Common use of Pilot Phase Clause in Contracts

Pilot Phase. (1) Upon completion of the Analytical Phase Sandoz shall implement the Process in its facilities and Manufacture the Pilot Batches of the API, although not necessarily in compliance with the API Specifications, for the purpose of qualifying the Process. In accordance with the Technology Transfer Plan, the Pilot Phase shall run for a minimum of **) **, with the actual number of total ** to be agreed upon by Unigene and Sandoz based on the results of the Pilot Phase. The parties acknowledge that Sandoz’s ability to conduct the Pilot Phase in accordance with this timetable is dependent on timely delivery by Unigene in accordance with the Technology Transfer Plan of agreed-upon Process Transfer Information. The parties agree to use their commercially reasonable endeavors to ensure that the timeline for the Pilot Phase is met. (2) If during the Pilot Phase the parties identify an unforeseeable technical problem, which prevents Sandoz from Manufacturing the Pilot Phase Batches, then the following procedure shall apply: (a) Sandoz may request further reasonable technical assistance from Unigene and Unigene shall according to Clause 4(8)(a)provide technical assistance as reasonably deemed appropriate by Sandoz. (b) Sandoz shall use its commercially reasonable endeavors to resolve the problem to both parties’ satisfaction and Unigene shall be entitled to have a representative present at the Sandoz site and to fully participate in solving such problem to ensure that this provision is satisfied. (3) If the parties are unable to resolve the problem in the manner described in Clause 3(2)(b) and are not progressing to a mutually agreeable resolution of the problem within a minimum of **) weeks of identification thereof, then Sandoz may terminate this Agreement, in which case the parties’ obligations hereunder shall terminate, other than each party’s obligation of confidentiality and to return the other party’s Confidential Information. (4) Subject to completion of the Pilot Phase, Sandoz will conduct the Demonstration Lot Campaign, and will deliver the Product produced therefrom to Novartis Pharma AG upon completion of such campaign. The parties agree that the Demonstration Lot Campaign means that Sandoz shall Manufacture (a) up to ** Engineering Batches of API and (b) ** cGMP Batches of API that meet the API Specifications, within the timeline stated in Clauses 9(1)(c) and 11(1). If during the Demonstration Lot Campaign the parties identify an unforeseeable technical problem, which prevents Sandoz from Manufacturing the Demonstration Lot Campaign, then Sandoz may request further reasonable technical assistance from Unigene and Unigene shall according to Clause 4(8)(a) provide technical assistance as reasonably deemed appropriate by Sandoz. (5) Deliverables during the technology transfer shall be provided by Unigene in accordance with Schedule 10.