EXHIBIT 10.1

 

 [lonza.jpg]

 

AMENDMENT NO. 2

 

 

 

To

 

 

MANUFACTURING SERVICES AGREEMENT

Dated 30 June 2015

 

Between

Proteon Therapeutics, Inc.

And

LONZA LTD

 

 

 

 

 

 

 

Exhibit A Project Plan A-1

Exhibit B-1 Scope of Work

Exhibit B-2 Scope of Work

Exhibit C Estimated Timeline

Exhibit D Price and Payment

 

 

 

 

 

Process Validation Supporting Activities & Process Charectazation DSP (PTN-001)
Confidential - Version 1/18

 

* CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.

 

 

 

 [lonza.jpg]

 

 

THIS AMENDMENT No. 2 is made on the date of the last signature set forth below

to the Manufacturing Services Agreement dated 30 June 2015 between Proteon
Therapeutics, Inc. (“Proteon” or “Customer”) and Lonza Ltd (“Lonza”) (the
“Agreement”),

 

BETWEEN:

 

Proteon, having its address at 200 West Street, Waltham, Massachusetts

 

and

 

Lonza, a Swiss Corporation having a place of business at Münchensteinerstrasse
38, CH-4002 Basel, Switzerland

 

WHEREAS

 

A.Proteon and Lonza entered into the Agreement, under which Lonza is required to
perform Services relating to the Cell Line and Product described therein, and

B.The Parties have identified a scrivener’s error in Section 12.5(b) of the
Agreement that they wish to correct,

C.Proteon wishes Lonza to perform additional Services as set forth herein, and,

D.Lonza is willing to perform the additional Services on the terms set out
herein.

 

NOW THEREFORE THE PARTIES AGREE AS FOLLOWS:

 

1.Section 12.5(b) of the Agreement is amended and restated as follows:

 

“(B) EXCEPT FOR BREACH OF CONFIDENTIALITY OBLIGATIONS UNDER CLAUSE 13 AND EXCEPT
AS OTHERWISE PROVIDED IN CLAUSE 12.2 WITH RESPECT TO THIRD PARTY CLAIMS,
CUSTOMER’S LIABILITY TO LONZA UNDER THIS AGREEMENT SHALL IN NO EVENT EXCEED, IN
THE AGGREGATE, THE TOTAL AMOUNTS PAID BY CUSTOMER TO LONZA UNDER THE PROJECT
PLAN GIVING RISE TO SUCH CLAIM FOR DAMAGES IN THE TWELVE (12) MONTH PERIOD
PRECEDING THE FIRST CLAIM FOR DAMAGES, EXCEPT TO THE EXTENT RESULTING FROM
CUSTOMER’S FRAUD, GROSS NEGLIGENCE OR INTENTIONAL MISCONDUCT.”

 

2.Appendix A of the Agreement shall be amended to include the additional
Services as set out in Exhibits A, B1, B-2 and C hereto

 

3.Appendix A of the Agreement shall be amended to include the provision of
payment for the additional Services, as set out in Exhibit D hereto

 

 

Process Validation Supporting Activities & Process Charectazation DSP (PTN-001)
Confidential - Version 2/18

 

* CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.

 

 

 

 [lonza.jpg]

 

Capitalized terms used, but not defined, herein shall have the meanings set
forth in the Agreement. Save as herein provided, all other terms and conditions
of the Agreement shall remain in full force and effect. The term "Agreement" as
used in the Agreement shall henceforth be deemed to be reference to the
Agreement as amended by the Amendment No. 2.

 

 

 

 

 

 

 

Process Validation Supporting Activities & Process Charectazation DSP (PTN-001)
Confidential - Version 3/18

 

* CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.

 

 

 

 

AS WITNESS the hands of the duly authorized representatives of the parties
hereto the day and year first before written.

 

 

 

SIGNED BY:   /s/ Marie Leblanc For and on behalf of   Marie Leblanc Lonza Ltd  
Associate Director     Key Account Management     Title           21 January
2016     Date       SIGNED BY:   /s/ Nadia Zieger For and on behalf of   Nadia
Zieger Lonza Ltd   Senior Legal Counsel     Title           21 Jan. 2016    
Date       SIGNED BY:   /s/ Timothy Noyes For and on behalf of   Timothy Noyes  
    Proteon Therapeutics, Inc.         Title           1-15-16     Date

 

 

 

Process Validation Supporting Activities & Process Charectazation DSP (PTN-001)
Confidential - Version 4/18

 

* CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.

 

 

 

 

 

 

 

[               ]* ±

 

 

 

 

 

 

 

 

 

 

 

 

* CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.

± Confidential Treatment has been requested for 14 pages.