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S-1
PROTEON THERAPEUTICS INC filed this Form S-1 on 09/16/2014
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4.4                               Transfer and Engineering Runs. If called for in the Project Plan, LONZA shall perform manufacture Transfer Batches and/or Engineering Batches in accordance with the Project Plan.

 

4.5                               Raw Materials and Consumables.

 

4.5.1                     Procurement. Unless specifically stated otherwise in the Project Plan, LONZA shall be responsible for the procurement of all Raw Materials, Resins, Consumables and Wearables necessary for the manufacture of the Drug Substance. LONZA shall not be responsible for delays in the purchase and/or delivery of Raw Materials, Resins, and Consumables that occur despite LONZA using Commercially Reasonable Efforts to avoid such delays. All Raw Materials, Resins, Consumables and Wearables shall be invoiced to PROTEON by LONZA at the relevant Acquisition Cost.

 

4.5.2                     Compliance with Specifications. All Raw Materials, Resins and Consumables used in the Manufacturing Process shall comply with the applicable Materials Specifications, or as otherwise agreed in writing by the Parties. LONZA or a Subcontractor approved in accordance with Section 4.8 shall perform testing and evaluation of the Raw Materials, Resins and Consumables as required to meet the foregoing obligations.

 

4.5.3                     PROTEON Equipment. At PROTEON’s request, LONZA shall use PROTEON’s Equipment and PROTEON shall reimburse LONZA for the acquisition, installation and validation of PROTEON Equipment in accordance with the Project Rates. However, PROTEON shall not be required to reimburse LONZA for the costs of acquiring PROTEON Equipment under this Agreement if PROTEON paid for such PROTEON Equipment directly or if PROTEON has already reimbursed LONZA for such costs.

 

4.6                               Retention and Reserve Samples. LONZA shall identify and retain certain reserve samples of all Raw Materials and intermediate production samples generated in the production of Clinical Batches as set forth in the applicable Materials Specifications, the applicable standard operating procedures, the Master Production Record or as otherwise agreed in writing by LONZA and PROTEON.

 

4.7                               Handling of Materials; Wastes. PROTEON must notify LONZA of any hazardous conditions or Wastes known to PROTEON that may exist or be produced by LONZA in the course of performing the services contemplated by this Agreement. At PROTEON’s expense, LONZA or a designated Third Party contractor shall handle, label, package, store, transport and dispose of all Wastes generated through performance of the manufacturing and processing activities hereunder in material compliance with all Federal, state and local laws, rules, and regulations applicable to such handling, labeling, packaging, storage, transport and disposal. Each Party shall promptly notify the other of any health hazards or potential health hazards of

 

confidential treatment

 


* 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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