Commercialization Plans. (a) The strategy for the Commercialization of Product to Physician Targets in the Field in the Territory during the term of this Agreement shall be described in one or more comprehensive plans that describe the pre-launch, launch and subsequent Commercialization activities (including estimated Shared Expenses, advertising, education, planning, marketing, sales force training and allocation) (each, a “Commercialization Plan”).
(b) Attached hereto as Exhibit 6.2(b) is a forecast of the prescriptions for Product in the in the Field in the Territory during each of the [***] following First Commercial Sale (the “Signing Date TRx Forecast”).
(c) No later than ninety (90) days following the Effective Date, the JCC shall have agreed upon and presented to the JSC an initial Commercialization Plan setting forth the pre-launch and launch year Commercialization activities and a preliminary Net Sales forecast and budget for Product in the in the Field in the Territory during the Product Launch Period. The amounts set forth in such Commercialization Plan (including without limitation, Net Sales forecast and budget, and other costs and expenses) will be based upon the prescription forecasts in the Signing Date TRx Forecast, and the prescription forecasts in such Commercialization Plan shall not vary from the Signing Date TRx Forecast without the mutual written consent of both MAP and ALLERGAN.
(d) Thereafter, on or before May 1 of each Calendar Year during the term of this Agreement, the JCC shall present to the JSC for its approval an updated Commercialization Plan including a budget for Shared Expenses in accordance with the then-current Annual Forecast And Budget for Product in the Field in the Territory for the next two (2) Calendar Years. On or before September 1 of such Calendar Year, the JSC shall have approved such Commercialization Plan, including the Annual Forecast And Budget contained therein. Notwithstanding anything contained herein, without the mutual written consent of both Parties, neither Party shall have the right to xxxx the other Party or include in Shared Expenses any direct or indirect Commercialization expenses other than those expressly provided for in the Annual Forecast and Budget, unless agreed to by the other Party.
(e) All Commercialization Plans developed in accordance with this Agreement shall generally conform to the level of detail utilized by ALLERGAN in preparation of its own product commercialization plans, with the overall objective ...
Commercialization Plans. 10.3.1 In-Vivo [***] Commercialization Plans. Subject to Applicable Law, NVS will prepare and provide to HMI (through the JSC): (a) an initial high-level summary of the anticipated Commercialization strategy and activities to be conducted for an In-Vivo [***] Product; and (b) an associated budget, no later than [***] for such In-Vivo [***] Product. In addition, NVS will prepare and provide to the JSC a Commercialization plan for each In-Vivo [***] Product that contemplates the commercial launch of, and the Commercialization activities to be taken in the first [***] after the First Commercial Sale of, such In-Vivo [***] Product in the Territory excluding the U.S. if HMI is the Commercializing Party and including the U.S. if NVS is the Commercializing Party (the “Global In-Vivo [***] Commercialization Plan”). If HMI is the Commercializing Party, then HMI will prepare and provide to the JSC a Commercialization plan for each In-Vivo [***] Product that contemplates the commercial launch of, and the Commercialization activities to be taken in the first [***] after the First Commercial Sale of, such In-Vivo [***] Product in the U.S. (the “U.S. In-Vivo [***] Commercialization Plan”). If HMI is the Commercializing Party, then each Party will provide the applicable Commercialization plan to the other Party no later than [***] such In-Vivo [***] Product in such Party’s territory. Subject to Applicable Law, (i) the strategic objectives and activities in the U.S. In-Vivo [***] Commercialization Plan will be consistent with the strategic objectives and activities in the Global In-Vivo [***] Commercialization Plan, unless otherwise agreed by the Parties; and (ii) the Global In-Vivo [***] Commercialization Plan and the U.S. In-Vivo [***] Commercialization Plan will each be reviewed, discussed, and approved by the JSC. Thereafter, at least once each [***], NVS will submit an updated Global In-Vivo [***] Commercialization Plan for each In-Vivo [***] Product, and HMI will submit an updated U.S. In-Vivo [***] Commercialization Plan, in each case, to the JSC for review, discussion, and approval.
Commercialization Plans. As soon as practicable after formation of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indica...
Commercialization Plans. Each Party shall submit a Commercialization Plan to the JSC for discussion no less [***] prior to the anticipated date of such Party obtaining Regulatory Approval for a Licensed Product. Thereafter, each Party shall provide a copy of the then-current Commercialization Plan to the JSC at least once each Calendar Year during the Licensed Product Royalty Term and Takeda Royalty Term, as applicable.
Commercialization Plans. Each Party shall use Diligent Efforts to prepare annual marketing plans for each Product, such plans shall contain the details contained in the marketing plans regularly prepared by such Party for its other products and shall include plans related to the pre-launch, launch, promotion and sale of the Product, and the general nature of the marketing, promotion and advertising campaigns proposed to be conducted, including, in the case of Enzon, the number of sales representatives proposed to detail the Product (each such plan a “Commercialization Plan”). Each Party shall provide the other Party a copy of all Commercialization Plans for each Product as soon as practicable after such plan is completed.
Commercialization Plans. Activities to be undertaken before the next annual report including, but not limited to, the type and objective of any necessary efforts and their projected starting and completion dates.
Commercialization Plans. Licensee shall provide ARCH with its ----------------------- strategic and detailed plans for the commercialization of the Licensed Products. Such plans shall include research and development plans, product milestones and related timetable schedules, government or regulatory timetables and sales and marketing plans. Licensee will update these plans at least on an annual basis.
Commercialization Plans. During the Royalty Term with respect to each Product, at least thirty (30) days prior to the commencement of each Calendar Year, Processa shall provide Elion, for information purposes only, a summary of the planned Commercialization activities to be conducted by or on behalf of Processa and its Affiliates and Sublicensees with respect to such Product in each country in the Territory during such Calendar Year (each such plan, a “Commercialization Plan”).
Commercialization Plans. For each Product, BMS shall be responsible for creating a [****]* forecast and a comprehensive [****]* commercialization plan setting forth the anticipated Commercialization activities in the U.S. (including without limitation market research, launch plans, product positioning, and detailing activities) (the “U.S. Commercialization Plan”) consistent with BMS then-current internal practices.
Commercialization Plans. The Parties shall cooperate to develop each Commercialization Plan setting forth the Promotion activities and other Commercialization activities to be conducted by Spectrum in the Territory with respect to each Product.
