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S-1
PROTEON THERAPEUTICS INC filed this Form S-1 on 09/16/2014
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which it is or becomes aware concerning exposure to or handling of the Raw Materials, Drug Substance or Wastes.

 

4.8                               Approval of Subcontracting. LONZA shall not subcontract or otherwise delegate all or any portion of its obligations under this Agreement without PROTEON’s prior written approval. Notwithstanding the foregoing, LONZA may subcontract certain non-essential or routine tasks without PROTEON’s consent (e.g., janitorial services, electrical upgrades, etc.). Any work relevant to the Project Plan subcontracted or delegated to a Third Party in accordance with this Section shall be invoiced to PROTEON by LONZA at cost.

 

4.9                               Document Changes. Any requests by LONZA or PROTEON for changes to documents which are part of LONZA’s cGMP documentation system, including but not limited to the Master Production Record and any standard operating procedures or Materials Specifications, will be handled by a Change Request using the procedures in Section 3.4.

 

ARTICLE 5
DELIVERIES

 

5.1                               Delivery Terms. LONZA will deliver each Clinical Batch EXW LONZA’s Visp Facility to the Designated Carrier in accordance with the Shipping Guidelines; provided that risk of loss in and title to the Clinical Batch shall pass to PROTEON when the Clinical Batch is placed upon the Designated Carrier’s vehicle. PROTEON shall arrange for shipment and take delivery of such Batch from LONZA’s Facility via the Designated Carrier, at PROTEON’s expense, within five (5) Business Days after PROTEON’s acceptance of a Clinical Batch pursuant to Article 10, or pay applicable storage costs. LONZA shall provide storage for such Batch in accordance with the [   ]* at no charge during such five (5) business day period; provided, that any additional storage beyond such five (5) business day period will be charged to PROTEON as Additional Services in accordance with the Project Rates. Notwithstanding anything to the contrary contained in this Agreement, in no event shall LONZA be required to store any Clinical Batch for more than twenty (20) calendar days after PROTEON’s acceptance of such Batch pursuant to Article 10. LONZA shall not be required to deliver any Batch to the Designated Carrier until the Designated Carrier informs LONZA that it has obtained all appropriate approvals and consents of any Gown-mental Authority necessary for the transportation or shipment of such Batch,

 

ARTICLE 6
PAYMENTS

 

6.1                               Compensation. For each deliverable specified in the Project Plan, PROTEON shall pay to LONZA the milestone payment amount corresponding to such deliverable, as set forth in the Project Plan. Each milestone payment shall become due and payable upon the completion by LONZA of the applicable deliverable. No milestone payment shall be contingent upon completion of any subsequent deliverable. In addition, PROTEON shall pay for any Acquisition Costs and Additional Services in accordance with the Project Rates, unless otherwise agreed to by the Parties.

 


* 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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