GENZYME CORPORATION for GENZYME CORPORATION

Copyright/Patent/Trademark CPT

Patent settlement legislation Preserve Access to Affordable Generics Act Creating and Restoring Equal Access to Equivalent Samples Act

Foreign entity interest: As the ultimate parent of Genzyme Corporation, Sanofi SA, identified on Form LD-1, has an interest in the issues lobbied.

Contacted: Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; SENATE

Trade (domestic/foreign) TRD

Trade legislation and other trade authority Protection and promotion of 12 years exclusivity for biologics Protection and promotion of Orphan Drug Act market exclusivity

Foreign entity interest: As the ultimate parent of Genzyme Corporation, Sanofi SA, identified on Form LD-1, has an interest in the issues lobbied.

Contacted: Centers For Medicare and Medicaid Services (CMS); SENATE; HOUSE OF REPRESENTATIVES

Taxation/Internal Revenue Code TAX

Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of health Care and Education Reconciliation Act (P.L. 111-152) Excise tax for drugs and biologics Issues and policies related to Orphan Drug Tax Credit Implementation of American Taxpayer Relief Act of 2012 Issues and policies related to tax reform, including border adjustable tax Corporate tax inversion Legislation pertaining to the applicability of the ACA tax carve out for non-orphan designated drugs

Foreign entity interest: As the ultimate parent of Genzyme Corporation, Sanofi SA, identified on Form LD-1, has an interest in the issues lobbied.

Contacted: HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS); SENATE

Health Issues HCR

Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconcilation Act (P.L. 111-152) 340B issues and legislative reform proposals Issues related to importation of prescription drugs Health technology assessment of orphan and specialty drugs Implementation of the FDA Safety and Innovation Act (FDASIA) (P.L. 112-144) H.R. 1628, American Health Care Act of 2017 H.R. 1231, RACE for Children Act S. 456, RACE for Children Act Preserve Access to Affordable Generics Act H.R. 878, Right To Try Act of 2017 S. 204, Trickett Wendler Right To Try Act of 2017 Creating and restoring Equal Access to Equivalent Samples Act H.R. 314, Health Care Choice Act of 2017 S. 191, Patient Freedom Act of 2017 H.R. 184, Protect Medical Innovation Act of 2017 Regulation of innovative biologic products for neurodegenerative diseases Issues and policies related to implementation of Orphan Drug Act and orphan drug development Implementation of newborn screening programs Issues and policies related to biosimilars exclusivity period, including FDA guidance Issues and polices related to FDA oversight and management, including workforce authorities modernization Issues and policies related to expanded access programs Legislation pertaining to FDA priority review vouchers,generally Issues related to the value of prescription medicines, including affordability Drug shortage issues Issues related to health care transparency

Foreign entity interest: As the ultimate parent of Genzyme Corporation, Sanofi SA, identified on Form LD-1, has an interest in the issues lobbied.

Contacted: SENATE; HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS)

Bills named: S. 204 (115th), H.R. 184 (115th), H.R. 878 (115th), H.R. 1231 (115th), H.R. 314 (115th), H.R. 1628 (115th), S. 191 (115th), S. 456 (115th)

Budget/Appropriations BUD

Funding for FDA and NIH Issues and policies related to FY 2017 and FY 2018 appropriations and all applicable amendments Issues associated with budget reconciliation processes

Foreign entity interest: As the ultimate parent of Genzyme Corporation, Sanofi SA, identified on Form LD-1, has an interest in the issues lobbied.

Contacted: SENATE; Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES

Medicare/Medicaid MMM

Medicare Part D coverage and patient access policies ESRD bundling and drug reimbursement issues HCPCS coding and reimbursement decisions Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) Least Costly Alternative (LCA) policy Changes regarding Medicare Part B and Average Sales Price Medicare secondary payor for ESRD services Extension of rebates on Medicare Part D drugs Performance measures for bone and mineral metabolism for ESRD program Implementation of American Taxpayer Relief Act of 2012 Access of ESRD patients to Medicare Advantage plans Chronic kidney care improvement

Foreign entity interest: As the ultimate parent of Genzyme Corporation, Sanofi SA, identified on Form LD-1, has an interest in the issues lobbied.

Contacted: Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; SENATE

Pharmacy PHA

Implementation of Food and Drug Safety and Innovation Act (FDASIA) Issues and policies related to biosimilars exclusivity period Biosimilars FDA guidance Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) Issues and policies related to FDA oversight and management Issues and policies related to expanded access programs Issues and policies related to patient involvement with FDA decision making S. 204, Trickett Wendler Right to Try Act of 2017 H.R. 878, Right to Try Act of 2017

Foreign entity interest: As the ultimate parent of Genzyme Corporation, Sanofi SA, identified on Form LD-1, has an interest in the issues lobbied.

Contacted: Centers For Medicare and Medicaid Services (CMS); SENATE; HOUSE OF REPRESENTATIVES

Bills named: H.R. 878 (115th), S. 204 (115th)