharmacological data and techniques, clinical
data, medical uses, product forms and product formulations and specifications.
1.17 “Licensed Product” shall mean any product or products containing niacinamide,
zinc, copper and folic acid, including without limitation, any product that was, is, or may be
listed in drug database services as substitutable for, and/or listed in place of the product sold
by DUSA under its trademark, Nicomide® or which is covered under the claims of U.S.
Patent No. 6,979,468 entitled “Oral Composition and Method for the Treatment of Inflammatory
Cutaneous Disorders” (the “468 Patent”).
1.18 “Net Revenues” shall mean, with respect to a Licensed Product, the [C.I.], in an
arms length transaction, by River’s Edge, [C.I.] and, as applicable, [C.I.], to Third Parties,
commencing with the First Commercial Sale, [C.I.] the [C.I.] from such [C.I.] which are [C.I.] or
[C.I.]:
(i) [C.I.] or [C.I.] for [C.I.] or [C.I.] of Licensed Products under [C.I.]
generally applicable, as modified from time to time, but for clarity, not Licensed
Product which is [C.I.] and cannot be [C.I.];
(ii) normal and customary [C.I.] and [C.I.] and [C.I.] (other than [C.I.] at the
time of invoicing which have been already been [C.I.] in the [C.I.] invoiced),
[C.I.] payments and [C.I.] under [C.I.] generally applicable, as modified from time
to time to [C.I.] or to [C.I.], [C.I.] and other [C.I.], including their [C.I.], or
to [C.I.]; provided, that where any such [C.I.] or [C.I.] for the Licensed Product
are based on [C.I.] to the [C.I.] of a [C.I.] in which the Licensed Product is
included (where such sales are permitted by law), the applicable [C.I.] or [C.I.]
for the Licensed Product in such [C.I.] arrangement shall be based on the [C.I.] or
[C.I.] of such [C.I.] of products and, further provided, the Licensed Product shall
not be [C.I.] for any reason including, without limitation, to create or attract
sales for other products sold or distributed by River’s Edge;
(iii) any [C.I.] and other [C.I.]; and
(iv) [C.I.] with applicable law), and [C.I.] and [C.I.], and other [C.I.] related to
the [C.I.] (but not including [C.I.] against the [C.I.] derived from such sale) of a
Licensed Product.
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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.
“Net Revenues” shall also include the [C.I.] for the Licensed Product [C.I.] for [C.I.] or where no
[C.I.]. Net Revenues, as set forth in this definition, shall be calculated in accordance with
[C.I.] practices applied on a consistent basis.
1.19 “Non-breaching Party” shall have the meaning assigned to such term in Section
11.2.
1.20 “Party” shall mean, as applicable, DUSA or River’s Edge and, when used in the
plural, shall mean and refer to both DUSA and River’s Edge.
1.21 “Patent Rights” shall mean DUSA’s rights that it now owns, or has acquired as of
the Effective Date of this Agreement, in information, inventions or discoveries encompassing the
compositions or use of the Licensed Product claimed in the patent listed on Exhibit 1 and any
reissues, reexaminations, or extensions thereof.
1.22 “Sublicensee” shall mean a Third Party to which River’s Edge or its Affiliates
grant a sublicense in accordance with the provisions of Section 2.1.1.
1.23 “Term” shall have the meaning assigned to such term in Section 11.1.
1.24 “Territory” shall mean the world.
1.25 “Third Party” shall mean any person or entity who or which is neither a Party
nor an Affiliate of a Party.
1.26 “United States” or “U.S.” shall mean The United States of America,
including its possessions, territories and commonwealths.
2. Grant of Rights.
2.1 License Grant to River’s Edge.
2.1.1 Subject to the terms and conditions of this Agreement, DUSA hereby grants
to River’s Edge and its Affiliates a limited, non-exclusive right and license to the
DUSA Technology, without the right to sublicense unless expressly agreed to in
writing by DUSA, to make, use, market, sell, and distribute the Licensed Product in
the Field in the Territory. For clarity, DUSA has the right, by way of example, to
grant non-exclusive licenses to other Third Parties in order to settle potential
future patent litigation.
2.1.2 Except as expressly set forth in this Agreement, no license is granted by
DUSA under its rights in any DUSA Technology whatsoever for any activities by River’s
Edge that are outside the scope of the license grants in Section 2.1.1, including,
without limitation, the sale and marketing of product(s) by any means and/or channels
other than those currently utilized and practiced by River’s
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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.
Edge (i.e. traditional pharmaceutical distribution channels — wholesalers,
retailers, data banks).
3. Consideration.
As consideration to DUSA for the license and other rights granted to River’s Edge under this
Agreement, River’s Edge shall pay to DUSA a share of all the revenues received by River’s Edge with
respect to the Licensed Product calculated and paid on a [C.I.] basis on the terms stated in the
Agreement and as follows:
[C.I.] of the amount [C.I.] the Cost of Goods is [C.I.] Net Revenues of the Licensed Product.
4. Payments And Reports.
4.1 Timing of Payments and Reports.
4.1.1 Within [C.I.] after the end of each calendar month beginning with July,
2008, River’s Edge shall deliver to DUSA a report, setting forth in a reasonably
detailed fashion the [C.I.] of the Licensed Product, [C.I.] during the relevant
[C.I.], and the calculation of the payment due thereon. Beginning with the First
Commercial Sale of Licensed Product and for each calendar month thereafter during the
Term payments shall be made to DUSA within [C.I.] following the end of each such
calendar month (together with a copy of the report for the calendar month stated
above). All other payments to be made under this Agreement shall be made in
accordance with the terms set forth in the applicable Section(s) regarding such
payments.
4.1.2 Within [C.I.] following the end of each calendar year during the Term, the
Parties shall reconcile (true-up) any adjustments in the last payment of each year
for mathematical errors that are determined during any year end review.
4.2 Mode of Payment. All payments required under this Agreement shall be made in U.S.
Dollars, regardless of the country(ies) in which sales are made, [C.I.] or [C.I.] of [C.I.] as
directed by DUSA from time to time. For the purposes of computing Net Revenues of Licensed Product
sold in a currency other than U.S. dollars, such currency shall be converted into U.S. dollars at
an exchange rate [C.I.] the [C.I.] of U.S. dollars published in the East Coast Edition of The
Wall Street Journal for the last business day of the applicable calendar month. Such payments
shall be [C.I.] of [C.I.].
4.3 Sales Records. Commencing with the First Commercial Sale of a Licensed Product,
River’s Edge shall keep complete and accurate records pertaining to the sale of Licensed Product
sold under this Agreement for at least [C.I.] after the calendar year in which the sale occurred in
sufficient detail to permit DUSA to confirm the accuracy of the amounts paid by River’s Edge to
DUSA hereunder.
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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.
4.4 Audits.
4.4.1 At the request [C.I.] of DUSA, River’s Edge shall permit DUSA, [C.I.], at
reasonable times and upon reasonable written notice, (but no more often than [C.I.]
calendar year unless (i) a deficiency of [C.I.] than [C.I.] was determined by a prior
audit, or (ii) an audit is [C.I.] to examine such records as may be necessary for the
sole purpose of verifying the calculation and reporting of Net Revenues, Costs of
Goods and the correctness of any payment made under this Agreement. [C.I.] shall
hold in confidence any confidential or proprietary information of River’s Edge,
except that [C.I.] to DUSA the fact of [C.I.], the [C.I.] or [C.I.], and the degree
thereof, including the [C.I.]. All results of any such examination shall be made
available to River’s Edge.
4.4.2 In the event that any audit reveals [C.I.] of the amount that [C.I.] by
River’s Edge to DUSA in accordance with this Agreement, then [C.I.] within [C.I.]
after DUSA [C.I.]. Such [C.I.] from the [C.I.] until the [C.I.], at the [C.I.] the
[C.I.]in the East Coast Edition of The Wall Street Journal for the date such
[C.I.]. In addition, if the [C.I.] is [C.I.] of [C.I.], then River’s Edge shall
reimburse DUSA for the cost of the audit.
4.4.3 In the event that River’s Edge [C.I.] determined under Section 4.4.2, DUSA
shall be entitled to file a Consent Judgment in the form and in accordance with the
terms of Section 11.2.2 and the First Amendment to the Settlement Agreement.
4.5 Taxes. In the event that River’s Edge is mandated under the laws of a country to
withhold any tax, tariff, levy or similar charge (“Taxes”) to the tax or revenue authorities in
such country in connection with any payment to DUSA, such Taxes shall be [C.I.] so that [C.I.]
under this Agreement. If for any reason River’s Edge has [C.I.], and DUSA becomes obligated to
[C.I.], then DUSA shall [C.I.] River’s Edge for such Taxes and [C.I.] within [C.I.] in accordance
with Section 4.2 above. DUSA shall secure and promptly send to River’s Edge [C.I.] or [C.I.] by
DUSA for the benefit of River’s Edge. The Parties shall cooperate reasonably with each other to
ensure that [C.I.] by DUSA are [C.I.] to the fullest extent permitted by law. [C.I.] shall be
made, or a [C.I.] shall be [C.I.], if River’s Edge furnishes a document from the appropriate tax
authorities to DUSA certifying that the payments are [C.I.] Taxes or subject to [C.I.], according
to the applicable convention for the avoidance of double taxation. DUSA shall be responsible for
DUSA’s income tax liability attributable to royalty payments received by DUSA under 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. Manufacturing And Supply
5.1 Commercial Supply. River’s Edge shall be responsible for manufacture of the
Licensed Product for use by River’s Edge or its Sublicensees.
5.2 Disclosure of Know-How. The Parties will cooperate to ensure a smooth and
efficient disclosure of DUSA Know-How in order to facilitate the manufacture of the Licensed
Product.
6. Ownership; Patents.
6.1 Ownership.
6.1.1 DUSA shall retain all right, title and interest in and to the DUSA
Technology, subject to the license granted to River’s Edge pursuant to Section 2.1.
6.2 Patent Prosecution and Maintenance.
6.2.1 DUSA shall have full responsibility for, and shall control the preparation
and prosecution of, and the maintenance of, all Patent Rights; provided, however,
DUSA shall have [C.I.] or [C.I.] such Patent Rights.
6.2.2 If DUSA elects [C.I.] or [C.I.] any Patent Rights Covering the Licensed
Product, DUSA shall notify River’s Edge in writing in a timely manner and River’s
Edge may do so [C.I.]. In the event that River’s Edge elects to proceed with any
such filing, prosecution or maintenance, DUSA shall [C.I.] and to such Patent Rights
[C.I.], and, subject to Section 11.5, all of DUSA’s rights in such Patent Rights
[C.I.].
6.2.3 Each Party agrees to cooperate with the other Party to execute all lawful
papers and instruments, to make all rightful oaths and declarations, and to provide
consultation and assistance as may be necessary in the preparation, prosecution,
maintenance and enforcement of all such patents. DUSA specifically agrees to
cooperate with River’s Edge should it choose to publicly record its license interest
in the Patent Rights.
6.2.4 DUSA specifically and expressly [C.I.] that any claims in the Patent
Rights are [C.I.].
6.3 Patent Enforcement.
6.3.1 If either Party learns of an infringement, unauthorized use,
misappropriation or ownership claim or threatened infringement or other such activity
(an “Infringement”) by a Third Party with respect to the Licensed Product,
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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.
such Party shall promptly notify the other Party in writing and shall promptly
provide such other Party with available evidence of such Infringement.
6.3.2 DUSA shall have the first right, but not the duty, to institute,
prosecute, and control any action or proceeding with respect to an Infringement based
on any DUSA Technology. If DUSA (or its designee) does not secure actual cessation
of such infringement or institute an infringement proceeding against an offending
Third Party within thirty (30) days after a receipt of evidence of the Infringement,
River’s Edge shall have the right, but not the duty, to institute, prosecute, and
control any action or proceeding with respect to such Infringement. The [C.I.] of
any such action (including fees of attorneys and other professionals) shall be
[C.I.], or, if the Parties elect to cooperate in instituting and maintaining such
action, such [C.I.] shall be [C.I.]. Each Party shall execute all necessary and
proper documents, take such actions as shall be appropriate to allow the other Party
to institute, prosecute, and control such Infringement actions and shall otherwise
cooperate in the institution and prosecution of such actions (including, without
limitation, consenting to being named as a nominal party thereto). Any award,
damages or other monetary awards recovered (whether by way of settlement or
otherwise) shall be [C.I.] both Parties for [C.I.] the Parties with respect to such
action [C.I.] and, if after [C.I.], they shall be [C.I.] as follows: (i) if DUSA has
instituted and maintained such action alone, DUSA shall be [C.I.]; (ii) if River’s
Edge has instituted and maintained such action alone, River’s Edge shall be [C.I.],
but [C.I.] as if such [C.I.]; or (iii) if the Parties have cooperated in instituting
and maintaining such action, the Parties shall allocate such remaining funds between
themselves [C.I.] of instituting and maintaining such action.
6.4 Infringement Action by Third Parties. In the event of the institution or
threatened institution of any suit by a Third Party against either Party for patent infringement
involving the use, manufacture, sale, offer for sale, distribution or marketing of the Licensed
Product, the Party being sued shall promptly notify the other Party in writing of such suit.
6.4.1 If the suit alleges any claim for damages where the damages could be based
on DUSA’s use, manufacture, sale, offer for sale, distribution or marketing of a
Licensed Product prior to the Effective Date, each Party may engage counsel of its
choice and appear and represent its own interests in the suit, at its own expense. If
both Parties are not named as parties to the suit, then the named Party will
cooperate with the other Party to take whatever action is appropriate in the
circumstances to add the other as a party. River’s Edge agrees to assist and
cooperate with DUSA in the defense of any patent infringement suit related to the
Licensed Product in which River’s Edge is not named and declines to participate in
the defense.
6.4.2 Unless otherwise covered in Sections 6.3.2 or 6.4.1, River’s Edge shall
defend any other patent infringement suit instituted by a Third Party against River’s
Edge involving the use, manufacture, sale, offer for sale,
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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.
distribution or marketing of the Licensed Product after the Effective Date,
[C.I.] and shall be responsible for [C.I.] as a result thereof. DUSA hereby agrees to
assist and cooperate with River’s Edge, at River’s Edge’s reasonable request [C.I.],
in the defense of any patent infringement suit related to the Licensed Product
(including, without limitation, consenting to being named as a nominal party
thereto).
6.4.3 River’s Edge shall be [C.I.] for any [C.I.] in any patent infringement
suit attributable to the use, manufacture, sale, offer for sale, distribution or
marketing of the Licensed Product after the Effective Date, and DUSA shall be [C.I.]
for any [C.I.] and any patent infringement suit attributable to the use, manufacture,
sale, offer for sale, distribution or marketing of product Covered by a Third Party’s
patent.
6.4.4 The initiation or pendency of any action covered by this Section 6.4 will
not excuse River’s Edge from [C.I.] to DUSA pursuant to this Agreement.
6.5 Product Marking. River’s Edge agrees to xxxx all Licensed Products in accordance
with 35 U.S.C. 287.
7. Regulatory Matters.
7.1 Adverse Reaction Reporting. River’s Edge shall be responsible to report to any
applicable regulatory authority any adverse drug experience in connection with the sale and use of
any Licensed Product manufactured by or for River’s Edge (which shall include, for the avoidance of
doubt, any adverse drug experience in connection with the separate use of the active ingredients
and additives incorporated into the Licensed Product), including the incidence or severity thereof,
associated with non-clinical toxicity studies, clinical uses, studies, investigations or tests,
whether or not determined to be attributable to the Licensed Product. DUSA shall be responsible to
report to any applicable regulatory authority any adverse drug experience in connection with the
sale and use of the batches of Nicomide® manufactured for DUSA (which shall include, for
the avoidance of doubt, any adverse drug experience in connection with the separate use of the
active ingredients and additives incorporated into such product), including the incidence or
severity thereof, associated with non-clinical toxicity studies, clinical uses, studies,
investigations or tests, whether or not determined to be attributable to Nicomide.
7.2 Recall; Withdrawal. In the event that any Licensed Product should be alleged or
proven not to meet the specifications or other mandatory standards for the Licensed Product in a
country or legal jurisdiction in the applicable Territory, River’s Edge shall [C.I.] with any
recall, or with respect to detaining or retaining the Licensed Product (voluntarily or by order of
a Regulatory Authority). The [C.I.] will not in any way impact the [C.I.] under the terms of this
Agreement except pursuant to Section 11.4 below.
7.3 Regulatory Obligations. DUSA hereby transfers all regulatory obligations,
including pharmacovigilance obligations, to River’s Edge on the date of First Commercial Sale
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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.
and River’s Edge shall be solely responsible for all regulatory activities in connection with
the Licensed Product. River’s Edge shall [C.I.] associated with [C.I.] including, without
limitation, any [C.I.] of River’s Edge or Third Parties which must be [C.I.] used in the
manufacture of Licensed Product by or on behalf of River’s Edge. River’s Edge shall list the
Licensed Product on the drug listing maintained by the United States Food and Drug Administration
under its labeller code (or the code of its manufacturer) before the next batch of a respective
Licensed Product is manufactured and will use that number on all future production of the Licensed
Products. River’s Edge hereby acknowledges that DUSA has disclosed to River’s Edge the regulatory
status of the Licensed Product as an unapproved marketed product, and that DUSA has directed
River’s Edge to review the publicly available Warning Letters issued by the U.S. Food and Drug
Administration regarding Nicomide®.
8. REPRESENTATIONS, WARRANTIES AND OTHER ACKNOWLEDGEMENTS.
8.1 Representations and Warranties of Both Parties. Each Party hereby represents and
warrants to the other Party, as of the Execution Date, that:
8.1.1 such Party: (i) is an organized business entity duly organized, validly
existing and in good standing under the laws of the jurisdiction in which it is
formed; and (ii) has the power and authority and the legal right to own and operate
its property and assets, to lease the property and assets it operates under lease,
and to carry on its business as it is now being conducted; and
8.1.2 such Party: (i) has, as an organized business entity, the power and
authority and the legal right to enter into this Agreement and to perform its
obligations hereunder; and (ii) has taken all necessary governance action on its part
to authorize the execution and delivery of this Agreement and the performance of its
obligations hereunder. The Agreement has been duly executed and delivered on behalf
of such Party, and constitutes a legal, valid, binding obligation, enforceable
against such Party in accordance with its terms except to the extent that
enforceability may be limited by applicable bankruptcy, insolvency or other laws
affecting the enforcement of creditors’ rights generally and subject to the general
principles of equity (regardless of whether enforcement is sought in a court of law
or equity).
8.2 Disclaimer Regarding [C.I.]. Other than as set forth in this Xxxxxxx 0, XXXX
hereby expressly disclaims any representation or warranty as to the [C.I.] of [C.I.] contained in
the [C.I.], the [C.I.] or other [C.I.] right or the prospects or likelihood of [C.I.] of a Licensed
Product.
8.3 Representations, Warranties and Covenants of River’s Edge. River’s Edge hereby
represents, warrants and covenants to DUSA, as of the Execution Date, that:
8.3.1 Except as otherwise specified, at all times during theTerm, that River’s
Edge is committed to the commercialization of the Licensed Product in accordance with
its obligations under in this Agreement and will make diligent
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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.
efforts, but in no case less than commercially reasonable efforts, to [C.I.] and
[C.I.] the Licensed Product during the Term.
8.3.2 River’s Edge represents and warrants to DUSA that it is not aware of any
pending or threatened litigation or action (i) which would impact its ability (A) to
manufacture or have the Licensed Product manufactured on its behalf, or (B) market
the Licensed Product in the manner contemplated by this Agreement; or (ii) which
alleges that River’s Edge interfered with the contractual relationship of any Third
Party in connection with the manufacture of a product that could be substituted for
Nicomide®.
8.4 Representations and Warranties of DUSA. DUSA hereby represents and warrants to
River’s Edge, as of the Execution Date, that:
8.4.1 To its knowledge, there is no threatened or pending litigation alleging
that the Licensed Product infringes any patent rights of any Third Party. DUSA
further represents and warrants that to its knowledge, it has not received any
communications, verbal or written in any form, alleging that the Licensed Product
infringes any patent or other intellectual property rights of any Third Party. DUSA
further represents that to its knowledge, it does not know of any reasonable claim
that could be brought alleging that the Licensed Product infringes the intellectual
property rights of any Third Party. DUSA further represents and warrants that to its
knowledge it has not received any communication, verbal or written, offering or
inviting DUSA to negotiate a license to any patents rights owned by any Third Party
and related to the Licensed Product.
8.4.2 That the rights granted to River’s Edge in this Agreement have not
previously been granted to any other Party.
8.5 Disclaimer. EXCEPT AS EXPRESSLY SET FORTH IN THIS SECTION 8, NEITHER PARTY MAKES
ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, AND EACH
PARTY EXPRESSLY DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND OF FITNESS FOR A PARTICULAR
PURPOSE OR USE, OR NON-INFRINGEMENT.
9. Publication; Confidentiality.
9.1 Publication.
9.1.1 Except as expressly provided in this Section 9, each Party agrees not to
make any public announcement or disclosure (including, without limitation, any press
release, summary or question and answer script or informal statement to any Third
Party) of the terms of this Agreement or Amendment to the Settlement Agreement,
without first obtaining the written approval of the other Party which approval shall
not be unreasonably withheld, conditioned, or delayed,
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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.
and agreement upon the nature and text of such public announcement or
disclosure, which approval shall not be unreasonably withheld or delayed.
9.1.2 Each Party agrees that it shall cooperate fully with the other with
respect to all disclosures regarding this Agreement and the First Amendment to the
Settlement Agreement required under applicable laws and regulations to the United
States Securities and Exchange Commission and any other comparable governmental or
regulatory agencies.
9.1.3 In addition, each Party agrees not to disclose, under any circumstances
except as set forth in this Section 9 or as otherwise required by law, the terms of
this Agreement or the First Amendment to the Settlement Agreement, to any Third Party
other than to professional advisors and financing sources, and in that case, only
under confidentiality terms at least as stringent in all material respects as this
Section 9.
9.2 Confidentiality; Exceptions. Except to the extent expressly authorized by this
Agreement or otherwise agreed in writing, the Parties agree that, [C.I.] and [C.I.], a receiving
Party shall keep, and shall ensure that its Affiliates, and their officers, directors, employees
and agents, keep, completely confidential and shall not publish or otherwise disclose and shall not
use for any purpose: (i) any information furnished to it by the disclosing Party; or (ii) developed
under or in connection with this Agreement by either Party; except in each of subclause (i) and
(ii) to the extent that it can be established by the receiving Party by competent written proof
that such information: (A) was already known to the receiving Party, other than under an obligation
of confidentiality, at the time of disclosure by the disclosing Party; (B) was generally available
to the public or otherwise part of the public domain at the time of its disclosure to the receiving
Party; (C) became generally available to the public or was otherwise part of the public domain
after its disclosure hereunder and other than through any act or omission of the receiving Party in
breach of this Agreement; or (D) was disclosed to the receiving Party, other than under an
obligation of confidentiality, by a Third Party who had no obligation to the disclosing Party not
to disclose such information to others (all such information to which none of the foregoing
exceptions applies, “Confidential Information”).
9.3 Exceptions to Obligation. The restrictions contained in Section 9.2 shall not
apply to Confidential Information that: (i) is provided by the receiving Party to Third
Parties under confidentiality agreements having provisions at least as stringent as those in this
Agreement, for [C.I.] and to Third Parties who are [C.I.] or other [C.I.] hereunder with respect to
any of the subject matter of this Agreement; (ii) is otherwise required to be disclosed in
compliance with applicable laws or regulations (including, without limitation and for the avoidance
of doubt, the requirements of the U.S. Securities and Exchange Commission, Nasdaq or any other
stock exchange on which securities issued by a Party are traded) or order by a court or other
regulatory body having competent jurisdiction; provided, that, if a Party is required to make any
such disclosure of the other Party’s Confidential Information such Party will give reasonable
advance written notice to the disclosing Party of such disclosure requirement and, except to the
extent inappropriate in the case of patent applications, will use its best 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.
secure confidential treatment of such Confidential Information required to be disclosed; or
(iii) was developed by the receiving Party independent of any disclosure received under this
Agreement.
9.4 Limitations on Use. Each Party shall use any Confidential Information obtained by
such Party from the other Party, its Affiliates, or its Sublicensees, pursuant to this Agreement or
otherwise, solely in connection with the activities or transactions contemplated hereby or
expressly permitted hereunder.
9.5 Remedies. Each Party shall be entitled, in addition to any other right or remedy
it may have, at law or in equity, to an injunction, without the posting of any bond or other
security, enjoining or restraining the other Party from any violation or threatened violation of
this Section 9.
10. Indemnification; Insurance.
10.1 By River’s Edge. River’s Edge shall indemnify, defend and hold harmless DUSA and
[C.I.], from and against any and all claims, demands, liabilities, damages, losses, costs and
expenses (including the reasonable fees of attorneys and other professionals) arising out of any
claims or suits brought by a Third Party that assert, arise out of or result from any or all of the
following:
10.1.1 the [C.I.] or [C.I.] or [C.I.] of River’s Edge, its [C.I.] and/or their
[C.I.], in connection with the activities contemplated under this Agreement,
including, without limitation, the [C.I.] of River’s Edge or its [C.I.] or its [C.I.]
with respect to the Licensed Product ;
10.1.2 any [C.I.] or [C.I.] of any Licensed Product or any [C.I.] of [C.I.] or
[C.I.] relating to or arising out of any [C.I.] of a Licensed Product by River’s Edge
after the Effective Date;
10.1.3 any [C.I.] (other than [C.I.] by governmental agencies) whatsoever
relating to or arising out of the [C.I.] or [C.I.] activities of River’s Edge or its
[C.I.] or its [C.I.] with respect to the Licensed Product, including without
limitation any [C.I.];
10.1.4 any breach of any representation or warranty made by River’s Edge
pursuant to Sections 8.1 or 8.3; or
10.1.5 any claims that may be brought or asserted against DUSA in either the
[C.I.] or in any subsequently filed litigations that are related to the facts that
have given rise to those litigations, except that DUSA shall not be entitled to
indemnification from River’s Edge should it be conclusively established that DUSA was
independently negligent or engaged in independent wrongful conduct and DUSA will
immediately reimburse River’s Edge for the costs incurred by River’s Edge in the
defense of DUSA.
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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.
10.2 By DUSA. DUSA shall indemnify, defend and hold harmless River’s Edge, [C.I.],
from and against any and all [C.I.] and [C.I.] arising out of any claims or suits brought by a
Third Party that assert, arise out of or result from any or all of the following:
10.2.1 [C.I.] or [C.I.] acts or omissions of DUSA or its [C.I.], and their
respective [C.I.] and [C.I.], in connection with the activities contemplated under
this Agreement;
10.2.2 any [C.I.] (but, for clarity, not the Licensed Product) or any [C.I.] of
[C.I.] [C.I.] or [C.I.] relating to or arising out of any [C.I.] of Nicomide by DUSA;
10.2.3 [C.I.] whatsoever relating to or arising out of the [C.I.] or [C.I.] of
DUSA or its [C.I.] with respect to Nicomide, including without limitation any [C.I.]
(but, for clarity, not the Licensed Product); or
10.2.4 any breach of any representation or warranty made by DUSA pursuant to
Sections 8.1 or 8.2.
10.3 Notice. Any party to this Agreement that seeks a defense and/or indemnification
under this Section 10 (the “Indemnitee”) shall notify the indemnifying Party (the
“Indemnitor”) of any Claim for which the Indemnitee seeks a defense and/or indemnification,
and the Indemnitor shall assume the defense thereof whether or not such Third Party claim is
rightfully brought; provided, however, that Indemnitee shall have the right to select its own
counsel [C.I.] if (a) Indemnitor does not assume the defense once tendered or (b) the
representation of such Indemnitee by the counsel retained by the Indemnitor would be inappropriate
due to an actual conflict or the potential for differing interests between such Indemnitee and any
other person represented by such counsel in such proceedings. In the event that the Indemnitee is
entitled to a defense and/or indemnification under Section 10.1 or 10.2 and is seeking same from
the Indemnitor, such Indemnitee shall inform the Indemnitor of the claim as soon as reasonably
practicable after such Indemnitee receives notice of such claim, shall permit the indemnifying
Party to assume direction and control of the defense of the claim (including the sole right to
settle it at the sole discretion of the indemnifying Party, provided that such settlement does not
impose any obligation on the Indemnitee or the other Party) and shall cooperate as requested [C.I.]
in the defense of the claim. The failure to deliver notice to the Indemnitor within a reasonable
time after the commencement of any such action shall only relieve such Indemnitor of any liability
to the Indemnitee under this Section 10 if the failure to provide such notice is found to have been
prejudicial to Indemnitor’s ability to defend such action,
10.4 Complete Indemnification. As the Parties intend complete indemnification,
[C.I.], including without limitation, [C.I.] and [C.I.] by an Indemnitee in connection with
enforcement of Sections 10.1 and 10.2 shall also [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.
10.5 Insurance. Each Party shall maintain, and shall require its [C.I.] and [C.I.]
hereunder to maintain, a [C.I.] and [C.I.] program on terms customary in the pharmaceutical
industry covering all activities and obligations of it, and, as the case may be, its [C.I.],
hereunder, or other programs with comparable coverage, [C.I.] and [C.I.] the [C.I.] or [C.I.] of
this Agreement during (i) the period that any Licensed Product or Nicomide is being commercially
distributed or sold by the respective Party, its Affiliates or Sublicensees, and (ii) a
commercially reasonable period thereafter.
11.
Term; Termination.
11.1 Term. This Agreement shall become effective as of the Effective Date (and with
respect to Paragraphs 3 and 4, the date of First Commercial Sale, if such date is earlier than the
Effective Date) and, unless earlier terminated pursuant to any other provisions of this Section 11,
shall be effective for an initial term of twelve (12) months following the Effective Date;
provided, however, that [C.I.] relating to the Nicomide® brand product, then the initial
term shall [C.I.], and in either case, thereafter may be automatically renewed for consecutive
periods of twelve (12) months at DUSA’s sole option (the “Term”). In the event that DUSA
[C.I.] this Agreement, DUSA shall provide River’s Edge with written notice of such intent a [C.I.]
or any renewal term hereof.
11.2 Termination for Cause. Either Party (the “Non-breaching Party”) may
terminate this Agreement, without prejudice to any other remedies available to it at law or in
equity, in the event the other Party (the “Breaching Party”) shall have materially breached
or defaulted in the performance of any of its material obligations hereunder and such breach or
default shall have continued for [C.I.] thereof was provided to the Breaching Party by the
Non-breaching Party (or, if such breach or default cannot be cured within such [C.I.] period, if
the Breaching Party does not commence and diligently continue actions to cure such breach or
default during such [C.I.]. Any such termination under this Section 11.2 shall become effective at
the end of such [C.I.] period unless the Breaching Party has cured any such noticed breach(es) or
default(s) prior to the expiration of such [C.I.] period (or, if such breach(es) or default(s)
cannot be cured within such [C.I.] period, if the Breaching Party has commenced and diligently
continued actions to cure such breach(es) or default(s)). The right of either Party to terminate
this Agreement as provided in this Section 11.2 shall not be affected in any way by its waiver or
failure to take action with respect to any previous breach or default.
11.2.1 In the event River’s Edge fails to pay to DUSA the amount reported by
River’s Edge under Sections 4.1.1 and/or 4.1.2, DUSA shall be entitled to file the
consent judgment provided for in Paragraph 5 of the Settlement Agreement and Mutual
Release contained in the Settlement Documents.
11.2.2 Any dispute over the [C.I.] under Section 4.4 shall be resolved by
submission [C.I.], to be selected by the Parties. Such [C.I.] may be commenced by
River’s Edge by notice to DUSA within [C.I.] of receipt of written notice from DUSA
that [C.I.] and which shall include River’s Edge’s suggested independent neutral
[C.I.]. The [C.I.] must be [C.I.], and must hold [C.I.]. If 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.
parties cannot agree, the [C.I.] will be chosen by [C.I.] upon request of any
Party. Within [C.I.] of selection of the [C.I.], each Party shall submit a statement
of its position to the [C.I.], with any supporting evidence. [C.I.] after submission
of the opening statements, each Party may submit a reply to the other’s statement.
The [C.I.] shall announce a decision within [C.I.]s of the date for submission of
reply statements. If the [C.I.] confirms a previous audit by DUSA, then the [C.I.]
shall be [C.I.]. If the [C.I.] determines that DUSA’s audit was erroneous by more
than [C.I.], then DUSA shall [C.I.] of the [C.I.]. In all other cases, the Parties
shall [C.I.]. In the event that River’s Edge fails [C.I.] following the decision by
the [C.I.], DUSA shall be entitled to file the consent judgment provided for in
Paragraph 5 of the Settlement Agreement and Mutual Release contained in the
Settlement Documents.
11.3 Termination for Challenges. In the event that River’s Edge or any of its [C.I.]
or [C.I.] make any request for, or file a declaration of, or undertake any action involving, any
interference, opposition, challenges as to ownership, assertions of invalidity or unenforceability,
revocation or reexamination relating to any DUSA Technology before any court, agency or other
tribunal, then DUSA shall have the right to immediately terminate this Agreement by sending written
notice of such termination to River’s Edge.
11.4 Cessation of Marketing. If River’s Edge ceases to sell or offer for sale the
Licensed Product [C.I.], either party shall have the right to terminate this Agreement on [C.I.]
prior written notice; provided, however, that the Parties shall agree to meet within such [C.I.]
period and discuss in good faith [C.I.] under Section 3 (which may be held by River’s Edge until
such meeting) should be made for sales from the date of the decision to cease such sales or offers
for sales until the time that [C.I.] under the terms of this Agreement. In no event will the [C.I.]
hereunder, if any, [C.I.] being held by River’s Edge.
11.5 Effect of Expiration or Termination. If this Agreement is terminated in its
entirety by DUSA pursuant to Section 11.2, Section 11.3 or Section 11.4, in addition to any other
remedies available at law or in equity: (i) all licenses and rights granted by DUSA to River’s Edge
under this Agreement shall terminate; (ii) at River’s Edge’s expense, River’s Edge shall promptly:
return to DUSA all relevant records and materials in River’s Edge’s possession or control
containing DUSA’s Confidential Information (provided that River’s Edge may keep one (1) copy of
such Confidential Information for archival purposes only); (iii) to the extent River’s Edge owns or
holds any right, title and interest in any trademarks, trade names, and logos under which a
Licensed Product has been or is being marketed or sold in the Territory, River’s Edge shall retain
all such rights; and (iv) all sublicenses granted by River’s Edge under this Agreement shall
continue in full force and effect in accordance with the terms and conditions of the respective
sublicense agreements, and River’s Edge will assign to DUSA all such sublicense agreements.
11.6 Accrued Rights; Surviving Obligations.
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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.
11.6.1 Termination, relinquishment or expiration of this Agreement for any
reason shall be without prejudice to any rights that shall have accrued to the
benefit of any Party prior to such termination, relinquishment or expiration
including, without limitation, any payment obligations under Section 4 and any and
all damages arising from any breach hereunder.
11.6.2 In addition to the provisions of this Agreement which expressly survive
as set forth elsewhere in this Agreement, all of the Parties’ rights and obligations
under, and/or the provisions contained in, Sections 1, 3, 5, 6.4, 7 (provided that
DUSA shall be responsible for regulatory obligations relating to any product it may
sell after the expiration, termination, or relinquishment of this Agreement), 9, 10,
11.4, 11.5, 13.3, 13.5, 13.6, 13.8, 13.11, 13.13, 13.15. shall survive the
expiration, termination, or relinquishment of this Agreement.
11.7 Section 365(n) of the Bankruptcy Code. All rights and licenses granted under or
pursuant to any Section of this Agreement are and shall otherwise be deemed to be for purposes of
section 365(n) of Title 11, of the United States Code (the “Bankruptcy Code”) licenses of
rights to “intellectual property” as defined in section 101(56) of the Bankruptcy Code. The
Parties shall retain and may fully exercise all of their respective rights and elections under the
Bankruptcy Code. Upon the bankruptcy of any Party, the non-bankrupt Party shall further be
entitled to a complete duplicate of, or complete access to, any such intellectual property, and
such, if not already in its possession, shall be promptly delivered to the non-bankrupt Party,
unless the bankrupt Party elects to continue, and continues, to perform all of its obligations
under this Agreement.
12. Force Majeure.
Any delay in the performance of any of the duties or obligations of either Party hereto (except the
payment of money due hereunder) shall not be considered a breach of this Agreement, and the time
required for performance shall be extended for a period equal to the period of such delay, if such
delay has been caused by or is the result of acts of God; acts of public enemy; insurrections;
riots; injunctions; embargoes; labor disputes, including strikes, lockouts, job actions, or
boycotts; fires; explosions; earthquakes; floods; shortages of energy; governmental prohibition or
restriction; or other unforeseeable causes beyond the reasonable control and without the fault or
negligence of the Party so affected. The Party so affected shall give prompt notice to the other
Party of such cause, and shall take whatever reasonable steps are necessary to relieve the effect
of such cause as rapidly as reasonably possible.
13. Miscellaneous.
13.1 Relationship of Parties. Nothing in this Agreement is intended or shall be
deemed to constitute a [C.I.] or [C.I.] between the Parties. No Party shall incur any debts or
make any commitments for the other, except to the extent, if at all, specifically provided herein.
13.2 Assignment. Except pursuant to a [C.I.] permitted under this Agreement, neither
Party shall be entitled to assign its rights or delegate its obligations hereunder without 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.
express written consent of the other Party hereto, except that each Party may assign its
rights and transfer its duties hereunder without such consent to any assignee of all or
substantially all of its business (or that portion thereof to which this Agreement relates) or in
the event of such Party’s merger, consolidation or involvement in a similar transaction. No
assignment and transfer shall be valid or effective unless done in accordance with this Section
13.2 and unless and until the assignee/transferee shall agree in writing to be bound by the
provisions of this Agreement.
13.3 Books and Records. Any books and records to be maintained under this Agreement
by a Party shall be maintained in accordance with pharmaceutical industry standards.
13.4 Further Actions. Each Party shall execute, acknowledge and deliver such further
instruments, and do all such other acts, as may be necessary or appropriate in order to carry out
the purposes and intent of this Agreement.
13.5 Notice. Any notice or request required or permitted to be given under or in
connection with this Agreement shall be deemed to have been sufficiently given if in writing and
personally delivered or sent by certified mail (return receipt requested), facsimile transmission
(receipt verified), or overnight express courier service (signature required), prepaid, to the
Party for which such notice is intended, at the address set forth for such Party below:
If to DUSA: | With a copy to: | |||
DUSA Pharmaceuticals, Inc. | Xxxx Xxxxx LLP | |||
25 Upton Drive | Princeton Xxxxxxxxx Village | |||
Xxxxxxxxxx, Xxxxxxxxxxxxx 00000 | 000 Xxxx Xxxxxx, Xxxxx 000 | |||
Xxxxxxxxx: President & CEO | Xxxxxxxxx, Xxx Xxxxxx 00000 | |||
Tel: 000-000-0000 | Attention: Xxxxxxx X. Xxxxxxx, Esq. | |||
Fax: 000-000-0000 | Tel: 000-000-0000 | |||
Fax: 000-000-0000 | ||||
If to River’s Edge: | With a copy to: | |||
River's Edge Pharmaceuticals, LLC | Baker, Donelson, Bearman, | |||
0000 Xxxxxx Xxxxxxx Xxxxxxx | Xxxxxxxx & Xxxxxxxxx, PC | |||
Building 504 | Suite 0000, Xxxxxxx Xxxxx | |||
Xxxxxxx, Xxxxxxx 00000 | 0000 Xxxxxxxxx Xxxx, X.X. | |||
Attention: Xxxxxxx Xxxxxx | Xxxxxxx, Xxxxxxx 00000 | |||
Tel: 000-000-0000 | Attention: Xxxxxx Xxxxxxx, Esq. | |||
Fax: 000-000-0000 | Tel: (000) 000-0000 | |||
Fax: (000) 000-0000 |
or to such other address for such Party as it shall have specified by like notice to the other
Party, provided that notices of a change of address shall be effective only upon receipt
thereof. With respect to notices given pursuant to this Section 13.5: (i) if delivered personally
or by facsimile
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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.
transmission, the date of delivery shall be deemed to be the date on which such notice or request
was given; (ii) if sent by overnight express courier service, the date of delivery shall be deemed
to be the next business day after such notice or request was deposited with such service; and (iii)
if sent by certified mail, the date of delivery shall be deemed to be the third business day after
such notice or request was deposited with the U.S. Postal Service.
13.6 Use of Name. Except as otherwise provided herein, neither Party shall have any
right, express or implied, to use in any manner the name or other designation of the other Party or
any other trade name, trademark or logo of the other Party for any purpose in connection with the
performance of this Agreement.
13.7 Waiver. Neither Party may waive or release any of its rights or interests in
this Agreement except in writing. The failure of either Party to assert a right hereunder or to
insist upon compliance with any term or condition of this Agreement shall not constitute a waiver
of that right or excuse a similar subsequent failure to perform any such term or condition. No
waiver by either Party of any condition or term in any one or more instances shall be construed as
a continuing waiver of such condition or term or of another condition or term.
13.8 Compliance with Law. Nothing in this Agreement shall be deemed to permit River’s
Edge to [C.I.] or otherwise [C.I.] any Licensed Product sold under this Agreement without
compliance with applicable laws.
13.9 Severability. If any provision hereof should be held invalid, illegal or
unenforceable in any jurisdiction, the Parties shall negotiate in good faith a valid, legal and
enforceable substitute provision that most nearly reflects the original intent of the Parties and
all other provisions hereof shall remain in full force and effect in such jurisdiction and shall be
liberally construed in order to carry out the intentions of the Parties hereto as nearly as may be
possible. Such invalidity, illegality or unenforceability shall not affect the validity, legality
or enforceability of such provision in any other jurisdiction.
13.10 Amendment. No amendment, modification or supplement of any provisions of this
Agreement shall be valid or effective unless made in writing and signed by a duly authorized
officer of each Party.
13.11 Governing Law. This Agreement shall be governed by and interpreted in
accordance with the laws of the [C.I.], without regard to conflict of law principles. The parties
expressly consent to the exclusive jurisdiction of the [C.I.] or [C.I.] courts of the [C.I.] as may
be appropriate with respect to any and all matters that relate in any way or arise from or under
the terms of this Agreement.
13.12 Entire Agreement. This Agreement, together with the Exhibits hereto, as
updated, and the Amendment to the Settlement Agreement and Mutual Release signed concurrently
herewith, sets forth the entire agreement and understanding between the Parties as to the subject
matter hereof and merges all prior discussions and negotiations between them, and neither of the
Parties shall be bound by any conditions, definitions, warranties, understandings or
representations with respect to such subject matter other than as expressly provided herein or as
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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.
duly set forth on or subsequent to the date hereof in writing and signed by a proper and duly
authorized officer or representative of the Party to be bound.
13.13 Parties in Interest. All of the terms and provisions of this Agreement shall be
binding upon, inure to the benefit of and be enforceable by the Parties hereto and their respective
permitted successors and assigns.
13.14 Descriptive Headings. The descriptive headings of this Agreement are for
convenience only, and shall be of no force or effect in construing or interpreting any of the
provisions of this Agreement.
13.15 Construction of Agreement. The terms and provisions of this Agreement represent
the results of negotiations between the Parties and their representatives, each of which has been
represented by counsel of its own choosing, and neither of which has acted under duress or
compulsion, whether legal, economic or otherwise. Accordingly, the terms and provisions of this
Agreement shall be interpreted and construed in accordance with their usual and customary meanings,
and each of the Parties hereto hereby waives the application in connection with the interpretation
and construction of this Agreement of any rule of law to the effect that ambiguous or conflicting
terms or provisions contained in this Agreement shall be interpreted or construed against the Party
whose attorney prepared the executed draft or any earlier draft of this Agreement.
13.16 Counterparts. This Agreement may be signed in counterparts, each and every one
of which shall be deemed an original, notwithstanding variations in format or file designation
which may result from the electronic transmission, storage and printing of copies of this Agreement
from separate computers or printers. Facsimile signatures shall be treated as original signatures.
* * *
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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.
IN WITNESS WHEREOF, each of the Parties has caused this Agreement to be executed by its
duly authorized representative as of the date first above written.
DUSA PHARMACEUTICALS, INC. |
||||
By: | /s/ Xxxxxxx X. O’Dell | |||
Name: | Xxxxxxx X. O’Dell | |||
Title: | EXEC. V P SALES & MARKETING | |||
Date: August 12, 2008 |
RIVER’S EDGE PHARMACEUTICALS, LLC |
||||
By: | /s/ Xxxxxxx Xxxxxx | |||
Name: | Xxxxxxx Xxxxxx | |||
Title: | PRESIDENT | |||
Date: August 12, 2008 | ||||
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Exhibit 1.
Patent Rights
Reference No. | Filing Date/Status | Title | ||
U.S. Patent No.
6,979,468
|
Issued | Oral Composition and Method for the Treatment of Inflammatory Cutaneous Disorders |