LICENSE AND SUPPLY
AGREEMENT
dated as of __ November 17,
2008__ between
MEDA AB
and
ULURU Inc.
THIS LICENSE
AND SUPPLY AGREEMENT (this “Agreement”) is made and
entered into as of this __ November 17, 2008___ (the
“Effective Date”), between MEDA AB, a corporation
organized and existing under the laws of Sweden, and having an
address at Pipers väg 2, Box 906 , 170 09 Solna, Sweden
(“MEDA”) and ULURU Inc., a corporation organized and
existing under the laws of Delaware and having an address at 4452
Beltway Drive, Addison, Texas, 75001, USA
(“ULURU”).
RECITALS
WHEREAS, ULURU
is the owner of the rights to OraDisc™ A (amlexanox) and
Aphthasol Paste (5% amlexanox paste) for the prevention and
treatment of aphthous ulcers;
WHEREAS, On
December 23, 1998, MEDA and ULURU entered into 5% Amlexanox Paste
License Agreement, whereas MEDA had been granted the rights to
register, market, promote, sell and distribute Aphthasol Paste (5%
amlexanox paste) in several European countries (hereinafter
referred to as the “Old Agreement”);
WHEREAS, the
Parties intend to extent the territory of the Old Agreement and to
add the promotion and distribution rights for OraDisc™ A
(amlexanox);
WHEREAS, ULURU
desires to grant to MEDA, and MEDA desires to obtain from ULURU, an
exclusive license to register, promote, market, sell and distribute
the Products (as defined below) and an exclusive right to purchase
from ULURU and distribute the Products, all under the terms and
subject to the conditions set forth herein;
WHEREAS, MEDA
and ULURU want to terminate the Old Agreement effective as of the
Effective Date and enter into this Agreement;
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:
As used in this
Agreement, the following capitalized terms have the meanings
indicated below:
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“Affiliate” means, in the case
of either Party, any corporation, joint venture, or other business
entity which directly or indirectly controls, is controlled by, or
is under common control with that Party. The term
“control,” as used in this definition, means having the
power to direct, or cause the direction of, the management and
policies of an entity, whether through ownership of voting
securities, by contract or otherwise. Notwithstanding the
foregoing, for purposes of this Agreement, the term
“Affiliate” does not include entities in which a Party
or its Affiliates owns a majority of the ordinary voting power to
elect a majority of the board of directors but is restricted from
electing such majority by contract or otherwise, until such time as
such restrictions are no longer in effect.
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“Batch” means the volume of
finished, packaged Products obtained from a validated Manufacturing
run.
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“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.
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“Confidential Information” means
either MEDA Confidential Information, ULURU Confidential
Information, or both, as the context requires.
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“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.
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“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.
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“Effective Date” has the meaning set
forth in the Preamble.
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“EMEA” means (a) the European
Medicines Evaluation Agency, London, United Kingdom, or (b) any
local regulatory agency or governmental entity which fulfills a
role similar to the EMEA, or any successor entities
thereto.
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“Facility” and / or
“Facilities” means any and all facilities regarding the
Manufacture of the Products and the supply of the Materials, which
are listed in Exhibit B or any subsequent or replacement
facilities approved by MEDA.
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“Field” means the prevention and
treatment of aphthous ulcers.
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“Force
Majeure Event” has the meaning set forth in Article
11.
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“Good
Manufacturing Practice” or “GMP” means (a) the
then current standards for the manufacture of pharmaceuticals, (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 C .
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“Indemnified Party” has the meaning
set forth in Section 8.1.3.
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“Indemnifying Party” has the meaning
set forth in Section 8.1.3.
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“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
Products.
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“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 Products, its
Manufacture and/or use.
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“Launch” means the date on which the
respective Product is sold by MEDA for the first time to a Third
Party for commercial distribution in the Territory.
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“Major
Countries” shall mean (i) initially France, Germany, Italy,
and United Kingdom and (ii) potentially later Spain, provided that
ULURU had re-acquired the rights back from Esteve S.A., Spain, in
accordance with Section 3.1.5.
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“Manufacture,”
“Manufactured” or “Manufacturing” means all
activities involved in the production of the Products, including,
without limitation, the preparation, formulation, finishing,
testing, packaging, storage and labeling of the Products and the
handling, storage and disposal of any residues or wastes generated
thereby.
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“Materials” means all
materials, including, without limitation, all raw materials,
ingredients, packaging supplies and labels, required for the
Manufacture of Products.
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“MEDA” has the meaning set forth in
the Preamble.
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“MEDA
Confidential Information” means all information,
specifications, know-how and data pertaining to MEDA’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 EMEA or
any other Regulatory Authority, clinical study data, analytical
data, operating procedures and all ordering and sales
information.
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“MEDA
Trademarks” means any trademarks, trade name, trade dress,
slogan, logo, or similar item selected by MEDA for use in
connection with the Products, including but not limited to the
trademark Apthasol®, as listed in Exhibit J .
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“Methods
of Analysis” means the methods of analysis for the Products
which are mutually agreed upon in writing between the Parties and,
on a date to be mutually agreed upon by the Parties, attached as an
exhibit to this Agreement.
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“Net
Sales” means, with respect to the Product, the gross invoiced
sales amount of the Products sold by MEDA 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 MEDA in return; (b) refunds, rebates,
governmental 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 Products 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 MEDA and/or its Affiliates (excluding
national, state or local taxes based on income). Such amounts shall
be determined from the books and records of MEDA and its Affiliates
maintained in accordance with generally accepted accounting
principles, consistently applied. Sales of the Products by and
between a Party and its Affiliates for further distribution to a
Third Party are not sales to Third Parties and shall be excluded
from Net Sales calculations for all purposes.
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“Old
Agreement” shall have the meaning as set fort in the Preamble
of this Agreement
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“Party” or “Parties”
means either MEDA, ULURU or both, as the context
requires.
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“Patents” shall mean (a) the patents
listed in Exhibit D 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
Products.
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“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.
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“Products” shall mean the
Products listed in Exhibit A
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“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 Products to Third Parties that
would have been subject to recall if it had been sold or
shipped.
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“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 Products in a country
within the Territory.
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“Regulatory Authority” means any
domestic or foreign, federal, national, regional, state, county,
city, municipal, local or other administrative, legislative
regulatory or other governmental authority, agency, department,
bureau, commission, or council involved in the granting of
Regulatory Approval for the Products in the Territory.
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“Rolling
Forecast” has the meaning set forth in Section
3.4.
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“Seizure” means any action by the
EMEA or any other Regulatory Authority to detain or destroy the
Products or prevent the release of the Products.
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“Specifications” means the
specifications for the Products as set forth in the Exhibit
E or in the Quality Agreement.
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“Supply
Failure” shall have the meaning as set forth in Section
3.7.2.
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“Term” means, with respect to each
country in the Territory, the period commencing on the Effective
Date and ending upon the expiration of the last-to-expire patent
within the Patents in such country, except as and if sooner
terminated in accordance with Article 9.
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Countries of
the Old Agreement, which are: Denmark, Sweden, Norway, Finland,
Estonia, Lithuania, Latvia and
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(bb) New
countries, which are
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European Union
countries: Austria, Belgium, Bulgaria, Cyprus, Czech Republic,
France, Germany, Hungary, Ireland, Italy, Luxembourg, Malta,
Netherlands, Poland, Romania, Slovakia, Slovenia, United Kingdom,
and
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(ii) Non-European
Union Countries: Switzerland, Turkey and
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Russia and CIS
Markets: Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan,
Moldova, Russia, Tajikstan, Ukraine, Uzbekistan and
Kyrgyzstan
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and (b)
potentially later Spain, Greece and Portugal provided that ULURU
had re-acquired the rights back from Esteve S.A., Spain, in
accordance with Section 3.1.5, and any other countries the Parties
may agree on to add to this Agreement.
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“Third
Party” means any Person other than MEDA, ULURU and their
respective Affiliates.
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“Trademarks” means all ULURU
trademarks OraDisc™.
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“ULURU” has the meaning set forth in
the Preamble.
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“ULURU
Confidential Information” means all information,
specifications (including, without limitation, the Specifications),
know-how and data pertaining to the Products and ULURU’s
business or its Manufacturing operations disclosed to MEDA 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 Products, and any correspondence
with the FDA, EMEA or any other Regulatory Authority, clinical
study data, analytical data, or operating procedures.
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Construction
of Certain Terms and Phrases.
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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.
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TERMINATION OF
THE OLD AGREEMENT
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MEDA and ULURU
hereby terminate by mutual agreement the Old Agreement effective as
of the Effective Date.
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The Parties
hereby agree that neither Party shall have any rights and/or
obligations towards the respective other Party resulting from the
Old Agreement and/ or its termination.
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Grant of
License / Expansion of the Territory.
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Subject to the
terms and conditions of this Agreement, ULURU hereby grants to MEDA
(a) the exclusive right and sub licensable license in the Field
under ULURU’s Intellectual Property Rights to market, offer
for sale, sell, distribute and import products, including the
Products, in the Territory, (b) the exclusive right and sub
licensable license in the Field under ULURU’s Intellectual
Property Rights to use the Products in the Territory, provided that
such right and license is limited to such use as is necessary for
MEDA to market, offer for sale, sell, distribute and import and,
subject to the terms and conditions set forth in Section 3.8,
Manufacture the Products in the Territory, and (c) a exclusive
right and sub licensable license to use the Products 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
Products. Except as expressly granted herein, ULURU retains all
rights in the Intellectual Property Rights and the
Products.
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Except as
specifically provided to the contrary in Section 3.1.1, the license
granted in Section 3.1.1 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 3.8, to grant any license relating
to ULURU’s methods of formulating, fabricating and
Manufacturing the Products; (c) to grant MEDA any rights in or to
the use of the Intellectual Property Rights by implication or
otherwise. MEDA shall mark or have marked all containers or
packages of the Products in accordance with the patent marking laws
of the jurisdiction in which such units of Products are to be used
or distributed.
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Upon expiration
of the Term in any country due to (i)the expiration of the
last-to-expire patent within the Patents in such country or (ii)
due to a termination of the Agreement for cause by MEDA in
accordance with the provisions of Section 3.7.3, 9.4 and/or 9.5,
MEDA shall have a non-exclusive, transferable, timely unrestricted
license to those licenses set forth in Section 3.1.1, provided that
MEDA will pay to ULURU the royalties in accordance with Articles
3.1.3 a)- d) of this Agreement:
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In
consideration for the license granted by ULURU to MEDA as set out
above in Article 3.1.3, MEDA shall pay to ULURU a royalty of 5 %
(five percent) on Net Sales of the Products.
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MEDA will pay
to ULURU the royalties quarterly (meaning any calendar quarter
ending on 31st March, 30th June, 30th September or 31st December)
within 30 (thirty) days after the end of the relevant calendar
quarter. The currency of the royalty payment shall be EURO. Each
royalty payment shall be accompanied by a statement in a form as
set forth in Article 3.9.3 d) of this Agreement.
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The rights and
obligations of the Parties as to ULURU´s right to inspect and
examine MEDA´s books - as laid down in Article 6.5.2 and
6.5.3 of this Agreement shall - apply accordingly.
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It is
understood that MEDA´s obligation to pay royalties to ULURU
shall cease on a product by product basis upon the expiration of
the last-to-expire patent within the Patents in such
country.
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MEDA is free to
decide whether (i) to use the Trademarks in the countries of the
Territory or (ii) to register, at MEDA’s expense, and to use
alternative MEDA Trademarks for the promotion, distribution and
sale of the Products.
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In case MEDA
decides to use the Trademarks and not to register and use the MEDA
Trademarks the following shall apply:
On request of
MEDA, ULURU agrees to register – at ULURU´s own costs
– in the respective countries of the Territory the Trademark
Ora Disc.
Subject to the
terms and conditions of this Agreement, ULURU hereby grants to MEDA
an exclusive, non-transferable (except in accordance with a
permitted assignment of this Agreement under Section 14.3) license
in the Field to use the Trademarks solely in connection with the
Manufacture, promotion, marketing, sale and
distribution of the Products under this Agreement,
within the Territory. Based on the information provided by ULURU,
MEDA acknowledges that ULURU is the exclusive owner of the
Trademarks and all associated goodwill and registrations. MEDA
agrees that it has no rights to use the Trademarks except for the
right to use the Trademarks as provided for in this Agreement and
all uses of the Trademark by MEDA, and the associated goodwill,
shall inure solely to the benefit of ULURU.
MEDA further
agrees that upon the termination or expiration of this Agreement,
all right to use the Trademarks provided to MEDA hereby shall
revert fully to ULURU.
Except as
consistently with this Agreement with respect to the Products, MEDA
shall not (a) use the Trademark as part of, or in conjunction with,
any other names or Trademarks without ULURU’s prior written
approval; (b) use the Trademarks or any confusingly similar marks,
terms or designs, except as expressly authorized in this Section
3.1.4; (c) attempt to register any such Trademarks, terms or
designs; (d) take any actions inconsistent with ULURU’s
ownership of the Trademark and any associated registrations, or
attack the validity of the Trademark, ULURU’s ownership
thereof, or any of the terms of this Section 3.1.4; (e) use the
Trademark in any manner that would indicate MEDA is using such
Trademark other than as a licensee of ULURU; nor (f) assist any
Affiliate or Third Party to do any of the same.
ULURU agrees
that MEDA is the exclusive owner of the MEDA Trademarks and all
associated goodwill and registrations. ULURU shall have no rights
to use the MEDA Trademarks except for the right to use the
Trademark as provided for in this Agreement.
ULURU further
agrees that upon the termination or expiration of this Agreement,
all right to use the MEDA Trademarks hereby shall revert fully to
MEDA.
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ULURU will
provide commercially reasonable efforts to re-acquire from Esteve
SA, Spain the exclusive rights for the Manufacture, marketing,
promotion, sale and distribution of the Products in Spain, Greece
and Portugal. ULURU will promptly inform MEDA once the rights had
been re-acquired from Esteve SA. In such a case, the parties agree
to extend the Territory and to add Spain, Greece and Portugal to
this Agreement. The Parties will stipulate the extension of the
Territory in an amendment to this Agreement. To avoid any
misunderstandings, the license payments applicable for Spain
mentioned in Exhibit I are subject to ULURU´s
successful re-acquisition of the Product rights for Spain, Greece
and Portugal.
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Registration
of the Products / Regulatory Approvals
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At MEDA’s
sole expense, MEDA agrees to make and maintain all Regulatory
Approvals for the Products from the Regulatory Authorities in the
countries of the Territory.
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ULURU will
provide MEDA with all documentation which is necessary for the
registration process and the obtaining of the Regulatory Approvals,
including but not limited to a certificate of pharmaceutical
product (“CPP”) and the US dossiers of the Products.
ULURU will use commercially reasonable efforts to assist MEDA in
the obtainment of the Regulatory Approvals.
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If MEDA decides
not to register OraDisc™ A (amlexanox) in one of the Major
Countries, the rights to the respective Product (and only to this
Product) in the respective country granted by ULURU according to
Section 3.1 shall revert to ULURU.
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To avoid any
misunderstandings, for any other countries other than the Major
Countries, MEDA is free to decide whether to make and /or maintain
the Regulatory Approvals or not.
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Any Regulatory
Approval shall become, if legally permitted in the respective
country of the Territory, the sole property of MEDA. MEDA shall be
(if legally permitted in the respective country of the Territory)
the holder of the Regulatory Approvals.
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Upon
termination and/or expiration of this Agreement for whatever
reason, ULURU shall transfer the Regulatory Approvals (if due to
legal regulations in a country of the Territory ULURU must be
holder of the Regulatory Approval) to MEDA or any Third Party
designated by MEDA.
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Subject to
Section 3.4, ULURU shall Manufacture and deliver the Products to
MEDA in such quantities and at such times as ordered by MEDA in
accordance with this Agreement. During the Term, ULURU shall
maintain the resources necessary to Manufacture the Products and
shall provide, at its own expense, all Materials and labor
necessary to do so.
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ULURU may not
transfer its Manufacturing and supply obligations under this
Agreement to any Third Party without MEDA’s prior written
consent. In any case, ULURU is solely responsible towards MEDA for
the fulfillment of all of ULURU’s Manufacturing and supply
obligations under this Agreement.
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MEDA herewith
approves the Third Party manufacturer of ULURU mentioned in
Exhibit B .
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If requested by
MEDA, ULURU shall be responsible for (a), at MEDA’s cost and
expense, supplying to MEDA, prior to the commencement of
Manufacturing of the Product, a full scale validation Batch and the
data reasonably requested by MEDA (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 Products and the validation
protocols and schedules for processes, equipment, cleaning and
packaging) and MEDA shall reimburse ULURU for ULURU’s actual,
reasonable, out-of-pocket costs for the supply of such Batch and
data, (b) at MEDA ’s cost and expense, scale-up, validation
and stability of the Products for commercial production of the
Products, including, without limitation, bulk production of the
benzocaine gel, production of the mucoadhesive disc and development
and validation of a mutually acceptable package configuration, (c)
cooperating with MEDA with respect to the obtaining by MEDA of any
Regulatory Approvals required to be obtained by MEDA with respect
to the marketing, sale, offering to sell, importing and/or
distribution of the Product, and (d) providing to MEDA complete
Batch records for all validation Batches and, on an annual basis,
providing one representative full Batch record.
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At least four
(4) months prior to Launch, MEDA shall submit to ULURU a forecast
of the quantity of the Products that MEDA anticipates ordering from
ULURU prior to MEDA’s anticipated Launch of Products. MEDA
shall submit to ULURU a forecast of the quantity of the Products
that MEDA anticipates ordering from ULURU during the twelve (12)
month period (broken down by month) following Launch and MEDA shall
update such forecast on a rolling twelve (12) months basis every
month thereafter (each, a “Rolling Forecast”). MEDA
shall place purchase orders for at least the quantity of the
Products 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. Except as set forth in this
Section 3.4, MEDA shall not be required to order any fixed minimum
quantity of the Products or any quantity of the Products,
notwithstanding any forecast or prior course of dealing.
MEDA shall
place its firm orders for the Product with ULURU by submitting a
purchase order, at least ninety (90) days prior to the delivery
date requested therein, which sets forth (a) the quantity of the
Product ordered for delivery; and (b) the delivery date for that
order. Any such purchase order which is in accordance with the
terms and conditions of this Agreement shall be deemed to be
accepted by ULURU.
For all other
purchase orders placed by MEDA, unless ULURU notifies MEDA 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 MEDA that it
is unable to fill a purchase order that is not in accordance with
the terms and conditions of this Agreement, it shall indicate the
portion of such purchase order ULURU cannot supply by the requested
delivery date and specify alternate delivery dates; provided that
in the event that MEDA 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. MEDA may cancel or modify
any firm purchase order (in whole or in part) at any time prior to
the delivery for any quantity of Products 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, MEDA 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 MEDA 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
operations. All Products shall be delivered F.O.B. the
Facility and in accordance with MEDA’s
instructions. Title, possession and risk of loss shall
pass to MEDA upon delivery of Products to MEDA’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.
ULURU shall
schedule Manufacturing operations so that all of the Products
delivered has the latest expiry date possible, and in no event
shall any Products be delivered to MEDA 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
MEDA whose expiry date does not conform to the requirements set
forth in this Section 3.6, ULURU shall promptly, at its sole
expense, replace the non-conforming Product.
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It is of
essence to this Agreement that ULURU delivers the Products at the
date stated in the purchase order. In the event that ULURU fails to
deliver the Products on or before the delivery date specified in
the applicable purchase order, ULURU or its Affiliates shall notify
MEDA of such delay and the Parties shall consult in good faith to
determine the period of such inability to supply such
Product.
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If (i) MEDA
reasonably determines that such or any other inability to so supply
a Product will continue for more than 90 (ninety) days, or (ii) if
ULURU fails to supply any of MEDA´s purchase orders for
Product and fails to cure such failure within 60 (sixty) days after
the requested delivery date therefore (each of (i) and (ii) shall
be referred to as a “Supply Failure”), then MEDA may,
at its option either (x) agree to have ULURU supply the undelivered
Product at a future date agreed upon the Parties or (ii) have up to
100 (hundred) % supplied by a secondary supplier of such Product as
provided for in Article 3.8 below.
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In any event
ULURU shall use commercial reasonable efforts to resume the
Manufacture as promptly as possible. In the event of a Force
Majeure, the Parties will work in good faith to try and
re-establish supply of Products as soon as possible.
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If ULURU
continues to be delayed with the delivery of the Products for a
period of six (6) consecutive months, MEDA has, without any time
restriction, the right to terminate this Agreement.
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MEDA shall have
the right to establish and maintain secondary supplier (s) for all
Products (in finished form). MEDA and UULURU shall jointly select
and agree on a secondary supplier(s), provided however that if the
Parties can not agree on a secondary supplier, then MEDA shall be
entitled to appoint a secondary supplier at its sole
discretion.
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ULURU shall
cooperate with MEDA in the transfer of copies of the ULURU
Confidential Information, technology and know- how necessary to
Manufacture the Products to MEDA and/or its designated secondary
supplier (s), (b) deliver to MEDA copies of such drawings,
specifications, and other information in ULURU’s possession
as may be necessary to Manufacture the Products or cause the
Products to be Manufactured and (c) grant to MEDA 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 MEDA’s distribution of the Product in the Territory,
the Products; 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 10 and MEDA’s designated secondary supplier shall be
required to enter into a confidentiality agreement with ULURU
containing substantially the same terms as Article 10; and further
provided that all items provided under clauses (a) and (b) above
will be subject to the license granted pursuant to clause
(c).
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Subject to
Section 3.8.1 following the establishment of any secondary supplier
hereunder, MEDA may obtain from such secondary supplier such
portion of its supplier requirements with the respect to the
Product as is necessary to maintain such secondary supplier’s
regulatory qualification, but in no event more than 10% of
MEDA´s total requirements for the Products. Product procured
until this section 3.8.3 will be subject to a royalty of 5% of Net
Sales in the Territory.
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Notwithstanding
the provisions of Section 3.8.3 above, but subject to Section 3.8.1
above, MEDA shall have the right to obtain from such secondary
supplier(s) up to 100% of its supply requirements with respect to
any Products in the event (a) of expiration of the Term of this
Agreement or (b) MEDA terminates the Agreement with respect to such
Product pursuant to Article 3.7.4, 9.4 and 9.5 of this Agreement,
(c) in the event of a Supply Failure occurs with respect to such
Product.
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Marketing,
Promotion and Distribution .
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ULURU agrees
that MEDA shall have only the obligation to market, promote, sell
and distribute OraDisc™ A (amlexanox) in the countries of the
Major Countries, Belgium, the Netherlands and in Turkey, provided
that, nothing shall require MEDA to continue to market or sell the
Products in any of these countries during a period of time that
MEDA determines, in its sole judgment, that such Product is
reasonably likely to be Subject to adverse regulatory or legal
action, or infringe any intellectual property right of any Third
Party in such country.
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MEDA agrees to
Launch in addition OraDisc™ A (amlexanox) in the countries of
the Major Countries, Belgium, the Netherlands and in Turkey, within
6 (six) months after Regulatory Approval has been granted, provided
that ULURU has delivered MEDA with Products as laid down in the
respective purchase order.
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If
OraDisc™ A (amlexanox) will not be launched in the countries
of the Major Countries, Belgium, the Netherlands and in Turkey
within 6 (six) months after Regulatory Approval has been granted,
then ULURU will give MEDA the right to remedy for another
4 (four) months. If Launch of the Products is not effected in
this additional 4 (four) months period, then the rights to the
respective Product (and only to this Product) in the respective
country granted by ULURU according to Section 3.1 shall revert to
ULURU.
To avoid any
misunderstandings, for any other countries than the countries of
the Major Countries, Belgium, the Netherlands and Turkey, MEDA is
free to decide whether to launch, market, promote, sell and
distribute the OraDisc™ A (amlexanox) or not. With regard to
Aphthasol Paste (5% amlexanox paste) MEDA is to decide whether to
launch, market, promote, sell and distribute it or not
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Subject to
Section 3.9.1 – 3.9.2 above, MEDA agrees
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a) to market,
sell and distribute the Products in accordance with the terms of
this Agreement.
b) that all
promotion and selling activities are to be undertaken by MEDA at
its own cost and expense and without right of reimbursement
therefore.
c) to provide
to all customers in the Territory customer support relating to the
Products.
d) to remit on
April 15 th
, July 15 th ,
October 15 th and January 15 th of each calendar quarter to ULURU a true,
detailed and accurate report, in units and in value, of all sales
of Products and samples in the Territory in the preceding calendar
quarter.
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ULURU agrees to
support MEDA, as far as possible for and available within ULURU, in
the promotion, marketing, sale and/or distribution of the Products
in the Territory. Any costs related to such support will be borne
by MEDA. If possible (i.e. where marketed by ULURU’s partners
e.g. USA), ULURU will provide MEDA with examples of promotional
material from its sub-licensees and distributors.
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As soon as
practicable after the Effective Date, the Parties will discuss in
good faith the terms and conditions (including but not limited the
quantities and prices) regarding ULURU´s obligation to supply
MEDA with samples of the Products.
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Clinical
trials / Clinical Data
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If (i) the
Parties mutually agree to conduct further clinical trials and/or
(ii) if a clinical trial is required for regulatory approval
purposes, ULURU will contribute fifty (50%) per cent towards the
cost of the respective clinical trial.
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MEDA shall have
the right to use and reference all clinical and other technical
data generated by ULURU and ULURU’S licensees relating to the
Products. ULURU and its licensees shall have the right to use and
reference all clinical and other technical data generated by MEDA
relating to Products.
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Additional
Responsibilities
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MEDA shall be
responsible, at MEDA’s cost and expense, for any consumer
product testing and commercialization of the Products, including,
without limitation, all sales and marketing activities related to
the Products and the design of all Product packaging and related
artwork, and the design of all labeling.
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MEDA shall
retain, at its own expense a selling and service organization with
adequate experience, ability and training for purposes of marketing
and selling the Products in the Territory.
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COMPLIANCE,
QUALITY AND ENVIRONMENTAL
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ULURU shall
conduct all Manufacturing hereunder in a safe and prudent manner,
in compliance with all applicable laws and regulations (including,
without limitation, those dealing with occupational safety and
health, those dealing with public safety and health, those dealing
with protecting the environment, and those dealing with disposal of
wastes), and in compliance with all applicable provisions of this
Agreement. ULURU shall obtain and maintain all necessary Regulatory
Approvals with respect to the Manufacture and supply of the
Products to MEDA. To the extent necessary for the Regulatory
Approval of the Products, ULURU shall permit the inspection of its
premises and the Facilities by Regulatory Authorities and shall
supply all documentation and information requested by MEDA or such
Regulatory Authority to obtain or maintain Regulatory Approval of
the Products.
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Manufacturing Quality; Storage.
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All Products
shall be Manufactured by ULURU at the Facilities 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 therefore. ULURU shall take all necessary
steps to prevent contamination and cross contamination of
Products.
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The Products
shall be unadulterated and free from contamination, dilutents and
foreign matter in any amount and 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
Products 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 MEDA 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 MEDA’s
designated representative by the date reasonably specified by such
representative.
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Within sixty
(60) days of the Effective Date, each of the Parties shall execute
and deliver the Quality Agreement substantially in the form of
Exhibit C 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 Products 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 MEDA.
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MEDA may test
the Product samples in accordance with the applicable Methods of
Analysis. If the analysis of any Product performed by or for MEDA
differs from ULURU´s analysis of the same Batch, MEDA shall
advise ULURU and ULURU and MEDA 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
MEDA and ULURU. The costs of the independent laboratory referred to
above shall be borne by (a) MEDA 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 MEDA 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
MEDA. MEDA shall not be obligated to pay for any of the Product
(and if MEDA has paid for such Product ULURU shall promptly
reimburse MEDA 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 MEDA must destroy (and certify destruction of) such
non-conforming Product.
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Samples and
Record Retention.
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ULURU shall
retain records and retention samples of each Batch of the Products
as required by the applicable laws, but for at least thirty-eight
(38) months after the expiration date of that Batch and shall make
the same available to MEDA upon request. Retention samples shall
only be destroyed after the required holding period; provided that
in the event that MEDA provides written notice to ULURU during such
retention period (at least thirty-eight (38) month) that it desires
ULURU to retain such retention samples for a longer period of time,
then ULURU shall comply with such request until notified by MEDA
that the sample need no longer be retained. During and after the
Term of this Agreement ULURU shall reasonably assist MEDA with
respect to any complaint, issue or investigation relating to the
Products.
ULURU shall
give access to representatives of MEDA, at all reasonable times
during regular business hours, to the Facilities and any other
facility in which Products are Manufactured, tested, packaged
and/or stored, and to all Manufacturing records with respect to the
Products, for the purpose of inspection. MEDA 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 10) records and Regulatory Approvals solely to evaluate
work practices and compliance with all applicable EMEA 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 4.5 does not impose upon MEDA
responsibility or liability for the operation of the Facility. Such
inspection shall be conducted after prior written notice to ULURU,
will be conducted in a manner that is not disruptive to
ULURU’s operations, and shall not be more frequent than is
reasonable.
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Adverse Drug
Events / Pharmacovigilance Agreement.
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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.
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Within sixty
(60) days of the Effective Date, each of the Parties shall execute
and deliver the Pharmacovigilance Agreement substantially in the
form of Exhibit G and as mutually agreed to by the parties.
Each Party agrees to perform its respective obligations under the
Pharmacovigilance Agreement in accordance with such
agreement.
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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
Products. If either Party determines that it is necessary to Recall
any Product, it shall immediately notify the other Party and, prior
to commencing any Recall, the Parties shall consult with one
another to determine whether or not a Recall is necessary. If it is
mutually agreed that a Recall is necessary (or if MEDA determines,
in its sole discretion, that a Recall is necessary), then the
Parties shall meet and determine the manner in which the Recall is
to be carried out and review any instructions or suggestions of the
applicable Regulatory Authorities. MEDA and ULURU shall effect the
Recall in the manner agreed upon between the Parties in as
expeditious a manner as possible and in such a way as to cause the
least disruption to the sales of any Product and to preserve the
goodwill and reputation associated with the Product. In any such
situation, MEDA shall have the right to make all final decisions
regarding such Recall.
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In the event
that a Recall results from any cause or event arising from
ULURU’s breach of Sections 4.1, 4.2, 4.4, 4.6. 4.8 or the
representations set forth in Sections 7.2.1, 7.2.4 or 7.2.5 and/or
the defective Manufacture, storage or handling of the Products by
ULURU (excluding defects relating to packaging or labeling supplied
by or prepared at and in accordance with the direction of MEDA),
ULURU shall be responsible for all expenses of the Recall incurred
by MEDA and ULURU shall promptly replace such Product at no
additional cost to MEDA 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 Products by MEDA or its
Affiliates, distributors or contractors (including but not limited
to defective Manufacture, storage, handling or dis
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