Medical*

According to its Annual Report filed with the SEC for fiscal year 2019: "The Group does not have a legal entity based in Iran, but in 2019 it exported certain medical devices to Iran, via sales by non- US entities, to a privately owned Iranian distributor for sale in Iran. Sales by the distributor were made to hospitals that we understand are owned or controlled by the Government of Iran.

The Group’s direct and indirect sales of US origin medical devices into Iran are permitted pursuant to section 560.530(a)(3)(i) of the Iranian Transactions and Sanctions Regulations, and its indirect sales of non-US origin medical devices into Iran are made in accordance with applicable law. The Group also provides training to its distributor(s) and surgeons in Iran as necessary and ordinarily incident to the safe and effective use of the medical devices, which is also permitted by applicable law.

In 2019, Smith+Nephew’s gross revenues from sales to Iran were approximately US$6.2m and net losses were approximately US$1.0m.

The Group is reporting the entire gross revenues and net losses for the activities described above, which figures include sales of US origin medical devices. Although the Group is not required to disclose the sales of US origin medical devices because such sales to Iran are licensed under US law, the Group is including sales of these devices in its total gross revenue and net profit figures as it does not separately break out revenues and profits by country of origin."  

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According to its Annual report filed with the SEC for fiscal year 2018: "The Group does not have a legal entity based in Iran, but in 2018 it exported certain medical devices to Iran, via sales by non- US entities, to a privately owned Iranian distributor for sale in Iran. Sales by the distributor were made to hospitals that we understand are owned or controlled by the Government of Iran.

The Group’s direct and indirect sales of US origin medical devices into Iran are permitted pursuant to section 560.530(a)(3)(i) of the Iranian Transactions and Sanctions Regulations, and its indirect sales of non-US origin medical devices into Iran are made in accordance with applicable law. The Group also provides training to its distributor(s) and surgeons in Iran as necessary and ordinarily incident to the safe and effective use of the medical devices, which is also permitted by applicable law.

In 2018, S&N’s gross revenues from sales to Iran were approximately US$3.4m and net losses were approximately US$1.1m.

The Group is reporting the entire gross revenues and net profits for the activities described above, which figures include sales of US origin medical devices. Although the Group is not required to disclose the sales of US origin medical devices because such sales to Iran are licensed under US law, the Group is including sales of these devices in its total gross revenue and net profit figures as it does not separately break out revenues and profits by country of origin."

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According to its Annual Report filed with the SEC for fiscal year 2017: "The Group does not have a legal entity based in Iran, but in 2017 it exported certain medical devices to Iran, via sales by non-US entities, to a new privately owned Iranian distributor for sale in Iran. Prior to 2017, the Group had sold products via non-US entities to a privately owned distributor based in the UAE who sold products into Iran. In both cases, sales were to hospitals that we understand are owned or controlled by the Government of Iran.

The Group’s direct and indirect sales of US origin medical devices into Iran are permitted pursuant to section 560.530(a)(3)(i) of the Iranian Transactions and Sanctions Regulations, and its indirect sales of non-US origin medical devices into Iran are made in accordance with applicable law.  The Group also provides training to its distributor(s) and surgeons in Iran as necessary and ordinarily incident to the safe and effective use of the medical devices, which is also permitted by applicable law. In 2017, the Group’s gross revenues from sales to Iran were approximately $5.2m and net losses were approximately $4.0m, due in part to the transition to the new distributor. For prior years, approximate gross revenues and net profits of the Group from sales to Iran were: 2016: gross revenues $1.2m, net losses $0.4m; 2015: gross revenues $4.0m, net profits $0.8m; 2014: gross revenues $3.8m, net profits $1.1m; and 2013: gross revenues $3.5m, net profits $1.2m."

According to its Annual Report filed with the SEC for fiscal year 2019: "We conduct limited business with certain Iranian entities which contributed $1.5 million or approximately 0.1% of our consolidated net sales in 2019. Further, we had sales of $25,000 to Syrian entities in 2019. Although these activities are compliant with applicable law and not financially material, the Iran Threat Reduction and Syria Human Rights Act of 2012 (the "Act") requires us to include the following disclosures in this report. Sales consisted of our consumables and instrumentation products. U.S. affiliates, or foreign affiliates controlled by U.S. affiliates, are not involved in these sales activities and we have not knowingly conducted a transaction or dealt with a person or entity designated in U.S. Executive Orders No. 13224 and 13382. No business has been transacted with the Governments of Iran or Syria as defined in the Act. We do not believe any of our activities are sanctionable under the Iran Sanctions Act or the Comprehensive Iran Sanctions, Accountability, and Divestment Act of 2010. In light of the nature of the products concerned, we do not currently intend to cease our commercial operations with Iranian or Syrian entities."

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According to its Annual Report filed with the SEC for fiscal year 2018: "We conduct limited business with certain Iranian entities which contributed $2.7 million or approximately 0.2% of our consolidated net sales in 2018. Although these activities are compliant with applicable law and not financially material, the Iran Threat Reduction and Syria Human Rights Act of 2012 (the "Act") requires us to include the following disclosures in this report. Sales consisted of our consumables and instrumentation products. U.S. affiliates, or foreign affiliates controlled by U.S. affiliates, are not involved in these sales activities and we have not knowingly conducted a transaction or dealt with a person or entity designated in U.S. Executive Orders No. 13224 and 13382. No business has been transacted with the Government of Iran as defined in the Act. We do not believe any of our activities are sanctionable under the Iran Sanctions Act or the Comprehensive Iran Sanctions, Accountability, and Divestment Act of 2010. In light of the nature of the products concerned, we do not currently intend to cease our commercial operations with Iranian entities."

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According to its Annual Report filed with the SEC for fiscal year 2017: "We conduct limited business with certain Iranian entities which contributed $3.5 million or approximately 0.2% of our consolidated net sales in 2017. Although these activities are compliant with applicable law and not financially material, the Iran Threat Reduction and Syria Human Rights Act of 2012 (the "Act") requires us to include the following disclosures in this report. Sales consisted of our consumables and instrumentation products. U.S. affiliates, or foreign affiliates controlled by U.S. affiliates, are not involved in these sales activities and we have not knowingly conducted a transaction or dealt with a person or entity designated in U.S. Executive Orders No. 13224 and 13382. No business has been transacted with the Government of Iran as defined in the Act. We do not believe any of our activities are sanctionable under the Iran Sanctions Act or the Comprehensive Iran Sanctions, Accountability, and Divestment Act of 2010. In light of the nature of the products concerned, we do not currently intend to cease our commercial operations with Iranian entities."

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According to its Annual Report filed with the SEC for fiscal year 2016: "We conduct limited business with certain Iranian entities which contributed $3.1 million or approximately 0.2% of our consolidated net sales in 2016. Although these activities are compliant with applicable law and not financially material, the Iran Threat Reduction and Syria Human Rights Act of 2012 (the "Act") requires us to include the following disclosures in this report. Sales consisted of our consumables and instrumentation products. U.S. affiliates, or foreign affiliates controlled by U.S. affiliates, are not involved in these sales activities and we have not knowingly conducted a transaction or dealt with a person or entity designated in U.S. Executive Orders No. 13224 and 13382. No business has been transacted with the Government of Iran as defined in the Act. We do not believe any of our activities are sanctionable under the Iran Sanctions Act or the Comprehensive Iran Sanctions, Accountability, and Divestment Act of 2010. In light of the nature of the products concerned, we do not currently intend to cease our commercial operations with Iranian entities."

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According to its Annual Report filed with the SEC for fiscal year 2015: "We conduct limited business with certain Iranian entities which contributed $1.5 million or approximately 0.1% of our consolidated net sales in 2015. Although these activities are compliant with applicable law and not financially material, the Iran Threat Reduction and Syria Human Rights Act of 2012 (the "Act") requires us to include the following disclosures in this report. Sales consisted of our consumables and instrumentation products. U.S. affiliates, or foreign affiliates controlled by U.S. affiliates, are not involved in these sales activities and we have not knowingly conducted a transaction or dealt with a person or entity designated in U.S. Executive Orders No. 13224 and 13382. No business has been transacted with the Government of Iran as defined in the Act. We do not believe any of our activities are sanctionable under the Iran Sanctions Act or the Comprehensive Iran Sanctions, Accountability, and Divestment Act of 2010. In light of the nature of the products concerned, we do not currently intend to cease our commercial operations with Iranian entities."

According to its Annual Report filed with the SEC for fiscal year 2019: "Two of our non-U.S. subsidiaries currently sell medical devices, including cardiac surgery and cardiopulmonary products, to privately held distributors in Iran.
We have limited visibility into the identity of these distributors’ customers in Iran. It is possible that their customers include entities, such as government-owned hospitals or sub-distributors, that are owned or controlled directly or indirectly by the Iranian government. To the best of our knowledge at this time, we do not have any contracts or commercial arrangements with the Iranian government.
Our gross revenues and net profits attributable to the above-mentioned Iranian activities were $1.6 million and $0.5 million for the three months ended December 31, 2019, respectively, and $10.3 million and $3.6 million for the twelve months ended December 31, 2019, respectively.
We believe our activities are consistent with applicable law, including U.S., EU, and other applicable sanctions laws, though such laws are complex and continue to evolve rapidly. We intend to continue our business in Iran."

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According to its Annual Report filed with the SEC for fiscal year 2018: "LivaNova has sold medical devices to Iran since we were formed in 2015. Two of our non-U.S. subsidiaries currently sell medical devices, including cardiac surgery and cardiopulmonary products, to privately held distributors in Iran.
We have limited visibility into the identity of these distributors’ customers in Iran. It is possible that their customers include entities, such as government-owned hospitals or sub-distributors, that are owned or controlled directly or indirectly by the Iranian government. To the best of our knowledge at this time, we do not have any contracts or commercial arrangements with the Iranian government.
For the year ended December 31, 2018, our gross revenues and net profits attributable to the above-mentioned Iranian activities were $10.3 million and $3.7 million, respectively.
We believe our activities are consistent with applicable law, including U.S., EU, and other applicable sanctions laws, though such laws are complex and continue to evolve rapidly. We intend to continue our business in Iran."

According to its Annual Report filed with the SEC for fiscal year 2019: "During the year ended December 31, 2019, the Company sold approximately €1 M of dialysis products to independent Iranian distributors and other foreign distributors for resale, processing and assembling in Iran. The products included fibre bundles, hemodialysis concentrates, dialysis machines and parts, and related disposable supplies. The sales of these products generated approximately €300,000 in operating income. All such sales were made by the Company's German subsidiaries. Based on information available to the Company, the Company believes that most if not all products were eventually sold to hospitals in Iran through state purchasing organizations affiliated with the Iranian Ministry of Health and were therefore sales to the "Government of Iran" as defined in ITSR § 560.304. The Company's 2019 sales to Iran represent 0.01% of its total revenues. The Company has no subsidiaries, affiliates or offices, nor does it have any direct investment or own any assets, in Iran. In light of the humanitarian nature of its products and the patient communities that benefit from our products, the Company expects to continue selling dialysis products to Iran, provided such sales continue to be permissible under applicable export control and economic sanctions laws and regulations."

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According to its Annual Report filed with the SEC for fiscal year 2018: "During the year ended December 31, 2018, the Company sold approximately €6 M of dialysis products to independent Iranian distributors and other foreign distributors for resale, processing and assembling in Iran. The products included fibre bundles, hemodialysis concentrates, dialysis machines and parts, and related disposable supplies. The sales of these products generated approximately €4 M in operating income. During 2018, we also paid approximately €400 in transportation costs most of which were reimbursed by the distributors. All such sales were made by the Company's German subsidiaries. Based on information available to the Company, the Company believes that most if not all products were eventually sold to hospitals in Iran through state purchasing organizations affiliated with the Iranian Ministry of Health and were therefore sales to the "Government of Iran" as defined in ITSR § 560.304. The Company's 2018 sales to Iran represent 0.04% of its total revenues. The Company has no subsidiaries, affiliates or offices, nor does it have any direct investment or own any assets, in Iran. In light of the humanitarian nature of its products and the patient communities that benefit from our products, the Company expects to continue selling dialysis products to Iran, provided such sales continue to be permissible under applicable export control and economic sanctions laws and regulations."

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Fresenius Medical Care AG & Co. KGaA (a German company) noted in its disclosure that certain exceptions apply when transactions involve the sale of medical devices. Fresenius referenced “OFAC’s public guidance provides that sales of medical devices to Iran by non-U.S. companies are generally subject to humanitarian exceptions.” Fresenius’ disclosure was notable because it was a departure from most filings, which as a general rule did not reference OFAC guidance but rather simply asserted that certain actions are permissible under all applicable laws.

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According to its Annual Report filed with the SEC for fiscal year 2016: "During the year ended December 31, 2016, the Company sold approximately $12.5 million of dialysis products to independent Iranian distributors and other foreign distributors for resale, processing and assembling in Iran. The products included fibre bundles, hemodialysis concentrates, dialysis machines and parts, and related disposable supplies. The sales of these products generated approximately $8.1 million in operating income. During 2016, we also paid approximately $2 thousand in transportation costs most of which were reimbursed by the distributors. All such sales were made by the Company's German subsidiaries. Based on information available to the Company, the Company believes that most if not all products were eventually sold to hospitals in Iran through state purchasing organizations affiliated with the Iranian Ministry of Health and were therefore sales to the "Government of Iran" as defined in ITSR § 560.304. The Company's 2016 sales to Iran represent 0.06% of its total revenues. The Company has no subsidiaries, affiliates or offices, nor does it have any direct investment or own any assets, in Iran. In light of the humanitarian nature of its products and the patient communities that benefit from our products, the Company expects to continue selling dialysis products to Iran, provided such sales continue to be permissible under applicable export control and economic sanctions laws and regulations."

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According to its Annual Report filed with the SEC for fiscal year 2015: "During the year ended December 31, 2015, the Company sold approximately $9.4 million of dialysis products to independent Iranian distributors and other foreign distributors for resale, processing and assembling in Iran. The products included fibre bundles, hemodialysis concentrates, dialysis machines and parts, and related disposable supplies. The sales of these products generated approximately $6.7 million in operating income. During 2015, we also paid approximately $11.5 thousand in transportation costs most of which were reimbursed by the distributors. All such sales were made by the Company's German subsidiaries. Based on information available to the Company, the Company believes that most if not all products were eventually sold to hospitals in Iran through state purchasing organizations affiliated with the Iranian Ministry of Health and were therefore sales to the "Government of Iran" as defined in ITSR § 560.304. The Company's 2015 sales to Iran represent 0.6% of its total revenues. The Company has no subsidiaries, affiliates or offices, nor does it have any direct investment or own any assets, in Iran. In light of the humanitarian nature of its products and the patient communities that benefit from our products, the Company expects to continue selling dialysis products to Iran, provided such sales continue to be permissible under applicable export control and economic sanctions laws and regulations."

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According to its Annual Report filed with the SEC for fiscal year 2014: "During the year ended December 31, 2014, the Company sold approximately $11.5 million of dialysis products to independent Iranian distributors and other foreign distributors for resale, processing and assembling in Iran. The products included fibre bundles, hemodialysis concentrates, dialysis machines and parts, and related disposable supplies. The sales of these products generated approximately $7 million in operating income. During 2014, we also paid approximately $32 thousand in transportation costs most of which were reimbursed by the distributors. All such sales were made by the Company's German subsidiaries. Based on information available to the Company, the Company believes that most if not all products were eventually sold to hospitals in Iran through state purchasing organizations affiliated with the Iranian Ministry of Health and were therefore sales to the "Government of Iran" as defined in ITSR § 560.304. The Company's 2014 sales to Iran represent 0.10% of its total revenues. The Company has no subsidiaries, affiliates or offices, nor does it have any direct investment or own any assets, in Iran. In light of the humanitarian nature of its products and the patient communities that benefit from our products, the Company expects to continue selling dialysis products to Iran, provided such sales continue to be permissible under applicable export control and economic sanctions laws and regulations."

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According to its Annual Report filed with the SEC for fiscal year 2012: "During the year ended December 31, 2012, the Company sold approximately $5.3 million of dialysis products to independent Iranian distributors for resale in Iran. The products included fibre bundles, hemodialysis concentrates, dialysis machines and parts, and related disposable supplies. The sales of these products generated approximately $0.46 million in operating income. During 2012, we also paid approximately $0.3 million in transportation costs for which we are reimbursed by the distributors. All such sales were made by the Company's German subsidiaries. Based on information available to the Company, the Company believes that most if not all products were eventually sold to hospitals in Iran through state purchasing organizations affiliated with the Iranian Ministry of Health and were therefore sales to the "Government of Iran" as defined in the Iranian Transactions and Sanctions Regulations, 31 C.F.R. section 560.304. In addition, during 2012, the Company received payments totalling €780,000 for dialysis machines and bicarbonate dialysate sold to Iranian customers in 2011 through a Paris branch of an Iranian bank. In January 2012, after the sales were completed but before the Company received payment for the products, the bank was listed on the Specially Designated Nationals and Blocked Persons List administered by OFAC pursuant to Executive Order 13382 (June 28, 2005). The 2012 payments by the bank to the Company's subsidiary were not subject to the ITSR or otherwise subject to U.S. jurisdiction. The approval and notification procedures with the German Federal Central Bank (Deutsche Bundesbank) for receiving the payments under European Union sanctions law are conducted by the Company's German banks in close coordination with the Company. The Company's 2012 sales to Iran represent less than 0.04% of its total revenue. The Company has no subsidiaries, affiliates or offices, nor does it have any direct investment or own any assets, in Iran. In light of the humanitarian nature of our products and the patient communities that benefit from our products, the Company expects to continue selling dialysis products to Iran, provided such sales continue to be permissible under applicable export control and economic sanctions laws and regulations."

EDAP TMS S.A. (a French company) disclosed that it honored warranty contracts in 2015 related to previous sales of lithotripsy devices (used to treat kidney stones) to three Iranian public hospitals. However, in a departure from previous years, EDAP noted that it did not invoice any medical equipment in 2016.

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According to its Annual Report filed with the SEC for fiscal year 2014: "in 2014 we honored warranty contracts on previous sales of lithotripsy devices to three Iranian public hospitals in order to provide the hospitals with the necessary disposables and services to treat patients with kidney stones using our devices. As part of these warranty commitments, in 2014 we did not invoice any medical equipment to the hospitals."

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According to its Annual Report filed with the SEC for fiscal year 2013: "In 2013 we honored warranty contracts on previous sales of lithotripsy devices to three Iranian public hospitals in order to provide the hospitals with the necessary disposables and services to treat patients with kidney stones using our devices. As part of these warranty commitments, in 2013 we did not invoice  any medical equipment to the hospitals. We intend to continue to honor previous warranty commitments and will provide the necessary parts and disposables to allow patients to be treated with our devices."

"Despite the international sanctions that have choked off much of Iran's foreign trade, many German companies have continued to do business here-legally-in recent years. Now those companies are likely to be among the first to benefit from the country's expected reopening, after a U.S.-led deal in July to ease the sanctions in exchange for curbs on Iran's nuclear program. As of last year, more than 75 German companies had operations in Iran, according to the Tehran-based German-Iranian Chamber of Industry and Commerce. Most of them were small, family-owned businesses that make specialty products not directly covered by the sanctions, often for the health-care, construction or automotive markets... 'We never really left the country,' said Mark Pace, the chief executive and co-owner of Dentaurum GmbH, which has done business in Iran for decades... 'No sanctions can last forever, and once they are lifted or relaxed, then we are already there, while others have to look for partners and start from the very beginning,' said Dentaurum’s Mr. Pace." (Wall Street Journal, "Small German Firms Hold Edge in Iran," 11/29/15)

Company specializes in prosthetic equipment. On its website, Otto Bock lists an area manager responsible for selling equipment to Iran. (Ottobock Website, "Locations").

Lists an office in Tehran, Iran on its company website. 

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Masimo Corporation’s company website lists Saadat, an Iranian company, as a partner.

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Over the last three presidential administrations, the United States government has granted Masimo Corporation 10 special licenses to do business in Iran. (New York Times, "Companies with Permission to Bypass Sanctions," 12/24/10)

Lists Pishraft Darman Co in Tehran, Iran as its contact.

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Over the last three presidential administrations, the United States government has granted GN Otometrics 10 special licenses to do business in Iran. (New York Times, "Companies with Permission to Bypass Sanctions," 12/24/10)

Over the last three presidential administrations, the United States government has granted Zoll Medical Corporation 13 special licenses to do business in Iran. (New York Times, "Companies with Permission to Bypass Sanctions," 12/24/10)