Massachusetts
|
000-21326
|
04-3145961
|
(State
or other jurisdiction of
|
Commission
file number
|
(I.R.S.
Employer
|
incorporation
or organization)
|
Identification
No.)
|
2.1*
|
Sales
and Purchase Agreement, dated December 30, 2009, between Anika
Therapeutics, Inc. and Fidia Farmaceutici
S.p.A.
|
10.1
|
Registration
Rights Agreement, dated December 30, 2009, between Anika Therapeutics,
Inc. and Fidia Farmaceutici S.p.A .
|
10.2
|
Lease
Agreement, dated as of December 30, 2009, between Fidia Farmaceutici
S.p.A. and Fidia Advanced Biopolymers
S.r.l.
|
10.3
|
Tolling
Agreement, dated as of December 30, 2009, between Fidia Farmaceutici
S.p.A. and Fidia Advanced Biopolymers
S.r.l.
|
10.4
|
Consent
and First Amendment, dated as of December 30, 2009, to the Credit
Agreement, dated as of January 31, 2008, among Anika Therapeutics, Inc.,
Anika Securities, Inc., and the lenders from time to time party thereto
and Bank of America, N.A., as administrative
agent.
|
99.1
|
Press
Release of Anika Therapeutics, Inc., dated December 31,
2009.
|
Anika Therapeutics, Inc. | |||
Dated: January
6, 2010
|
By:
|
/s/ Kevin W. Quinlan | |
Kevin W. Quinlan | |||
Chief Financial Officer | |||
2.1*
|
Sales
and Purchase Agreement, dated December 30, 2009, between Anika
Therapeutics, Inc. and Fidia Farmaceutici S.P.A
.
|
10.1
|
Registration
Rights Agreement, dated December 30, 2009, between Anika Therapeutics,
Inc. and Fidia Farmaceutici S.P.A.
|
10.2
|
Lease
Agreement, dated as of December 30, 2009, between Fidia Farmaceutici
S.p.A. and Fidia Advanced Biopolymers
S.r.l.
|
10.3
|
Tolling
Agreement, dated as of December 30, 2009, between Fidia Farmaceutici
S.p.A. and Fidia Advanced Biopolymers
S.r.l.
|
10.4
|
Consent
and First Amendment, dated as of December 30, 2009, to the Credit
Agreement, dated as of January 31, 2008, among Anika Therapeutics, Inc.,
Anika Securities, Inc., and the lenders from time to time party thereto
and Bank of America, N.A., as administrative
agent.
|
99.1
|
Press
Release of Anika Therapeutics, Inc., dated December 31,
2009.
|
ARTICLE
I
Whereas - Interpretation - Certain
Definitions
|
|
1.01
|
Whereas.
|
1.02
|
Interpretation.
|
1.03
|
Certain
Definitions.
|
ARTICLE
II
The Transaction
|
|
2.01
|
The
Sale and Purchase of the Quota.
|
2.02
|
Closing
Date.
|
2.03
|
Closing
Obligations.
|
2.04
|
Board
of Directors Resignations and Quotaholders Meeting.
|
2.05
|
Receivables
of the Company.
|
ARTICLE
III
The Purchase Price
|
|
3.01
|
The
Purchase Price.
|
3.02
|
Payment
of the Purchase Price.
|
3.03
|
Dividends.
|
3.04
|
Seller’s
Undertakings.
|
ARTICLE
IV
Purchase Price
Adjustment
|
|
4.01
|
Estimated
Closing Balance Sheet - Estimated Net Working Capital.
|
4.02
|
Preparation
of the Final Closing Balance Sheet.
|
4.03
|
Working
Capital Adjustment.
|
4.04
|
Cash
Availability.
|
ARTICLE
V
Representations and Warranties of the
Buyer
|
|
5.01
|
Representations
and Warranties of the Buyer.
|
5.02
|
Certain
Definitions.
|
ARTICLE
VI
Representations and Warranties of the
Seller
|
|
6.01
|
Representations
and Warranties of the Seller.
|
ARTICLE
VII
Survival of Representations and
Warranties
|
|
7.01
|
Survival
of Representations and Warranties of the Seller.
|
7.02
|
Survival
of Representations and Warranties of the
Bayer.
|
Exhibit
A
|
Powers
of the Seller.
|
Exhibit
B
|
Powers
of the Buyer.
|
Exhibit
1.03(I)
|
Amendments
to Existing Product Agreements.
|
Exhibit
1.03(II)
|
Final
drafts of the Commercial Agreements.
|
Exhibit
1.03(III)
|
Company’s
Receivables.
|
Exhibit
1.03(IV)
|
Executed
copy of the Escrow Agreement.
|
Exhibit
1.03(V)
|
Financial
statements for the years ended on December 31, 2007 and December 31,
2008.
|
Exhibit
1.03(VI)
|
Interim
Financial Statements.
|
Exhibit
1.03(VII)
|
Registration
Rights Agreement.
|
Exhibit
1.03(VIII)
|
Seller’s
Receivables.
|
Exhibit
2.03(a)(ii)
|
Executed
copies of (i) product registration transfer agreement and (ii)
trademark transfer agreements.
|
Exhibit
2.03(a)(v)
|
Deed
of Transfer.
|
Exhibit
2.04(b)
|
New
Board of Directors.
|
Exhibit
3.02
|
Bank
account details.
|
Exhibit
4.01
|
Estimated
Closing Balance Sheet and Estimated Net Working
Capital.
|
Exhibit
4.02
|
Table
related to (i) the Closing Balance Sheet and (ii) the Closing Net Working
Capital.
|
Exhibit
9.05
|
Assumed
Obligations.
|
Exhibit
9.15
|
Insurances.
|
Schedule
5.01.3
|
No
Third Party Consent.
|
Schedule
5.01.4
|
No
Breach.
|
Schedule
5.01.9
|
Litigation.
|
Schedule
5.01.14
|
Permits.
|
Schedule
5.01.16
|
No
Material Adverse Change.
|
Schedule
5.01.17
|
Brokers.
|
Schedule
5.01.21
|
Compliance
with Law – Violations.
|
Schedule
6.01.3
|
No
breach.
|
Schedule
6.01.6
|
Subsidiaries.
|
Schedule
6.01.13
|
Guarantees.
|
Schedule
6.01.14
|
Litigation.
|
Schedule
6.01.15(a)
|
Employee
List.
|
Schedule
6.01.15(c)
|
Supply
of workmanship agreements.
|
Schedule
6.01.15(d)
|
Collective
Bargaining Agreement.
|
Schedule
6.01.16(a)
|
IP
List: (i) Patents and Marks; (ii) Licenses In; (iii) Licenses
Out.
|
Schedule
6.01.16(b)
|
IP
Exceptions.
|
Schedule
6.01.17
|
Insurance
policies.
|
Schedule
6.01.22
|
Bank
account and power of attorney.
|
Schedule
6.01.23
|
Contracts.
|
Schedule
6.01.27
|
Costumers.
|
Schedule
6.01.35
|
Restrictive
legends concerning the Shares.
|
“Accountants”:
|
shall
have the meaning ascribed to such term in Section 4.02(d)
below;
|
“Accounting
Principles”:
|
shall
mean the generally accepted accounting principles established by the
“
Consiglio Nazionale dei
Dottori Commercialisti e Consiglio Nazionale dei Ragionieri
”, as
further amended and integrated by the “
Organismo Italiano di
Contabilità
”, or in their absence, the international accounting
standards established by the International Accounting Standards
Board;
|
“Affiliate”:
|
shall
mean with respect to any person, an individual, corporation, partnership,
firm, association, unincorporated organization or other entity directly or
indirectly Controlling, Controlled by or under common Control with such
person;
|
“Agreement”:
|
shall
mean this stock purchase agreement and the Schedules and the Exhibits
attached to the same;
|
“Amendments
to the Existing
|
|
Product
Agreements”
:
|
shall
mean the amendments to the Existing Product Agreements to be executed
within the Closing Date and attached herewith as
Exhibit
1.03(I)
;
|
“Cash Purchase
Price”:
|
shall
have the meaning ascribed to such term in Section
3.01(a);
|
“Closing”:
|
shall
mean the completion of the sale to, and purchase by, the Buyer of the
Quota (as hereinafter defined) and the completion of the Transaction
contemplated by this Agreement which are to occur simultaneously as
described in Article II herein
below;
|
“Closing Balance
Sheet”:
|
shall
have the meaning ascribed to such term in Section 4.02(a)
below;
|
“Closing Cash
Payment”:
|
shall
mean US$17,055,000;
|
“Closing
Date”:
|
shall
have the meaning ascribed to such term in Section 2.02 herein
below;
|
“
Closing Net Working
Capital
”
:
|
shall
have the meaning ascribed to such term in Section 4.02(a)
below;
|
“Commercial
Agreements”:
|
means
the following agreements:
|
|
CA-1:
|
Raw
Material Manufacture and Supply Agreement of Hyaluronic
Acid;
|
|
CA-2:
|
Tolling
Agreement;
|
|
CA-3:
|
Services
Agreement;
|
|
CA-4:
|
Lease
Agreement;
|
|
CA-5:
|
Patent
License Agreement;
|
|
CA-6:
|
Trademark
License Agreement;
|
|
CA-7:
|
Marketing
Services Agreement;
|
|
CA-8:
|
Receivables
Management Agreement;
|
“Company’s
Receivables”:
|
shall
mean the accounts receivable of the Company as at the Closing Date in an
aggregate amount of Euro 2,000,000 as attached hereto as
Exhibit
1.03(III)
and to be reflected as such in the Closing Balance Sheet
and in the Closing Net Working
Capital;
|
“Control”:
|
shall
mean (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 or a Subsidiary,
by contract or otherwise, or (ii) the beneficial ownership, directly or
indirectly, of at least 50% of the voting securities of a
person;
|
“Cronofil &
Gellofil”:
|
shall
mean the Cronofil and Gellofil products of the Company in respect of which
the Seller holds the right to obtain an own label brand CE registration
under the CE registration for such products held by the
Company;
|
“Dispute
Notice”:
|
shall
have the meaning ascribed to such term in Section 4.02(c)
below;
|
“Employee”:
|
shall
mean any employee who is on the payroll of the Company as at the date
hereof;
|
“Encumbrance”:
|
shall
mean any mortgage, charge, pledge, lien, security interest or attachment
of any nature whatsoever, options, title retention, third party’s rights
or other security agreement or
arrangement;
|
“Environment”:
|
shall
mean any of the following media namely the air (including, without
limitation, the atmosphere as well as the air within buildings and other
natural or manmade structures whether above or below ground), water
(including, without limitation, surface and ground water and water within
pipes, drains or sewers) and land (including, without limitation, the
soil, sub-soil, sediment or other terrestrial material) and any organism
(including, without limitation, man) or ecological system supported by any
such media;
|
“Environmental
Authorizations”:
|
shall
mean
any
permit, licence, authorization, approval or consent, agreements or
undertakings required under or in relation to Environmental Laws relating
to either the carrying on of the business of the Company, or the use of,
or any activities or operations carried out at, any site owned, occupied
or used by the Company;
|
“Environmental
Authority”:
|
shall
mean any governmental or regulatory agency or body with administrative
powers or jurisdiction in relation to Environmental Laws (as defined
below);
|
“Environmental
Laws”:
|
shall
mean all or any applicable law which have been adopted or given and/or are
in force at or prior to the date hereof including (i) any supranational
and national, federal, state or regional legislation, regulations or
directives, regional, state, provincial or local statutes or other laws or
legislation (including any rules, regulations or orders made thereunder);
(ii)any legally enforceable ordinances, notices, directives, circulars
permits, licences, permissions or consents made or issued under (i) above;
(iii) any civil code or case law; (iv) any judgments, notices, orders,
directions, instructions or awards of any Environmental Authority under
(i) to (iii) above, which have as a purpose or effect the protection of,
and/or prevention of harm or damage to the Environment and/or the
provision of remedies or compensation for harm or damage to the
Environment or which relate to emissions, discharges, releases or escapes
of Hazardous Materials (as defined below) into the Environment or to the
presence, production, processing, distribution, management, use, control,
treatment, storage, burial, disposal, transport or handling of Hazardous
Materials (as defined below) but excluding matters relating to health and
safety or to town and country
planning;
|
“Environmental
Matters”:
|
shall
mean, in relation to the business or acts or omissions of the Company or
to the real property rights or leases, all matters related to pollution or
protection of the Environment including, without limitation, emissions,
discharges and releases of any substances into the Environment or the
manufacture, processing, treatment, storage, presence, disposal, transport
or handling of any materials or substances which, whether alone or in
combination, are capable of causing material harm to the
Environment;
|
“Escrow
Agent”:
|
shall
mean American Stock Transfer and Trust
Company;
|
“Escrow
Agreement”:
|
shall
mean the executed agreement among the Seller, the Buyer and the Escrow
Agent attached hereto as
Exhibit
1.03(IV)
;
|
“Escrow
Shares”:
|
shall
mean initially no. 800,000 of the Shares to be decreased to 500,000 of the
Shares starting January 1, 2011 pursuant to the terms of the Escrow
Agreement;
|
“Estimated
Closing
|
|
Balance
Sheet”
:
|
shall
have the meaning ascribed to such term in Section 4.01
below;
|
“Estimated
Net
|
|
Working
Capital”:
|
shall
have the meaning ascribed to such term in Section 4.01
below;
|
“Existing Product
Agreements”:
|
shall
mean the Own Brand Label Products Agreement, the Italian Distributed
Products Agreement, the IAL-System ACP Agreement and the Woundcare
Agreement to be amended within the Closing Date pursuant to the Amendments
to the Existing Product Agreements;
|
“
Final Closing Balance
Sheet
”
:
|
shall
have the meaning ascribed to such term in Section 4.02(b)
below;
|
“Final Net Working
Capital”:
|
shall
have the meaning ascribed to such term in Section 4.02(b)
below;
|
“Financial
Statements”:
|
shall
mean the duly audited balance sheets, the profit and loss accounts, the
statements of stockholders’ equity, the statements of cash flows, the
explanatory notes and yearly board of directors reports of the Company for
the years ended on December 31, 2007 and December 31,
2008, attached to this Agreement as
Exhibit 1.03(V)
as well as the Interim Financial Statements, prepared according to the
Accounting Principles on a basis consistent with the audited Financial
Statements;
|
“Former
Sites”:
|
shall
mean
any
real estate property or leases which are currently not anymore owned,
occupied or used by the Company, but which were formerly so owned,
occupied or
used by Company;
|
|
“Hazardous
Materials”:
|
shall
mean
all
natural or artificial substances or materials whether in a solid,
semi-solid, liquid, gaseous or vaporous form – including energy
(including, but not limited to, sound, vibration, heat and ionising and
non-ionising radiation) - which alone or in combination with other
substances are capable of causing harm to man or the environment or damage
to property, including but not limited to (i) any petroleum or petroleum
products, flammable, explosive or radioactive material, ozone depleting
substances, asbestos or polychlorinated biphenyls (PCBs) and (ii) any
substance, material or waste, which may be defined as, or is included in
the definition of, or deemed by any Environmental Law or any Environmental
Authority or agency to be, “hazardous”, “toxic”, a “contaminant”, “waste”,
a “pollutant”, a “hazardous substance”, “hazardous waste”, “restricted
hazardous waste”, “hazardous material”, “extremely hazardous waste”, a
“toxic substance”, a “toxic pollutant” or any other words with similar
meaning;
|
“IAL System
ACP”:
|
shall
mean the IAL System ACP product of the Company in respect of which the
Seller holds an own brand label CE registration under the CE registration
for such product held by the
Company;
|
“IAL-System ACP
Agreement”:
|
shall
mean the agreement dated January 10, 2005 between the Seller and the
Company in respect of IAL-System ACP pursuant to which the Company sold
the rights related to the IAL-System ACP product CE registration and
undertook not to register such product for certain uses, subject to
certain limited exceptions, and to sell the product only as a vehicle for
cells or cell component under trademarks owned by the
Company;
|
“Indemnified
Party”:
|
shall
have the meaning ascribed to such term in Section 8.04(b) herein
below;
|
“Indemnifying
Party”:
|
shall
have the meaning ascribed to such term in Section 8.04(b) herein
below;
|
“Interim
|
|
Financial
Statements”:
|
shall
mean the balance sheets and profit and loss accounts of the Company for
the period starting from January 1, 2009 up to September 30, 2009 and for
the corresponding period in 2008 attached to this Agreement as
Exhibit
1.03(VI)
;
|
“Italian Distributed
Products”:
|
shall
mean the products Hyalofil, Hyalgran and Jaloskin in respect of which the
Company holds a CE registration;
|
“
Italian
Distributed
|
|
Products
Agreement”:
|
shall
mean the exclusive distribution agreement dated January 3, 2008 between
the Seller and the Company in respect of the Italian Distributed Products
pursuant to which the Seller was nominated exclusive distributor of the
Italian Distributed Products until 2023 in Italy, San Marino and the
Vatican State and to be amended within the Closing Date pursuant to the
Amendments to the Existing Product
Agreements;
|
“Knowledge of the
Seller”:
|
shall
mean the actual knowledge of any of the Seller’s directors or executives
and/or the Company’s directors or
executives;
|
“Material Adverse
Effect”:
|
shall
mean with respect to the Seller, the Company or the Buyer as applicable
any fact, event, change, development or effect that is or would be
reasonably likely to be, individually or when taken in the aggregate,
materially adverse to (a) the business, assets, liabilities,
financial condition or results of operations of the Seller, the Company or
the Buyer as applicable (b) the ability of the Seller, the Company or
the Buyer as applicable to perform their or its obligations under this
Agreement or other Transaction Documents or to consummate the Transaction;
provided
,
however
,
that none of the following shall be deemed in itself, or in any
combination, to constitute, and none of the following shall be taken into
account in determining whether there has been or shall be, or would
reasonably be expected to be, a Material Adverse Effect: any fact, event,
change, development or effect resulting from or arising out of (i) the
economy or financial markets in general,
provided
that
such conditions do not have a substantially disproportionate effect on the
Seller, the Company or the Buyer as applicable as compared to similarly
situated companies, (ii) conditions generally affecting the pharmaceutical
or medical device industry,
provided
that
such conditions do not have a substantially disproportionate effect on the
Seller, the Company or the Buyer as applicable as compared to similarly
situated companies, (iii) the Transactions contemplated by this Agreement,
(iv) actions required to be taken under any changes to applicable laws,
provided
that such event does not have a substantially disproportionate effect on
the Seller, the Company or the Buyer as applicable as compared to
similarly situated companies, (v) acts of terrorism or war (whether or not
threatened, pending or declared),
provided
that
such event does not have a substantially disproportionate effect on the
Seller, the Company or the Buyer as applicable as compared to similarly
situated companies, (vi) the public announcement of this Agreement or the
Transactions contemplated hereby;
|
“Material
Agreements”:
|
shall
have the meaning set forth in Section
6.01.23(a);
|
“Net Working
Capital”
:
|
shall
mean the net sum of total current assets of the Company minus total
current liabilities of the Company determined in accordance with the
Accounting Principles consistently applied with the accounting policies
and procedures used in the Financial Statements as specified in
Exhibit
4.02
;
|
“Notice of
Claim”:
|
shall
have the meaning ascribed to such term in Section 8.04(b) herein
below;
|
“Own Brand Label
Products”:
|
shall
mean Wet, Hyalofemme-Hyalogyn and Genaid products of the Company in
respect of which the Seller holds the right to obtain an own brand label
CE registration under the CE registration for such products held by the
Company;
|
“Own
Brand Label
|
|
Products
Agreements”:
|
shall
mean three worldwide exclusive licence and distribution agreements dated
December 17, 2001 between the Seller and the Company related to the Own
Brand Label Products scheduled to have an initial expiry date in 2017, but
renewable automatically for successive five year periods unless terminated
with one year prior notice and to be amended within the Closing Date
pursuant to the Amendments to the Existing Product
Agreements;
|
“Purchase
Price”:
|
shall
have the meaning ascribed to such term in Section 3.01
below;
|
“Quota”:
|
shall
mean the quota, equaling to 100% of the outstanding capital stock of the
Company and owned by the Seller;
|
“
Registration Rights
Agreement
”:
|
shall
mean the agreement a final draft of which is attached herewith as
Exhibit
1.03(VII)
;
|
“Seller’s
Receivables”:
|
shall
mean the accounts receivable of the Seller towards the Company as at the
Closing Date in an aggregate amount of Euro 2,000,000 attached hereto as
Exhibit
1.03(VIII)
as will be reflected in the Closing Balance Sheet and in
the Closing Net Working Capital;
|
“Shares”:
|
shall
mean
1,981,192
shares of Buyer’s
common stock, par value US$ 0.01 per
share;
|
“Shares Purchase
Price”:
|
shall
have the meaning ascribed to that term in Section
3.01(b);
|
“Tax”:
|
shall
mean any and all, state, local, regional, tax or withholding tax of any
nature, including, but not limited to, all taxes, on income (e.g. the
corporate income tax, “IRES”), on operating profit (e.g. the local
operating profit tax, “IRAP”), on gross receipts, sales, use, value added,
importation and exportation of goods and services, registration of acts or
documents, license, payroll, employment, severance, stamp, occupation,
environment, franchise, profits, social security (or similar),
unemployment disability, real estate property, personal property or assets
together with all penalties, charges and interests relating to any of
them;
|
“Transaction”:
|
shall
mean, collectively, all the transactions described in Article II
below;
|
“
Transaction
Documents
”
:
|
means
this Agreement, the schedules and exhibits attached hereto, the Commercial
Agreements, Escrow Agreement, the Registration Right Agreement, the
Amendments to the Existing Product Agreements
and any other
documents or agreements explicitly contemplated
hereunder;
|
“Trademark
Family”:
|
shall
mean the Hyal™-IAL HIAL family of
trademarks;
|
“Working Capital
Adjustment”:
|
shall
have the meaning ascribed to such term in Section 4.03
below;
|
“Woundcare
|
|
Agreements”:
|
shall
mean the integration agreement dated January 3, 2008 in respect of
Cronofil & Gellofil and the agreement dated January 10, 2005 pursuant
to which the Seller acquired the right to obtain an own brand label CE
registration for Hyalofill-F, Hyalofill-R, Hyalogran, Jaloskin,
Hyalomatrix, Hyalomatrix P.A. and exclusive royalty-free distribution
rights for Italy, San Marino and the Vatican State as such agreements will
be amended within the Closing Date pursuant to the Amendments to the
Existing Product Agreements.
|
|
(i)
|
the
Seller shall deliver to Buyer an executed copy signed in original of the
Amendments to the Existing Product
Agreements;
|
|
(ii)
|
the
Seller shall deliver to Buyer an executed copy signed in original of the
transfer of product registration agreement and the trademark transfer
agreements attached hereto as
Exhibit
2.03(a)(ii)
;
|
|
(iii)
|
the
Seller shall provide written evidence that before the Closing Date all
loans from Seller or any Affiliate of the Seller to the Company and any
other amounts owned by the Company to the Seller or any Affiliate of the
Seller other than the Seller’s Receivables have been
forgiven;
|
|
(iv)
|
the
Seller shall provide written evidence that at the Closing Date (a) the
Seller’s Receivables and the Company’s Receivables are both equal to Euro
2,000,000 and (b) that the Company’s available cash is equal to at least
Euro 500,000;
|
|
(v)
|
the
Seller and the Buyer shall execute before the Notary, which shall be
appointed by the Buyer or such other notary public as may be agreed by the
Parties, a notarial deed of transfer relating to the sale of the Quota
pursuant to Article 2470 of the Italian Civil Code substantially in the
form attached as
Exhibit
2.03(a)(v)
; (the “
Deed of
Transfer
”);
|
|
(vi)
|
the
Seller, the Buyer and the Escrow Agent shall execute the Escrow
Agreement;
|
|
(vii)
|
the
Buyer shall issue the Shares to the
Seller;
|
|
(viii)
|
the
Buyer shall pay to the Seller the Purchase Price, all in accordance with
the provisions of Section 3.02 herein
below;
|
|
(ix)
|
the
Seller and the Buyer shall execute the Registration Rights
Agreement;
|
|
(x)
|
the
Seller and the Buyer shall jointly instruct the Notary to effect the
formalities of the file of the Deed of Transfer with the Company Register
pursuant to Article 2470, second paragraph, of the Italian Civil
Code;
|
|
(xi)
|
the
Parties shall execute the Commercial Agreements which shall become
effective; and
|
|
(xii)
|
the
Buyer shall provide written evidence that a waiver has been given under
its principal financing agreement in respect of the
Transaction.
|
(a)
|
The
Seller undertakes to duly and promptly instruct the Escrow Agent to
release the Escrow Shares if no Notice of Claim is made by the date
falling 18 months after the Closing
Date.
|
(b)
|
The
Seller undertakes not to delay in the issue of shares certificates, as
provided for in Section 3(c) of the Escrow
Agreement.
|
/s/ Antonio Germani
|
/s/ Charles H. Sherwood
|
|
Fidia Farmaceutici S.p.A.
|
Anika Therapeutics Inc.
|
|
(Mr. Antonio Germani)
|
(Dr. Charles Sherwood)
|
ANIKA
THERAPEUTICS, INC.
|
|||
|
By:
|
/s/ Charles H. Sherwood | |
Name: Charles H. Sherwood | |||
Title: Chief
Executive Officer and President
|
|||
FIDIA
FARMACEUTICI S.P.A.
|
|||
|
By:
|
/s/ Antonio Germani | |
Name: Antonio Germani | |||
Title: Managing Director | |||
FIDIA
FARMACEUTICI S.PA.
and
FIDIA
ADVANCED BIOPOLYMERS S.R.L.
|
||||
LEASE
AGREEMENT
|
(A)
|
Fidia
and Anika Therapeutics, Inc. a company incorporated in the Commonwealth of
Massachusetts, U.S.A. with its main office at 32 Wiggins Avenue, Bedford,
MA 01730, U.S.A. (“
Anika
”) entered into a
share purchase agreement (the “Purchase Agreement”) dated the date hereof,
pursuant to which Fidia sold the entire quota capital of the Lessee to
Anika, all as more fully set forth in the Purchase
Agreement;
|
(B)
|
the
Parties wish to enter into an agreement setting forth the terms pursuant
to which the Lessor will grant certain leases to the Lessee effective from
the Closing Date (as defined in the Purchase
Agreement);
|
(C)
|
the
Lessor is the owner of the premises located at Abano Terme (PD), Via Ponte
della Fabbrica 3/A and 3/B, registered with the NCT F. 10
mapp
. 632 and NCEU F.10
mapp.
632, as
described by the extract from the Land Registry and maps as per Annex A
hereto and identified as follows (the "
Property
”):
|
|
(1)
|
portion
of the building named F2 (“Building F2 – Maps 0008_59 and 0008_02”) per mq
380 for warehouse use;
|
|
(2)
|
portion
of the building named “Istituto di Ricerca” (LR1 - Maps 0005 e 006) for mq
1,055 for laboratories and production facility Tissue Tech and per mq 982
for office (ground floor and first
floor);
|
(D
|
the
Property, as identified above, is a portion of a bigger real estate
complex (the “
Complex
”) owned by the
Lessor and used by the Lessor for other commercial activities already
known to the Lessee;
|
(E)
|
the
Parties agree that the previous lease agreement in force between Fidia and
FAB has been terminated by mutual consent on the occasion of the signature
of the Purchase Agreement.
|
1.
|
OBJECT OF THE
LEASE
|
1.1
|
Description of the
Property
|
|
1.1.1
|
The
Lessor grants on lease to the Lessee, who accepts, the Property of which
the Lessor is full owner.
|
|
1.1.2
|
The
Property will be destined for the following permitted uses: research
laboratories, production facilities, warehouse and
offices.
|
1.2
|
Availability of the Property
and Lessor and Lessee
Warranties
|
|
1.2.1
|
The
Property shall be made available to the Lessee and this Agreement shall be
effective as of the Closing Date.
|
|
1.2.2
|
The
Lessee accepts the Property in its current condition (
stato di fatto e di
diritto
) as of the time of delivery to the
Lessee.
|
|
1.2.3
|
The
Lessor represents and warrants (i) to be the legitimate owner of the
Property, to have the free and unconditional right to lease the Property
according to this Agreement; (ii) that the Property was duly built in all
material aspects based on valid building licenses and concessions and
according to all applicable, material and relevant administrative,
national and local regulations; (iii) that the use of Property according
to the above Section 1.1.2 is compliant with all applicable, material and
relevant administrative, national and local regulations; (iv) there are no
third parties’ rights which could adversely affect the right of the Lessee
on the Property under this Agreement in all material
aspects.
|
|
1.2.4
|
The
Lessee undertakes to vacate the Property in its current condition (
stato di fatto e di
diritto
) as of the time of delivery to the Lessee, except for
the normal deterioration caused by use of the Property. To this
end, the Parties shall enter into an initial and a final minute of
delivery of the Property (
verbale di consegna
).
Without prejudice to the provisions under Article 10 below, any
discrepancy between the final conditions of the Property and the initial
conditions of the Property shall cause the Lessee to pay to the Lessor any
related costs and expenses.
|
|
1.2.5
|
Fidia
and FAB expressly agree that any and all existing lease agreements between
them having as object the Property, are terminated with immediate effect
by mutual consent and notwithstanding anything contained in such
agreements to the contrary, no rights or obligations thereunder shall
survive such termination. Fidia and FAB expressly acknowledge
to each other that there are no outstanding rights arising from such
terminated agreements and that, in case, any right or obligations, credit,
liability or obligation, that exists or shall arise on the basis of the
terminated lease agreement, it is hereby waived by both Fidia and
FAB.
|
2.
|
DURATION, EXTENSION AND
WITHDRAWAL
|
2.1
|
Duration and extension of the
Agreement
|
|
2.1.1
|
This
Agreement will be effective for 6 years starting from the date indicated
in Section 1.2.1.
|
|
2.1.2
|
After
the second year of this Agreement and with effects from the first day of
the third year, the Lessee may, at any time and for any reason at its sole
discretion, withdraw from this Agreement by giving at least six months'
previous notice to the Lessor by registered mail. Such withdrawal shall
take effect on the date set out in the notice (which need not necessarily
coincide with the anniversary of this
Agreement).
|
|
2.1.3
|
At
the expiry of the validity of this Agreement, the Lessee may refuse to
renew the same by notifying this via registered mail addressed to the
Lessor, at least 6 months prior to the date of expiration. If the Lessee
does not exercise the right to refuse the renewal of the Agreement, the
period of validity of this Agreement will be extended automatically for 6
year period.
|
|
2.1.4
|
The
Lessor is not entitled to deny an extension of this Agreement at the end
of the initial 6-year term. To such purpose, the Lessor expressly waives
its rights under article 29 of Law No.
392/1978.
|
3.
|
RENT
|
3.1
|
Determination of the
rent
|
Area
|
Mq.
|
Monthly
rent/mq
(Euro)
|
Monthly
rent
(Euro)
|
Istituto
di Ricerca
(LR1
- Maps 0005 e
006)
- Offices
|
982
|
14.29
|
14,033
|
Warehouse
(“Building
F2 – Map
0008_59”)
|
373
|
5.11
|
1,906
|
Warehouse
(“Building
F2 – Map
0008_02”)
|
7
|
14.29
|
100
|
Istituto
di Ricerca
(LR1
- Map 0005)-
Research
Laboratories
|
536
|
17.05
|
9,138
|
Istituto
di Ricerca
(LR1
- Map 006)-
Production
facility
Tissue
Tech
|
519
|
17.05
|
8,849
|
Amount
|
2,417
|
34,026
|
3.2
|
Updating and review of the
rent
|
|
3.2.1
|
Under
the law currently in force, the Amount will be updated after the second
anniversary of this Agreement by applying an increase equal to 75% of the
ISTAT index relating to the consumer prices for workers' and employees'
families (the “
ISTAT
index
”) recorded in the previous
year.
|
|
3.2.2
|
The
Amount shall be updated following the publication of the ISTAT index. In
case the ISTAT index is published after the payments due for the first
quarter following the second anniversary of this Agreement, the balance of
the updated Amount (i.e. the difference between (i) the updated Amount due
for the first quarter and (ii) the Amount not updated as actually paid for
the first quarter before the publication of the ISTAT index) shall be paid
upon the payments of the Amount payable in the next
quarter.
|
4.
|
AUTHORISATIONS AND
TAXES
|
4.1
|
Authorisations
|
4.2
|
Taxes
|
5.
|
PAYMENT OF RENTS AND ADDITIONAL
CHARGES
|
5.1
|
Payment
deadline
|
6.
|
ORDINARY AND EXTRAORDINARY
MAINTENANCE
|
6.1
|
Ordinary
maintenance
|
|
6.1.1
|
The
Lessee undertakes to keep the Property in good maintenance and working
conditions, subject to normal wear and
tear.
|
|
6.1.2
|
Any
expenses and the relevant ordinary maintenance costs shall be borne by the
Lessor, being such costs included in the base rate. In any
case, out-of-pocket expenses regarding materials used to carry out such
ordinary maintenance shall be borne by the
Lessee.
|
|
6.1.3
|
It
is understood that ordinary maintenance means any work required by the
normal deterioration caused by use and that shall be periodically carried
out.
|
|
6.1.4
|
It
is understood that any work required to have the Property in compliance
with new regulations applicable to the Lessee and irrespective of the
Property itself or to be carried out upon Lessee’s instructions shall be
borne exclusively by the Lessee, save for what is provided under Section
6.2.1 below.
|
6.2
|
Extraordinary
maintenance
|
|
6.2.1
|
Extraordinary
maintenance is at the Lessor’s expense. Extraordinary maintenance includes
activities that are necessary to maintain the facility’s condition for its
intended use, however beyond the scope of routine
maintenance. Examples of extraordinary maintenance include but
not limited to replacement of floorings and roofs, replacement of heating
and cooling equipment, maintenance and replacement of standby and
emergency power equipment, replacement of windows, resurfacing of parking
lots, and upgrade of security
infrastructures.
|
|
6.2.2
|
In
case of need or emergency
and
delay to act of the Lessor
, the Lessee, upon notice to the Lessor,
is expressly authorised to carry out extraordinary maintenance works. In
that event, any amount paid by the Lessee for such works shall be deducted
from the rent following the submission of the relevant invoices stating
the kind of works done and their
cost.
|
6.3
|
Works to comply with the
regulations in force
|
|
6.3.1
|
Extraordinary
maintenance works also include any work required by the enforcement of new
provisions, laws or regulations issued by the relevant authorities where
such works affect in general the Property irrespective of the
Lessee.
|
7.
|
IMPROVEMENTS
|
7.1
|
Improvements
|
|
7.1.1
|
In
the event of the Lessor and the Lessee agreeing that improvements shall be
carried out to the Property, the parties shall agree at such time as to
how the costs of such improvements shall be
covered.
|
|
7.1.2
|
The
agreement in respect of such improvements shall be reached on each
occasion and stated in writing by the Parties depending on the kind of
improvement.
|
8.
|
ALTERATIONS TO THE
PROPERTY
|
8.1
|
Alterations
|
|
8.1.1
|
Any
internal and external alteration to the Property can be carried out by the
Lessee at its own expense subject to the prior written authorisation from
the Lessor, who can not unreasonably deny or delay it. The Lessor shall
also provide the Lessee with all the necessary executed documents required
by the law in order to file the proper and required request of
authorizations and/or permits with the competent
Authorities.
|
|
8.1.2
|
Except
as may be otherwise agreed, upon approval of alterations, if it is
determined that the Lessor desires restoration to the original condition,
the Lessee shall bear all costs and expenses for such restoration and the
Lessor and the Lessee shall agree on a mutually satisfactory term within
which such restoration shall be completed. The Parties acknowledge that in
the event the Parties mutually agree that the alterations improve the
value of the Property the Lessee shall not be required to carry out any
restoration at its own costs and
expenses.
|
9.
|
DESTINATION AND USE OF THE
PROPERTY
|
9.1
|
Destination of the
Property
|
|
9.1.1
|
The
Lessee shall not have the right to perform any activity that might modify
the nature and use of the Property.
|
9.2
|
Use of the
Property
|
|
9.2.1
|
For
the entire term of the Agreement, the Lessee undertakes to keep the leased
Property with care and diligence and to surrender it upon the expiration
of the term hereof, in a good state and condition, wear and tear
excluded.
|
|
9.2.2
|
The
Lessee undertakes to employ all necessary precautions to avoid and prevent
any damage to the interior of the
Property.
|
|
9.2.3
|
The
costs related to any safety measures mandated by the law and relating to
the structure of the Property are the responsibility of and shall be borne
by the Lessor, while those relating to the use of the Property shall be
borne by the Lessee.
|
10.
|
CUSTODY
|
10.1
|
Lessee’s
liability
|
11.
|
ACCESS TO THE
PROPERTY
|
11.1
|
Lessor’s
access
|
12.
|
SIGNS
|
12.1
|
Installation and maintenance of
signs
|
|
12.1.1
|
Under
this Agreement, the Lessee shall have the right to place, maintain and
replace, throughout the whole duration of the lease, commercial signs only
with the prior written consent of the Lessor to their positioning, such
consent not to be unreasonably withheld. The Lessor shall also provide the
Lessee with all the necessary executed documents required by the law in
order to file the proper and required request of authorizations and/or
permits with the competent
Authorities.
|
|
12.1.2
|
All
signs shall be placed and maintained by the Lessee at its own expense and
the Lessee shall take care to secure all the required authorisations,
permits and approvals by the relevant
authorities.
|
13.
|
INSURANCE
|
13.1
|
Insurance
|
14.
|
TERMINATION
|
14.1
|
Termination
|
|
14.1.1
|
In
the event the Property is destroyed as a result of a flood, war,
earthquake or any other independent event beyond the control of the
Lessor, and without there having been any prejudice to the rights of the
Lessee and of the Lessor, this Agreement shall automatically terminate
with immediate effect.
|
|
14.1.2
|
In
the event the Property is only partially destroyed as a result of one of
the events set out in Section 14.1.1 above, the Lessee shall have the
right to terminate this Agreement or to continue with the Agreement
reducing the Amount proportionally up to the date of the complete
restoration of the Property.
|
15.
|
TRANSFER OF THE
AGREEMENT
|
15.1
|
Transfer of the
agreement
|
|
15.1.1
|
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 written 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) the assigning Party, in case of assignment to an
Affiliate, 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 Section 15.1.1 shall be void. This Agreement shall inure
to the benefit of, and be binding upon, the legal representatives,
successors and permitted assigns of each of the
Parties.
|
15.1.2
|
The
Lessee is allowed to transfer this Agreement or sub-let or give in
gratuitous loan for use (
comodato
), whether in
full or in part and whether temporarily or not, the Property without the
Lessor’s prior written agreement, provided the transfer takes place with
entities belonging to or controlled by the Anika group of
companies.
|
15.1.3
|
The
Parties acknowledge that the provisions of law No. 392 of 27 July 1978
apply to transfers of the Property.
|
16.
|
MISCELLANEOUS
|
16.1
|
Expenses
|
16.2
|
Amendments
|
16.3
|
Penalties
|
16.4
|
Jurisdiction
|
16.5
|
Communications
|
16.6
|
Language
|
16.7
|
Confidentiality
|
17.
|
FORCE
MAJEURE
|
18.
|
APPLICABLE
LAW
|
18.1
|
This
Agreement is governed by the Italian law. Unless otherwise provided for
explicitly in this Agreement, the provisions of law No. 392/1978 will
apply and, unless they have been expressly derogated, the Civil Code
provisions on lease agreements will also
apply.
|
IN
WITNESS WHEREOF, the Parties have duly executed this Agreement as of the
day and year first above written.
FIDIA
FARMACEUTICI S.P.A.
|
/s/
Antonio Germani
Name:
Antonio Germani
Title:
[President] Managing Director
|
FIDIA
ADVANCED BIOPOLYMERS S.R.L.
|
/s/
Charles H. Sherwood
Name:
Charles Sherwood
Title:
President
|
(1)
|
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
|
(2)
|
FI
DIA 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
")
.
|
1.
|
INTERPRETATION
|
1.1
|
In
this Agreement:
|
1.2
|
In
this Agreement, a reference to:
|
|
1.2.1
|
a
document is a reference to that document as modified or replaced from time
to time;
|
|
1.2.2
|
a
person includes a reference to a corporation, body corporate, association,
partnership or other legal entity;
|
|
1.2.3
|
a
person includes a reference to that person’s legal personal
representatives, successors and permitted
assigns;
|
|
1.2.4
|
the
singular includes the plural and vice versa;
and
|
|
1.2.5
|
a
clause or Annex, unless the context otherwise requires, is a reference to
a clause of or Annex to this
Agreement.
|
1.3
|
The
headings in this Agreement do not affect its
interpretation.
|
2.
|
PRODUCTS
|
2.1
|
The
Manufacturer shall manufacture and supply Products and/or Intermediates
for the Customer pursuant to the provisions of this
Agreement.
|
2.2
|
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. T
he 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.
|
2.3
|
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.
|
2.4
|
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.
|
3.
|
TERM
|
3.1
|
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.
|
4.
|
FORECASTS AND
ORDERS
|
4.1
|
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.
|
4.2
|
For
the Forecast covering the period from
1 July 2010 to 30
June 2011, a
lthough 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.
|
4.3
|
For
each Forecast covering the period from 1 July 2011 to
30 June 2012,
and each subsequent consecutive twelve (12) month period
thereafter,
a
lthough 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.
|
4.4
|
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.
|
4.5
|
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.
|
4.6
|
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.
|
4.7
|
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
.
|
4.8
|
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
.
|
4.9
|
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:.
|
a)
|
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
|
b)
|
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.
|
5.
|
DELIVERY
TERM
|
5.1
|
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.
|
6.
|
ACCEPTANCE AND
CLAIMS
|
6.1
|
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.
|
6.2
|
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.
|
6.3
|
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.
|
6.4
|
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.
|
7.
|
ADDITIONAL
OBLIGATIONS
|
7.1
|
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.
|
7.2
|
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.
|
7.3
|
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.
|
7.4
|
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.
|
7.5
|
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:
|
|
a)
|
the
Customer shall not pay for the non-conforming Product and shall send the
same back to the Manufacturer; and
|
|
b)
|
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
|
|
c)
|
the
Manufacturer shall pay for all costs for transporting the non-conforming
Products and/or Intermediates to and from its Facility;
and
|
|
d)
|
the
non-conforming Products
and/or Intermediates
shall
count towards the binding forecast requirements of clause
4.1.
|
7.6
|
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:
|
|
a)
|
clause
7.5 shall apply, and
|
|
b)
|
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.
|
7.7
|
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.
|
7.8
|
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.
|
7.9
|
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.
|
7.10
|
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.
|
7.11
|
Products
and Intermediates will have the following minimum shelf life when
delivered to the Customer:
|
a)
|
Products
and/or Intermediates with 24 month expiration dating will have a
minimum of 20 months remaining when
delivered;
|
b)
|
Products
and/or Intermediates with 36 month expiration dating will have a
minimum of 24 months remaining when delivered;
and
|
c)
|
Products
and/or Intermediates with 48 month expiration dating will have a minimum
of 36 months remaining when
delivered.
|
7.12
|
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.
|
7.13
|
The
Manufacturer will support the Customer in the investigation of complaints
in accordance with the attached Quality
Agreement.
|
7.14
|
Manufacturer
shall have the right to use Customer Owned Equipment for the manufacture
of Customer’s products. Manufacturer
shall:
|
a)
|
be
responsible for any damage (normal wear and tear excepted) to the Customer
Owned Equipment caused by
Manufacturer;
|
b)
|
not
subject the Customer Owned Equipment to any liens or
encumbrances;
|
c)
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
Signed
by:
|
||
For
and on behalf of
|
||
Fidia
Farmaceutici S.p.A.
|
||
/s/ Antonio Germani
|
Signature
|
|
Signed
by:
|
||
For
and on behalf of
|
||
Fidia
Advanced Biopolymers S.r.l.
|
||
/s/ Charles H. Sherwood
|
Signature
|
Fiscal
Year
|
Amount
|
2010
|
$4,000,000
|
2011
|
$600,000
|
2012
|
$600,000
|
2013
|
$600,000
|
2014
|
$600,000
|
2015
|
$600,000
|
LOAN PARTIES
|
|
ANIKA
THERAPEUTICS, INC.
|
|
By:
/s/ Charles H.
Sherwood
|
|
Name:
Charles H.
Sherwood
|
|
Title:
Chief Executive Officer and
President
|
|
ANIKA
SECURITIES, INC.
|
|
By:
/s/
Charles H. Sherwood
|
|
Name:
Charles H.
Sherwood
|
|
Title:
Chief Executive
Officer and President
|
|
LENDERS
|
|
BANK
OF AMERICA, N.A.
|
|
By:
/s/ Jean S.
Manthorne
|
|
Name:
Jean S.
Manthorne
|
|
Title:
Senior Vice
President
|
|
ADMINISTRATIVE AGENT
|
|
BANK
OF AMERICA, N.A., as
|
|
Administrative
Agent
|
|
By:
/s/ Jean S.
Manthorne
|
|
Name:
Jean S.
Manthorne
|
|
Title:
Senior Vice
President
|
|