AMENDMENT TO LICENSE AGREEMENT
EXHIBIT 10(c)
Execution Copy
AMENDMENT TO LICENSE AGREEMENT
THIS AMENDMENT TO LICENSE AGREEMENT (this “Amendment”) is made on the 21st day of April, 2009
(the “Amendment Date”), by and among DUSA Pharmaceuticals, Inc., a company incorporated in the
State of New Jersey, having its principal offices at 00 Xxxxx Xxxxx, Xxxxxxxxxx, Xxxxxxxxxxxxx
(“DUSA”), and River’s Edge Pharmaceuticals, LLC, a Georgia limited liability company, having its
principal offices at 0000 Xxxxxx Xxxxxxx Xxxxxxx, Xxxxxxxx 000, Xxxxxxx, Xxxxxxx 00000 (“River’s
Edge”).
RECITALS
WHEREAS, DUSA and River’s Edge previously entered into that certain License Agreement, dated
July 3, 2008, (the “License Agreement”) concurrently with amending a certain Settlement Agreement
and Mutual Release by entering the First Amendment to the Settlement Agreement also dated July 3,
2008; and
WHEREAS, the Parties wish to amend the terms of the License Agreement to extend the term
thereof, to broaden the scope of the Licensed Products, and to amend payment and other terms as
hereafter agreed.
NOW, THEREFORE, the Parties, in furtherance of the foregoing and for good and valuable
consideration, the receipt and adequacy of which are hereby acknowledged, intending to be legally
bound, agree as follows:
1. All capitalized terms used, but not specifically defined herein, shall have the meaning
provided for such terms in the License Agreement.
2. Section 1.8 of the License Agreement is hereby deleted in its entirety and replaced with
the following:
“DUSA Know-How” shall mean all Know-How owned or controlled by DUSA or
its Affiliates as of the Amendment Date which is reasonably necessary for the
manufacture, use, offer for sale, sale or importation of Licensed Products.
Notwithstanding anything herein to the contrary, DUSA Know-How shall exclude:
(i) DUSA patent rights relating to any product other than the Licensed Products;
and (ii) Know-How owned or controlled by DUSA or its Affiliates relating to any
product other than the Licensed Products.
3. Section 1.12 of the License Agreement is hereby deleted in its entirety.
4. Section 1.13 of the License Agreement is hereby deleted in its entirety and replaced with
the following:
“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.
5. Section 1.17 of the License Agreement is hereby deleted in its entirety and replaced with
the following:
“Licensed Products” shall mean any product or products containing
niacinimide, zinc, copper and folic acid, including without limitation, any
product that was sold by DUSA under its trademark, Nicomide®, or any
product that is, or may be listed in drug database services as substitutable
for, and/or listed in place of the product, or any product 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”), including without limitation, a product sold pursuant to appropriate
labeling under the Dietary Supplement Health and Education Act (hereafter,
“DSHEA”).
6. Section 1.21 of the License Agreement is hereby deleted in its entirety and replaced with
the following:
“Patent Rights” shall mean DUSA’s rights that it now owns, or has
acquired as of the Amendment Date of this Agreement, in information inventions
or discoveries encompassing the compositions or use of the Licensed Products
claimed in the patent listed on Exhibit 1 and any reissues, reexaminations or
extensions thereof.
7. Section 1.26 of the License Agreement is hereby redesignated at Section 1.27, and new
Section 1.26 is hereby replaced with the following:
“Trademark” shall mean the xxxx Nicomide®, registered with
the United States Patent and Trademark Office.
8. Section 2.1.1 of the License Agreement is hereby deleted in its entirety and replaced with
the following:
“Subject to the terms and conditions of this Agreement, DUSA hereby grants to
River’s Edge and its Affiliates an 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
Products in the Territory.” Notwithstanding the foregoing in this Section 2.1.1
and subject to Tiber Laboratories LLC becoming bound to all of the terms and
conditions of this License Agreement as amended pursuant to Section 13.2,
River’s Edge may sublicense its rights granted hereunder to Tiber Laboratories
LLC.
9. Section 2.1.2 of the License Agreement is hereby deleted in its entirety and replaced with
the following:
“DUSA also hereby grants to River’s Edge an exclusive license to all rights,
title and interest that it owns or controls to the Trademark and trade dress
used in connection with the sale by DUSA of the NicomideÒ,
without the right to
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sublicense unless expressly agreed to in writing by DUSA; except that River’s
Edge shall have no rights or interest in the product label currently used by
DUSA, or in the copyright owned by DUSA relating to the Licensed Product. DUSA
reserves all rights not expressly granted herein. This Section 2.1.2 shall be
subject to the limitations, representations, warranties, covenants and
acknowledgments of the Parties in Sections 7.3 and 8 of this Agreement.“
Notwithstanding the foregoing in this Section 2.1.2 and subject to Tiber
Laboratories LLC becoming bound to all of the terms and conditions of this
License Agreement as amended pursuant to Section 13.2, River’s Edge may
sublicense its rights granted hereunder to Tiber Laboratories LLC.
10. Section 3 of the License Agreement is hereby deleted in its entirety and replaced with the
following:
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) all amounts due
for the full month in which the Amendment Date occurs based on the formula
stated in Section 3 of the License Agreement prior to this Amendment, and (b)
the following sums specified in Sections 3.1 and 3.2 below:
3.1 Guaranteed Minimum Royalty. Subject to Section 11.4, River’s Edge
shall pay to DUSA a guaranteed minimum royalty of Two Million Six Hundred
Thousand Dollars ($2,600,000), in thirteen (13) equal installments of Two
Hundred Thousand Dollars ($200,000) per month to be payable as set forth in
Section 4 below, which amount shall be paid in any and all events, including
without limitation, if this Agreement is terminated for any reason (other than
an action or documented request by a government agency under Section 11.4) or if
River’s Edge ceases to sell the Licensed Products for any reason whatsoever
(other than an action or documented request by a government agency under Section
11.4) (the “Fixed Payment”). The first installment of the Fixed Payment shall be
immediately due and payable upon the execution of this Amendment by both
Parties. The next twelve (12) monthly installments shall be due and payable
commencing on the first day of the second calendar month following the first
installment payment, and then on the first calendar day of each month thereafter
until the Fixed Payment is paid in full (collectively the “Fixed Payment
Period”).
3.2 Margin Payments. Commencing with the month following the final
installment of the Fixed Payment, and continuing in each calendar month
thereafter, until the earlier of (1) sixteen (16) consecutive calendar
months (subject to 3.3 below), or (2) payment by River’s Edge to DUSA of
Five Million Dollars ($5,000,000), in the aggregate, including the Fixed
Payment, (the “Margin Royalty Period”). River’s Edge shall pay to DUSA a share
of all revenues received by River’s Edge or its Affiliates with respect to the
Licensed Products. The share of such revenues under this Section 3.2 shall be
fifty percent (50%) of the amount remaining after the Cost of Goods is
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subtracted from Net Revenues of the Licensed Products resulting from activities
in the prior calendar month as described below. The timing of payments shall be
made in accordance with Section 4 below.
For the purposes of clarity, if the first monthly installment of the Fixed
Payment due under Section 3.1 is made on March 15, 2009, the second such
installment shall be made on May 1, 2009, the third such installment shall be
made on June 1, 2009, etc. If the first payment in the Margin Royalty Period is
due May 15, 2010, the DUSA share of the Net Revenues will be calculated on Net
Revenues received during March 2010.
3.3 Subject to Section 11.4, if River’s Edge has not made payments to DUSA which
in the aggregate, including the Fixed Payment, total Five Million Dollars
($5,000,000) on or before the sixteenth (16th) payment during the
Margin Royalty Period, then River’s Edge shall have the option of either
terminating the Agreement under Section 11.4 (as amended by Section 22 hereof)
or continuing to pay the Margin Royalty payments under Section 3.2 hereof as
amended until the total of Five Million Dollars ($5,000,000) has been paid (but
no later than the date that this Agreement expires under Section 11.1), at which
time the license for the Licensed Products and Trademark shall be fully paid up
and no further royalties or license fees shall be due to DUSA under this
Agreement. At such time as Five Million Dollars ($5,000,000) has been paid
hereunder, River’s Edge shall be the owner of all rights, title and interest in
and to the DUSA Technology and Trademark relating to the Licensed Products; and
DUSA shall deliver duly executed assignments of the Patent and Trademark in
forms appropriate for recording with the U.S. Patent and Trademark Office and a
xxxx of sale evidencing River’s Edge’s ownership of the DUSA Technology and
Trademarks. Upon the transfer of ownership hereunder and except as set forth in
Section 11.6.2, this Agreement and the parties’ rights and obligations hereunder
shall terminate. If River’s Edge elects to continue the Margin Royalty payments
this Agreement and Licenses granted hereunder shall continue and River’s Edge
will continue to use commercially reasonable efforts to market and distribute
the Licensed Product.
3.4 The Parties hereby acknowledge and agree that the Patent Rights, Trademark
and DUSA Know-How licensed pursuant to this Agreement justify royalties of
differing amounts with respect to sales of the Licensed Products and Trademark,
and that if such royalties were calculated separately, royalties relating to the
Patent Rights, Trademark and royalties relating to the DUSA Know-How would last
for different terms. In light of such considerations and for reasons of
convenience, the Parties have hereby determined that blended compensation for
the Patent Rights, Trademark and the DUSA Know-How licensed hereunder will apply
during a single royalty term and that the utilization of such blended
compensation is advantageous to both Parties.
11. Section 4.1 of the License Agreement is hereby deleted in its entirety and replaced
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with the following:
4.1.1 Within fifteen (15) days after the end of each calendar month beginning
with March, 2009, River’s Edge shall deliver to DUSA a report, setting forth in
a reasonably detailed fashion the total gross unit sales each of the Licensed
Products, total Net Revenues for each of the Licensed Products (including an
itemization of the deductions applied to such gross sales to derive such Net
Revenues) during the relevant calendar month, and the calculation of the payment
due thereon, whether during the Fixed Payment Period or the Margin Royalty
Period. Payments during the Margin Royalty Period, as well as the final payment
in the event of a termination of this Agreement, shall be made to DUSA within
forty-five (45) days 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.
Notwithstanding the provision set forth in Section 11.6.2 below, River’s Edge
shall have no obligation to report sales made after transfer of ownership of the
DUSA Technology and Trademarks to River’s Edge as provided in Section 3.3. For
clarity, sales made during the month, up to and including the date in which a
termination of this Agreement occurs, shall be reported to DUSA and a pro rated
portion of the Fixed Payment or the royalties due for the Margin Royalty Period,
as applicable, shall be paid within forty-five (45) days following the end of
the calendar month in which such termination occurs.
4.1.2 Within seventy-five (75) days following the end of each calendar year
during the Margin Royalty Period, 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.
12. Section 6.1.1 of the License Agreement is hereby deleted in its entirety and replaced with
the following:
Until the transfer of the ownership of the DUSA Technology and Trademark to
River’s Edge as provided in Section 3.3, DUSA shall retain all right, title and
interest in and to the DUSA Technology and the Trademark, subject to the license
granted to River’s Edge pursuant to Section 2.1.
13. Section 6.3.2 of the License Agreement is hereby deleted in its entirety and replaced with
the following:
River’s Edge 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 River’s Edge (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, DUSA shall have the right, but not the duty, to
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institute, prosecute, and control any action or proceeding with respect to such
Infringement. The costs and expenses of any such action (including fees of
attorneys and other professionals) shall be borne by the Party instituting the
action, or, if the Parties elect to cooperate in instituting and maintaining
such action, such costs and expenses shall be borne by the Parties in such
proportions as they may agree in writing. 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 applied first to reimburse both
Parties for all costs and expenses incurred by the Parties with respect to such
action on a pro rata basis and, if after such reimbursement any funds remain
from such award, they shall be allocated as follows: (i) if DUSA has instituted
and maintained such action alone, DUSA shall be entitled to retain such
remaining funds; (ii) if River’s Edge has instituted and maintained such action
alone, River’s Edge shall be entitled to retain such remaining funds, but shall
pay DUSA as if such remaining funds constituted Net Revenues made within the
month the funds are received; or (iii) if the Parties have cooperated in
instituting and maintaining such action, the Parties shall allocate such
remaining funds between themselves in the same proportion as they have agreed to
bear the expenses of instituting and maintaining such action.
14. Section 6.4 of the License Agreement is hereby deleted in its entirety and replaced with
the following:
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 or infringement of the
Trademark, the Party being sued shall promptly notify the other Party in writing
of such suit.
15. Section 6.4.2 of the License Agreement is hereby deleted in its entirety and replaced with
the following:
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, distribution or
marketing of the Licensed Product after the Effective Date, and for any
trademark infringement suit after the Amendment Date, at its own expense and
shall be responsible for all damages incurred as a result thereof. DUSA hereby
agrees to assist and cooperate with River’s Edge, at River’s Edge’s reasonable
request and expense, in the defense of any patent infringement suit related to
the Licensed Product (including, without limitation, consenting to
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being named as a nominal party thereto).
16. Section 6.4.3 of the License Agreement is hereby deleted in its entirety and replaced with
the following:
River’s Edge shall be solely responsible for any damages awarded 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
for any trademark infringement suit after the Amendment Date.
17. Sections 8.3 and 8.4 of the License Agreement is hereby amended by adding the following:
8.3.3 River’s Edge acknowledges that DUSA has disclosed to River’s Edge the
nature of the FDA’s concerns regarding association of the use of the Trademark
with a Licensed Product sold pursuant to DSHEA, and that DUSA has been in
discussions with the FDA regarding a DSHEA labeled product, and that the FDA may
object to the use of the Trademark in connection with sales of a DSHEA product.
DUSA has also disclosed to River’s Edge that there was a stability failure in
regard to the release rate of the zinc on its annual lot for 2007 which calls
into question the stability of batches manufactured subsequent to such annual
batch; i.e., 4 additional batches. DUSA is completing its internal
investigation and is unsure what action FDA may request, which could include
that Sirius Laboratories, Inc. or the manufacturer of Nicomide, Actavis Totowa,
Inc., recall those batches of Nicomide. The annual batch from 2007 has expired
but the other 4 are within date. River’s Edge shall not be responsible for the
recall, if required, or any cost or liability associated therewith.
8.4.3 DUSA represents and warrants that to the best of its information,
knowledge and belief, it has disclosed all possible adverse communications from
the FDA to or with DUSA and its manufacturer concerning the Licensed Product.
18. Section 10.2.2 of the License Agreement is hereby deleted in its entirety and replaced
with the following:
| 10.2.2 | any tort claims of personal injury (including death) or property damage relating to or arising out of any storage, use, distribution, sale, offer for sale of Nicomide by DUSA prior to the Amendment Date; |
19. Section 10.2.4 of the License Agreement is hereby deleted in its entirety and
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replaced with the following:
| 10.2.4 | any breach of any representation or warranty made by DUSA pursuant to Section 8.1 of this Agreement. |
20. Section 11.1 of the License Agreement is hereby deleted in its entirety and replaced with
the following:
Term. This Agreement shall become effective as of the Effective Date
(and with respect to Sections 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 Agreement, including Sections 3.3 or
11, shall be effective for a term of thirty (30) months following the Amendment
Date, subject to extension under Section 3.3, but no later than 48 months
following the amendment date (the “Term”).
21. Section 11.3 of the License Agreement is hereby deleted in its entirety and replaces with
the following:
Termination for Challenges. In the event that River’s Edge or any of
its Affiliates or Sublicensees 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. If this Agreement
is terminated pursuant to this Section 11.3, River’s Edge shall remain liable to
DUSA for any unpaid portion of the compensation due under Sections 3.1 and 3.2
(i.e. $5,000,000), and such unpaid portion of such payments shall become
immediately due and payable to DUSA in their entirety.
22. Section 11.4 of the License Agreement is hereby deleted in its entirety and replaced with
the following:
Cessation of Marketing. If River’s Edge ceases to sell or offer for
sale the Licensed Products for any reason, other than an action or documented
request by a government agency, River’s Edge shall have the right to terminate
this Agreement on thirty (30) days prior written notice to DUSA; provided,
however, that (i) any unpaid portion of the Fixed Payment shall be and remain
due and payable by River’s Edge to DUSA pursuant to the terms of this Agreement,
and (ii) if River’s Edge so terminates prior to payment to DUSA of Five Million
Dollars ($5,000,000) in the aggregate under this Agreement, then all licenses
and rights granted by DUSA to River’s Edge under this Agreement shall terminate
and revert back to DUSA. If River’s Edge ceases to sell or offer for sale the
Licensed Products due to an action or documented
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request by a government agency, River’s Edge shall have the right to terminate
this Agreement under Section 11.8. In such an event, except for Margin
Royalties due on Licensed Products sold pursuant to Section 3.2, and any pro
rated Fixed Payment due under Section 4.1.1, nothing further will be due to DUSA
from River’s Edge under Sections 3.1 and 3.2 after the date River’s Edge ceases
to sell or offer to sale the Licensed Product.
23. Section 11.5 of the License Agreement is hereby deleted in its entirety and replaced with
the following:
Effect of Expiration or Termination. If this Agreement is terminated in
its entirety by DUSA pursuant to Sections 11.2 or 11.3, by River’s Edge pursuant
to Sections 11.4 or 11.8, then subject to 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 and revert back to DUSA; (ii)
at River’s Edge’s expense, River’s Edge shall promptly return to DUSA all
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.
24. Section 11.6 of the License Agreement is hereby deleted in its entirety and replaced with
the following:
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 Sections 3 and 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, 4, 5, 6.4,
7, 9, 10, 11.2-11.8, 13.3, 13.5, 13.6, 13.8, 13.11, 13.13, 13.15 shall survive
the expiration, termination, or relinquishment of this Agreement.
25. Section 11.8 of the License Agreement is added as the following:
Termination by Notice. Subject to Sections 3, 11.4, 11.5 and 11.6, and
notwithstanding any other provision of this Section 11, River’s Edge shall have
the right to terminate this Agreement during the Margin Royalty Period
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upon thirty (30) days prior written notice to DUSA.
26. All references in this Amendment, to the singular shall include the plural and vice versa,
in this Amendment, unless the context requires otherwise. References to a Licensed Product in the
License Agreement shall include Licensed Products as defined in this Amendment, unless the context
clearly indicates otherwise. All other terms and conditions of the License Agreement shall remain
unchanged and in full force and effect.
27. This Amendment shall not constitute a waiver or modification of any of the Parties’ rights
and remedies or of any of the terms, conditions, warranties, representations, or covenants
contained in the License Agreement, except as specifically set forth above, and each Party hereby
reserves all of its rights and remedies pursuant to the License Agreement and applicable law.
28. This Amendment may be executed in counterparts, each of which, when taken together, shall
be deemed to be one and the same instrument.
IN WITNESS WHEREOF, the Parties have executed and delivered this Amendment to License
Agreement as of the date first written above.
| DUSA Pharmaceuticals, Inc. |
||||
| By: | /s/ Xxxxxxx X. O’Dell | |||
| Name: | Xxxxxxx X. O’Dell | |||
| Title: | EXECUTIVE VP SALES & MARKETING | |||
| River’s Edge Pharmaceuticals, LLC |
||||
| By: | /s/ Xxxxxx X. Xxxxxxx with express permission | |||
| Name: | Xxxxxx X. Xxxxxxx, on behalf of Xxxxxxx Xxxxxx, President |
|||
| Title: | Xxxxxxx Xxxxxx, Pres. | |||
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