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EXHIBIT 10.30

LICENSE AND SUPPLY AGREEMENT

dated as of October 19, 2012

between

ULURU INC.

and

ORADISC GMBH

 
 

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THIS LICENSE AND SUPPLY AGREEMENT (this “Agreement”) is made and entered into as
of this 19th  day of October, 2012 (the “Effective Date”), between ULURU Inc., a
corporation organized and existing under the laws of Nevada and having an
address at 4452 Beltway Drive, Addison, TX 75001 (“ULURU”) and OradsicORADISC
GmbH, a corporation organized and existing under the laws of Austria and having
an address at Herrengasse 6-8, Vienna AT 1010 (“ORADISC”).

RECITALS

WHEREAS, ULURU  has developed a mucoadhesive oral drug delivery product as more
fully described in Exhibit A attached hereto (the “Product”), and has obtained
United States Patent No. 6,585,997 in connection with the Product

WHEREAS, ORADISC possesses substantial expertise in the commercialization and
marketing of such products; and

WHEREAS, ULURU desires to grant to ORADISC, and ORADISC desires to obtain from
ULURU, an exclusive license to market the Product and an exclusive right to
purchase from ULURU and distribute the Product, all under the terms and subject
to the conditions set forth herein.

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           Definitions.

As used in this Agreement, the following capitalized terms have the meanings
indicated below:

1.1.1           “ULURU” has the meaning set forth in the Preamble.

1.1.2           “ULURU Confidential Information” means all information,
specifications (including, without limitation, the Specifications), know-how and
data pertaining to the Product and ULURU’s business or its Manufacturing
operations disclosed to ORADISC or its Affiliates, Third Party manufacturers or
distributors hereunder, including, without limitation, all information,
Specifications, know-how and data related to the design, implementation,
performance and manufacture of the Product, and any correspondence with the FDA
or any other Regulatory Authority, clinical study data, analytical data, or
operating procedures.

1.1.3           “ULURU Trademark” means any trademark, trade name, trade dress,
slogan, logo, or similar item used by ULURU prior to or as of the Effective
Date, or subsequent to the Effective Date in connection with any ULURU product
other than the Product.

 
 

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1.1.4           “Affiliate” means, in the case of either Party, any corporation,
joint venture, or other business entity which directly or indirectly controls,
is controlled by, or is under common control with that Party.  The term
“control,” as used in this definition, means having the power to direct, or
cause the direction of, the management and policies of an entity, whether
through ownership of voting securities, by contract or
otherwise.  Notwithstanding the foregoing, for purposes of this Agreement, the
term “Affiliate” does not include entities in which a Party or its Affiliates
owns a majority of the ordinary voting power to elect a majority of the board of
directors but is restricted from electing such majority by contract or
otherwise, until such time as such restrictions are no longer in effect.

1.1.5           “Batch” means the volume of finished, packaged Product obtained
from a validated Manufacturing run.

1.1.6           “Certificate of Analysis” means the document identifying the
results of the Methods of Analysis for a specific Batch of Product in a form
agreed to by the Parties in writing but which shall include, without limitation,
the applicable Product Batch’s manufacturing date, expiration date, lot number
and testing results and data.

1.1.7           “Confidential Information” means either ORADISC Confidential
Information, ULURU Confidential Information, or both, as the context requires.

1.1.8           “Contract Year” means each consecutive twelve (12) month period
during the Term, the first of which shall commence on the first day of the
calendar month following the date of Launch and end on the first anniversary
thereof.

1.1.9          “Control” means, with respect to any item of information or
intellectual property right, the possession, whether by ownership or exclusive
license, of the right to grant a license or other right with respect thereto.

1.1.10           “Effective Date” has the meaning set forth in the Preamble.

1.1.11           “Facility” means ULURU’s initial Third Party Manufacturing
facilities, and any subsequent or replacement Third Party Manufacturing
facilities identified to and approved by ORADISC in accordance with Section 2.8.

1.1.12           “FDA” means (a) the United States Food and Drug Administration,
or (b) with respect to countries in the Territory other than the United States,
any foreign regulatory agency or governmental entity which fulfills a role
similar to the United States Food and Drug Administration, or any successor
entities thereto.

1.1.13           “FD&C Act” means (a) the Federal Food, Drug and Cosmetic Act,
and all regulations promulgated thereunder, or (b) with respect to countries in
the Territory other than the United States, any foreign laws, statutes, rules or
regulations fulfilling a role similar to the Federal Food, Drug and Cosmetic Act
(and all regulations promulgated thereunder), as the same may be amended or
supplemented from time to time.

1.1.14           “Field” means the human oral care and dental market.

1.1.15           “Force Majeure Event” has the meaning set forth in Article 10.

 
 

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1.1.16           “Good Manufacturing Practice” or “GMP” means (a) the then
current standards for the manufacture of pharmaceuticals, as set forth in the
FD&C Act, (b) such standards of good manufacturing practice as are required by
the applicable laws and regulations of countries in which the Product is
intended to be sold, to the extent such standards are not inconsistent with the
then current standards for the manufacture of pharmaceuticals as set forth in
the FD&C Act, and (c) any quality requirements set forth in this Agreement or
the Quality Agreement attached hereto as Exhibit B.

1.1.17           “Indemnified Party” has the meaning set forth in Section 7.1.3.

1.1.18           “Indemnifying Party” has the meaning set forth in Section
7.1.3.

1.1.19           “Intellectual Property Rights” means Patents, designs,
formulae, trade secrets, know-how, industrial models, and technical information
Controlled by ULURU and whether now existing or coming into existence during the
Term and which are necessary for and/or related to the use or distribution of
the Product.

1.1.20           “Invention” means any new or useful method, process,
manufacture, compound or composition of matter, whether or not patentable or
copyrightable, or any improvement thereof arising during the Term with respect
to the Product, its Manufacture and/or use.

1.1.21           “Launch” means the date on which the Product is sold by ORADISC
for the first time to a Third Party for commercial distribution in the
Territory.

1.1.22           “Manufacture,” “Manufactured” or “Manufacturing” means all
activities involved in the production of the Product, including, without
limitation, the preparation, formulation, finishing, testing, packaging, storage
and labeling of the Product and the handling, storage and disposal of any
residues or wastes generated thereby.

1.1.23           “Materials” means all materials, including, without limitation,
all raw materials, ingredients, packaging supplies and labels, required for the
Manufacture of Product.

1.1.24           “Methods of Analysis” means the methods of analysis for the
Product contained in the regulatory filings or internal quality control
documents.

1.1.25           “Net Sales” means, with respect to the Product, the gross
invoiced sales amount of the Product sold by ORADISC or its Affiliates to
non-affiliate Third Parties, after deduction of the following items, to the
extent that such deductions are reasonable and actually allowed, taken or
incurred, and (provided that such items do not exceed reasonable and customary
amounts in the country in which the sale occurred): (a) trade and quantity
discounts, net of any give-backs received by ORADISC in return; (b) refunds,
rebates, retroactive price adjustments, service allowances and broker’s or
agent’s commissions; (c) credits or allowances given for rejection or return of
previously sold Product or for wastage replacement actually taken or allowed;
and (d) any tax, duties or government charge levied on the sale of Product and
borne by ORADISC and/or its Affiliates (excluding national, state or local taxes
based on income). Such amounts shall be determined from the books and records of
ORADISC and its Affiliates maintained in accordance with generally accepted
accounting principles, consistently applied.  Sales of the Product by and
between a Party and its Affiliates for further distribution to a Third Party are
not sales to Third Parties and shall be excluded from Net Sales calculations for
all purposes.

 
 

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1.1.26           “Party” or “Parties” means either ORADISC, ULURU or both, as
the context requires.

1.1.27           “Patents” shall mean (a) U.S. Patent Nos. 6,585,997, and (b)
any and all patents, patent applications, patent disclosures awaiting filing
determination, patent divisionals, continuations, continuations-in-part,
reissues, re-examinations, renewals and extensions thereof Controlled by ULURU
during the Term, within the Territory, which are necessary for the Manufacture,
use or distribution of the Product.

1.1.28           “Person” means any natural person, corporation, general
partnership, limited partnership, limited liability company, limited liability
partnership proprietorship, other business organization, trust, union,
association or governmental authority.

1.1.29           “Product” has the meaning set forth in the first recital above.

1.1.30           “Recall” means any action by any Party to recover title to or
possession of any Product sold or shipped to Third Parties or any action to
prevent or interrupt the sale or shipment by a Party of the Product to Third
Parties that would have been subject to recall if it had been sold or shipped.

1.1.31           “Regulatory Approval” means all consents, permits, approvals,
licenses, authorizations, qualifications, notices or orders that are issued or
granted by Regulatory Authorities which are required for the manufacture,
marketing, promotion, pricing and sale of the Product in a country within the
Territory.

1.1.32           “Regulatory Authority” means any domestic or foreign, federal,
national, regional, state, county, city, municipal, local or other
administrative, legislative regulatory or other governmental authority, agency,
department, bureau, commission, or council involved in the granting of
Regulatory Approval for the Product in the Territory.

1.1.33           “Rolling Forecast” has the meaning set forth in Section 2.3.

1.1.34           “Seizure” means any action by the FDA or any other Regulatory
Authority to detain or destroy the Product or prevent the release of the
Product.

1.1.35           “Shortfall” has the meaning set forth in Section 2.6.

1.1.36           “Specifications” means the specifications for the Product
contained in a regulatory filing or internal quality control documents.

1.1.37           “Term” means, with respect to each country in the Territory,
the period commencing on the Effective Date and ending upon the expiration of
the last-to -expire patent within the Patents in such country, except as and if
sooner terminated in accordance with Section 8.

1.1.38           “Territory” means the countries outlined on Exhibit F.

 
 

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1.1.39           “Third Party” means any Person other than ORADISC, ULURU and
their respective Affiliates.

1.1.40           “Trademark” means any trademark, trade name, trade dress,
slogan, logo, or similar item selected by ORADISC for use in connection with the
Product.

1.1.41           “ORADISC” has the meaning set forth in the Preamble.

1.1.42           “ORADISC Confidential Information” means all information,
specifications, know-how and data pertaining to ORADISC’s business disclosed to
ULURU, its Affiliates or its Third Party manufacturer hereunder, including,
without limitation, marketing and sales plans, artwork, formats, equipment,
logos, drawings, customer lists, regulatory filings, correspondence with the FDA
or any other Regulatory Authority, clinical study data, analytical data,
operating procedures and all ordering and sales information.

1.2           Construction of Certain Terms and Phrases.

Unless the context of this Agreement otherwise requires, (i) words of any gender
include each other gender; (ii) words using the singular or plural number also
include the plural or singular number, respectively; (iii) the terms “hereof,”
“herein,” “hereby” and derivative or similar words refer to this entire
Agreement; (iv) the terms “Article” or “Section” refer to the specified Article
or Section of this Agreement; and (v) Article and Section headings shall not
affect the meaning or construction of any provision of this Agreement.

2.           SUPPLY

2.1           Grant of License.

2.1.1           Subject to the terms and conditions of this Agreement, ULURU
hereby grants to ORADISC (a) the exclusive right and license in the Field under
ULURU’s Intellectual Property Rights to market, offer for sale, sell, distribute
including sublicensing, and import products, including the Product, in the
Territory, (b) the exclusive right and license in the Field under ULURU’s
Intellectual Property Rights to use the Product in the Territory, provided that
such right and license is limited to such use as is necessary for ORADISC to
market, offer for sale, sell including sub-licensing, import and, subject to the
terms and conditions set forth in Section 2.6, Manufacture the Product in the
Territory, and (c) a non-exclusive right and license to use the Product and all
information and Intellectual Property Rights with respect thereto (including,
without limitation, data, studies and clinical trials) solely for the purpose of
obtaining Regulatory Approvals for the Product.  Except as expressly granted
herein, ULURU retains all rights in the Intellectual Property Rights and the
Product.

                      2.1.2           Except as specifically provided to the
contrary in Section 2.1.1, the license granted in Section 2.1.1 shall not be
construed (a) to effect any sale of ULURU’s Intellectual Property Rights or any
other proprietary ULURU technology; (b) subject to the terms and conditions set
forth in Section 2.6, to grant any license relating to ULURU’s methods of
formulating, fabricating and Manufacturing the Product; (c) to grant ORADISC any
rights in or to the use of the Intellectual Property Rights by implication or
otherwise.  ORADISC shall mark or have marked all containers or packages of the
Product in accordance with the patent marking laws of the jurisdiction in which
such units of Product are to be used or distributed.

 
 

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2.2           Manufacture; Marketing.

Subject to Section 2.3, ULURU shall Manufacture and deliver the Product to
ORADISC in such quantities and at such times as ordered by ORADISC in accordance
with this Agreement.  During the Term, ULURU shall maintain the resources
necessary to Manufacture the Product and shall provide, at its own expense, all
Materials and labor necessary to do so.  ORADISC shall market and sell the
Product in each country in the Territory; provided that, nothing shall require
ORADISC to continue to market or sell the Product in any country within the
Territory during a period of time that ORADISC determines, in its sole judgment,
that such Product is reasonably likely to be subject to adverse regulatory or
legal action, or infringe any intellectual property right of any Third Party in
such country.

2.3           Forecasts.

At least four (2) months prior to Launch, ORADISC shall submit to ULURU a
forecast of the quantity of the Product that ORADISC anticipates ordering from
ULURU prior to ORADISC’s anticipated Launch of Product.  ORADISC shall submit to
ULURU a forecast of the quantity of the Product that ORADISC anticipates
ordering from ULURU during the twelve (12) month period (broken down by
quarters) following Launch and ORADISC shall update such forecast on a rolling
twelve (12) months basis every month thereafter (each, a “Rolling
Forecast”).  ORADISC shall place purchase orders for at least the quantity of
the Product specified in the first three (3) months of each such Rolling
Forecast and the remaining nine (9) months shall be a non-binding good faith
estimate.

2.4           Orders and Delivery.

2.4.1           ORADISC shall place its firm orders for the Product with ULURU
by submitting a purchase order, at least ninety (90) days prior to the delivery
date requested therein, which sets forth (a) the quantity of the Product ordered
for delivery; and (b) the delivery date for that order.  Any such purchase order
which is in accordance with the terms and conditions of this Agreement shall be
deemed to be accepted by ULURU.  For all other purchase orders placed by
ORADISC, unless ULURU notifies ORADISC in writing within seven (7) days of
receipt of a purchase order that it is unable to deliver the Product in
accordance with such purchase order, ULURU shall be deemed to have accepted such
purchase order as a binding order.  If ULURU notifies ORADISC that it is unable
to fill a purchase order that is not in accordance with the terms and conditions
of this Agreement, it shall indicate the portion of such purchase order ULURU
cannot supply by the requested delivery date and specify alternate delivery
dates; provided that in the event that ORADISC delivers a purchase order less
than ninety (90) days prior to the requested delivery date, ULURU shall use
commercially reasonable efforts to meet such requested delivery date despite the
shortened lead time, and ULURU will not be in breach of its obligations
hereunder if, despite such commercially reasonable efforts, ULURU is not able to
meet such requested delivery date with respect to such order.  All Product shall
be delivered F.O.B. the Facility and in accordance with ORADISC’s
instructions.  Title, possession and risk of loss shall pass to ORADISC upon
delivery of Product to ORADISC’s designated carrier at the Facility’s loading
dock.  The provisions of this Agreement shall prevail over any inconsistent
statement or provisions contained in any document related to this Agreement
passing between the parties hereto including, but not limited to, any purchase
order, acknowledgment, confirmation or notice.

 
 

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2.5           Shelf Life.

ULURU shall schedule Manufacturing operations so that all of the Product
delivered has the latest expiry date possible, and in no event shall any Product
be delivered to ORADISC with an expiry date less than the maximum established
expiry date (as set forth in the Specifications) less three (3) months.  If
Product is delivered to ORADISC whose expiry date does not conform with the
requirements set forth in this Section 2.5, ULURU shall promptly, at its sole
expense, replace the non-conforming Product.

2.6           Alternative Supply.

Notwithstanding any provision herein to the contrary, in the event that (1)
ULURU is in default of its supply obligations under this Agreement with respect
to one  (1) accepted ORADISC purchase orders  (a “Shortfall”), or (2) if during
Manufacture or supply of the Product to ORADISC there is a material violation of
the requirements set forth in Sections 2.8, 3.1, 3.2, 3.4, 3.6. or the
representations set forth in Sections 6.2.1, 6.2.4 or 6.2.5 (a “Regulatory
Shortfall”) that is not cured within ten  (10) days of the later to occur of the
(i) date of the violation or (ii) notice to ULURU of such violation, then
ORADISC, in addition to any other rights and remedies  shall have the right to
Manufacture the Product itself and/or qualify an alternative supplier of
Product.  ULURU shall, at its cost, (a) cooperate with ORADISC in the transfer
of copies of the Confidential Information, technology and know-how necessary to
Manufacture the Product to ORADISC and/or its designated alternative supplier,
(b) deliver to ORADISC copies of such drawings, specifications, and other
information in ULURU’s possession as may be necessary to Manufacture the Product
or cause the Product to be Manufactured and (c) grant to ORADISC a limited
license in the Field under ULURU’s Intellectual Property Rights during the Term
of this Agreement to Manufacture, make, or have made for ORADISC’s distribution
of the Product in the Territory, the Product; provided that to the extent that
such technology and know-how constitutes ULURU Confidential Information (or any
information constitutes Confidential Information of ULURU’s Third Party
manufacturer) it shall be subject to the provisions of Article 9 and ORADISC’s
designated alternative supplier shall be required to enter into a
confidentiality agreement with ULURU containing substantially the same terms as
Article 9; and further provided that all items provided under clauses (a) and
(b) above will be subject to the license granted pursuant to clause (c).  In
addition to ORADISC’s aforementioned right to Manufacture the Product itself
and/or qualify an alternative supplier of the Product by reason of a Shortfall,
ORADISC shall be relieved of its obligation to order its purchase requirements
of the Product from ULURU if ULURU, for any reason, is unable, anticipates that
it will be unable or is unwilling to supply Product meeting ORADISC’s forecasted
requirements for a period of time of three (3) months until such ability or
willingness to supply resumes; provided that ORADISC shall continue to be
relieved of its obligation to order its purchase requirements of Product from
ULURU to the extent necessary to fulfill any reasonable contractual commitment
entered into during such period and to the extent that it has accumulated an
inventory of Product during such period.  In the case of a Regulatory Shortfall,
ORADISC shall immediately be relieved of any obligation to order its purchase
requirements of the Product from ULURU and shall not be required to purchase or
accept any Product from ULURU until and unless the Regulatory Shortfall has been
remedied.

 
 

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2.7           Non-Compete.

During the Term, neither ORADISC nor any Affiliate of ORADISC may directly or
indirectly market, offer for sale, sell, import or distribute in the Territory
any product,  in the Field and in the form of the Product other than the
Product.  For the avoidance of doubt, this Agreement shall not preclude ORADISC
from continued manufacture and sale of any product which was marketed, offered
for sale, sold, imported or distributed by ORADISC as of the Effective Date.

2.8           Third-Party Manufacturer.

ULURU shall, in accordance with the terms of this Section 2.8, establish a
Manufacturing Facility (operated by a Third Party manufacturer) in compliance
with the FDA’s requirements, including, without limitation, compliance with the
written requirements of ORADISC as provided as of the Effective Date. As of the
Effective Date, ULURU has identified to ORADISC the Third Party manufacturer it
intends to use to Manufacture and supply to ORADISC the Product and the location
of the Facility.  ULURU shall promptly provide ORADISC with access to the
Facility for inspection by ORADISC.  In addition, ULURU shall promptly provide
ORADISC with information requested by ORADISC regarding the Third Party
manufacturer (including, without limitation, any information requested by
ORADISC in accordance with ORADISC’s due diligence, its GMP audit procedures and
its “Level One Compliance Assessment”).  During the Term and upon reasonable
prior notice to ULURU, ORADISC shall have the right, from time to time, to audit
the Facility and the performance of the Third Party manufacturer to ensure that
the Facility and the Third Party manufacturer are in compliance with GMP and
ORADISC’s other manufacturing standards.  Any such audits or inspections shall
be undertaken by ORADISC in accordance with the provisions of Section 3.5.

2.9           Additional Responsibilities.

2.9.1           ORADISC shall be responsible, at ORADISC’s cost and expense, for
commercialization of the Product, including, without limitation, all sales and
marketing activities related to the Product and the design of all Product
packaging and related artwork, and the design of all labeling as well as the
trademark registration in the Territory.

2.9.2           ORADISC shall retain, at its own expense a selling and service
organization with adequate experience, ability and training for purposes of
marketing and selling the Product in the Territory.

2.10           ULURU Manufacturing and Supply Obligations.
 
                      It is understood and agreed by the Parties that ULURU will
be entering into an agreement with a Third Party manufacturer to perform the
Manufacturing and supply obligations that ULURU has under this Agreement.  In
accordance with such understanding, ULURU acknowledges and agrees that with
respect to ULURU’s obligations to ORADISC under this Agreement (a) , ULURU shall
be fully responsible for the performance of such as though it were performing
such Manufacturing and supply obligations itself, (b) all of the provisions of
this Agreement (including, without limitation, indemnification) shall be
interpreted in such a way as to impute any actions or omissions by the Third
Party manufacturer to ULURU, and (c) except with respect to any matters falling
within the scope of Section 10, ULURU shall not be relieved or excused of any of
its obligations hereunder due to any action or failure to act by the Third Party
manufacturer.  For avoidance of doubt, with respect to the obligations of ULURU
regarding Manufacture and supply to ORADISC of the Product, reference to ULURU
in this Agreement shall also mean ULURU’s contractors, Third Party manufacturer
and Affiliates.

 
 

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3           COMPLIANCE, QUALITY AND ENVIRONMENTAL

3.1           Compliance with Law.

ULURU shall conduct all Manufacturing hereunder in a safe and prudent manner, in
compliance with all applicable laws and regulations (including, without
limitation, those dealing with occupational safety and health, those dealing
with public safety and health, those dealing with protecting the environment,
and those dealing with disposal of wastes), and in compliance with all
applicable provisions of this Agreement.  ULURU shall obtain and maintain all
necessary Regulatory Approvals with respect to the Manufacture and supply to
ORADISC of the Product.  To the extent necessary for the Regulatory Approval of
the Product, ULURU, shall permit the inspection of its premises and the Facility
by Regulatory Authorities and shall supply all documentation and information
requested by ORADISC or such Regulatory Authority to obtain or maintain
Regulatory Approval of the Product.

3.2           Manufacturing Quality; Storage.

All Product shall be Manufactured by ULURU at the Facility using Materials and
processing aids free of animal derived materials.  ULURU shall sample and
analyze all Materials upon receipt to ensure that such Materials are
unadulterated, free of defects and meet the applicable Specifications therefor.
ULURU shall take all necessary steps to prevent contamination and cross
contamination of Product.  The Product shall be unadulterated and free from
contamination, dilutents and foreign matter in any amount in accordance with the
Product specifications and generally accepted pharmaceutical standards. ULURU
shall perform the quality control tests (both when the Product is in-process and
when it is finished) with respect to the Product in accordance with the Methods
of Analysis. ULURU shall promptly, upon completion of such tests, deliver to
ORADISC a copy of the record of such tests performed on, and a Certificate of
Analysis for, each Batch of Product. Within thirty (30) days of the Effective
Date, each of the Parties shall execute and deliver the Quality Agreement
substantially in the form of Exhibit B and as mutually agreed to by the parties.
Each Party agrees to perform its respective obligations under the Quality
Agreement in accordance with such agreement.  Prior to shipment, the Product
shall be stored at all times in conditions at least as favorable as those set
forth on the Product’s label, or in accordance with conditions reasonably
specified by ORADISC.

3.3           Samples and Record Retention.

ULURU shall retain records and retention samples of each Batch of the Product
for at least twelve (12) months after the expiration date of that Batch and
shall make the same available to ORADISC upon request.  Retention samples shall
only be destroyed after the required holding period; provided that in the event
that ORADISC provides written notice to ULURU during such twelve (12) month
period that it desires ULURU to retain such retention samples for a longer
period of time, then ULURU shall comply with such request until notified by
ORADISC that the sample need no longer be retained.  During and after the Term
of this Agreement ULURU shall reasonably assist ORADISC with respect to any
complaint, issue or investigation relating to the Product.

 
 

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3.4           Inspection.

ULURU shall give access to representatives of ORADISC, at all reasonable times
during regular business hours, to the Facility and any other facility in which
Product is Manufactured, tested, packaged and/or stored, and to all
Manufacturing records with respect to the Product, for the purpose of
inspection.  ORADISC shall have the right while at any such Facility to inspect
and copy (provided that to the extent that such copies constitute ULURU
Confidential Information (or Confidential Information of ULURU’s Third Party
Manufacturer) they shall be subject to the provisions of Article 9) records and
Regulatory Approvals solely to evaluate work practices and compliance with all
applicable FDA and other Regulatory Authority laws and regulations, occupational
health and safety, and environmental laws and regulations, GMP and warehousing
practices and procedures.  The conduct of (or right to conduct) any inspection
under this Section 3.5 does not impose upon ORADISC responsibility or liability
for the operation of the Facility.  Such inspection shall be conducted after
prior written notice to ULURU, will be conducted consistently with the ORADISC
policies and procedures provide to ULURU as of the Effective Date (and as such
policies and procedures are modified and provided in writing to ULURU from time
to time, which modified policies and procedures shall not conflict with any of
the provisions of this Agreement) and in a manner that is not disruptive to
ULURU’s operations, and shall not be more frequent than is reasonable.

3.5           Adverse Drug Experience Reporting.

Each Party shall fully, accurately and promptly provide the other Party with all
data known to it at any time during the Term of this Agreement or thereafter,
which data indicate that any Product is or may be unsafe, lacks utility, or
otherwise does not meet the Specifications in accordance with the Adverse Event
Reporting Procedures set forth in Exhibit C attached hereto (as the same may be
amended from time to time by notice in writing from ORADISC to ULURU; provided
that such amendment shall not conflict with any of the provisions of this
Agreement).  ULURU shall determine whether such information is required to be
reported to the FDA and any other Regulatory Authority.

3.6           Recalls and Seizure.

3.6.1           Each Party shall keep the other Party promptly and fully
informed of any notification or other information whether received directly or
indirectly which might result in the Recall or Seizure of the Product.  If
either Party determines that it is necessary to Recall any Product, it shall
immediately notify the other Party and, prior to commencing any Recall, the
Parties shall consult with one another to determine whether or not a Recall is
necessary.  If it is mutually agreed that a Recall is necessary (or if ORADISC
determines, in its sole discretion, that a Recall is necessary), then the
parties shall meet and determine the manner in which the Recall is to be carried
out and review any instructions or suggestions of the applicable Regulatory
Authorities.  ULURU and ORADISC shall effect the Recall in the manner agreed
upon between the Parties in as expeditious a manner as possible and in such a
way as to cause the least disruption to the sales of any Product and to preserve
the goodwill and reputation associated with the Product.  In any such situation,
ORADISC shall have the right to make all final decisions regarding such Recall.

 
 

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3.6.2           In the event that a Recall results from any cause or event
arising from ULURU’s  breach of Sections 2.8, 3.1, 3.2, 3.4, 3.6. or the
representations set forth in Sections 6.2.1, 6.2.4 or 6.2.5 and/or the defective
Manufacture, storage or handling of the Product by ULURU (excluding defects
relating to packaging or labeling supplied by or prepared at and in accordance
with the direction of ORADISC), ULURU shall be responsible for all expenses of
the Recall  incurred by ORADISC and indemnify ORADISC for all losses occurred by
this Recall  and ULURU shall promptly replace such Product at no additional cost
to ORADISC consistent with directions received from the appropriate Regulatory
Authority.  In the event that a Recall results from any cause or event arising
from defective Manufacture, storage, handling, or distribution of the Product by
ORADISC or its Affiliates, distributors or contractors (including but not
limited to defective Manufacture, storage, handling or distribution undertaken
at the direction of ORADISC and consistently with ORADISC’s instructions),
ORADISC shall be responsible for the expenses of the Recall, including the cost
of replacement Product.  For the purposes of this Agreement, the expenses of a
Recall shall include, without limitation, the expenses of notification and
destruction or return of the recalled Product and all other costs incurred in
connection with such Recall, including reasonable costs and attorneys’ fees.

4.           MANUFACTURING CHANGES

4.1           Voluntary Changes.

ULURU shall not make, nor shall any other Person make, any changes to the
Manufacturing process, the Manufacturing equipment, the Specifications, the
Materials, the sources of Materials or the Methods of Analysis without the prior
written consent of ORADISC.  If either Party requests in writing a change in the
Manufacturing process, the Manufacturing equipment, the Specifications, the
Materials, the source of Materials or Methods of Analysis with respect to the
Product that is not the result of a requirement of the FDA or any other
Regulatory Authority, the other Party shall use commercially reasonable efforts
to make or accept such change, as the case may be.  The requesting Party shall
provide the other Party with a detailed written report of all proposed changes
to the Manufacturing process, the Manufacturing equipment, the Specifications,
the Materials, the sources of Materials or the Methods of Analysis.

4.2           Required Changes.

If the FDA or any other Regulatory Authority requests or requires, or takes any
action that requires, any change in the Manufacturing process, the Manufacturing
equipment, the Specifications, the Materials, the source of Materials or Methods
of Analysis with respect to the Product, the Parties shall meet and discuss an
implementation plan for such change and use commercially reasonable efforts to
accommodate as soon as practicable such change to meet the FDA’s or such other
Regulatory Authority’s requirements.  ULURU will bear its respective costs
associated with, or incurred as a result of, such change.  Each Party agrees to
promptly forward to the other copies of any written communication received by
such Party from the FDA or any other Regulatory Authority that may affect the
Manufacture, supply, or distribution of the Product as contemplated herein.

 
 

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5.           PRICE AND PAYMENT

5.1           Price.

ULURU shall invoice ORADISC for the Product supplied to ORADISC hereunder at the
applicable price per Product set forth on Exhibit D.

5.2           License Payments.

During the Term, the license payments set forth in Exhibit E shall be due and
payable from ORADISC to ULURU within ten (10) days after signing of this
Agreement.

5.3           Royalty Payments.

In addition to the payments set forth above, ORADISC shall pay to ULURU a
royalty (the “Royalty”), on a country-by-country basis in the Territory, equal
to five percent (5%) of Net Sales of the Product in such country during each
calendar quarter (or portion thereof) during the Term (each such period, a
“Royalty Period”), commencing as of the date on which the Product is sold by
ORADISC for the first time to a Third Party for commercial distribution in such
country.  Each Royalty will be payable not later than thirty (30) days following
the expiration of each applicable Royalty Period.  ORADISC shall pay the Royalty
with respect to a country that accrues during the Term of this Agreement for so
long as the license granted by ULURU under Section 2.1.1 remains in effect in
such country.  ORADISC will include with each such payment a written report
detailing (i) the number of Product units, per country, and the sales price of
such Product units by ORADISC and its Affiliates; and (ii) Net Sales of the
Product during the applicable Royalty Period, all in a manner consistent with
ORADISC’s internal sales reporting.

5.4           Payment.

ORADISC shall pay invoices for Product delivered hereunder not later than
seventy five (75) days after the later of receipt of Product covered by such
invoice and receipt of such invoice.

5.5           Taxes and Other Charges.

All Product prices are exclusive of taxes, shipping costs to the point of
delivery, customs duties and other charges, and ORADISC agrees to bear and be
responsible for the payment of all such charges imposed, excluding taxes based
upon ULURU’s net income.

 
 

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5.6           Audit Rights.

5.6.1           ORADISC shall maintain books of account with respect to its
sales of the Product in each country in the Territory.  ULURU shall have the
right, not more than once during each calendar year, to have an independent
accountant selected and retained by ULURU to inspect and examine such books of
ORADISC during regular business hours for the purpose of verifying the
statements of the aggregate Net Sales resulting from sales of Product and
determining the correctness of the Royalties paid.  Subject to Section 5.6.2, if
such independent certified public accountant’s report shows any underpayment by
ORADISC, ORADISC shall pay to ULURU within thirty (30) days after ORADISC’s
receipt of such report, (a) the amount of such underpayment, and (b) if such
underpayment exceeds five percent (5%) of the total amount owed for the period
then being audited, the reasonable fees and expenses of any independent
accountant performing the audit on behalf of ULURU. Subject to Section 5.6.2, if
such independent certified public accountant’s report shows any overpayment by
ORADISC, ULURU shall remit to ORADISC within thirty (30) days after ULURU’s
receipt of such report, the amount of such overpayment. Any audit or inspection
conducted under this Agreement by ULURU or its agents or contractors will be
subject to the confidentiality provisions of this Agreement, and ULURU will be
responsible for compliance with such confidentiality provisions by such agents
or contractors.

5.6.2           If any dispute arises under this Section 5.6 between the Parties
relating to overpayments or underpayments, and the Parties cannot resolve such
dispute within thirty (30) days of a written request by either Party to the
other Party, the Parties shall hold a meeting, attended by the Chief Executive
Officer or President of each party (or their respective designees), to attempt
in good faith to negotiate a resolution of the dispute.  If, within sixty (60)
days after such meeting request, the Parties have not succeeded in negotiating a
resolution of the dispute, either Party may pursue any other available remedy,
including, upon prior written notice to the other Party, instituting legal
action.

5.7           Late Payments.

If any payment due to ULURU under this Agreement is not received by ULURU within
ten (10) days of the due date, then, commencing from the date on which such
payment was due the amount of such payment shall accrue interest calculated at
an annual rate equal to the prime rate plus two percent (2%) until such time as
payment of the overdue amount is made in full; provided that no interest shall
accrue on any amounts being disputed in good faith by ORADISC with respect to
which ORADISC is making diligent and good faith efforts to resolve.

5.8           Currency Exchange.

All payments to be made pursuant to this Agreement shall be made in United
States dollars.  Amounts based on Net Sales in currencies other than United
States dollars shall be converted to United States dollars at the exchange rate
being the average of the prior month’s rates as reported by a mutually agreed
upon bank. In case of a significant change of the Currency Exchange rate the
parties mutually agree to renegotiate the pricing conditions defined in EXHIBIT
D.

 
 

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5.9           Option.                      ULURU hereby grants to ORADISC a
twenty four (24) month option to utilize the technology for drug delivery for
migraine, nausea and vomiting, pain and cough and cold. A separate licensing
agreement for these applications will be negotiated.

5.10           Purchase of Aphthasol United States Rights.

ORADISC is granted the right to acquire the United States rights to Aphthasol.
These rights would be added to the license on terms to be negotiated once ULURU
has secured these rights.

6.           REPRESENTATIONS AND WARRANTIES

6.1           Representation and Warranties of Each Party.

Each of ORADISC and ULURU hereby represents, warrants and covenants to the other
Party hereto as follows:

6.1.1           it is a corporation or entity duly organized and validly
existing under the laws of the state or other jurisdiction of incorporation or
formation;

6.1.2           the execution, delivery and performance of this Agreement by
such Party has been duly authorized by all requisite corporate action and do not
require any shareholder action or approval;

6.1.3           it has the power and authority to execute and deliver this
Agreement and to perform its obligations hereunder;

6.1.4           the execution, delivery and performance by such Party of this
Agreement and its compliance with the terms and provisions hereof does not and
will not conflict with or result in a breach of any of the terms and provisions
of or constitute a default under (a) a loan agreement, guaranty, financing
agreement, agreement affecting a product or other agreement or instrument
binding or affecting it or its property; (b) the provisions of its charter or
operative documents or by laws; or (c) any order, writ, injunction or decree of
any court or governmental authority entered against it or by which any of its
property is bound; and

6.1.5           it shall comply with all applicable laws and regulations
relating to its activities under this Agreement.

 
 

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6.2           Representations and Warranties of ULURU.

ULURU hereby further represents and warrants to ORADISC that:

6.2.1           as of the date of each delivery of the Product by ULURU to a
carrier, the Product (a) has been Manufactured, stored and shipped in strict
accordance with GMPs, all applicable laws, rules, regulations or requirements
and all applicable Regulatory Approvals in effect at the time of Manufacture;
(b) conforms to the Specifications and the Quality Agreement, and is free from
defects and are merchantable; (c) is not adulterated or misbranded; and (d) has
been shipped and stored in accordance with procedures requested by ORADISC;

6.2.2           as of the date of each delivery of the Product by ULURU to a
carrier, ULURU has good and marketable title to the Product and the Product is
free from all liens, charges, encumbrances and security interests;

6.2.3           to ULURU’s actual knowledge as of the Effective Date, the
Manufacture, use, importation, offer for sale and sale of the Product does not
infringe any intellectual property rights of any Third Party within the
Territory;

6.2.4           as of the date of each delivery of the Product by ULURU to a
carrier, neither ULURU not any Affiliate, contractor or Third Party manufacturer
of ULURU, used or uses in any capacity the services of any person debarred under
the U.S. Generic Drug Enforcement Act, 21 USA §335a(k)(l) and further it did not
use any person who has been convicted of a crime as defined under the Generic
Drug Enforcement Act in connection with the Manufacture of Product;

6.2.5           as of the date of each delivery of the Product by ULURU to a
carrier, ULURU possesses all necessary Regulatory Approvals relating to ULURU’s
Manufacture and supply to ORADISC of the Product;
6.2.6           as of the Effective Date, U.S. Patent No. 6,585,997  is existing
and have not been held to be invalid or unenforceable, in whole or in part;

6.2.7           as of the Effective Date, ULURU is the sole and exclusive owner
of the Intellectual Property Rights existing as of the Effective Date, all of
which are free and clear of any liens, charges and encumbrances (other than any
licenses granted by ULURU to Third Parties, which grants do not conflict with
the license grants to ORADISC hereunder);

6.2.8           as of the Effective Date, and, except as disclosed to ORADISC in
writing, as of the date of each delivery of the Product by ULURU to a carrier,
ULURU has received no notice that the practice of the Intellectual Property
Rights or the Mark  are subject to an infringement claim of any issued patent or
Mark owned or possessed by any Third Party within the Territory;
 
6.2.9           as of the Effective Date, the Intellectual Property Rights are
not the subject to any funding agreement with any government or governmental
agency; and

 
 

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6.3           No Presumption.

Each Party hereto represents that it has been represented by legal counsel in
connection with this Agreement and acknowledges that it has participated in the
drafting hereof.  In interpreting and applying the terms and provisions of this
Agreement, the Parties agree that no presumption shall exist or be implied
against the Party which drafted such terms and provisions.

6.4           Remedy.

As ORADISC’s sole and exclusive remedy for any breach of Section 6.2.1
discovered prior to the distribution by ORADISC or its Affiliates of the
applicable Product, ULURU shall promptly replace, at its sole cost and expense,
any Product which fails to comply with the representations set forth in Section
6.2.1; provided that such non-conforming Product shall be returned to
ULURU   Except as otherwise provided expressly in this Agreement, each Party is
free to seek legal and equitable recourse against the other in the event of any
breach of this Agreement (including, without limitation, any breach of such
other Party’s obligations, representations, or warranties under this Agreement),
subject to the limitations of liability set forth in Section 6.7 and, in such
case, the breaching party shall be liable for all damages, losses, liabilities,
expenses or penalties (excluding attorneys’ fees and expenses) incurred,
assessed or sustained by or against the non-breaching party, its Affiliates,
directors, officers, employees or agents arising out of such breach.

6.5           ORADISC Responsibility.

           ORADISC shall not be responsible for any loss or cost incurred by
ULURU during Manufacture of the Product in compliance with the requirements of
Section 6.2.1.

6.6           Disclaimer.

6.6.1           THE FOREGOING WARRANTIES ARE THE SOLE AND EXCLUSIVE WARRANTIES
GIVEN BY ULURU WITH THE RESPECT TO THE PRODUCTS AND SERVICES PROVIDED HEREUNDER,
AND ULURU GIVES AND MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS
OR IMPLIED, OTHER THAN THE FOREGOING.
6.6.2           EXCEPT FOR THE WARRANTIES GIVEN BY ORADISC AS EXPRESSLY PROVIDED
IN SECTION 6, ORADISC GIVES AND MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY
KIND OR NATURE, EXPRESS OR IMPLIED, WITH RESPECT TO THE MATTERS ADDRESSED IN
THIS AGREEMENT.

6.6.3           The warranties set forth in this Section 6 do not apply to any
non-conformity of the Product resulting from (a) repair, alteration, misuse,
negligence, abuse, accident, mishandling or storage in an improper environment
by any party other than ULURU (or its contract manufacturer), or (b) use,
handling, storage or maintenance other than in accordance with Product
Specifications or Product label.

 
 

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           6.7           Limitation of Liability.

ULURU’S LIABILITY, AND THE EXCLUSIVE REMEDY, IN CONNECTION WITH THE SALE OR USE
OF THE PRODUCT (WHETHER BASED ON CONTRACT, NEGLIGENCE, BREACH OF WARRANTY,
STRICT LIABILITY OR ANY OTHER LEGAL THEORY), SHALL BE STRICTLY LIMITED TO
ULURU’S OBLIGATIONS AND ORADISC’S RIGHTS AS SPECIFICALLY AND EXPRESSLY PROVIDED
IN THIS AGREEMENT.

7.           INDEMNIFICATION AND INSURANCE

7.1           Indemnification.

7.1.1 ULURU shall indemnify ORADISC for, defend ORADISC against, and hold
ORADISC harmless from any and all loss, liability, damage, claim, cost and
expenses, including after prior written consent of ULURU reasonable attorney
fees, incurred by ORADISC, arising from actions taken by third parties as a
result of or in relation to the development and the manufacture of the Product
by ULURU, according to provisions agreed between the Parties in this Agreement,
and / or arising from actions taken by third parties as a result of alleged
infringement of third party intellectual property rights by ORADISC by
exercising its rights under this Agreement. Same obligation applies to ORADISC.

7.1.2 Any Party seeking to be indemnified by virtue of the terms hereof shall
notify the Party from which indemnification is sought in writing promptly of any
claims, suits, charges or proceedings made or instituted against it in respect
of which indemnification may be sought hereunder.

7.1.3           The indemnification provided by this Section 7 shall be the
Parties’ sole and exclusive remedy in connection with any third party claim.

7.2           Insurance.

At the time of Launch and continuing through the Term of this Agreement, ULURU
shall maintain the following kinds of insurance with the minimum limits set
forth below.
Kind of Insurance
Minimum Limits
   
Commercial General Liability, including Contractual, Completed Operations and
Product Liability
$1,000,000 Per Occurrence
$5,000,000 Aggregate
   
Workers Compensation
Statutory with Employer’s Liability of not less than $1,000,000 Per
Accident/Disease
   
Automobile Bodily Injury Liability (including hired automobile and non-ownership
Liability)
$1,000,000 Each Accident Combined Single Limit

 
 

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Upon request, ULURU shall furnish insurance certificates as directed by ORADISC,
satisfactory in form and substance to ORADISC, showing the above coverages, and
providing for at least thirty (30) days’ prior written notice to ORADISC by the
insurance company of cancellation or modification.

8.           TERM AND TERMINATION

8.1           Term.

This Agreement shall commence on the Effective Date and continue, unless sooner
terminated as set forth below in this Article 8 or as otherwise specifically
stated in this Agreement, for the duration of the Term.

8.2           Termination Without Cause.

ORADISC may terminate this Agreement at any time after Launch by giving twelve
(12) months prior written notice to ULURU if ORADISC, in its sole discretion,
determines to cease marketing the Product.

8.3           Termination for Regulatory Action or Claim of Infringement.

ORADISC may terminate this Agreement in its entirety immediately if the FDA or
any other Regulatory Authority takes any action, the result of which is to
prohibit or permanently or otherwise restrict the Manufacture, storage,
importation, sale, offer for sale or use of the Product in any way that will
have a material, adverse effect on the sale price or sales volumes of the
Product, or if any claim is made that the Manufacture, storage, importation,
sale, offer for sale or use of the Product infringes any patent or other
proprietary or protected right of any Third Party.

8.4           Termination for Breach.

If either Party shall at any time fail to discharge any of its obligations
hereunder and shall fail to correct such default within thirty (30) days after
the other Party shall have given written notice to it thereof, the aggrieved
Party shall be entitled to notify the other Party that it intends to terminate
this Agreement unless such default is corrected and may so terminate ten (10)
days after the end of such thirty (30) day period if such default is continuing;
provided that if such default by the other Party shall be a recurring default
and the other Party does not reasonably satisfy the aggrieved party that such
defaults shall cease to occur, the aggrieved Party shall be entitled to
terminate this Agreement upon the occurrence of such default and the other Party
shall not be entitled to correct such default.

8.5           Termination for Bankruptcy.

8.5.1           If either Party by voluntary or involuntary action goes into
liquidation, dissolves or files a petition for bankruptcy or suspension of
payments, is adjudicated bankrupt, has a receiver or trustee appointed for its
property or estate, becomes insolvent or makes an assignment for the benefit of
creditors, the other Party shall be entitled by notice in writing to such Party
to terminate this Agreement forthwith.

 
 

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8.5.2           All rights and licenses granted under or pursuant to this
Agreement by each party to the other party are, and shall otherwise be deemed to
be, for purposes of Section 365 (n) of the United States Bankruptcy Code, or
replacement provision therefor (the Code), that each party as a licensee
hereunder shall retain and may fully exercise all of its rights and elections
under the Code. The parties further agree that, in the event of the commencement
of bankruptcy proceedings by or against either party as a licensor hereunder
under the Code, the other party shall be entitled to retain all of its rights
under the Agreement.

8.6           Effect of Termination.

Termination or expiration of this Agreement, in whole or in part, shall be
without prejudice to the right of either Party to receive all payments accrued
and unpaid at the effective date of such termination or expiration, without
prejudice to the remedy of either Party in respect to any previous breach of any
of the representations, warranties or covenants herein contained and without
prejudice to any other provisions hereof which expressly or necessarily call for
performance after such termination or expiration.

8.7           ORADISC’s Rights on Termination.

Upon termination or expiration of this Agreement for any reason, then (a) at
ORADISC’s request, ULURU shall supply ORADISC with its inventory of Materials,
Product and/or works-in-progress for the Manufacture, packaging and labeling of
Product and ORADISC shall pay ULURU the manufacturing fee for the Product, a
prorated portion thereof for work-in-progress commenced against firm orders by
ORADISC and the cost of Materials; and (b) at ORADISC’s request, ULURU shall
return to ORADISC all retention samples of the Product.

8.8           Survival.

The following provisions shall survive the expiration or termination of this
Agreement: Sections 3.4, 3.6, 3.7, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 7.1, 8.7, 8.8,
and 8.9 and Articles 6, 9, 11, 12 and 13.

 
 

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9.           CONFIDENTIALITY

9.1           Nondisclosure Obligation.

Each of ULURU and ORADISC shall use only in accordance with this Agreement and
shall not disclose to any Third Party the Confidential Information received by
it from the other Party pursuant to this Agreement, without the prior written
consent of the other Party.  The foregoing obligations shall survive for a
period of five (5) years after the termination or expiration of this
Agreement.  These obligations shall not apply to Confidential Information that:
(a) is known by the receiving Party at the time of its receipt, and not through
a prior disclosure by the disclosing Party, as documented by business records;
(b) is at the time of disclosure or thereafter becomes published or otherwise
part of the public domain without breach of this Agreement by the receiving
Party; (c) is subsequently disclosed to the receiving Party by a Third Party who
has the right to make such disclosure; (d) is developed by the receiving Party
independently of the Confidential Information received from the disclosing Party
and such independent development can be documented by the receiving Party; or
(e) is required by law, regulation, rule, act or order of any governmental
authority or agency to be disclosed by a Party, provided that notice is promptly
delivered to the other Party in order to provide an opportunity to seek a
protective order or other similar order with respect to such Confidential
Information and thereafter the disclosing Party discloses to the requesting
entity only the minimum Confidential Information required to be disclosed in
order to comply with the request, whether or not a protective order or other
similar order is obtained by the other Party.

9.2           Permitted Disclosures.

Each Party may disclose the other Party’s Confidential Information to its
employees and Affiliates on a need-to-know basis and to its agents or
consultants to the extent required to accomplish the purposes of this Agreement;
provided that the recipient Party obtains prior agreement from such agents and
consultants to whom disclosure is to be made to hold in confidence and not make
use of such Confidential Information for any purpose other than those permitted
by this Agreement.  Each Party will use at least the same standard of care as it
uses to protect proprietary or confidential information of its own to ensure
that such employees, agents, consultants, and Affiliates do not disclose or make
any unauthorized use of the other Party’s Confidential Information.

9.3           Disclosure of Agreement.

Neither ULURU nor ORADISC shall release to any Third Party or publish in any way
any non-public information with respect to the terms of this Agreement without
the prior written consent of the other Party, which consent shall not be
unreasonably withheld or delayed, provided that either Party may disclose the
terms of this Agreement (a) to the extent required to comply with applicable
laws, including, without limitation, the rules and regulations promulgated by
the United States Securities and Exchange Commission; provided, further, that
prior to making any such disclosure, the Party intending to so disclose the
terms of this Agreement shall (i) provide the nondisclosing Party with written
notice of the proposed disclosure and an opportunity to review and comment on
the intended disclosure which is reasonable under the circumstances and (ii)
shall seek confidential treatment for as much of the disclosure as is reasonable
under the circumstances, including, without limitation, seeking confidential
treatment of any information as may be requested by the other Party; or (b) to
one or more Third Parties and/or their advisors in connection with a proposed
spin-off, joint venture, divestiture, merger or other similar transaction
involving all, or substantially all, of the Product, assets or business of the
disclosing Party to which this Agreement relates or to lenders, investment
bankers and other financial institutions of its choice solely for purposes of
financing the business operations of such Party; provided, further, that either
(i) the other Party has consented to such disclosure or (ii) such Third Parties
have signed confidentiality agreements with respect to such information on terms
no less restrictive than those contained in this Article 9; or (c) to its legal
counsel.

9.4           Publicity.

All publicity, press releases and other announcements relating to this Agreement
or the transactions contemplated hereby shall be reviewed in advance by, and
shall be subject to the approval of, both Parties.

10.           FORCE MAJEURE

If the Manufacture, production, delivery, acceptance or use of Product specified
for delivery under this Agreement or if the performance of any other obligation
hereunder is prevented, restricted or interfered with by reason of fires,
accidents, explosions, earthquakes, floods, breakdown of plant, embargoes,
government ordinances or requirements, civil or military authorities, acts of
God or of the public enemy, or other similar causes beyond the reasonable
control of the Party whose performance is affected (any of the foregoing a
“Force Majeure Event”), then the Party affected, upon giving prompt written
notice to the other Party, shall be excused from such performance on a
day-for-day basis to the extent of such prevention, restriction, or interference
(and the other Party shall likewise be excused from performance of its
obligations on a day-for-day basis to the extent such Party’s obligations relate
to the performance so prevented, restricted or interfered with); provided that
the Party so affected shall use commercially reasonable efforts to avoid or
remove such causes of non-performance and both Parties shall proceed to perform
their obligations with dispatch whenever such causes are removed or cease.  If
such Force Majeure Event continues for a period of ninety (90) consecutive days
or more and as a result either party has been unable to perform its obligations
under this Agreement for such ninety (90) day period, the other Party may
terminate this Agreement effective immediately, upon delivery of a notice of
termination in writing, provided that such event of Force Majeure Event is
continuing.  If as a result of any Force Majeure Event above, ULURU is unable to
fully supply ORADISC’s orders hereunder, ULURU shall allocate all available
quantities of Materials and Product to ORADISC in the ratio that the quantities
ordered by ORADISC in the twelve (12) month period immediately preceding such
force majeure event bears to ULURU’s requirements for its own use and for supply
to Third Parties for that same period; provided that if this Agreement has not
been in effect for a full twelve (12) month period, then such shorter period
shall be used in lieu of a twelve (12) month period.

 
 

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11.           INTELLECTUAL PROPERTY

11.1           Trademarks; ORADISC Intellectual Property.

11.1.1           ORADISC may advertise, promote, market and sell the Product
either separately or as part of other products under any of its Trademarks
and/or trade dress, whether registered or unregistered, in its sole discretion;
provided that except as otherwise expressly permitted with respect to the Mark,
(see Article 11.6) 11.1.2For the avoidance of doubt, ORADISC shall at all times
retain sole and exclusive ownership of its intellectual property, including,
without limitation, all marketing and sales plans, artwork, formats, equipment,
logos, drawings, customer lists, regulatory filings, correspondence with the FDA
or any other Regulatory Authority, clinical study data, analytical data,
operating procedures and all ordering and sales information.

11.2           Inventions.

11.2.1           Except as otherwise provided for in this Section 11.2, each
Party shall own all Inventions made solely by employees of such Party (or Third
Parties acting on behalf of such Party) and shall jointly own with the other
Party any Invention made jointly by employees of both Parties (or Third Parties
on behalf of one or both Parties); provided that such Inventions were made
without violation of any term or condition of this Agreement.  All
determinations of inventorship under this Agreement shall be made in accordance
with United States law.

11.2.2           If and to the extent applicable, Inventions Controlled by ULURU
and know-how arising during the Term which relates to the Product and is
Controlled by ULURU shall be automatically included in the Intellectual Property
Rights under which ORADISC is licensed pursuant to Section 2.1.1 hereof.  With
respect to any Inventions or know-how Controlled by ORADISC specifically
relating to the Product, ORADISC hereby grants to ULURU an exclusive (subject to
retained rights in ORADISC), royalty-free license to use such Invention for the
Manufacture of the Product for ORADISC in the Territory during the Term.

11.2.3           During the Term of this Agreement both Parties shall require
their employees and personnel involved in the performance of its duties under
this Agreement to deliver such assignments, confirmations of assignments or
other written instruments as are necessary to vest in the respective Party clear
and marketable title to the Inventions.

11.2.5           All rights, title, and interest in and to know-how, which is
developed jointly by the Parties during the Term of this Agreement and related
to the Product, its Manufacture and/or use shall be owned jointly by the
Parties.  All rights, title, and interest in and to any Regulatory Approval the
primary responsibility for which is allocated to a particular Party hereunder
that is developed or collected solely or jointly by the Parties in the Territory
during the Term of this Agreement shall be owned exclusively by such Party.

11.3           Confidentiality of Information related to Intellectual Property.

Any and all information and material, including, without limitation, any and all
intellectual property rights therein and thereto, assigned to a Party pursuant
to the terms of this Agreement shall constitute Confidential Information of such
Party which shall be deemed the Disclosing Party with respect to such
Confidential Information.

 
 

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11.4           Patent Rights to New Inventions.

11.4.1           ULURU, at its own expense, shall use commercially reasonable
efforts to prepare, file, prosecute and maintain its Intellectual Property
Rights in the agreed countries of the Territory.

11.4.2           With respect to any filings after the Effective Date, ULURU
shall consult in good faith with ORADISC with respect to such applications in
the Territory, and shall supply ORADISC with a copy of such applications in the
Territory as filed, together with notice of its filing date and serial
number.  ULURU shall inform ORADISC about the status of the prosecution of all
patent applications included within the ULURU Intellectual Property Rights and
its Intellectual Property Rights to Inventions and the maintenance of any
patents included within the ULURU Intellectual Property Rights and its
Intellectual Property Rights to Inventions in a country in the Territory.

11.4.3           ULURU shall consider in good faith, but will not be bound by,
ORADISC’s suggestions with respect to all submissions in the Territory made to
any Regulatory Authority in the Territory with respect to any such patent
application or patent.

11.4.4           If ULURU elects not to file a patent application with respect
to its new Inventions or to cease the prosecution and/or maintenance of any
Patent under the ULURU Intellectual Property Rights in a country in the
Territory, ULURU shall provide ORADISC with written notice promptly after the
decision to not file or continue the prosecution of such patent application or
maintenance of such patent.

11.4.5           In such event, ULURU shall permit ORADISC, in ORADISC’s sole
discretion, to file a patent application with respect to such Invention or
continue prosecution or maintenance of any such Patent under the ULURU
Intellectual Property Right in such country at ORADISC’s own expense.  If
ORADISC elects to continue such prosecution or maintenance, ULURU shall execute
such documents and perform such acts, at ORADISC’s expense, as may be reasonably
necessary to permit ORADISC to file, prosecute or maintain such application or
Patent in such country. In such event, ORADISC shall own such patent application
or Patent filed by ORADISC hereunder.

11.4.6           In the event that ORADISC continues the prosecution or
maintenance of such patent application or Patent pursuant to this Section,
ORADISC’s Royalty obligations hereunder, and this Agreement, shall expire if,
and at such time, that such patent application or Patent becomes the only
non-expired Patent rights within the Intellectual Property Rights.

11.4.7           (a)           The Parties shall mutually agree in good faith on
a case-by-case-basis on which of the Parties shall have the first right to
prepare, file, prosecute and maintain any jointly owned Invention and patent
rights thereon (“Joint Patent Rights”) throughout the world as well as on the
split of the applicable expenses and costs.

 
 

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(b)           The acting Party shall keep the other Party completely informed
during the whole application procedure as well as during the whole patent
duration.  The acting Party shall provide the other Party advance copies of any
official correspondence related to the filing, prosecution and maintenance of
such patent filings, and shall provide the other Party a reasonable opportunity
to comment on all correspondence received from and all submission to be made to
any government patent office or authority with respect to any such patent
application or patent, and shall consider in good faith the other Party’s
suggestions with respect to all submission made to any government office or
authority.

(c)           If either Party (the “Declining Party”) at any time declines to
share in the costs of filing, prosecuting and maintaining any such Joint Patent
Right, on a country by country basis, the Declining Party shall provide the
other Party (the “Continuing Party”) with thirty (30) days prior written notice
to such effect, in which event, the Declining Party shall (i) have no
responsibility for any expenses incurred in connection with such Joint Patent
Right and (ii) if the Continuing Party elects to continue prosecution or
maintenance, the Declining Party, upon the Continuing Party’s request, shall
execute such documents and perform such acts, at the Continuing Party’s expense,
as may be reasonably necessary (x) to assign to the Continuing Party all of the
Declining Party’s right, title and interest in and to such Joint Patent Rights
and (y) to permit the Continuing Party to file, prosecute and/or maintain such
Joint Patent Right.

(d)           If ORADISC is (i) the sole owner of a Joint Patent Right or (ii)
the Continuing Party, such Joint Patent Right shall no longer be considered to
be part of the ULURU Intellectual Property Rights for purposes of this Agreement
and thereafter shall be part of ORADISC’s intellectual property.

(e)           If ULURU is (i) the sole owner of a Joint Patent Right or (ii) is
the Continuing Party, such Joint Patent Rights shall no longer be considered to
be part of ORADISC’s intellectual property for purposes of this Agreement and
thereafter shall be part of the ULURU Intellectual Property Rights.

11.4.8           Each Party shall, and shall cause its Affiliates, employees,
attorneys and agents to, cooperate fully with the other Party and provide all
information and data and execute any documents reasonably required or requested
in order to allow the other Party to prosecute, file, and maintain patents and
patent applications pursuant to this Section 11.4.  Neither Party shall require
the other Party to make any payment or reimburse for any expenses in connection
with such cooperation, provision of information and data and execution of
documents.

11.5           Enforcement of Intellectual Property Rights.

11.5.1           If either Party becomes aware of any infringement of any of the
Intellectual Property Rights or the Mark, or the validity of any of the
Intellectual Property Rights or the Mark is challenged by a Third Party in the
Territory, such Party will notify the other Party in writing to that
effect.  Any such notice shall include, as applicable, evidence to support an
allegation of infringement by such Third Party.

11.5.2           ULURU shall have the first right, but not the obligation, to
take action to obtain a discontinuance of infringement or bring suit against a
Third Party infringer of Intellectual Property Rights and/or the Mark in the
Territory.  Such right shall remain in effect until ten (10) days after the date
of notice given under Section 11.5.1.  In the event that ULURU exercises such
right, then: (a) ULURU shall not consent to the entry of any judgment or enter
into any settlement with respect to such an action or suit without the prior
written consent of ORADISC (not to be unreasonably withheld), and (b) ULURU
shall bear all the expenses of any such suit brought by ULURU claiming
infringement of any Intellectual Property Rights and/or the Mark.  If, after the
expiration of the ninety (90) day period, ULURU has not obtained, or is not
diligently pursuing, a discontinuance of infringement of the Intellectual
Property Rights and/or the Mark, filed suit against any such Third Party
infringer of the Intellectual Property Rights and/or the Mark, or provided
ORADISC with information and arguments demonstrating to ORADISC’s reasonable
satisfaction that there is insufficient basis for the allegation of such
infringement of the Intellectual Property Rights and/or the Mark, then ORADISC
shall have the right, but not the obligation, to bring suit against such Third
Party infringer of the Intellectual Property Rights and/or the Mark and to join
ULURU as a party plaintiff, provided that ORADISC shall bear all the expenses of
such suit.  In such event, ORADISC shall not consent to the entry of any
judgment or enter into any settlement with respect to such an action or suit
without the prior written consent of ULURU (which consent shall not unreasonably
be withheld) if such judgment or settlement includes a finding or agreement that
such Intellectual Property Right and/or the Mark is invalid or would enjoin or
grant other equitable relief against ULURU.

11.5.3           Each Party shall cooperate (including, without limitation, by
executing any documents reasonably required to enable the other Party to
initiate such litigation, testifying when requested or providing relevant
documents) with the other Party in any suit for infringement of Intellectual
Property Rights and/or the Mark brought by the other Party against a Third Party
in accordance with this Section and shall have the right to consult with the
other Party and to participate in and be represented by independent counsel in
such litigation at its own expense.

11.5.4           Neither Party shall be required pursuant to this Section 11.5
to undertake any activities, including, without limitation, legal discovery at
the request of a Third Party except as may be required by lawful process of a
court of competent jurisdiction.

11.5.5           Neither Party shall incur any liability to the other Party as a
consequence of any such litigation or any unfavorable decision resulting
therefrom, including, without limitation, any decision holding any of the
patents within the Intellectual Property Rights invalid or unenforceable.

11.5.6           Any recovery obtained by either Party as a result of any such
proceeding against a Third Party infringer shall be allocated as follows: (a)
such recovery shall first be used to reimburse each Party for all litigation
costs in connection with such litigation paid by that Party; and (b) the Party
bringing the action shall receive the remaining portion of such recovery after
payment of the amounts specified in clause (a).

 
 

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11.6           Trademarks.

Subject to the restrictions in Sections 11.1, ORADISC shall select and own all
Trademarks in connection with the marketing, promotion and sale of the Product
in the Territory. ORADISC hereby grants to ULURU a limited, non-exclusive,
non-transferable, fully paid, royalty free, sublicensable license in and to all
ORADISC Trademarks and copyrights to be contained in any such labeling for the
sole purpose of manufacturing and applying such labels to the Product in the
conduct of ULURU’s obligations hereunder; provided, however, that ULURU agrees
to cooperate with and offer reasonable assistance to ORADISC in facilitating
ORADISC’s control of the quality of the Product branded with ORADISC’s
trademarks hereunder; but further provided that in no event is ULURU obligated
to provide such cooperation or assistance in any way that will (i) lower the
quality of the Product below that which ULURU deems acceptable for general
commercial distribution, (ii) be contrary to or in violation of any regulatory
or statutory obligations, or (iii) increase the cost of manufacturing and
delivering the Product hereunder beyond that contemplated by the parties as of
the Effective Date.

11.7           Publications.

11.7.1           The Parties recognize that limited rights of review and/or
comment exist for certain Third Party publications, such as medical, academic
and scientific publications.  Each Party agrees to provide the other Party with
any such proposed publication or presentation promptly upon its receipt.  Each
Party may advise the other of any comments that it may have relating to such
proposed publication or presentation and do so within the applicable time frame.

11.7.2           During the Term of this Agreement, unless otherwise prohibited
by law, each Party shall submit to the other Party for review and approval any
proposed publication or public presentation, especially including, without
limitation, academic, scientific and medical information, which contains the
non-disclosing Party’s Confidential Information or which disclose any non-public
information contained within the Intellectual Property Rights or which makes any
reference to the subject matter of this Agreement or the Product.

11.7.3           Written copies of each such proposed publication or
presentation required to be submitted hereunder shall be submitted to the
non-disclosing Party no later than fifteen (15) days before its intended
submission for publication or presentation.  The non-disclosing Party shall
provide its comments with respect to such publications and presentations within
ten (10) business days of its receipt of such written copy.  The review period
may be extended for an additional thirty (30) days in the event the
non-disclosing Party can demonstrate reasonable need for such extension.  By
mutual agreement of the Parties in writing, this period may be further extended.

11.7.4           Regarding their publications under this Section 11.7, ULURU and
ORADISC will each comply with standard academic practice regarding authorship of
scientific publications and recognition of contribution of other parties in any
publication.

 
 

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12.           NOTICES

12.1           Ordinary Notices.

Correspondence, reports, documentation, and any other communication in writing
between the Parties in the course of ordinary implementation of this Agreement
shall be delivered by hand, sent by facsimile or by overnight courier to the
employee or representative of the other Party who is designated by such other
Party to receive such written communication at the address or facsimile numbers
specified by such employee or representative.

12.2           Extraordinary Notices.

Extraordinary notices and communications (including, without limitation, notices
of termination, Force Majeure Event, material breach, change of address,
requests for disclosure of Confidential Information, claims or indemnification)
shall be in writing and shall be delivered by hand, sent by facsimile or by
overnight courier (and shall be deemed to have been properly served to the
addressee upon receipt of such written communication) to the address set forth
in Section 12.3 or such other address as notified in writing by such Party to
the other Party.

12.3           Addresses.

If to ULURU:

ULURU Inc.
4452 Beltway Drive
Addison, TX 75001
Attention: Kerry P. Gray, President & CEO
Facsimile No.:  (214) 905-5145

With a copy to:

John J. Concannon, Esq.
Bingham McCutchen LLP
150 Federal Street
Boston, MA  02110
Facsimile No.:  (617) 951-8736

 
If to ORADISC:

 
ORADISC  GmbH

Herrengasse 6-8
Vienna, AT 1010
Attention:
Facsimile No.:  +41 41 760 6336

 
 

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 13.           GENERAL

13.1           Governing Law.

This Agreement shall be construed in accordance with and governed by the law of
the State of Delaware, without giving effect to its conflict of laws provisions,
and to the exclusion of the provisions of the United Nations Convention on
Contracts for the International Sale of Goods.

13.2           Assignment.

This Agreement shall not be assignable or transferable by either Party without
the prior written consent of the other Party(which consent shall not be
unreasonably withheld); provided that either Party may assign this Agreement and
its rights and obligations hereunder without the other Party’s consent in
connection with the transfer or sale of all or substantially all of the business
of such party to which this Agreement relates (or, if applicable, the business
unit or division of such Party primarily responsible for performance under this
Agreement) to another party, whether by merger, sale of stock, sale of assets or
otherwise.  In the event that ORADISC sublicenses the Agreement, with ULURU’s
consent which shall not be unreasonably withheld, or any rights or obligations
hereunder in accordance with the previous sentence, then ORADISC shall guaranty
the performance of the sublicensee.  In the event that either ORADISC or ULURU
assigns this Agreement in accordance with this Section 13.2, then the assigning
Party shall be released from its obligations hereunder and shall have no further
obligations to the other Party pursuant to this Agreement.  The rights and
obligations of the parties under this Agreement shall be binding upon and inure
to the benefit of the successors and permitted assigns of the parties. Any
attempted assignment in violation of this Section 13.2 shall be null and void,
without any force or effect.

13.3           Entire Agreement.

This Agreement and all Exhibits attached hereto (as the same may be amended from
time to time by the written agreement of the Parties) constitute the entire
agreement between the Parties with respect to the subject matter hereof and
supersedes all other documents, agreements, verbal consents, arrangements and
understandings between the Parties with respect to the subject matter
hereof.  This Agreement shall not be amended orally, but only by an agreement in
writing, signed by both Parties that states that it is an amendment to this
Agreement.

 
 

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13.4           Severability.

If any term of this Agreement shall be found to be invalid, illegal or
unenforceable, it is the intention of the parties that the remainder of this
Agreement shall not be affected thereby; provided that neither Party’s rights
under this Agreement are materially adversely affected.  It is further the
intention of the parties that in lieu of each such provision which is invalid,
illegal or unenforceable, there be substituted or added as part of this
Agreement a provision which shall be as similar as possible in the economic and
business objectives intended by the Parties to such invalid, illegal or
unenforceable provision, but which shall be valid, legal and enforceable.  In
the event that either Party’s rights are materially adversely affected as a
result of a change in this Agreement as contemplated by this Section, such Party
may terminate this Agreement by notice in writing to the other Party given no
later than sixty (60) days after such change.

13.5           Independent Contractor.

Each Party shall act as an independent contractor and neither Party shall have
any authority to represent or bind the other Party in any way.

13.6           No Waiver.

Any waiver by one Party of any right of such Party or obligation of the other
Party must be in writing and shall not operate as a waiver of any subsequent
right or obligation.

13.7           Counterparts.

This Agreement may be executed in two or more counterparts (including, without
limitation, by facsimile transmission), each of which when so executed and
delivered shall be an original, but all of which together shall constitute one
and the same instrument.

 
 

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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the Effective
Date.

ULURU Inc.

By:           /s/ Kerry P. Gray
Name:  Kerry P. Gray
Title:           President & CEO

ORADISC  GmbH

By:           /s/ Helmut Kerschbaumer
Name:
Title:

 
 

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EXHIBIT A

Product

Means OraDisc Erodible Film Technology, in Bulk or in finished form.
All applications of OraDisc Erodible Film
Technology for dental applications including:
▬  
Benzocaine

▬  
Amlexanox (Exclusive of Europe, Canada, Korea, Taiwan and Hong Kong) Disc

▬  
Re-mineralization Dental Strips

▬  
Fluoride Dental Strips

▬  
Long Acting Breath Freshener

ORADISC will be granted a 24 month option to utilize the technology for drug
delivery for migraine, nausea and vomiting, pain and cough and cold. A separate
License Agreement would be signed on terms to be negotiated.

 
 

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EXHIBIT B

Quality Agreement

TO BE AGREED WITHIN 60 DAYS OF SIGNING THE LICENSE AGREEMENT.

 
 

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EXHIBIT C

Procedures for Reporting Adverse Events

TO BE AGREED WITHIN 60 DAYS OF SIGNING THE LICENSE AGREEMENT.

 
 

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EXHIBIT D

Price

MELMED HOLDING will pay ULURU to manufacture and supply MELMED Holding®. An
amount equal to the manufacturing cost of the product paid by ULURU to third
parties plus 5% of this cost to cover internal administrative and production
planning costs.

 
 

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EXHIBIT E

License Payments

Licensing fee of $250,000 will be paid on signing.

 
 

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EXHIBIT F

Territory

Worldwide – Excluding
Aphthasol and OraDisc A in Europe
Canada, Korea, Taiwan and Hong Kong and Aphthasol in the United States

 
 

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EXHIBIT G

Investment Agreement

 
 

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