Novo Nordisk

Novo Nordisk Pars (“NN Pars”), a wholly-owned affiliate of Novo Nordisk A/S located in Iran contracts with four GOI-controlled companies (EXIR, Darou Pakhsh Trading Co., Darou Pakhsh Co., and Hedjat Distribution Co.) to import and distribute its products. NN Pars also sponsors educational programs and congresses organized by GOI-controlled medical universities, and hosts health care professionals employed by these medical universities at similar programs in Iran and other locations. Additionally, NN Pars provides funding for clinical research and trials conducted by scientists and health care professionals employed by or associated with GOI-controlled medical universities. NN Pars receives payments from, and makes payments to Iranian banks (certain of which are owned by the GOI and/or are designated under Executive Order 13224 or Executive Order 13382) relating to the sales of pharmaceutical products and devices.

According to its Annual Report filed with the SEC for fiscal year 2018: "Novo Nordisk Pars (“NN Pars”), a wholly-owned affiliate of Novo Nordisk A/S located in Iran, contracts with five companies that may be controlled by the Government of Iran ("GOI") to distribute its products. NN Pars also sponsors educational programs and congresses organized by GOI-controlled medical universities, and hosts health care professionals employed by these medical universities at similar programs in Iran and other locations. Additionally, NN Pars makes donations to GOI-controlled public health organizations focusing on diabetes awareness and policy. NN Pars receives payments from, and makes payments to, Iranian banks (certain of which may be GOI-controlled) relating to the sales of pharmaceutical products and devices. NN Pars makes payments incidental to its ordinary business activities to Iranian government entities and entities that are or may be GOI-controlled, such as taxes, customs fees, insurance, product registration fees and telecommunications services expenses. (https://www.sec.gov/Archives/edgar/data/353278/000162828019000875/novo-b20xf12x31x18.htm)

The German subsidiary of NNE Pharmaplan A/S, a wholly-owned subsidiary of Novo Nordisk A/S, has a contract with SOHA Helal Iran Medical Devices Co., a GOI-controlled company, to provide raw materials and spare parts for production of dialysis and leucocyte filters and syringes."

In 2018, NN Pars contracted with a GOI-controlled company to serve as a contract manufacturer for biopharmaceutical products. However, no transactions took place under the contract and it was terminated. Currently only a Memorandum of Understanding remains in effect, and no activity is currently expected with respect thereto.

NNE A/S is a party to a contract with an Iranian blood fractionation company that Novo Nordisk has learned may be GOI-owned or controlled for the provision of certain engineering services to the Iranian customer. There were no activities conducted under this contract in 2019, but unpaid amounts remain due from the Iranian customer for services performed in prior years by NNE A/S’s affiliate. It is uncertain when NNE A/S will receive payment from the Iranian customer with respect to these unpaid amounts."

According to its Annual Report filed with the SEC for fiscal year 2013: "Novo Nordisk’s activities in Iran relate primarily to sales of pharmaceutical products and devices within the diabetes care and biopharmaceutical business segments. Novo Nordisk has established a wholly-owned affiliate, Novo Nordisk Pars, in Tehran, Iran and has business dealings with a GOI-controlled local manufacturing partner that, under a license agreement with Novo Nordisk Pars, produces Norditropin® based on semi-finished products supplied by Novo Nordisk, and re-packing of certain Novo Nordisk products. Novo Nordisk Pars sells human insulins based on semi-finished products to a GOI-controlled local manufacturing partner. A wholly-owned affiliate of Novo Nordisk, NNE Pharmaplan A/S, has entered into a contract with the Iranian Blood Research & Fractionation Company, which is owned by the Iranian Ministry of Health, for the engineering, procurement and construction of a human plasma fractionation plant for the production of human plasma derivates. Finally, Novo Nordisk conducts to a limited extent clinical research studies and trials, in collaboration with certain Iranian state universities that are related to Novo Nordisk’s diabetes care and biopharmaceuticals businesses." (https://www.sec.gov/Archives/edgar/data/353278/000120864614000046/c109473_20f.htm)

Novo Nordisk previously maintained an inactive bank account with an Iranian bank, which became designated under Executive Order 13224 in October 2018, whereafter Novo Nordisk terminated the account.

"Danish drug maker Novo Nordisk signed a deal with Barakat Pharmed Co. in June 2016 to build a manufacturing plant for insulin pens in a specially developed industrial site. Barakat belongs to Setad. Novo Nordisk said earlier it would make a 70 million euro ($75 million) investment. The choice will allow Novo Nordisk to access infrastructure and transportation and create jobs, a Novo Nordisk spokeswoman said. A Barakat official, Nasrallah Fathiyan, said Khamenei doesn't own the company but supervises it, "so that everything goes smoothly." Setad said the agreement was a contract to give the company land for the plant rather than a business deal." (Reuters, "Post-Sanctions Deals with Iranian Firms Linked to Khamenei," 1/19/2017). (http://www.dailymail.co.uk/wires/reuters/article-4136746/Post-sanctions-deals-Iranian-firms-linked-Khamenei.html)

According to its Annual Report filed with the SEC for fiscal year 2015: "As a global organization, Novo Nordisk conducts business with customers in Iran, including the Government of Iran (the “GOI”). Novo Nordisk’s activities in Iran relate primarily to sales of pharmaceutical products and devices within the diabetes and obesity care and biopharmaceutical business segments. (https://www.sec.gov/Archives/edgar/data/353278/000117184316007795/f20f_021016.htm)

"Danish drugmaker Novo Nordisk, the world's top insulin supplier, expects to be ahead of the pack now nuclear sanctions are lifted in Iran, thanks to a continuous presence and a pre-emptive investment plan. The country is an attractive target for Big Pharma seeking to sell new medicines to its large and growing population, but going in at ground level and securing good relations with authorities will be key, industry executives say... 'With the sanctions being lifted, we can operate more freely,' Jakob Riis, Novo's head of marketing told Reuters at the World Economic Forum in Davos, Switzerland. The Danish company has maintained a staff of around 130 in Iran through the sanctions era and it now plans to more than double that, adding 160 additional staff, following a decision in September to invest 70 million euros ($76 million) on a factory in the country. 'Novo has been there throughout. Now there are a lot of companies lining up to get into Iran and I think we are going to benefit from having been there for a while,' Riis said... Other drugmakers are actively pursuing the opportunity. 'It's a significant country,' said Christophe Weber, CEO of Takeda, Japan's biggest drugmaker. 'We have a team assessing the situation.' ... Also ahead of the curve, Indian generics maker Cipla set up a manufacturing plant in Iran in 2014." (Reuters, “Novo aims to be ahead of pharma pack with Iran investment,” 1/21/2016) (http://www.reuters.com/article/us-iran-pharmaceuticals-idUSKCN0UZ266)

In addition, in 2016, NN Pars purchased land from a GOI-controlled land holding company in order to construct a manufacturing facility in Iran, and during 2018 made payments to the GOI-controlled land holding company for services and utilities required for construction and operation of its local manufacturing site. This relationship was terminated. For a brief period during 2018, NN Pars contracted with another entity which may have been GOI-controlled for utility and related services, but terminated the relationship with this entity. NN engaged a non-GOI-controlled entity for the delivery of utility and related services going forward. Novo Nordisk expects to invest approximately DKK 520 million over the course of five years to build the manufacturing facility, which will be used for assembly and packaging of insulin pens for use in Iran.

In 2014, Novo Nordisk sold its products and devices directly to two GOI-controlled pharmaceutical companies (Exir Pharmaceutical Co. (“Exir”) and Darou Pakhsh Trade Development Co., ) and contracted with two GOI-controlled pharmaceutical manufacturers to fill, formulate, and/or re-pack certain Novo Nordisk products (Exir and Darou Pakhsh Pharma. Chem. Co.,).

NNE Pharmaplan A/S, a wholly-owned affiliate of Novo Nordisk, has a contract with the Iranian Blood Research & Fractionation Company (“IBRF”) for the engineering, procurement and construction of a human plasma fractionation plant in Iran for the production of human plasma derivatives. IBRF was wholly owned by the Iranian Ministry of Health until April 2014, at which point 80 percent of the shares in IBRF were sold to private investors. NNE Pharmaplan also has a contract with SOHA Helal Iran Medical Devices Co., a GOI-controlled company, to provide raw materials for dialysis filters."

Novo Nordisk receives payments from, and makes payments to, certain GOI-owned or controlled banks with respect to the activities conducted by Novo Nordisk Pars. All payments by Novo Nordisk into and out of Iran are made through non-Iranian and non-sanctioned banks.

In 2015, Novo Nordisk A/S provided a small amount of diabetes product free of charge to Exir Pharmaceutical Co. (“Exir”), a GOI-controlled company. In addition, in 2015, Novo Nordisk entered into a memorandum of understanding with the Food and Drug Administration, an agency within the Ministry of Health and Medical Education of Islamic Republic of Iran, pursuant to which Novo Nordisk will invest approximately EUR 70 million over the course of five years to build a manufacturing facility in Iran. The facility will facilitate the production of insulin pens for use in Iran. There were no revenues or net profits to Novo Nordisk in 2015 in connection with this project.

According to its Annual report filed with the SEC for fiscal year 2017: "The purpose of Novo Nordisk’s Iran-related activities is to provide access to important and life-saving pharmaceutical products such as insulin and haemophilia products to patients in Iran, and to improve the healthcare of the Iranian people in accordance with Novo Nordisk’s access to care strategy. For that purpose, Novo Nordisk intends to continue these activities." (https://www.sec.gov/Archives/edgar/data/353278/000162828018001266/novo-b20xf12x31x17.htm)

"Novonordisk Iran, a world leader healthcare company, came as the second best place to work, thanks to a clear vision and an unparalleled work environment providing learning opportunities, development and evolution for the employees. “Our office is filled with energy, passion and momentum around bringing change for people living with chronic conditions in Iran,” said Ghobad Shahbazi, General Manager & Corporate Vice President for Novonordisk Iran." (January 2018) (https://www.businesswire.com/news/home/20180318005078/en/Sanofi-Novonordisk-Novartis-Iran-recognized-Places-Work)

According to its Annual Report filed with the SEC for fiscal year 2019: "Novo Nordisk Pars (“NN Pars”), a wholly-owned subsidiary of Novo Nordisk A/S located in Iran, contracts with five companies that may be controlled by the Government of Iran ("GOI") to distribute its products. NN Pars also sponsors educational programs and congresses organized by GOI-controlled medical universities, and hosts and/or engages as scientific delegates or lecturers/speakers health care professionals employed by these medical universities at similar programs in Iran and other locations. Additionally, NN Pars makes donations to GOI-controlled public health organizations focusing on diabetes awareness and policy. NN Pars receives payments from, and makes payments to, Iranian banks (some of which may be GOI-controlled) relating to the sales of pharmaceutical products and devices. NN Pars makes payments incidental to its ordinary business activities to Iranian government entities and entities that are or may be GOI-controlled, such as taxes, customs fees, insurance, product registration fees and telecommunications services expenses. (https://www.sec.gov/Archives/edgar/data/353278/000162828020001021/novo-b20xf12x31x19.htm)

The purpose of Novo Nordisk’s Iran-related activities is to provide access to important and life-saving pharmaceutical products such as insulins and haemophilia products to patients in Iran, and to improve the healthcare of the Iranian people in accordance with a key component of Novo Nordisk’s access to care strategy. For that purpose, Novo Nordisk intends to continue these activities."

The German subsidiary of NNE A/S, a wholly-owned subsidiary of Novo Nordisk A/S, previously sold raw materials and spare parts for production of dialysis filters and leucocyte filters and syringes to a GOI-controlled company. This business relationship, however, was wound down during 2018. NNE A/S currently holds an open receivable from such GOI-controlled entity related to such sales. In 2018, the Iranian customer tried to pay the amounts due, but the payment, which was routed through a GOI-owned bank in Europe, was never received by NNE A/S’s subsidiary. It was held up in transit after the United States imposed sanctions on the bank, and the payment was ultimately returned in 2019 to a GOI-owned bank in Iran. Each of those two GOI-owned banks was designated by the U.S. Government in 2018 under Executive Order 13224. It is uncertain when NNE A/S will receive payment from the Iranian customer with respect to the outstanding receivable.

The German affiliate of NNE A/S, a wholly-owned subsidiary of Novo Nordisk A/S, sold raw materials and spare parts for production of dialysis filters and leucocyte filters and syringes to a GOI-controlled company. This business relationship, however, was wound down during 2018. NNE A/S also contracts with a privately owned pharmaceutical manufacturer to provide engineering consulting services for an end-user that that is a basic and applied medical research centre which may be GOI-controlled. During 2018, however, no activities were conducted under this contract."

According to its Annual Report filed with the SEC for fiscal year 2014: "As a global organization, Novo Nordisk conducts business with customers in Iran, including the Government of Iran (the “GOI”). Novo Nordisk’s activities in Iran relate primarily to sales of pharmaceutical products and devices within the diabetes care and biopharmaceutical business segments. (https://www.sec.gov/Archives/edgar/data/353278/000117184315000625/f20f_020515.htm)

According to its Annual Report filed with the SEC for fiscal year 2016: In 2016, NN Pars purchased land from Barakat Industrial and Pharmaceutical Company (“Barakat”), a GOI-controlled land holding company, in order to construct a manufacturing facility in Iran. NN Pars will make monthly payments to Barakat for the duration of NN Pars’ ownership of the land, which Barakat will use to facilitate delivery of utility services to the site from GOI-owned utility companies. Novo Nordisk expects to invest approximately EUR 70 million over the course of the next five years to build the manufacturing facility, which will be used for assembly and packaging of insulin pens for use in Iran." (https://www.sec.gov/Archives/edgar/data/353278/000117184317000780/f20f_020917.htm)

Novo Nordisk’s gross revenue related to transactions with GOI-owned or controlled entities in 2012 was not in excess of DKK 400 million. Novo Nordisk does not allocate its net profit on a country-by-country or activity-by-activity basis, other than as set forth in Novo Nordisk’s consolidated financial statements prepared in accordance with IFRS as issued by the IASB; however, Novo Nordisk estimates that its net profit attributable to the transactions with the GOI discussed above would not exceed a small fraction of the gross revenue from such transactions.

In 2018, NN Pars contracted with a GOI-controlled company to serve as a contract manufacturer for biopharm products. However, no transactions took place under the contract and it was terminated. Currently only a Memorandum of Understanding remains in effect, and no activity is currently expected with respect thereto.

In addition, in 2016, NN Pars purchased land from a GOI-controlled holding company in order to construct a manufacturing facility in Iran. NN engaged a non-GOI-controlled entity in 2018 for the delivery of utility and related services in connection with the construction of the facility, and this entity provided services to NN Pars during 2019. Novo Nordisk expects to invest approximately DKK 520 million over the course of five years, which started in 2015, to build the manufacturing facility, which will be used for assembly and packaging of insulin pens for use in Iran.

Novo Nordisk Pars (“NN Pars”), a wholly-owned subsidiary of Novo Nordisk A/S located in Iran, contracts with four GOI-controlled companies (Exir, Ferdows Distribution Co., Darou Pakhsh Distribution Co. and Hedjat Distribution Co.) to distribute its products. NN Pars also sponsors educational programs and congresses organized by GOI-controlled medical universities, and hosts health care professionals employed by these medical universities at similar programs in Iran and other locations. Additionally, NN Pars makes donations to GOI-controlled public health organizations focusing on diabetes awareness and policy. NN Pars receives payments from, and makes payments to Iranian banks (certain of which are owned by the GOI and/or are designated under Executive Order 13224 or Executive Order 13382) relating to the sales of pharmaceutical products and devices.

According to its Annual Report filed with the SEC for fiscal year 2012: "As a global organization, Novo Nordisk conducts business with customers in Iran, including the Government of Iran (the “GOI”), as described under the section ‘Our business’ on pages 15-43 in the Annual Report 2012. Novo Nordisk’s activities in Iran relate primarily to sales of pharmaceutical products and devices within the diabetes care and biopharmaceutical business segments. Novo Nordisk has established a wholly-owned affiliate, Novo Nordisk Pars, in Tehran, Iran and has business dealings with a GOI-controlled local manufacturing partner that, under a license agreement with Novo Nordisk Pars, produces human insulins based on semi-finished products supplied by Novo Nordisk. A wholly-owned affiliate of Novo Nordisk, NNE Pharmaplan A/S, has entered into a contract with the Iranian Blood Research & Fractionation Company, which is owned by the Iranian Ministry of Health, for the engineering, procurement and construction of a human plasma fractionation plant for the production of human plasma derivates. Finally, Novo Nordisk conducts to a limited extent clinical research studies and trials, in collaboration with certain Iranian state universities, that are related to Novo Nordisk’s diabetes care and biopharmaceuticals businesses. (https://www.sec.gov/Archives/edgar/data/353278/000120864613000047/c107892.htm)

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