U.S. Commercialization Plan. (a) U.S. No later than [***] prior to the anticipated submission of the first BLA for the first Co-Co Product for Regulatory Approval from the FDA in the U.S. (as set forth in the Celgene Co-Co Development Plan), Celgene (after good faith consultation with Jounce) will prepare an initial U.S. Commercialization Plan for such Co-Co Product covering the first [***] after First Co-Co Sale of such Co-Co Product in the U.S., and the JCC will review and approve such initial U.S. Commercialization Plan. Thereafter, Celgene (after good faith consultation with Jounce) will update the U.S. Commercialization Plan (for the current Calendar Year and the [***]) each Calendar Year, and the JCC will review and approve any such update or other amendment to the U.S. Commercialization Plan. Either Party may request at any time that the JCC consider and approve other updates to the U.S. Commercialization Plan.
U.S. Commercialization Plan. As further described in this Section 5.2, the comprehensive strategy for the Commercialization of each Product in the U.S. shall be described in a comprehensive plan that describes the pre-launch, launch and subsequent Commercialization of such Product in the U.S. (including without limitation the high level strategies regarding messaging, branding, pricing, advertising, planning, marketing, sales force training and allocation, and reimbursement/managed care), key tactics for implementing those activities and the relative responsibilities of the Parties (each such plan, a “U.S. Commercialization Plan”), and the associated budget for such activities that details the anticipated Commercialization Costs (each such budget, a “U.S. Commercialization Budget”).
U.S. Commercialization Plan. Buyer shall have delivered to Seller at or immediately prior to Closing, the U.S. Commercialization Plan for calendar year 2015.
U.S. Commercialization Plan. (a) [***] shall develop and periodically update, and the JSC shall approve, a written plan for Commercialization of the Products in the Field in the U.S. (the “U.S. Commercialization Plan”) as described in this Section 5.2.2.
U.S. Commercialization Plan. 7.3.1 Within [**] after the Initiation of a Phase III Clinical Trial of a Collaboration Product in the Field in the Territory, the JCC shall develop an initial high-level Commercialization plan for the Collaboration Products in the Field in the Collaboration Territory (such plan, if and when approved by the JSC and as may be amended from time to time in accordance with this Agreement, the “US Commercialization Plan”).
U.S. Commercialization Plan. In collaboration with JBI, Pharmacyclics shall develop, and submit to the JCC for review, an updated [**] plan for Commercializing the Products in the United States for each Calendar Year (and the two succeeding Calendar Years), which shall include an updated U.S. Commercialization Budget for such three-year period. The JCC shall submit each such U.S. Commercialization Plan to the JSC for review and approval in time to permit the JSC’s preliminary approval to occur no later than September 1 of the prior Calendar Year. Upon the JSC’s preliminary approval, such plan shall be submitted to each Party for its internal budgeting process with a target for final approval by the JSC no later than December 1 of the prior Calendar Year, and after final approval by the JSC, such U.S. Commercialization Plan shall take effect on the first day of the Calendar Year to which such U.S. Commercialization Plan applies. The JCC shall review each Party’s (and its Affiliates’) performance under the U.S. Commercialization Plan (including the U.S. Commercialization Budget) on a quarterly basis, and shall develop detailed and specific updates and substantive amendments to the U.S. Commercialization Plan that reflect such performance. The JCC shall also reasonably consider any proposed updates and amendments to the U.S. Commercialization Plan presented by either Party. The JSC shall review such proposed amendments presented by the JCC and may approve such proposed amendments or any other proposed amendments that the JSC may consider from time to time in its discretion and, upon such approval by the JSC, the U.S. Commercialization Plan shall be amended accordingly. Amendments and updates to the U.S. Commercialization Plan, including the U.S. Commercialization Budget, shall not be effective without the approval of the JSC or the Executive Officers pursuant to Section 13.1, or determination of the Expert pursuant to Section 13.3, as applicable. In the event that the JSC does not approve an updated U.S. Commercialization Plan, including the U.S. Commercialization Budget, prior to the start of the next Calendar Year, either Party may initiate procedures to resolve the issue pursuant to Sections 13.1 and 13.3, and the then-current U.S. Commercialization Plan, together with the budgeted amounts set forth in the [**] U.S. Commercialization Budget, shall continue to apply until the U.S. Commercialization Plan is agreed by the JSC or the Executive Officers pursuant to Section 13.1, or determi...
U.S. Commercialization Plan. The Parties shall cooperate to develop, the JCC shall review, and the JSC shall review and approve, a U.S. Commercialization Plan for Cost Profit Sharing Products that sets forth the Commercialization activities to be undertaken with respect to Cost Profit Sharing Products in the Field in the United States The U.S. Commercialization Plan *** Certain information has been excluded from this agreement because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. shall at all times be consistent with the Global Strategic Launch Plan and Section 5.1.3 above. The joint Commercialization of the Cost Profit Sharing Products in the Field in the United States shall be governed by the U.S. Commercialization Plan, which shall allocate such Commercialization activities between the Parties in accordance with the terms of this Agreement, including the principles set forth in Section 5.1.2 and the provisions of Sections 5.1.3 (and if applicable, Section 5.8 below). Unless otherwise determined by the JCC, the U.S. Commercialization Plan shall be a [***] [***] rolling plan, updated annually as provided in Section 5.3.5(b). The initial U.S. Commercialization Plan shall be submitted to the JCC for review no later than [***] prior to anticipated First Commercial Sale in the United States, and submitted to the JSC for approval no later than [***] [***] prior to anticipated First Commercial Sale in the United States. The U.S. Commercialization Plan shall include [***]. The terms of and activities set forth in the U.S. Commercialization Plan shall at all times be designed to be in compliance with all applicable Laws and the Compliance Program.
U.S. Commercialization Plan. The PT shall prepare a written plan for the Product Commercialization efforts in the United States, which shall set forth the goals and objectives for Commercialization of the Product in the pertinent Calendar Year (including determinations of Product Trademarks, subject to Section 14.1.1 and the proviso to (b)), a budget therefor (as further described below) and applicable items described in Section 6.2.4, and shall assign responsibilities to the Parties, subject to any allocation of responsibilities set forth in this Agreement (as agreed, approved and amended from time to time pursuant hereto, the "U.S. Commercialization Plan"). In connection with the preparation and implementation of the U.S. Commercialization Plan, CancerVax and Serono will make available to the PT global marketing intelligence and market research information then in their possession pertaining to the Product, the usage of the Product and market trends. For clarity, unless the context clearly indicates to the contrary, references herein to the "U.S. Commercialization Plan" shall mean the Provisional U.S. Commercialization Plan or the then-current U.S. Commercialization Plan, as the case may be.
U.S. Commercialization Plan. (a) Contents. The U.S. Commercialization Plan shall set forth the strategy for the Commercialization of the Profit Share Product in the U.S., the key Commercialization activities to be performed to implement such strategy, and the staffing requirements for each such Commercialization activity. If Fate exercises the U.S. Commercialization Option pursuant to Section 5.1.3 of this Exhibit, the U.S. Commercialization Plan shall allocate responsibility between the Parties for Commercialization activities with respect to the Profit Share Product in the U.S., which allocation shall be consistent with Section 5.1.3 of this Exhibit.
U.S. Commercialization Plan. The Parties shall conduct all Commercialization of Products in the Field in the U.S. in accordance with a comprehensive commercialization plan that is consistent with this Agreement (as amended in accordance with this Agreement, the “U.S. Commercialization Plan”), the initial version of which MEI will prepare and provide to the JCC for review and discussion (and subsequently present to the JSC for final approval), [*CONFIDENTIAL*] prior to the anticipated Regulatory Approval of Product in the Field in the U.S. From time to time, but at least once every Calendar Year, the JCC will update the U.S. Commercialization Plan and submit such updated plan to the JSC for final
