1.88 [ ]*
COMMITMENT TO DEVELOP AND MANUFACTURE; PURCHASE
2.1 Commitment to Develop and Manufacture.
2.1.1 Development. PROTEON hereby retains LONZA to develop the Manufacturing Process at the LONZA Facility, LONZA shall use Commercially Reasonable Efforts to develop the same, and PROTEON shall pay LONZA for such development work, all in accordance with the Project Plan and Exhibit B.
2.1.2 Manufacture. Subject to the successful completion of the development of the Manufacturing Process at the LONZA Facility as defined in the Project Plan, PROTEON retains LONZA as a manufacturer of Drug Substance. LONZA shall provide sufficient services and capacity to manufacture Drug Substance for PROTEON in accordance with the Project Plan and in accordance with the Master Production Record, and PROTEON shall purchase such services and capacity from LONZA in accordance with the Project Plan and Milestone Payment Summary (Exhibits A&B).
PROJECT PLAN; PROJECT MANAGEMENT
3.1 Project Plan. In order to enable the Parties to fulfill their respective obligations under this Agreement, the Parties shall implement and perform their obligations as set out in the Project Plan. The Project Plan will be written by LONZA and submitted for PROTEON approval.
3.1.1 The Project Plan may be amended by agreement of the Parties through the Change Order procedures set forth in Section 3.4. In the case of a Change Order to a Project Plan, that Change Order becomes the controlling document.
3.1.2 LONZA may from time to time notify PROTEON that LONZA requires approvals or other actions by PROTEON relating to the services that do not represent a change in the terms of the Project Plan (each, a Decision Request). Adherence to the time-scales set out in the Project Plan is contingent in part on PROTEONs reasonably expedient review and response to such Decision Requests. When making a Decision Request, LONZA shall provide PROTEON with written notice that includes a description of the approval that it is seeking and copies of the requisite documents, data and development paths to which such approval relates. PROTEON shall respond to each Decision Request notice within the period of time specified in the Decision Request notice (not to be less than one (1) Business Day nor more than two (2) Business Days after PROTEON has received from LONZA the Decision Request and the requisite documents, data and development paths). Any change from an approved Decision Request shall be subject to the procedures specified in Section 3.4. If PROTEONs decision on a Decision Request affects the
* 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.