Commercialization Plan/Budget Clause Samples
Commercialization Plan/Budget. The Joint Commercialization Committee, no later than [* * *] months prior to the anticipated commercial launch of the first Licensed Product and thereafter no later than [* * *] of each Contract Year, shall approve a strategic commercialization plan for the Licensed Products in the Field in North America (the “Commercialization Plan/Budget”) which sets forth the matters agreed upon by the Joint Commercialization Committee. The Joint Commercialization Committee shall prepare the initial Commercialization Plan/Budget no later than [* * *] months prior to the anticipated commercial launch of the first Licensed Product. Thereafter, the Joint Commercialization Committee shall prepare a draft of the Commercialization Plan/Budget no later than [* * *] of each Contract Year. The Joint Commercialization Committee will consider including (but is not required to include) (a) a multi-year marketing strategy that includes plans for market research, health economics, pricing and reimbursement, medical affairs and value added initiatives, (b) a multi-year communications strategy that includes plans for public relations, conferences and exhibitions, and other external meetings, internal meetings and communications, publications and symposia, internet activities, and core brand package, (c) a multi-year strategy for Post-Approval Clinical Trials and lifecycle management activities, (d) a high level operating plan for the implementation of such strategies on an annual basis, including information related to product positioning, core messages to be communicated, share of voice requirements and pricing strategies, (e) a commercially reasonable level of detailing activity, (f) a commercialization budget, and (g) all other activities to be conducted in connection with the Commercialization of the Licensed Products in the Field in North America. As between the Parties, Celgene will book all sales of Licensed Products and will have the sole responsibility for the sale, invoicing and distribution of the Licensed Products in the Territory.
Commercialization Plan/Budget. Responsibility for any Commercialization Plan budget shall rest with the CT, which shall develop budgets for Commercialization in the Field in the Territory, subject to final approval by the JSC. Budgets will be prepared annually as set forth in Section 4.2.2. Any disputes relating to the amount of a Commercialization Plan budget shall be considered a Reserved Dispute subject to resolution pursuant to Section 12.2. The budgets shall be divided between the Marketing Plan and the Medical Activity Plan. Such budgets shall include Sales Representative FTE Rates for the Sales Representatives FTEs, Treatment System Specialist FTE Rates for the Treatment System Specialists FTEs, and Commercialization FTE Rates for other FTEs conducting Product Commercialization activities. The financial representatives from Cephalon and Alkermes appointed pursuant to Section 3.2 will be responsible for identifying, analyzing and reporting to the CT all significant [**] between the budget and the applicable Commercialization Costs and all [**] between the budget and the Commercialization Costs. If any costs for a Commercialization activity result in an increase [**] in the approved budget for a calendar quarter of more than [**] percent ([**]%), the CT shall forward to the JSC the report it received from the financial representatives, and the JSC shall review such costs and shall designate them as Commercialization Costs if the JSC determines that incurring such costs was [**]. [**]. A [**]-year long-range plan for Commercialization of the Products in the Field in the Territory (including the budget for Commercialization Costs) shall be established on a yearly basis under the direction of the CT as set forth in Section 4.2.2 and shall be submitted to the JSC for final approval.
Commercialization Plan/Budget. Licensee shall be responsible for preparing a detailed budget for Commercialization Costs relating to the activities set forth in the Commercialization Plan for each Product for each Calendar Year covered by the Commercialization Plan (as amended from time to time, the “Commercialization Plan Budget”), Licensee shall submit each initial Commercialization Plan Budget and any amendments thereto to the JPC for review and comment in accordance with Article VI. The Commercialization Plan Budgets for the Initial Products in the EU shall be discussed at the first JPC after the Effective Date.
Commercialization Plan/Budget. Responsibility for any Commercialization Plan budget shall rest with the CT, which shall develop budgets for Commercialization in the Field in the Territory, subject to final approval by the JSC. Budgets will be prepared annually as set forth in Section 4.2.
Commercialization Plan/Budget. 30 4.9 Product Label and Packaging..................................... 31 4.10