LICENSE AND SUPPLY AGREEMENT AMENDMENT
LICENSE
AND SUPPLY AGREEMENT AMENDMENT
This
LICENSE AND SUPPLY AGREEMENT AMENDMENT (this “Amendment”)
is
made and entered into as of this 18th day of November, 2005 (the “Effective
Date”),
between Discus Dental Inc., a corporation organized and existing under the
laws
of California (“DISCUS”)
and
Uluru, Inc., (“ULURU”)
a
corporation organized and existing under the laws of Delaware and successor
in
interest to Access Pharmaceuticals, Inc. (“ACCESS”).
RECITALS
WHEREAS,
ACCESS
and DISCUS entered into a License and Supply Agreement dated April 15, 2005
under which Access licensed certain rights to DISCUS (“the
Agreement”).
WHEREAS,
ULURU
purchased the topical product assets of ACCESS, including but not limited
to the
proprietary oral paste and the proprietary oral mucoadhesive, erodible patch
that contains amlexanox as the active ingredient for the prevention ad treatment
of canker sores, and has obtained United States Patents No. 6,585,997 and
No.
5,362,737 and an assignment of ACCESS’ rights and liabilities under the
Agreement.
WHEREAS,
DISCUS
consents, to the extent required, to the assignment of the Agreement to
ULURU.
WHEREAS,
ULURU
and DISCUS agree that the provision of the Agreement that contemplated DISCUS
purchasing an equity investment in ACCESS (Section F of Exhibit F) shall
be null
and void and DISCUS shall have no such right or obligation to pay the associated
$750,000 for the purchase of such equity.
WHEREAS,
originally in the Agreement, DISCUS was granted the right to market, to offer
for sale, sell and import Aphthasol in the Professional Channel only, during
the
Single Channel Period.
WHEREAS,
ULURU
and DISCUS agree to amend the Agreement to grant Discus the immediate right
to
market, to offer for sale, sell and import Aphthasol in both the Professional
Channel and the Pharmacy Channel within
NOW,
THEREFORE,
in
consideration of the mutual covenants and agreements set forth herein, and
for
good and valuable consideration the receipt and sufficiency of which are
hereby
acknowledged, the parties hereto hereby agree as follows:
1. DEFINITIONS
1.1
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Definitions.
As used in this Agreement, the following capitalized terms have
the
meanings indicated below:
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1.1.1
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“ULURU”
has the meaning set forth in the Preamble. The term “ACCESS” shall
continue to be mused to refer to the licensor ULURU as the successor
in
interest to ACCESS for consistency with the terms used in the
Agreement.
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1.1.2
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Construction
of Terms. Unless defined otherwise herein, all capitalized terms
shall
have the same meaning as capitalized terms defined in the
Agreement.
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2.
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SUPPLY
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2.1
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Grant
of License.
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2.1.1
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Section
2.1 of the Agreement shall be amended to read as
follows:
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“Subject to the terms and conditions of this Agreement, ACCESS hereby grants to DISCUS the exclusive right and license for applications of Products in the Field, in the Territory, under ACCESS’s Intellectual Property Rights during theTerm of this Agreement (a) to market, to offer for sale, sell and import Aphthasol in the Professional Channel and the Pharmacy Channel and (b) to market, to offer for sale, sell and import OraDisc A and all Products; provided that all of such foregoing rights and licenses are limited to such use as is necessary for DISCUS to market, offer for sale, sell and import the Products for applications in the Field in the Territory in accordance with this Agreement. Except as expressly granted herein, ACCESS retains all rights in ACCESS’s Intellectual Property Rights and the Products. Notwithstanding the foregoing, ACCESS specifically reserves for itself and its agents and subcontractors the right under ACCESS’s Intellectual Property Rights to develop, modify, and manufacture the Products, and to perform its rights, activities and obligations under this Agreement, provided that, subject to Section 2.9, all developments and modifications of the Products for use in the Field shall be Products and shall be covered by the license hereunder.
5.4 Royalty
Payments.
5.4.1 Paragraph
C of Exhibit F shall be amended to read as follows:
5.4.1.1 “During
the Single Channel Period: For Sales in the professional Channel, $3.70
multiplied by the total Net Unit Sales of the 5 gram tube of Aphthasol or
$3.45
multiplied by the total Net Unit Sales of the 3 gram tube of Aphthasol, provided
that D1SCUS may, in its sole discretion, create and distribute portions of
Aphthasol to third parties in packages containing 3 grams or less (“Samples”) on
a royalty free basis provided that such Samples are (i) provided to third
parties free of charge and (ii) clearly marked as “sample not for resale”.
ACCESS agrees that Samples will be supplied to DISCUS at no more than Standard
Cost.
5.4.1.2 During
the Single Channel Period: For Sales in Pharmacy Channel, $12.00 multiplied
by
the total Net Unit Sales of the 5 gram tube or 3 gram tube of Aphthasol up
to a
maximum of 3,100 per calendar month in Net Unit Sales; thereafter royalties
owed
shall be defined by Section 5.4.1.1 above.
5.4.1.3 After
the
Single Channel period but prior to expiration or invalidation of U.S. Patent
No.
5,362,737: (i) 15% of Net Sales of Aphthasol achieved through the Pharmacy
Channel, (ii) 10% of Net Sales of Aphthasol achieved through the Professional
Channel, and (iii) 7% of Net Sales of Aphthasol achieved through
Over-the-Counter sales.
5.4.2 Paragraph
F of Exhibit F of the Agreement shall be deleted in its entirety.
13.8
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Integration.
Except to the extent stated in writing in this Amendment, the parties
do
not make any further modification to the Amended Agreement and
all terms
stated therein shall govern and
control.
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IN
WITNESS WHEREOF, the Parties have executed this Agreement as of the Effective
Date.
DISCUS
DENTAL, INC.
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ULURU,
INC.
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By:
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/s/
Xxx Xxxxxxxxxx
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By:
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/s/
Xxxxx X. Xxxx
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Name:
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Xxx
Xxxxxxxxxx
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Name:
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Xxxxx
Xxxx
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Title:
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COO
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Title:
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President
and CEO
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