Common use of U.S. Commercialization Plan Clause in Contracts

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. As further described in this Section 5.2The Parties shall cooperate to develop, and submit to the comprehensive strategy JCC for review, an updated [***] [***] rolling plan for Commercializing the Commercialization of each Product Cost Profit Sharing Products in the United States for each Calendar Year (and the [***] [***]), which shall include an updated U.S. Commercialization Budget for such [***] [***] 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 [***] of the prior Calendar Year. Upon the JSC’s preliminary approval, such plan shall be described in submitted to each Party for its internal budgeting process with a comprehensive plan that describes target for final approval by the pre-launchJSC no later than [***] of the prior Calendar Year, launch and subsequent 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 Product in U.S. Commercialization Plan applies. The JCC shall review each Party’s (and its Affiliates’) performance under the U.S. Commercialization Plan (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 on a [***] basis, and shall develop detailed and specific updates and substantive amendments to the Effective DateU.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 JCC (or if not formed, U.S. Commercialization Plan shall be amended accordingly. Amendments and updates to the JSC) will determine the initial pre-commercial activities for which AstraZeneca will prepare an initial U.S. Commercialization Plan, which activities will include [*]including the U.S. Commercialization Budget, but need shall not include all activities described in be effective without the first paragraph approval of this the JSC or the Executive Officers pursuant to Section 5.213.1, or determination pursuant to Section 13.3, as applicable. Within ninety (90) days thereafterIn the event that the JSC does not approve an updated U.S. Commercialization Plan, AstraZeneca will present such plan to including the JCC for review and approval. Within two (2) years after the Effective Date but in any event not later than two (2) years U.S. Commercialization Budget, prior to the then currently anticipated NDA submission datestart of the next Calendar Year, AstraZeneca will present either Party may initiate procedures to resolve the JCC a 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 [***] [***] rolling U.S. Commercialization Budget, shall continue to apply until the 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 is agreed 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 Planor determined pursuant to Section 13.1 or Section 13.3. (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. 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. As further described in this Section 5.2In collaboration with JBI, Pharmacyclics shall develop, and submit to the comprehensive strategy JCC for review, an updated [**] plan for Commercializing the Commercialization of each Product 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 described in submitted to each Party for its internal budgeting process with a comprehensive plan that describes target for final approval by the pre-launchJSC no later than December 1 of the prior Calendar Year, launch and subsequent 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 Product in U.S. Commercialization Plan applies. The JCC shall review each Party’s (and its Affiliates’) performance under the U.S. Commercialization Plan (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 on a quarterly basis, and shall develop detailed and specific updates and substantive amendments to the Effective DateU.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 JCC (or if not formed, U.S. Commercialization Plan shall be amended accordingly. Amendments and updates to the JSC) will determine the initial pre-commercial activities for which AstraZeneca will prepare an initial U.S. Commercialization Plan, which activities will include [*]including the U.S. Commercialization Budget, but need shall not include all activities described in be effective without the first paragraph approval of this the JSC or the Executive Officers pursuant to Section 5.213.1, or determination of the Expert pursuant to Section 13.3, as applicable. Within ninety (90) days thereafterIn the event that the JSC does not approve an updated U.S. Commercialization Plan, AstraZeneca will present such plan to including the JCC for review and approval. Within two (2) years after the Effective Date but in any event not later than two (2) years U.S. Commercialization Budget, prior to the then currently anticipated NDA submission datestart of the next Calendar Year, AstraZeneca will present either Party may initiate procedures to resolve the JCC a 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 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 is agreed by the JSC such U.S. Commercialization Plan promptly after receipt thereof. If or 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 ProductExecutive Officers pursuant to Section 13.1, or at such other time determined by the JSCExpert pursuant to Section 13.3. [**] 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.

U.S. Commercialization Plan. As further described in this Section 5.2, Each US Commercialization Plan will describe the comprehensive strategy plan for the Commercialization of each the Product in the U.S. United States, specify in reasonable detail the Commercialization activities to be performed by each Party for the Product for a particular Year, and include a detailed budget for all such efforts. For clarity, the US Commercialization Plan shall not include any activities, responsibilities or budgetary items that are included in the other Commercialization Plans. The Parties shall jointly prepare each US Commercialization Plan through the US Commercialization Working Group. The Parties shall provide each US Commercialization Plan for review and comment to the JCC, which shall recommend such plans to the JSC for approval. The initial US Commercialization Plan 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 submitted 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 approval at least [ * ] prior to the then currently anticipated NDA submission datecommencement of Commercialization activities in the United States, AstraZeneca will present and thereafter each US Commercialization Plan shall be submitted 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 no later than [ * ]. Each US Commercialization Plan shall include the key prelaunch and launch activities, marketing and sales deployment required for the initial launch of following with respect to the Product and associated budgets. The JCC shall reviewin the United States, 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.as applicable: (a) an executive summary; (b) AstraZeneca will prepare a detailed U.S. Commercialization Plan general strategies, consistent with JCC guidance, for the Promoting, Detailing and U.S. Commercialization Budget marketing of each indication for the Product and allocation of responsibilities for marketing activities in preparation the United States, including [ * ]; (c) identification of individual accounts for U.S. launch Detailing in the United States, in accordance with Section 3.2.4; (d) market research plans and market assessment, (e) general plans for the marketing, promotion and sale of the Product to Managed Care Organizations, with appropriate input as to financial matters from the JFC; (f) the nature of any other key promotional activities, if any, and any other information contemplated by Section 3.2.4; (g) a market, unit sales, US Allowable Expenses, and Net Profit/Net Loss forecast; provided, however, that the Parties shall not be required to mutually agree to a Net Sales forecast or a Profit/Net Loss forecast (but shall cooperate as set forth in to Section 4.1.2(d)); (h) distribution and reimbursement strategy and associated tactics, and pricing and discounting policy for review the United States consistent with JCC and approval by US Pricing Working Group guidance; (i) advertising, public relations and other promotional product support programs and activities, including speaker, peer-to-peer activity and promotional programs; (j) the allocation of Commercialization activities between the Parties consistent with Article 3 and the Collaboration Agreement; (k) free goods program plans, a vendor/Product returns policy, and patient assistance and indigent access programs; (l) key performance indicators to monitor and assess Product performance, [ * ]; (m) general plans for field-facing activities, including a comprehensive joint call plan; (n) advocacy/stakeholder engagement budgets; and (o) other matters within the scope of the JCC no later than the submission involving a significant expenditure of the first NDA for the Productfunds or incurrence of expense, or at such other time determined by the JSCa significant use of resources.