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S-1
PROTEON THERAPEUTICS INC filed this Form S-1 on 09/16/2014
Entire Document
 

 

 

PROCESS DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT

 

This Process Development and Manufacturing Services Agreement (this “Agreement”) is effective as of September 1, 2009 (the “Effective Date”), by and between Proteon Therapeutics, a Delaware corporation, with an address at 200 West Street, Waltham, Massachusetts (“PROTEON”), and Lonza Ltd, a Swiss company with an address at Muenchensteinerstrasse 38, CH-4002 Basel, Switzerland (“LONZA”) (each, a “Party” and together the “Parties”).

 

RECITALS

 

WHEREAS, PROTEON intends to develop and commercialize certain products containing a recombinant form of Type 1 human pancreatic elastase as the active pharmaceutical ingredient known by PROTEON as PRT-201 (“API”) and wishes to contract with a contract manufacturing organization for the process development, manufacture and supply of API; and

 

WHEREAS, LONZA has process development, manufacturing and related services experience and expertise and owns a facility that is or would be suitable for production of API; and

 

WHEREAS, PROTEON desires to retain LONZA as a manufacturer of clinical quantities of API and to purchase process development and manufacturing services to supply clinical quantities of such product from LONZA, and LONZA desires to perform such services for PROTEON, all on the terms and conditions set forth in this Agreement.

 

AGREEMENT

 

NOW, THEREFORE, in consideration of the mutual promises and covenants herein contained and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound hereby, the Parties hereto agree as follows:

 

ARTICLE 1
DEFINITIONS

 

The following capitalized terms, whether used in the singular or plural, shall have the meanings assigned to them below for purposes of this Agreement:

 

1.1                               Acquisition Cost” means the actual price paid by LONZA to any Third Party (net of any discounts, rebates, credits or the like) for any materials (including the Raw Materials, Resins, Consumables and Wearables) used in the manufacture of the Drug Substance under this Agreement, including, but not limited to, shipping and handling costs and customs duties incurred and paid by LONZA to that Third Party in connection with the acquisition of such materials, and also including [    ]* of such actual price to cover LONZA’s acquisition and storage costs for such materials.

 


* CONFIDENTIAL TREATMENT REQUESTED.  OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

 

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