EX-1.01 2 d183272dex101.htm EX-1.01 EX-1.01

Exhibit 1.01

HeartWare International, Inc.

Conflict Minerals Report

For The Year Ended December 31, 2015

Unless the context requires otherwise, references in this Conflict Minerals Report to “HeartWare,” “the Company,” “we,” “us” and “our” refer to HeartWare International, Inc. and its consolidated direct and indirect subsidiaries.

This is the Conflict Minerals Report of HeartWare for the calendar year ended December 31, 2015, which has been prepared pursuant to Rule 13p-1 (the “Rule”) promulgated under the Securities Exchange Act of 1934, as amended. The Rule was adopted by the Securities and Exchange Commission (SEC”) to implement reporting and disclosure requirements related to conflict minerals as directed by the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010. The Rule imposes certain disclosure obligations on SEC reporting registrants that manufacture or contract to manufacture products for which the minerals specified in the Rule are necessary to the functionality or production of those products. The specified minerals include cassiterite, columbite-tantalite, gold, wolframite, and their derivatives, which are limited to tin, tantalum, tungsten, and/or gold (collectively,3TG” orConflict Minerals” for the purposes of this assessment) that originated in the Democratic Republic of the Congo (DRC) or certain adjoining countries (collectively, the “Covered Countries”).

If a registrant has reason to believe that any 3TG in its supply chain may have originated in a Covered Country, or if a registrant is unable to determine the country of origin of a Conflict Mineral, then the registrant must exercise due diligence to identify the Conflict Mineral’s source and chain of custody. The registrant must annually submit to the SEC a report, called a Conflict Minerals Report, which includes a description of those due diligence measures and the registrant’s assessment of the results of its diligence efforts.

In accordance with the Rule, HeartWare has conducted a good faith reasonable country of origin inquiry to determine the origin of the 3TG contained in its products. This good faith reasonable country of origin inquiry was designed to determine whether any of the 3TG originated in the Covered Countries and whether any of the 3TG may be from recycled or scrap sources. Following this inquiry, the Company was unable to determine whether the 3TG necessary to the functionality or production of certain of its products (as further discussed below) originated in the Covered Countries and whether 3TG may be from recycled or scrap sources. The Company then made additional efforts to determine the source and chain of custody of the 3TG. The Company’s due diligence efforts were consistent with the framework described in the OECD Due Diligence Guidance for Responsible Supply Chains of Minerals from Conflict-Affected and High-Risk Areas: Second Edition (including the Supplement on Tin, Tantalum and Tungsten and the Supplement on Gold). “OECD” is an abbreviation for the Organization for Economic Co-operation and Development. The OECD Due Diligence Guidance is an internationally recognized due diligence framework.

No independent private sector audit related to this Conflict Minerals Report has been completed.

1. Company Overview

HeartWare is a medical device company that develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat patients suffering from advanced heart failure. We have one operating segment, which designs, manufactures and markets our medical devices. We are headquartered in Framingham, Massachusetts, and have primary facilities in Miami Lakes, Florida and Hannover, Germany.

The HeartWare Ventricular Assist System (the “HVAD® System”), which includes a ventricular assist device (“VAD”) or blood pump, patient accessories and surgical tools, is designed to provide circulatory support for patients in the advanced stage of heart failure. The core of the HVAD System is a proprietary continuous flow blood pump, the HVAD Pump, which is a full-output device capable of pumping up to 10 liters of blood per minute. The HVAD System is designed to be implanted adjacent to the heart, avoiding abdominal surgery, which is generally required to implant similar devices.

The HVAD System has been available in the European Union since receiving CE marking in 2009. In May 2012 we received an expanded European label for long-term use of the HVAD System in all patients at risk of death from refractory, end-stage heart failure. In November 2012 we received approval from the United States Food and Drug Administration (“FDA”) for the HVAD System as a bridge to heart transplantation in patients with end-stage heart failure. As of December 31, 2015, there have been over 10,000 implants of the HVAD System in patients at over 320 health care sites in 47 countries. HeartWare is also developing next-generation blood pumps.

 

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2. 3TG Due Diligence Process

HeartWare’s 3TG due diligence process has encompassed the development of a Conflict Minerals Policy, an internal working group with cross functional team members as well as senior executives, modifications to supply agreements and requests to suppliers to incorporate requirements related to supply chain sourcing and 3TG, and communications to suppliers that provide product components that contain 3TG. HeartWare’s executive leadership team has been apprised of progress, and that team has in turn periodically updated the Audit Committee of the Board of Directors with respect to HeartWare’s due diligence efforts and ongoing compliance obligations.

3. Product Analysis

HeartWare conducted an analysis of its products and determined that 3TG can be found in certain components of the HVAD System as well as products under development. Therefore, HeartWare products are subject to the reporting obligations of the Rule.

The following table describes the presence of 3TG in HeartWare products. Unless otherwise specified, 3TG is present in the product components of the HVAD System and of products under development.

 

3TG ITEM   PRODUCT COMPONENT

Tin

  Semiconductor packaging; Solder; Connectors; Wire

Tungsten

  Integrated circuits

Tantalum

  Capacitors

Gold

 

Integrated circuits; Printed circuit boards; Connectors

HVAD System: Connector crimp contacts

Products under development: USB cable; Connector contact blocks; Connector braze

4. Reasonable Country of Origin Inquiry (RCOI)

HeartWare does not purchase raw ore or unrefined 3TG directly from mines, smelters or refiners. The Company makes no direct purchases in the Covered Countries, and does not perform or direct audits of entities in the Covered Countries. The Company’s supply chain is complex. There are multiple intermediaries and third parties in the supply chain between the manufacture of the components that contain 3TG and the original source(s) of the 3TG. HeartWare must therefore rely upon its suppliers to provide information on the origin of the 3TG contained in components and materials supplied to HeartWare, including sources of 3TG that are supplied to HeartWare suppliers from upstream suppliers. Further, the Company believes that the smelters and refiners of 3TG are best situated to identify the sources of the 3TG, and therefore has taken steps to identify the smelters of 3TG in HeartWare’s supply chain.

HeartWare identified nine (9) suppliers from which it purchases components for HeartWare products that may include 3TG. HeartWare requested the Conflict Minerals Reporting Template (“CMRT”) for calendar year 2015, which had been made available on the website of the Conflict-Free Sourcing Initiative, from each of these nine (9) suppliers. The CMRT requires a supplier to make representations regarding (i) whether any of the 3TG contained in the components or products it provides to the Company originates in the Covered Countries, (ii) the suppliers of 3TG in the supplier’s supply chain, (iii) the smelters of 3TG in the supplier’s supply chain, (iv) whether the supplier has its own Conflict Minerals policy that requires its own direct suppliers to be conflict-free, and (v) whether the supplier uses the CMRT with its own suppliers to gather similar information.

All nine (9) HeartWare direct suppliers completed their respective CMRTs and provided the completed CMRTs to HeartWare. HeartWare has relied on these supplier responses to provide information about the source of 3TG contained in the product components supplied to HeartWare. HeartWare’s direct suppliers may be similarly reliant upon information provided to them by upstream suppliers.

The majority of the supplier responses that HeartWare received provided data that were “Company-wide” in scope. We also received a response that was “User-defined” in scope, and too broad to determine whether the data applied to the product components that we received from the supplier in 2015. In these instances we requested information at the Product level. We have listed below the smelters included on the CMRT that included data at the Product level.

 

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5. Smelter Information

Based on information provide to HeartWare by its suppliers and otherwise obtained through our due diligence process, HeartWare has determined that the smelters and refineries listed in the table below are among those that may be used to process the 3TG contained in HeartWare products:

 

    

CONFLICT
MINERAL

  

SMELTER NAME

   SMELTER FACILITY
LOCATION: COUNTRY

  1

   Gold    AngloGold Ashanti Córrego do Sítio Mineração    Brazil

  2

   Gold    Argor-Heraeus SA    Switzerland

  3

   Gold    Asahi Pretec Corporation    Japan

  4

   Gold    CCR Refinery – Glencore Canada Corporation    Canada

  5

   Gold    Dowa    Japan

  6

   Gold    Heraeus Ltd. Hong Kong    China

  7

   Gold    Heraeus Precious Metals GmbH & Co. KG    Germany

  8

   Gold    Johnson Matthey Inc.    United States

  9

   Gold    Johnson Matthey Limited    Canada

10

   Gold    Kennecott Utah Copper LLC    United States

11

   Gold    Kojima Chemicals Co., Ltd.    Japan

12

   Gold    Materion    United States

13

   Gold    Matsuda Sangyo Co., Ltd.    Japan

14

   Gold    Metalor Technologies (Hong Kong) Ltd.    China

15

   Gold    Metalor Technologies SA    Switzerland

16

   Gold    Metalor USA Refining Corporation    United States

17

   Gold    Nihon Material Co., Ltd.    Japan

18

   Gold    Ohio Precious Metals, LLC    United States

19

   Gold    Royal Canadian Mint    Canada

20

   Gold    Tanaka Kikinzoku Kogyo K.K.    Japan

21

   Gold    Umicore SA Business Unit Precious Metals Refining    Belgium

22

   Gold    United Precious Metal Refining, Inc.    United States

23

   Gold    Western Australian Mint Trading as The Perth Mint    Australia

Tracing 3TG back to their mine of origin is a complex aspect of sourcing in a supply chain. We have relied primarily upon our supplier CMRT submissions and believe that the smelters identified represent the most reasonable known mine of origin information available.

 

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