UNITED STATES

SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 

FORM SD



Specialized Disclosure Report
 

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CRYOLIFE, INC.

(Exact name of registrant as specified in its charter)
 

_________________________

 

 

1655 Roberts Boulevard, N.W., Kennesaw, Georgia  30144
(Address of principal executive office) (zip code)
 

Registrant's telephone number, including area code: (770) 419-3355
 

_____________________________________________________________

 

(Former name or former address, if changed since last 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:



☒Rule 13p-1 under the Securities Exchange Act (17 CFR 240.13p-1) for the reporting period from January 1 to December 31, 2020





 

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Section 1 -- Conflict Minerals Disclosure

Item 1.01  Conflict Minerals Disclosure and Report

This Form SD of CryoLife, Inc. (the “Company”) is filed pursuant to Rule 13p-1 promulgated under the Securities Exchange Act of 1934, as amended, for the reporting period January 1, 2020 to December 31, 2020.    

A copy of the Company’s Conflict Minerals Report is provided as Exhibit 1.01. This Form SD and the Conflict Minerals Report is publicly available on the Company’s website at http://investors.cryolife.com.

Item 1.02  Exhibit

As specified in Section 2, Item 2.01 of this Form SD, the Company is hereby filing its Conflict Minerals Report as Exhibit 1.01 to this Form SD.

Section 2 -- Exhibits

Item 2.01 Exhibits



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SIGNATURES

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

 



 

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CryoLife, Inc.

Conflict Minerals Report

For the reporting period January 1, 2020 to December 31, 2020



Background



This Conflict Minerals Report (the “Report”) of CryoLife, Inc. (“CryoLife,” the “Company,”  “we,” or “us”)  has been prepared pursuant to Rule 13p-1 and Form SD (the “Rule”) promulgated under the Securities Exchange Act of 1934, as amended, for the reporting period January 1, 2020 to December 31, 2020. The Rule requires disclosure of certain information when a company manufactures or contracts to manufacture products, and the minerals specified in the Rule are necessary to the functionality or production of those products. The specified minerals, which we collectively refer to in this Report as the “Conflict Minerals,” are gold, columbite-tantalite (coltan), cassiterite, and wolframite (including their derivatives, which are limited to tantalum, tin, and tungsten). The “Covered Countries,” for purposes of the Rule and this Report, are the Democratic Republic of the Congo, the Republic of the Congo, the Central African Republic, South Sudan, Uganda, Rwanda, Burundi, Tanzania, Zambia, and Angola.



Company Overview and Conflict Minerals Approach



The Company, incorporated in 1984 in Florida, is a leader in the manufacturing, processing, and distribution of medical devices and implantable human tissues used in cardiac and vascular surgical procedures focused on aortic repair. Our medical devices and processed tissues primarily include four product families: BioGlue® Surgical Adhesive; On-X® mechanical heart valves and surgical products; JOTEC endovascular and surgical products; and cardiac and vascular human tissues including the CryoValve® SG pulmonary heart valve and the CryoPatch® SG pulmonary cardiac patch, both of which are processed using our proprietary SynerGraft® technology. In addition to these four major product families, we sell or distribute the NEXUS endovascular stent graft system, CardioGenesis cardiac laser therapy, PerClot® hemostatic powder,  and PhotoFix® bovine surgical patch.   



Our approach to Conflict Minerals is based, to the extent applicable and feasible, on the framework set forth in the Organization for Economic Co-operation and Development Due Diligence Guidance for Responsible Supply Chain of Minerals from Conflict-Affected and High Risk Areas: Third Edition, including the related supplements on gold, tin, tantalum, and tungsten (the “Guidance”). As part of our approach, we maintain a Conflict Minerals Policy (the “Policy”), which incorporates the standards set forth in the Guidance. The Policy has been reviewed and approved by senior management and presented to the Audit Committee of the Company’s Board of Directors. In addition, our Purchasing and Legal and Compliance departments have been directed by management to communicate the Policy to employees who have responsibilities for applying, enforcing, or communicating it internally or to relevant outside parties. The Policy is maintained on our website.



Reasonable Country of Origin Inquiry



Under the Rule, if any Conflict Minerals are necessary to the functionality or production of a product manufactured by the Company or contracted by the Company to be manufactured, then the Company must conduct, in good faith, a reasonable country of origin inquiry (“RCOI”) regarding those Conflict Minerals to determine if the Conflict Minerals originated from a Covered Country or are from recycled or scrap sources. We undertook a process to identify any necessary Conflict Minerals and conducted an RCOI to determine whether any of these Conflict Minerals originated from the Covered Countries or are from recycled or scrap sources. Through that process, eleven of our suppliers indicated that Conflict Minerals are added or used in the product or in the production process.  Five of these suppliers certified to our reasonable satisfaction that the Conflict Minerals did not originate in the Covered Countries. Four of these suppliers indicated that they obtain Conflict Minerals indirectly from the Covered Countries, and two of these suppliers, notwithstanding their due diligence, were unable to determine whether  they obtain Conflict Minerals from the Covered Countries.  As of May 10,  2021, the Company had an overall supplier response rate of 61%.

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Due Diligence Process and Results



Based on our RCOI, with respect to our suppliers who had obtained Conflict Minerals indirectly from the Covered Countries, we exercised reasonable due diligence on the source and chain of custody of the Conflict Minerals. The first of these suppliers obtains the Conflict Minerals directly from Global Tungsten & Powders Corp., a smelter located in Pennsylvania, USA, which in turn obtains Conflict Minerals from Covered Countries.  The second of these suppliers obtains Conflict Minerals from at least three smelters that reportedly obtain Conflict Minerals from Covered Countries: Mitsui Mining and Smelting Co., Ltd.  (Japan), Mitsubishi Materials Corporation  (Japan), and Japan New Metals Co., Ltd.  (Japan). The third of these suppliers obtains Conflict Minerals from multiple suppliers that reportedly obtain Conflict Minerals from Covered Countries. This supplier removes high-risk smelters from its supply chain. The fourth supplier also obtains Conflict Minerals from multiple suppliers. Although each of the reported smelters obtains Conflict Minerals from Covered Countries, each smelter participates in the Responsible Mineral Initiative (“RMI”) independent third-party audit that examines the purchasing activities, processes, and systems associated with their smelting pursuant to the Responsible Minerals Assurance Process (“RMAP”). As of the date of this report, each is listed as a  conformant smelter by RMI. With respect to our two suppliers who were unable to determine whether they obtain Conflict Minerals from the Covered Countries, we exercised reasonable due diligence and received information about our suppliers’ Conflict Minerals policies and due diligence procedures, as well as their efforts to determine the country of origin of all Conflict Minerals. For the reporting period, however, our suppliers  were unable to conclusively determine the country of origin of all these minerals.



There are many third parties in the supply chain between our direct suppliers and the original sources of any actual or potential Conflict Minerals. In this regard, we do not purchase Conflict Minerals directly from mines, smelters, or refiners. We must therefore rely on our suppliers and their upstream supplier to provide information regarding the origin of any Conflict Minerals.



This Conflict Minerals Report is unaudited.



Risk Mitigation



We intend to take the following steps to mitigate the risk that our necessary Conflict Minerals benefit armed groups:





Forward-Looking Statements

 

Statements made in this Report that look forward in time or that express management’s beliefs, expectations, or forecasts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements reflect the views of management at the time such statements are made. These statements include those regarding the steps the Company expects to take to improve its due diligence measures and further mitigate the risk that necessary Conflict Minerals contained in the Company’s products finance or benefit armed groups in the Covered Countries. These forward-looking statements are subject to a number of risks, uncertainties, estimates, and assumptions that may cause actual results to differ materially from current expectations. These risks and uncertainties include, but are not limited to, internal and external resource constraints, the continued implementation of satisfactory traceability and other compliance measures by our direct and indirect suppliers on a timely basis or at all, whether smelters, refiners, and other market participants responsibly source Conflict Minerals, and political and regulatory developments, whether in the Covered Countries, the United States, or elsewhere. These risks and uncertainties also include the risk factors detailed in our Securities and Exchange Commission filings, including our Form 10-K for the year ended December 31, 2020. CryoLife assumes no obligation, and expressly disclaims any duty, to update publicly any such forward-looking statements, whether as a result of new information, future events, or otherwise.



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