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S-1
PROTEON THERAPEUTICS INC filed this Form S-1 on 09/16/2014
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use such Project Intellectual Property with respect to the Product and other elastase products (i.e., any proteinase that possesses the ability to solubilize elastin) and (ii) LONZA shall only use such Project Intellectual Property with respect to products that are not elastase products.

 

(e)                                  During the term of this Agreement, each Party shall promptly disclose to the other in writing any Project Intellectual Property that might, under applicable law, be patentable or otherwise protectable and the determination of inventorship of such Project Intellectual Property shall be made in accordance with the rules of inventorship of the United States of America. The Parties hereby agree that neither Party shall be considered an “employee or agent” of the other Party. PROTEON shall control the filing, prosecution, maintenance and enforcement of any Patents constituting jointly-owned Project Intellectual Property, at its sole cost and expense, and shall keep LONZA regularly informed with respect to such activities.

 

(f)                                   Each Party shall sign all necessary documents or take such other actions as may reasonably be requested in order to perfect any and all rights of the applicable Party(ies) in Project Intellectual Property. Each Party will obtain all assignments and agreements necessary from their respective employees and agents and Subcontractors to secure such rights. All costs and expenses for perfecting and enforcing a Party’s rights in such Project Intellectual Property, shall be borne by the owner except as otherwise provided in Section 13.1(e).

 

13.2                        PROTEON Materials. As between the Parties, PROTEON shall own all rights in and title to the [    ]*.

 

13.3                        Ownership of PROTEON Equipment. PROTEON shall own all right, title and interest in and to any and all PROTEON Equipment, as well as all materials and other assets purchased by LONZA, for which the cost is reimbursed by PROTEON to LONZA. PROTEON shall be liable for all damage and risk of loss to the PROTEON Equipment, unless caused by LONZA’s negligence or willful misconduct.

 

13.3.1              PROTEON is responsible for the testing, installation, qualification and validation, as required, of PROTEON Equipment. LONZA will operate and maintain the PROTEON Equipment as per approved procedures once such equipment is commissioned and in operation.

 

13.3.2              PROTEON shall be liable for repair of all damage and risk of any loss to the PROTEON Equipment, unless caused by LONZA’s negligence or willful misconduct.

 

13.3.3              PROTEON is responsible for any delays to the Project Plan caused in whole or in part by delays in the delivery, testing, qualification or validation of PROTEON Equipment, including any resulting changes in the GMP Suite Activation Date as described in Section 18.2.

 

ARTICLE 14
REPRESENTATIONS AND WARRANTIES

 

14.1                        PROTEON. PROTEON hereby represents and warrants to LONZA that:

 


* 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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14.1.1              Materials and Information. PROTEON is free to supply to LONZA the [     ]* PROTEON Confidential Information (including, without limitation, any portion of the Manufacturing Documentation supplied by PROTEON to LONZA), and any other information or materials supplied by PROTEON to LONZA;

 

14.1.2              No Patent Infringement. No Third Party has filed, pursued or maintained or threatened in writing to file, pursue or maintain any claim, lawsuit, charge, complaint or other action alleging infringement of a Third-Party Patent based on the manufacture, use, import, offer for sale or sale of the Drug Substance or the Product;

 

14.1.3              No Infringement by Performance of Obligations. To the best of PROTEON’s knowledge, PROTEON’s supply to LONZA of the [     ]* and PROTEON Confidential Information (including, without limitation, any portion of the Manufacturing Documentation supplied by PROTEON to LONZA), and any other information or materials that PROTEON intends to supply to LONZA hereunder, and LONZA’s use thereof in accordance with the terms of and in performance of its obligations under this Agreement, does not infringe any Third-Party Patent or any other intellectual property rights of any Third Party for which PROTEON lacks the right to grant LONZA a valid sublicense to manufacture the Drug Substance;

 

14.1.4              No Infringement through Manufacturing Process. To the best of PROTEON’s knowledge, the manufacturing process for the Drug Substance in effect as of the Effective Date, as well as any other Manufacturing Process to be provided by PROTEON to LONZA under this Agreement, does not infringe any Third-Party Patent or any other intellectual property rights of any Third Party for which PROTEON lacks the right to grant LONZA a valid sublicense to manufacture the Drug Substance;

 

14.1.5              No Hazards. PROTEON has made LONZA aware of any known hazards involved in handling the [   ]*, the Raw Materials, the Drug Substance, and any Wastes generated through performance of the process development and manufacturing activities contemplated hereunder;

 

14.1.6              License. PROTEON has the right, power and authority to grant LONZA the license set forth in Section 12.1 above and will not enter into any contract, arrangement or commitment in the future which prohibits the grant of such license.

 

14.1.7              Power and Authority. PROTEON has the corporate power, the authority, the financial capacity and the legal right to enter into this Agreement and to perform its; obligations under this Agreement; and

 

14.1.8              Execution, Delivery and Performance of the Agreement. PROTEON has taken all necessary corporate action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations under this Agreement. This Agreement has been duly executed and delivered on behalf of PROTEON, and constitutes a legal, valid, binding obligation, enforceable against PROTEON and its successors and assigns in accordance with its terms, except as enforceability may be limited by bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium and other laws relating to or affecting creditors’ rights generally and by general equitable principles. The execution, delivery and performance of this Agreement does not

 


* 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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