0000885725-19-000028.txt : 20190529 0000885725-19-000028.hdr.sgml : 20190529 20190529163005 ACCESSION NUMBER: 0000885725-19-000028 CONFORMED SUBMISSION TYPE: SD PUBLIC DOCUMENT COUNT: 2 13p-1 1.01 20181231 1.02 20181231 FILED AS OF DATE: 20190529 DATE AS OF CHANGE: 20190529 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BOSTON SCIENTIFIC CORP CENTRAL INDEX KEY: 0000885725 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 042695240 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: SD SEC ACT: 1934 Act SEC FILE NUMBER: 001-11083 FILM NUMBER: 19862400 BUSINESS ADDRESS: STREET 1: 300 BOSTON SCIENTIFIC WAY CITY: MARLBOROUGH STATE: MA ZIP: 01752-1234 BUSINESS PHONE: 508-683-4000 MAIL ADDRESS: STREET 1: 300 BOSTON SCIENTIFIC WAY CITY: MARLBOROUGH STATE: MA ZIP: 01752-1234 SD 1 formsdfy2018.htm SD 2018 CONFLICT MINERALS REPORT Document


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549

FORM SD

Specialized Disclosure Report

BOSTON SCIENTIFIC CORPORATION
(Exact name of registrant as specified in its charter)
DELAWARE
 
1-11083
 
04-2695240
(State or other
 
(Commission
 
(IRS employer
jurisdiction of
 
file number)
 
identification no.)
incorporation)
 
 
 
 

300 Boston Scientific Way, Marlborough, Massachusetts
 
01752-1234
(Address of principal executive offices)
 
(Zip code)
Desiree Ralls-Morrison
Senior Vice President, General Counsel and Corporate Secretary
(508) 683-4000
(Name and telephone number, including area code, of the person to
contact in connection with this report)

Check the appropriate box to indicate the rule pursuant to which this form is being filed, and provide the period to which the information in this form applies:

x Rule 13p-1 under the Securities Exchange Act (17 CFR 240.13p-1) for the reporting period from January 1 to December 31, 2018






Section 1 — Conflict Minerals Disclosure
Item 1.01. Conflict Minerals Disclosure and Report

This Form SD of Boston Scientific Corporation for the 2018 calendar year is filed in accordance with the rules under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Rule 13p-1 under the Exchange Act (the “Rule”) requires certain registrants with the Securities and Exchange Commission (“SEC”) to file this specialized disclosure report on Form SD if such registrants have tin, tantalum, tungsten, and gold (collectively, “conflict minerals”) that are necessary to the functionality or production of a product manufactured by the registrant or contracted by that registrant to be manufactured. Terms not defined in this Form SD are defined in the Rule, Form SD and the Exchange Act Release No. 34-67716 (August 22, 2012). When used in this Form SD, the terms “we,” “us,” “our,” “Boston Scientific” and “the Company” mean Boston Scientific Corporation and its divisions and subsidiaries.

The Company has developed a conflict minerals policy that is publicly available on its website at http://www.bostonscientific.com/en-US/corporate-citizenship/compliance-ethics/conflict-minerals-policy.html.

We have determined that conflict minerals exist in at least one component of at least one product in each of our core businesses. These components contain conflict minerals that are necessary to the functionality or production of these products that we manufacture or contract to manufacture. Therefore, in accordance with the Rule and Form SD, we initiated a reasonable country of origin inquiry (“RCOI”) with our suppliers to determine whether any of the conflict minerals used in the production of our products may have been obtained from recycled or scrap sources and/or originated in the Covered Countries (as defined below).

Our RCOI process employed a number of measures to make this determination, including the following:

Communication and engagement with our suppliers;
Distribution to our suppliers of the Responsible Business Alliance and The Global e-Sustainability Initiative Conflict Minerals Reporting Template (“CMRT”);
Collection of the completed CMRT;
Review of the collected CMRTs to identify supplier risk level, as described further in our Conflict Minerals Report, determine country of origin and/or sourcing from recycled or scrap sources and determine if due diligence is required;
Implementation of a comprehensive system and business process to facilitate long-term sustainability of the RCOI process. This includes an inquiry into the presence of conflict minerals in every new or modified component that Boston Scientific purchases. The system and business process includes:
Maintenance and tracking of supplier communications;
Long-term storage and version history of supplier responses and forms;
Determination of conflict minerals status of individual products; and
Automatic “red flag” validations of completed CMRTs;
Follow-up communication with suppliers to update forms if their responses did not meet our review requirements and to understand and mitigate risks related to conflict minerals in their supply chains.

Based on our RCOI, the Company has reason to believe that some of the conflict minerals used in the production of products that we manufacture or contract to manufacture may have originated in the Democratic Republic of the Congo (the “DRC”) or in adjoining countries (collectively, with the DRC, the “Covered Countries”), and we have reason to believe that such conflict minerals may not be from recycled or scrap sources. As a result, we conducted due diligence on the source and chain of custody of these conflict minerals. Our due diligence process is described in our Conflict Minerals Report, which is attached as Exhibit 1.02 to this Form SD and is incorporated herein by reference.

This Form SD and the associated Conflict Minerals Report are publicly available on our website at: [http://www.bostonscientific.com/content/dam/bostonscientific/corporate/citizenship/compliance-ethics/citizenship_conflict_minerals_report_2018.pdf]. Information on or connected to our website (or the website of any third party) referenced in this Form SD is in addition to and not a part of or incorporated by reference into this Form SD (other than the Conflict Minerals Report, which is attached as Exhibit 1.01 to this Form SD and is incorporated herein by reference). Such additional information speaks as of the date thereof and is not intended to be confirmed or updated by reference herein. Boston Scientific disclaims any liability or responsibility for or endorsement of the information on or connected to the website of a third party.






Item 1.02. Exhibit

Item 2.01 of this Form SD is incorporated by reference into this Item 1.02.

Section 2 — Exhibits

Item 2.01. Exhibits







SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the duly authorized undersigned.

 
 
BOSTON SCIENTIFIC CORPORATION
 
 
 
Date: May 29, 2019
By:
/s/ John Bradley Sorenson
 
 
John Bradley Sorenson, Senior Vice President,
 
 
Manufacturing and Supply Chain







EX-1.01 2 exhibit102-conflictmineral.htm EXHIBIT 1.01 Exhibit


Exhibit 1.01

Conflict Minerals Report of Boston Scientific Corporation

For the Year Ended December 31, 2018

This Conflict Minerals Report (this “Report”) of Boston Scientific Corporation for the 2018 calendar year is filed in accordance with the rules under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Rule 13p-1 under the Exchange Act (the “Rule”) imposes certain reporting and disclosure obligations on registrants with the Securities and Exchange Commission (“SEC”) that have tin, tantalum, tungsten, and gold (collectively, “conflict minerals”) that are necessary to the functionality or production of a product manufactured by the registrant or contracted by that registrant to be manufactured. Terms not defined in this Report are defined in the Rule, Form SD and the Exchange Act Release No. 34-67716 (August 22, 2012). When used in this report, the terms “we,” “us,” “our,” “Boston Scientific,” “BSC” and “the Company” mean Boston Scientific Corporation and its divisions and subsidiaries.

Information on or connected to our website (or the website of any third party) referenced in this Report is in addition to and not a part of or incorporated by reference into this Report. Such additional information speaks as of the date thereof and is not intended to be confirmed or updated by reference herein. Boston Scientific disclaims any liability or responsibility for or endorsement of the information on or connected to the website of a third party.

Company and Product Overview

Boston Scientific Corporation is a worldwide developer, manufacturer and marketer of medical devices that are used in a broad range of interventional medical specialties. Our mission is to transform lives through innovative medical solutions that improve the health of patients around the world.

During 2018, our products were offered for sale by seven core businesses: Interventional Cardiology (“IC”), Peripheral Interventions (“PI”), Cardiac Rhythm Management (“CRM”), Electrophysiology, Endoscopy, Urology and Pelvic Health and Neuromodulation. These products are generally sold directly to hospitals or physicians, making Boston Scientific the final step in the supply chain prior to these products reaching the end customer. Our seven core businesses are organized into three reporting segments, described below. Effective January 1, 2018, following organizational changes to align the structure of our business with our focus on active implantable devices, we revised our reportable segments, in accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification Topic 280, Segment Reporting. The revision reflects a reclassification of our Neuromodulation business from our Medical Surgical (MedSurg) segment to our newly created Rhythm and Neuro segment.

Cardiovascular Segment. Our IC business develops, manufactures and markets technologies for diagnosing and treating coronary artery disease and other cardiovascular disorders. We also offer structural heart products in certain markets, which include a device for transcatheter aortic valve replacement and a device designed to close the left atrial appendage. Our PI business develops solutions used to diagnose and treat peripheral vascular disease and renal denervation systems in certain markets for the treatment of hypertension.

Rhythm and Neuro Segment. Our CRM business develops, manufactures and markets a variety of implantable devices including implantable cardioverter defibrillator systems and pacemaker systems that monitor the heart and deliver electricity to treat cardiac abnormalities. Our Electrophysiology business develops less-invasive medical technologies used in the diagnosis and treatment of rate and rhythm disorders of the heart. Our Neuromodulation business develops and manufactures devices to treat various neurological movement disorders and manage chronic pain.

MedSurg Segment. Our Endoscopy business develops and manufactures devices to treat a variety of medical conditions including diseases of the digestive and pulmonary systems. Our Urology and Pelvic Health business develops and manufactures devices to treat various urological and pelvic disorders.

Report Overview

We completed a review of the products within each of our core businesses. We have determined that conflict minerals exist in at least one component of at least one product in each business. We have also determined that these conflict minerals are necessary to the functionality or production of these products that we manufacture or contract to manufacture.






In accordance with the Rule and Form SD, we initiated a reasonable country of origin inquiry ("RCOI") with 22 of our direct material suppliers who indicated for newly purchased materials in 2018 that conflict minerals are present in supplied parts, reasonably designed to determine whether the conflict minerals in the components supplied to us originated in the Democratic Republic of the Congo (the "DRC") or an adjoining country (collectively with the DRC, the "Covered Countries") or are from recycled or scrap sources. BSC focused on suppliers who indicated in 2018 that conflict minerals are present in supplied parts. Based on our RCOI, we have reason to believe that the necessary conflict minerals in some of the components supplied to us may have originated in the Covered Countries, and we have reason to believe that such conflict minerals may not be from recycled or scrap sources.  As a result, we conducted due diligence on the source and chain of custody of those conflict minerals.

Conflict Minerals Framework

We designed our due diligence measures to conform, in all material respects, with the internationally recognized due diligence framework developed by the Organisation for Economic Co-operation and Development (“OECD”). See OECD (2013), OECD Due Diligence Guidance for Responsible Supply Chains of Minerals from Conflict-Affected and High-Risk Areas: Second Edition, OECD Publishing, available at http://dx.doi.org/10.1787/9789264185050-en, and the related Supplements for gold, tin, tantalum and tungsten (collectively, the “OECD Guidance”).

Company Management Systems

We have established company management systems as follows:

Conflict Minerals Policy. We have adopted a conflict minerals policy that is publicly available on our website at http://www.bostonscientific.com/en-US/corporate-citizenship/compliance-ethics/conflict-minerals-policy.html.
Internal Team. We have established a team of subject matter experts that is responsible for implementing our conflict minerals compliance program. Management oversight includes representatives from operations, supply chain, legal and finance.
Control Systems. We generally do not have direct relationships with smelters and refiners with respect to our conflict minerals. Therefore, we actively engage with our suppliers to help identify entities upstream from us in our supply chain. We have built processes into our quality systems for assessing components and products for conflict minerals and have built-in check points in our product lifecycle development process.
Supplier Engagement. We have strong engagement with suppliers through our supplier quality agreements, a supplier on-boarding process and quality systems assessments. We provide a copy of our Supplier Guidebook to suppliers and request that suppliers complete component material assessment forms to identify the presence of conflict minerals during component qualification. We provide suppliers with instructional materials specifically related to conflict minerals and completing a Conflict Minerals Reporting Template (“CMRT”).
Grievance Mechanism. We have an advice line, accessible on our external website, whereby employees and third parties, including suppliers, may ask questions, obtain guidance or report concerns. We have also established a dedicated mailbox, conflictminerals@bsci.com, to receive supplier requests, communications, feedback and questions.
Maintain records. We use our documentation management system to retain relevant documents. All conflict minerals supplier responses and forms are uploaded into our long-term information systems solution for conflict minerals. These records are kept in accordance with our document retention policies, at least 5 years.

Identification and Assessment of Supply Chain Risk

For direct suppliers who indicate that they provide materials with 3TGs, we initiate our RCOI process which includes: a request for a completed conflict minerals reporting template (CMRT); follow-up and escalation for non-responsive suppliers; review of the CMRT; and determination if further actions are needed based on response. To review the CMRT, we conduct up to 5 verifications on each supplier's CMRT to uncover inconsistencies or risk in the supplier's response. In addition, we currently utilize a commercial system that performs automatic validations of each supplier's response on the CMRT.

We also actively worked with our suppliers to identify entities upstream from us in our supply chain. We completed this survey process with 22 of our direct material suppliers, that either (i) indicated the presence of conflict minerals in parts provided to Boston Scientific and did not have a CMRT that covered these parts, or (ii) did not previously provide a declaration indicating that no conflict minerals are utilized in their supply chain. We rely on these suppliers to provide us with information about the source of conflict minerals contained in the components supplied to us. Our suppliers are similarly reliant upon information provided to them by their suppliers.

Design and Implementation of a Strategy to Respond to Risks






In response to this risk assessment, Boston Scientific has developed a risk management plan, through which the RCOI and Due Diligence Process are implemented, managed and monitored. We designed this risk management plan pursuant to the OECD Guidance. Updates to our risk assessment are provided to members of management on an as-needed basis.

As described above, we are working closely with our suppliers to identify the entities that are upstream from Boston Scientific in the supply chain. As part of our risk management plan, to help ensure suppliers understand our expectations, we have sent out communications via e-mail with details on our conflict minerals framework, updated our guidebook for suppliers, and provided suppliers with links to the Conflict-Free Smelter Program training website. Additionally, we have instructional materials that clearly outline our expectations for suppliers available to both our external website and the supplier portal where suppliers submit completed forms.

Smelter Audits

We generally do not have direct relationships with smelters and refiners with respect to conflict minerals and do not perform or direct audits of these entities within our supply chain. We support audits through our reliance upon the Responsible Minerals Initiative (RMI).

Due Diligence Results

Through our RCOI process, we determined whether due diligence was required for each supplier that we surveyed. Our RCOI process is outlined in our Form SD. Our due diligence process was a continuation of the RCOI process for those suppliers that indicated on their CMRT that they know or have reason to believe they are sourcing from Covered Countries or that the source of the conflict minerals was uncertain or unknown, or as a result of our red flag tests. We exercised due diligence on the source and chain of custody of conflict minerals from these suppliers. We conducted a due diligence review of the completed CMRTs of these suppliers and took other appropriate steps as described below.

When we received a response indicating that a supplier’s sourcing of conflict minerals was uncertain or unknown, or as a result of our red flag tests, our due diligence process included the following steps:

Documenting whether the supplier intends to be conflict free (if indicated on their CMRT);
Following-up with the supplier with a minimum of 3 attempts in 30 days or more to obtain country of origin information on the conflict minerals in its supply chain;
Incorporating a supplier into our risk management plan for follow-up if the supplier was non-responsive to our requests or responded that the supplier did not intend to survey its own suppliers.

When we received a response indicating that a supplier was sourcing from the Covered Countries, our due diligence process included the following steps:

Documenting whether the supplier intends to be conflict free (if indicated on their CMRT);
Performing a review of the supplier’s known smelters and identifying which of those smelters were sourcing from Covered Countries;
Comparing the supplier’s smelters against the Conflict-Free Smelter Program list of certified smelters;
Following-up with the supplier on its next steps, if the smelters from Covered Countries were not certified under the Conflict-Free Smelter Program;
Incorporating the supplier into our risk management plan for appropriate follow-up (if needed).

Based on our review of the CMRTs and these other due diligence measures, we categorize each supplier based on risk.

Through our due diligence process, we identified 4 suppliers in our supply chain that had smelters in their supply chains that sourced from the Covered Countries and confirmed that materials from these smelters are used in the production of Boston Scientific products. The smelters are listed below; all smelters are Responsible Minerals Initiative (RMI) certified. All other suppliers provided company-level information. As a result, we were not able to determine whether the specific conflict minerals from such suppliers that were sourced from the Covered Countries were included in components we obtained from the suppliers and used in our products.

Smelters utilized in BSC’s Supply Chain:





Metal
 
Smelter Name
 
Smelter Country
 
RMI Identification
 
Conflict Free Certified?
Tin
 
Malaysia Smelting Corp
 
Malaysia
 
CID001105
 
Y
Tantalum*
 
F&X
 
China
 
CID000460
 
Y
Tantalum*
 
Global Advanced Metals
 
United States
 
CID002557
 
Y
Tantalum*
 
HC Starck GmbH
 
Germany
 
CID002545
 
Y
Tantalum*
 
Ulba
 
Kazakhstan
 
CID001969
 
Y
Gold
 
Metalor USA Refining Corporation
 
United States
 
CID001157
 
Y
* While the applicable CMRT indicated that the Boston Scientific supplier uses Tantalum in the production of its products at least some of which originates from the Covered Countries, the form does not distinguish between the Tantalum smelters used by the supplier that do source from the Covered Countries and the Tantalum smelters used by the supplier that do not source from the Covered Countries. As such, all of the Tantalum smelters used by the applicable supplier are included in the table above.

2018 Product Determinations

Pursuant to SEC staff guidance, no company, including Boston Scientific, is required to describe its products as "DRC conflict free" having "not been found to be 'DRC conflict free'", or "DRC conflict undeterminable."

Facilities and Mine or Location of Origin

As described above, the Company is several steps downstream from the facilities that process the necessary conflict minerals and the mines where the ore is located. The majority of responses we received from our suppliers that sourced from Covered Countries included information at a company level. Where product level responses were received, and Boston Scientific was able to identify smelters that provide materials used directly in the production of our products, only smelter location, as shown above, was provided by the supplier. No mine information was available. As a result, we were unable to determine which facilities were used to process the necessary conflict minerals specific to our products. Similarly, we were unable to determine the country of origin of the necessary conflict minerals specific to our products. Our due diligence process, described above, reflects our efforts to determine with the greatest specificity the mines or location of origin of the conflict minerals necessary to the functionality or production of products we manufacture or contract to manufacture. We have not identified smelters sourcing from the Covered Countries that can be traced specifically to our products.

Continuous Improvement Efforts

In 2018, BSC began implementation of an upgrade to our commercial software system related to our conflict minerals compliance efforts for surveying suppliers and storing CMRT forms. Boston Scientific employees responsible for conflict minerals compliance efforts have completed appropriate training in global procedures to ensure long-term sustainability and global harmonization of the RCOI process. The system and process include:

Maintenance and tracking of supplier communications, including automation of late notification responses;
Improved tracking for smelter-level information for both company level and product level CMRTs;
Long-term storage and version history of supplier responses and forms, including searchability for smelter information;
Determination of conflict minerals status of individual products; and
Automatic “red flag” validations of completed CMRTs.