Commercialization Plan and Budget. ORTHO, after taking --------------------------------- into consideration CTI's comments, shall develop and the JCC shall review, to the extent reasonably practical given the stage of development of each Collaboration Product and consistent with ORTHO's reasonable business practice, a commercialization plan ("Commercialization Plan") for each Collaboration Product for the Co-Promotion Territory, which shall include but not be limited to (i) market dynamics, market strategies, estimated launch dates in the Co- Promotion Territory, a sales and expense forecast (including at least ***** of estimated sales and expenses) in the Co-Promotion Territory, manufacturing plans and expected product profile based upon the Development Plan, (ii) a market plan (including Advertising forecasts and pricing strategies pertaining to discounts, samples and nominal price sales) for the Co-Promotion Territory; it being understood that such market plan will evolve over time and shall be similar to existing market plans developed at such time by ORTHO within the Co-Promotion Territory, (iii) a commercialization budget ("Commercialization Budget") for each Collaboration Product, initially for the Development Indications, for the Co-Promotion Territory, including the Third Parties to be utilized and the arrangements with them that have been or are proposed to be agreed upon. Each Commercialization Budget shall include a budget of the expenses expected to be incurred in connection with performing the Commercialization Plan, including Pre-Marketing Expenses and Allowable Operating Expenses in the Co-Promotion Territory. (The information below marked by ***** has been omitted by a request for confidential treatment. The omitted portion has been separately filed with the Commission.) The first Commercialization Plan shall be in the form of an initial outline and the first Commercialization Budget shall be in the form of an estimated budget. ORTHO shall submit such outline of the first Commercialization Plan and an estimated Commercialization Budget for a Collaboration Product for a BMT Indication to the JCC for review and approval by a date to be established by the JCC taking into account ORTHO's and CTI's annual budget planning calendars. It is understood that such outlines may contain open issues and identify areas wherein more information is needed to complete the outlines (The information below marked by ***** has been omitted by a request for confidential treatment. The omitted por...
Commercialization Plan and Budget. Amgen shall prepare an initial Global Brand Plan for each Product not later than […***…] prior to the anticipated Regulatory Approval of the applicable Product in the Collaboration Territory. For each Product, BeiGene shall prepare an initial draft Commercialization Plan, Commercialization Budget and Access and Pricing Plan not later than […***…] prior to the anticipated Regulatory Approval of the applicable Product in the Collaboration Territory. Thereafter, the Parties will continue to discuss and refine such initial, draft Commercialization Plan, Commercialization Budget and Access and Pricing Plan. Amgen shall submit the Global Brand Plan to the JSC for review, and BeiGene shall submit the Commercialization Plan, Commercialization Budget and Access and Pricing Plan to the JSC for approval, not later than […***…] prior to the anticipated Regulatory Approval of the applicable Product in the Collaboration Territory or as otherwise determined by the JSC. Thereafter, the Global Brand Plan, Commercialization Plan, Commercialization Budget and Access and Pricing Plan for each Product will be updated annually (or such other timeframe determined by the JSC) and submitted to the JSC for approval.
Commercialization Plan and Budget. (a) The Parties shall conduct all Commercialization of Products in the Field in the Territory in accordance with a written plan prepared by the JSC (each such plan, as updated or amended from time to time in accordance with Section 5.8,“a “Commercialization Plan and Budget”).
(b) Within ninety (90) days of beginning a Phase 3 Clinical Trial for a Product, and no later than sixty (60) days prior to the anticipated Regulatory Approval of any Product, the JSC shall prepare and share with the Parties, the Commercialization Plan and Budget for such Product.
(c) Each Commercialization Plan and Budget will set out:
(i) the identity of the Product and each indication for Commercialization in the Territory;
(ii) a coordinated Commercialization strategy for such Product in the Territory, including a timeline and reasonably detailed description of the key elements of such Product’s Commercialization strategy (including branding, marketing, advertising, market access, pricing and reimbursement, and sales force positioning);
(iii) the allocation of responsibility between the Parties for all Commercialization activities (pre- and post-First Commercial Sale) that the Parties agree to conduct for such Product, [***];
(iv) a Manufacturing plan for commercial supply of such Product following Regulatory Approval, which shall provide, among other things, [***] (each, a “Commercial Manufacturing and Supply Plan”);
(v) a non-binding sales and marketing expenditures forecast;
(vi) a non-binding projection of Net Sales of such Product; and
(vii) a good faith estimated budget for all such Commercialization activities, including the number of FTEs committed by each Party and anticipated Out-of-Pocket Costs for the next three (3) Annual Periods.
Commercialization Plan and Budget. Following exercise of the Option, Pfizer shall provide to eFFECTOR an estimated plan and budget for Commercialization of the Product in the U.S. when it is available and annual updates to such plan and budget for eFFECTOR’s budgeting and planning purposes. In the event that eFFECTOR does not exercise its Option with respect to a Product, or if the Opt Out Right is subsequently exercised, then after the end of the Co-Development Co-Promotion Term, Pfizer shall not be obligated to provide any such plan and budget.
Commercialization Plan and Budget. (a) Commercialization Plan. Licensee will develop, the JCC will review, and the JSC will review and approve, a Commercialization Plan that sets forth the Commercialization activities to be undertaken with respect to Licensed Products in the Field in the Territory (which may set forth Commercialization activities in the Territory on a regional basis, rather than a country-by-country basis, defining the regions in a manner consistent with Licensee’s internal procedures). Nogra will be permitted to consult with Licensee in the development of such Commercialization Plan, provided that such consultation will not delay Licensee from developing such Commercialization Plan in accordance with its internal schedule for such development. The Commercialization of the Licensed Products in the Field in the Territory will be governed by the Commercialization Plan. The Commercialization Plan will be an [***] written plan, updated annually as provided in Section 6.2(c). Licensee will have responsibility for determining strategy and overall guidelines regarding the marketing, market access, medical affairs, and sales for Licensed Products in the Field in the Territory. The initial Commercialization Plan will be submitted to the JCC for review and approval no later than [***] prior to anticipated First Commercial Sale in the Territory. The Commercialization Plan will include an overall strategy for the Commercialization of the Licensed Products in the Field throughout the Territory, a tactical plan to accomplish such strategy, the Commercialization Budget, and annual Net Sales forecasts for the Territory. The terms of and activities set forth in the Commercialization Plan will 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.
Commercialization Plan and Budget. To facilitate commercialization of each Product, the PCT shall [****], develop a multi-year strategic Commercialization Plan that describes (i) the proposed strategy, and plans for Regulatory Approval for the applicable Product (Strategic Launch Concept subsequently modified into a Strategic Launch Plan) in at least the Major Markets; and (ii) the proposed strategy, plans and proposed budgets for commercialization of the Product in the U.S. (U.S Product Plan and Budget), for each Initial Indication, including: [****], as well as advertising and other promotional materials to be used in the Product marketing in the U.S.
Commercialization Plan and Budget. SCHERING, after --------------------------------- taking into consideration MYRIAD's and the JMC's comments, shall develop and the JMC shall review, to the extent reasonably practical given the stage of development of each Co-Promotion Product and consistent with SCHERING's reasonable business practice, a commercialization plan ("Commercialization Plan") and a commercialization budget ("Commercialization Budget") for each Co- Promotion Product for the Co-Promotion Territory, including the Third Parties to be utilized and the arrangements with them that have been or are proposed to be agreed upon. Each Commercialization Budget shall include a budget of the expenses expected to be incurred in connection with performing the Commercialization Plan in each applicable country of the Co-Promotion Territory. Each Commercialization Plan and Commercialization Budget shall be submitted to the JMC for review and approval by a date to be established by the JMC taking into account SCHERING's and MYRIAD's annual budget planning calendars. The Commercialization Plan and Commercialization Budget shall be approved by the JMC no later than December 31 of each preceding year.
Commercialization Plan and Budget. The Commercialization Plan shall cover only activities for commercialization of the Combination Product in the Territory that shall be conducted by a single Member Party or that must be coordinated between the Member Parties, which activities shall conform to the Collaboration Principles and the provisions of this Section 5.
Commercialization Plan and Budget. ORTHO shall submit to ERGO a --------------------------------- commercialization plan ("Commercialization Plan") for each Collaboration Product for the Profit/Loss Sharing Territory, which shall be comparable to existing marketing and or business plans for similar products developed at such time by ORTHO within the Profit/Loss Sharing Territory, and a commercialization budget ("Commercialization Budget") for each Collaboration Product, initially for each extant Development Indication and each extant Additional Indication for the Profit/Loss Sharing Territory. Such Commercialization Plan shall include estimated sales for the upcoming year and a rough estimate of sales for the year following the date of such plan. In addition, the Commercialization Plan shall identify co-promotion arrangements, if any, and contract sales force arrangements, if any. Each Commercialization Budget shall include a budget of the expenses expected to be incurred in connection with performing the Commercialization Plan, including Pre-Marketing Expenses and Allowable Operating Expenses in the Profit/Loss Sharing Territory. On or about December 1 of each year, or earlier if available, ORTHO will provide the Commercialization Plan and Commercialization Budget to ERGO for at least the subsequent calendar year and, so long as ORTHO maintains its current two-year forecasting cycle on which to base such estimates, at least the subsequent two calendar years. ORTHO shall make all final decisions with respect to Commercialization Plans and Commercialization Budgets (except for the costs of the Phase IIIB Clinical Trials described in Exhibit E). Any significant change in a Commercialization Plan or Commercialization Budget made by ORTHO during the course of the year will be communicated promptly to ERGO.
Commercialization Plan and Budget. For each Joint Product, at such time as is typically conducted by Gilead with respect to commercialization plans and budgets for its other products, or as otherwise agreed by the JCC, Gilead shall prepare, in consultation with Arcus, for review and discussion by the JCC and final approval by the JSC, a commercialization plan and budget for such Joint Product (each, a “Commercialization Plan and Budget”). The JCC shall review, at least [***], the Commercialization Plan and Budget for each Joint Product and suggest any applicable amendments thereto for review and approval by the JSC. The Commercialization Plan and Budget for a Joint Product shall include commercial strategy, branding principles, high-level pricing strategy and a budget for Commercialization Costs. To the extent Arcus exercises its Co-Promotion Option, the Commercialization Plan and Budget shall also include the Co-Promotion Activities assigned to Arcus and the budget therefor.
