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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)

FIDIA ADVANCED BIOPOLYMERS S.r.l. , an Italian limited liability company with registered office in Via Ponte della Fabbrica 3B, Abano Terme (PD), Italy (the " Customer ").

 

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 ” meansall know-how, technical information, documents, manufacturing processes, specifications, sourcing information, and quality control and testing procedures that are reasonably necessary for the manufacture of Products and/or Intermediates by a party that is generally experienced in the field of medical device manufacturing;  

 

Facility ” mean the Manufacturers' facility located at Abano Terme, Italy;

 

FDA ” means the Food and Drug Administration of the United States of America and/or any other governmental or regulatory agencies as may regulate or control the sale of drugs in the American territory;

 

FDC Act ” means the U.S. Federal Food, Drug and Cosmetic Act (21 U.S.C. §301 et. seq.) as amended from time to time, and all regulations promulgated pursuant thereto;

 

“FOB” has the meaning ascribed to it in INCOTERMS (2000 version);

 

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Initial Term ” shall have the meaning set forth in clause 3.1 of this Agreement;

 

Intermediate ” means a chemically modified derivative of hyaluronic acid used to manufacture Products;

 

LCA Rules  shall have the meaning set forth in clause 22.1 of this Agreement;

 

Manufacturing Process ” shall mean the processes and procedures used to manufacture the Product and/or Intermediates in accordance with the Master Batch Record, including all protocols and standard operating procedure documents referenced therein and the other requirements set forth in this Agreement;

 

Master Batch Record ” shall mean the document containing the formula (listing intermediate and raw materials), procedures for the manufacturing (listing components and containers), quality assurance of the Product and/or Intermediates and in-process and finished product specifications for the Product and/or Intermediates;

 

Product Fee ” shall mean the manufacturing fee to be charged by Manufacturer for the Products to be provided to Customer hereunder, which fee shall include the costs of materials, manufacturing, standard quality control and quality assurance, testing, documentation and packaging, which fee is set forth in Annex E ;

 

Parties ” means, collectively, the Manufacturer and the Customer, and “ Party ” means any of them;

 

Product ” means any of the products listed in Annex A ;

 

Purchase Agreement ” means the share purchase agreement dated the date hereof agreed between Manufacturer and Anika Therapeutics Inc. in respect of the purchase and sale of the Customer;

 

Quality Agreement ” means the quality agreement attached hereto as Annex D , as the same may be amended or modified from time to time by mutual written agreement of the Parties;

 

Receiving Party ” shall have the meaning set forth in clause 16.1 of this Agreement;

 

Regulatory Authority ” means any applicable supranational, federal, national, regional, state or local regulatory agency, department, bureau, commission, council or other government entity with authority over the development, manufacture, use, marketing and/or sale of a pharmaceutical product or medical device in any regulatory jurisdiction throughout the world, including the FDA in the United States, the EMEA in the Europe.

 

Renewal Term ” shall have the meaning set forth in clause 3.1 of this Agreement;

 

Specifications ” means the specifications for each Product and/or Intermediate set out in Annex B ;

 

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Territory ” means all of the countries of the world; and

 

Year ” or means each successive period of twelve (12) months commencing on the Commencement Date.

 

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. The Parties therefore agree that Customer shall not be under any obligation to purchase (i) Products and/or Intermediates exclusively from the Manufacturer, or (ii) any minimum quantities of Products and/or Intermediates from the Manufacturer, except as expressly set forth in clause 4.2.

 

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, although the aggregate quantities actually ordered during such twelve (12) month period may exceed one hundred fifty percent (150


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