Exhibit
10.3
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FIDIA
FARMACEUTICI S.P.A.
AND
FIDIA
ADVANCED BIOPOLYMERS S.R.L.
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TOLLING
AGREEMENT
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THIS
AGREEMENT is
made on December 30, 2009 (the “ Commencement Date
”)
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FIDIA
FARMACEUTICI S.p.A. , a
company duly registered in Italy with its main office at via Ponte
della Fabbrica 3/A, 35031 Abano Terme, Italy (the "
Manufacturer "); and
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FIDIA
ADVANCED BIOPOLYMERS S.r.l. , an
Italian limited liability company with registered office in Via
Ponte della Fabbrica 3B, Abano Terme (PD), Italy (the "
Customer ").
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The
Manufacturer is in the business of manufacturing pharmaceutical and
medical device products, and the Manufacturer represents that it
has the necessary expertise, experience, authorizations, personnel
and facilities to manufacture such products;
The
Customer desires to have the Manufacturer manufacture certain
Products (as defined below) for the Customer, and the Manufacturer
desires to manufacture such Products for the Customer;
The
Parties are willing to carry out the foregoing pursuant to the
terms and conditions set forth in this Agreement.
THE
PARTIES AGREE as
follows:
“
Affiliate ” means, with respect to a person, any
company or entity which controls, is controlled by or is under
common control with such person, where control, for purposes of
this definition, means (i) the possession, directly or indirectly,
of the power to direct the management or policies of a person or to
veto any material decision relating to the management or policies
of a person or a majority of the composition of the board of
directors (or similar governing body), in each case, whether
through the ownership of voting securities, by contract or
otherwise, or (ii) the beneficial ownership, directly or
indirectly, of at least 50% of the voting securities of a
person;
“
Calendar Quarter ” means each of the respective
periods of three consecutive calendar months ending on 31 March, 30
June, 30 September and 31 December; provided that the first
Calendar Quarter of this Agreement shall begin on the Commencement
Date and end on 31 March 2010;
“
Calendar Year ” means the period from 1
January to 31 December of each year;
“
cGMP ” means the current good manufacturing practice
regulations promulgated by FDA pursuant to the FDC Act;
“
Certificate of Analysis ” means a certificate issued
by Manufacturer stating that a batch of Product and/or Intermediate
has been manufactured, packaged and supplied in accordance with the
Master Batch Record and stating the final release test
results;
“Certificate
of Compliance” means a
written document, signed by an authorized representative of
Manufacturer, certifying that a specific lot or batch of Product
and/or Intermediate was manufactured in accordance with the Master
Batch Record, cGMP, other applicable laws, and the requirements set
forth in this Agreement and the Quality Agreement;
“Confidential
Information ”
means information about a Party’s marketing plans, business
plans, business methodologies, strategies, technology, development
plans, customers, prospective customers, billing records, and
products or services, and other non-public information that is
disclosed or provided by a Party or its Affiliates to the other
Party or its Affiliates, regardless of whether any of the foregoing
is marked “confidential” or “proprietary”
or communicated to the other by the disclosing Party or its
Affiliates in oral, written, graphic, or electronic
form;
“
Disclosing Party ” shall have the meaning set forth in
clause 16.1 of this Agreement;
“
Existing Product Agreements ” means the agreements
between Manufacturer and Customer listed in Annex F
;
“
Existing Purchase Orders ” means the purchase orders
between Customer and Manufacturer that are attached hereto as
Annex G , which purchase orders were placed by FAB and
accepted by Manufacturer prior to the Commencement Date;
“
FAB Specific Know-How ” meansall know-how, technical
information, documents, manufacturing processes, specifications,
sourcing information, and quality control and testing procedures
that are reasonably necessary for the manufacture of Products
and/or Intermediates by a party that is generally experienced in
the field of medical device manufacturing;
“
Facility ” mean the Manufacturers' facility located at
Abano Terme, Italy;
“
FDA ” means the Food and Drug Administration of the
United States of America and/or any other governmental or
regulatory agencies as may regulate or control the sale of drugs in
the American territory;
“
FDC Act ” means the U.S. Federal Food, Drug and
Cosmetic Act (21 U.S.C. §301 et. seq.) as amended from time to
time, and all regulations promulgated pursuant thereto;
“FOB”
has
the meaning ascribed to it in INCOTERMS (2000 version);
“
Initial Term ” shall have the meaning set forth in
clause 3.1 of this Agreement;
“
Intermediate ” means a chemically modified derivative
of hyaluronic acid used to manufacture Products;
“
LCA Rules ” shall have the meaning set
forth in clause 22.1 of this Agreement;
“
Manufacturing Process ” shall mean the processes and
procedures used to manufacture the Product and/or Intermediates in
accordance with the Master Batch Record, including all protocols
and standard operating procedure documents referenced therein and
the other requirements set forth in this Agreement;
“
Master Batch Record ” shall mean the document
containing the formula (listing intermediate and raw materials),
procedures for the manufacturing (listing components and
containers), quality assurance of the Product and/or Intermediates
and in-process and finished product specifications for the Product
and/or Intermediates;
“
Product Fee ” shall mean the manufacturing fee to be
charged by Manufacturer for the Products to be provided to Customer
hereunder, which fee shall include the costs of materials,
manufacturing, standard quality control and quality assurance,
testing, documentation and packaging, which fee is set forth in
Annex E ;
“
Parties ” means, collectively, the Manufacturer and
the Customer, and “ Party ” means any of
them;
“
Product ” means any of the products listed in Annex
A ;
“
Purchase Agreement ” means the share purchase
agreement dated the date hereof agreed between Manufacturer and
Anika Therapeutics Inc. in respect of the purchase and sale of the
Customer;
“
Quality Agreement ” means the quality agreement
attached hereto as Annex D , as the same may be amended or
modified from time to time by mutual written agreement of the
Parties;
“
Receiving Party ” shall have the meaning set forth in
clause 16.1 of this Agreement;
“
Regulatory Authority ” means any applicable
supranational, federal, national, regional, state or local
regulatory agency, department, bureau, commission, council or other
government entity with authority over the development, manufacture,
use, marketing and/or sale of a pharmaceutical product or medical
device in any regulatory jurisdiction throughout the world,
including the FDA in the United States, the EMEA in the
Europe.
“
Renewal Term ” shall have the meaning set forth in
clause 3.1 of this Agreement;
“
Specifications ” means the specifications for each
Product and/or Intermediate set out in Annex B ;
“
Territory ” means all of the countries of the world;
and
“
Year ” or means each successive period of twelve (12)
months commencing on the Commencement Date.
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In this
Agreement, a reference to:
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a
document is a reference to that document as modified or replaced
from time to time;
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a
person includes a reference to a corporation, body corporate,
association, partnership or other legal entity;
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a
person includes a reference to that person’s legal personal
representatives, successors and permitted assigns;
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the
singular includes the plural and vice versa; and
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a
clause or Annex, unless the context otherwise requires, is a
reference to a clause of or Annex to this Agreement.
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The
headings in this Agreement do not affect its
interpretation.
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The
Manufacturer shall manufacture and supply Products and/or
Intermediates for the Customer pursuant to the provisions of this
Agreement.
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The
Parties agree and acknowledge that it is the Customer’s
intent to manufacture and supply its own requirements for certain
Products and/or Intermediates, by itself and/or through suitable
affiliated or third party manufacturers, as soon as commercially
practicable following the Commencement Date. The Parties therefore
agree that Customer shall not be under any obligation to purchase
(i) Products and/or Intermediates exclusively from the
Manufacturer, or (ii) any minimum quantities of Products and/or
Intermediates from the Manufacturer, except as expressly set forth
in clause 4.2.
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The
Manufacturer shall provide the Products exclusively to the
Customer, and shall not manufacture for or supply Product to any
person other than Customer, except with respect to
Manufacturer’s own brand-label products manufactured pursuant
to the Existing Product Agreements in the form provided to Anika
Therapeutics, Inc. prior to the Commencement Date as amended
pursuant to Purchase Agreement.
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The
Parties agree to comply with the requirements and provisions set
forth in the Quality Agreement attached hereto as Annex D
and made a part hereof. In the event of a conflict between the
terms of the Quality Agreement and the terms of this Agreement, the
terms of this Agreement shall prevail.
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This
Agreement has an initial term beginning on the Commencement Date
and ending on 31 December 2014 (the “ Initial Term
”), unless terminated earlier pursuant to clause 14. At the
end of the Initial Term, this Agreement shall expire unless
Customer provides Notice of its intent to renew this Agreement for
an additional two (2) year term (“ Renewal Term
”), giving to the Manufacturer not less than six (6) months
Notice of renewal prior the expiration of the Initial
Term. At the end of each Renewal Term, this Agreement
shall expire unless Customer provides Notice of its intent to renew
this Agreement for an additional two (2) year Renewal Term, given
to the Manufacturer not less than six (6) months Notice of renewal
prior the expiration of the then-current Renewal Term.
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For the
period up to 30 June 2010, the non-binding forecast attached as
Annex I will apply. Beginning with the twelve (12) month
period starting on 1 July 2010, and for each consecutive twelve
(12) month period thereafter, Customer shall provide Manufacturer
with a written twelve (12) month forecast of its estimated orders
for Product and/or Intermediates, if any (each a “
Forecast ”). Each Forecast shall be delivered to
Manufacturer at least sixty (60) days prior to the beginning of the
applicable twelve (12) month period. Each Forecast is a
non-binding estimate and shall not obligate Customer to purchase
the volume of Product and/or Intermediates set forth in it;
provided, however, that eighty percent (80%) of the aggregate
volume forecasted in such Forecast shall be binding upon Customer
and Customer shall deliver Orders to Manufacturer pursuant to
clauses 4.3 and 4.4 (each, an “ Order ”) during
such twelve (12) month period for quantities of Product and/or
Intermediates which, in the aggregate, amount to at least the
binding portion of such Forecast.
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For the
Forecast covering the period from 1 July 2010 to 30 June 2011,
although the aggregate quantities actually ordered during such
twelve (12) month period may exceed one hundred fifty percent
(150
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