GENENTECH, INC for GENENTECH INC

Manufacturing MAN

- Issues related to pharmaceutical supply chains - Issues related to reporting on location of origin of pharmaceutical products - Issues related to drug shortages - Issues related to pharmaceutical manufacturing

Contacted: White House Office; Homeland Security, Dept of (DHS); Patent & Trademark Office (PTO); SENATE; Labor, Dept of (DOL); U.S. Trade Representative (USTR); Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES

Financial Institutions/Investments/Securities FIN

- Foreign Investment Risk Review Modernization Act (FIRRMA) H.R. 5841/S. 2098 legislation that would reform the Committee on Foreign Investment in the United States (CFIUS)

Contacted: HOUSE OF REPRESENTATIVES; Homeland Security, Dept of (DHS); Labor, Dept of (DOL); SENATE; Patent & Trademark Office (PTO); U.S. Trade Representative (USTR); White House Office; Health & Human Services, Dept of (HHS)

Bills named: S. 2098 (117th), H.R. 5841 (117th)

Immigration IMM

- Issues relating to limits and restrictions on the immigration of high skilled workers - Issues relating to the immigration of medical researchers

Contacted: Labor, Dept of (DOL); U.S. Trade Representative (USTR); Homeland Security, Dept of (DHS); SENATE; White House Office; Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; Patent & Trademark Office (PTO)

Trade (domestic/foreign) TRD

- Issues relating to trade policy and negotiations impacting the biopharmaceutical industry - Issues related to the United States-Mexico-Canada Agreement - Issues related to other Free Trade Agreements (UK, Kenya, Chile, Colombia, Peru, CAFTA-DR) - Issues related to compulsory licensing of foreign patents

Contacted: Homeland Security, Dept of (DHS); U.S. Trade Representative (USTR); SENATE; Labor, Dept of (DOL); White House Office; Patent & Trademark Office (PTO); HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS)

Defense DEF

S.4049 - National Defense Authorization Act for Fiscal Year 2021 H.R.2500 - National Defense Authorization Act for Fiscal Year 2021 H.R. 6395, William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 - Issues related to pharmaceutical supply chains and related security issues

Contacted: Labor, Dept of (DOL); U.S. Trade Representative (USTR); Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; Homeland Security, Dept of (DHS); SENATE; White House Office; Patent & Trademark Office (PTO)

Bills named: H.R. 6395 (117th), S. 4049 (117th), H.R. 2500 (117th)

Taxation/Internal Revenue Code TAX

H.R. 1304, the American Innovation and R&D Competitiveness Act) and S. 749 American Innovation and Jobs Act - Issues related to R&D tax deductions and expense amortization - Issues related to supply chain incentives

Contacted: White House Office; HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); Patent & Trademark Office (PTO); Labor, Dept of (DOL); SENATE; U.S. Trade Representative (USTR); Homeland Security, Dept of (DHS)

Bills named: H.R. 1304 (117th), S. 749 (117th)

Copyright/Patent/Trademark CPT

- Intellectual property and process patent issues - Patent litigation reform - IPR process - Section 101 Reform - Domestic and international compulsory licensing issues - March-in Rights - Product hopping - Orange and purple book disclosures - Hatch Waxman litigation - Trade secret protections

Contacted: U.S. Trade Representative (USTR); SENATE; Labor, Dept of (DOL); Health & Human Services, Dept of (HHS); Homeland Security, Dept of (DHS); HOUSE OF REPRESENTATIVES; Patent & Trademark Office (PTO); White House Office

Health Issues HCR

H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act, 2020 S. 3548 - CARES Act (Coronavirus Stimulus 3), 2020 H.R. 3 - Lower Drug Costs Now Act of 2019 H.R.19, Lower Costs, More Cures Act of 2019 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book H.R. 1499 - Protecting Consumer Access to Generic Drugs Act of 2019 S.3129 - Lower Costs, More Cures Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S. 2543, Prescription Drug Pricing Reduction Act of 2019 S.551 - REFUND Act of 2019 S.4760, The Pioneering Antimicrobial Subscriptions To End Up Surging Resistance Act of 2020 S.1712/H.R.4100 - DISARM Act of 2019 H.R.133 - Consolidated Appropriations Act, 2021 H.R. 6800 - The Heroes Act H.R. 1319 , American Rescue Plan Act of 2021 H.R. xx - Safe Step Act (no bill number yet) S.4796, The Fair Care Act of 2020 H.R.1966/S.946 - Henrietta Lacks Enhancing Cancer Research Act of 2019 H.R.133 - Consolidated Appropriations Act, 2021, 116th Congress (2019-2020) S. 4626, SAFE DATA Act S. 3456, Consumer Data Privacy and Security Act H.R. 2013, Information Transparency & Personal Data Control Act S. 2968, Consumer Online Privacy Rights Act - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. - Issues related to healthcare legislation - Patient access to Part B medicines during the COVID-19 public health emergency - Issues related to diversity in clinical trials - Issues related to advanced development and procurement of medical countermeasures (MCMs) - Issues relating to privacy and securing the data of and personal information of consumers - Issues relating to medical research data

Contacted: Homeland Security, Dept of (DHS); Patent & Trademark Office (PTO); SENATE; Labor, Dept of (DOL); Health & Human Services, Dept of (HHS); U.S. Trade Representative (USTR); HOUSE OF REPRESENTATIVES; White House Office

Bills named: H.R. 2013 (117th), S. 2968 (117th), H.R. 1319 (117th), H.R. 1520 (117th), H.R. 1966 (117th), S. 3129 (117th), S. 4626 (117th), H.R. 6201 (117th), S. 946 (117th), S. 1895 (117th), H.R. 2113 (117th), S. 551 (117th), S. 1712 (117th), H.R. 1499 (117th), H.R. 6800 (117th), H.R. 4100 (117th), S. 3456 (117th), S. 4760 (117th), H.R. 3 (117th), S. 3548 (117th), S. 2543 (117th), S. 4796 (117th), H.R. 133 (117th), H.R. 19 (117th), H.R. 6074 (117th)

Medicare/Medicaid MMM

H.R. 3 - Lower Drug Costs Now Act of 2019 H.R.19, Lower Costs, More Cures Act of 2019 S.3129 - Lower Costs, More Cures Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S. 2543, Prescription Drug Pricing Reduction Act of 2019 S.977 - Transparent Drug Pricing Act of 2019 S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act S. 3013, Encouraging Innovative Benefit Design to Lower Costs for Seniors Act H.R. 2296 - More Efficient Tools to Realize Information for Consumers Act H.R. 5741- Strengthening Innovation in Medicare and Medicaid Act H.R. 1319, The American Rescue Plan of 2021 H.R./S. XX American Jobs Plan S. 920 - The Affordable and Safe Prescription Drug Importation Act S. 909 - The Prescription Drug Price Relief Act S. 908 - The Medicare Drug Price Negotiation Act S.4796, The Fair Care Act of 2020 - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part B and general reference pricing - Issues related to CMMI

Contacted: Health & Human Services, Dept of (HHS); Patent & Trademark Office (PTO); HOUSE OF REPRESENTATIVES; SENATE; White House Office; Homeland Security, Dept of (DHS); Labor, Dept of (DOL); U.S. Trade Representative (USTR)

Bills named: S. 908 (117th), S. 3013 (117th), S. 2543 (117th), S. 4796 (117th), H.R. 1520 (117th), H.R. 1503 (117th), S. 3129 (117th), H.R. 1319 (117th), S. 1895 (117th), H.R. 5741 (117th), H.R. 3 (117th), S. 551 (117th), H.R. 19 (117th), H.R. 1499 (117th), S. 977 (117th), S. 920 (117th), S. 909 (117th), H.R. 2296 (117th)

Budget/Appropriations BUD

H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act, 2020 S. 3548 - CARES Act (Coronavirus Stimulus 3), 2020 H.R.133 - Consolidated Appropriations Act, 2021 H.R. 8337 - Continuing Appropriations Act of 2021 H.R. 1319 - American Rescue Plan Act, 2021 H.R. XX - FY 2022 Labor, HHS, Education and Related Agencies Appropriations H.R. XX - FY 2022 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation - Issues related to FDA and HHS program funding for the FY22 Labor, HHS, Education and Related Agencies, and FY22 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation bills - Strategic National Stockpile (SNS) Funding and Oversight - Funding for FDA e-labeling rule implementation - Patient access to Part B medicines during the COVID-19 public health emergency - Issues related to 340B program oversight

Contacted: Labor, Dept of (DOL); Health & Human Services, Dept of (HHS); White House Office; Patent & Trademark Office (PTO); SENATE; HOUSE OF REPRESENTATIVES; Homeland Security, Dept of (DHS); U.S. Trade Representative (USTR)

Bills named: H.R. 8337 (117th), H.R. 6074 (117th), H.R. 133 (117th), H.R. 1319 (117th), S. 3548 (117th), H.R. 6201 (117th)

Pharmacy PHA

S.2543: Prescription Drug Pricing Reduction Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.19: Lower Costs, More Cures Act of 2019. S.551, REFUND Act of 2019 HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program S.4796, The Fair Care Act of 2020 - Drug pricing issues - Prescription Drug User Fee Act reauthorization - Issues related to prescription drug value

Contacted: Labor, Dept of (DOL); U.S. Trade Representative (USTR); Homeland Security, Dept of (DHS); HOUSE OF REPRESENTATIVES; Patent & Trademark Office (PTO); White House Office; Health & Human Services, Dept of (HHS); SENATE

Bills named: S. 2543 (117th), H.R. 19 (117th), S. 551 (117th), H.R. 4710 (117th), S. 4796 (117th), H.R. 3 (117th)

Medical/Disease Research/Clinical Labs MED

S. 2852 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 S. 3548 - CARES Act (Coronavirus Stimulus 3) S.4760, The Pioneering Antimicrobial Subscriptions To End Up Surging Resistance Act of 2020 H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act H.R.133 - Consolidated Appropriations Act, 2021 - Issues related to public health protection including influenza development and preparedness - Issues related to antimicrobial and antiviral research and product development - Issues related to novel coronavirus and COVID-19 research and product development - Issues related to drug development including PDUFA and Cures 2.0

Contacted: HOUSE OF REPRESENTATIVES; SENATE; White House Office; Health & Human Services, Dept of (HHS); Patent & Trademark Office (PTO); U.S. Trade Representative (USTR); Labor, Dept of (DOL); Homeland Security, Dept of (DHS)

Bills named: S. 2852 (117th), H.R. 6074 (117th), S. 3548 (117th), H.R. 133 (117th), S. 4760 (117th), H.R. 6201 (117th)