First MED-Project Annual Report For 2019 Operating Period State of Washington Due July 1, 2020 Prepared By: MED-Project WA, LLC Submitted To: Washington State Department of Health Table of Contents I. Executive Summary ............................................................................................................... 3 II. Annual Budget ...................................................................................................................... 3 Table 1: Annual Budget .................................................................................................................. 4 Appendix A ................................................................................................................................ 5 List of Covered Manufacturers ......................................................................................................... 5 Table 2: List of Covered Manufacturers.......................................................................................... 21 2 I. Executive Summary MED-Project WA, LLC’s (“MED-Project”) Product Stewardship Plan for Covered Drugs from Households (“Plan”) was approved by the Washington State Department of Health (the "Department") on May 25, 2020. Per the Plan, MED-Project will initiate operations by November 21, 2020, which is within 180 days of the Plan approval date. This first Annual Report for the 2019 reporting period was requested by the Department and includes an update to the annual budget that occurred after the submission of the proposed Plan and a list of Covered Manufacturers participating as of May 2020. No operational information for the Department is available to report for the 2019 calendar year because the MED-Project operations start date is November 21, 2020. II. Annual Budget MED-Project has developed a budget based on the assumptions covered in Section XI of the Plan. The Program budget for total cash expenditures includes forecasts, projections, and other predictive statements that represent MED-Project’s assumptions and expectations in light of currently available information. This program budget is based on MED-Project’s current knowledge of performance, industry trends, and other factors, and involves risks, variables, and uncertainties. MED-Project’s actual performance results may differ from those projected in the program budget. No guarantee is implied as to the accuracy of the program budget. MED-Project updated the annual budget based on modifications made during the proposed plan review process with the Department. As a result, MED-Project is projecting an increased budget estimate from the annual budget submitted in the approved Plan. In accordance with RCW 69.48.090(1) and WAC 246-480-040(5)(a-c), MED-Project’s budget is summarized in Table 1: 3 Annual Budget COST AMOUNT1 Administrative Costs2 $1,456,000 Collection and Disposal Costs3 $2,237,000 Communication Costs4 $541,000 Total Program Costs $4,234,000 Table 1: Annual Budget 1 The Program start is Q2 2020. The budget covers a 12-month calendar period of anticipated program implementation and operations from June 2020 through May 2021 (Note: Budget estimate does not include the Program Operator initial fee in 2019 payable to the Department). 2 Administrative Costs take into account: − Contracted and employed personnel overhead costs. − Legal fees. − Local and state business licensing fees. − Local, state, and federal taxes. − Property costs, including rentals. − Utilities, phone, and internet. − General equipment and supplies. 3 Collection and Disposal Costs take into account: − Collection, transportation, and disposal of drugs. − Purchase, maintenance, and replacement of collection receptacles. − Compensation of authorized collectors, if separate from personnel costs covered in the Administrative Costs above. − Contracted and employed personnel costs associated with collection and disposal. − Production, distribution, and postage of mailers. 4 Communication Costs take into account: − Advertising. − Marketing. − Contracted and employed personnel costs associated with communication. − Website creation and maintenance. − Operation of a toll-free call center. 4 Appendix A List of Covered Manufacturers A list of the Covered Manufacturers participating in the Product Stewardship Program during the Reporting Period. PARENT COMPANY COMPANY NAME 3M Corporation 3M Corporation 3M Corporation 3M Drug Delivery Systems 3M Corporation 3M ESPE 3M Corporation 3M Health Care 3M Corporation 3M Personal Care AbbVie Inc. AbbVie Inc. AbbVie Inc. Pharmacyclics, subsidiary of AbbVie Inc. ACADIA Pharmaceuticals Inc. ACADIA Pharmaceuticals Inc. Accord Healthcare Inc. Accord Healthcare Inc. Aclaris Therapeutics, Inc. Aclaris Therapeutics, Inc. Acorda Therapeutics, Inc. Acorda Therapeutics, Inc. Acorda Therapeutics, Inc. Acorda Therapeutics, Inc. Acorda Therapeutics, Inc. Civitas Therapeutics, Inc. Adapt Pharma Inc. Adapt Pharma Inc. Advantice Health Advantice Health Aegerion Pharmaceuticals, Inc. Aegerion Pharmaceuticals, Inc. Afaxys Inc. Afaxys Inc. Ajanta Pharma USA Inc. Ajanta Pharma USA Inc. AkaRx, Inc., dba Dova Pharmaceuticals AkaRx, Inc., dba Dova Pharmaceuticals Akebia Therapeutics, Inc. Akebia Therapeutics, Inc. Akorn, Inc. Akorn, Inc. Akorn, Inc. Advanced Vision Research Inc. d.b.a. Akorn Consumer Health Akorn, Inc. Akorn Animal Health, Inc. Akorn, Inc. Clover Pharmaceuticals Corp. Akorn, Inc. Hi-Tech Pharmacal Co., Inc. 5 PARENT COMPANY COMPANY NAME Akorn, Inc. Inspire Pharmaceuticals, Inc. Akorn, Inc. Oak Pharmaceuticals, Inc. Akorn, Inc. Olta Pharmaceuticals Corp. Akorn, Inc. Versapharm, Incorporated AKRON COATING & ADHESIVES AKRON COATING & ADHESIVES Alembic Pharmaceuticals Inc. Alembic Pharmaceuticals Inc. Allergan, Inc. Allergan, Inc. Allergan, Inc. Actavis Pharma, Inc. (only for labeler code 52544) Allergan, Inc. Allergan Sales, LLC Allergan, Inc. Allergan USA, Inc. Allergan, Inc. Aptalis Pharma US, Inc. Allergan, Inc. Durata Therapeutics US Limited Allergan, Inc. Forest Laboratories, LLC Allergan, Inc. Pacific Pharma, Inc. Allergan, Inc. Warner Chilcott (US), LLC Allergan, Inc. Watson Laboratories, Inc. (only for labeler code 52544) Almirall LLC Almirall LLC Alva-Amco Pharmacal Companies, Inc. Alva-Amco Pharmacal Companies, Inc. Alvogen Pharma US, Inc. Alvogen Pharma US, Inc. Alvogen Pharma US, Inc. Almaject, Inc. Alvogen Pharma US, Inc. Almatica Pharma, Inc. Alvogen Pharma US, Inc. Alvogen, Inc. Alvogen Pharma US, Inc. County Line Pharmaceuticals LLC Alvogen Pharma US, Inc. Norwich Pharmaceuticals, Inc. AMAG Pharmaceuticals, Inc. AMAG Pharmaceuticals, Inc. AMAG Pharmaceuticals, Inc. AMAG Pharma USA, Inc. Amarin Pharma, Inc. Amarin Pharma, Inc. Amarin Pharma, Inc. Amarin Corp. PLC Amarin Pharma, Inc. Amarin Pharma Inc. 6 PARENT COMPANY COMPANY NAME Amarin Pharma, Inc. Amarin Pharmaceuticals Ireland Ltd. Amerigen Pharmaceuticals, Inc. Amerigen Pharmaceuticals, Inc. Amerigen Pharmaceuticals, Inc. Amerigen Pharmaceuticals, Inc. Amgen Inc. Amgen Inc. Amgen Inc. Amgen USA Amgen Inc. Immunex Corporation Amgen Inc. Onyx Pharmaceuticals Amici Pharmaceuticals LLC Amici Pharmaceuticals LLC Amneal Pharmaceuticals LLC Amneal Pharmaceuticals LLC Amneal Pharmaceuticals LLC Amedra Laboratories LLC Amneal Pharmaceuticals LLC CorePharma, LLC Amneal Pharmaceuticals LLC Gemini Laboratories, LLC Amneal Pharmaceuticals LLC Impax Laboratories, Inc. Amneal Pharmaceuticals LLC Lineage Therapeutics Inc. Amphastar Pharmaceuticals, Inc. Amphastar Pharmaceuticals, Inc. Amphastar Pharmaceuticals, Inc. Armstrong Pharmaceuticals, Inc. Amphastar Pharmaceuticals, Inc. International Medication Systems, LTD Amring Pharmaceuticals Inc. Amring Pharmaceuticals Inc. ANI Pharmaceuticals, Inc. ANI Pharmaceuticals, Inc. Apotex Holdings, Inc. Apotex Holdings, Inc. Apotex Holdings, Inc. ApoPharma USA, Inc. Apotex Holdings, Inc. Apotex Corp. Apotex Holdings, Inc. Aveva Drug Delivery Systems, Inc. Aprecia Pharmaceuticals, LLC Aprecia Pharmaceuticals, LLC Aptevo BioTherapeutics LLC Aptevo BioTherapeutics LLC Arbor Pharmaceuticals, Inc. Arbor Pharmaceuticals, Inc. Ascend Laboratories, LLC Ascend Laboratories, LLC Ascend Therapeutics US, LLC Ascend Therapeutics US, LLC Asclemed USA dba Enovachem Asclemed USA dba Enovachem Pharmaceuticals, Pharmaceuticals, Enovachem Enovachem Manufacturing Manufacturing 7 PARENT COMPANY COMPANY NAME Assertio Therapeutics, Inc. Assertio Therapeutics, Inc. Astellas Pharma US, Inc. Astellas Pharma US, Inc. AstraZeneca Pharmaceuticals LP AstraZeneca Pharmaceuticals LP AstraZeneca Pharmaceuticals LP AstraZeneca Pharmaceuticals LP Aubio Life Sciences Aubio Life Sciences Aurobindo Pharma USA, Inc Aurobindo Pharma USA, Inc Azurity Pharmaceuticals, Inc. Azurity Pharmaceuticals, Inc. Azurity Pharmaceuticals, Inc. Silvergate Pharmaceuticals, Inc. B.F. Ascher & Co., Inc. B.F. Ascher & Co., Inc. Bausch Health Companies Bausch Health Companies Bausch Health Companies Bausch + Lomb Bausch Health Companies Salix Baxter Healthcare Corporation Baxter Healthcare Corporation Bayer HealthCare LLC Bayer HealthCare LLC Bayer HealthCare LLC Bayer Consumer Care Holdings LLC Bayer HealthCare LLC Bayer HealthCare Animal Health Inc. Bayer HealthCare LLC Bayer HealthCare Pharmaceuticals Inc. Bayer HealthCare LLC Bayer HealthCare Pharmaceuticals LLC Bayer HealthCare LLC MSD Consumer Care Inc. BE Pharmaceuticals, Inc. BE Pharmaceuticals, Inc. BestCo, Inc. BestCo, Inc. Bimeda Inc. Bimeda Inc. Biocon Pharma, Inc. Biocon Pharma, Inc. Biogen Inc. Biogen Inc. BioMarin Pharmaceutical Inc. BioMarin Pharmaceutical