U.S. Commercialization Budget. The U.S. Commercialization Plan shall include a ​ rolling budget for Allowable Expenses to be incurred by the Parties in conducting Commercialization activities for the Profit Share Product in the U.S. pursuant to the U.S. Commercialization Plan during ​ the “U.S. Commercialization Budget”). The U.S. Commercialization Budget shall include budgeted amounts for Commercial FTE Costs and Out-of-Pocket Expenses, broken down by Calendar Quarter for ​, for Commercialization activities in the U.S. and a breakout of costs by functional area or category, as determined by the USJCC in conjunction with the JFC. The ​ of the U.S. Commercialization Budget ​ to the extent provided in the Financial Exhibit, and the ​ shall serve as ​ (subject to any other applicable restrictions in this Exhibit). Each U.S. Commercialization Budget shall also include an annual amount for strategic commercial efforts that will be undertaken by Janssen and its Affiliates at the global team level in accordance with the global commercialization strategy described in [Section 5.1.2(e)], of which ​ percent (​) shall be allocable to the U.S. (the “Allocable Global Costs”).

U.S. Commercialization Reports. In advance of each meeting of the USJCC, unless otherwise agreed between the Parties, each Party will provide to the USJCC a ​.

U.S. Pricing Matters. Janssen shall be solely responsible for and have sole authority with respect to the prices charged and discounts, rebates and other sale and reimbursement terms and conditions for the Profit Share Products in the U.S. Janssen shall keep Fate reasonably informed through the USJCC of such matters. ​.

U.S. Recalls. Janssen shall decide, in its sole discretion, whether to conduct a recall of any Profit Share Product in the U.S. and shall have sole discretion to determine the manner in which any such recall shall be conducted. Janssen shall notify Fate prior to commencing any recall and shall in good faith take into account any reasonable suggestions made by Fate in respect of such recall.

U.S. Medical Inquiries. Janssen shall handle all medical questions or inquiries from members of the medical profession in the U.S. regarding the Profit Share Products. Janssen shall keep Fate reasonably informed through the USJCC of any material medical question or inquiry from members of the medical profession in the U.S. regarding the Profit Share Products.

U.S. Pre-Tax Profits and Losses. In partial consideration for the licenses granted by Fate to Janssen in accordance with [Section 5.1.2] of the Agreement with respect to the Profit Share Product, the Parties shall share in U.S. Pre-Tax Profits and Losses as follows: Fate shall bear (and be entitled to) ​, and Janssen shall bear (and be entitled to) ​. The U.S. Pre-Tax Profits and Losses shall be calculated as set forth in the Financial Exhibit.

“U.S. Corresponding Debt” means the Obligations, other than the U.S. Parallel Debt; and

“U.S. Parallel Debt” means any amount which a Loan Party owes to the Administrative Agent under [Section 11.22(b)(i)].

“U.S.” means the United States of America, including its territories and possessions.

“U.S. Net Sales Milestones” has the meaning set forth in [Section 8.5.2] (U.S. Net Sales Milestones Following Opt-Out).