NON-INTERVENTIONAL STUDIES. 13.1 Non-Interventional Studies (“NISs”) must address a scientifically and medically valid question to which the Company needs the answer. 13.2 The Company must not be involved in the decision to place a particular Patient on a specific Company Product. That decision is made solely by the Patient’s HCP. 13.3 NISs must be observational in nature and the collected data must undergo a formal analysis by the Company or by a Third Party on the Company’s behalf. 13.4 See Section 2 of this Policy for further requirements on NISs. Employees must also refer to the Relevant Procedures (i.e., International Procedures)
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Samples: License, Development and Commercialization Agreement (Fibrogen Inc), License, Development and Commercialization Agreement, License, Development and Commercialization Agreement (Fibrogen Inc)
