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”).
(a) Promptly after the Effective Date, the JCC (or if not formed, the JSC) will determine the initial pre-commercial activities for which AstraZeneca will prepare an initial U.S. Commercialization Plan, which activities will include [*], but need not include all activities described in the first paragraph of this Section 5.2. Within ninety (90) days thereafter, AstraZeneca will present such plan to the JCC for review and approval. Within two (2) years after the Effective Date but in any event not later than two (2) years prior to the then currently anticipated NDA submission date, AstraZeneca will present to the JCC a U.S. Commercialization Plan covering all activities described in the first paragraph of this Section 5.2, for review and approval by the JCC, which plan will include the key prelaunch and launch activities, marketing and sales deployment required for the initial launch of the Product and associated budgets. The JCC shall review, revise and recommend for approval by the JSC such U.S. Commercialization Plan promptly after receipt thereof. If the JCC is not yet formed by any of the foregoing dates, the JSC will review, revise and approve the applicable U.S. Commercialization Plan.
(b) AstraZeneca will prepare a detailed U.S. Commercialization Plan and U.S. Commercialization Budget in preparation for U.S. launch of the Product for review and approval by the JCC no later than the submission of the first NDA for the Product, or at such other time determined by the JSC.
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. 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.
(b) The U.S. Commercialization Plan shall set forth the strategy for the Commercialization of the Products in the Field in the U.S., the key Commercialization activities to be performed to implement such strategy and the staffing requirements for each such Commercialization activity. The U.S. Commercialization Plan will be consistent with the Global Commercialization Strategy Plan.
(c) The U.S. Commercialization Plan shall include the U.S. Commercialization Budget, annual Net Trade Sales forecasts for the U.S. for a given Calendar Year and the succeeding Calendar Year (which shall be Confidential Information of each Party), [***]. The “U.S. Commercialization Budget” means the budget for Allowable Expenses to be incurred by the Parties in conducting Commercialization activities for the Products in the Field in the U.S. pursuant to the U.S. Commercialization Plan [***]. Each U.S. Commercialization Budget shall include [***].
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”).
7.3.2 Each US Commercialization Plan shall contain, as applicable: [**].
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. 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
U.S. Commercialization Plan. 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 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. In collaboration with JBI, Pharmacyclics shall develop, the JCC shall review, and the JSC shall review and approve, a U.S. Commercialization Plan that sets forth the Commercialization activities to be undertaken with respect to Products in the Field in the United States. The joint Commercialization of the Products in the Field in the United States shall be governed by the U.S. Commercialization Plan. The U.S. Commercialization Plan 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. The U.S. Commercialization Plan shall be a [**], updated annually as provided in Section 5.3.5(a). Unless otherwise determined by the JCC, Pharmacyclics will have primary responsibility for determining marketing strategy and overall guidelines regarding medical affairs, and JBI will initially have primary responsibility for performing market access (and with an increasing level of participation by Pharmacyclics as described in Sections 5.1.2, 5.1.3 and 5.1.4), for Products in the Field in the United States. 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 an overall strategy for the Commercialization of the Products in the Field in the United States, a tactical plan to accomplish such strategy (including specific staffing requirements for each Commercialization activity set forth therein, permitted pricing discounts, etc.), the U.S. Commercialization Budget, and annual Net Trade Sales forecasts for the United States. 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 to be conducted in accordance with professional and ethical standards customary in the pharmaceutical industry, taking into account where applicable each Party’s health care compliance policies and applicable SOPs. [**] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
