Except as described in the Registration Statement and the Prospectus, and except as would not, individually or in the aggregate, have, or reasonably be expected to result in, a Material Adverse Effect: (1) the Company has not received any warning letter, untitled letter or other written correspondence or notice from the FDA, or any other court or arbitrator or federal, state, local or foreign governmental or regulatory authority, alleging or asserting noncompliance with the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.) (the “ FFDCA ”), or similar law; (2) the Company is and since January 1, 2011 has been in compliance with applicable health care laws, including without limitation, the FFDCA, the federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. §1320d et seq.), or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. §17921 et seq.) and the regulations promulgated pursuant to such laws, and comparable state laws, and all other local, state, federal, national, supranational and foreign health care laws relating to the regulation of the Company (collectively, “ Health Care Laws ”); (3) the Company possesses all licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Health Care Laws and/or to carry on its businesses as currently conducted (“ Authorizations ”) and such Authorizations are in full force and effect and the Company is not in violation of any term of any such Authorizations; (4) the Company has not received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any U.S. or non-U.S. federal, state, local or other governmental or regulatory authority, governmental or regulatory agency or body, court, arbitrator or self-regulatory organization (each, a “ Governmental Authority ”) alleging that any product operation or activity is in violation of any Health Care Laws or Authorizations and, to the Company’s knowledge, no Governmental Authority is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (5) the Company has not received written notice that any Governmental Authority has taken, is taking or intends to take action to limit, suspend, make a material adverse modification or revoke any Authorizations and to the Company’s knowledge no Governmental Authority is considering such action; and (6) the Company has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, submissions and supplements or amendments as required by any Health Care Laws or Authorizations and all such reports, documents, forms, notices, applications, records, submissions and supplements or amendments were complete, correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission).