FIDIA FARMACEUTICI S.P.A. AND FIDIA ADVANCED BIOPOLYMERS S.R.L. TOLLING AGREEMENT
Exhibit
10.3
THIS AGREEMENT is made on
December 30, 2009 (the “Commencement
Date”)
BETWEEN:
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(1)
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FIDIA FARMACEUTICI
S.p.A., a company duly registered in Italy with its main office at
via ▇▇▇▇▇ ▇▇▇▇▇ Fabbrica ▇/▇, ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇ (the "Manufacturer");
and
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(2)
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FIDIA ADVANCED BIOPOLYMERS
S.r.l., an
Italian limited liability company with registered office in ▇▇▇ ▇▇▇▇▇
▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇, ▇▇▇▇▇ ▇▇▇▇▇ (▇▇), ▇▇▇▇▇ (the "Customer").
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WHEREAS
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:
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1.
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INTERPRETATION
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1.1
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In
this Agreement:
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“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;
2
“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);
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“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;
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“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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1.2
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In
this Agreement, a reference to:
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1.2.1
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a
document is a reference to that document as modified or replaced from time
to time;
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1.2.2
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a
person includes a reference to a corporation, body corporate, association,
partnership or other legal entity;
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1.2.3
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a
person includes a reference to that person’s legal personal
representatives, successors and permitted
assigns;
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1.2.4
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the
singular includes the plural and vice versa;
and
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1.2.5
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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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1.3
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The
headings in this Agreement do not affect its
interpretation.
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2.
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PRODUCTS
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2.1
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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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2.2
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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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2.3
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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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2.4
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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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5
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3.
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TERM
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3.1
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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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4.
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FORECASTS AND
ORDERS
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4.1
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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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4.2
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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%) of the aggregate amounts set forth in the Forecast, the supply
obligations of Manufacturer shall not exceed one hundred twenty percent
(120%) of the aggregate amounts forecast for such twelve (12) month
period. The Manufacturer shall use its reasonable endeavours to supply any
Product and/or Intermediate that is in excess of one hundred twenty
percent (120%) but less than one hundred fifty percent (150%) of the
aggregate amount set forth in the Forecast, and if it is unable to do so,
the Manufacturer’s only obligation with respect to such excess portion
over one hundred twenty percent (120%) is to inform the Customer as soon
as reasonably practicable, but in any event within ten (10) days of
receipt of the applicable Order, of Manufacturer’s inability to supply,
and the Customer may at its option agree an alternative delivery date for
such excess.
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4.3
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For
each Forecast covering the period from 1 July 2011 to 30 June 2012,
and each subsequent consecutive twelve (12) month period
thereafter, although the
aggregate quantities actually ordered may exceed one hundred twenty
percent (120%) of the aggregate amounts set forth in such Forecast, the
supply obligations of Manufacturer shall not exceed one hundred twenty
percent (120%) of the aggregate amount forecast for such twelve (12) month
period. The Manufacturer shall use its reasonable endeavours to supply any
Product and/or Intermediate set forth in an Order that is in excess of one
hundred twenty percent (120%) of the amount set forth in the Forecast for
such month, but if it is unable to do so, the Manufacturer’s only
obligation with respect to such excess portion is to inform the Customer
as soon as reasonably practicable, but in any event within ten (10) days
of receipt of the applicable Order, of Manufacturer’s inability to supply,
and the Customer may at its option agree an alternative delivery date for
such excess.
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4.4
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Customer
shall order Product and/or Intermediate by submitting either written
purchase orders, in such form as the Parties shall agree from time to time
or the order placement function of Customer, and each electronic
submission of such an order shall constitute an Order placed by Customer
with Manufacturer. Each Order shall specify the quantities of Product
and/or Intermediates ordered, and the desired delivery date for such
Product and/or Intermediate in accordance with the terms of this
Agreement. Unless otherwise agreed by the Parties, Customer shall order
Product and/or Intermediate in lots of a defined number of units/lot
pursuant to each Order in not less than the minimum batch size or its
multiples, of each Product and/or Intermediate set out in Annex C. Except
as set forth in clause 4.8, or as otherwise agreed by the Parties, any
Order for less than the minimum batch size shall be deemed to be for the
minimum batch size.
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4.5
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Manufacturer
shall make each delivery of Product and/or Intermediate in the quantity
and on the delivery date specified for it on Customer’s Order to the Party
specified on such Order. Manufacturer shall address each
delivery with the delivery point set forth in the applicable
Order. Any Order for Product and/or Intermediate submitted by
Customer to Manufacturer shall reference this Agreement and shall be
governed exclusively by the terms contained herein. The Parties hereby
agree that the terms and conditions of this Agreement shall supersede any
term or condition in any Order, confirmation or other document furnished
by either Party to the other Party that is in any way in addition to or
inconsistent with these terms and
conditions.
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4.6
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Once
a firm Order for Products and/or
Intermediates has been received and accepted by the Manufacturer
from the Customer, it shall be irrevocable and may be modified only as
mutually agreed to by both Parties.
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4.7
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The
Customer shall order Products and/or Intermediates from the Manufacturer
on the basis of firm Orders to be placed at least ninety (90) days in
advance of required delivery dates, provided however that any such days
falling within the months of August or December shall not be counted when
calculating such ninety (90) day period.
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4.8
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To
support the Customer’s efforts to transfer production of certain products
to the Customer’s facility, if agreed to by the Parties, the Manufacturer
will supply Intermediates to the Customer in quantities less than the
minimum batch size at the prices listed in Annex E.
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4.9
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Subject
to clause 4.2 and 4.3, Manufacturer shall deliver 100% of the Product
and/or Intermediates set forth in an Order with a range of tolerance equal
to +/- 5% within five days following, or one day prior to, the date
specified on the applicable Order. Should the Manufacturer more
than once during rolling twelve (12) month period fail to provide any
quantity of the Product and/or Intermediates ordered with an Order placed
for forecasted quantity and not cure such default within ninety (90) days
after the date of such failure, then the Customer reserves the right to
take any or all of the following
actions:.
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a)
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arrange
for direct expedited routing of the Product and/or Intermediates (with the
entire cost of such expedited routing to be borne by Manufacturer);
or
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b)
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terminate
the Order upon Notice to Manufacturer and purchase substitute Product
and/or Intermediate from another supplier. Such Product and/or
Intermediate purchased from another supplier shall count towards the total
quantity with respect to the binding forecast requirements of clause
4.1.
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5.
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DELIVERY
TERM
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5.1
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Delivery
shall be FOB to the Customer’s facility in Abano Terme, Italy, or to the
nearest airport to the Customer’s facility in Abano Terme, Italy, unless
otherwise agreed by the Parties. All Product and/or
Intermediate shall be properly packed, marked and delivered by
Manufacturer in accordance with the Specifications and instructions
included in the Order in a format previously agreed upon by the
Parties.
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6.
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ACCEPTANCE AND
CLAIMS
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6.1
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The Manufacturer
will be responsible for providing the Products and/or Intermediates to the
Customer in accordance with the Specifications, in strict compliance with
cGMP and with any applicable regulations of any applicable
Regulatory Authorities, and
Manufacturer shall not provide any Products and/or
Intermediates that do not comply in all respects with the
Specifications, cGMP and the requirements of any applicable Regulatory
Authorities.
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6.2
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For
each delivery of Product and/or Intermediate, the Manufacturer shall
provide the Customer with a duly drafted and signed Certificate of
Analysis and Certificate of
Compliance.
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6.3
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Neither the
Specifications, nor the current manufacturing processes will be changed or
amended without the prior written consent of the Customer. Customer
may request changes to the Specifications
and/or the current manufacturing processes, and following any such
request, Customer and Manufacturer shall in discuss in good faith such
requested changes. Manufacturer shall, to the extent technologically
feasible, accommodate Customer's requested changes, provided that Customer
shall reimburse Manufacturer for any one-time, reasonable, documented,
out-of-pocket incremental costs associated exclusively with the
implementation of such changes which are agreed upon by Manufacturer and
Customer, provided that such costs and any related Product Fee change are
pre-agreed in advance by Customer and
Manufacturer.
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6.4
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Customer
shall have the right to amend the Specifications for labeling or packaging
for Product and/or Intermediate. In the event that Customer
provides Notice to Manufacturer with respect to any changes to the
Specifications for labeling or packaging, Manufacturer shall implement
such changes and Customer agrees to pay all reasonable, out-of-pocket
additional costs actually incurred with the implementing of such changes,
including costs associated with up to six months (determined by reference
to the Forecast then in effect for the Product and/or Intermediate at
issue) of labeling or inventory rendered obsolete by such change.
Notwithstanding the foregoing, if any changes are required to be made to
the Specifications for packaging or labeling as a result of changes
requested by Manufacturer, Manufacturer shall bear the expenses
thereof.
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7.
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ADDITIONAL
OBLIGATIONS
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7.1
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Upon
the arrival of each delivery of Products and/or
Intermediates at the Customer’s premises, the Customer may make a
preliminary visual inspection (label check, customary transport packaging
check, customary quantity check) as to determine any defects or missing
quantities as far as reasonably practical. The Customer may
also perform analytical testing of the Products and/or
Intermediates according to the Specifications. The Customer may
also perform analytical testing of the Products and/or
Intermediates according to the
Specifications.
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7.2
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If
a shipment
of Products and/or
Intermediates upon delivery does not contain those
Products and/or Intermediates
actually ordered by Customer pursuant to the applicable Order, or does
not comply with, or has not been manufactured in strict accordance
with the Specifications, cGMP and/or the other terms and conditions of
this Agreement, including those set forth in clause 6.1, the Products
and/or
Intermediates shall be deemed non-conforming. The warranties set
forth in clause 13.1, which are given solely at the delivery date, shall
not be invalidated by any inspection or acceptance by Customer, provided
that nothing herein shall expand the scope of the warranties set forth
herein.
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7.3
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Any
claim by the Customer for defects to the delivered Products and/or
Intermediates according to this Agreement shall be made by Notice
and with a preliminary description of the nature of the defect, and sent
to the Manufacturer no later than ten (10) business days after their
discovery by the Customer.
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7.4
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The
Customer shall not send back to the Manufacturer the Products and/or
Intermediates without the written consent of the Manufacturer. The
Manufacturer shall retain samples of the Products and/or
Intermediates supplied under this Agreement for at least two (2)
Calendar Years after the expiration
date.
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7.5
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If
the Customer notifies to the Manufacturer of a claim pursuant to this
clause, the Manufacturer shall analyse a sample of the same batch of
Products and/or
Intermediates taken from its in-house retained
quantity.
Should the
Manufacturer agree with the complaint, then as the sole remedy of the
Customer under this Agreement with regard to the non-conforming Product
and/or Intermediates:
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a)
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the
Customer shall not pay for the non-conforming Product and shall send the
same back to the Manufacturer; and
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b)
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the
Manufacturer shall promptly replace the non-conforming quantity of
delivered Product with an equal quantity of the Product and/or
Intermediates that meets the Specifications and is in compliance with
cGMP; and
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c)
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the
Manufacturer shall pay for all costs for transporting the non-conforming
Products and/or Intermediates to and from its Facility;
and
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d)
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the
non-conforming Products and/or Intermediates shall
count towards the binding forecast requirements of clause
4.1.
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7.6
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In
the event that the Manufacturer does not agree with the Customer’s
complaint the matter shall, at the request of either Party, be submitted
to an independent analytical laboratory acceptable to both Parties, which
will resolve the discrepancy in the analysis taking into consideration the
rejected Products and/or Intermediates and the counter-sample of the
rejected Products and/or
Intermediates, kept by the Manufacturer.
The
decision of said laboratory shall be final, not subject to appeal and
neither Party shall unreasonably withhold its approval of an independent
laboratory proposed by the other.
Should
the independent laboratory agree with the complaint,
then:
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a)
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clause
7.5 shall apply, and
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b)
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the
cost of the analytical testing and any other services performed by the
independent laboratory shall be borne by the Party whose opinion was not
supported by the independent
laboratory.
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7.7
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The
provisions of clause 7.5 shall not apply if the Parties agree or the
independent laboratory declares that (a) the Products and/or
Intermediates fully complied with the Specifications upon delivery
or (b) that the failure of such non–conforming quantity of the Products
and/or
Intermediates to meet the Specifications results from the
Customer’s negligent or defective transportation or handling of the
Products and/or
Intermediates, following the delivery by the
Manufacturer.
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7.8
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The
Manufacturer agrees that the Customer may send representatives to the
Manufacturer’s manufacturing Facility for audit inspection for the
supplied Product and/or Intermediate, and the Manufacturer will allow the
Customer’s representatives reasonable access to the necessary
manufacturing records for the supplied Product and/or Intermediate so as
to ensure that the Manufacturer is in compliance with cGMP provided that
the Customer shall give the Manufacturer at least one (1) month prior
Notice and provide for any such audit the names of the representatives and
the audit agenda before audit inspection. Any audit inspection of
Manufacturer by Customer shall be scheduled during normal working hours,
at the sole expense of Customer, shall be subject to the obligations of
confidentiality set forth in clause 16 of this Agreement, and shall not
last more than three days, provided that if the inspection discloses
problems that will require more than three days to review, such two-day
period shall be extended as reasonably necessary to complete a customary
and reasonable inspection under the circumstances. The Manufacturer
furthermore undertakes to accept, and to procure that all approved
sub-contractors accept audit inspections from all applicable governmental
and Regulatory Authorities and to handle and respond to any inspection
with respect to the manufacture of the Products and/or
Intermediates
and to promptly advise and inform the Customer of the results of such
audit inspections which can negatively impact the supply of the Products
and/or Intermediates.
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7.9
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It
is the Customer’s intent to transfer the manufacturing of certain Products
and Intermediates to its facilities during the term of this
Agreement. Customer may thereafter undertake such manufacturing
itself or under contract with a third party. In order to
facilitate an orderly transition with respect to the transfer of
manufacturing responsibility to Customer, Manufacturer shall fully
cooperate in the transfer of (i) certain manufacturing equipment owned by
Customer and listed in Annex
H
(“Customer
Owned Equipment”) and (ii)
FAB Specific Know-How to Customer. Manufacturer shall also make
available to Customer, in writing, electronically or other accessible
tangible form to the extent reasonably convertible, all FAB Specific
Know-How then in Manufacturer’s possession or at its free disposal and
shall provide reasonable assistance to Customer in the establishment of a
manufacturing facility. Manufacturer shall also reasonably
assist Customer, at Customer’s request and expense, in connection with all
regulatory activities required in order to effect the transfer of
manufacturing in accordance with this clause 7.9. Costs of
relocating and installing the Customer Owned
Equipment shall be the responsibility of Customer. All
reasonable costs and expenses incurred by Manufacturer that have been
pre-approved by Customer in advance for travel and time required by
Manufacturer’s personnel to assist in the transfer and the establishment
of a manufacturing facility shall be borne by Customer. In
order to have been successfully completed, Customer, with the assistance
of Manufacturer, shall have produced three successive lots of Products
meeting the then-current Specifications. The Manufacturer will support the
Customer’s requests for planning and reasonable inventory builds to
maintain continuity of supply during the transfer. Any inventory build
will be delivered to Customer and invoiced when the relevant equipment is
removed from operation at the
Facility.
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7.10
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Product
Recalls. In the event Customer, after notification to and
consultation with Manufacturer, makes a recall because the Products and/or
Intermediates were not manufactured and supplied in conformance
with Manufacturer’s warranties and covenants herein, Manufacturer shall
bear all reasonable and actual out of pocket costs and expenses in
connection with such recall to the extent caused by such breach. However,
if it is established that the Products and/or Intermediates became
nonconforming as a result of actions or omissions on the part of Customer,
then Customer shall bear all reasonable and actual out of pocket costs and
expenses in connection with such
recall.
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7.11
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Products
and Intermediates will have the following minimum shelf life when
delivered to the Customer:
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a)
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Products
and/or Intermediates with 24 month expiration dating will have a
minimum of 20 months remaining when
delivered;
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b)
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Products
and/or Intermediates with 36 month expiration dating will have a
minimum of 24 months remaining when delivered;
and
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c)
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Products
and/or Intermediates with 48 month expiration dating will have a minimum
of 36 months remaining when
delivered.
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7.12
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Manufacturer
shall keep complete and accurate records pertaining to the manufacture,
including quality control, of the Product and
Intermediates. Records shall be kept for at least two (2)
years after expiration date of the
material.
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7.13
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The
Manufacturer will support the Customer in the investigation of complaints
in accordance with the attached Quality
Agreement.
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7.14
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Manufacturer
shall have the right to use Customer Owned Equipment for the manufacture
of Customer’s products. Manufacturer
shall:
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a)
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be
responsible for any damage (normal wear and tear excepted) to the Customer
Owned Equipment caused by
Manufacturer;
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b)
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not
subject the Customer Owned Equipment to any liens or
encumbrances;
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c)
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not
modify the Customer Owned Equipment without the consent of the Customer;
and
|
|
d)
|
service,
maintain and repair the Customer Owned Equipment as may be necessary to
keep the equipment is good working
order.
|
|
8.
|
IMPORT AND EXPORT
LICENSES
|
|
8.1
|
The
Customer is responsible for obtaining at its cost such import licenses and
other consents in relation to the Products
and/or Intermediates as are
from time to time required including, without limitation, those required
by an applicable Regulatory Authority and, if reasonably requested by the
Manufacturer, will make copies of those licenses and consents available to
the Manufacturer prior to the relevant
delivery.
|
12
|
8.2
|
The
Manufacturer is responsible for obtaining such export licenses in relation
to the manufacture and supply of Products
and/or Intermediates to the
Customer as are from time to time required including, without limitation,
those required by an applicable Regulatory Authority, and if reasonably
requested by Customer, will make copies of those licenses and consents
available to the Customer prior to the relevant
delivery.
|
|
9.
|
RISK
|
|
9.1
|
The
risk of loss in connection with Products and/or
Intermediates shall pass to the Customer upon delivery in
accordance with FOB.
|
|
10.
|
TITLE
|
|
10.1
|
Title
to the Products and/or
Intermediates will pass upon delivery to the Customer in accordance
with FOB.
|
|
11.
|
PRODUCT
FEES
|
|
11.1
|
The
Customer shall purchase the Products and/or
Intermediates from the Manufacturer at the applicable Product Fee
set forth in Annex E and in
accordance with the terms of this Agreement. The Product Fee shall include
all costs associated with the manufacturing and delivery of the Products
and/or
Intermediates in accordance with this Agreement, and the costs of
the approved sub-contractors.
|
|
11.2
|
During
the first Year, the Manufacturer shall use commercially reasonable and
diligent efforts to identify ways in which to reduce the costs associated
with the manufacture and supply of Products and Intermediates hereunder,
and the Parties shall meet in July 2010 to discuss Manufacturer’s
efforts taken pursuant to this clause 11.2. Prior to
such meeting, Manufacturer shall provide Customer with a written summary
of its efforts taken pursuant to this clause 11.2. Once the
Parties agree to any such cost reduction measures to be undertaken by
Manufacturer, the Product Fees shall be adjusted accordingly and Annex E will be
amended accordingly.
|
|
12.
|
PAYMENT
|
|
12.1
|
The
Manufacturer shall, on delivery, invoice the Customer for all Products
and/or
Intermediates delivered and shall include in such invoice such
information as may reasonably be requested by the Customer, including, but
not limited to, details of quantities of each Product and/or
Intermediate so ordered. The date of such invoice shall not precede
the date of delivery.
|
|
12.2
|
The
Manufacturer shall invoice the Customer upon delivery and Customer shall,
unless otherwise agreed to by the Parties, pay each invoice received
during the first Year of this Agreement in Euro in full within 270 days of
the invoice date in cleared funds to the bank nominated by the
Manufacturer. The Customer shall, unless otherwise agreed to by the
Parties, pay each invoice received during each subsequent Year of this
Agreement in Euro in full within 60 days of the invoice date in cleared
funds to the bank nominated by the
Manufacturer.
|
13
|
12.3
|
The
Customer shall pay interest on all overdue amounts at the rate of 0.5% per
month from the due date for payment until receipt by the Manufacturer of
the full amount.
|
|
13.
|
WARRANTY AND
LIABILITY
|
|
13.1
|
The
Manufacturer warrants to the Customer that the Products and/or
Intermediates supplied to the Customer pursuant to this
Agreement, on delivery:
|
|
13.1.1
|
will
be manufactured in manufacturing facility duly authorized under Italian
regulations in strict accordance with ISO 13485, all applicable cGMP’s and
with all applicable laws, rules and regulations, including any applicable
regulations of any applicable Regulatory
Authorities;
|
|
13.1.2
|
will
comply in all respects with the Specifications;
and
|
|
13.1.3
|
will
be free from defects in manufacturing and
materials.
|
|
13.2
|
Manufacturer
further represents, warrants and covenants that as of the date hereof and
during the term of this Agreement (a) Manufacturer is and will be in full
compliance with all applicable laws and regulations with respect to the
performance of its obligations hereunder, including the manufacturing and
storage of Products and/or Intermediates and the maintenance of
its facilities used in the manufacture of Products and/or Intermediates
hereunder; and (b) Manufacturer holds and will hold all licenses, permits
and similar governmental authorizations, including as required by any
Regulatory Authority, necessary or required for Manufacturer to perform
its obligations hereunder, including the manufacture and storage of
Products and/or Intermediates.
|
|
13.3
|
Each
Party (the “Indemnifying
Party”) agrees that it shall protect, indemnify and save the other
Party (the “Indemnified
Party”) harmless from and against all liabilities, actions,
damages, claims, demands, judgments, losses, expenses, suits or actions
and reasonable attorneys fees, and shall defend such Party in any suit for
injuries to or death of any person or persons arising out of the
Indemnifying Party’s breach of its representations, warranties or
covenants hereunder. The Indemnified Party shall give the Indemnifying
Party prompt Notice of any claim, action or suit asserted against it and
the Indemnifying Party shall have the sole right to defend and settle such
action or suit.
|
|
13.4
|
Except for willful
misconduct, gross negligence or fraud or as provided in clause 13.3 with
respect to the death or bodily injury of any person, neither Party shall
be liable to the other Party, whether for negligence, breach of
contract, misrepresentation or otherwise, for indirect
or consequential loss, loss of business, loss of profit, goodwill,
business opportunity or anticipated saving suffered by such other
Party.
|
14
|
13.5
|
The
invalidity, illegality or unenforceability of the whole or part of clause
13.4 does not affect or impair the continuation in force of the remainder
of this clause.
|
|
14.
|
TERMINATION
|
|
14.1
|
Except
as otherwise stated herein, this Agreement may be terminated by either
Party in the case of a material or persistent breach by the other Party or
its Affiliates of any one or more of the terms of this Agreement which is
not remedied within sixty (60) days after receipt of Notice of the breach
by the terminating Party, or if such breach cannot reasonably be cured
with such sixty (60) day period, the breaching Party has failed to
commence such cure within such period and diligently prosecute such cure
to completion within a reasonable time
thereafter.
|
|
14.2
|
On
termination, upon written request of the Manufacturer, the Customer shall
purchase from the Manufacturer all Products
and/or Intermediates already ordered by the Manufacturer as at that
date subject to the terms of this Agreement. Unless this Agreement is
terminated by Customer for Manufacturer’s breach or otherwise agreed by
the Parties, the Manufacturer shall complete all work in process on Orders
received prior to termination.
|
|
14.3
|
The
following clauses shall survive any expiration or termination of this
Agreement: 1, 7.10, 7.12, 7.13, 13, 14, 16, 17, 18, 19, 21 and
22.
|
|
15.
|
FORCE
MAJEURE. No Party
hereunder shall be liable to the other for its failure to perform
hereunder caused by contingencies beyond its control which may include
acts of God, fire, flood, wars, acts of terrorism, sabotage, strike,
government actions and any other similar occurrence beyond the
non-performing Party’s control; provided that financial inability in and
of itself shall not be deemed an inability to perform any obligation
hereunder. Any Party asserting its inability to perform any obligation
hereunder for any such contingency shall promptly notify the other Party
of the existence of any such contingency, and shall use its reasonably
diligent efforts to re-commence its performance of such obligation as soon
as commercially practicable.
|
|
16.
|
CONFIDENTIALITY
|
|
16.1
|
Each
Party (the “Receiving
Party”) receiving Confidential Information of the other Party (the
“Disclosing
Party”) (or that has received any such Confidential Information
from the other Party prior to the Effective Date) shall (i) maintain in
confidence such Confidential Information using not less than the efforts
such Receiving Party uses to maintain in confidence its own proprietary
industrial information of similar kind and value (but in no event less
than reasonable efforts), (ii) not disclose such Confidential Information
to any Third Party without the prior written consent of the Disclosing
Party, except for disclosures expressly permitted below, and (iii) not use
such Confidential Information for any purpose except those permitted by
this Agreement.
|
15
|
16.2
|
The
obligations in clause 16.1 shall not apply with respect to any portion of
the Confidential Information that the Receiving Party can show by
competent written proof:
|
|
16.2.1
|
is
publicly disclosed by the Disclosing Party, either before or after it is
disclosed to the Receiving Party hereunder;
or
|
|
16.2.2
|
was
known to the Receiving Party or any of its Affiliates, without any
obligation to keep it confidential or any restriction on its use, prior to
disclosure by the Disclosing Party;
or
|
|
16.2.3
|
is
subsequently disclosed to the Receiving Party or any of its Affiliates by
a Third Party lawfully in possession thereof and without any obligation to
keep it confidential or any restriction on its
use.
|
|
16.3
|
The
Receiving Party may disclose Confidential Information belonging to the
Disclosing Party only to the extent such disclosure is reasonably
necessary in the following
instances:
|
|
16.3.1
|
regulatory
filings;
|
|
16.3.2
|
prosecuting
or defending litigation;
|
|
16.3.3
|
complying
with applicable laws (including, without limitation, the rules and
regulations of any national securities exchange or the Securities and
Exchange Commission) and with judicial process, if in the reasonable
opinion of the Receiving Party’s counsel, such disclosure is necessary for
such compliance; and
|
|
16.3.4
|
disclosure,
solely on a “need to know basis”, to Affiliates, potential and future
collaborators (including permitted sublicensees), permitted acquirers or
assignees under clause 19.4 research collaborators, subcontractors,
investment bankers, investors, lenders, and each of the Parties’
respective directors, employees, contractors and agents, each of whom
prior to disclosure must be bound by written obligations of
confidentiality and non-use no less restrictive than the obligations set
forth in this clause 16; provided, however, that the Receiving Party shall
remain responsible for any failure by any Person who receives Confidential
Information pursuant to this clause 16.3 to treat such Confidential
Information as required under this clause
16.
|
If and
whenever any Confidential Information is disclosed in accordance with this
clause 16.3, such disclosure shall not cause any such information to cease to be
Confidential Information except to the extent that such disclosure results in a
public disclosure of such information (otherwise than by breach of this
Agreement). Other than with respect to a disclosure made pursuant to
clause 16.3.3, where reasonably possible the Receiving Party shall notify the
Disclosing Party of the Receiving Party’s intent to make such disclosure
pursuant to this clause 16.3 sufficiently prior to making such disclosure so as
to allow the Disclosing Party adequate time to take whatever action it may deem
appropriate to protect the confidentiality of the information.
16
|
16.4
|
The
Parties acknowledge that the terms of this Agreement shall be treated as
Confidential Information of both
Parties.
|
|
17.
|
COSTS
|
|
17.1
|
Except
where this Agreement provides otherwise, each Party shall pay its own
costs relating to the negotiation, preparation, execution and
implementation by it of this Agreement and of each document referred to in
it.
|
|
18.
|
ENTIRE
AGREEMENT
|
|
18.1
|
This
Agreement constitutes the entire agreement, and supersedes any previous
agreements, between the Parties relating to the subject matter of this
Agreement.
|
|
18.2
|
Each
Party acknowledges that it has not relied on or been induced to enter this
Agreement by a representation other than those expressly set out in this
Agreement.
|
|
18.3
|
A
Party is not liable to the other Party for a representation that is not
set out in this Agreement.
|
|
19.
|
GENERAL
|
|
19.1
|
A
variation of this Agreement is valid only if it is in writing and signed
on behalf of each Party.
|
|
19.2
|
A
failure to exercise or delay in exercising a right or remedy provided by
this Agreement does not constitute a waiver of the right or remedy or a
waiver of other rights or remedies under this Agreement. No single or
partial exercise of a right or remedy provided by this Agreement prevents
further exercise of the right or remedy or the exercise of another right
or remedy under this Agreement.
|
|
19.3
|
The
rights and obligations provided for in this Agreement may not be assigned,
delegated or transferred by either Party without the prior written consent
of the other Party (which consent shall not be unreasonably withheld,
conditioned or delayed), except that this Agreement may be assigned or
transferred in full to an Affiliate or to a successor in ownership of all
or substantially all of the business or assets of the assigning Party
(whether by merger, sale or otherwise) without the prior consent of the
other Party provided that such assigning Party provides Notice to the
other Party of such assignment and the assignee of this Agreement agrees
in writing to be bound as such Party hereunder, and provided further that (x)
this Agreement must be assigned to a successor in ownership of all
or substantially all of the business or assets of the assigning Party and
(y) in connection with an assignment to an Affiliate, the assigning
Party shall be
jointly liable with such Affiliate for breach, no further assignment shall
be allowed without consent and if such Affiliate ceases at any time to be
an Affiliate of the assigning Party, the Agreement shall be automatically
assigned back to the assigning Party.
Notwithstanding anything to the contrary in this Agreement, any
assignment, delegation or transfer, or any such assignment or transfer, in
violation of this clause 20.1 shall be void. This Agreement
shall inure to the benefit of, and be binding upon successors and
permitted assigns of each of the Parties. Manufacturer shall
not sub-contract any of its obligations hereunder, provided that nothing
herein shall prevent the Manufacturer from using Manufacturers and
sub-contractors (i) that have been pre-approved by Customer, or (ii) that
are specifically identified in the
Specifications.
|
17
|
20.
|
NOTICES
|
|
20.1
|
A
notice under or in connection with this Agreement (a “Notice”):
|
|
|
20.1.1
|
shall
be in writing; and
|
|
|
20.1.2
|
shall
be sent by (i) reputable international mail courier service with
confirmation of delivery, (ii) registered return letter, or (iii) fax, in
each case to the Party due to receive the Notice at its address set out in
this Agreement or to another address or fax number specified by that Party
by not less than 7 days’ written notice to the other Party received before
the Notice was dispatched.
|
|
21.
|
GOVERNING
LAW
|
|
21.1
|
This
Agreement and all matters arising from or connected with it are governed
by Italian law.
|
|
22.
|
ARBITRATION
|
|
22.1
|
The
Parties shall use their best endeavours to settle any dispute arising out
or in connection with the performance of any obligation undertaken
hereunder. To this effect, the Parties shall consult and negotiate with
each other in good faith in order to reach a just and equitable solution
satisfactory to both Parties. If the Parties do not reach such amicable
solution within sixty (60) days from the Notice sent by one Party
expressly stating that such Notice triggers the starting of the
negotiation period hereunder, then the dispute shall be finally settled by
arbitration in London in accordance with the then applicable London Court
of Arbitration Rules (“LCA Rules”).
|
|
22.2
|
There
shall be one arbitrator that is mutually agreeable to the Parties,
appointed in accordance with the LCA Rules. If the appointment of the
arbitrator is not effected within the terms provided for by the LCA Rules,
the arbitrator shall be appointed by the LCA Court. The arbitrator must be
fluent in Italian and English.
|
|
22.3
|
Unless
otherwise agreed in writing by the Parties, the arbitration will take
place in London, England, in the English language. It is understood,
however, that no translations shall be made of documents in the Italian or
in the English language.
|
|
22.4
|
The
cost of the arbitration, including attorneys fees, will be assessed by the
arbitrators who will be required to make such cost allocation with respect
to any award issued, provided, however, that the arbitrator shall not have
the ability to assess damages against either Party which are expressly
disclaimed in this Agreement.
|
18
|
22.5
|
The
arbitrator shall decide the dispute according to Italian substantive and
procedural law (“arbitrato rituale secondo
diritto”) and the arbitral award may appealed for reasons of law
according to article 829 paragraph 3 of the Italian Civil Procedure
Code.
|
[Remainder of Page Intentionally Left
Blank]
19
IN WITNESS
WHEREOF, the Parties hereto have executed this Agreement in multiple originals,
all of which shall for all purposes be deemed an original.
|
Signed
by:
|
||
|
For
and on behalf of
|
||
|
Fidia
Farmaceutici S.p.A.
|
||
|
/s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
|
Signature
|
|
|
Signed
by:
|
||
|
For
and on behalf of
|
||
|
Fidia
Advanced Biopolymers S.r.l.
|
||
|
/s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
|
Signature
|
20