Common use of Phase 3 Program Plan and U Clause in Contracts

Phase 3 Program Plan and U. S. Commercial Plan. Sanofi will provide Principia with an updated version of the Initial Phase 3 Program Plan for the Optioned Product and each updated version thereof, on a semi-annual basis commencing with the date of the Exercise Notice, as well as any other Indications under Development by, or under contemplation for Development by, Sanofi with respect to the Optioned Product and the progress and results of such Development. In addition, solely if the Profit (Loss) Share is in effect, Sanofi will, approximately eighteen (18) months before the anticipated launch of the Optioned Product in the U.S., provide Principia with a high-level commercial plan for the U.S. (the “U.S. Commercial Plan”), which will include a high level annual budget for the current and the following two (2) Calendar Years (the “U.S. Budget”), and will provide any updated version thereof on a semi-annual basis thereafter. For clarity, as between the Parties, Sanofi will have the sole right to (a) create and amend the U.S. Commercial Plan (including the U.S. Budget), and (b) conduct the U.S. Commercial Plan. [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.