Exhibit 1.02
HeartWare International, Inc.
Conflict Minerals Report
For The Year Ended December 31, 2013
Unless the context requires otherwise, references in this Conflict Minerals Report to “HeartWare,” “the Company,” “HeartWare Group,” “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, 2013, 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” or “Conflict 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 3TG, then the registrant must exercise due diligence to identify the 3TG’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 certain of 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 Organisation for Economic Co-operation and Development. TheOECD 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. 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.
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. 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. The HVAD System has been implanted in patients at over 230 health care sites in 37 countries.
HeartWare is also developing next-generation blood pumps that contain 3TG.
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2. 3TG Review Process
HeartWare’s 3TG review process included the development of a Conflict Minerals Policy, the establishment of an internal working group with cross functional team members as well as senior executives, initiation of modifications to supply agreements to incorporate requirements related to supply chain sourcing and 3TG, communications to suppliers and a due diligence compliance process. 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 the HVAD System as well as products under development.
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. Products under development: USB cable and connector braze |
Therefore, HeartWare products are subject to the reporting obligations of the Rule.
3. Reasonable Country of Origin Inquiry (RCOI)
HeartWare does not purchase raw ore or unrefined 3TG directly from mines, smelters or refiners and makes no direct purchases of any minerals in the Covered Countries. The Company’s supply chain is complex, with multiple intermediaries and third parties in the supply chain between the manufacture of the components that contain 3TG and the original sources 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 them 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 provided the EICC-GeSI Conflict Minerals Reporting Template (“Template”) to each of these nine (9) suppliers. The Template requires a supplier to make representations regarding (i) the country of origin for the Conflict Minerals contained in the components or products it provides to the Company, (ii) all of the smelters in the supplier’s supply chain for Conflict Minerals, (iii) whether the smelter has been validated as being in compliance with the Conflict-Free Smelter Program, (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 Template with its own suppliers to gather similar information.
Most HeartWare direct suppliers have completed their respective Templates and provided the completed Templates 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.
4. Product Component Determination: DRC Conflict Undeterminable
On the basis of the due diligence measures described in this Conflict Minerals Report, HeartWare has concluded in good faith that during the reporting period from January 1 to December 31, 2013 (“Reporting Period”), the 3TG contained in our products that originated or may have originated from the Covered Countries are DRC conflict undeterminable. HeartWare reached this conclusion because we do not have sufficient information from suppliers regarding all of the upstream suppliers, smelters or refiners that processed the 3TG in our product components to conclude whether the 3TG originated in the Covered Countries and, if so, whether the 3TG were from recycled or scrap sources or were or were not from other conflict-free sources.
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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:
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| | CONFLICT MINERAL | | SMELTER NAME | | SMELTER FACILITY LOCATION: COUNTRY |
1 | | Gold | | Aida Chemical Industries Co. Ltd | | Japan |
2 | | Gold | | Allgemeine Gold- und Silberscheideanstalt A.G. | | Germany |
3 | | Gold | | AngloGold Ashanti Mineração Ltda | | Brazil |
4 | | Gold | | Argor-Heraeus SA | | Switzerland |
5 | | Gold | | Asahi Pretec Corporation | | Japan |
6 | | Gold | | Asaka Riken Co. Ltd | | Japan |
7 | | Gold | | Aurubis AG | | Germany |
8 | | Gold | | Bauer Walser AG | | Germany |
9 | | Gold | | Caridad | | Mexico |
10 | | Gold | | Chugai Mining | | Japan |
11 | | Gold | | Codelco | | Chile |
12 | | Gold | | Dowa | | Japan |
13 | | Gold | | Foxxconn | | Taiwan |
14 | | Gold, Tin | | FSE Novosibirsk Refinery | | Russian Federation |
15 | | Gold | | Guang Zhou Jin Ding | | China |
16 | | Gold | | Harmony Gold Refinery | | South Africa |
17 | | Gold, Tin | | Heraeus Ltd Hong Kong | | Hong Kong |
18 | | Gold | | Heraeus Precious Metals GmbH & Co. KG | | Germany |
19 | | Gold | | Heraeus USA | | United States |
20 | | Gold | | Hisikari Mine | | Japan |
21 | | Gold | | Hon-Hai | | Taiwan |
22 | | Gold | | Ishifuku Metal Industry Co., Ltd. | | Japan |
23 | | Gold | | Johnson Matthey Inc | | United States |
24 | | Gold | | Johnson Matthey Limited | | Canada |
25 | | Gold | | JX Nippon Mining & Metals Co., Ltd | | Japan |
26 | | Gold | | Kennecott Utah Copper LLC | | United States |
27 | | Gold | | Kojima Chemicals Co. Ltd | | Japan |
28 | | Gold | | LS-Nikko Copper Inc | | Korea, Republic of |
29 | | Gold | | Materion | | United States |
30 | | Gold | | Matsuda Sangyo Co. Ltd | | Japan |
31 | | Gold | | Metalor Technologies (Hong Kong) Ltd | | Hong Kong |
32 | | Gold | | Metalor Technologies SA | | Switzerland |
33 | | Gold | | Metalor USA Refining Corporation | | United States |
34 | | Gold, Tin, Tungsten | | Mitsubishi Materials Corporation | | Japan |
35 | | Gold | | Mitsui Mining and Smelting Co., Ltd. | | Japan |
36 | | Gold | | Navoi Mining and Metallurgical Combinat | | Uzbekistan |
37 | | Gold | | Nihon Material Co. LTD | | Japan |
38 | | Gold | | Ohio Precious Metals LLC. | | United States |
39 | | Gold | | OMG Electrochemicals | | United States |
40 | | Gold | | Pan Pacific Copper Co. LTD | | Japan |
41 | | Gold | | Royal Canadian Mint | | Canada |
42 | | Gold | | SEMPSA Joyeria Plateria SA | | Spain |
43 | | Gold | | Senju Metal Industry Co Ltd | | Japan |
44 | | Gold | | Shandong Zhaojin Gold & Silver Refinery Co., Ltd | | China |
45 | | Gold | | Shenzhen Tiancheng Chemical Co Ltd | | China |
46 | | Gold | | So Accurate Refining | | United States |
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47 | | Gold | | Solar Applied Materials Technology Corp. | | Taiwan |
48 | | Gold | | Sumitomo Metal Mining Co. Ltd. | | Japan |
49 | | Gold | | Suzhou Xingrui Noble | | China |
50 | | Gold | | Tanaka Kikinzoku Kogyo K.K. | | Japan |
51 | | Gold | | The Great Wall Gold and Silver Refinery of China | | China |
52 | | Gold | | The Refinery of Shandong Gold Mining Co., Ltd | | China |
53 | | Gold | | Timah Company | | Indonesia |
54 | | Gold | | Tokuriki Honten Co. Ltd | | Japan |
55 | | Gold | | UBS AG Bahnhofstr. | | Switzerland |
56 | | Gold | | Umicore SA Business Unit Precious Metals Refining | | Belgium |
57 | | Gold | | United Precious Metal Refining, Inc. | | United States |
58 | | Gold | | Western Australian Mint trading as The Perth Mint | | Australia |
59 | | Gold | | Williams Bufalo | | United States |
60 | | Gold | | Wuxi Middle Treasure Materials | | China |
61 | | Gold | | Xstrata Canada Corporation | | Canada |
62 | | Gold | | Yokohama Metal Co Ltd | | Japan |
63 | | Gold | | Yoo Chang Metal | | Korea, Republic of |
64 | | Gold | | Zhongjin Gold Corporation Limited | | China |
65 | | Gold | | Zhongyuan Gold Smelter of Zhongjin Gold Corporation | | China |
66 | | Gold | | Zijin Mining Group Co. Ltd | | China |
67 | | Tin | | Amalgamet Inc | | Peru |
68 | | Tin | | Brinkmann Chemie AG | | Germany |
69 | | Tin | | CFC Cooperative dos Fundidores de Cassiterita da Amazônia Ltda. | | Brazil |
70 | | Tin | | China Tin Group Co. Ltd | | China |
71 | | Tin | | CNMC (Guangxi) PGMA Co. Ltd. | | China |
72 | | Tin | | Cookson | | United States |
73 | | Tin | | Cooper Santa | | Brazil |
74 | | Tin | | CV DS Jaya Abadi | | Indonesia |
75 | | Tin | | CV Duta Putra Bangka | | Indonesia |
76 | | Tin | | CV JusTindo | | Indonesia |
77 | | Tin | | CV Makmur Jaya | | Indonesia |
78 | | Tin | | CV Nurjanah | | Indonesia |
79 | | Tin | | CV Prima Timah Utama | | Indonesia |
80 | | Tin | | CV Serumpun Sebalai | | Indonesia |
81 | | Tin | | CV United Smelting | | Indonesia |
82 | | Tin | | EM Vinto | | Bolivia |
83 | | Tin | | Feinhütte Halsbrücke GmbH | | Germany |
84 | | Tin | | Fenix Metals | | Poland |
85 | | Tin | | Fuji Metal Mining Corp | | Taiwan |
86 | | Tin | | Geiju Non-Ferrous Metal Processing Co. Ltd. | | China |
87 | | Tin | | Gejiu Zi-Li | | China |
88 | | Tin | | Gold Bell Group | | China |
89 | | Tin | | Guangxi Pinggui PGMA Co. Ltd. | | China |
90 | | Tin | | Huichang Jinshunda Tin Co. Ltd | | China |
91 | | Tin | | Huichang Shun Tin, Kam Industries Ltd. | | China |
92 | | Tin | | Jiangxi Nanshan | | China |
93 | | Tin | | Kai Unita Trade Limited Liability Company | | China |
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94 | | Tin | | KOBA | | Indonesia |
95 | | Tin | | Linwu Xianggui Smelter Co | | China |
96 | | Tin | | Liuzhou China Tin | | China |
97 | | Tin | | Malaysia Smelting Corporation (MSC) | | Malaysia |
98 | | Tin | | Mentok Smelter | | Indonesia |
99 | | Tin | | Metallo Chimique | | Belgium |
100 | | Tin | | Mineração Taboca S.A. | | Brazil |
101 | | Tin | | Minmetals Ganzhou Tin Co. Ltd. | | China |
102 | | Tin | | Minsur | | Peru |
103 | | Tin | | Novosibirsk Integrated Tin Works | | Russian Federation |
104 | | Tin | | OM Manufacturing Phils. Inc. | | Philippines |
105 | | Tin | | OMSA | | Bolivia |
106 | | Tin | | PT Alam Lestari Kencana | | Indonesia |
107 | | Tin | | PT Artha Cipta Langgeng | | Indonesia |
108 | | Tin | | PT Babel Inti Perkasa | | Indonesia |
109 | | Tin | | PT Babel Surya Alam Lestari | | Indonesia |
110 | | Tin | | PT Bangka Kudai Tin | | Indonesia |
111 | | Tin | | PT Bangka Putra Karya | | Indonesia |
112 | | Tin | | PT Bangka Timah Utama Sejahtera | | Indonesia |
113 | | Tin | | PT Bangka Tin Industry | | Indonesia |
114 | | Tin | | PT Belitung Industri Sejahtera | | Indonesia |
115 | | Tin | | PT BilliTin Makmur Lestari | | Indonesia |
116 | | Tin | | PT Bukit Timah | | Indonesia |
117 | | Tin | | PT DS Jaya Abadi | | Indonesia |
118 | | Tin | | PT Eunindo Usaha Mandiri | | Indonesia |
119 | | Tin | | PT Fang Di MulTindo | | Indonesia |
120 | | Tin | | PT HP Metals Indonesia | | Indonesia |
121 | | Tin | | PT Koba Tin | | Indonesia |
122 | | Tin | | PT Mitra Stania Prima | | Indonesia |
123 | | Tin | | PT Panca Mega | | Indonesia |
124 | | Tin | | PT Refined Banka Tin | | Indonesia |
125 | | Tin | | PT Sariwiguna Binasentosa | | Indonesia |
126 | | Tin | | PT Stanindo Inti Perkasa | | Indonesia |
127 | | Tin | | PT Sumber Jaya Indah | | Indonesia |
128 | | Tin | | PT Tambang Timah | | Indonesia |
129 | | Tin | | PT Timah | | Indonesia |
130 | | Tin | | PT Timah Nusantara | | Indonesia |
131 | | Tin | | PT Tinindo Inter Nusa | | Indonesia |
132 | | Tin | | PT Yinchendo Mining Industry | | Indonesia |
133 | | Tin | | Pure Technology | | Russian Federation |
134 | | Tin | | Rohm und Haas | | Germany |
135 | | Tin | | Samhwa Mon-ferrorus Metal Ind. Co. Ltd | | Korea, Republic of |
136 | | Tin | | Shen Mao Solder(m) Sdn Bhd | | Malaysia |
137 | | Tin | | Tamura | | Japan |
138 | | Tin | | Thaisarco | | Thailand |
139 | | Tin | | Unit Timah Kundur PT Tambank | | Indonesia |
140 | | Tin | | Westfalenzinn J. Josh KG | | Germany |
141 | | Tin | | White Solder Metalurgia | | Brazil |
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142 | | Tin | | WKK PCB Trading Ltd. | | China |
143 | | Tin | | Xihai | | China |
144 | | Tin | | Yunnan Chengfeng | | China |
145 | | Tin | | Yunnan Tin Company Limited | | China |
146 | | Tin | | YunXi | | China |
147 | | Tungsten | | A.L.M.T. Corp. | | Japan |
148 | | Tungsten | | Chaozhou Xianglu Tungsten Industry Co Ltd | | China |
149 | | Tungsten | | China National Non-ferrous | | China |
150 | | Tungsten | | Gan Bei Tungsten Industry | | China |
151 | | Tungsten | | Ganzhou Huaxing Tungsten | | China |
152 | | Tungsten | | Global Tungsten & Powders Corp | | United States |
153 | | Tungsten | | HC Starck GmbH | | Germany |
154 | | Tungsten | | Hitachi | | Japan |
155 | | Tungsten | | Jiangxi Rare Earth & Rare Metals Tungsten Group Corp | | China |
156 | | Tungsten | | Jiangxi Tungsten Industry Group Co Ltd | | China |
157 | | Tungsten | | Taegutee | | Korea, Republic of |
158 | | Tungsten | | Williams Brewster | | United States |
159 | | Tungsten | | Wolfram Company CJSC | | Russian Federation |
160 | | Tungsten | | Xiamen Tungsten Co Ltd | | China |
161 | | Tungsten | | ZhuZhou Cemented Carbide Works Imp.&Exp.co | | China |
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 Template submissions and believe that the smelters identified represent the most reasonable known mine of origin information available.
We have been notified by one of our suppliers that a potential smelter of tin in its supply chain may have sourced from the Covered Countries during the Reporting Period. However, this smelter has been audited by a third party and verified as compliant with the Conflict-Free Smelter Program (CSFP) assessment protocol.
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