UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549


FORM 8-K

CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934


Date of Report (Date of earliest event reported):  December 30, 2009

Anika Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
____________________

Massachusetts
000-21326
04-3145961
(State or other jurisdiction of
Commission file number
(I.R.S. Employer
incorporation or organization)
 
Identification No.)
 
32 Wiggins Avenue, Bedford, MA 01730
(Address of principal executive offices) (Zip code)


Registrant’s telephone number, including area code:    781-457-9000



(Former name or former address, if changed since last report)

____________________



Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 
Section 1—Registrant’s Business and Operations

Item 1.01  Entry into a Material Definitive Agreement

Purchase Agreement

On December 30, 2009, Anika Therapeutics, Inc. (the “Company”) entered into a Sale and Purchase Agreement (the “Purchase Agreement”) with Fidia Farmaceutici S.p.A., a privately held Italian corporation (the “Seller”) pursuant to which the Company acquired 100% of the issued and outstanding stock of Fidia Advanced Biopolymers S.r.l., a privately held Italian corporation (“FAB”) for a purchase price consisting of $17.1 million in cash and 1,981,192 shares of the Company’s common stock (the “Acquisition”), and is subject to potential post-closing adjustments.  The completion of the Acquisition occurred simultaneously with the signing of the Purchase Agreement.  In connection with the Acquisition, the parties also entered into certain other on-going ancillary agreements, some of which are described below.

The Purchase Agreement contains customary representations, warranties and indemnification provisions.  A portion of the shares issued as part of the purchase price have been placed in escrow for a period of up to 18 months in order to secure the indemnification obligations of the Seller. The Purchase Agreement also contains non-competition and non-solicitation provisions pursuant to which the Seller agrees not to engage in certain competitive activities for a period of five years following the closing, including customary restrictions relating to employees.  In addition, the Purchase Agreement provides that the Seller may request that the Company appoint an unaffiliated independent board designee to the Company’s Board of Directors, which right shall terminate automatically at such time as the Seller ceases to hold, directly or indirectly, at least 1,400,000 shares of the Company’s common stock (as adjusted for stock splits, stock dividends, recapitalizations or the like).

The above description of the Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Purchase Agreement, which is filed as Exhibit 2.1 to this Current Report on Form 8-K and incorporated herein by reference.
 
On December 31, 2009, the Company issued a press release that announced the closing of the Acquisition. Such press release is attached hereto as Exhibit 99.1.

Registration Rights Agreement

On December 30, 2009, in connection with the Acquisition, the Company entered into a registration rights agreement (the “Registration Rights Agreement”) with the Seller.  The Registration Rights Agreement provides for certain so-called “piggyback” registration rights and that the Company will file a “resale” registration statement covering all of the shares issued in connection with the Acquisition upon request from the Seller no earlier than 12 months from the completion of the Acquisition.  The Registration Rights Agreement terminates at such time as the Seller may sell its shares of Company common stock without restriction under Rule 144 promulgated under the Securities Act of 1933, as amended. 

The above description of the Registration Rights Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Registration Rights Agreement, which is filed as Exhibit 10.1 to this Current Report on Form 8-K and incorporated herein by reference.
 
Lease Agreement

In connection with the Acquisition, FAB entered into a Lease Agreement with the Seller, dated as of December 30, 2009 (the “Lease Agreement”), whereby FAB will lease approximately 26,000 square feet of office, manufacturing, research and warehouse space from the Seller for a monthly rent of Euro 34,026, for an initial term of six years, with early termination rights, and the option to renew for another six-year term, upon six months prior notice.

The above description of the Lease Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Lease Agreement, which is filed as Exhibit 10.2 to this Current Report on Form 8-K and incorporated herein by reference.


 
Tolling Agreement

In connection with the Acquisition, FAB entered into a Tolling Agreement with the Seller, dated as of December 30, 2009 (the “Tolling Agreement”), whereby the Seller will manufacture certain product intermediates and finished products for FAB.  The initial term of the Tolling Agreement is for five years, with the initial term expiring on December 31, 2014.  FAB has the option to renew the Tolling Agreement for subsequent two year renewal terms by providing six-months notice to Seller prior to the end of the then-current term, unless the Tolling Agreement has been terminated earlier pursuant to the terms of the agreement.  The Tolling Agreement provides that FAB will make annual forecasts to the Seller of its estimated requirements of products set forth in each such forecast, and a certain percentage of the aggregate volume forecasted in each such forecast shall be binding upon FAB.

The above description of the Tolling Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Tolling Agreement, which is filed as Exhibit 10.3 to this Current Report on Form 8-K and incorporated herein by reference.

Amendment to Credit Agreement

On December 30, 2009, the Company entered into a Consent and First Amendment (the “Consent Agreement”) to the Credit Agreement, dated as of January 31, 2008, among the Company, Anika Securities, Inc., and the lenders from time to time party thereto and Bank of America, N.A., as administrative agent (the “Credit Agreement”), pursuant to which the lenders consented to the Acquisition on the terms and conditions set forth in the Purchase Agreement and amended certain provisions under the Credit Agreement.

The Consent Agreement contains customary representations and warranties of the Company, affirmative and negative covenants regarding the Company’s operations and financial covenants and a condition subsequent that by February 26, 2010, the Company enter into a pledge and security agreement among the Company, FAB and the Administrative Agent, in form and substance reasonably satisfactory to the Administrative Agent, providing for a pledge by the Company of 65% of the equity of FAB in favor of the Administrative Agent.  In connection with the closing of the Consent Agreement, the applicable interest rate associated with Eurodollar rate loans was increased from 0.75% to 1.25%, the Company paid an a non-refundable amendment fee to Bank of America of $74,000 and agreed to pay Bank of American’s invoiced costs and expenses (including reasonable attorneys’ fees) incurred on behalf of the Administrative Agent in connection with the Consent Agreement.

The above description of the Consent Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Consent Agreement, which is filed as Exhibit 10.4 to this Current Report on Form 8-K and incorporated herein by reference.

Section 2--Financial Information

Item 2.01  Completion of Acquisition or Disposition of Assets.

Please see the disclosure set forth above under Item 1.01 relating to the Purchase Agreement, which is hereby incorporated by reference into this Item 2.01 and its qualified in its entirety by reference to the full text of the Purchase Agreement, a copy of which is attached hereto as Exhibit 2.01 and incorporate herein by reference.

Section 3—Securities and Trading Markets

Item 3.02  Unregistered Sales of Equity Securities.

The information set forth in Item 1.01 of this Current Report on Form 8-K with respect to the Purchase Agreement is incorporated herein by reference into this Item 3.02.  The shares issued in connection with the Acquisition were issued in reliance upon the exemptions from the registration provisions of Section 4(2) of the Securities Act of 1933, as amended (and the regulations promulgated thereunder) relating to sales by an issuer not involving a public offering.The Seller has represented to the Company in the Purchase Agreement that it is acquiring the shares for investment and not for distribution, that it can bear the risks of the investment and that it has had an opportunity to ask questions of, and receive answers from, the Company regarding the terms and conditions of the issuance of the shares pursuant to the Purchase Agreement.



Section 9--Financial Statements and Exhibits

Item 9.01.  Financial Statements and Exhibits.
 
(a)   Financial statements of businesses acquired.
 
        The financial statements required by Item 9.01(a) of Form 8-K will be filed no later than 75 days from the date of the Acquisition.
 
(b)   Pro forma financial information.
 
        The pro forma financial statements required by Item 9.01(b) of Form 8-K will be filed no later than 75 days from the date of the Acquisition.
 
(d)   Exhibits
 
Exhibit
Number                                   Description
 
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.

*   The Company has omitted certain schedules and exhibits pursuant to Item 601 (b)(2) of Regulation S-K and shall furnish supplementally to the Commission copies of any of the schedules or exhibits upon request.
 



[Remainder of page left blank intentionally]
 

 
SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be filed on its behalf by the undersigned hereunto duly authorized.

  Anika Therapeutics, Inc.  
     
       
Dated:      January 6, 2010
By:
/s/ Kevin W. Quinlan  
    Kevin W. Quinlan  
    Chief Financial Officer  
       
 
 


Exhibit Index

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.

*   The Company has omitted certain schedules and exhibits pursuant to Item 601 (b)(2) of Regulation S-K and shall furnish supplementally to the Commission copies of any of the schedules or exhibits upon request.
 
 
 
Exhibit 2.1




________________________________________________



Sale and Purchase Agreement



by and between



Fidia Farmaceutici S.p.A.

as seller


and


Anika Therapeutics Inc.

as buyer


_______________________________________________












 
Table of contents
 
 
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.

 
2

 
ARTICLE VIII
Indemnification
   
8.01
Seller’s Indemnification.
8.02
Seller’s Indemnification - Limitation.
8.03
Buyer’s Indemnification.
8.04
Indemnification Procedure.
8.05
Escrow Shares.
8.06
Other Remedies.
   
ARTICLE IX
Miscellaneous
   
9.01
Lock Up.
9.02
Anika’s Board of Directors.
9.03
US GAAP Account.
9.04
GAAP Accounts and SEC Requirements.
9.05
Release of the Guarantees.
9.06
Seller’s Receivables.
9.07
Non Competition.
9.08
Further Assurances.
9.09
Use of Names.
9.10
Records Retention.
9.11
Waiver of Action.
9.12
Employee Stability.
9.13
Administrative Requirements.
9.14
Integration Services.
9.15
Insurances.
9.16
Confidentiality - Public Announcement.
9.17
Changes in Writing.
9.18
Successors. Assignment Prohibited.
9.19
Notices.
9.20
Domicile.
9.21
Severability.
9.22
Fees and Expenses.
   
ARTICLE X
Law - Jurisdiction
   
10.01
Applicable Law.
10.02
Arbitration.
10.03
Enforceability.

 
3

 
LIST OF EXHIBITS

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.

4

 
LIST OF SCHEDULES

Buyer’s Schedules.

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.

Seller’s Schedules.
 
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.
 
 
5

 
This Sale and Purchase Agreement (hereinafter the “ Agreement ”) is entered in Milan, on December 30, 2009,

between

(1)            Fidia Farmaceutici S.p.A. , a company duly incorporated under the laws of Italy, whose registered office is at Abano Terme (PD), CAP 35031, Via Ponte della Fabbrica 3/A, VAT number and registered with the Company’s Register of Padua at number 00204260285, acting by its legal representative Mr. Antonio Germani pursuant to the board of directors resolutions dated  November 19, 2009, attached hereto under Exhibit A (hereinafter the “ Seller ”);

and

(2)            Anika Therapeutics Inc. , a company duly incorporated under the laws of Massachusetts, whose registered office is at 32 Wiggins Avenue, Bedford, Massachusetts 01730 Italian tax code number 97542640152, acting by its legal representative Dr. Charles Sherwood pursuant to the board of directors resolutions attached hereto under Exhibit B (hereinafter the “ Buyer ” or “ Anika ”);

(the Seller and Buyer are hereinafter jointly referred to as the “ Parties ” and each as a “ Party ”).

RECITALS

WHEREAS the Seller is the owner of a quota representing 100% of the issued and outstanding capital stock of Fidia Advanced Biopolymers S.r.l., whose registered office is in Abano Terme (PD), C.A.P. 35031, Via Ponte della Fabbrica 3/,B capital stock equal to Euro 1,848,915.00 (one million eight hundred forty eight thousand nine hundred fifteen/00), VAT number 03641500289 and registered with the Company’s Register of Padua at number 01510440744 (hereinafter referred to as the “ Company ”) and, therefore, the Seller is the owner of the entire issued and outstanding capital stock of the Company;

WHEREAS   the Company is a company active in the business of research and development, manufacturing and distributing of medical products based on hyaluronic acid;

WHEREAS   Anika is a company active in the business of research and development, manufacturing and distributing of medical products based on hyaluronic acid and whose ordinary shares are listed on the NASDAQ Stock Exchange;

WHEREAS the Seller wishes to sell and Buyer wishes to purchase the Quota (as hereinafter defined) upon the terms and subject to the conditions set forth in this Agreement;

NOW THEREFORE, in consideration of the mutual covenants contained herein, the Parties covenant and agree as follows:

ARTICLE I
Whereas - Interpretation – Certain Definitions

1.01 Whereas .

The WHEREAS clauses to this Agreement constitute an integral and essential part of the same.

1.02 Interpretation.

In this Agreement, unless the context requires otherwise, references to:

6

(a)           “ this Agreement ” includes the Exhibits and the Schedules;

(b)           a statute or statutory provision includes any consolidation, re-enactment, modification or replacement of the same, any statute or statutory provision of which it is a consolidation, re-enactment, modification or replacement and any subordinate legislation in force under any of the same from time to time;

(c)           Articles, Sections or Paragraphs, contained in this Agreement shall be deemed to be a reference to Articles, Sections, or Paragraphs hereto;

(d)           “ Business Day ” shall mean each calendar day other than Saturdays, Sundays and any other days on which credit institutions are permitted to close in the city of Padua and Boston;

(e)           the table of contents and the headings are included for convenience only and shall not affect the interpretation of this Agreement;

(f)           a “ Schedule ” is to a Schedule attached to this Agreement;

(g)           an “ Exhibit ” is to an Exhibit attached to this Agreement.

1.03 Certain Definitions.

In addition to the other terms defined in other clauses and whereas of this Agreement, for the purposes of the same, the following words and terms shall have the meaning set forth below:

“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;
 
7

 
“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;
final drafts of which are attached herewith as Exhibit 1.03(II) ;

“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;

8

 
“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;

9

 
“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;

10

 
“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;

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“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;

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“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.
 
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ARTICLE II
The Transaction

2.01 The Sale and Purchase of the Quota.

The Seller hereby agrees to sell and transfer to the Buyer, and the Buyer hereby agrees to buy and be transferred from the Seller, on the Closing Date, the Quota, including any rights ancillary thereto, for the Purchase Price as per Article III below.

2.02 Closing Date.

The Closing shall be on December 30, 2009 (the “ Closing Date ”) in the offices of Notary Enrico Sipione (the “ Notary ”)  in Milan

2.03 Closing Obligations.

(a)           On the Closing Date:

 
(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;

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(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.
 
(b)         The Transaction and, therefore, all the activities indicated in Section 2.03(a) above and in Section 2.04 below are deemed to be essential and shall occur simultaneously. The Parties hereby expressly agree that the sale, purchase, transfer and assignment of the Quota under this Agreement shall be effective from the Closing Date only upon completion of all formalities above described.

(c)           The Parties hereby expressly agree that the execution of the Deed of Transfer pursuant to Section 2.04(a)(v) above of this shall not be construed as constituting a novation ( novazione ) of this Agreement, but as constituting mere execution of the obligations of the Parties hereunder, it being understood that to such purpose Articles 1230 and following of the Italian Civil Code shall not apply.

2.04 Board of directors resignations and quotaholders meeting.

On the Closing Date:

(a)           the Seller shall deliver to Buyer the letters evidencing the irrevocable resignations, effective date as of the Closing Date, of all the directors of the Company, confirming that they do not have against the Company any claim of any nature whatsoever arising from their office, and that any accrued directors’ fees has been entirely paid before Closing;

(b)           the Seller shall hold an ordinary quotaholder meeting that shall appoint the new board of directors of the Company as specified in Exhibit 2.04(b) .

2.05 Receivables of the Company.

The Parties acknowledge that certain receivables of the Company have been assigned to the Seller prior to Closing. The Buyer covenants to procure that the Company will cooperate in good faith with the Seller in fully informing the relevant customers so that payments are made to the Seller and to the extent following the Closing Date that any payments are received by the Company in respect of such receivables, such amounts will be promptly forwarded by the Company to the Seller.

ARTICLE III
The Purchase Price

3.01 The Purchase Price.

The Parties hereby represent and acknowledge that the purchase price which is payable as described below to be paid by the Buyer to the Seller for the Quota (the “ Purchase Price ”) shall be equal to:

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(a) the Closing Cash Payment subject to the adjustments referred to in Article IV (the “ Cash Purchase Price ”); plus

(b) the Shares of Buyer’s common stock (the “ Shares Purchase Price ”).
 
3.02 Payment of the Purchase Price.
 
(a)     At the Closing, the Closing Cash Payment shall be paid by the Buyer to the Seller in immediately available funds by wire transfer to the account of the Seller indicated in Exhibit 3.02, subject to adjustments as provided in Article IV.

(b)     At the Closing, the Buyer will deliver or cause to be delivered to the Seller no. 1,181,192 of the Shares under Seller’s name which shall consist of the balance of the Shares minus the Escrow Shares.

(c)     At the Closing, and subject to and in accordance with the provisions hereof and the Escrow Agreement, the Buyer will deposit or cause to be deposited the Escrow Shares into an escrow account with the Escrow Agent.

3.03 Dividends.

Starting from the Closing Date, the payment of all the dividends pertaining to: (a) the Quota,   if any, will be entirely for the benefit of the Buyer; and (b) the Shares, if any, will be entirely for the benefit of the Seller.

3.04 Seller’s Undertakings

(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.

ARTICLE IV
Purchase Price Adjustment

4.01 Estimated Closing Balance Sheet - Estimated Net Working Capital.

The Seller has prepared (A) an estimated closing balance sheet, reflecting thereon the Seller’s best estimate of all balance sheet items of the Company (the “ Estimated Closing Balance Sheet ”) as at December 30, 2009 and (B) the Net Working Capital of the Company as at December 30, 2009 based on the Estimated Closing Balance Sheet (the “ Estimated Net Working Capital ”) plus all supporting details.  The Estimated Closing Balance Sheet and the Estimated Net Working Capital are attached herewith as Exhibit 4.01 and have been prepared in accordance with the Accounting Principles, consistently applied with the Financial Statements.

4.02 Preparation of the Final Closing Balance Sheet.

(a)           As promptly as practicable, but no later than Febraury 9, 2010, the Seller shall prepare and deliver to the Buyer (A) a balance sheet of the Company as of December 30, 2009 (the “ Closing Balance Sheet ”) plus all supporting details and (B) the Net Working Capital of the Company based on the Closing Balance Sheet and to be calculated on the basis of Exhibit 4.02 (the “ Closing Net Working Capital ”). The Closing Balance Sheet and the Closing Net Working Capital shall be prepared in accordance with the Accounting Principles consistently applied with the Financial Statements.

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(b)           Unless the Buyer delivers the Dispute Notice (as defined below) within 10 days after receipt of the Closing Balance Sheet, such Closing Balance Sheet shall be deemed the “ Final Closing Balance Sheet ” and the related Closing Net Working Capital shall be deemed the “ Final Net Working Capital   and both shall be binding upon the Parties and shall not be subject to dispute or review for purposes of this Section only.

(c)           If the Buyer disagrees with the Closing Balance Sheet and/or the Closing Net Working Capital, the Buyer may, within 10 days after receipt thereof, notify the Seller in writing (hereinafter the “ Dispute Notice ”), which Dispute Notice shall provide reasonable detail of the nature of each disputed item on the Closing Balance Sheet and/or the Closing Net Working Capital, including all supporting documentation thereto, and the Buyer shall be deemed to have agreed with all other items and amounts contained in the Closing Balance Sheet and/or the Closing Net Working Capital delivered pursuant to this Section 4.02.  The Parties shall first use commercially reasonable efforts to resolve such dispute between themselves and, if they are able to resolve such dispute, the Closing Balance Sheet shall be revised to the extent necessary to reflect such resolution, shall be deemed the Final Closing Balance Sheet (as defined below) and the Closing Net Working Capital shall be revised to the extent necessary to reflect such resolution and shall be deemed the Final Net Working Capital (as defined below) and, for purposes of this Section only, shall be conclusive and binding upon the Parties and shall not be subject to dispute or review.

(d)           If the Parties are unable to resolve the dispute within 10 days after receipt by Seller of the Dispute Notice, the Parties shall submit the dispute to Deloitte, Milan Office (the “ Accountants ”).  The Accountants shall act as experts and not arbiters and shall determine only those items in dispute on the Closing Balance Sheet and/or the Closing Net Working Capital.  Promptly, but no later than 15 days after engagement, the Accountants shall deliver a written report to the Parties as to the resolution of the disputed items, the resulting Closing Balance Sheet and the resulting calculation of Closing Net Working Capital to be calculated on the basis of Exhibit 4.02 .  The Closing Balance Sheet and the Closing Net Working Capital as determined by the Accountants shall be deemed the “Final Closing Balance Sheet” and the “Final Net Working Capital” respectively, shall be conclusive and binding, for purposes of this Section only, upon the Parties and shall not be subject to dispute or review, for purposes of this Section only.  The fees and expenses of the Accountants in connection with the resolution of disputes pursuant to this Section 4.02 shall be paid by (A) the Seller, if Buyer’s calculation of the portion of the Closing Net Working Capital  in dispute is closer to the Accountants’ determination than the Seller’s calculation thereof, (B) Buyer, if the reverse is true or (C) except as provided in clauses (A) or (B) above, equally by the Parties.  The Parties will, and agree to cause their respective representatives and independent accountants to cooperate and assist in the preparation of the Closing Balance Sheet and/or the Closing Net Working Capital and in the conduct of the audits and reviews referred to in this Section 4.02, including, without limitation, the making available to the extent necessary of books, records, work papers and personnel.

4.03 Working Capital Adjustment.

The Closing Cash Payment shall be adjusted, Euro for Euro, up or down, as appropriate, to the extent that the Final Net Working Capital is greater than or less than the Estimated Net Working Capital, as applicable (the “ Working Capital Adjustment ”). Within three Business Days following determination and acceptance of the Final Closing Balance Sheet, (A) if the Final Net Working Capital is less than the Estimated Net Working Capital, Seller shall pay to Buyer an amount equal to the difference between such amounts (B) if the Final Net Working Capital is greater than the Estimated Net Working Capital, Buyer shall pay to the Seller the difference between the Final Net Working Capital and the Estimated Net Working Capital.

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4.04 Cash Availability.

In the event Final Closing Balance Sheet reports an available amount of cash of the Company lower than Euro 500,000, the Seller shall pay to the Buyer, Euro per Euro, within three Business Days following determination and acceptance of the Final Closing Balance Sheet, an amount equal to the difference between Euro 500,000 and the available amount of cash of the Company resulting from the Final Closing Balance Sheet.
 
In the event the Seller is required to make a cash payment to the Buyer under this Section 4.04, any such payment, to the extent actually made by the Seller to the Buyer, shall be taken into account in the determination of the Final Closing Balance Sheet and the Final Net Working Capital.

ARTICLE V
Representations and Warranties of the Buyer

5.01 Representations and Warranties of the Buyer.

Except as disclosed in the SEC Reports or as set forth in the Schedules delivered herewith which shall be deemed a part hereof and shall qualify any representation made herein to the extent of the disclosure contained in the corresponding section of the Schedules, the Buyer hereby makes to the Seller the representations and warranties as of the date hereof (except for the representations and warranties that speak as of a specific date, which shall be made as of such date) as listed and specified in this Article V.

5.01.1 Good Standing – Authority.

The Buyer is a corporation validly existing, duly incorporated and in good standing under the laws of the Commonwealth of Massachusetts; the Buyer has all necessary corporate powers to enter into this Agreement and to perform any and all of its obligations under this Agreement and the other Transaction Documents to which it is a party, and the person who has executed this Agreement on behalf of the Buyer is a duly authorised representative of the same vested with full powers to bind it in relation to any and all of such obligations and each of the other Transaction documents to which it is a party.

5.01.2 No Bankruptcy Proceedings.

The Buyer is validly existing and no liquidator, administrative receiver, administrator or similar officer has been appointed in respect of it and no action is currently being taken with a view to appoint any such liquidator, receiver, administrative receiver, administrator or similar officer; the Buyer has not agreed to the assignment of its assets (or any part of them) for the benefit of its creditors. There is no action or proceeding now pending or threatened in writing to dissolve the Buyer or to declare its respective corporate rights and powers, or any of them, to be null and void or to declare that it or its board of directors or any of its directors, officers, agents or employees has or have exceeded or violated any of its corporate rights or powers.

5.01.3 No Third Party Consent.

Except as disclosed in Schedule 5.01.3 , no consent, license, permit, certificate, registration, approval, or authorization is necessary on the part of any governmental agency, third parties or of any creditors of the Buyer for the execution of this Agreement or of the Transaction contemplated hereby except as would not individually or in the aggregate, have or reasonably be expected to result in a Material Adverse Effect.

5.01.4 No Breach.

Except as disclosed in Schedule 5.01.4, the execution of this Agreement by the Buyer and the Transaction contemplated by this Agreement will not result in breach or violation of any of the provisions of, or constitute a default under, or conflict with, violate, or cause the acceleration or the revocation, termination, modification of, any obligation or right of the Buyer under: (i) the articles of organization of the Buyer; (ii) any governmental order applicable to the Buyer or any of its assets, properties or businesses; (iii) any Material Contract executed by the Buyer; (iv) any judgment, injunction, decree, order or award of any court, governmental body or arbitrator having jurisdiction over the Buyer; or (iii) any applicable law, except in each case as would not, individually or in the aggregate, have or reasonably be expected to result in a Material Adverse Effect.

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5.01.5 Knowledge of Misrepresentations or Omissions

The Buyer does not have any actual knowledge that any of the warranties of the Seller made in Article VI of this Agreement are not true and correct.

5.01.6 Public Information.

Since January 1, 2008 the Buyer has filed all reports, schedules, forms, statements and other documents required to be filed by it under the Exchange Act, including pursuant to Section 13(a) or 15(d) thereof (the foregoing materials, including the exhibits thereto and documents incorporated by reference therein, being collectively referred to herein as the “ SEC Reports ”, and the SEC Reports, together with the disclosure schedules, being collectively referred to as the “ Disclosure Materials ”).  As of their respective filing dates, or to the extent corrected by a subsequent restatement, the SEC Reports complied in all material respects with the requirements of the Securities Act and the Exchange Act and the rules and regulations of the Commission promulgated thereunder, and none of the SEC Reports, when filed, contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading.

5.01.7 Financial Statements.

The financial statements of the Buyer included in the SEC Reports complied in all material respects with applicable accounting requirements and the rules and regulations of the Commission with respect thereto as in effect at the time of filing (or to the extent corrected by a subsequent restatement).  Such financial statements have been prepared in accordance with US GAAP applied on a consistent basis during the periods involved, except as may be otherwise specified in such financial statements or the notes thereto or otherwise permitted by SEC disclosure requirements, and fairly present in all material respects the financial position of the Buyer and its consolidated subsidiaries taken as a whole as of and for the dates thereof and the results of operations and cash flows for the periods then ended, subject, in the case of unaudited statements, to normal, immaterial year-end audit adjustments.

5.01.8 Taxes.

The Buyer (i) has accurately and timely prepared and filed all foreign, federal and state income and all other tax returns, reports and declarations required by any jurisdiction to which it is subject, (ii) has paid all taxes and other governmental assessments and charges that are material in amount, shown or determined to be due on such returns, reports and declarations, except those being contested in good faith, with respect to which adequate reserves have been set aside on the books of the Buyer and (iii) has set aside on its books provisions reasonably adequate for the payment of all taxes for periods subsequent to the periods to which such returns, reports or declarations apply, except, in the case of each of the clauses above, where the failure to so pay or file any such tax, assessment, charge or return would not have or reasonably be expected to result in a Material Adverse Effect. 

5.01.9 Litigation.

Other than those listed in Schedule 5.01.9 , there are no claims, actions, suits, proceedings or investigations pending or threatened in writing and received in writing or otherwise before any court or governmental or regulatory or administrative authority, domestic or foreign, or before any arbitrator of any nature to which the Buyer is a party which would have a Material Adverse Effect.

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5. 01.10 The Shares.

All consents required to be obtained by the Buyer necessary for the issuance of the Shares to the Seller have been obtained or will be obtained by the Closing Date.

At the Closing, the Shares will have been duly authorized and, when issued in accordance with the terms of this Agreement and the Transaction Documents, will be duly and validly issued, fully paid and non assessable and free and clear of all Encumbrances other than as provided for in the Transaction Documents or imposed by applicable securities laws, and are not subject to rights of first refusal or preemptive or similar rights. The issuance of the Shares in accordance with the terms of this Agreement and the Transaction Documents, assuming the accuracy of the Seller’s representations contained in Section 6.01.35, will be in compliance with all applicable U.S. federal and state securities laws. Upon delivery of the Shares to the Seller on the Closing Date, good and valid title to the Shares will pass to the Seller.  The Shares shall have the benefit of all rights associated with the Buyer’s common stock under the Buyer’s organizational documents and applicable law, including, for the avoidance of doubt, the right to dividends, if any, that are declared or paid by the Buyer in respect thereof after the date of this Agreement.

5.01.11 Investment Company.

The Buyer as a result of the offer and sale of the Shares, will not become, an “investment company” under, and as such term is defined in, the U.S. Investment Company Act of 1940 (the “ Investment Company Act ”).

5.01.12 No Public Offering in Italy.

No action has been taken or will be taken in any jurisdiction by the Buyer or by any of its affiliates (as defined in Rule 405 under the Securities Act) that would permit or require a public offering of the Shares in the Republic of Italy.

5.01.13 Employment Matters.

No material labor dispute exists or, to the actual Buyer’s knowledge, is imminent with respect to any of the employees of the Buyer which would have or reasonably be expected to result in a Material Adverse Effect.  None of the Buyer’s employees is a member of a union that relates to such employee’s relationship with the Buyer, the Buyer is not a party to a collective bargaining agreement.

5.01.14  Permits.

Except as disclosed in Schedule 5.01.14, the Buyer possess all certificates, authorizations and permits issued by the appropriate federal, state, local or foreign regulatory authorities necessary to conduct its respective business as currently conducted and as described in the SEC Reports, except where the failure to possess such permits, individually or in the aggregate, has not and would not have or reasonably be expected to result in a Material Adverse Effect (“ Material Permits ”), and the Buyer has not received any written notice of action or proceeding relating to the revocation or modification of any such Material Permits.

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5.01.15 Internal Accounting Controls.

The Buyer maintains a system of internal accounting controls with respect to its business sufficient to provide reasonable assurance that (1) transactions are executed in accordance with management’s general or specific authorisations; (2) transactions are recorded as necessary to permit preparation of financial statements in conformity with generally accepted accounting principles and to maintain asset accountability; (3) access to assets is permitted only in accordance with management’s general or specific authorisation; and (4) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences, all in compliance with the guidelines set out by the SEC and other relevant authorities in the United States.

5.01.16  No Material Adverse Change.

Except as disclosed in Schedule 5.01.16, since the date of the latest audited financial statements included within the SEC Reports of the Buyer, except as specifically disclosed in a subsequent SEC Report filed prior to the date hereof, there have been no events, occurrences or developments that have had or would reasonably be expected to have, either individually or in the aggregate, a Material Adverse Effect.

5.01.17 Brokers.

Except as disclosed in Schedule 5.01.17, the Buyer has not entered into any contract, arrangement or understanding with any person or firm that may result in the obligation of the Buyer to pay any finder’s fees, brokerage or agent’s commissions or other like payments in connection with the Transaction and any Transaction Documents contemplated in this Agreement.

5.01.18 Private Placement.

Assuming the accuracy of the Seller’s representations and warranties set forth in this Agreement, no registration under the Securities Act is required for the offer and sale of the Shares by the Buyer to the Seller under this Agreement and the Transaction Documents.

5.01.19 Restrictions on Dividend Payment.

Except as set forth in the Buyer’s SEC Reports and in the agreements listed thereto, the Buyer is not currently prohibited, directly or indirectly, from paying any dividends to its shareholders, or from making any other distribution on its capital stock.

5.01.20 Capitalization.

The number of shares and type of all authorized, issued and outstanding capital stock, options and other securities of the Buyer as of December 28, 2009 is 12,581,787.  The Buyer has not issued any capital stock since the date of its most recently filed SEC Report other than to reflect stock option exercises and vesting of restricted stock.

5.01.21 Compliance with Law.

(a)           The operations of the Buyer are conducted and since January 1, 2008 have been conducted in compliance with all applicable laws, regulations, orders and other requirements of all courts and other governmental or regulatory authorities having jurisdiction over the Buyer save to the extent that would not have a Material Adverse Effect.
 
(b)           Since January 1, 2008 up to the date hereof, the Buyer has not received a written notification of any material violation of any such law, regulation, order or requirement except for such violations or defaults listed in Schedule 5.01.21 or as disclosed in the SEC Reports.

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5.02 Certain definitions.

For purposes of this Article V only the following terms shall have the following meaning:

Commission ” means the United States Securities and Exchange Commission.

Securities Act ” means the Securities Act of 1933, as amended, or any successor statute, and the rules and regulations promulgated thereunder.

Exchange Act ” means the Securities Exchange Act of 1934, as amended, or any successor statute, and the rules and regulations promulgated thereunder.

Material Contract ” means any contract of the Company that has been filed or was required to have been filed as an exhibit to the SEC Reports pursuant to Item 601(b)(4) or Item 601(b)(10) of Regulation S-K.

ARTICLE VI
Representations and Warranties of the Seller

6.01 Representations and Warranties of the Seller.

The Seller makes to the Buyer the representations and warranties as listed and specified in this Article VI.

6.01.1 Good standing – Authority.

The Seller is a corporation validly existing and duly incorporated under the laws of Italy; the Seller has all necessary corporate powers to enter into this Agreement and to perform any and all of its obligations under this Agreement, and the person who has executed this Agreement on behalf of the Seller is a duly authorised representative of the same vested with full powers to bind it in relation to any and all of such obligations and each of the other transaction documents to which it is a party.

6.01.2 No Bankruptcy Proceedings.

No liquidator, administrative receiver, administrator or similar officer has been appointed in respect of Seller and/or the Company to the Knowledge of the Seller and no action is currently being taken with a view to appoint any such liquidator, receiver, administrative receiver, administrator or similar officer; the Seller has not agreed to the assignment of its assets (or any part of them) for the benefit of its creditors. There is no action or proceeding now pending or threatened in writing that has been received, to dissolve the Seller and/or the Company or to declare that it or its board of directors or officers has exceeded or violated any of its corporate powers.

6.01.3 No breach – No Third Party Consent.

The execution of this Agreement and the Transaction contemplated by this Agreement will not result in breach or violation of any of the provisions of, or constitute a default under, or conflict with, violate, or cause the acceleration or the revocation, termination, modification of, any obligation or right of the Seller and/or the Company under: (i) the corporate documents of the Seller and/or the Company; (ii) any law or governmental order applicable to the Seller and/or the Company or any of their respective assets, properties or businesses; (iii) any judgment, injunction, decree, order or award of any court, governmental body or arbitrator having jurisdiction over the Seller and/or the Company; (iv) any license, permit, certificate, registration, approval, consent or authorisation necessary to the ownership of the Quota or to the conduct of the business of the Seller and/or the Company of this Section and/or (v) save as disclosed in the Material Agreements or as listed in Schedule 6.01.3 , any contract, agreement or other arrangement executed by the Seller and/or the Company; to an extent that would have, in the cases under (ii), (iii), (iv) and (v), a Material Adverse Effect.

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By way of exception to the above, in case of termination of the Project Disc Regeneration agreements as a consequence of the Transaction, the Seller acknowledges and accepts to keep the Buyer indemnified from any cost, expense, penalty or amount that the Buyer and/or the Company is required to pay or return as a consequence of such termination.

6.01.4 Title to Quota.

The Seller is, and on Closing Date will be, the sole registered and beneficial owner of the Quota, with full legal title to the Quota. On Closing Date, Seller will be entitled to sell or cause the transfer of the full legal ownership of the Quota to Buyer.
 
The Quota is, and on Closing Date will be, free from any Encumbrances and on the Closing Date there will be no outstanding options, warrants, agreements, conversion rights, pre-emption rights or other rights to subscribe for purchase or otherwise acquire the Quota or part of the Quota, including shareholders’ agreements and/or voting syndicates and/or block syndicates.
 
Upon consummation of the Transaction in accordance with the terms of this Agreement, the Buyer will hold good and marketable title to all of the Quota purchased from the Seller herein, free and clear of any Encumbrances whatsoever.

6.01.5 Title to dividend.

The Seller has no continuing right to cash a dividend declared or distributed by the Company in relation to the Quota and concerning the current corporate year or prior corporate years.

6.01.6 Subsidiaries.

Other than the participations to consortium listed in a Schedule 6.01.6 , the Company does not, and on Closing Date will not, own any participation and/or interest in any company and/or subsidiary.

6.01.7 Corporate capital.

The issued and outstanding corporate capital of the Company is equal to Euro 1,848,915.00 and is represented by the Quota. All such issued and outstanding corporate capital has been duly authorised and is fully paid and owned as indicated in the first WHEREAS.
 
There is no other authorised or pending corporate capital nor any securities of the Company convertible with or exchangeable for any of its quota nor other securities of the Company or subscriptions, options, warrants or other rights entitling any person to acquire from the Company or the Seller the Quota or part of it or other securities of the Company.

6.01.8 Good Standing.

(a)           The Company  is a corporation validly existing and duly incorporated under the Italian law.

(b)           The Company is not, nor has been since January 1, 2008, engaged in other business or activities other than those recalled in the second WHEREAS.

(c)           The Company has all necessary powers and authority to own, operate or lease the properties and assets now owned, operated or leased by the Company and to carry on the business as it is currently conducted.

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Since January 1, 2008, all material corporate actions taken by the Company have been duly authorised and the Company has not taken any action that, in any material respect, conflicts, constitutes a default under or results in any violation of, any provision of its by-laws. The Company is duly licensed and/or qualified to do its business in Italy and no material licenses and/or qualification are needed in any other jurisdictions where the Company conducts its business.

6.01.9 Financial Statements.

The Financial Statements: (i) have been prepared in accordance with the Accounting Principles consistently applied; (ii) are true and correct; (iii) fairly represent the assets, liabilities (“ situazione patrimoniale ”), financial position and results of the Company as at the date and for the period covered thereby.

6.01.10 Inventory.

On Closing Date, the Company will have quantities of saleable inventory that are reasonable for the ordinary conduct of the business in a manner consistent with the past practice. The inventory comprised of such materials, works in process and finished goods as are necessary for the present conduct of the business of the Company has been purchased in accordance with past practice and the volumes of purchases and orders therefore have not been reduced or increased in anticipation of the transactions contemplated by this Agreement.

6.01.11 Books and records.

Since January 1, 2008, all books and records of the Company have been fully, properly and accurately kept and completed in accordance with any applicable law.

6.01.12 Conduct of business.

Other than those listed in Section 2.03(a), since December 31, 2008, the Company’s business has been carried on in the ordinary course and in a manner consistent with past practice. Particularly, until the date hereof there has not been:

(a)           any (i) material adverse change in the Company’s financial conditions, results of operation, assets, properties, liabilities or business activities and (ii) event or circumstance with respect to the Company’s assets, business and properties that threaten to disrupt, prevent, impair or otherwise materially and adversely affect the conduct and operations of the Company;

(b)           except as reserved for or reflected in the Interim Financial Statements as of September 30, 2009, any direct or indirect redemption or other acquisition by the Company of any share or quota of any company, or any declaration, setting aside or payment of any dividend or other distribution in respect of its capital stock;

(c)           any issuance of quota of capital by the Company;

(d)           any grant of any option to purchase, or other right to acquire, a quota of the Company, granted to any person (other than the rights granted under the Agreement);

(e)           any increase in the compensation payable or to become payable by the Company to any of its directors, officers, employees or agents, other than the increases granted in the ordinary course of business (which consist of normal periodic performance reviews and related compensation and benefit increases);

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(f)           any new employment, bonus or deferred compensation agreement entered by and amongst the Company and any of their directors, officers, agents or other employees or consultants or any payment of bonuses or commissions of any nature whatsoever by the Company;

(g)           any amendment of the by-laws of the Company;

(h)           the imposition of any Encumbrance with respect to the assets, tangible or intangible, of the Company, other than those arising in the ordinary course of business;

(i)           any commitment of Seller and/or Seller’s Affiliates and/or the Company to buy/sell fixed assets owned by the Company;

(j)           any acquisition or disposition of, or commitment to acquire or dispose of, any property or asset other than those arising in the ordinary course of business or any entry into or commitment to enter into any such contract, agreement or commitment, by the Company, individually in excess of Euro 20,000.00;

(k)           any change in the accounting methods, principles or practices of the Company, other than those agreed in writing with Buyer;

(l)           any merger or corporate reorganization of any kind;

(m)           any transfer or sale of the inventory of the Company other than any sale which is in the ordinary course of business;

(n)           any release of, or compromise with reference to, any accounts receivable of the Company other than those carried out in the ordinary course of business consistent with past practice;

(o)           any amendment or termination of agreements of the Company, or any waiver of any other rights of substantial value to the Company;

(p)           any material indebtedness;

(q)           any assignment of any credit, either pro soluto or pro solvendo ;

(r)           any agreement, whether in writing or otherwise, to take any of the actions specified in this Section 6.01.12 or any grant of any options to purchase, rights of first refusal, rights of first offer or any other similar rights with respect to any of the actions specified in this Section 6.01.12.

6.01.13 Guarantees.

Save as set out in Schedule 6.01.13 or as specifically referred to in the Financial Statements, as of the date hereof, (i) the Company has no outstanding issued guarantees and/or patronage letters in favor of any third party including the Seller and (ii) the Seller or its subsidiaries have not issued or granted any guarantees, performance bonds, patronage letters or any other security with respect to any obligation or liability of the Company.

6.01.14 Litigation.

Other than those listed in Schedule 6.01.14 , there are no claims, actions, suits, proceedings or investigations pending or threatened in writing and received or otherwise before any court or governmental or regulatory or administrative authority, domestic or foreign, or before any arbitrator of any nature to which the Company is a party which would have a Material Adverse Effect.

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6.01.15 Labour matters.

(a)            Schedule 6.01.15(a) lists by name all Employees of the Company and evidences who holds as of the date hereof any power of attorney to represent the Company before any relevant authority including any pharmaceutical authority.

(b)           As regards to labour matters:

(i)           the Company is in compliance with all applicable laws and collective bargaining agreements governing labour, employment and employment practices, terms and conditions of employment, wages, hours and benefits and health and safety laws and/or any other applicable contractual provisions;

(ii)           the Company is not delinquent in payments to any such Employees for any wages, salaries, commissions, bonuses, benefits or other direct or indirect compensation for any services performed to the date hereof or amount required to be reimbursed to such Employees agents or consultants;

(iii)           up to the date hereof no Employee has performed or currently performs tasks which are not substantially corresponding to those prescribed by the relevant provisions of the collective bargaining agreements and of its individual employment agreement;

(iv)           there is no labour strike actually pending or, at the Knowledge of the Seller and the Company, threatened in writing, against or involving the Company;

(v)           other than as required by the law or by any applicable individual or collective bargaining agreement, there is no Employee bonus, stock option, incentive, deferred compensation, retiree medical or life insurance, supplemental retirement, pension or severance plans to which the Company is party or which are maintained, contributed to or sponsored by the Company for the benefit of the Employees;

(vi)           the Company has: (1) paid with to the competent authorities all compulsory social welfare and social security funds and provided to such authorities any requested document concerning the same (also in relation to their agents); (2) totally paid or, as the case may be, allocated in the Financial Statements the TFR ( trattamento di fine rapporto ); and (3) withheld and paid to the competent authorities the total contributions and taxes to be withheld from the paid wages and (4) duly calculated and accrued in compliance with any applicable laws or contractual provision the termination indemnity funds (“ fondo indennità e preavviso e cessazione dei rapporti di agenzia e di indennità suppletiva di clientele ”);

(vii)           no Employee and/or manager is entitled to receive any payment of any nature whatsoever in consequence of the execution of the Agreement and/or of the transactions contemplated by the Agreement;

(c)           The Company is a party to the supply of workmanship agreements listed in Schedule 6.01.15(c) with certain labor agencies according to which certain workers employed by such agencies (hereinafter the “ Workers ”) are presently working or have in the past 2 years worked at the Company’s premises. None of the Workers have accrued any right to be employed by the Company.

(d)           The collective bargaining agreements applicable by the Company (including any applicable specific company agreements) are set forth in Schedule 6.01.15(d) . There are no other material applicable regulations or contractual provisions which go beyond legal requirements.

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6.01.16. Intellectual property.

(a)     Schedule 6.01.16(a) contains a list of all (i) Patents owned by the Company (hereinafter the “ Company Patents ”), registered and material unregistered Marks owned by the Company (hereinafter the “ Company Marks ”) , and registered Copyrights owned by the Company (hereinafter the “ Company Copyrights ”) (ii) licenses, sublicenses or other agreements under which the Company is granted rights by others in Company Intellectual Property Assets (hereinafter the “ Licenses In ”) (other than commercial off the shelf software which is made available for a total cost of less than Euro 2,000.00), and (iii) licenses, sublicenses or other agreements under which the Company has granted rights to others in Company Intellectual Property Assets (hereinafter the “ Licenses Out ”).

(b)     Except as set forth on Schedule 6.1.16 (b) :

(i)    the Company owns or has a right or license to use the all Intellectual Property Assets used in the Business, as at the date hereof.
With respect to the Company Intellectual Property Assets (A) purported to be owned by the Company, the Company exclusively owns such Company Intellectual Property Assets and (B) licensed to the Company by a third party (other than commercial off the shelf software which is made available for a total cost of less than Euro 2,000.00), such Company Intellectual Property is the subject of a written license or other agreement; in the case of the foregoing clauses (A) and (B) above, free and clear of all Encumbrances;

(ii)   all Company Intellectual Property Assets owned by the Company are currently in compliance with all applicable formal legal requirements necessary to maintain registration, where applicable;

(iii)  no Company Patent owned by the Company  is now involved in any interference, reissue, re­examination or opposition proceeding;

(iv)  to the Knowledge of the Seller,  n one of the Company Intellectual Property Assets nor the operation of the Business, infringes the   intellectual property rights   of any third party ;

(v)   to the Knowledge of the Seller,  there is no infringement or violation by any person or entity of any of the Company Intellectual Property Assets;

(vi)  the Company has taken all reasonable security measures to protect the secrecy, confidentiality and value of all Trade Secrets owned by the Company or used by the Company in the Business (hereinafter the “ Company Trade Secrets ”);
 
(vii) as per with art. 64.3 of the Italian Industrial Property Code, the Company has duly exercised its option to purchase or obtain a (exclusive or non-exclusive) license on any Patent resulting from occasional inventions, improvements or discoveries by any former or current employees, contractants and consultors relating to the business of the Company or to any of the products sold by the Company.

(c)     For purposes of this Agreement Section 6.01.16,

(i)     “ Business ” means the business of the Company as currently conducted by the Company;
 
(ii)     “Company Intellectual Property Assets ” means the Intellectual Property Assets owned by the Company or used in the Business, including the Company Patents, Company Marks, Company Copyrights and Company Trade Secrets;

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(iii)  “ Intellectual Property Assets ” means any and all of the following, as they exist throughout the world: (A) patents, patent applications (collectively, “ Patents ”);  (B) rights in registered and unregistered trademarks and registrations and applications and rights therein for registration of any of the foregoing (collectively, “ Marks ”); (C) copyrights in both published and unpublished works, including without limitation all compilations, databases and computer programs, manuals and other documentation and all copyright registrations and applications, and all rights in, and derivatives, translations, adaptations and combinations of the above (collectively, “ Copyrights ”); (D) rights in know-how, trade secrets, confidential or proprietary information, research in progress, algorithms, data, designs, processes, formulae, drawings, schematics, blueprints, flow charts, models, strategies, prototypes, techniques, source code, source code documentation, Beta testing procedures and Beta testing results (collectively, “ Trade Secrets ”).

6.01.17  Insurances.

(a)              The insurance policies entered into by the Company and currently in force are those listed in Schedule 6.01.17 .

(b)           All premiums concerning the insurance policies indicated in Schedule 6.01.17 have been paid at the due date.

(c)           To the Knowledge of the Seller no event relating to the Company has occurred which could reasonably be expected to result in upward adjustments in premiums under any new insurance policy arrangement in which the Company shall enter after Closing.

(d)           To the Knowledge of the Seller  no material event has occurred, including, without limitation, the failure by the Company to give any notice or information or giving any inaccurate or erroneous notice or information, which limits or impairs the rights of the Company to make a claim under any such insurance policies.

6.01.18 Environment.

(a) Environmental Laws .

(i)           The Company is in compliance with all Environmental Laws and Environmental Authorizations;

(ii)          The Company has not used, generated, treated, stored, transported, released, deposited or disposed of Hazardous Materials generated by the Company on any plant, factory, shed, machinery, store, warehouse, office facility or land such as to give rise to a violation of Environmental Laws and/or Environmental Authorizations;

(iii)         There are no Former Sites.

(b) Other .

There are no reports, audits, assessments, reviews or investigations (including any testing, sampling or monitoring results) carried out on behalf of the Company or, to the Knowledge of the Seller, by any competent body or authority within the last 2 years relating to Environmental Matters and Environmental Authorizations directly or indirectly affecting the Company that have evidenced any actual or potential violation of Environmental Laws and Environmental Authorizations.

6.01.19 Permits.

(a)           Except for those referred to in the Commercial Agreements, or in the Existing Product Agreements or as necessary to the occupancy of the leased premises occupied by the Company, neither the Seller nor any Affiliate to the Seller has any claim or right in any permit, license, authorisation, approval, franchise, invention, patent, proprietary right, trademark, or any industrial or commercial property right which the Company is using at present or the use of which is necessary for the proper conduct of the Company’s business, including the manufacturing and distribution of all products of the Company.

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(b)           The Company owns all licenses, permits, certificates, registrations, authorisations and approvals, including but not limited to all those related to each specific product manufacturing and distribution (hereinafter collectively the “ Permits ”) that are necessary to own, operate and carry out its business as it is presently operated and carried out. All Permits are in full force and effect and are sufficient for the ownership and conduct of the business of the Company.

Since January 1, 2008 up to the date hereof, the Company has not received written notification of a violation in respect of any Permit. As of the date hereof, no proceeding to vary, suspend, revoke or limit any Permit is pending or, since January 1, 2008, has been notified in writing to the Company.

(c)           The Company manufactures and sells in the EU, amongst others, Tissue Engineering products, as defined by Regulation (EC) N. 1394/2007, which were legally on the Community market in accordance with national or Community legislation on December 30, 2008. The Company has fulfilled all duties and obligations relevant to the Marketing Authorization of the Tissue Engineering products and has already started the necessary activities to comply with the relevant legislation and to obtain, within the term provided by EU Law (30.12.2012) the relevant marketing authorization.

6.01.20 Compliance with Law.

(a)           The operations of the Company are conducted and since January 1, 2008 have been conducted in compliance with all applicable laws, regulations, orders and other requirements of all courts and other governmental or regulatory authorities having jurisdiction over the Company save to the extent that would not have a Material Adverse Effect.

(b)           Since January 1, 2008 up to the date hereof, the Company has not received a written notification of any material violation of any such law, regulation, order or requirement.

6.01.21 Regulatory matters.

(a)           There are no actions, proceedings or complaints by or submitted and/or lodged before any competent authorities, including but not limited to national and/or EEA (European Economic Area) competent authority or bodies, which would prohibit, impede or merely hinder the production or sale of any product currently manufactured or sold by the Company into any market now pending or threatened in writing or, to the Knowledge of the Seller, threatened in writing. No agreement, practice or arrangement carried on by the Company or to which the Company is a party with respect to its business breaches any competition, anti-restrictive trade practice, antitrust or consumer protection in any relevant jurisdiction.

There are no actions, proceedings or complaints by the competent authorities which may suspend or interrupt the manufacture or cause the recall of the Products or that concern the production plant of the Company.

(b)           No stay of legal action or proceedings before the EC Commission and/or any other relevant authority or concerning matters related to EC and/or any other relevant authority regulations is pending against the Company and there is no threat in writing received by the Company of any such action or proceeding against the Company.

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6.01.22 Bank account and powers of attorney.

Schedule 6.01.22 contains a list showing: (i) the name of each bank with which the Company has an account or safe deposit box; and (ii) the names of any person holding powers of attorney from the Company in relation to such bank accounts.

6.01.23 Contracts.

(a)           Other than those listed in Schedule 6.01.23 , the Company is not a party to any written or oral:

(i)           agreement, contract or commitment for the future purchase of, or payment for, supplies or products, or for the performance of services by a third party whose supplies, products or services involve in any one case Euro 20,000 or more;

(ii)          agreement, contract or commitment exceeding Euro 20,000 in value;

(iii)         agreement, contract or commitment which cannot be terminated with less than 30 days prior notice and which has a consideration greater than Euro 20,000;

(iv)         distribution, dealer, representative or sales agency agreement, contract, renewal or commitment which would involve a commitment in excess of Euro 20,000;

(v)          lease under which the Company is either lessor or lessee which would involve a commitment in excess of Euro 20,000;

(vi)         note, debenture, bond, equipment trust agreement, hedging agreement, letter of credit agreement, loan agreement or other contract or commitment for the borrowing or lending of money or agreement or arrangement for a line of credit or guarantee, pledge or undertaking of the indebtedness of any other person;

(vii)        agreement, contract or commitment for any charitable or political contribution;

(viii)       commitment or agreement for any capital expenditure or leasehold improvement in excess of Euro 20,000;

(ix)         agreement, contract or commitment limiting or restraining the Company or any successor thereto from engaging or competing in any manner in the Business;

(x)          agreement, contract or commitment relating to research and development which would involve a commitment in excess of Euro 20,000;

(xi)         agreement, contract or commitment not made in the ordinary course of business; and/or

(xii)        distribution, dealer, representative or sales agency agreement, contract, renewal or commitment entered or received on or after July 9, 2009;

 together, referred to as “ Material Agreements ”.

(b)           The Company is in compliance of all Material Agreements except for immaterial breaches which do not give rise to the right to terminate any relevant Material Agreement by the other party and, to the Knowledge of the Seller, no other party to any of the Material Agreement is in material default in the performance, observance or fulfillment of any obligation, covenant or condition contained therein except for immaterial breaches which do not give rise to the right to terminate any relevant Material Agreement.

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6.01.24 Title to property and assets.

Save to the extent in the ordinary course of business and that in any event are not material in aggregate, the Company has good title to and legal and beneficial ownership of all of its properties which are all free and clear of Encumbrances.

6.01.25 Real property leases.

As of the Closing Date, (i) the Company is not a party to any real property lease agreement other than the lease agreement included in the Commercial Agreements and (ii) save as provided for in the Estimated Closing Balance Sheet, all rents as well as any other payment due to previous agreements with the Seller in respect of the lease of its premises have been paid.

6.01.26 Condition of assets.

(a)           All the Company’s principal operating assets which are necessary to operate the business as currently operated are in good operating condition and repair, subject to normal wear and maintenance and usable in the regular and ordinary course of business.

(b)           Save for title retention provisions or Encumbrances arising in the ordinary course of business, no person other than the Company owns any equipment or other tangible assets or properties situated on the premises of the Company which is necessary for the operation of the Business of the Company.

6.01.27 Customers - Suppliers.

Schedule 6.01.27 contains a list showing the top twenty costumers for revenues in the year 2009. Since January 1, 2009, no current customer accounting for more than 10% of all sales of any particular product of, or supplier accounting for more than 10% of supplies of any particular material or component to the Company has notified in writing to the Company an intention to terminate or materially adversely modify its business relationship with the Company.

6.01.28 Product liability and recall.

(a)           All products currently manufactured and/or sold by the Company since January 1, 2007 complied in all material respects with any applicable Italian laws, rules and regulations and their technical specifications.

(b)           Since January 1, 2004 none of the products manufactured and/or sold by the Company has caused any product liability claim and required any recall activity and, to the Knowledge of the Seller, there are no facts or circumstances that may give rise or are likely to cause any such product liability claims or recall activity.

6.01.29 Taxes.

With respect to Taxes:

(a)           all tax returns, reports or other filings that are required to be filed by the Company on or before the date hereof with any tax or social authorities in the Republic of Italy and/or any relevant country, have been timely filed. Such tax returns, reports or other filings, adequately reflect the tax and social liabilities of the Company, at the time of the filing, for the relevant period covered thereby in all material respects;

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(b)           all Taxes of the Company: (I) that are payable on or before the date hereof; or (II) that are attributable to any relevant period up to the date hereof, but are not yet due and payable as of the date hereof, in each case have been timely and duly paid or appropriate provisions have been made therefore in the Financial Statements or the Interim Financial Statements or otherwise in the books and records of the Company; an

(c)           since January 1, 2003 no claim for assessment or collection of Taxes has been asserted against the Company and, there are no such claims threatened in writing against the Company.

6.01.30 Loan to or by the Seller.

Save as set out in the Estimated Closing Balance Sheet, there is no outstanding indebtedness or other financial liability owed by the Company towards Seller or any Seller’s Affiliate or to any director or executive of the Company or any person connected with a director or executive of the Company, nor is there any indebtedness owed by any such companies towards the Company.

6.01.31 Intercompany transactions.

(a)           All transactions currently outstanding between Seller and the Company and between the Company and any Seller’s Affiliate and between Seller and its subsidiaries with any director or executive ( dirigente ) of the Company or between any of the companies above referred with their directors, executives ( dirigenti ) have been approved, if necessary, under all applicable laws and were and are on full arm’s length terms and were not conducted outside of the ordinary course of business.
 
(b)           There are no circumstances as of Closing Date which could cause any tax authority to make any adjustment for tax purposes to the terms on which any such transaction is treated as taking place and no such adjustment has been made or attempted in fact.

6.01.32 Certain business practices and regulations – Potential conflicts of interest.

In carrying out the business since January 1, 2007, none of the Company or any director, or Employee of the Company has: (i) used any corporate funds of the Company for unlawful contributions, gifts, entertainment or other unlawful expenses relating to political activity; (ii) made any unlawful payment to government officials or to political parties or campaigns from corporate funds of the Company.

6.01.33   No Restrictions on Business Activities .

Except as otherwise disclosed in any Schedule attached hereto, there is no agreement (non-competition or otherwise), commitment, judgment, injunction, order or decree to which the Company is a party or otherwise binding upon the Company which has had or could be reasonably expected to have the effect of prohibiting or impairing any business practice of the Company, any acquisition of property (tangible or intangible) by the Company or the conduct of business by the Company, or otherwise limiting the freedom of the Company to engage in any line of business or to compete with any person.  Other than those listed in any Schedule hereto, the Company has not (a) entered into any agreement under which the Company is restricted from selling, licensing, manufacturing or otherwise distributing its technology or products or from providing services to customers, potential customers or any class of customers, in any geographic area, during any period of time or in any segment of the market or (b) granted any person exclusive rights to sell, license, manufacture or otherwise distribute any of its technology or products in any geographic area or with respect to any customers or potential customers or any class of customers during any period of time or in any segment of the market.

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6.01.34 No brokers.

Neither the Company nor the Seller has entered into any contract, arrangement or understanding with any person or firm that may result in the obligation of the Company or Buyer to pay any finder’s fees, brokerage or agent’s commissions or other like payments in connection with the Transaction and any Transaction Documents contemplated in this Agreement.

6.01.35 Investment Representations.

(a)            Accredited Investor .  Seller is an “accredited investor” within the meaning of Securities and Exchange Commission Rule 501 of Regulation D promulgated under the Securities Act. Seller is able to fend for itself, can bear the economic risk of its investment and has such knowledge and experience in financial or business matters that it is capable of evaluating the merits and risks of the investment in the Shares. Seller has not been organized for the purpose of acquiring the Shares. Seller understands that the Shares will be characterized as “restricted securities” within the meaning of Rule 144 promulgated under the Securities Act to the extent they are being acquired from Buyer in a transaction not involving a public offering, and that under the Securities Act and applicable regulations such securities may be resold without registration only in certain limited circumstances. Seller understands and agrees that the certificate issued to it representing the Shares shall bear the restrictive legends set out on Schedule 6.01.35 .

(b)            Adequate Information .  Seller: (a) is a sophisticated purchaser with respect to the Shares; (b) has had an opportunity to discuss Buyer’s business, management, financial affairs and the terms and conditions of the offering of the Shares with Buyer’s management; (c) has had an opportunity to review Buyer’s facilities; (d) has reviewed Buyer’s public filings submitted to the Securities and Exchange Commission; (e) has conducted, to the extent it deemed necessary, an independent investigation of such matters as, in its judgment, is necessary for it to make an informed investment decision with respect to the Shares, Buyer and this Agreement; and (f) save as set out in Article V has not relied upon Buyer for any investigation into, assessment of, or evaluation with respect to the Shares, Buyer or this Agreement. Seller acknowledges that Buyer may have possession of confidential or material, non-public information concerning the Shares (collectively, the “Excluded Information”), which, if publicly disclosed, could affect the trading price of the Shares, including information that may be indicative that the value of the Shares is substantially different than the consideration Seller is paying for the Shares in the Transaction contemplated by this Agreement. Notwithstanding any possession of Excluded Information by Buyer and the absence of disclosure thereof to Seller, Seller desires to acquire the Shares pursuant to the transactions contemplated by this Agreement for its own business purposes.  For the avoidance of doubt, nothing in this Paragraph (b) shall alter the representations and warranties of the Buyer set forth in Article V.

(c)            Foreign Investor .  The Seller hereby represents that it has satisfied itself as to the full observance of the laws of its jurisdiction in connection with its purchase of the Shares, including (i) the legal requirements within its jurisdiction for the purchase of the Shares, (ii) any foreign exchange restrictions applicable to such purchase, (iii) any governmental or other consents that may need to be obtained, and (iv) the income tax and other tax consequences, if any, that may be relevant to the purchase, holding, redemption, sale, or transfer of the Shares.  Seller’s subscription and payment for and continued beneficial ownership of the Shares will not violate any applicable securities or other laws of Seller’s jurisdictions.

ARTICLE VII
Survival of Representations and Warranties

7.01 Survival of Representations and Warranties of the Seller.

(a)           All the representations and warranties of the Seller as set forth in Article VI shall survive the Closing Date and shall be effective and enforceable until the following expiration dates:

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(i)           18 months after the Closing Date, for all matters other than those indicated in Paragraph (a)(ii) below;

(ii)           the expiration of the respective statutes of limitation periods with respect to any liability arising from a breach of the representation and warranties under Section 6.01.04 ( Title to Quota ), Section 6.01.15 ( Labour ), Section 6.01.18 ( Environment ) and Section 6.01.29 ( Tax ).

(b)           In the event that a Notice of Claim concerning any of the matters above is notified by Buyer to the Seller according to Article VIII below within the terms above, the right to be indemnified claimed by such Notice of Claim shall survive until such time as the relevant claim is finally resolved.

7.02 Survival of Representations and Warranties of the Buyer.

All the representations and warranties of Buyer as set forth in this Agreement shall survive the Closing Date and be effective until the following expiration dates:

(i)           18 months after the Closing Date, for all matters other than those indicated in Paragraph (ii) below;

(ii)           the expiration of the respective statutes of limitation periods with respect to any liability arising from a breach of the representation and warranties under Section 5.01.08 ( Taxes ), Section 5.01.10 ( Shares ), Section 5.01.13 ( Labour ).

ARTICLE VIII
Indemnification

8.01 Seller’s Indemnification.

(a)           Subject to Article VII above, during the period specified in Section 7.01 above and subject to the terms, conditions, exceptions and limitations set forth below, the Seller hereby agrees to indemnify Buyer for and against any loss and/or damage incurred or suffered by Buyer and/or the Company, resulting or deriving from:

(i)           any breach or failure to perform any and/or all covenants of the Seller contained in this Agreement;

(ii)           any error, inaccuracy, or breach of any and/or all representations and warranties given by the Seller pursuant to Article VI of this Agreement;

(iii)           any and all actions, suits, proceedings, claims, assessments, judgments, costs and expenses (including reasonable attorney’s fees and disbursements) incident to any of the foregoing Paragraphs (a)(i) and (a)(ii) of this Section 8.01; and

(iv)           all costs and expenses (including reasonable attorneys’ fees and disbursements) incurred by the Buyer in enforcing their rights of indemnification in respect of a claim under this Agreement.

8.02 Seller’s Indemnification – Limitation.

(a)           The Parties hereto expressly agree that:

(i)           the aggregate obligation of indemnification of the Seller for breaches of Representations and Warranties under Article VI of this Agreement shall not exceed an amount equal to Euro 7,000,000 (seven million) it being understood that such limitation does not apply to any breach of Section 6.01.04 ( Title to Quota ), Section 6.01.15 ( Labour ), Section 6.01.18 ( Environment ) and Section 6.01.29 ( Tax ).

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(ii)           the obligation of the Seller under this Article VIII to indemnify Buyer for breaches of Representations and Warranties under Article VI of shall not have effect until the aggregate amount claimed by Buyer, together with any amount already claimed by Buyer, exceeds Euro 200,000 (two hundred thousand), it being understood that once the losses exceed such amount the Buyer is entitled to recover the entire loss Euro for Euro it being understood that such limitation does not apply to any breach of Section 6.01.04 ( Title to Quota ), Section 6.01.18 ( Environment ) and Section 6.01.29 ( Tax );

(iii)           no individual claim shall be counted for the purposes of making a claim unless it exceeds Euro 7,500 it being understood that individual claims of the same nature and that arises from the same set of facts shall be deemed as a single claim for purposes of this Section 8.02(a)(iii).

(iv)           if any payment is made by the Seller to the Buyer in respect of any claim for any breach of this Agreement or pursuant to this Article VIII, the payment, to the fullest extent possible, shall be treated as an adjustment to the consideration paid by the Buyer for the Quota and the consideration shall be deemed to have been reduced by the amount of such payment;

(v)           the Buyer on or after Closing shall not be entitled to recover damages or otherwise obtain reimbursement or restitution more than once in respect of any event that breaches more than one Representation and Warranty or to the extent taken into account in the Working Capital Adjustment under Article 4.03 of this Agreement;

(vi)           the Seller shall not be liable to the Buyer under this Agreement to the extent the Company has actually been reimbursed under any policy of insurance in force (net of any increase in insurance premium);

(b)           No claim shall be brought against the Seller under this Agreement:

(i)           in respect of any matter to the extent that it occurs as a result of, or is attributable to a change in, the accounting policies or practices of the Buyer or the Company introduced or having effect after Closing unless such change is necessary to implement a correction to address a breach of any Representation and Warranty under Article VI of this Agreement;

(ii)           in respect of any matter to the extent that such claim arises, or the amount thereof is increased as a result of any legislation, decision, regulation or administrative practice not in force as at the date hereof or any change in any such legislation, decision, regulation or administrative practice not in force as at the date hereof.

(c)           Buyer hereby acknowledges and agrees that, from and after Closing, its sole remedy with respect to any and all claims and losses for any matter that would be a breach of Article VI of this Agreement shall be pursuant to the indemnification provisions set forth in this Article VIII. Apart from any interim measure ( misura cautelare ), Buyer hereby waives, from and after Closing, to the fullest extent permitted by law, any and all other rights, it may have against Seller relating to any matter that would be a breach of Article VI of this Agreement.

(d)           Notwithstanding anything to the contrary, if the Seller has paid an amount in discharge of any claim under this Agreement and the Buyer or Company subsequently recovers (whether by payment, discount, credit, relief or otherwise) from any person a sum which indemnifies or compensates the Buyer or the Company (in whole or in part) in respect of the loss or liability which is the subject matter of the claim, the Buyer shall procure that the Company shall pay to the Seller as soon as practicable after receipt an amount equal to the lesser of (i) the sum recovered from the person less any costs and expenses incurred in obtaining recovery, less any Taxation attributable to the recovery after taking into account any relief available in respect of any matter giving rise to the claim, or (ii) the amount previously paid by the Seller or the Buyer less any Taxation attributable to it.

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(e)           For purposes of determining indemnification, in any Representation and Warranty modified by “Material Adverse Effect”, “materiality” or words of similar effect  such language shall have no effects whatsoever, such that the only limitations to the indemnifications are those expressly listed in this Section 8.02.

(f)           The limitations under this Section shall not apply in cases of fraud or willful misconduct by the Seller.

8.03 Buyer’s Indemnification.

(a)           Subject to Article VII above, during the period specified in Section 7.02 above and subject to the terms, conditions, exceptions and limitations within the limits set forth in this Section 8.03, Buyer shall indemnify  for and against any loss and/or damage incurred or suffered by the Seller resulting or deriving from any error, inaccuracy or breach of, or failure to perform, any and all covenants, representations and warranties given by Buyer contained in this Agreement, including any and all actions, suits, proceedings, claims, assessments, judgments, costs and expenses (including reasonable attorneys’ fees and disbursements) incident to any of the foregoing and all costs and expenses (including reasonable attorneys’ fees and disbursements) incurred by the Seller in enforcing its rights of indemnification in respect of any claim under this Agreement.

(b)            The Parties acknowledge that all limitations to indemnity under Section 8.02 shall apply in all applicable respects to the Buyer’s indemnification.

8.04 Indemnification Procedure.

(a)           Provided that written notice of a claim has been given prior to the expiration of the applicable period of time set forth in Article VII above with respect to indemnification obligations by any Indemnified Party (as hereinafter defined) to any Indemnifying Party (as hereinafter defined), then the applicable indemnification obligations shall survive as to such claims, until the claim has been finally resolved.

(b)           Whenever any claim or any fact arises for which any Party may seek indemnification under Article VIII hereof, the Party seeking indemnification (hereinafter the “ Indemnified Party ”) shall notify the Party from whom indemnification is sought (hereinafter the “ Indemnifying Party ”) in writing, as soon as reasonably practicable after such Indemnified Party has actual and full knowledge of such claim or of the facts constituting the basis for such claim (hereinafter the “ Notice of Claim ”). The Notice of Claim shall specify all facts known to such Indemnified Party giving rise to such indemnification claim, the amount or an estimate of the amount of the liability arising therefrom, and the basis of the Indemnified Party’s request for indemnification under this Agreement, and shall have attached copy of any papers served with respect to such claim.

(c)           The Parties hereby agree that the Buyer shall be entitled to request for indemnification under this Article VIII in respect to any indemnifiable loss on behalf of itself or the Company, in relation to any Seller’s breach of representations, warranties or covenants under this Agreement.

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(d)           If the facts giving rise to any indemnification claim under this Article VIII shall involve any actual claim or demand by any third party against the Indemnified Party, without prejudice to the right of the Indemnified Party to participate to the defence at its expense through counsel of its own choice, the Indemnifying Party shall be entitled to contest or defend such claim at its expense and through counsel of its own choice if it gives written notice of its intention to do so. In the event that the Indemnifying Party does not so elect to contest or defend any such claim the Indemnified Party may assume such defence. In the event that the Indemnifying Party so elects to contest or defend any such claim, the Indemnified Party shall co-operate fully with the Indemnifying Party in connection with such contest or defence and shall not interfere in any way with the defence or handling of the matter by the Indemnifying Party, provided that the Indemnified Party shall have the opportunity to consult with the Indemnifying Party at such times as it may reasonably request.

(e)           An Indemnified Party shall take all steps required by the ordinary diligence as referred to under Artcle 1227 paragraph 2 of the Italian Civil Code to mitigate all indemnifiable losses upon and after becoming aware of any event that could reasonably be expected to give rise to any losses that are indemnifiable hereunder.

8.05 Escrow Shares.

The Buyer shall be entitled to recover any amount due to the same under this Article VIII also by enforcing the Escrow Agreement.

8.06 Other Remedies

Subject to any mandatory provisions of Italian law, no breach or inaccuracy of any representation, warranty or obligation of any Parties set forth herein shall give rise to any right on the other Party to rescind or terminate this Agreement.

ARTICLE IX
Miscellaneous

9.01 Lock Up.

Save in respect of granting the Escrow Shares pursuant to Section 3.02(c), the Seller hereby agrees that it will not for the period from the Closing Date through the first anniversary of the Closing Date, (i) lend; offer; pledge; sell; contract to sell; sell any option or contract to purchase; purchase any option or contract to sell; grant any option, right, or warrant to purchase; or otherwise transfer or dispose of, directly or indirectly, any of the Shares or (ii) enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of the Shares, whether any such transaction described in clause (i) or (ii) above is to be settled by delivery of securities, in cash, or otherwise. Notwithstanding this Section 9.01, in the event there is a tender offer to acquire all of Buyer’s securities and such tender offer is recommended by the board of directors of the Buyer, the Seller shall be permitted to tender its Shares with the proceeds in respect of any Shares that are then subject to the Escrow Agreement to be placed under the Escrow Agreement.
 
9.02 Anika’s Board of Directors
 
(a)           Following the Closing Date, Seller may request that Buyer appoint a Board Designee (as defined below) to Buyer’s Board of Directors.  If Seller so requests, Buyer and Seller shall work together in good faith to identify and select a mutually acceptable candidate to serve on the Buyer’s Board of Directors, it being understood that if Seller proposes a candidate that is a qualified independent director, Buyer will not unreasonably withhold its agreement to such candidate.  Such candidate shall not be an Affiliate of Seller or any of Seller’s Affiliates, and shall be an independent third party and must generally be qualified and vetted by the Buyer’s Board of Directors under it existing policies and procedures.  A candidate identified and selected as provided above shall be referred to as a “ Board Designee ”.Once identified and selected, the Board Designee shall be appointed to Buyer’s Board of Directors (whether by replacement of an existing director or by expansion of the Board). From the point in time a mutually acceptable candidate is identified, the qualification and vetting process will take no longer than 90 days.  Once appointed to the Board, the Board Designee will be treated the same as any of the Buyer’s independent, non-executive, non-employee Directors (an “ Independent Director ”), for all purposes, including without limitation, provision of materials, compensation and expense reimbursement.
 
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(b)           Upon, joining the Board of Directors, the Board Designee shall be subject to the Buyer’s insider trading policy and statement and all other policies applicable to members of the Buyer’s Board of Directors.  The Buyer shall, subject to the same process as for all of its Independent Directors, nominate the Board Designee for re-election as a director at the end of each term of such Board Designee as part of the slate proposed by the Buyer’s Board of Directors that is included in the proxy statement of the Buyer relating to the election of directors, and shall provide the same level of support for the Board Designee as it provides to any other person standing for election as a director of the Buyer as part of such slate proposed by the Buyer’s Board of Directors.
 
 
(c)           The right to a Board Designee as set forth in this Section 9.02 shall terminate automatically at such time as the Seller ceases to hold, directly or indirectly, at least 1,400,000 Shares (as adjusted for stock splits, stock dividends, recapitalizations or the like).  In the event that a vacancy is created on the Buyer’s Board of Directors at any time by the resignation, death or disability of the Board Designee, so long as the Seller holds, directly or indirectly, at least 1,400,000 Shares (as adjusted for stock splits, stock dividends, recapitalizations or the like), another Board Designee may be selected as provided above to fill the vacancy created thereby, and the Buyer agrees to take at any time and from time to time, all actions necessary to accomplish the same.  In addition, the Buyer reserves the right to request the resignation of the Board Designee at such time as the Seller ceases to hold, directly or indirectly, less than 1,400,000 Shares (as adjusted for stock split, stock dividends, recapitalizations or the like).

9.03 US GAAP Account.

The Seller acknowledges that the Buyer will be required by applicable SEC regulations to report on a balance sheet of the Company as at the Closing Dateunder US GAAP. To this end the Seller agrees to use all reasonable endeavors  to cooperate with, and provide back-up documentation to the Buyer and the, auditors to be appointed by the Buyer for the purposes of re-stating the financial statements of the Company as at the Closing Date under US GAAP, at Buyer’s costs.

9.04 GAAP Accounts and SEC Requirements.

The Seller acknowledges that the Buyer will be required by applicable SEC regulations to report certain financial information of the Company after the Closing Date under US GAAP.  For the purpose of allowing the Buyer to comply with such applicable SEC regulations, the Seller shall provide by no later than January 31, 2010, the following:

(i)           audited financial statements of the Company as of December 31, 2008 and December 31, 2007, performed in accordance with U.S. Generally Accepted Auditing Standards, including the related balance sheets, statements of operations, cash flows and stockholders’ equity (deficit) for each of the years then ended, certified by the Company’s independent public accountants and accompanied by a copy of such auditor’s report;

(ii)           unaudited financial statements of the Company as of September 30, 2009 and September 30, 2008 prepared in similar format and detail as in (i) above;

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(iii)           such financial statements in (i) and (ii) above to be prepared in accordance with Italian GAAP and to include a footnote reconciliation of Italian GAAP net loss and quota holders’ equity to U.S. GAAP.  Buyer agrees to assist Seller and it’s auditors in this process; and

(iv)           all back-up documentation to the Buyer, its auditors and advisors.

All costs of producing the above materials under Italian GAAP shall be borne by Seller. All costs of re-statement under US GAAP shall be borne by Buyer.

9.05 Release of the Guarantees.

(a)           The Buyer shall decide in its own discretion, and shall communicate to the Seller such decision within 60 days of the day hereof whether or not to continue with the project and related financing to which the Assumed Obbligations (as defined below) are related.

If the Buyer decides to continue the project, the Buyer shall use all reasonable endeavors (including providing covenants of its own) to procure the release of Seller from all guarantees listed in Exhibit 9.05 (the “ Assumed Obligations ”) and shall indemnify and keep indemnified the Seller and all its Affiliates from all claims, liabilities, costs and expenses or by reason of any failure or breach by Buyer from and after the Closing Date that may trigger any third party rights under the Assumed Obligations without prejudice to any indemnification right that the Buyer may have against the Seller under this Agreement. The Buyer shall indemnify the Seller from all claims against the Seller arising from any action taken by the Buyer up to the date in which the relevant decision is communicated to the Seller.

(b)           The Seller represents and warrants that as of the Closing Date the Seller is not in breach of any agreement that may trigger any payment under the Assumed Obligations. Any indemnification obligations of the Seller under this Section 9.05 shall be subject to the limitations under Article VIII.

9.06 Seller’s Receivables

(a)           During the term of the Receivables Management Agreement all amounts recovered by the Company in respect of the Company’s Receivables shall be managed by the Seller pursuant to the Receivables Management Agreement and shall be used by the Company to pay the Seller’s Receivables as provided in the Receivables Management Agreement. At the end of the two year term of the Receivables Management Agreement, all outstanding Seller’s Receivables are hereby forgiven by the Seller.

(b)           The Seller undertakes, with respect to any Company’s receivables that is transferred to the Seller before Closing, not to commence any legal action to collect such receivables unless the intention to commence such action is previously communicated in writing to the Buyer.

9.07 Non competition.

(a)           The Seller, for itself and for its Affiliates hereby undertakes, for a period of 5 years after the Closing Date and within the Territory (as hereinafter defined):

(i)           not to, either on its own account or in conjunction with or on behalf of any person, carry on, engage, be concerned or interested, directly or indirectly, in the manufacture, sale, development or servicing of products competing with the products currently manufactured and/or sold and/or developed by the Company and/or with future products within the current Company’s areas of focus that  the Company will be completing, manufacturing or selling within the five years following the Closing Date;

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(ii)           without prior written consent of Anika, not to, either on its own account or in conjunction with or on behalf of any third party, hire, solicit or endeavour to entice away from the Company any person who at the Closing Date is an officer, manager, employee, consultant or servant of the Company, whether or not such person would commit a breach of contract by reason of leaving service or office.

(b)           The Seller and Buyer hereby represent to each other and acknowledge that the provisions contained in Paragraph (a) above of this Section 9.07 are necessary for the protection of Buyer’s interests. The compensation for all the obligations contained in this Section 9.07 has been taken into account in determining the Purchase Price.

(c)           For the purposes of Section 9.07(a) “ Territory ” shall mean all the countries in the world.

(d)           By way of exception to the undertakings of the Seller in Section 9.07(a), the Buyer acknowledges and accepts the existence and validity going forward of each of the Existing Product Agreements to be amended on the Closing Date and the Marketing Services Agreement, the Tolling Agreement and the Patent Licence Agreement.

(e)           The Buyer covenants at the Company’s election that the Company will (i) maintain CE product registrations for Wet products, Hyalogin – Hyalofemme products and Gen Aid products, each as provided in the relevant Existing Product Agreement or, (ii) make available to the Seller all relevant documentation to allow the Seller to obtain its own CE product registration for such Wet products, Hyalogin – Hyalofemme products and Gen Aid products.

9.08 Further Assurances.

From time to time, as and when requested by any Party and subject to the limitations set forth herein, the other Party will execute and deliver, or cause to be executed and delivered, all such documents and instruments as may be reasonably necessary to consummate the Transaction contemplated in this Agreement.

9.09 Use of Names.

The Buyer covenants to procure that the Company shall change its name to a name not including the words “Fidia Advanced Biopolymers™” within a period of 12 months after Closing, or such longer term that may be reasonably required also, without limitation, by any needed authorization procedure to be taken before any competent authority, and shall procure that all references to such name and to the trademark FAB™, to the extent allowed by any relevant laws, regulation and competent authority, are removed from all letterhead, signage, products publicity materials, commercial documents and materials owned or used by the Company within a period of 12 months after the Closing Date or such longer term that may be reasonably required also, without limitation, by any needed authorization procedure to be taken before any competent authority.

9.10  Records Retention.

(a)           The Buyer agrees, from and after the Closing, to retain all records relating to the Company and the development and manufacture of products thereby prior to the Closing Date, for as long as such records may be called upon for production by regulators or authorities or in court proceedings under applicable law. So long as such records are required to be retained by the Company or the Seller, the Seller shall have the right, upon reasonable prior notice during normal business hours, to inspect and obtained copies of any such records to comply to any request from regulators or authorities or courts decisions or requests and in respect of any matter related to this Agreement and the Transactions contemplated herein provided however that the Seller shall not be permitted to have access to financial and other business related information of the Company or the Buyer regarding the period after the Closing.

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(b)           The Parties agree that (A) the Seller may retain for as long as may be required under law after the Closing Date a copy of (1) all financial records of the Company, (2) any other books and records to the extent necessary for tax, accounting, litigation or other valid business purposes (B) any attorney work product, attorney-client communications and other items protected by privilege and any documents that were received from third parties in connection with the Transactions or that were prepared by the Seller or its Affiliates or the Company in connection therewith shall be excluded; and (C) both the Seller and the Buyer have a requirement to maintain records which are deemed to be active at the Closing Date. Consequently, the Seller may, upon request by regulators or authorities or in courts, obtain copies primarily in the format of digital images of these records and leave the Company with the original records. The Buyer will grant the Seller the right to process records which are deemed to be active just before and on the Closing Date as well as the operating space for processing records and adequate space for storing boxes, provided however this will cause no disruption to the Company.
 
9.11 Waiver of Action
 
The Buyer and the Seller waive (in the absence of fraud or willful misconduct) any right to bring a claim against any employee, director, advisor or officer of the Seller or the Buyer and any of their respective Affiliates  that may arise from any of the representations and warranties under Article V and Article VI or any other representation and warranties made in connection with the Transaction.

9.12  Employee Stability.

(a)           The Buyer warrants that for a period of 1 (one) year (the " Stability Period ") starting from the Closing Date:

(i)           the economic and general treatment of each Employee (" trattamento economico e normativo ") in any way paid, as well as the relevant " inquadramento ", included any rights, benefits, welfare programs, exit bonuses, any super minimo and pension funds schemes, shall be guaranteed by the Company in the same way as it is provided for by regulations and all applicable individual and collective bargaining agreements in force in the Company on the Closing Date;

(ii)           any dismissal of Employees by the Company shall be solely for just cause ( giusta causa ) or justified objective or subjective reasons ( giustificato motivo oggettivo o soggettivo ) or collective dismissal ( licenziamento collettivo ); and in any case in accordance with all applicable regulations under Italian law and collective or individual bargaining  agreements.
The Parties acknowledge that the previous Paragraph of this Section 9.12 shall in no event be interpreted as posing any limitation to the ability of the Buyer and/or the Company to carry out any individual or collective dismissal.

(b)           The Buyer shall indemnify and keep indemnified the Seller against any direct loss suffered by it as a result of any breach of the obligations of the Buyer under this Section provided that:
 
(i)           such indemnification shall be due only if any Employees involved obtain from a competent court a final judgment confirming the occurance of such breach; and
 
(ii)           the indemnification obligations of the Buyer shall be subject to the limitations under Article VIII.
 
9.13 Administrative Requirements.

(a)           Subject to the Seller meeting all costs and expenses incurred by the Buyer or the Company in connection therewith, the Buyer shall provide (and shall procure that the Company shall provide) the Seller with all such information and assistance as the Seller may reasonably require for the purposes of enabling the Seller to comply with any legal or regulatory requirements (and in particular, without limitation, for the purposes of preparing accounts or tax computations, or dealing with tax issues) and in particular, without limitation, the Buyer shall procure that the Buyer and the Company shall deliver to the Seller, in a timely manner, such data in connection with the fiscal year 2009 as the Seller may reasonably require.

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(b)           The Seller acknowledges that the confidentiality obligations arising under Section 9.16 shall also cover all the information disclosed to Seller under this Section 9.13.

9.14  Integration Services.

For one (1) year following the Closing Date, the Seller covenants to nominate a team leader and to cause such team leader to  assist the Buyer in the transition and integration of the Company from the Seller to the Buyer and agrees that all salary, wages, expenses and any benefits under any Seller benefit plans to which such employee is entitled shall be paid at Seller's sole expense.

Nothing contained in this Agreement shall create any third party beneficiary rights in such employee, any beneficiary or dependent thereof, with respect to the benefits that may be provided to such employee by the Seller or with respect to any entitlement of such employee to employment or continued employment with the Buyer or any Affiliate for any specified period after the Closing Date.  In addition, nothing in this Section 9.14 shall be construed as creating any employment agreement or right to future employment.

9.15 Insurances.

The Seller represents that the insurance policies referred to in Exhibit 9.15 shall remain in full force and effect after the Closing Date according to their expiration term as indicated therein.

9.16 Confidentiality - public announcement.

(a)           No announcement or disclosure to any entity other than the Parties concerning the sale of the Quota (or any ancillary matter) and this Agreement shall be made by either Party without the prior written approval of the other (such approval not to be unreasonably withheld or delayed). This Paragraph (a) does not apply in the circumstances described in Paragraph (b) below.

(b)           Either Party may, after consultation with the other Party, make an announcement concerning the purchase and sale of the Quota and this Agreement if (but to no greater extent than):

(i)           required by law; and

(ii)          necessary or advisable pursuant to any securities exchange or regulatory or governmental body to which that Party is subject, wherever situated, whether or not the requirement has the force of law or in connection with Buyer’s status as a public company;

in which cases the Party concerned shall take all such steps as may be reasonable and practicable in the circumstances to agree on the contents of such announcement with the other Party before making such announcement. Notwithstanding Paragraphs (a) and (b) above, the Buyer shall make such press release announcements or filings in connection with the Closing of the Transaction contemplated in this Agreement, which press release or filing shall include such disclosure as the Buyer’s counsel deems necessary or advisable in order to satisfy the Buyer’s securities law disclosure obligations.

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(c)           Each Party shall treat as Confidential Information all information received or obtained as a result of or in connection with the diligence, negotiations, signing and execution of this Agreement (including, without limitation, the execution of Section 9.10 below) which relates, among the others, to:

(i)           the content of this Agreement;

(ii)          the negotiations relating to this Agreement; and/or

(iii)         the other Party.

Each Party shall not use such Confidential Information for any purpose other than those permitted by, or needed for the execution of, this Agreement.  For purposes of this Agreement, “Confidential Information” includes, without limitation, all information, notes, analyses, compilations, Excel spread sheets, data, reports, studies, interpretations or other documents furnished to a Party or such Party’s Representatives (as defined below) or prepared by a Party or such Party’s Representatives to the extent such materials reflect or are based upon, in whole or in part, the Confidential Information.  For purposes of this Agreement the term “Representatives” shall include each Party and its Affiliates (as such term is defined in Rule 12b-2 of the Securities Exchange Act of 1934, as amended), directors, officers, employees, attorneys, accountants, financial advisors and other professional representatives and shall also include any of such Party’s sources of senior and/or subordinated debt financing.

(d)           Notwithstanding the other provisions of this Section 9.16, either Party may disclose Confidential Information:

(i)           to its employees, its Affiliates and any employees of its Affiliates who need to know such information if such persons are bound by confidentiality restrictions under the responsibility of the disclosing Party;

(ii)          to its professional advisors, auditors assisting in respect of the Transaction, if such professional advisors and auditors have agreed to appropriate confidentiality obligations under the responsibility of the disclosing Party;

(iii)         if and to the extent the information has already become public information through no fault or breach of any confidentiality obligation of that Party; and

(iv)         if and to the extent the other Party has given prior written consent to the disclosure.

(e)           In addition to any other confidentiality obligation pursuant to this Section 9.16, the Seller undertakes not to disclose to any third party any information, including Confidential Information, it may have on the Company and its business and not to use any such information for any purpose other than those permitted by, or needed for the execution of, this Agreement.  Seller hereby acknowledge that Seller, its Affiliates and its Representatives are aware that the United States securities laws prohibit any person who has material, non-public information concerning a company from purchasing or selling securities of such company or from communicating such information to any other person under circumstances in which it is reasonably foreseeable that such person is likely to purchase or sell such securities and you hereby acknowledge that Seller, its Affiliates and its Representatives are aware of the sanctions attaching to misuse or improper disclosure of any such material, non-public information relating to the Company.

(f)           The confidentiality provisions of this Section 9.16 shall replace those of any other confidentiality agreement effective between the Parties up to the Closing Date.

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(g)           The restrictions contained in Section 9.16(a) and Section 9.16(b) shall expire on the second anniversary of the Closing Date and the restriction with respect to the reminder of the  Confidential Information in this Section 9.16 shall expire on the fourth anniversary of the Closing Date; provided, however, that nothing in this Section 9.16 shall be deemed to prohibit the Buyer or the Company from making any disclosure to the extent which its respective counsel deems necessary or advisable in order to satisfy such party’s disclosure obligations imposed by law or in order to fulfill any covenant or obligation pursuant to this Agreement.

9.17 Changes in Writing.
 
This Agreement:

(a)           supersedes all prior agreements relating to the same matter including without limitation any previous letter of letter of intent;

(b)           may only be waived, changed, modified or discharged by an agreement in writing signed by all the Parties hereto, which shall also apply to this Section 9.17(b); and

(c)           contains, jointly with the Transaction Documents, the entire understanding between the Parties with respect to the subject matter thereof.

9.18 Successors. Assignment Prohibited.

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, consolidation, 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, in the case of assignment to an Affiliate, the Assigning Party remains jointly liable with such Affiliate and the agreement is automatically re-assigned if the Affiliate ceases to be an Affiliate of the Assigning Party, and provided further that this Agreement must be assigned to a successor in ownership of all or substantially all of the business or assets of 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 9.18 shall be void.  This Agreement shall inure to the benefit of, and be binding upon, the successors and permitted assigns of each of the parties.
 
9.19 Notices.

Any communication or notice required or permitted to be given under this Agreement shall be made in writing and in the English language and shall be deemed to have been duly and validly given (i) in the case of notice sent by letter, upon receipt of same, and (ii) in the case of notice sent by telefax, upon acknowledgement of successful and complete transmission by the fax machine of the sending Party, addressed, in each case, at the addresses indicated in the preamble or to such other address as each Party may hereafter furnish to the others by written notice, as herein provided.

9.20 Domicile.

Each Party for any purpose under this Agreement (including that of any judicial service) elects its domicile at the addresses referred to under Section 9.19 above.

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9.21 Severability.

If any provision of this Agreement is held to be illegal, invalid, or unenforceable under present or future laws effective during the term of this Agreement, such provision shall be fully severable; this Agreement shall be construed and enforced as if such illegal, invalid, or unenforceable provision had never comprised a part of this Agreement; and the remaining provisions of this Agreement shall remain in full force and effect and shall not be affected by the illegal, invalid or unenforceable provision or by its severance from this Agreement. Furthermore, in lieu of each such illegal, invalid, or unenforceable provision there shall be added automatically as a part of this Agreement a provision as similar in terms to such illegal, invalid or unenforceable provision as may be possible and be legal, valid and enforceable.

9.22 Fees and Expenses.

(a)           Each of Buyer and Seller shall bear its own costs and expenses incurred in connection with this Agreement (including but not limited to advisors' and attorneys' fees) regardless of whether the Transaction or Closing is consummated or not and none of such costs and expenses shall be borne by or be for the account of the Company.

(b)           All stamp duties, registration taxes and notary fees relating to the sale of the Quota and the issue of the Shares to the Seller shall be borne by the Buyer.

ARTICLE X
Law - Jurisdiction

10.01 Applicable Law.

This Agreement shall be governed, in all respects, including validity, interpretation and effect by the laws of the Republic of Italy.

10.02 Arbitration.

(a)           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”).

(b)           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.

(c)           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.

(d)           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.

(e)           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.

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(f)           Notwithstanding the dispute resolution process set forth in this Section 10.02, in the event of an actual or threatened breach hereunder, the aggrieved Party may seek equitable relief (including restraining orders, specific performance or other injunctive relief) in a court of competent jurisdiction without submitting to such dispute resolution process if there is a reasonable likelihood of the occurrence of irreparable harm during the period of the dispute resolution process.

10.03 Enforceability.

Each Party represents and warrants to the other Party that any award rendered against such Party in accordance with Section 10.02 above shall be enforceable in its country and jurisdiction according to applicable laws and that the other Parties shall be entitled to institute proceedings to this effect including proceedings for attachment against such Party’s properties before any court of competent jurisdiction and venue.

---§---

 
 
 
/s/ Antonio Germani
 
/s/ Charles H. Sherwood
     Fidia Farmaceutici S.p.A.
 
     Anika Therapeutics Inc.
     (Mr. Antonio Germani)
 
     (Dr. Charles Sherwood)
 
 
 
 
 
46

Exhibit 10.1
 
Execution Copy
 
REGISTRATION RIGHTS AGREEMENT
 
THIS REGISTRATION RIGHTS AGREEMENT (“ Agreement ”) is entered into as of December 30, 2009 between ANIKA THERAPEUTICS INC., a company incorporated under the laws of the Commonwealth of Massachusetts (the “ Company ”) and FIDIA FARMACEUTICI S.P.A., a company incorporated under the laws of Italy (the “ Investor ”).
 
RECITALS
 
WHEREAS , pursuant to that certain Sale and Purchase Agreement, dated as of the date hereof (the “ Purchase Agreement ”), the Company has agreed to issue to the Investor 1,981,192 shares (the “ Shares ”) of the Company’s common stock, par value U.S. $0.01 per share (“ Common Stock ”), pursuant to the terms and conditions of the Purchase Agreement and for the consideration specified therein; and
 
WHEREAS , it is a condition precedent to the closing under the Purchase Agreement that the Company and the Investor have entered into this Agreement.
 
NOW, THEREFORE , in consideration of the recitals and the mutual premises, covenants and agreements contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto hereby agree as follows:
 
1.            Definitions .  For purposes of this Agreement:
 
1.1.           “ Damages ” means any loss, damage, or liability (joint or several) to which a party hereto may become subject under the Securities Act, the Exchange Act, or other U.S. federal or U.S. state law, insofar as such loss, damage, or liability (or any action in respect thereof) arises out of or is based upon (i) any untrue statement or alleged untrue statement of a material fact contained in any registration statement of the Company, including any preliminary prospectus or final prospectus contained therein or any amendments or supplements thereto; (ii) an omission or alleged omission to state therein a material fact required to be stated therein, or necessary to make the statements therein not misleading; or (iii) any violation or alleged violation by the indemnifying party (or any of its agents or Affiliates (as defined in the Purchase Agreement)) of the Securities Act, the Exchange Act, any state securities law, or any rule or regulation promulgated under the Securities Act, the Exchange Act, or any state securities law.
 
1.2.           “ Demand Registration Period ” means any period of time after the first anniversary of the Closing Date (as defined in the Purchase Agreement) during which the Company is eligible to use a Form S-3.
 
1.3.           “ Exchange Act ” means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.
 
1.4.           “ Excluded Registration ” means (i) a registration statement relating to the sale of securities to employees of the Company or a subsidiary of the Company pursuant to a stock option, stock purchase, or similar equity incentive plan; (ii) a registration statement relating to an SEC Rule 145 transaction; (iii) a registration statement on any form that does not include substantially the same information as would be required to be included in a registration statement covering the sale of the Registrable Securities; or (iv) a registration statement relating to the issuance by the Company of securities other than (A) the Company’s Common Stock or (B) any securities having substantially equivalent rights and ranking with the Company’s Common Stock (“ Equivalent Stock ”).
 

 
1.5.           “ Form S-1 ” means such form under the Securities Act as in effect on the date hereof or any successor registration form under the Securities Act subsequently adopted by the SEC.
 
1.6.           “ Form S-2 ” means such form under the Securities Act as in effect on the date hereof or any successor registration form under the Securities Act subsequently adopted by the SEC.
 
1.7.           “ Form S-3 ” means such form under the Securities Act as in effect on the date hereof or any registration form under the Securities Act subsequently adopted by the SEC that permits incorporation of substantial information by reference to other documents filed by the Company with the SEC.
 
1.8.           “ Registrable Securities ” means (i) the Shares; and (ii) any Common Stock issued as (or issuable upon the conversion or exercise of any warrant, right, or other security that is issued as) a dividend or other distribution with respect to, or in exchange for or in replacement of, (a) the Shares or (b) any shares of Common Stock issuable under this clause (ii).
 
1.9.           “ SEC ” means the United States Securities and Exchange Commission.
 
1.10.         “ SEC Rule 144 ” means Rule 144 promulgated by the SEC under the Securities Act.
 
1.11.         “ SEC Rule 145 ” means Rule 145 promulgated by the SEC under the Securities Act.
 
1.12.         “ Securities Act ” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.
 
1.13.         “ Selling Expenses ” means all underwriting discounts, selling commissions, and stock transfer taxes applicable to the sale of Registrable Securities, and fees and disbursements of counsel for the Investor.
 
2.            Registration Rights .  The Company covenants and agrees as follows:
 
2.1.            Demand Registration .
 
(a)           Subject to termination of the registration rights under Section 2.3 and to the limitations of   Section 2.3 , (i)   at any time during a Demand Registration Period, the Investor may by notice to the Company request that the Company file a Form S-3 registration statement with respect to the outstanding Registrable Securities of the Investor and (ii) upon such request, the Company shall as soon as practicable, and in any event within forty-five (45) days after the date such request is given by the Investor, file a Form S-3 registration statement under the Securities Act covering all Registrable Securities that the Investor requests to be included in such registration statement.  Notwithstanding anything contained herein to the contrary, the Investor may not make any demand pursuant to Section 2.1(a)(i) after a registration statement has become effective for Registrable Securities of the Investor pursuant to a previous demand under Section 2.1(a)(i) .  The Company shall not be obligated to effect, or to take any action to effect, any registration statement pursuant to Section 2.1(a)(i) during the period that is thirty (30) days before the Company’s good faith estimate of the date of filing of, and ending on a date that is ninety (90) days after the effective date of, a Company-initiated registration of Common Stock (other than a registration that is an Excluded Registration), provided , that the Company is actively employing in good faith commercially reasonable efforts to cause such registration statement to become effective.
 
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(b)           Notwithstanding the foregoing obligations, if the Company furnishes to the Investor a certificate signed by the Company’s chief executive officer stating that in the good faith judgment of the Company’s board of directors it would be materially detrimental to the Company and its stockholders for such registration statement to either become effective or remain effective for as long as such registration statement otherwise would be required to remain effective, because such action would (i) interfere with a significant acquisition, corporate reorganization, or other similar transaction involving the Company; (ii) require premature disclosure of material information that the Company has a bona fide business purpose for preserving as confidential; or (iii) render the Company unable to comply with requirements under the Securities Act or Exchange Act, then the Company shall have the right to defer taking action with respect to such filing, for a period of not more than one hundred twenty (120) days after the request of the Investor is given; provided , however , that the Company may not invoke this right more than once in any twelve (12) month period; and provided , further , that the Company shall not register any securities for its own account or that of any other stockholder during such one hundred twenty (120) day period other than any registration specified in clauses (i), (ii) or (iv) of the definition of Excluded Registration.
 
2.2.            Piggyback Registration .  If the Company proposes to register (including, for this purpose, a registration effected by the Company for stockholders other than the Investor) any of its Common Stock or Equivalent Stock under the Securities Act in connection with the public offering of such securities solely for cash (other than in an Excluded Registration), the Company shall, at such time, promptly give the Investor notice of such registration.  Upon the request of the Investor given within fifteen (15) days after such notice is given by the Company, the Company shall, subject to the provisions of Sections 2.3, 2.4(b) and 3.10 , cause to be registered all of the Registrable Securities that the Investor requests to be included in such registration.  The Company shall have the right to terminate or withdraw any registration initiated by it under this Section 2.2 before the effective date of such registration, whether or not the Investor has elected to include Registrable Securities in such registration.  The expenses (other than Selling Expenses) of such withdrawn registration shall be borne by the Company in accordance with Section 2.7 .
 
2.3.            Termination of Registration Rights .  The right of the Investor to request registration pursuant to Section 2.1 shall terminate after a registration statement has become effective for Registrable Securities of the Investor pursuant to a request made by the Investor under Section 2.1 .  The right of the Investor to request inclusion of Registrable Securities in any registration pursuant to Section 2.2 shall terminate at such time as the Investor holds fewer than twenty-five percent (25%) of the Shares (as adjusted for any stock splits, stock dividends, recapitalizations or the like).
 
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2.4.            Underwriting Requirements .
 
(a)           A registration requested under Section Section   2.1 may not be by means of an underwriting.
 
(b)           In connection with any offering involving an underwriting of shares of the Company’s capital stock pursuant to Section 2.2 , the Company shall not be required to include any of the Investor’s Registrable Securities in such underwriting unless the Investor accepts the terms of the underwriting as agreed upon between the Company and its underwriters, and then only in such quantity as the underwriters in their sole discretion determine will not jeopardize the success of the offering by the Company.  If the total number of Registrable Securities requested by the Investor to be included in such offering exceeds the number of securities to be sold that the underwriters in their sole discretion determine is compatible with the success of the offering, then the Company shall be required to include in the offering only that number of Registrable Securities, which the underwriters and the Company in their sole discretion determine will not jeopardize the success of the offering.   
 
2.5.            Obligations of the Company .  Whenever required under this Section 2 to effect the registration of any Registrable Securities, the Company shall, as expeditiously as reasonably possible:
 
(a)           prepare and file with the SEC a registration statement with respect to such Registrable Securities and use its commercially reasonable efforts to cause such registration statement to become effective and keep such registration statement effective for a period of no less than one hundred twenty (120) days or, if earlier, until the distribution contemplated in the registration statement has been completed; provided , however , that (i) such one hundred twenty (120) day period shall be extended for a period of time equal to the period the Investor refrains, at the request of the Company, from selling any securities included in such registration, and (ii) in the case of any registration of Registrable Securities on Form S-3 that are intended to be offered on a continuous or delayed basis, subject to compliance with applicable SEC rules, such one hundred twenty (120) day period shall be extended for up to ninety (90) days, if necessary, to keep the registration statement effective until all such Registrable Securities are sold;
 
(b)           prepare and file with the SEC such amendments and supplements to such registration statement, and the prospectus used in connection with such registration statement, as may be necessary to comply with the Securities Act in order to enable the disposition of all securities covered by such registration statement;
 
(c)           furnish to the Investor such numbers of copies of a prospectus, including a preliminary prospectus, as required by the Securities Act, and such other documents as the Investor may reasonably request in order to facilitate its disposition of its Registrable Securities;
 
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(d)           use its commercially reasonable efforts to register and qualify the securities covered by such registration statement under such other U.S. securities or blue-sky laws of such U.S. jurisdictions as shall be reasonably requested by the Investor; provided that the Company shall not be required to qualify to do business or to file a general consent to service of process in any such states or jurisdictions, unless the Company is already subject to service in such jurisdiction and except as may be required by the Securities Act;
 
(e)           in the event of any underwritten public offering under Section 2.2 , enter into and perform its obligations under an underwriting agreement, in usual and customary form, with the underwriter(s) of such offering;
 
(f)           use its commercially reasonable efforts to cause all such Registrable Securities covered by such registration statement to be listed on a U.S. national securities exchange or trading system and each securities exchange and trading system (if any) on which similar securities issued by the Company are then listed;
 
(g)           provide a transfer agent and registrar for all Registrable Securities registered pursuant to this Agreement and provide a CUSIP number for all such Registrable Securities, in each case not later than the effective date of such registration;
 
(h)           at least 48 hours prior to the filing of any registration statement or prospectus with respect to such Registrable Securities, or any amendment or supplement thereto, furnish a copy thereof to the Investor and refrain from filing any such registration statement, prospectus, amendment or supplement to which counsel to the Investor shall have reasonably objected on the grounds that such document does not comply in all material respects with the requirements of the Securities Act, unless, in the case of an amendment or supplement, in the opinion of counsel for the Company the filing of such amendment or supplement is reasonably necessary to protect the Company from any liabilities under any applicable federal or state law and such filing will not violate applicable laws;
 
(i)           notify the Investor, promptly after the Company receives notice thereof, of the time when such registration statement has been declared effective or a supplement to any prospectus forming a part of such registration statement has been filed; and
 
(j)           after such registration statement becomes effective, notify the Investor of any request by the SEC that the Company amend or supplement such registration statement or prospectus.
 
2.6.            Furnish Information .  It shall be a condition precedent to the obligations of the Company to take any action pursuant to this Section 2 with respect to the Registrable Securities of the Investor that the Investor shall furnish to the Company such information regarding itself, the Registrable Securities held by it, and the intended method of disposition of such securities as is reasonably required to effect the registration of the Investor’s Registrable Securities.
 
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2.7.            Expenses of Registration .  All expenses (other than Selling Expenses) incurred in connection with registrations, filings, or qualifications pursuant to this Section 2 , including all registration, filing, and qualification fees; printers’ and accounting fees; and fees and disbursements of counsel for the Company, shall be borne and paid by the Company; provided , however , that the Company shall not be required to pay for any expenses of any registration proceeding begun pursuant to Section 2.1 if the registration request is subsequently withdrawn at the request of the Investor (in which case the Investor shall bear such expenses), unless the Investor agrees to forfeit its registration rights under Section 2.1 (a) ; provided further that if, at the time of such withdrawal, the Investor has learned of a material adverse change in the condition, business, or prospects of the Company from that known to the Investor at the time of its request and that has not otherwise been publicly disclosed by the Company in its SEC filings, and has withdrawn the request with reasonable promptness after learning of such information, then the Investor shall not be required to pay any of such expenses and shall not forfeit its registration rights under Section 2.1(a) .  All Selling Expenses relating to Registrable Securities registered pursuant to this Section 2 shall be borne and paid by the Investor.
 
2.8.            Indemnification .  If any Registrable Securities are included in a registration statement under this Section 2 :
 
(a)           To the extent permitted by law, the Company will indemnify and hold harmless the Investor, and the partners, members, officers, directors, Affiliates, and stockholders of the Investor; legal counsel and accountants for the Investor; any underwriter (as defined in the Securities Act) for the Investor; and each Person (as defined in the Purchase Agreement), if any, who controls such Investor or underwriter within the meaning of the Securities Act or the Exchange Act, against any Damages, and the Company will pay to the Investor, underwriter, controlling Person, or other aforementioned Person any legal or other expenses reasonably incurred thereby in connection with investigating or defending any claim or proceeding from which Damages may result, as such expenses are incurred; provided , however , that the indemnity agreement contained in this Section 2.8(a) shall not apply to amounts paid in settlement of any such claim or proceeding if such settlement is effected without the consent of the Company, nor shall the Company be liable for any Damages to the extent that they arise out of or are based upon actions or omissions made in reliance upon and in conformity with written information furnished by or on behalf of the indemnified Person expressly for use in connection with such registration.
 
(b)           To the extent permitted by law, the Investor will indemnify and hold harmless the Company, and each of its directors, each of its officers who has signed the registration statement, each Person (if any), who controls the Company within the meaning of the Securities Act, legal counsel and accountants for the Company, any underwriter (as defined in the Securities Act), and any controlling Person of any such underwriter, against any Damages, in each case only to the extent that such Damages arise out of or are based upon actions or omissions made in reliance upon and in conformity with written information furnished by or on behalf of the Investor expressly for use in connection with such registration; and the Investor will pay to the Company and each other aforementioned Person any legal or other expenses reasonably incurred thereby in connection with investigating or defending any claim or proceeding from which Damages may result, as such expenses are incurred; provided , however , that the indemnity agreement contained in this Section 2.8(b) shall not apply to amounts paid in settlement of any such claim or proceeding if such settlement is effected without the consent of the Investor; and provided further that in no event shall any indemnity under this Section 2.8(b) exceed the proceeds from the offering received by the Investor (net of any Selling Expenses paid by the Investor), except in the case of fraud or willful misconduct by the Investor.
 
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(c)           Promptly after receipt by an indemnified party under this Section 2.8 of notice of the commencement of any action (including any governmental action) for which a party may be entitled to indemnification hereunder, such indemnified party will, if a claim in respect thereof is to be made against any indemnifying party under this Section 2.8 , give the indemnifying party notice of the commencement thereof, but any failure or delay in giving such notice shall not relieve the indemnifying party from any liability except to the extent that it is materially prejudiced by such failure or delay.  The indemnifying party shall at its election have the right to either (i) participate in such action or (ii) to assume the defense thereof; provided , however , that the indemnified parties as a group (together with all other indemnified parties that may be represented without conflict by one counsel) shall have the right to retain one separate counsel, with the reasonable fees and expenses to be paid by the indemnifying party, if representation of such indemnified party(ies) by the counsel retained by the indemnifying party would be inappropriate due to actual or potential differing interests between such indemnified party(ies) and any other party represented by such counsel in such action.
 
(d)           To provide for just and equitable contribution to joint liability under the Securities Act in any case in which either (i) any party otherwise entitled to indemnification hereunder makes a claim for indemnification pursuant to this Section 2.8 but it is judicially determined (by the entry of a final judgment or decree by a court of competent jurisdiction and the expiration of time to appeal or the denial of the last right of appeal) that such indemnification may not be enforced in such case, notwithstanding the fact that this Section 2.8 provides for indemnification in such case, or (ii) contribution under the Securities Act may be required on the part of any party hereto for which indemnification is provided under this Section 2.8 , then, and in each such case, such parties will contribute to the aggregate losses, claims, damages, liabilities, or expenses to which they may be subject (after contribution from others) in such proportion as is appropriate to reflect the relative fault of each of the indemnifying party and the indemnified party in connection with the statements, omissions, or other actions that resulted in such loss, claim, damage, liability, or expense, as well as to reflect any other relevant equitable considerations.  The relative fault of the indemnifying party and of the indemnified party shall be determined by reference to, among other things, whether the untrue or allegedly untrue statement of a material fact, or the omission or alleged omission of a material fact, relates to information supplied by the indemnifying party or by the indemnified party and the parties’ relative intent, knowledge, access to information, and opportunity to correct or prevent such statement or omission; provided , however , that, in any such case, (x) the Investor will not be required to contribute any amount in excess of the public offering price of all such Registrable Securities offered and sold by the Investor pursuant to such registration statement, and (y) no Person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) will be entitled to contribution from any party who was not guilty of such fraudulent misrepresentation; and provided further that in no event shall the Investor’s liability pursuant to this Section 2.8(d) , when combined with the amounts paid or payable by the Investor pursuant to Section 2.8(b) , exceed the proceeds from the offering received by the Investor (net of any Selling Expenses paid by the Investor), except in the case of willful misconduct or fraud by the Investor.
 
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(e)           Unless otherwise superseded by an underwriting agreement entered into in connection with the underwritten public offering under Section 2.2 , the obligations of the Company and the Investor under this Section 2.8 shall survive the completion of any offering of Registrable Securities in a registration under this Section 2 2.8 , and otherwise shall survive the termination of this Agreement.
 
2.9.            Reports Under Exchange Act .  With a view to making available to the Investor the benefits of SEC Rule 144 and any other rule or regulation of the SEC that may at any time permit the Investor to sell securities of the Company to the public without registration or pursuant to a registration on Form S-3, the Company shall:
 
(a)           use commercially reasonable efforts to make and keep available adequate current public information, as those terms are understood and defined in SEC Rule 144;
 
(b)           use commercially reasonable efforts to file with the SEC in a timely manner all reports and other documents required of the Company under the Securities Act and the Exchange Act; and
 
(c)           furnish to the Investor, forthwith upon request (i) to the extent accurate, a written statement by the Company that it has complied with the reporting requirements of SEC Rule 144, the Securities Act, and the Exchange Act, or that it qualifies as a registrant whose securities may be resold pursuant to Form S-3; and (ii) such other information as may be reasonably requested in availing the Investor of any rule or regulation of the SEC that permits the selling of any such securities without registration or pursuant to Form S-3.
 
2.10.            “Market Stand-off” Agreement .  The Investor hereby agrees that it will not, without the prior written consent of the managing underwriter, during the period commencing on the date of the final prospectus relating to the registration by the Company for its own behalf of shares of its Common Stock or any other securities of the Company, under the Securities Act on a registration statement on Form S-1, Form S-2, or Form S-3 and ending on the date specified by the Company and the managing underwriter (such period not to exceed ninety (90) days, which period may be extended upon the request of the managing underwriter, to the extent required by any NASD rules, for an additional period of up to fifteen (15) days if the Company issues or proposes to issue an earnings or other public release within fifteen (15) days of the expiration of the 90-day lockup period), (i) lend; offer; pledge; sell; contract to sell; sell any option or contract to purchase; purchase any option or contract to sell; grant any option, right, or warrant to purchase; or otherwise transfer or dispose of, directly or indirectly, any shares of Common Stock or any securities convertible into or exercisable or exchangeable (directly or indirectly) for Common Stock held immediately before the effective date of the registration statement for such offering or (ii) enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of such securities, whether any such transaction described in clause (i) or (ii) above is to be settled by delivery of Common Stock or other securities, in cash, or otherwise.  The foregoing provisions of this Section 2.10 shall not apply to (i) any shares included in such registration statement pursuant to the Investor’s rights under Section 2.2 or (ii) the sale of any shares to an underwriter pursuant to an underwriting agreement, and shall be applicable to the Investor only if all senior officers and directors of the Company are subject to the same restrictions.  The underwriters in connection with such registration are intended third-party beneficiaries of this Section 2.10 and shall have the right, power, and authority to enforce the provisions hereof as though they were a party hereto.  The Investor further agrees to execute such agreements as may be reasonably requested by the underwriters in connection with such registration that are consistent with this Section 2.10 or that are necessary to give further effect thereto.
 
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3.            Miscellaneous .
 
3.1.            Successors and Assigns .  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, except that this Agreement may be assigned or transferred in full to a successor in ownership of all or substantially all of the business or assets of the Investor (whether by merger, consolidation, sale or otherwise) without the prior consent of the Company; provided, that the Investor provides written notice to the Company of such assignment and the assignee of this Agreement agrees in writing to be bound as such party hereunder; and provided further, that this Agreement must be assigned to and shall be assumed by and enforceable against a successor in ownership of all or substantially all of the business or assets of the Company (whether by merger, consolidation, sale or otherwise).  Notwithstanding anything to the contrary in this Agreement, any assignment, delegation or transfer, or any such assignment or transfer, in violation of this Section 3.1 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. 
 
3.2.            Governing Law .  This Agreement shall be governed, in all respects, including validity, interpretation and effect by the laws of the Commonwealth of Massachusetts, without regards to conflicts of law principles that could result in the application of the law of any other jurisdiction.
 
3.3.            CONSENT TO JURISDICTION .  EACH PARTY HERETO HEREBY IRREVOCABLY AGREES THAT ANY SUIT, ACTION, PROCEEDING OR CLAIM AGAINST IT ARISING OUT OF OR IN ANY WAY RELATING TO THIS AGREEMENT, OR ANY JUDGMENT ENTERED BY ANY COURT IN RESPECT THEREOF, MAY BE BROUGHT OR ENFORCED IN THE STATE OR FEDERAL COURTS LOCATED IN THE COMMONWEALTH OF MASSACHUSETTS, AND EACH PARTY HERETO HEREBY IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY LAW, ANY OBJECTION WHICH IT MAY NOW OR HEREAFTER HAVE TO THE VENUE OF ANY PROCEEDING BROUGHT IN THE COMMONWEALTH OF MASSACHUSETTS AND FURTHER IRREVOCABLY WAIVES ANY CLAIMS THAT ANY SUCH PROCEEDING HAS BEEN BROUGHT IN AN INCONVENIENT FORUM.
 
3.4.            Counterparts ; Facsimil e .  This Agreement may be executed and delivered  (i) by facsimile or PDF signature and (ii) in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
 
-9-

 
3.5.            Titles and Subtitles .  The titles and subtitles used in this Agreement are for convenience only and are not to be considered in construing or interpreting this Agreement.
 
3.6.            Notices .  Any communication or notice required or permitted to be given under this Agreement shall be made in writing and in the English language and shall be deemed to have been duly and validly given (i) in the case of notice sent by letter, upon receipt of the same, and (ii) in the case of notice sent by telefax, upon acknowledgement of successful and complete transmission by the fax machine of the sending party, addressed, in each case, to the addresses indicated in the preamble of the Purchase Agreement or to such other address as each party may hereafter furnish to the other by written notice, as herein provided.
 
3.7.            Amendments and Waivers .  This Agreement may only be waived, changed, modified or discharged by an agreement in writing signed by the Company and the Investor.  No waivers of or exceptions to any term, condition, or provision of this Agreement, in any one or more instances, shall be deemed to be or construed as a further or continuing waiver of any such term, condition, or provision.
 
3.8.            Severability .  In case any one or more of the provisions contained in this Agreement is for any reason held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality, or unenforceability shall not affect any other provision of this Agreement, and such invalid, illegal, or unenforceable provision shall be reformed and construed so that it will be valid, legal, and enforceable to the maximum extent permitted by law.
 
3.9.            Entire Agreement .  This Agreement: (a) supersedes all prior agreements relating to the same matter and (b) contains, jointly with the Purchase Agreement, the entire understanding between the Investor and the Company with respect to the subject matter hereof.
 
3.10.            Termination .  Notwithstanding anything contained in this Agreement to the contrary, this Agreement shall terminate and the Company shall have the right to terminate or withdraw any then effective registration statement relating to Registrable Securities, at any time that the Investor is able to sell its outstanding Registrable Securities without restriction under SEC Rule 144(b)(1) as a Person that is not an “affiliate” of the Company (within the meaning of SEC Rule 144).  For all purposes of this Agreement, whether the Investor is able to “sell its outstanding Registrable Securities without restriction under SEC Rule 144(b)(1),” including without limitation whether the Investor is not an “affiliate” of the Company (within the meaning of SEC Rule 144), shall be determined by the Investor, reasonably and in good faith after consultation with its counsel.  In the event the Company and the Investor disagree as to the Investor’s status as an “affiliate,” then the Company and the Investor agree to discuss such matter in good faith; provided , that the final determination shall be made by the Investor, acting reasonably and in good faith, and taking into consideration the discussions with the Co mpany.
 
[Remainder of Page Intentionally Left Blank]
 
 
-10-

 
IN WITNESS WHEREOF , the parties have executed this Agreement as of the date first written above.
 
 
 
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  
       
 
 
 
-11-

Exhibit 10.2
 
 
 
 
 
 
 
 
 
 
FIDIA FARMACEUTICI S.PA.
 
and
 
FIDIA ADVANCED BIOPOLYMERS S.R.L.
 
 
 
 
     
 
 
 
LEASE AGREEMENT
 
 
 
 
 
 
 
 
 
 
 
 
 

 

 
This Lease Agreement (“ Agreement ”) is entered into on December 30, 2009,

between

Fidia Farmaceutici S.p.A., an Italian limited liability company with registered office in Via Ponte della Fabbrica 3A, Abano Terme (PD), Italy (“ Fidia ” or the “ Lessor ”)

and

Fidia Advanced Biopolymers S.r.l., located at   Via Ponte della Fabbrica 3B, Abano Terme (PD), Italy (" FAB " or the " Lessee ")
 
(hereinafter jointly referred to as the “ Parties ” and each one as a “ Party ”)
 
WHEREAS

(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.
 
In consideration of the mutual covenants contained herein, the Parties covenant and agree as follows:

2

 
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).
 
3

 
 
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
 
Subject to any agreed adjustment on the basis of the number of square metres leased as set out in this Section, the total rent for the Property has been agreed to be Euro 34,026 monthly (the “ Amount ”) starting from the date of the delivery of the Property pursuant to Section 1.2.1 above, with the exclusion of the additional charges indicated in Article 6, plus VAT as set by the law.
 
The Amount shall be calculated as follows:
 
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

4

 
In the event that the Lessee, at any time and for any reason, needs either to reduce or to extend the occupancy of the above listed areas of the Property, the Lessor and Lessee expressly undertake to discuss in good faith terms and conditions of such extension/reduction, which shall not be unreasonably denied by the Lessor.
 
The Parties acknowledge that the Amount already include consumption of electricity, drinking and industrial water, gas, heating, air-conditioning and cleaning (in the latter case, with the exclusion of the cleaning of the production facility Tissue Tech whose costs shall be paid directly by FAB).
 
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
 
Any authorisation applied for in connection with business activities, the environment, security and any administrative permits required for the regular performance of the commercial activities of the Lessee will be at the Lessee’s expense. Any charge required to obtain the relevant authorisations and their maintenance cost shall be at the Lessee’s expense. All material authorizations required to be obtained by the Lessor or by the lessee prior to the Closing Date and needed to operate the business are currently in effect.
 
4.2
Taxes
 
During each taxable period falling within the whole duration of the Agreement, any taxes relating to the use of the Property, including the waste collection tax, shall be borne by the Lessee. For sake of clarity, the Local Tax on Immovable Property ( Imposta Comunale sugli Immobili ) shall be borne solely by the Lessor.
 
5

 
5.
PAYMENT OF RENTS AND ADDITIONAL CHARGES
 
5.1
Payment deadline
 
The Amount payable by the Lessee shall be invoiced monthly on the first day of each month. The payment date shall be 60 days after the date of each invoice.
 
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.
 

6

 
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.
 
7

 
10.
CUSTODY
 
10.1
Lessee’s liability
 
The Lessee is responsible for the custody of the leased Property and will be liable for any damage that may occur to it under article 1588 of the Italian Civil Code.
 
11.
ACCESS TO THE PROPERTY
 
11.1
Lessor’s access
 
The Lessor and its designated representatives will at any time have full access to the Property by giving at least 48 hours’ written notice to the Lessee prior to his visit except in emergency cases, for the purpose to check the state and condition of the leased premises and to carry out any relevant intervention and repair work.
 
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
 
The Lessee undertakes to subscribe, at its own expense, appropriate insurance policies with a major insurance company to cover any risks concerning the activity exercised in the Property and the movable assets, owned by the Lessee, located in the Property and to deliver to the Lessor a certificate of insurance naming the Lessor as additional insured (including, without limitation, fire, hazard and civil liability).
 
The Lessor undertakes to subscribe, at its own expense, appropriate insurance policies with a major insurance company to cover any risks relating to ownership of the Property, including, without limitation, risk of fire, storm damage and other natural disasters and to deliver the Lessee a certificate of insurance naming the Lessee as additional insured.

8

 
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.
 
For purposes of this Agreement:
 
(i)            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 Affiliates, by contract or otherwise, or (ii) the beneficial ownership, directly or indirectly, of at least 50% of the voting securities of a person.
 
(ii)            Affiliates : means, with respect to a person, means any company or entity which Controls, is Controlled by or is under common Control with such person.
 
9

 
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
 
The registration fee related to this Agreement shall be borne on a 50/50 basis by the Parties.
 
16.2
Amendments
 
Any amendments to this Agreement will be effective as long as it is done in writing and signed by both Parties.
 
16.3
Penalties
 
At the expiry of this Agreement for any reasons whatsoever, the Lessee shall release the Property free of people and items and in the full availability to the Lessor on the 10 th day subsequent to the expiry of this Agreement. In case of delay, a penalty shall apply equal to Euro 1,000 for any day of delay, without prejudice to the reimbursement of any greater damages.
 
16.4
Jurisdiction
 
The Court of Padua shall have jurisdiction to hear any dispute arising out of the interpretation and performance of this Agreement.
 
16.5
Communications
 
Any communication between the Parties under this Agreement shall be in writing to the addresses set out at the heading of this Agreement and will be not considered valid unless they are delivered personally or sent via registered mail to such addresses.
 
16.6
Language
 
This Agreement is drawn up and executed in the English language. In addition, a translation of this Agreement into Italian will be executed for the purposes of registration purposes in Italy. In case of any dispute, the English language text prevails.
 
10

 
16.7
Confidentiality
 
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 date hereof) 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; provided, that the obligations in this Section 16.7 shall not apply with respect to any portion of the Confidential Information that the Receiving Party can show by competent written proof (i) is publicly disclosed by the Disclosing Party, either before or after it is disclosed to the Receiving Party hereunder; or (ii) 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 (iii) 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; provided, further that 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: (i) regulatory filings; (ii) prosecuting or defending litigation; (iii) complying with applicable laws (including, without limitation, the rules and regulations of any national securities exchange and 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 (iv) disclosure, solely on a “need to know basis”, to Affiliates, subcontractors, 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 Section 16.7; provided, however, that the Receiving Party shall remain responsible for any failure by any person who receives Confidential Information pursuant to this Section 16.7 to treat such Confidential Information as required under this Section 16.7. If and whenever any Confidential Information is disclosed in accordance with this Section 16.7, 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). Where reasonably possible except in the case of paragraph (iii) above, the Receiving Party shall notify the Disclosing Party of the Receiving Party’s intent to make such disclosure pursuant to this Section 16.7 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. Upon expiration or earlier termination of this Agreement, the Receiving Party shall, as the Disclosing Party may direct in writing, either destroy or return to the Disclosing Party all tangible forms of Confidential Information previously disclosed by the Disclosing Party together with all copies thereof; provided, however, the Receiving Party may retain one archival copy thereof for the purpose of determining any continuing obligations of confidentiality.
 
For the purposes of this Section 16.7, “ Confidential Information ” shall mean all materials and other information that are disclosed or provided by such party or its Affiliates to the other party or its Affiliates in relation to the subject of this Agreement, regardless of whether any of the foregoing are marked “confidential” or “proprietary” or communicated to the other by the Disclosing Party or its Affiliates in oral, written, graphic, or electronic form.
 
17.
FORCE MAJEURE
 
No Party hereunder shall be liable to the other for its failure to perform hereunder caused by contingencies due to the impossibility to perform for a cause not attributable (“ imputabile ”) directly or indirectly to such Party that may include, without limitation, acts of God, fire, flood, wars, acts of terrorism, sabotage, strike, government actions; 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.
 
11

 
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
 
 
 
12

 
ANNEX A
DESCRIPTION OF THE PROPERTY
 
 


 
 

 

 




Exhibit 10.3
 
 
 
 
 
 
 
 
FIDIA FARMACEUTICI S.P.A.
 
AND
 
FIDIA ADVANCED BIOPOLYMERS S.R.L.
 
 
 
 
     
     
 
 
 
TOLLING AGREEMENT
 
 
 
 

 
 
 
 
 
 
 
 
 

 
 
THIS AGREEMENT is made on December 30, 2009 (the “ Commencement Date ”)

BETWEEN :

(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 ") .
 
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:
 
1.
INTERPRETATION
 
1.1
In this Agreement:
 
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;
 
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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 ” means all 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.
 
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.
 
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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.
 
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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 .
 
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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.    
 
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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.
 
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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.
 
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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.
 
 
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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.
 
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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.
 
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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.
 
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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.  
 
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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.
 
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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/ Antonio Germani
 
Signature
     
     
     
Signed by:
   
For and on behalf of
   
Fidia Advanced Biopolymers S.r.l.
   
     
/s/ Charles H. Sherwood
 
Signature

 










20
Exhibit 10.4
 
[EXECUTION
COUNTERPART]
 
CONSENT AND FIRST AMENDMENT
 
CONSENT AND FIRST AMENDMENT dated as of December 30, 2009 (this “ Amendment ”) by and among ANIKA THERAPEUTICS, INC., a Massachusetts corporation (“ Borrower ”); ANIKA SECURITIES, INC., a Massachusetts securities corporation (“ Anika Securities ”); each lender signatory hereto (collectively, the “ Lenders ” and individually, a “ Lender ”); and BANK OF AMERICA, N.A., as Administrative Agent (as such term is defined in the Credit Agreement referred to below).
 
WHEREAS, the Borrower, Anika Securities, Lenders and Administrative Agent are parties to a Credit Agreement dated as of January 31, 2008 (as amended from time to time, the “ Credit Agreement ”), pursuant to which the Lenders agreed to make certain loans to the Borrower.
 
WHEREAS, the Borrower has requested the Lenders to consent to the FAB Acquisition described below and to amend certain provisions of the Credit Agreement, and the Lenders are willing to consent to the foregoing, all on the terms and conditions provided herein.
 
NOW, THEREFORE, in consideration of the foregoing and the mutual covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:
 
1.            Definitions .  Except as otherwise defined in this Amendment, terms defined in the Credit Agreement are used herein as defined therein.
 
2.            Consent to FAB Acquisition .  Subject to the satisfaction of the conditions precedent specified in Section 5 below, but effective as of the date hereof, the Required Lenders hereby consent to the acquisition by the Borrower, on the terms and conditions set forth in the FAB Purchase Agreement, from the Seller of 100% of the outstanding capital stock of FAB owned by the Seller.  For avoidance of doubt and notwithstanding any other provision of this Amendment, the foregoing consent shall not be deemed to be a consent to any Change of Control.
 
3.            Amendments to Credit Agreement .  Subject to the satisfaction of the conditions precedent specified in Section 5 below, but effective as of the date hereof:
 
(a)           Section 1.01 of the Credit Agreement shall be amended by adding the following new definitions in their appropriate alphabetical order:
 
Collateral ” means all of the “Collateral” referred to in the Pledge Agreement and all of the other property that is or is intended under the terms of the Pledge Agreement to be subject to Liens in favor of the Administrative Agent for the benefit of the Secured Parties.
 

 
FAB ” means Fidia Advanced Biopolymer S.r.l., a company incorporated under the laws of Italy with its registered office in Abano Terme (PD), C.A.P. 35031, Via Ponte della Fabbrica 3/B, VAT number 03641500289 and registered with the Company’s Register of Padua at number 01510440744, and a wholly-owned Subsidiary of the Borrower.
 
FAB Acquisition ” means the acquisition by the Borrower, on the terms and conditions set forth in the FAB Purchase Agreement, from the Seller of 100% of the outstanding capital stock of FAB owned by the Seller.
 
FAB Purchase Agreement ” means the Sale and Purchase Agreement dated December 30, 2009 between the Seller and the Borrower, as in effect on December 30, 2009.
 
Pledge Agreement ” means the pledge and security agreement among the Borrower, FAB and the Administrative Agent, in form and substance reasonably satisfactory to the Administrative Agent, delivered pursuant to and in accordance with Section 6.13 and providing for a pledge by the Borrower of 65% of the equity of FAB in favor of the Administrative Agent.
 
Related Documents ” means the FAB Purchase Agreement and Registration Rights Agreement (as such term is defined therein).
 
Secured Parties ” means, collectively, the Administrative Agent, the Lenders, the Hedge Banks, the Cash Management Banks, each co-agent or sub-agent appointed by the Administrative Agent from time to time pursuant to Section 9.05, and the other Persons the Obligations owing to which are or are purported to be secured by the Collateral under the terms of the Pledge Agreement.
 
Seller ” means Fidia Farmaceutici S.p.A., a company duly incorporated under the laws of Italy.
 
(b)           The definition of  “Applicable Rate” in Section 1.01 of the Credit Agreement shall be amended by replacing the reference to “0.75%” in clause (b) of said definition with “1.25%”.
 
(c)           The definition of  “Loan Documents” in Section 1.01 of the Credit Agreement shall be amended by adding the phrase “(including without limitation the Pledge Agreement)” after the phrase “pursuant to Section 6.13” in said definition.
 
(d)           The first sentence of Section 5.15 of the Credit Agreement shall be amended by adding the following phrase to the end of said sentence:  “(including as specifically disclosed in Schedule 5.15 )”.
 
(e)           Section 5.16 of the Credit Agreement shall be amended by adding the phrase “Except as specifically disclosed in Schedule 5.16 ,” to the beginning of said Section 5.16.
 
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(f)           Section 6.13 of the Credit Agreement shall be amended by replacing the phrase “(and in any event within 30 days)” therein with the phrase “(and in any event, on or before February 26, 2010 for FAB, and within 30 days for any other such Person)”.
 
(g)           Section 7.02(c) of the Credit Agreement shall be amended by adding the following phrase at the end of said Section 7.02(c):
 
provided , that the aggregate amount of Investments made by the Loan Parties in FAB shall not exceed during each fiscal year set forth below, the amount set forth opposite such fiscal year:
 
Fiscal Year
Amount
2010
$4,000,000
2011
$600,000
2012
$600,000
2013
$600,000
2014
$600,000
2015
$600,000
 
; provided , further , that (1) so long as no Default has occurred and is continuing or would result from such Investment, any portion of any amount set forth above, if not expended in the fiscal year for which it is permitted above, may be carried over for expenditure in the next following fiscal year and (2) if any such amount is so carried over, it will be deemed used in the applicable subsequent fiscal year before the amount set forth opposite such fiscal year above.”
 
(h)           Section 7.02(h) of the Credit Agreement shall be amended and restated in its entirety to read as follows:
 
“(h)           the FAB Acquisition; and”
 
(i)           A new clause (i) shall be added to Section 7.02 of the Credit Agreement as follows:
 
“(i)           so long as no Default has occurred and is continuing or would result therefrom, other Investments not exceeding $500,000 in the aggregate in any fiscal year of the Borrower.”
 
(j)           A new Section 7.11 shall be added to the Credit Agreement as follows:
 
“7.11            FAB Purchase Agreement .  (a) Cancel or terminate any Related Document or consent to or accept any cancellation or termination thereof; (b) amend, modify or change in any material manner any term or condition of any Related Document or give any consent, waiver or approval thereunder; (c) waive any default under or any material breach of any term or condition of any Related Document; or (d) take any other action in connection with any Related Document that would materially impair the rights or interests of the Administrative Agent or any Lender.”
 
3

 
(k)           Section 8.02(j) of the Credit Agreement shall be amended by adding the following phrase at the end of said Section 8.02(j):
 
“or the Pledge Agreement after delivery thereof pursuant to Section 6.13 shall for any reason (other than pursuant to the terms thereof) cease to create a valid and perfected first priority Lien on the Collateral purported to be covered thereby;”
 
(l)            Schedules 5.06, 5.13, 7.01 and 7.03 to the Credit Agreement shall be replaced in their entirety with Schedules 5.06, 5.13, 7.01 and 7.03 hereto.
 
(m)          New Schedules 5.15 and 5.16 shall be added to the Credit Agreement in the forms attached as Schedules 5.15 and 5.16, respectively, hereto.
 
4.            Representations and Warranties .  Each Loan Party represents and warrants to the Lenders and Administrative Agent that the representations and warranties of such Loan Party set forth in the Credit Agreement and in each other Loan Document to which such Loan Party is party are true and correct in all material respects (except that any representation and warranty that is qualified as to “materiality” or “Material Adverse Effect” shall be true and correct in all respects) on the date hereof, as if made on and as of the date hereof (except to the extent that such representations and warranties expressly relate to an earlier date), after giving effect to the FAB Acquisition, and as if each reference therein to the Credit Agreement included reference to this Amendment and the Credit Agreement as amended hereby.
 
5.            Conditions Precedent .  This Amendment shall become effective, as of the date hereof, upon the Administrative Agent’s receipt of the following, each in form and substance satisfactory to the Administrative Agent and the Lenders:
 
(a)           this Amendment, duly executed and delivered by the Loan Parties and Required Lenders;
 
(b)           such certificates of resolutions or other action, incumbency certificates and/or other certificates of Responsible Officers of each Loan Party as the Administrative Agent may reasonably require evidencing the identity, authority and capacity of each Responsible Officer thereof authorized to act as a Responsible Officer in connection with the Loan Documents to which such Loan Party is a party or is to be a party;
 
(c)           such documents and certifications as the Administrative Agent may reasonably require to evidence that FAB is duly organized or formed, and that FAB is validly existing, in good standing and qualified to engage in business in Italy;
 
(d)           confirmation satisfactory to the Required Lenders of the consummation of the FAB Acquisition strictly in accordance with the terms of the FAB Purchase Agreement (other than the consent of the Required Lenders), without any waiver or amendment not consented to by the Required Lenders of any term, provision or condition set forth therein, and in compliance with all applicable requirements of Law;
 
4

 
(e)           certificates attesting to the solvency of each Loan Party before and after giving effect to the FAB Acquisition, from its chief financial officer;
 
(f)           an officer’s certificate of the Loan Parties, (1) to the effect set forth in Sections 4, 5(g) and 5(h) hereof, and (2) attaching a certified, true and correct copy of the FAB Purchase Agreement and related documents;
 
(g)           evidence that no Default shall have occurred and be continuing, nor shall any Default result from the consummation of the transactions contemplated herein and in the FAB Purchase Agreement;
 
(h)          evidence that all consents (other than the consent of the Lenders), licenses and approvals required in connection with the execution, delivery and performance by the Loan Parties of this Amendment, the FAB Acquisition, the FAB Purchase Agreement and the transactions contemplated hereby and thereby shall have been obtained and shall be in full force and effect;
 
(i)           evidence that the Borrower shall have paid in full to the Administrative Agent for account of the Lenders a non-refundable amendment fee equal to $74,000, which fee shall be fully earned, due and payable on the date of this Amendment and which fee shall not be refunded in whole or in part under any circumstance;
 
(j)           evidence that the Borrower shall have paid in full to the Administrative Agent all invoiced costs and expenses (including reasonable attorneys’ fees) incurred on behalf of the Administrative Agent in connection with this Amendment; and
 
(k)          such other certificates or documents as the Administrative Agent may reasonably require.
 
The Loan Parties agree that the amendment fee described in Section 5(i) hereof shall be fully earned when paid and shall not be refundable for any reason whatsoever.
 
6.            Condition Subsequent .  To induce the Lenders to consent to the FAB Acquisition and the amendments to the Credit Agreement set forth in Section 3 hereof prior to the satisfaction of certain requirements of Section 6.13 of the Credit Agreement, and without limiting any other provisions contained in the Credit Agreement or the other Loan Documents, the Borrower hereby agrees to deliver to the Administrative Agent, on or before February 26, 2010, the following documents, each in form and substance satisfactory to the Administrative Agent and the Lenders:
 
(a)           the Pledge Agreement, duly executed and delivered by each of the parties thereto, together with evidence of the completion of all actions, recordings and filings of or with respect to the Pledge Agreement that the Administrative Agent may deem necessary or desirable in order to perfect the Liens created thereby;
 
(b)           documents of the types referred to in clauses (iii) and (iv) of Section 4.01(a) of the Credit Agreement; and
 
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(c)           favorable legal opinions of Massachusetts and Italian counsel to the Loan Parties, and of Italian counsel to the Administrative Agent, each in form and substance reasonably satisfactory to the Administrative Agent, regarding the Pledge Agreement and the creation, perfection and enforceability of the security interest created thereunder, and related matters as counsel to the Administrative Agent may reasonably request, under applicable Massachusetts and Italian laws.
 
7.            Effect on Loan Documents .  The Credit Agreement and the other Loan Documents shall be and remain in full force and effect in accordance with their terms and are hereby ratified and confirmed in all respects.  Except as expressly set forth herein, the execution, delivery, and performance of this Amendment shall not operate as a waiver or an amendment of any right, power, or remedy of the Administrative Agent or Lenders under the Credit Agreement or any other Loan Document.  Each Loan Party hereby ratifies and confirms in all respects all of its obligations under the Credit Agreement and the other Loan Documents.  For avoidance of doubt, the Loan Parties confirm that breach of Section 6.13 (as amended hereby) shall constitute an Event of Default.
 
8.            No Novation; Entire Agreement .  This Amendment is not a novation or discharge of the terms and provisions of the obligations of the Loan Parties under the Loan Documents.  There are no other understandings, express or implied, among the Loan Parties, Administrative Agent, Lenders and other parties hereto regarding the subject matter hereof or thereof.
 
9.            Governing Law .  This Amendment shall be governed by, and construed in accordance with, the law of The Commonwealth of Massachusetts.
 
10.          Counterparts; Facsimile Execution .  This Amendment may be executed in any number of counterparts and by different parties and separate counterparts, each of which when so executed and delivered shall be deemed an original, and all of which, when taken together, shall constitute one and the same instrument.  Delivery of an executed counterpart of a signature page to this Amendment by facsimile shall be as effective as delivery of a manually executed counterpart of this Amendment.  Any party delivering an executed counterpart of this Amendment by facsimile also shall deliver a manually executed counterpart of this Amendment (but the failure to deliver a manually executed counterpart shall not affect the validity, enforceability, and binding effect of this Amendment).
 
11.          Construction .  This Amendment is a Loan Document.  Upon and after the effectiveness of this Amendment, each reference in the Credit Agreement to “this Agreement”, “hereunder”, “herein”, “hereof” or words of like import referring to the Credit Agreement, and each reference in the other Loan Documents to “the Credit Agreement”, “thereunder”, “therein”, “thereof” or words of like import referring to the Credit Agreement, shall mean and be a reference to the Credit Agreement as amended hereby.
 
6

 
IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be executed as of the date first above written.
 
 
 
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
   
   
   
 
 
7

 
 
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
   

 
 
8

Exhibit 99.1

Contact:
Anika Therapeutics, Inc.
Charles H. Sherwood, Ph.D., CEO
Kevin W. Quinlan, CFO
Tel:  781-457-9000


Anika Therapeutics Acquires Fidia Advanced Biopolymers: A Leading Innovator in Hyaluronic Acid Based Tissue Engineered Products
 
Acquisition Provides Novel Technology Platform for Growth & Broadens Anika’s
Product Portfolio and Development Pipeline
 
Company to Develop Direct Sales Capability for MONOVISC™ and FAB Products


BEDFORD, Mass, – December 31, 2009 – Anika Therapeutics, Inc. (Nasdaq: ANIK) today announced that it has  acquired Fidia Advanced Biopolymers, s.r.l. (“FAB”), a wholly-owned subsidiary of privately held Italian pharmaceutical company, Fidia Farmaceutici S.p.A.  FAB provides hyaluronic acid-based (“HA”) products in several therapeutic areas including for the regeneration of connective and structural tissues damaged by injuries, aging or degenerative diseases.  The Company also announced that it will develop its own direct U.S. sales capability to capture significantly higher margins from the domestic sales of MONOVISC™, its single-injection osteoarthritis treatment.  Direct commercialization activities will also include the portfolio of FAB orthopedic products once approvals are achieved in the United States.

Under the terms of the sale and purchase agreement, Anika purchased FAB in exchange for USD $17.1 million in cash and 1,981,192 shares of its common stock.  FAB recorded product revenue of approximately USD $11.1 million in the 12 months ended September 30, 2009.  Anika anticipates that the acquisition will be accretive to earnings in the second year of combined operations.

FAB has approximately 50 employees at its headquarters in Abano Terme,  Italy, which includes R&D and cell culture laboratories, as well as commercial and manufacturing operations.  FAB’s unique, patented technology for modifying HA to produce fibers, films and textile biomaterials is used in a wide variety of medical device applications.   FAB also pioneered in Europe the development of tissue engineered products for cartilage regeneration and treatment of burns and diabetic ulcers.  FAB’s modified HA technology is also commercialized in a range of orthopedic, otolaryngology, and urogynecology products.

“FAB provides Anika with an exciting new growth platform and advances our vision to offer therapeutic products that go beyond pain relief to protect and restore damaged tissue,” said Charles H. Sherwood, Ph.D., Anika’s President and Chief Executive Officer.  “FAB’s complementary regenerative technology allows us to expand Anika’s commercial product portfolio and development pipeline with innovative joint health and other therapeutic products.  FAB also has a strong research ability that complements Anika’s excellent development and manufacturing resources.”


 
“FAB’s innovative orthopedic product portfolio will provide us with a critical mass of products to sell into the U.S. market along with MONOVISC upon its approval,” said Sherwood.  “We filed the final module of our MONOVISC PMA containing the clinical data on December 24 th , and we expect to receive U.S. FDA approval in the second half of 2010.  Internationally, we are planning to leverage FAB’s strong distributor partners in Europe and Asia to enhance sales of MONOVISC and Anika’s other products in new and existing international markets.”
 
“The acquisition of FAB and the decision to build a direct Anika sales capability are two important, mutually reinforcing milestones that we expect to propel Anika to a new stage of growth.  We are confident that our integrated team will realize significant upside potential from the combined company, and we look forward to welcoming FAB’s talented employees to Anika,” concluded Sherwood.

Conference Call
Anika will conduct a special conference call on Monday, January 4, 2010 at 10 a.m. (Eastern time) to provide an overview of the transaction   and other business and financial matters affecting the Company, some of which may contain information that has not been previously disclosed.  To listen to the conference call, dial 800-299-7089 (International callers dial 617-801-9714) and use the passcode 31471402. Please call approximately 10 minutes before the starting time and reference Anika Therapeutics. In addition, the conference call will be available to interested parties through a live audio webcast in the "Investor Relations" section of Anika’s website, www.anikatherapeutics.com.  The call will be archived and accessible on the same website shortly after the conclusion of the call.

The webcast also is being distributed through the Thomson StreetEvents Network. Individual investors can listen to the call at www.earnings.com, Thomson's individual investor portal, powered by StreetEvents.  Institutional investors can access the call via Thomson StreetEvents (www.streetevents.com), a password-protected event management site.


About Anika Therapeutics, Inc.

Headquartered in Bedford, Mass., Anika Therapeutics, Inc . develops, manufactures and commercializes therapeutic products for tissue protection, healing and repair.  These products are based on hyaluronic acid (HA) , a naturally occurring, biocompatible polymer found throughout the body.  Anika’s products include ORTHOVISC ® , a treatment for osteoarthritis of the knee available internationally and marketed in the U.S. by DePuy Mitek; HYVISC ® , a treatment for equine osteoarthritis marketed in the U.S. by Boehringer Ingelheim Vetmedica, Inc.; the ELEVESS, ELEVESS Light, and HYDRELLE family of aesthetic dermatology products for facial wrinkles, scar remediation and lip augmentation; AMVISC ® , AMVISC ® Plus, STAARVISC™-II and Shellgel™ injectable viscoelastic HA products for ophthalmic surgery; INCERT ® , an HA-based anti-adhesive for surgical applications; ORTHOVISC ®   mini a treatment for osteoarthritis targeting small joints and available in Europe; MONOVISC™ a single-injection osteoarthritis product based on Anika’s proprietary cross-linking technology and available in Europe, Turkey and Canada; and next generation products for joint health and aesthetic dermatology based on the Company’s proprietary, chemically modified HA.
 

 
This press release contains, and the Company’s conference call may contain, forward-looking statements within the meaning of the federal securities laws.  The statements made in this press release and those that may be made during the Company’s conference call which are not statements of historical fact are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including, without limitation, statements that may be identified by words such as “expectations,” “remains,” “focus,” “expected,” “prospective,” “expanding,” “building,” “continue,” “progress,” “plan,” “efforts,” “hope,” “believe,” “objectives,” “opportunities,” “will,” “seek,” “expect” and other expressions which are predictions of or indicate future events and trends and which do not constitute historical matters identify forward-looking statements.  These statements also include: (i) expectations about the Company’s development of its own direct U.S. sales capability to capture significantly higher margins from the domestic sales of MONOVISC and FAB products; (ii) expectations that the acquisition of FAB will be accretive to the Company’s earnings, realize significant upside potential, and propel the Company to a new stage of growth; (iii) expectations that the FAB acquisition will provide the Company with new growth platforms and advances, including expanding the Company’s commercial product portfolio and development pipeline and providing a critical mass of products to sell into the U.S. market as well as leveraging FAB’s distributor partners in Europe and Asia to enhance sales of MONOVISC and other products in new and existing international markets; (iv) the Company’s expectations concerning its MONOVISC product, including the U.S. clinical trials and receiving Food and Drug Administration (“FDA”) approval of the MONOVISC PMA filing in 2010;and (v) the Company’s ability to capitalize on exciting growth opportunities and fulfill its joint health vision to alleviate pain, repair and restore damaged tissue.  These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks, uncertainties and other factors. The Company’s actual results could differ materially from any anticipated future results, performance or achievements described in the forward-looking statements as a result of a number of factors including: (i) the Company’s future sales and product revenues, including geographic expansions, possible retroactive price adjustments, and expectations of unit volumes or other offsets to price reductions; (ii) the Company’s manufacturing capacity and efficiency gains and work-in-process manufacturing operations; (iii) the timing, scope and rate of patient enrollment for clinical trials; (iv) the development of possible new products; (v) the Company’s ability to achieve or maintain compliance with laws and regulations; (vi) the timing of and/or receipt of the FDA, foreign or other regulatory approvals and/or reimbursement approvals of current, new or potential products, and any limitations on such approvals; (vii) negotiations with potential and existing partners, including the Company’s performance under any of the Company’s  existing and future distribution or supply agreements or the Company’s expectations with respect to sales and sales threshold milestones pursuant to such agreements; (viii) the level of the Company’s revenue or sales in particular geographic areas and/or for particular products, and the market share for any of the Company’s products; (ix) the Company’s current strategy, including the Company’s corporate objectives and research and development and collaboration opportunities; (x) the Company’s and Bausch & Lomb’s performance under the existing supply agreement for certain of the ophthalmic viscoelastic products, the Company’s ability to remain the exclusive global supplier for AMVISC and AMVISC Plus to Bausch & Lomb, and the Company’s expectations regarding revenue from ophthalmic products; (xi) the Company’s ability, and its distribution partner’s ability, to market its aesthetic dermatology product; (xii) the Company’s intention to increase market share for joint health products in international and domestic markets or otherwise penetrate growing markets for osteoarthritis of the knee and other joints; (xiv) the Company’s ability to license its aesthetics product to new distribution partners outside of the United States; (xiii) the rate at which the Company uses cash, the amounts used and generated by operations, and expectations regarding the adequacy of such cash; (xv) possible negotiations or re-negotiations with existing or new distribution or collaboration partners; (xvi) expectations regarding the Company’s existing manufacturing facility and the Bedford, MA facility, the Company’s expectations related to costs, including financing costs, to build-out and occupy the new facility, and the Company’s ability to obtain FDA licensure for the facility; (xvii) the Company’s ability to comply with debt covenants and obtain additional funds through equity or debt financings, strategic alliances with corporate partners and other sources, to the extent the Company’s current sources of funds are insufficient; (xviii) the Company’s plans to address the FDA’s Warning Letter and Form 483 Notice of Observations and the impact any associated regulatory action would have on its business and operations; and (xix) the Company’s expectations regarding its joint health products, including expectations regarding new products, expanded uses of existing products, new distribution and revenue growth, next generation osteoarthritis/joint health product developments, clinical trials, regulatory approvals, and commercial launches, HYVISC sales, the development and commercialization of INCERT, and the market potential for INCERT, HYDRELLE product sales in the U.S., product gross margin, next generation osteoarthritis/joint health product developments, clinical trials, regulatory approvals, and commercial launches, commencement of clinical trial for CINGAL and ability to obtain regulatory approvals for CINGAL, existing aesthetics product’s line extensions, increases in operating expenses, including research and development and selling, general and administrative expenses, capital expenditures spending and decline in interest income, Certain other factors that might cause the Company’s actual results to differ materially from those in the forward-looking statements include those set forth under the headings “Business,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2008 and on Form 10-Q for the period ended September 30, 2009, as well as those described in the Company’s other press releases and SEC filings.  The Company’s results may also be affected by factors of which the Company is not currently aware. The Company may not update these forward-looking statements, even though its situation may change in the future, unless it has obligations under the federal securities laws to update and disclose material developments related to previously disclosed information.