LICENSE AND SUPPLY AGREEMENT ERODIBLE ORAL MUCOADESIVE FILM BENZOCAINE Dated as of February 6, 2007 between DEXO BIOPHARM LTD. and ULURU INC.
ERODIBLE
ORAL MUCOADESIVE FILM BENZOCAINE
Dated
as of February 6, 2007
between
DEXO
BIOPHARM LTD.
and
THIS
LICENSE AND SUPPLY AGREEMENT (this “Agreement”) is made and entered into as of
this 6th day of February, 2007 (the “Effective Date”), between DEXO BIOPHARM LTD
a company incorporated under the laws of England and Wales whose registered
office is at 15 - 17 Cambridge Science Park, ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇,
▇▇▇▇▇▇ ▇▇▇▇▇▇▇ (“DEXO”) and ULURU, Inc., a corporation organized and existing
under the laws of Nevada and having an address at ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇,
▇▇▇▇▇ ▇▇▇▇▇ (“ULURU”).
RECITALS
WHEREAS,
ULURU is developing a proprietary oral mucoadhesive, erodible form of drug
that
contains benzocaine as the active ingredient for oral pain (but excluding sore
throat pain) 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,
DEXO possesses substantial resources and expertise in the commercialization
and
marketing of over-the-counter pharmaceutical products; and
WHEREAS,
ULURU desires to grant to DEXO, and DEXO desires to obtain from ULURU, an
exclusive license to market the Product in the Territory and an exclusive right
to purchase from ULURU and distribute the Product in the Territory, 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 DEXO 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.
|
| 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.
|
| 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 DEXO 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. |
“Extraordinary
Event Increase” has the meaning set forth in Section
5.2.2.
|
| 1.1.12. |
“Facility”
means ‘s initial Third Party Manufacturing facility, and any subsequent or
replacement Third Party Manufacturing facility identified to and approved
by DEXO in accordance with Section 2.8.
|
| 1.1.13. |
“FDA”
means the United States Food and Drug Administration, or any foreign
regulatory agency or government entity which fulfills a role similar
to
the United States Food and Drug Administration, or any successor entities
thereto.
|
| 1.1.14. |
“FD&C
Act” means the Federal Food, Drug and Cosmetic Act, and all regulations
promulgated thereunder, or any foreign laws, statute, 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.
|
| 1.1.15. |
“Field”
means the treatment of oral mouth pain utilizing anesthetics (excluding
the treatment of sore throat).
|
| 1.1.16. |
“Force
Majeure Event” has the meaning set forth in Article
10.
|
| 1.1.17. |
“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.
|
| 1.1.18. |
“Indemnified
Party” has the meaning set forth in Section
7.1.3.
|
| 1.1.19. |
“Indemnifying
Party” has the meaning set forth in Section
7.1.3.
|
| 1.1.20. |
“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.
|
| 1.1.21. |
“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.
|
| 1.1.22. |
“Launch”
means the date on which the Product is sold by DEXO for the first time
to
a Third Party for commercial distribution in the
Territory.
|
| 1.1.23. |
“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.
|
| 1.1.24. |
“▇▇▇▇”
has the meaning set forth in Section
2.1.4.
|
| 1.1.25. |
“Materials”
means all materials, including, without limitation, all raw materials,
ingredients, packaging supplies and labels, required for the Manufacture
of Product.
|
| 1.1.26. |
“Methods
of Analysis” means the methods of analysis for the Product which is
mutually agreed upon in writing between the Parties and, on a date
to be
mutually agreed upon by the Parties
|
| 1.1.27. |
“Net
Sales” means, with respect to the Product, the gross invoiced sales amount
of the Product sold by DEXO 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 DEXO 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 DEXO and/or its Affiliates (excluding
national, state or local taxes based on income). Such amounts shall
be
determined from the books and records of DEXO 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.
|
| 1.1.28. |
“Party”
or “Parties” means either DEXO, ULURU or both, as the context
requires.
|
| 1.1.29. |
“Patents”
shall mean (a) U.S. Patent No. 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.
|
| 1.1.30. |
“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.
|
| 1.1.31. |
“PPI
Adjustment” has the meaning set forth in Section
5.2.
|
| 1.1.32. |
“Product”
has the meaning set forth in the first recital
above.
|
| 1.1.33. |
“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.
|
| 1.1.34. |
“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.
|
| 1.1.35. |
“Regulatory
Authority” shall mean all permissions which are necessary for the
manufacture, use, marketing, distribution and sale of the Product
including price reimbursement approval (if necessary) for the Price
of the
Product in any country of the Territory.
|
| 1.1.36. |
“Rolling
Forecast” has the meaning set forth in Section
2.3.
|
| 1.1.37. |
“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.
|
| 1.1.38. |
“Shortfall”
has the meaning set forth in Section 2.6.
|
| 1.1.39. |
“Specifications”
means the specifications for the Product which are mutually agreed
upon in
writing between the Parties and, on a date to be mutually agreed upon
by
the Parties.
|
| 1.1.40. |
“Term”
means, with respect to the Agreement shall commence on the date of
the
first sale of the Product and shall continue in full force for a period
often (10) years. Thereafter, the Agreement shall be automatically
extended for subsequent two (2) year periods unless terminated by either
Party in writing giving at least one hundred and eighty (180) days
prior
notice.
|
| 1.1.41. |
“Territory”
means, Europe including CEE (Central Eastern Europe) and CIS (Commonwealth
of Independent States) regions and the Middle
East.
|
| 1.1.42. |
“Third
Party” means any Person other than DEXO, ULURU and their respective
Affiliates.
|
| 1.1.43. |
“Trademark”
means any trademark, trade name, trade dress, slogan, logo, or similar
item selected by DEXO, and approved by Uluru, for use in connection
with
the Product.
|
| 1.1.44. |
“DEXO”
has the meaning set forth in the
Preamble.
|
| 1.1.45. |
“DEXO
Confidential Information” means all information, specifications, know-how
and data pertaining to DEXO’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.
|
| 1.2.1. |
Subject
to the terms and conditions of this Agreement, ULURU hereby grants
to DEXO
(a) the exclusive right and license in the Field to market, offer for
sale, sell and import the Product, in the Territory, (b) the exclusive
right and license in the Field to use the Product provided that such
right
and license is limited to such use as is necessary for DEXO to market,
offer for sale, sell and import the Product in the Territory 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 in the Territory and (d) the right to sub-license the Product
to
third party distributors in any country in the Territory where DEXO
does
not have its own marketing affiliate, subject to the written approval
of
ULURU, such approval not to be unreasonably withheld, Except as expressly
granted herein, ULURU retains all rights in the Intellectual Property
Rights and the Product.
|
| 1.2.2. |
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 DEXO any rights
in
or to the use of the Intellectual Property Rights by implication or
otherwise. DEXO shall ▇▇▇▇ 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.
|
| 1.2.3. |
Upon
expiration of the Term, DEXO shall have a non-exclusive, fully paid
up
license to those licenses set forth in Section
2.1.1.
|
| 1.2.4. |
Subject
to the terms and conditions of this Agreement, ULURU hereby grants
to DEXO
an exclusive, non-transferable (except in accordance with a permitted
assignment of this Agreement under Section 13.3) license in the Field
to
use ULURU’s “ORADISC” trademark (the “▇▇▇▇”) solely in connection with the
production, marketing and sale of the Product under this Agreement,
within
the Territory. Based on the information provided by ULURU, DEXO
acknowledges that ULURU is the exclusive owner of the ▇▇▇▇ and all
associated goodwill and registrations. DEXO agrees that it has no rights
to use the ▇▇▇▇ except for the right to use the ▇▇▇▇ as provided for
in
this Agreement and all uses of the ▇▇▇▇ by DEXO, and the associated
goodwill, shall inure solely to the benefit of ULURU. DEXO further
agrees
that upon the termination or expiration of this Agreement, all right
to
use the ▇▇▇▇ provided to DEXO hereby shall revert fully to ULURU. DEXO
shall faithfully reproduce the Mark’s design and appearance, as such
design and/or appearance may be modified from time to time by ULURU.
DEXO
shall not modify the design or appearance of the ▇▇▇▇ unless requested
to
do so in writing by ULURU. If in the event of Territory requirements,
either regulatory, legal or any other reasonable reason, DEXO may alter
the appearance of the ▇▇▇▇ with prior written approval from ULURU,
which
should not be unreasonably withheld. All uses of the ▇▇▇▇ shall be
subject
to ULURU’s prior written approval on the basis of samples submitted by
DEXO and shall be made in strict conformance with such specifications
as
ULURU shall establish, as such specifications may be modified by ULURU
from time to time. All displays of the ▇▇▇▇ shall bear such trademark
notices as ULURU shall require. Except as consistent with this Agreement
with respect to the Product, DEXO shall not (a) use the ▇▇▇▇ as part
of,
or in conjunction with, any other names or marks without ULURU’s prior
written approval; (b) use the ▇▇▇▇ or any confusingly similar marks,
terms
or designs, except as expressly authorized in this Section 2.1.4; (c)
attempt to register any such marks, terms or designs; (d) take any
actions
inconsistent with ULURU’s ownership of the ▇▇▇▇ and any associated
registrations, or attack the validity of the ▇▇▇▇, ULURU’s ownership
thereof, or any of the terms of this Section 2.1.4; (e) use the ▇▇▇▇
in
any manner that would indicate DEXO is using such ▇▇▇▇ other than as
a
licensee of ULURU; nor (f) assist any Affiliate or Third Party to do
any
of the same. ULURU, and/or its authorized agents or representatives,
shall
have the right from time to time, upon reasonable notice to DEXO, to
inspect DEXO’s (or its contractors’) facilities and operations during
regular business hours, that are involved in the Manufacture of the
Product pursuant to Section 2.6; provided that such inspections shall
be
subject to, and ULURU shall require its authorized agents and
representatives to agree in writing to, the confidentiality provisions
set
forth in Section 9 of this Agreement. Upon ULURU’s request, DEXO shall
provide ULURU with examples of all uses of the ▇▇▇▇ as actually used
by
DEXO, and a reasonable number of actual samples of the goods produced,
marketed and sold by DEXO under the ▇▇▇▇. DEXO agrees to cooperate
with
and offer reasonable assistance to ULURU in facilitating ULURU’s control
of the quality of the Product (and associated labels and marketing
materials and other documentation) branded with the ▇▇▇▇
hereunder.
|
| 2.2. |
Manufacture;
Marketing.
|
Subject
to Section 2.3 and only until the execution of a definitive Manufacturing
Agreement between the Parties, ULURU shall use commercially reasonable efforts
to Manufacture (or cause the Manufacture) and deliver the Product to DEXO in
such quantities, quality and at such times as ordered by DEXO in accordance
with
this Agreement. A condition of this License and Supply Agreement is that the
Parties commit to negotiate a Manufacturing Agreement to transfer the
manufacturing for the erodible oral mucoadesive film products from BioMed
Sciences Inc., to DEXO’s manufacturing site in Tampa, Florida starting within 90
days of signing this agreement. During the period while ULURU has responsibility
for manufacturing, ULURU shall use commercially reasonable efforts to ensure
that the resources necessary to manufacture the Product are available and shall
provide, at its own expense, all Materials and labor necessary to do so. DEXO
shall market and sell the Product in each country in the Territory; provided
that, nothing shall require DEXO to continue to market or sell the Product
in
any country within the Territory during a period of time that DEXO determines,
in its reasonable 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.
On
executing this License and Supply Agreement, the Parties will work as
expeditiously as possible to enter into a Manufacturing Agreement which will
provide for the transfer of manufacturing to DEXO’s Tampa manufacturing site and
find a more cost effective packaging alternative to Cardinal Healthcare. During
this transition period, ULURU is willing to take a reduced manufacturing and
supply margin to be mutually agreed upon. However, the Parties agree that the
manufacturing margin lost during this period will be recouped when manufacturing
is initiated at the DEXO manufacturing site.
| 2.3. |
Forecasts
and Minimum Sales.
|
At
least
six (6) months prior to Launch, DEXO shall submit to ULURU a forecast of the
quantity of the Product that DEXO anticipates ordering from ULURU prior to
DEXO’s anticipated Launch of Product and prior to DEXO’s assumption of
Manufacturing responsibility. DEXO shall submit to ULURU a forecast of the
quantity of the Product that DEXO anticipates ordering from ULURU (or, after
transfer of Manufacturing, selling) during the twelve (12) month period (broken
down by quarter) following Launch and DEXO shall update such forecast on a
rolling twelve (12) months basis every 3 months thereafter (each, a “Rolling
Forecast”). DEXO 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.
The orders placed should be in line with an appropriate and agreed production
batch size. DEXO will agree minimum sales percentages of the annual sales
forecast to be sold in each of the major markets as set forth in Exhibit
F.
| 2.4. |
Orders
and Delivery.
|
Prior
to
the transfer of Manufacturing, DEXO shall place its firm orders, either by
writing or electronic means (fax or email) 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 DEXO,
unless ULURU notifies DEXO in writing within fifteen (15) 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 DEXO that it or its Contract Manufacturer
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 DEXO 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. DEXO may cancel
or
modify any firm purchase order (in whole or in part) at any time prior to the
delivery for any quantity of Product for which Manufacturing has not been
completed pursuant to such purchase order at the time that notice of
cancellation or modification is received by ULURU; provided that if
Manufacturing has commenced but not completed pursuant to such firm purchase
order, DEXO shall reimburse ULURU for Material and labor costs in respect of
any
works-in-progress pursuant to such cancelled or modified purchase order (or
part
thereof) at the time notice of cancellation or modification is received by
ULURU; and provided, further, that DEXO shall reimburse ULURU for the actual,
reasonable out-of-pocket cost of any other Material purchased by ULURU to fill
a
cancelled purchase order (or part thereof) that are unique to the Product and
cannot within a reasonable period of time otherwise be used in ULURU’s or its
Manufacturer’s operations. All Product shall be delivered Ex Works, the Facility
and in accordance with DEXO’s instructions. Title, possession and risk of loss
shall pass to DEXO upon delivery of Product to DEXO’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. DEXO reserve the right
to split a manufacturing batch into different packaging in line with its
regulatory requirements within the territory.
| 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 DEXO 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 DEXO whose expiry date does not conform with the requirements set forth
in
this Section 2.4, 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 three (3)
accepted DEXO purchase orders within any twelve month period (a “Shortfall”), or
(2) the current manufacturing sites are deregulated, deregistered or requested
to cease manufacture for any reason from manufacturing pharmaceutical products
thereby restricting the sale of products to the TERRITORY or (3) if during
Manufacture or supply of the Product to DEXO there is a material violation
of
the requirements set forth in Sections 2.8, 3.1, 3.2, 3.4, 3.6. 3.8 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 forty-five (45) days of the later to occur
of the (i) date of the violation or (ii) notice to ULURU of such violation,
then
DEXO, in addition to any other rights and remedies it may have, shall have
the
right to Manufacture the Product itself and/or qualify an alternative registered
pharmaceutical supplier of Product; provided that such right shall be subject
to
the parties mutually agreeing upon a royalty arrangement that would reflect
ULURU’s lost manufacturing margin resulting from such transfer of manufacturing.
ULURU shall, at its cost, (a) cooperate with DEXO in the transfer of copies
of
the Confidential Information, technology and know-how necessary to Manufacture
the Product to DEXO and/or its designated alternative supplier, (b) deliver
to
DEXO copies of such drawings, specifications, and other information in ULURU’s
possession as may be necessary to Manufacture the Product, cause the Product
to
be Manufactured or in order to effect a pharmaceutical marketing authorization
within the TERRITORY and (c) grant to DEXO 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 DEXO’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 DEXO’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 DEXO’s
aforementioned right to Manufacture the Product itself and/or qualify an
alternative supplier of the Product by reason of a Shortfall, DEXO 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 DEXO’s forecasted requirements
for a period of time of three (3) months until such ability or willingness
to
supply resumes; provided that DEXO 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, DEXO 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.
In the event that DEXO elects to manufacture the Product itself and/or qualify
an alternative supplier of the Product in accordance with this Section 2.6,
then
ULURU shall reimburse DEXO for DEXO’s reasonable additional cost in obtaining
and establishing an alternateive supplier. In the event of ULURU ceasing to
be
the manufacturer of the product ULURU commits to retain all manufacturing batch
records for a period of seven (7) years.
| 2.7. |
Non-Compete.
|
During
the Term, neither DEXO nor any Affiliate of DEXO may directly or indirectly
market, offer for sale, sell, import or distribute in the Territory any human,,
mucoadhesive, erodible disc or film 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 DEXO from continued development, manufacture and sale of any
product in its own XGEL immediate release
dissolving
film technology, offered for sale, sold, imported or distributed by DEXO as
of
the Effective Date.
| 2.8. |
Third-Party
Manufacturer.
|
ULURU
shall, in accordance with the terms of this Section 2.8, use commercially
reasonable efforts to establish a Manufacturing Facility (operated by a Third
Party manufacturer) in compliance with the Regulatory Authorities requirements
pertaining in the TERRITORY, including, without limitation, compliance with
the
written requirements of DEXO as provided as of the Effective Date. As of the
Effective Date, ULURU has identified to DEXO the Third Party manufacturer it
intends to use to Manufacture and supply to DEXO the Product and the location
of
the Facility. ULURU shall promptly provide DEXO with access to the Facility
for
inspection by DEXO. In addition, ULURU shall promptly provide DEXO with
information requested by DEXO regarding the Third Party manufacturer (including,
without limitation, any information requested by DEXO in accordance with DEXO’s
due diligence, its GMP audit procedures and its “Level One Compliance
Assessment”). During the Term and upon reasonable prior notice to ULURU, DEXO
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. Any such audits or
inspections shall be undertaken by DEXO in accordance with the provisions of
Section 3.5.
| 2.9. |
Product
for Sale.
|
ULURU
and
DEXO acknowledge and agree that, as of the Effective Date, the Product is not
ready for sale and has to complete stability to the standard of the
International Committee on Harmonisation (ICH) of pharmaceutical products in
its
final packaging material for sale sufficient to effect product registration
and
to maximize the product shelf life. Product for sale must include (a) the
mutually agreed upon Methods of Analysis, and (b) the mutually agreed upon
Specifications. ULURU shall, at its own cost and expense use commercially
reasonable efforts to implement each of the stages in accordance with the
applicable specifications or criteria before Launch will occur.
| 2.10. |
Additional
Responsibilities.
|
| 2.10.1. |
ULURU
shall be responsible for (a) at ULURU’s cost and expense, supplying to
DEXO, prior to the commencement of Manufacturing of the Product, the
data
reasonably requested by DEXO (including, without limitation, the final
Product formulation, the processing requirements from start to finish
for
all production, the validated analytical methods, the Specifications
and
test method (both chemical and physical) for all elements of the disc
component and the Product through the finished production of the Product
and the validation protocols and schedules for processes, equipment,
cleaning and packaging) and (b) at ULURU’s cost and expense, scale-up,
validation and stability of the Product for commercial production of
the
Product, including, without limitation, production of the mucoadhesive
disc and development and validation of a mutually acceptable package
configuration, (c) cooperating with DEXO with respect to the obtaining
by
DEXO of any Regulatory Approvals required to be obtained by DEXO with
respect to the marketing, sale, offering to sell, importing and/or
distribution of the Product, and (d) providing to DEXO complete Batch
records for all validation Batches and providing one copy of each full
Batch record within 7 working days upon request.
|
| 2.10.2. |
DEXO
shall be responsible, at DEXO’s cost and expense, for any clinical trials,
consumer product testing and 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.
|
| 2.10.3. |
DEXO
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.
|
| 2.10.4. |
In
the TERRITORY, DEXO shall be responsible at its cost for registration,
maintenance of registration and price reimbursement approval (if
applicable). DEXO will be furnished with chemistry, manufacturing,
stability and technical data for regulatory approval purposes in the
Territory. DEXO shall have the right to use and reference all technical,
manufacturing and clinical data generated by ULURU and its licensees
for
such purpose. ULURU and its licensees shall have the right to use and
reference all technical, manufacturing and clinical data generated
by DEXO
and its licensees. If DEXO decides not register the Product in the
TERRITORY or any specific country in the TERRITORY, the commercial
rights
to the Product shall revert to ULURU. DEXO shall be the marketing
authorization holder in the TERRITORY. Upon written approval by ULURU,
DEXO may appoint a sub-license in certain markets where the local company
has to remain the local marketing authorization holder due to regulatory
requirements. This sub-license would be granted on terms similar to
this
agreement with specific exclusion of any manufacturing data other than
that to effect registration.
|
| 2.11. |
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 prior to entering into
the Manufacturing Agreement with DEXO. In accordance with such understanding,
ULURU acknowledges and agrees that with respect to ULURU’s obligations to DEXO
under this Agreement (a) despite the performance by the Third Party manufacturer
of ULURU’s Manufacturing and supply obligations hereunder, 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. The Third Party Manufacturer must remain fully authorized and
regulated to carry on the manufacture of pharmaceutical products. For avoidance
of doubt, with respect to the obligations of ULURU regarding Manufacture and
supply to DEXO of the Product, reference to ULURU in this Agreement shall also
mean ULURU’s contractors, Third Party manufacturer and Affiliates.
| 2.12. |
Marketing
Obligations.
|
Following
regulatory approval, issuance of licenses and if applicable, listing of the
Product on the reimbursement list DEXO shall make all reasonable commercial
efforts to Launch the Product in each country of the TERRITORY within six (6)
months. If product launch cannot occur, DEXO can make written application to
ULURU for an extension to the timeframe, stating its clear commercial intentions
and the specific reasons for any delay. Such an extension will not be
unreasonably withheld by ULURU, but any such extention granted may be limited
in
time by ULURU. DEXO and its distributors shall use reasonable commercial efforts
to promote the commercialization and sales of the Product, subject to compliance
with all applicable laws and regulations to promote and market the Product.
DEXO
and its distributors shall maintain a competent marketing and sales organization
in the TERRITORY. If DEXO decides not to, or is unable to, Launch the Product
in
the TERRITORY or a specific country in the TERRITRORY under the terms as laid
out in 2.12, the commercial rights in relation to that country to the Product
shall revert to ULURU.
| 2.13. |
Marketing
|
DEXO
shall have sole responsibility for marketing the Product in the TERRITORY.
In
countries in the TERRITORY where DEXO does not have its own marketing affiliate,
DEXO will have the right to appoint third party distributors subject to the
written approval of ULURU, such approval not to be unreasonably withheld. DEXO
shall furnish ULURU with written reports twice a year in the major markets
listed in Exhibit F, covering the market share of the Product, business trends
and key marketing issues relating to the Product.
| 3. |
COMPLIANCE,
QUALITY AND ENVIRONMENTAL
|
| 3.1. |
Compliance
with Law.
|
ULURU
shall use commercially reasonable efforts to cause its contract manufacturer
to
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 DEXO 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 DEXO 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’s contract manufacturer 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, the cost of such to be
included in the price hereinafter specified. ULURU shall promptly, upon
completion of such tests, deliver to DEXO a copy of the record of such tests
performed on, and a Certificate of Analysis for, each Batch of Product. ULURU
shall deliver a representative sample from each Batch of Product to DEXO’s
designated representative by the date reasonably specified by such
representative. 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 DEXO.
| 3.3. |
Testing
by DEXO.
|
DEXO
may
test the Product samples in accordance with the applicable Methods of Analysis.
If the analysis of any Product performed by or for DEXO differs from ULURU’s
analysis of the same Batch, DEXO shall advise ULURU and ULURU and DEXO agree
to
consult with each other in order to explain and resolve the discrepancy between
each other’s determination. If, after good faith attempt by the Parties to do
so, such consultation does not resolve the discrepancy, an independent,
reputable laboratory as mutually agreed by the Parties shall repeat the
applicable Methods of Analysis on representative samples from such Batch
provided by both ULURU and DEXO. The costs of the independent laboratory
referred to above shall be borne by (a) DEXO if such laboratory determines
that
the Product conforms to the Specifications or (b) ULURU if such laboratory
determines that the Product does not conform to the Specifications. If so
requested by DEXO in writing, ULURU shall promptly send a new Batch of the
Product (of similar quantity as to the amount of such Product being analyzed
as
set forth above) to DEXO. DEXO shall not be obligated to pay for any of the
Product (and if DEXO has paid for such Product ULURU shall promptly reimburse
DEXO for the cost of replacing such Product, including, without limitation,
related costs such as testing and transportation costs) that such laboratory
determines does not conform to the Specifications, but shall be obligated to
pay
for any new Batch of Product that is sent as specified above; provided that
DEXO
must destroy (and certify destruction of) such nonconforming
Product.
| 3.4. |
Samples
and Record Retention.
|
ULURU
shall retain records and retention samples of each Batch of the Product for
at
least seven years after the manufacturing date of that Batch and shall make
the
same available to DEXO upon request. Retention samples shall only be destroyed
after the required holding period; provided that in the event that DEXO provides
written notice to during and after the Term of this Agreement ULURU shall
reasonably assist DEXO with respect to any complaint, issue or investigation
relating to the Product.3
| 3.5. |
Inspection.
|
ULURU
shall give access to representatives of DEXO, 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. DEXO 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 DEXO 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 DEXO policies and procedures provided 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 or its contract manufacturer’s
operations, and shall not be more frequent than is reasonable.
| 3.6. |
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 DEXO to ULURU; provided that such
amendment shall not conflict with any of the provisions of this Agreement).
DEXO
shall determine whether such information is required to be reported to the
FDA
and any other Regulatory Authority.
| 3.7. |
Recalls
and Seizure.
|
| 3.7.1. |
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,
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 DEXO 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.
|
| 3.7.2. |
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. 3.8 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 DEXO), ULURU shall
be
responsible for all expenses of the Recall incurred by DEXO and ULURU
shall promptly replace such Product at no additional cost to DEXO
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 DEXO or its Affiliates, distributors or contractors
(including but not limited to defective Manufacture, storage, handling
or
distribution undertaken at the direction of DEXO and consistently with
DEXO’s instructions), DEXO 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, but shall not
include lost profits of either party.
|
| 3.8. |
Environmental,
Occupational Health and Safety.
|
| 3.8.1. |
ULURU
shall promptly report to DEXO after any of the following incidents
related
to the Manufacturing operations hereunder occurs: (a) fatalities and/or
significant injuries or occupational illness; (b) property damage in
excess of $50,000; (c) inspections by any environmental protection
agency
or occupational health and safety agency; or (d) requests for information,
notices of violations or other significant governmental and safety
agency
communications relating to environmental, occupational health and safety
compliance.
|
| 3.8.2. |
As
between ULURU and DEXO, LILURU shall have title to and be responsible
for
disposing in an environmentally safe manner all residue and waste
resulting from the Manufacturing operations performed hereunder. ULURU
shall not use DEXO trademarks or trade dress to identify any waste
materials or residues.
|
| 4. |
MANUFACTURING
CHANGES
|
| 4.1. |
Voluntary
Change
|
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 DEXO. 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
any of
the Regulatory Authorities 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 Regulatory
Authority’s requirements. Each Party 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 Regulatory Authority that may affect the Manufacture, supply, or
distribution of the Product as contemplated herein.
| 5. |
PRICE
AND PAYMENT
|
| 5.1. |
Price.
|
ULURU
shall invoice DEXO for the Product supplied to DEXO hereunder at the applicable
price per Product set forth on Exhibit D. The supply price of Product shall
remain in effect unless and until the price of the Product is adjusted pursuant
to this Article 5.
| 5.2. |
Price
Adjustment.
|
| 5.2.1. |
Commencing
on any date in the second Contract Year, ULURU may adjust the then-current
price to reflect documented increases or decreases in labor costs,
variable overhead costs or the acquisition cost of Materials per unit
of
Product at the beginning of the Contract Year in question as compared
to
the acquisition cost of such labor, variable overhead or Materials
per
unit of Product at the beginning of the immediately preceding Contract
Year; provided that ULURU gives DEXO not less than ninety (90) days’ prior
written notice of any price increase or decrease and that ULURU may
not
increase the price more than once during any Contract Year; and provided,
further, that except as provided in Section 5.2.2, any price increase
per
unit of Product shall not exceed the PPI Adjustment for the Contract
Year
in question. Until the effective date of such price increase, ULURU
shall
supply DEXO such Product at the prices then in effect without such
price
increase. “PPI Adjustment” means for the Contract Year in question, the
amount calculated in accordance with the following
formula;
|
MC
x PPI
- BPPI
BPPI
Where,
|
MC =
|
the
documented labor costs, variable overhead costs and the acquisition
cost
of all Materials per unit of Product at the beginning of the Contract
Year
immediately preceding the Contract Year in question;
|
|
BPPI =
|
the
Bureau of Labor Statistics Producer’s Price Index for Pharmaceutical
Preparations (Code 2834) for the first month of the Contract Year
immediately preceding the Contract Year in question;
and
|
|
PPI =
|
the
Bureau of Labor Statistics Producer’s Price Index for Pharmaceutical
Preparations (Code 2834) for the first month of the Contract Year
in
question.
|
Notwithstanding
anything to the contrary contained in this Section 5.2.1, there shall be no
price increases made due to any increases with respect to the fixed overhead
component of the cost of the Product.
| 5.2.2. |
Notwithstanding
anything to the contrary in Section 5.2.1, in the event of an
extraordinary event that results in a documented material increase
(with
“material increase” meaning, for purposes of this Section 5.2.2, an
increase of at least fifteen (15%) percent in the aggregate) in the
collective cost of a major component of Manufacturing for the Product
during any annual period after the end of the first Contract Year (an
“Extraordinary Event Increase”), ULURU need not wait until the next annual
period to adjust the pricing for the Product. Upon ULURU’s determination
that an Extraordinary Event Increase has occurred, ULURU shall notify
DEXO
in writing of the applicable price adjustment, together with supporting
documentation evidencing such change including without limitation,
evidence that ULURU shall have used its commercially reasonable efforts
to
secure alternative sources of supply for any components or consumables,
at
lesser costs without detracting from the quality or efficacy of the
Product. Any such pricing adjustment will become effective thirty (30)
days following the date of ULURU’ s written notice
thereof.
|
| 5.3. |
Continuous
Improvement Price Adjustment.
|
Continuous
improvement initiatives, mutually agreeable to the Parties shall be established
annually to provide for attempting to achieve continuous cost reductions during
the Term hereof. Continuous improvement teams consisting of equal representation
from each Party shall use reasonable efforts to work to identify and implement
cost savings at a targeted rate of five percent (5%) of DEXO’s purchase price
per Contract Year. Any documented savings shall be allocated to the Parties
equally once production has been transferred to DEXO. Any cost savings allocated
to DEXO shall be in the form of reduced purchase price, effective (with respect
to any subsequent DEXO purchase orders) immediately upon documentation and
allocation of the savings.
| 5.4. |
License
Payments.
|
DEXO
shall notify ULURU in writing within fifteen (15) days of each license fee
milestone event and make the appropriate payment to ULURU in US dollars within
thirty (30) days of the occurrence of the applicable milestone set forth in
Exhibit E.
| 5.5. |
Royalty
and Royalty Payments.
|
In
addition to the payments set forth above, where DEXO out-licenses the Product
in
specific countries in the Territory where it does not have its own marketing
affiliate, ULURU will receive fifteen (15%) per cent of all royalty and
licensing or other payments DEXO receives from sub-licensees. DEXO 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. DEXO 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 DEXO and its Affiliates; and (ii) Net Sales
of
the Product during the applicable Royalty Period, all in a manner consistent
with DEXO’s internal sales reporting. Royalty payments shall be paid to ULURU in
US dollars thirty (30) days following the close of the calendar quarter at
the
relevant spot exchange rate published in the London Financial Times at the
end
of the calendar quarter.
| 5.6. |
Payment
for Product
|
DEXO
shall pay invoices for Product delivered hereunder not later than thirty (30)
days after the later of receipt of Product covered by such invoice and receipt
of such invoice.
| 5.7. |
Taxes
and Other Charges.
|
All
Product prices are exclusive of taxes, shipping costs to the point of delivery,
customs duties and other charges, and DEXO agrees to bear and be responsible
for
the payment of all such charges imposed, excluding taxes based upon ULURU’s net
income.
| 5.8. |
Audit
Rights.
|
| 5.8.1. |
DEXO
shall have the right, at its own expense, to access the books and records
of ULURU and its Affiliates as may be reasonably necessary to verify
the
accuracy of the labor costs and Material costs referred to in Section
5.2.
Such access shall be conducted after thirty (30) days’ prior written
notice to ULURU and during ordinary business hours, will be conducted
in a
manner that is not disruptive to ULURU’s operations, and shall not be more
frequent than once per Contract Year. Subject to Section 5.8.3, if
such
independent certified public accountant’s report shows any overpayment by
DEXO, ULURU shall remit to DEXO within thirty (30) days after ULURU’s
receipt of such report, (a) the amount of such overpayment, and (b)
if
such overpayment 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 DEXO. Subject
to
Section 5.8.3, if such independent certified public accountant’s report
shows any underpayment by DEXO, DEXO shall pay to ULURU within thirty
(30)
days after DEXO’s receipt of such report, the amount of such underpayment.
Any audit or inspection conducted under this Agreement by DEXO or its
agents or contractors will be subject to the confidentiality provisions
of
this Agreement, and DEXO will be responsible for compliance with such
confidentiality provisions by such agents or
contractors.
|
| 5.8.2. |
DEXO
shall maintain books of account with respect to its sales of the Product
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 DEXO 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, milestones or up-front payments paid.
Subject to Section 5.8.3, if such independent certified public
accountant’s report shows any underpayment by DEXO, DEXO shall pay to
ULURU within thirty (30) days after DEXO’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 UTJJRU. Subject to Section 5.8.3, such independent
certified public accountant’s report shows any overpayment by DEXO, ULURU
shall remit to DEXO 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 contractors.
|
| 5.8.3. |
If
any dispute arises under this Section 5.8 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.
|
| 5.9. |
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 frill; provided that no interest shall accrue
on
any amounts being disputed in good faith by DEXO with respect to which DEXO
is
making diligent and good faith efforts to resolve.
| 5.10. |
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 on the last business day of each calendar month
to
United States dollars at the DEXO financial statement exchange rate applied
by
DEXO on a consistent basis in DEXO’s own financial accounting.
| 6. |
REPRESENTATIONS
AND WARRANTIES
|
| 6.1. |
Representation
and Warranties of Each Party.
|
Each
of
DEXO 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.
|
| 6.2. |
Representations
and Warranties of ULURU.
|
ULURU
hereby further represents and warrants to DEXO 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; (e) is not adulterated or misbranded;
and
(d) has been shipped and stored in accordance with procedures requested
by
DEXO;
|
| 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 DEXO of the
Product;
|
| 6.2.6. |
as
of the Effective Date, U.S. Patent No. 6,585,997 is existing and has
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 DEXO
hereunder);
|
| 6.2.8. |
as
of the Effective Date, and, except as disclosed to DEXO 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 ▇▇▇▇ are subject to an infringement claim of any issued patent
or
▇▇▇▇ 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
|
| 6.2.10. |
as
of the Effective Date, or within ten (10) days thereof, ULURU has provided
DEXO with any and all information relating to the Product, its Manufacture
and formulation necessary for DEXO to conduct a freedom to operate
opinion
relating to the Territory, and all information has been provided so
that
DEXO may complete its due diligence.
|
| 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
DEXO’s
sole and exclusive remedy for any breach of Section 6.2.1 discovered prior
to
the distribution by DEXO 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
nonconforming Product shall be returned to ULURU in accordance with ULURU’s
return procedures, and only if after ULURU’s inspection, such Product is
determined to have been non-conforming pursuant to the procedures set forth
in
Section 3.3. 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. |
DEXO
Responsibility.
|
DEXO
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 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. WITHOUT LIMITING THE GENERALITY
OF THE
FOREGOING, EXCEPT FOR THE WARRANTIES EXPRESSLY PROVIDED IN SECTION
6, NO
IMPLIED WARRANTY OF MERCHANTABILITY, VALIDITY, NONINFRINGEMENT, TITLE,
FITNESS FOR ANY PARTICULAR PURPOSE, AND NO IMPLIED WARRANTY ARISING
BY
USAGE OF TRADE, COURSE OF DEALING OR COURSE OF PERFORMANCE IS GIVEN
OR
MADE BY ULURU OR SHALL ARISE BY OR IN CONNECTION WITH ANY SALE OR
PROVISION OF PRODUCTS OR SERVICES BY ULURU, OR DEXO’S USE OR SALE OF THE
PRODUCT, OR ULURU’S AND/OR DEXO’S CONDUCT IN RELATION THERETO OR TO EACH
OTHER. NO REPRESENTATIVE OF ULURU IS AUTHORIZED TO GIVE OR MAKE ANY
OTHER
REPRESENTATION OR WARRANTY OR TO MODIFY THE FOREGOING WARRANTY IN ANY
WAY
|
| 6.6.2. |
EXCEPT
FOR THE WARRANTIES GIVEN BY DEXO AS EXPRESSLY PROVIDED IN SECTION 6,
DEXO
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 nonconformity
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.
|
| 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 DEXO’S RIGHTS AS SPECIFICALLY AND EXPRESSLY PROVIDED IN THIS
AGREEMENT.
IN
NO
EVENT WHATSOEVER SHALL EITHER PARTY HAVE ANY LIABILITY, OBLIGATION OR
RESPONSIBILITY TO THE OTHER PARTY OR SUCH OTHER PARTY’S AFFILIATES FOR ANY
INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES
ARISING IN ANY WAY IN CONNECTION WITH PRODUCT OR ITS PURCHASE, SALE, USE OR
INABILITY TO USE.
| 7. |
INDEMNIFICATION
AND INSURANCE
|
| 7.1. |
Indemnification.
|
| 7.1.1. |
ULURU
shall defend, indemnify and hold harmless DEXO, its Affiliates, directors,
officers, employees and agents from and against all damages, losses,
liabilities, expenses, claims, demands, suits, penalties or judgments
or
administrative or judicial orders (including, without limitation,
reasonable attorneys’ fees and expenses) incurred, assessed or sustained
by or against DEXO, its Affiliates, directors, officers, employees
or
agents with respect to a claim by a Third Party arising out of (a)
the
negligent acts or omissions of ULURU; (b) any breach by ULURU of this
Agreement or its representations, warranties or covenants hereunder;
(c)
any Recall or Seizure attributable to ULURU’s performance (including,
without limitation, amounts DEXO pays or credits to its customers for
Product so Recalled or Seized); (d) product liability, tort, nuisance
or
other claim arising out of the defective manufacture, storage or supply
of
the Product by ULURU; (e) any allegation that the manufacture,
importation, sale, offer for sale or use of the Product infringes any
patent or other intellectual property, proprietary or protected right
within the Territory; provided that ULURU will not be obligated to
indemnify DEXO if and to the extent that the alleged infringement is
caused by: (i) DEXO’s (including, without limitation, its Affiliates,
agents, contractors, and sub-distributors) or its customers misuse
or
modification of the Product; or (ii) DEXO’s (including, without
limitation, its Affiliates, agents, contractors, and sub-distributors)
or
its customers use of the Product in combination with any products or
materials not provided by ULURU; and further provided that if the Product
is held to constitute an infringement or misappropriation of any Third
Party’s intellectual property rights or if in ULURU’s opinion, the Product
is, or is likely to be held to constitute, an infringement or
misappropriation, ULURU may at its expense and option: (x) procure
the
right for DEXO to continue distributing the Product; (y) upon prior
approval by DEXO, which approval will not be unreasonably withheld
or
delayed, promptly replace the Product with a non-infringing and
non-misappropriating equivalent product conforming to the applicable
Product Specifications and Regulatory Approvals; provided that there
shall
not be any material delay in any such replacement; or (z) upon prior
approval by DEXO, which approval will not be unreasonably withheld
or
delayed, modify the Product to make it non-infringing and
non-misappropriating while conforming to the applicable Product
Specifications and Regulatory Approvals; provided that there shall
not be
any material delay in any such modification; (f) any enforcement or
other
action by any Regulatory Authority relating to the Manufacture, the
pricing of the Product by ULURU to DEXO or sale of the Product by ULURU
to
DEXO; or (f) ULURU’s failure to comply with any applicable law, regulation
or order (including, without limitation, environmental laws, regulations
and orders). The foregoing indemnification obligation shall not apply
in
the event and to the extent that such claim arose as a result of any
indemnitee’s negligence, intentional misconduct or breach of this
Agreement. The provisions of this Section shall survive the termination
or
expiration of this Agreement.
|
| 7.1.2. |
DEXO
shall defend, indemnify and hold harmless ULURU, its directors, officers,
employees and agents from and against all damages, losses, liabilities,
expenses, claims, demands, suits, penalties or judgments or administrative
or judicial orders (including, without limitation, reasonable attorneys’
fees and expenses) incurred, assessed or sustained by or against ULURU,
its directors, officers, employees or agents with respect to a claim
by a
Third Party arising out of (a) the negligent acts or omissions of DEXO;
(b) any breach by DEXO of this Agreement or of its representations,
warranties or covenants hereunder; (c) any allegation that the Trademarks
or DEXO’s packaging or DEXO’s (or any Affiliate of DEXO’s) marketing
materials infringes any patent or other proprietary or protected right
of
any Third Party; (d) any Recall or Seizure attributable to DEXO’s
performance;
|
(e)
any
enforcement or other action by any Regulatory Authority relating to the
distribution, the pricing of the Product by DEXO or sale of the Product by
DEXO
to Third Parties; (f) DEXO’s failure to comply with any applicable law,
regulation or order (including, without limitation, environmental laws,
regulations and orders), or (g) the marketing and distributing of the Product
by
DEXO, its Affiliates or sub-distributors. The foregoing indemnification
obligation shall not apply in the event and to the extent that such claim arose
as a result of any indemnitee’s negligence, intentional misconduct or breach of
this Agreement. The provisions of this Section shall survive the termination
or
expiration of this Agreement.
| 7.1.3. |
To
receive the benefit of indemnification under this Section 7.1, the Party
and its Affiliates, directors, officers, employees or agents seeking
indemnification (an “Indemnified Party”) shall promptly notify the other
Party (the “Indemnifying Party”), in writing, of any claim asserted or
threatened against such Indemnified Party for which such Indemnified
Party
is entitled to indemnification hereunder from the Indemnifying Party.
With
respect to any such claim the Indemnified Party shall, at no out-of-pocket
expense to it, reasonably cooperate with and provide such reasonable
assistance to such Indemnifying Party as such Indemnifying Party may
reasonably request. Such reasonable assistance may include, without
limitation, providing copies of all relevant correspondence and other
materials that the Indemnifying Party may reasonably request. The
obligations of an Indemnifying Party under Sections 7.1.1 and 7.1.2
are
conditioned upon the delivery of written notice to the Indemnifying
Party
of any asserted or threatened claim promptly after the Indemnified
Party
becomes aware of such claim; provided that the failure of the Indemnified
Party to give such notice or any delay thereof shall not affect the
Indemnified Party’s right to indemnification hereunder, except to the
extent that such failure or delay impairs the Indemnifying Party’s ability
to defend or contest any such claim. The Indemnifying Party shall have
the
right to assume the defense of any suit or claim for which indemnification
is sought with counsel reasonably acceptable to the Indemnified Party.
If
the Indemnifying Party defends the suit or claim, the Indemnified Party
may participate in the defense thereof at its sole cost and expense.
An
Indemnifying Party may not settle a suit or claim without the consent
of
the Indemnified Party if (a) such settlement would impose any monetary
obligation on the Indemnified Party for which indemnification is not
provided hereunder, (b) or require the Indemnified Party to submit
to an
injunction or otherwise limit the Indemnified Party’s rights under this
Agreement, or (e) does not include a release of the Indemnified Party
from
all liability arising out of such suit or claim. Any payment made by
an
Indemnifying Party to settle any such suit or claim shall be at its
own
cost and expense.
|
| 7.1.4. |
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
|
$2,000,000
Per Occurrence
|
|
Workers
Compensation
|
$5,000,000
Aggregate 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.
|
Upon
request, ULURU shall furnish insurance certificates as directed by DEXO,
satisfactory in form and substance to DEXO, showing the above coverages, and
providing for at least thirty (30) days’ prior written notice to DEXO by the
insurance company of cancellation or modification. DEXO shall be named as an
additional insured on the ULURU’s policies. Coverage shall be procured with
carriers having an A.M. Best rating of A-Vu or better.
| 8. |
TERM
AND TERMINATIONS.
|
| 8.1. |
Term.
|
This
Agreement shall commence on the date of first sale of the Product in the
Territory and shall continue in hill force for a period often (10) years.
Thereafter, the Agreement shall be automatically extended for subsequent
two-year (2) periods unless terminated by either party in writing giving at
least one hundred (180) days prior notice to the end of the initial term or
any
extension thereof.
| 8.2. |
Termination
Without Cause.
|
DEXO
may
terminate this Agreement at any time (a) after Launch by giving twelve (12)
months prior written notice to ULURU if DEXO, in its sole discretion, determines
to cease marketing the Product, or (b) prior to Launch by giving thirty (30)
days prior written notice to ULURU if DEXO, in its sole discretion, determines
not to Launch the Product. If DEXO decides not to launch the Product in any
specific country in the Territory, the commercial rights shall revert to ULURU.
If DEXO terminates this Agreement pursuant to subsection (a) above, DEXO is
not
obligated to transfer to ULURU any data relating to the Product (including,
without limitation, marketing studies or otherwise) that DEXO generated prior
to
such termination. If DEXO terminates this Agreement pursuant to subsection
(b)
above, then, subject to the exceptions set forth in Section 8.3, DEXO shall
transfer to ULURU any data relating solely to the Product that DEXO
generated.
| 8.3. |
Termination
for Regulatory Action or Claim of
Infringement.
|
DEXO
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.
|
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.
| 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. |
DEXO’s
Rights on Termination.
|
Upon
termination or expiration of this Agreement for any reason, then (a) at DEXO’s
request, ULURU shall supply DEXO with its inventory of Materials, Product and/or
works-in-progress for the Manufacture, packaging and labeling of Product and
DEXO shall pay ULURU the manufacturing fee for the Product, a prorated portion
thereof for work-in-progress commenced against firm orders by DEXO and the
cost
of Materials.
| 8.8. |
Survival.
|
The
following provisions shall survive the expiration or termination of this
Agreement:
Sections
3.4, 3.6, 3.7, 5.5, 5.6, 5.7, 5.8, 5.9, 5.10, 7.1, 8.6, 8.7 and 8.8, and
Articles 9, 11, 12 and 13.
| 9. |
CONFIDENTIALITY
|
| 9.1. |
Nondisclosure
Obligation.
|
Each
of
ULURU and DEXO 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 DEXO 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 DEXO’s orders hereunder, ULURU shall allocate all available
quantities of Materials and Product to DEXO in the ratio that the quantities
ordered by DEXO 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.
| 11. |
INTELLECTUAL
PROPERTY
|
| 11.1. |
Trademarks:
DEXO Intellectual Property.
|
| 11.1.1. |
DEXO
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 under Section 2.1.4 with respect
to the ▇▇▇▇, DEXO may not use or adopt any ULURU Trademark or trade
dress,
or any such item confusingly similar thereto used or intended to be
used
prior to the first use of such Trademark. ULURU shall have no right,
title
or interest in or to any such DEXO Trademark or trade dress, and DEXO
shall have no right, title or interest in or to any such ULURU Trademark
(except for the license to the ▇▇▇▇ granted under Section 2.1.4). So
long
as DEXO or any Affiliate of DEXO shall have any interest in any such
Trademark or trade dress, whether registered or unregistered, whether
as
proprietor, owner, or licensee in any country of the world, ULURU shall
not adopt, use, apply for registration, register or own such Trademark
or
trade dress, or any such item confusingly similar thereto in any country
of the world, or take any action which weakens or undermines DEXO’s
proprietary rights therein. So long as ULURU or any Affiliate of ULURU
shall have any interest in any such ULURU Trademark or trade dress,
whether registered or unregistered, whether as proprietor, owner, or
licensee in any country of the world, except as otherwise expressly
permitted under Section 2.1.4 with respect to the ▇▇▇▇, DEXO shall
not
adopt, use, apply for registration, register or own such ULURU Trademark
or trade dress, or any such item confusingly similar thereto in any
country of the world, or take any action which weakens or undermines
ULURU’s proprietary rights therein.
|
| 11.1.2. |
For
the avoidance of doubt, DEXO 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 specifically relates to the Product and
is
Controlled by ULURU shall be automatically included in the Intellectual
Property Rights under which DEXO is Licensed pursuant to Section 2.1.1
hereof. With respect to any Inventions or know-how Controlled by DEXO
specifically relating to the Product, DEXO hereby grants to ULURU an
exclusive (subject to retained rights in DEXO), royalty-free license
to
use such Invention for the Manufacture of the Product for DEXO 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.
|
| 11.2.4. |
All
rights, title and interest in and to the ULURU Intellectual Property
Rights shall remain exclusively owned by ULURU. The Inventions owned
by
ULURU under this Section shall be referred to herein as “ULURU
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.
| 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
countries of the Territory.
|
| 11.4.2. |
With
respect to any filings after the Effective Date, ULURU shall give DEXO
a
reasonable opportunity to review and comment upon the text of such
applications in the Territory before filing, shall consult in good
faith
with DEXO with respect to such applications in the Territory, and shall
supply DEXO with a copy of such applications in the Territory as filed,
together with notice of its filing date and serial number. ULURU shall
inform DEXO 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 consult with DEXO and provide DEXO with reasonable opportunity
to
comment on all correspondence received from and all submissions to
be made
to any Regulatory Authority in the Territory with respect to any such
patent application or patent. ULURU shall consider in good faith, but
will
not be bound by, DEXO’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 DEXO 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 DEXO, in DEXO’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 DEXO’s own expense. If DEXO elects to continue
such prosecution or maintenance, ULURU shall execute such documents
and
perform such acts, at DEXO’s expense, as may be reasonably necessary to
permit DEXO to file, prosecute or maintain such application or Patent
in
such country. In such event, DEXO shall own such patent application
or
Patent filed by DEXO hereunder.
|
| 11.4.6. |
In
the event that DEXO continues the prosecution or maintenance of such
patent application or Patent pursuant to this Section, DEXO’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.
|
(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
DEXO 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 DEXO’ 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
DEXO’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 ▇▇▇▇, or the validity of any of the Intellectual
Property Rights or the ▇▇▇▇ 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 ▇▇▇▇ in
the
Territory. Such right shall remain in effect until ninety (90) 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 DEXO (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 ▇▇▇▇. 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 ▇▇▇▇, filed
suit against any such Third Party infringer of the Intellectual Property
Rights and/or the ▇▇▇▇, or provided DEXO with information and arguments
demonstrating to DEXO’s reasonable satisfaction that there is insufficient
basis for the allegation of such infringement of the Intellectual Property
Rights and/or the ▇▇▇▇, then DEXO shall have the right, but not the
obligation, to bring suit against such Third Party infringer of the
Intellectual Property Rights and/or the ▇▇▇▇ and to join ULURU as a party
plaintiff, provided that DEXO shall bear all the expenses of such suit.
In
such event, DEXO 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 ▇▇▇▇ 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 ▇▇▇▇ 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 there from,
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).
|
| 11.6. |
Trademarks.
|
Subject
to the restrictions in Sections 2.1.4 and 11.1, DEXO shall select and own all
Trademarks in connection with the marketing, promotion and sale of the Product
in the Territory other than the ULURU Trademarks. DEXO hereby grants to ULURU
a
limited, non-exclusive, non-transferable, fully paid, royalty free,
sublicensable license in and to all DEXO 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 DEXO in facilitating DEXO’s control of the quality of
the Product branded with DEXO’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 with respect to the Product 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 nondisclosing 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. |
The
Parties acknowledge that as publicly held corporations, the Parties
may
not lawfully disclose in advance certain information to any party,
including, without limitation, the other Party. This may affect the
Parties’ ability to submit for review certain proposed publications and
public presentations.
|
| 11.7.5. |
Regarding
their publications under this Section 11.7, ULURU and DEXO will each
comply with standard academic practice regarding authorship of scientific
publications and recognition of contribution of other parties in any
publication.
|
| 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.
|
| 12.2.1. |
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
DEXO:
DEXO BioPharm
Ltd.
▇▇▇▇▇▇▇
▇▇▇▇▇
▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇,
▇▇▇ ▇▇▇
Attention:
Chief Executive Officer
Facsimile
No.: 011-44-207-098-9883
Copy
to:
Company Secretary
If
to
ULURU:
▇▇▇▇
▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇,
▇▇ ▇▇▇▇▇
Attention:
President & CEO
Facsimile
No.: 214-905-5145
With
a
copy to:
▇▇▇▇
▇.
▇▇▇▇▇▇▇▇▇, Esq.
▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇ LLLP
▇▇▇
▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇,
▇▇ ▇▇▇▇▇
Facsimile
No.: ▇▇▇-▇▇▇-▇▇▇▇
| 13. |
GENERAL
|
| 13.1. |
Governing
Law.
|
This
Agreement shall be construed in accordance with and governed by the law of
the
State of New York, 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. |
Equal
Opportunity Clause.
|
The
Equal
Opportunity Clause required by Executive Orders 11246, as amended (41-CFR
60-1.4) and 11375, the Employment Assistance to Veterans Clause required by
Executive Order 11701(41 CFR 60-250.4), the Vietnam Era Veteran Readjustment
Act
of 1972, the Employment of the Handicapped Clause required by the Rehabilitation
Act of 1973 (41 CFR 60-74 1.4) and the Americans with Disabilities Act of 1991
are part of this Agreement and binding upon ULIURU unless exempted by rules,
regulations or orders of the Secretary of Labor. ULURU agrees that the
applicable clause with regard to the utilization of minority contractors set
forth at 41 CFR 1-1.303 and the applicable clause with regard to the Utilization
of Small Business Concerns and Small Business Concerns Owned and Controlled
by
Socially and Economically Disadvantaged Individuals set forth at 41 CFR 1-1.13
are incorporated herein by reference, as applicable. ULURU agrees to provide
information and documentation with respect to the foregoing to DEXO upon
request.
| 13.3. |
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 DEXO sublicenses the Agreement or any rights or
obligations hereunder in accordance with the previous sentence, then DEXO shall
guaranty the performance of the sublicensee. In the event that either DEXO
or
ULURU assigns this Agreement in accordance with this Section 13.3, 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 13.3 shall be null and void,
without any force or effect.
| 13.4. |
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.
| 13.5. |
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.
| 13.6. |
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.
| 13.7. |
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.
| 13.8. |
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.
|
DEXO
BIOPHARM LTD
|
|
|
By:
|
/s/
▇▇▇▇▇ ▇▇▇▇▇▇
Name:
▇▇▇▇▇ ▇▇▇▇▇▇
Title:
Chief Development Officer
|
|
ULURU,
INC.
|
|
|
By:
|
/s/
▇▇▇▇▇ ▇. ▇▇▇▇
Name:
▇▇▇▇▇ ▇. ▇▇▇▇
Title:
President & CEO
|
EXHIBIT
A
Product
Erodible
oral mucoadhesive disc (OraDisc B) containing 15mg of benzocaine packaged in
blister packs of 8 and/or 16 (2x8) benzocaine erodible discs in an outer carton
for the treatment of oral pain.
EXHIBIT
B
Quality
Agreement
Will
be
incorporated into a Manufacturing and Control Agreement to be agreed between
the
Parties.
EXHIBIT
C
Procedures
for Reporting Adverse Events
Promptly
following the Effective Date of this Agreement the Parties shall agree upon
the
appropriate procedures for dealing with adverse event reporting. Product
complaints and recalls consistent with the applicable regulatory requirements
in
the countries in which the Product are sold will be agreed between the
Parties.
DEXO
shall keep records of its distributors and sales of the Product undertaken
by it
to enable appropriate procedures to be implemented in the event that a voluntary
or mandatory recall of any Product is required.
EXHIBIT
D
Price
Through
its Contract Manufacturer ULURU will supply DEXO with bulk blister packs of
8
Benzocaine discs (OraDisc B) and/or 16 (2x8) packaged in an outer carton. If
DEXO requires a certain pack which is different from the above, this will be
identified at least six (6) months prior to launch. The supply price (ex works)
for these two packs will be:
| – |
blister
packs of 2x8 erodible oral benzocaine discs$1.50
|
| – |
blister
packs of 8 erodible oral benzocaine discs$0.76
|
Batch
sizes for the supply to DEXO will be agreed in the manufacturing
agreement.
EXHIBIT
E
License
Payments
In
consideration of the license and the rights granted, DEXO will make the
following license payments to ULURU in US Dollars:
|
On
signature of Supply & License Agreement $600,000 (non-refundable), the
amount of to be paid in BIOPROGRESS PLC. company stock that can be
immediately placed onto the open stock market*.
|
$600,000
|
|
One
(1) year after signing the Agreement or upon The first submission
of the
agreed registration dossier with any of the countries within the
TERRITORY, whichever is the later event, the amount of $600,000 to
be paid
in BIOPROGRESS PLC. company stock that can be immediately placed
Immediately onto the open stock market*
|
$600,000
|
|
Upon
Regulatory and price reimbursement approval, If applicable, whichever
event is the later of OraDisc™ B prorated for the following
markets:
|
$500,000
|
| – |
Germany
20% ($100,000)
|
| – |
France
20% ($100,000)
|
| – |
UK
20% ($100,000)
|
| – |
Italy
20% ($100,000)
|
| – |
Spain
20%($ 100,000)
|
|
Cumulative
net sales in the Territory equivalent to $US5 million for OraDisc™
B:
|
$250,000
|
|
|
Cumulative
net sales in the Territory equivalent to $US10 million for OraDisc™
B:
|
$250,000
|
|
|
Cumulative
net sales in the Territory equivalent to $US25 million for OraDisc™
B:
|
$500,000
|
*BioProgress
and DEXO shall guarantee that the net amount received by Uluru with respect
to
the sale of the shares shall be $600,000 U.S. Such amount shall not be reduced
by (a) any fluctuation in the share price prior to sale, (b) any brokerage
or
other commissions paid in connection with the sale or (c) any other
charge.
EXHIBIT
F
Minimum
Sales
DEXO
agrees to annually sell the following percentages of the Volume Sales Forecast
provided in the Territory (“Minimum Sales”) for the Product:
Year
1 25% of forecast
Year
2 30% of forecast
Year
3 35% of forecast
Year
4 40% of forecast
Year
5 50% of forecast
If
DEXO
fails to achieve the annual Minimum Sales in the Territory, DEXO will have
the
option to either pay ULURU the shortfall of gross margin or royalties for the
Product or to modify the license from exclusive to semi-exclusive in the
Territory, provided however, in the event that DEXO sells during the ensuing
90-day period, the difference between the amount actually sold and the minimum
sales requirement, then ULURU shall not be entitled to receive shortfall in
Product or modify the license to semi-exclusive. The amount sold to meet the
minimum sales requirement during such 90-day period, shall be attributed to
the
prior year, and not to the year during which such sales are made. For the
avoidance of doubt, if DEXO makes up the short fall for the annual Minimum
Sales, then ULURU will not have the right to modify the License and Supply
Agreement from exclusive to semi-exclusive.
*
Forecast will be for full calendar year. Launching in part of a calendar year
will result in an equivalent percentage reduction.
Unit
Sales forecast for Major European markets in blister packs of 8:
|
EU
|
Yr
1
|
Yr
2
|
Yr
3
|
Yr
4
|
Yr
5
|
|
EU
|
200,000
|
400,000
|
600,000
|
800,000
|
1,000,000
|