Plan Contents. (1) The plan shall indicate the steps that will be taken consistent with other goals and objectives of the program, as provided in parts 92 and 570 of this title, to minimize the displacement of families and individuals from their homes and neighborhoods as a result of any assisted activities.
(2) The plan shall provide for relocation assistance in accordance with § 42.350.
(3) The plan shall provide one-for-one replacement units to the extent required by § 42.375.
Plan Contents. The procedures to identify and evaluate the goals and progress of the Partnering for Growth Agreement (hereinafter referred to as “Agreement”) are provided on the following pages.
Plan Contents. The Commercialization Plan shall include a reasonably detailed description of Commercialization activities and budget for each calendar year covered by such plan, including a timeline for initiation and completion of Commercialization Plan tasks and a list of proposed Launch Dates country-by-country in the Shared Territory as may be consistent with the JCC decision to whether to Develop and Commercialize Collaboration Compound and Collaboration Product outside the United States. The Commercialization Plan will include (a) general strategies for promoting Collaboration Products in the Field in the Shared Territory; (b) marketing plans, including advertising and public relations programs; (c) an outline of promotion, detailing and marketing activities in each country in the Shared Territory as may be appropriate; (d) plans related to Phase IV Clinical Trials and Post-Marketing Studies of Collaboration Products in the Field in the Shared Territory as may be appropriate; and (e) a budget for all of the foregoing, including Pre-Marketing Expenses and Allowable Expenses in the Shared Territory.
Plan Contents. The Commercialization of the Licensed Product in the Field in the Territory shall be conducted pursuant to a comprehensive multi-year plan to be prepared by Salix pursuant to Section 6.2.2 (such plan, as amended from time to time, the “Commercialization Plan”), which plan shall be consistent with Salix’s obligations set forth in Section 6.1. Without limiting the generality of the foregoing, the Commercialization Plan shall set forth the Promotion efforts, including the positioning of the Licensed Product in the detailing of physicians or other health care professionals and the type and level of other sales force activities to be performed by Salix in furtherance of the Commercialization Plan. The Commercialization Plan shall further set forth quarterly spending commitments and timelines for meeting Commercialization goals proposed by the JSC.
Plan Contents. Each Marketing Plan shall include a review of the marketplace, marketing objectives, strategies, and supporting tactics (with respective costs, timing, and responsibilities), clinical support plans, marketing study plans for future clinical and/or marketing studies, Sales Force effort, pricing, inventory requirements and distribution plans for the Product, together with sales, revenue and expense forecasts for Product sales in the Territory. The content of the Marketing Plan shall be determined by the JCC, but shall generally be in a form consistent with the outline attached hereto as Exhibit B, and shall include among other items the overall level of anticipated field sales resource commitments. All budgets contained in the Marketing Plan shall be based on estimates of the Quintiles Fully Loaded costs and associated pass-through expenses of the component services contained in the Marketing Plan.
Plan Contents. Each Marketing Plan shall include a review of the marketplace, marketing objectives/strategies, clinical support plans, marketing study plans for Phase IIIB/IV Studies, Sales Force effort, pricing, inventory requirements and distribution plans for the Product, together with a revenue and expense forecast for Product sales in the Territory. Such Marketing Plan shall be in a form generally consistent with the outline attached hereto as Exhibit B, and shall include among other items the overall level of anticipated resource commitments on the part of each Party in the relevant time period. Each Marketing Plan shall set forth the overall level of Territory Representative efforts. Each Marketing Plan shall be in accordance with this Agreement and all applicable laws, rules and regulations, including but not limited to those promulgated by the FDA, the Department of Health and Human Services Office of Inspector General (OIG), and state agencies and/or departments.
Plan Contents. (a) The Global Development and Commercialization Plans shall be consistent with the principle of maximizing the value of the Product on a worldwide basis. To achieve this, the Parties shall cooperate in the review and development of the Plans and budgets.
(b) The Global Development and Commercialization Plans and budgets therein shall contain sufficient detail as provided in Section 4.1 (a), and as allowed by applicable laws, with respect to the commercialization and development tactics and other matters to enable the JSC to conduct a meaningful review of such plans.
(c) Either Party may also develop and submit to the JOCs from time to time proposed amendments to the Plans. The JOCs shall review and comment on such proposed amendments and submit such substantive amendments to the JSC for review. Subject to each Party performing its respective responsibilities substantially in accordance with the Global Development Plan and the Commercialization Plan, (i) Licensee shall be solely responsible for all decisions regarding the Development and Commercialization of Licensed Products in the Territory, including prices charged for the Licensed Product in the Territory, as well as discounts, rebates and all other deductions from Net Sales in the Territory, and (ii) MGI shall be solely responsible for all decisions regarding development and commercialization of the Product outside the Territory, including the prices charged for the Product in the United States and Mexico, as well as discounts, rebates and all other deductions from net sales in the United States and Mexico. *.
Plan Contents. The Annual Marketing Plan for each Calendar Year beginning with the 2019 Calendar Year shall contain at a minimum the categories set forth in Exhibit 3.3(b) and such other information that the JOC or JSC believes is necessary. The 2018 Annual Marketing Plan shall contain a high-level summary of the Sales Deployment Plan and use of Shared M&P Expenses for the remainder of 2018.
Plan Contents. The Back-Up Plan will contain:
(a) key business objectives and associated performance requirements,
(b) key assumptions,
(c) a high-level system strategic architecture,
(d) an itemization of the architecture elements to be replicated,
(e) a bar chart showing an approximate timeframe for assembling the strategic architecture,
(f) a detailed plan to cover the implementation activity,
(g) a listing of equipment necessary to implement the Back-Up Plan, along with projected ordering dates, prices (if applicable), anticipated delivery dates and required installation intervals,
(h) engineering drawings and specifications,
(i) a listing of connectivity requirements,
(j) an itemization regarding Z-Tel cost recovery,
(k) procedures and timetables for testing of the Back-Up System's ability to takeover primary OSS functions from Z-Tel's Tampa system, and
(l) procedures and expectations concerning amendments and updates of the Back-Up Plan.
Plan Contents. Each Business Plan shall, at a minimum, include: a review of the marketplace and competition; Marketing and Promotion objectives/strategies for the Product; clinical and publication support plans and plans (if any) for Phase IIIb/IV studies and investigator-sponsored studies; delineation of Sales Force efforts, including a profile of Target Physicians, a Sales Call Plan, and a Samples plan; general delineation of Sales Territories; strategies and plans for Product pricing, inventory requirements and distribution; budgets; and revenue and expense forecasts for the Product in the Territory. The Business Plan shall also contain agreed upon promotional guidelines for the Product (the “Product Promotion Guidelines”), which shall be updated from time to time as necessary or desirable. Such Business Plan shall be in a form generally consistent with the outline attached hereto as Exhibit B, and shall include, among other items, the overall level of anticipated resource commitments on the part of each Party in the relevant time period. Each Business Plan shall also include a multi-year projection of Product plans, budgets and forecasts.
