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S-1
PROTEON THERAPEUTICS INC filed this Form S-1 on 09/16/2014
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services specified in the Project Plan, then PROTEON shall issue a PROTEON Change Request and such PROTEON Change Request shall be subject to the procedures specified in Section 3.4.

 

3.2                               Project Management

 

3.2.1                     This Section Intentionally Omitted.

 

3.2.2                     The daily interactions and management with respect to the Project will be performed by two project managers, one appointed by each Party and each one having the authority to manage the Project in conjunction with the other Project Manager and to further the daily tasks and goals of each Party (each, a “Project Manager).

 

3.2.3                     The Project Managers shall be the principle points of contact between the Parties. As part of their duties, the Project Managers shall be responsible for monitoring and revising the Project Plan (in accordance with the procedures set forth in Section 3.4, responding to Decision Requests (in the case of PROTEON), establishing operating guidelines for the Project, defining communication formats, forming and approving Project teams and monitoring the general progress of the Project.

 

3.2.4                     The Project Managers shall be appointed by each respective Party no later than August 17, 2009. The LONZA Operations executive responsible for the early phase tasks may continue in the role of Project Manager for a designated period of time, as agreed to by PROTEON.

 

3.2.5                     Neither Party shall remove or replace its Project Manager without giving 30 days notice in writing to the other Party; provided that, such removal or replacement may be made with less than thirty (30) days notice where such person has left the employment of the relevant Party, where such Person has taken a leave of absence, where such Person is out on disability or sick leave for more than a two-week period, or if the other Party agrees in writing to such removal or replacement.

 

3.3                               Project Administration

 

3.3.1                     “Project Administration” tasks include, but are not limited to, meeting attendance, document review, document approval and project consultation.

 

3.3.2                     All hours invoiced for Project Administration must be attributed to tasks directly related to the Project and incurred only by LONZA employees who have been pre-approved by the PROTEON to accrue Project Administration hours. LONZA will submit a list of employees to PROTEON for approval. The pricing quoted in Exhibit A includes Project Administration costs and such Project Administration services shall not constitute Additional Services.

 

3.4                               Project Change Order Process. (a) Any amendments or modifications to the services specified in the Project Plan shall be set forth in writing in a Change Order mutually agreed upon by the Parties using the procedure set forth in this Section 3.4. During the Project, PROTEON may request amendments to the Project Plan to effect changes in the services specified in the Project Plan. If PROTEON wishes to make a change it shall notify LONZA of the requested change specifying the change with sufficient details to enable

 


* 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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LONZA to evaluate it (a “PROTEON Change Request”). Within five (5) Business Days following the date of LONZA’s receipt of a PROTEON Change Request, LONZA shall deliver a Change Order document that: (i) assesses the impact of the change on the schedule, and (ii) incorporates a description of the requested change and the cost therefor.

 

(b)                                 Within five (5) Business Days following PROTEON’s receipt of a LONZA Change Order (“Response Period”), PROTEON will notify LONZA whether or not it accepts the Change Order. If PROTEON accepts the Change Order, then the provisions of this Agreement shall be deemed amended to incorporate such change in accordance with the Change Order. If PROTEON notifies LONZA not to proceed within the Response Period, then the PROTEON Change Request shall be deemed withdrawn and LONZA shall take no further action in respect of it. If LONZA has not received any notice by the expiration of the Response Period, then PROTEON shall be deemed to have advised LONZA not to proceed, A separate Change Order will be required for each PROTEON Change Request but a PROTEON Change Request may include multiple changes; and each Change Order will become subject to this Agreement when signed by LONZA and PROTEON. Change Orders shall be implemented as soon as commercially practicable to do so. PROTEON shall be responsible for payment of any price increase resulting from any such Change Order, which shall be priced on a time and materials basis, as mutually agreed upon by the Parties; provided such pricing shall be based upon the Project Rates.

 

(c)                                  LONZA may not make any changes in the Project Plan without PROTEON’s prior written approval, which shall not be unreasonably withheld. LONZA may recommend amendments to the Project Plan to effect changes in the services specified in the Project Plan if necessary to respond to difficulties encountered in achieving the technical objectives of the Project. If LONZA wishes to recommend a Change Request, it shall notify PROTEON of the requested change in accordance with LONZA’s SOP and provide PROTEON with a LONZA Change Request and a Change Order and the provisions of Section 3.4(a)-(b) shall apply.

 

ARTICLE 4
SERVICES

 

4.1                               Quality Agreement. The Quality Agreement specifies certain testing, storage, release, cGMP, regulatory and other quality assurance requirements relating to manufacture and shipment of Drug Substance by LONZA under this Agreement, all of which shall be deemed a material part of this Agreement.

 

4.2                               LONZA Facility. All Drug Substance manufactured for PROTEON hereunder shall be manufactured by LONZA at a LONZA Facility. LONZA shall be solely responsible for all scheduling related to the LONZA Facility and for the operation of such facility.

 

4.3                               [            ]*

 

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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