A. Selected financial data N/A B. Capitalization and indebtedness N/A C. Reasons for offer and use of proceeds N/A D. Risk factors Important factors that could cause actual financial, business, research, or operating results to differ materially from expectations are disclosed in this annual report, including without limitation the following risk factors. Investors should carefully consider all the information set forth in the following risk factors and elsewhere in this document before deciding to invest in any of the Company’s securities. In addition to the risks listed below, we may be subject to other material risks that as of the date of this report are not currently known to us or that we deem immaterial at this time. Risks relating to legal and regulatory matters Product liability claims could adversely affect our business, results of operations and financial condition Product liability is a significant risk for any pharmaceutical company, given that liability claims relating to our industry are unforeseeable by nature. The evolving regulatory environment worldwide (the ever-more stringent regulatory requirements applicable to the pharmaceutical industry, plus more stringent data, quality, and supply obligations) clearly impacts our potential liability, and we may incur different liability claims to what we have handled in the past, in terms of their nature, scope, and level. For a description of the regulatory environment in which we operate, refer to “Item 4. Information on the Company - B. Business Overview - B.5.3. Regulatory framework.” Substantial damages have been awarded by some jurisdictions and/or settlements agreed – notably in the United States and other common law jurisdictions – against pharmaceutical companies based on claims for injuries allegedly caused using their products. Such claims can also lead to product recalls, withdrawals, or declining sales, and/or be accompanied by consumer fraud claims by customers, third-party payers seeking reimbursement of the cost of the product and/or other claims, including potential civil or criminal governmental actions. We are currently defending several product liability claims (see Note D.22.a. to our consolidated financial statements included at