Strategic Plan Content Examples Sample Clauses

Strategic Plan Content Examples. The following are examples of items that may be included in the Strategic Plan, as appropriate, based on the stage of Development or Commercialization of the applicable Product. i. Indications that will be pursued for each Product (which indications will be added to or refined over time) and the on-going pre-clinical Development, including registries and natural history studies, in support of such indications; ii. Timing and launch sequence of initial and subsequent indications for each Product; iii. Clinical Trials that the Parties will conduct for each Product, including patient populations, study designs, primary and secondary endpoints, length and size of study, associated timelines and budgets; iv. Safety data delivery procedures governing the collection, investigation, reporting, and delivery of information between the Parties concerning any adverse experiences, and any product quality and product complaints involving adverse experiences related to, or class effects that could impact, the Products, sufficient to enable the Parties to comply with its legal and regulatory obligations and internal processes, as applicable; v. Global regulatory strategy, including timing and key implementation items to support each targeted indication; vi. Timing, budget, and design of all nonclinical and pre-clinical studies supporting the Development or Commercialization of the Products; vii. Upcoming scientific, development, or commercial events of Akcea or competitors that may impact the Products; viii. Publication plan (including scientific publications and presentations at medical meetings) and key messaging for Products on a rolling 12-month basis; ix. Key elements of the manufacturing planning and strategy, including raw material supply, manufacturing scale-up, process validation, and inventory build plan to support Development, Product Approvals, and Commercialization; and x. Key elements of the global Commercialization strategy for each Product, including, for example, high level pricing and reimbursement plans, market access strategy, Product positioning, sales forecasts (with supportive core assumptions), launch sequence, and other key Commercialization plans and goals. Based on actual costs for raw materials. Identify the number of dedicated FTEs required to support the manufacture of budgeted production volume. Divide fully burdened salaries for these FTEs by the budgeted production volume. These are the costs associated with supporting our manufacturing eq...