42 If we fail to comply with i health l care laws,s we couldl face substantia t l penaltie t s and our busine i ss, operations and fina i ncial conditi d ons couldl be adverse r ly affe f cted t .d Our current and future arrangements with healthcare providers, third-party payors, customers, and others may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations, which may constrain the business or financial arrangements and relationships through which we research, as well as, sell, market and distribute any products for which we obtain marketing approval. The laws that may impact our operations include: • the federal Anti-Kickba k ck Statut t e, which prohibits, among other things, persons and entities from knowingly and willful f ly soliciting, receiving, offe f ring or paying any remuneration (including any kickba k ck, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce, or in return for, either the referral of an individual, or the purchase, lease, order or recommendation of any good, facility, item or service for which payment may be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs. A person or entity does not need to have actual knowledge of the statut t e or specific intent to violate it in order to have committed a violation. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statut t e constitutes a false or fraudulent claim for purpos r es of the False Claims Act; • federal civil and criminal false claims laws, including the False Claims Act, which can be enforced by private citizens on behalf of the government through civil whistleblower or qui tam actions, and civil monetary penalty laws, which impose criminal and civil penalties against individuals or entities from knowingly presenting, or causing to be presented, claims for payment or approval from Medicare, Medicaid or other third-party payors that are false or fraudulent or knowingly making a false statement to improperly avoid, decrease or conceal an obligation to pay money to the federal government; • the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created new federal criminal statut t es that prohibit knowingly and willful f ly executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of,f any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willful f ly falsifyi f ng, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery r of,f or payment for, healthcare benefits, items or services relating to healthcare matters. Similar to the federal Anti- Kickba k ck Statut t e, a person or entity does not need to have actua t l knowledge of these statut t es or specific f intent to violate them in order to have committed a violation; • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective implementing regulations, which impose requirements on certain covered healthcare providers, health plans and healthcare clearinghouses and their respective business associates and their subc u ontractors that perform services for them that involve the use, or disclosure of,f individually identifiable health information as well as their covered subc u ontractors, relating to the privacy, security and transmission of individually identifiable health information; • the federal Physician Payments Sunshine Act, created under the ACA, and its implementing regulations, which require manufact f ur t ers of drugs r , devices, biologicals and medical suppl u ies for which payment is availabl a e under Medicare, Medicaid or the Children’s Health Insurance Program to report annually to the CMS under the Open Payments Program, information related to payments or other transfer f s of value made to physicians (defin f ed to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare profes f sionals (such as physician assistant and nurse practitioners), and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; • federal consumer protection and unfai f r competition laws, which broadly regulate marketpl t ace activities and activities that potentially harm consumers; and