Robert W. Jones Pfizer, Inc. 235 €,42™ Street, Fl. 11 New York, NY 10017 1 AMIES9 July 7, 2017 Ohio Department of Rehabilitation and Correction ATTN: Gary Mohr, Director 770 West Broad Street Columbus, OH 43222 RE: Request for Return of Pfizer Products for Use in Lethal Injection for Capital Punishment Dear Director Mohr: It has come to our attention that the Ohio Department of Rehabilitation and Correction has acquired midazolam, ‘otassium chloride, and rocuronium bromide for use in an uocoming execution by lethal injection. While we do not believe these products were manufactured by Hospira or Pfizer ("Pfizer"), in an abundance of caution, we want to restate our policy objecting to the misuse of Pfizer products in lethal injection and, if they were manufactured by Ptizer, seek their immediate return In an August 2016 and February 2017 letter, Pfizer notified the Ohio Department of Rehabilitation and Correction of our objection to the use of our products in the lethal injection process for capital punishment and our implementation of an enhanced restricted distribution protocol for eleven Restricted Products: hydromorphone, midazolam, pancuronium bromide, potassium chloride, propofol, rocuronium bromide and vecuronium bromide, atracurium besylate, etomidate, potassium acetate, and potassium phosphates. Under our policy, these products will not to be sold to correctional facilities or other affiliated organizations where they may be misused for lethal injection. A copy of the Pfizer policy on Restricted Products is enclosed and can be accessed at http://www. pfizer com files/b26/GlobalPolicyPaperlethalinjection.pdf. Pfizer will continually review its product offerings and update this policy as necessary to prevent the misuse of our products in lethal injection protocols As in the August and February letters, we request that you return to us any Pfizer manufactured Restricted Product listed above in your possession. Pfizer will provide full credit for any returned Restricted Product regardless of from where you purchased it, Return instructions are enclosed for your convenience. Enclosed with this letter is a list of the Restricted Products and their NDCs to assist with your identification of them. If you seek to use or purchase Restricted Product to address a legitimate medical need, we request that your Medical Director contact Jerry Boesch (Director, Commercial Services & Analysis) at (224) 212-2462 or jerry boesch@pfizer com ‘Thank you for your attention to this matter. Respectfully, Robert Jones Vice President US. Government Relations Encl.(04009-8062-01_| AMIDATE 2MG/ML 10 ML AMPULE [U}, (00409-6695-01__| AMIDATE 2MG/ML 10 ML VIAL [V] (00409-6695-01 __| AMIDATE 2MG/ML 10 ML VIAL IV] (00409-6695-02 | AMIDATE 2MG/ML 20 ML VIAL (V) (00409-6695-02 __| AMIDATE 2MG/ML 20 ML VIAL IVI (00409-8060-29 | AMIDATE USP 20M ABBO! (00409-6695-10 | Amidate USP 2mg/ml 10mL FTV NOVAPLUS (00809-6695-20 | Amidate USP 2mg/ml 20mL FTV NOVAPLUS (00409-1105-02 | ATRACURIUM INI 1OMG/ML IN JOML VIAL (00409-1109-01 | ATRACURIUMINI JOMG/ML IN SMIL VIAL (00409-1283-10 __| HYDROMORPHONE HCL INI USP Ci IMG ISECURE SYR (00409-1283.31 | HYDROMORPHONE HCL IN USP Cll MG 1ML/2ML CPLL SLP (00809-2552-01__ | HYDROMORPHONE HCL NJ USP Cll MG/ML IML AMP (00809-1312.30 | HYDROMORPHONE HCL IN) USP Cll 2MG IML CIT LL SLMPK (00809-1312-10 _| HYDROMORPHONE HCL INJ USP Cll 2MG ISECURE SYR (00409-3356-01 | HYDROMORPHONE HCL IN] USP Cll 2MIG/ML IML AMP (00409-3365-01 | HYDROMORPHONE HCL IN) USP Cll 7MG/ML IML FTV (00409-1304.31 | HYDROMORPHONE HCL INJ USP Cll 4MG/ML IML CITLLSLP (00409-2634.01 | HYDROMORPHONE HCl INJECTION USP Cll 1OMG/ML IML (00409-2634-50 | HYDROMORPHONE HCL INJECTION USP Cll 1OMG/ML SOML (00409-2634.05 __| HYDROMORPHONE HCL INJECTION USP Cll TOMG/ML SML (00408-2540.01 | HYOROMORPHONE HYDROCLORIOE INJ USP Cll aMG/ML2ML (00409-1283-05 | HYDROMORPHONE ISEC 1MG/ML 0.SMLI0 (00403-2306-62 __| MIDAZOLAM HCL INI CIV (PF) MG/ML 2ML CPJ LL SLMPK. (00409-2305-17 __| MIDAZOLAM HCL INI CIV (PF) IMG/NiL 2MU FTV (00409-2305-21 | MIDAZOLAM HCLINI CIV (PF) IMG/ML 2ML FTV NOVATION (00409-2307-60 __| MIDAZOLAM HCL INI CIV (PF) SMG/ML IML CP) LL SLMPK. "00409-2306-12 _| MIDAZOLAM HCL IN) CIV PF AMG/ML 2MIL ISECURE SYR V2, (00409-2305-02 _| MIDAZOLAM HCL IN, CIV (PF) MG/ML 2ML FIV (00409-2305-05 __| MIDAZOLAM HCL INI, Civ (PF) MG/ML SML FTV (00409-2308-01 | MIDAZOLAM HCL IN, CIV (PF) SMG/ML IML/2ML FTV (00409-2308-02 _| MIDAZOLAM HCL NI, CIV [PF] SMG/ML2ML FTV (00409-2587-05 __| MIDAZOLAM HCLINI, CIV IMG/ML LOML FTV (00409-2587-53 | MIDAZOLAM HCL NI, CIV IMG/ML 10ML FTV NOVATION (00409-2596-05 | MIDAZOLAMHCLIN, CIV SMG/ML1OML FTV (00409-259653 | MIDAZOLAM HCLINi, CIV SMG/ML 10ML FTV NOVATION (00409-2596-03 | MIDAZOLAM HCL IN, CIV SMG/ML SML FTV (00409-2595-52 __| MIDAZOLAM HCL iN, CIV SMG/ML SML FTV NOVATION (00409-2305-49 | MIDAZOLAM HCL IN CV PF) IMG/ML 2ML FTV NOVATION| (00409-2305-50 | MIDAZOLAM HCL INI,CIV (PF) 1MG/ML SML FTV NOVATION (00409-2308-50 __| MIDAZOLAM HCL INI,CIV (PF) SMG/MIL 2ML FTV NOVATION(00409-2308-29 | MIDAZOLAM HCL INJCIV(PFISMG/ML 1ML/2ML FTV NOVATN, (00409:2306-22 __| MIDAZOLAM HYDROCHLORIDE INI USP 2MG/2MLISEC SYR (00409-2307-21__| MIDAZOLAM HYDROCHLORIDE IN) USP SMG/IMLISEC SYR (00409-8686-01_| PANCURONIUM BROM IDE INJ (1. MG/ML) 10 ML FTV (00409-1513-02 _| POT CLINI 500 MEQ TOT BULK ADD SOLUTION 250M (00409-3294-25 _| POTASSIUM ACET 2MEQ SOML FTV NOVAPLUSIU] (00209-8183-25 _| POTASSIUM ACET 4oMEQZ0ML FTV NOVAPLUS[U] (00409-8183-01 __| POTASSIUM ACETATE 4OMEQ 20/30ML IU] (00409-6635-01__| POTASSIUM CLIN) 10MEQ SMiL/1OML FTV (00409-6651.06 | POTASSIUM CLIN] Z0MEQ 1OML IN 20ML FTV (00409-6636-02 __| POTASSIUM CL INI 30MEQ 15ML/30ML FTV (00409-6653-05 | POTASSIUM CLINI 40MEG 20ML IN 30ML FTV, (00805-7295-17 __| POTASSIUM PHOSPHATES INJECTION, USP 45N1M 15/20ML FTV (00209-7295-01_| POTASSIUM PHOSPHATES INJECTION, USP SMP (00409-3298-51 | POTASSUM ACETATE 2MEQ SO ML (U] (00209-4699-24 | PROPOFOL 1% INJECTABLE EMULSION 100M SDV (00409-8699-30 | PROPOFOL 1% INJECTABLE EMULSION 20ML SOV, (00409-8699-33 | PROPOFOL 1% INJECTABLE EMULSION SOML SOV (00409-95580 | ROCURONIUM BROMIDE IN 10 MG/ML 10ML FTV NOVATION (00409-9558-10 | ROCURONIUM BROMIDE IN) 10 MG/ML 10ML FTV STANDARO (00808-9558-89 _| ROCURONIUM BROMIDE IN) 10 MG/ML SNL FTV NOVATION (00809-9558-05 | ROCURONIUM BROMIDE IN) 1OMG/ML SML FTV STANDARD (00409-1632-01__| VECURONIUM BROMIDE FOR INJ 1OMG 10MIL FIV. (00409-1632-49 _| VECURONIUM BROMIDE FOR INJ JONG 10ML FTV NOVATION. (00409-1634-01 _| VECURONIUM BROMIDE FOR IN] 20MG 25M FTVFrom: Mohr, Gary Sent: Saturday, July 8, 2017 7:36 AM To: Gray, Stephen Subject: Fwd: Request for Return of Pfizer Products for Use in Lethal Injection for Capital Punishment Attorney client communication Sent from my iPhone Begin forwarded message: From: "Robert W. Jones" Date: July 7, 2017 at 10:07:14 PM EDT To: "Gary.mohri@odre.state.oh.us" Subject: Request for Return of Pfizer Products for Use in Lethal Injection for Capital Punishment Robert W. Jones Pfizer, inc. 235. 42" Street, Fl. 11 New York, NY 10017 July 7, 2017, ‘Ohio Department of Rehabilitation and Correction ATTN: Gary Mohr, Director 770 West Broad Street Columbus, OH 43222 jequest for Return of Pfizer Products for Use in Lethal Injection for Capital Pur Dear Director Mohr: It has come to our attention that the Ohio Department of Rehabilitation and Correction has acquired midazolam, potassium chloride, and rocuronium bromide for use in an upcoming execution by lethal injection, While we do not believe these products were manufactured by Hospira or Pfizer ("Pfizer"), in ‘an abundance of caution, we want to restate our policy objecting to the misuse of Pfizer products in lethal injection and, if they were manufactured by Pfizer, seek their immediate return. In an August 2016 and February 2017 letter, Pfizer notified the Ohio Department of Rehabilitation and Correction of our objection to the use of our products in the lethal injection process for capital punishment and our implementation of an enhanced restricted distribution protocol for eleven Restricted Products: hydromorphone, midazolam, pancuronium bromide, potassium chloride, propofol, rocuronium bromide and vecuronium bromide, atracurium besylate, etomidate, potassium acetate, and 1potassium phosphates. Under our policy, these products will not to be sold to correctional facilities or ‘other affiliated organizations where they may be misused for lethal injection. A copy of the Pfizer policy ‘on Restricted Products is enclosed and can be accessed at http://www.pfizer.com/files/b2b/GlobalPolicyPaperLethalinjection.pdf. Pfizer will continually review its product offerings and update this policy as necessary to prevent the misuse of our products in lethal Injection protocols. As in the August and February letters, we request that you return to us any Pfizer manufactured Restricted Product listed above in your possession. Pfizer will provide full credit for any returned Restricted Product regardless of from where you purchased it. Return instructions are enclosed for your convenience. Enclosed with this letter is a lst of the Restricted Products and their NDC to assist with your identification of them. if you seek to use or purchase Restricted Product to address a legitimate medical need, we request that your Medical Director contact Jerry Boesch (Director, Commercial Services & Analysis) at (224) 212-2462 or jerry.boesch@pfizer.com._ ‘Thank you for your attention to this matter. Respectfully,Tee Eanes '04009.8062.01 | AMIDATE 2MG/ML 10 ML AMPULE [UI (0109-6695.01 | AMIDATE 2MG/ML 10 ML VIALV] 00100-6695.01 | AMIDATE 2MG/ML 10 MLVIALIV (00108-6695.02 | AWIDATE MG/ML 20 MLVIAL V) "00100-6695-02 | AMIDATE 2MG/I-20 ML VIAL) (003088060.29 | AMIDATE USP 20M ABHO! (00105-6695-10 | Aridate USP 2mg/ml 10M FIV NOVAPLUS (00400 6695:20 | Amidate USP mg/ml 20m FIV NOVAPLUS (004001105-02 | ATRACURIUM IN TOMG/MILIN TON VIAL (00409-1109-01 | ATRACURIUMIN JOMG/MLIN SML VIAL (004091283-10 | HYOROMORPHONE HCL IN] USP Cll IMG ISECURE SYR (00409-1283-31___| HYDROMORPHONE HCLINJ USP GIANG IBML/2ML CPLL SUP (00109.2552-01__| HYDROMORPHONE HCL INI USP Cll IMG/NL IML AMP (00109-1312-30 | HYDROMORPHONE HCL INI USP IMG IMI CIT UL SLMPK. (00109-1312-10 | HYDROMORPHONE HCLINI USP CII2MG ISECURE SYR (00409-3356.01 | HYDROMORPHONE HCLINI USP Cl 2MIG/ML IML AMP, (00109-3365 01 | HYOROMORPHONE CLINI USP CI 2MG/ML AMLFTY "00908-1304-31 | HYDROMORPHONE HCLINI USP Cl aMG/RAL ANAL CITLL SL 00409-2634.01 | HYOROMORPHONE HCL INJECTION USP Ci TOMG/ML_IME 100109-2634-50___| HYDROMORPHONE HCL INJECTION USP II 1OMG/MU SOM 100109-2634-05 | HYDROMORPHONE HCL INJECTION USP ll 10MG/ML SNL ‘00408-2580-01 | HYDROMORPHONE HYDROCLORIDE IN USP Cll MG/ML IML (008091283-05 | HYDROMORPHONE ISEC IMG/MLOSMLI0 (00409-2306-62 | MIDAZOLAM CLINI CI (PF) IMG/ML2ML CPI L SIMPK. (00405-2305-17 | MIDAZOLAM HCLINI CIV (PF) AMG/ML2MLFTV, (00409-2305:21___| MIDAZOLAM HCLINI CIV (PF) MG/ML 2ML FTV NOVATION (00409:2307-60__| MIDAZOLAM HCLINI CIV [PF) SMG/MU TMU CPI IL SUMP, (00409°2306-12 | MIDAZOLAM HCLINICIV PF 1MG/ML2MLISECURE SYR V2 (00409:2305:02___ | MIDAZOLAM HCLINI, CIV (PF) MG/ML 2ML FTV (00409-2305-05 | MIDAZOLAM HCLIN), CIV (PF) IMG/MLSMLFTV '00409-2308-03 | MIDAZOLAM HELIN), CV (PF) MG/ML IML/2ML FTW (00409-2308-02 __ | MIDAZOLAM HCLIN), CV (PF) MG/ML DML FTV (00409-2587-05 | WIDAZOLAM HELIN), CIV MG/ML TOML FTV (00409-2587.53 | MIDAZOLAM HCL IN), CIV IMG/ML 1ONIL FTV NOVATION (00409-2596.05 __ | MIDAZOLAM HCL IN), CIV SMIG/MUTONL FTV 100409-2596°53 | MIDAZOLAM HCL IN), CIV SMG/ML 10M FTV NOVATION 100409.259603 | MIDAZOLAM HCL IN), CIV SMG/MALSMUFN 100409-2596.52 | MIDAZOLAM HCL INI, CIV SMG/MLSMLFTV NOVATION 10409-2305-49 | MIDAZOLAM HCL IND IV (PF) IMG/ML 2M FTV NOVATION 100409-2305-50 | MIDAZOLAM HCL IN) CIV (PF) IMG/ML SMI FIV NOVATION {00409-2308 50 | MIDAZOLAM HCL INI IV [PF] SMG/MI 2M FIV NOVATION[wea] [00409-2308-49 | MIDAZOLAM HCL INL CIV|PF]SMG/ML IMLU/2ML FTV NOVATN [00109-230622 | MIDAZOLAM HYDROCHLORIDE INIUSP 2MG/2NL SEC SYR [00108-2307-21 | MIDAZOLAM HYDROCHLORIDE INI USP SMG/IMLISEC SYR (00100.-4696-01 | PANCURONIUM BROMIDE INI (1, MG/MU) 10 ML FIV [00108:1513-02 | POT CLINI S00 MEQ TOT BULK ADD SOLUTION 250M ‘0008 3294-25 | POTASSIUM ACET 2MEQ SOM FTV NOVAPLUSIU] (00109,8183.25 | POTASSIUM ACET AOMEGZOML FTV NOVAPLUSIUL ‘00909-8183-01 | POTASSIUM ACETATE 4OMEG 70/30N4 [UL (00109-6535-01 | POTASSIUM CLINY 10MEG{5MI/IOML FTV (00409-6651-06 | POTASSIUM CLIN 20MEQ.1OMLIN 20ML FTV (00409-6636-01 | POTASSIUM CLIN) 3OMEQ 1SML/30ML FIV (00409 6653-05 | POTASSIUM CL IN AOMEQ,20MILIN 30ML FIV (004097295-17 | POTASSIUM PHOSPHATES INJECTION, USP ASMM 15720MU FTV (00109-7295-01 _ | POTASSIUM PHOSPHATES INJECTION, USP aSMIMP (004003294:51 | POTASSUM ACETATE 2MEQ SO ML[U] (00409 4599-24 | PROPOFOL 16 INJECTABLE EMULSION 1O0MU SOV (00400-4599-30 | PROPOFOL 15 INIECTAGLE EMULSION 20M SOV (00409-4599-33 | PROPOFOL 1% INJECTABLE EMULSION SOMIL SDV (00109-9558-50 | ROCURONIUM BROMIDE INI TO MG/ML TOMI FIV NOVATION (00400,9558-20 | ROCURONIUM BROMIDE INI 10 MG/ML 1OMI FIV STANDARD (00409-9558-49 | ROCURONIUM BROMIDE INI 10 MG/ML SMI FIV NOVATION (00809.9558-05 | ROCURONIUM BROMIDE INI TOMG/NL SNL FTV STANDARD (004091632-01__ | VECURONIUM BROMIDE FOR NI 1OMG 10ML FTV (00409-1637-49 | VECURONIUM BROMIDE FOR NI OMG 10M FTV NOVATION (0809163401, VECURONIUM BROMIDE FOR INI 20MG 2501 FTVDIRECTOR'S OF Fic: Ee B/BRAUN we ee, 211 JUL-1 wys1o:52 Gommunieatone B, Braun Medleal Inc, 824 Twelth Avenue Bethlehem, PA 18018 Telephone: (610) 691-5400 ext 4276 7 ‘Sent via Federal Express 1-614-387-0588 July 7, 2017 : Gary Mobr ‘ Director Ohio Department of Rehabilitation and Correction 77 W. Broad Street Columbus, OF 43222 Dear Mr. Mohr, Ithas come to the attention of B. Braun Medical Inc. (“B.Braun’) that the Ohio Department of Rehabilitation and Correction (‘ODRC”) has procured certain vials of 250ml Potassium Chloride (“KC!1 Vials"). KCl Vials are used for several therapeutic purposes, and it is B.Braun's intent that its products be used solely to promote a patient's health and well- being. However, it is B.Braun’s understanding that KCI Vials might also be used by a correctional facility in combination with other drug substances for the purpose of performing lethal injections to carry out capital punishment sentences. “According to our records, BBraun has had no direct or indirect sales of any KCI Vials to the ODRC. In an effort to assess our supply chain, please confirm whether your supply of KCL ‘Vials are B.Braun-manufactured products. If so, please advise from what source your supply of such KCI Vials originated. We would appreciate a reply to this inquiry by July 21, 2017. Thank you very much for ‘your prompt attention to and cooperation with this request. Sincerely, Cota bible. Constance Walkeree are Delivering quality pharmaceuticals Gary.mohe@odre state oh. VIA FAX 614-752-1171 July 7,2017 Gary €. Mohr, Director ‘Ohio Department of Rehabilitation and Corrections 770 West Broad Street Columbus, Ohio 43222 ear Director Mohr, We understand that the State of Ohio has scheduled executions by lethal injection starting later this month and that the sedative Midazolam will be used as part ofthe execution protocol. As a manufacturer of Midazolam, ‘we are aware of the risk that this product may be diverted for use in lethal injection. In December we wrote to ‘you-along with the Governor and Attorney General in every US state in which capital punishment is, permitted—to remind you of our corporate policy on this matter. In short, we strongly abject to the use of any (of our products for capital punishment. Inthe ceferenced letter we also requested your support in upholding our policy and our values, Given the scheduled executions and the State's planned protocol, we request that you please confirm whether ‘the Ohio Department of Rehabilitation and Corrections isin possession of West-Ward's Midazolam, If s0, we ask that you immediately return this product. \We are committed to ensuring that Midazolam—as wel as any of our other products, including Phenobarbital Sodium, Etomidate and Hydromorphone Hydrachloride—are used only for saving and improving patients lives. [As such, we have implemented a number of controls with respect to the sale of products that we know are useg in lethal injection protocols, For example, one such contro is to require that these products are only supplied to pre-authorized customers who agree in writing not to sell them to Departments of Correction or other entities ‘that intend to use them for lethal injection ‘sa significant employer in the State, and as a company committed to enhancing the lives of not oniy our nearly 1,200 Ohio employees, but all Ohioans, we are committed to playing an important role in manufacturing much needed products to improve health. Given cur commitment to the State, we would expect that the State would bbe a strong partner in upholding our policies and our values, ‘Therefore, in ight of the imminent executions later this month, we would respecttully request a response by ‘end of day Tuesday, July 12, 2017. Thank you for your prompt attention to this serious matter. Sincerely, CEO West-Ward Pharmaceuticals Corporate Headquarters Wer Warderamescate Cor, {ex naieal Hay Eatonton, NOM 206 Teer sansoa | Fora scone rennwest-wardcom7 Sandor ‘00 cage Roae West Peter, NJ 06540 USA, vow Sarde com SANDOZ‘ Phone +1.509-627-9500 July 10, 2017 VIA EMAIL and FEDEX Governor John Kasich 77 South High Street 30th Floor Columbus, OH 43215 Fax: 614/466-9354 CIO Chief of Staff Beth Hansen (beth hansen@governor.ohio.gov); Assistant to the Chief of Staff Margaret Rochon (margaret.rochon@governor.ohio. gov) Attorney General Mike DeWine State Oice Tower 30 E. Broad St. Columbus, OH 43286-0410 CIO Communications Director Lisa Peterson: (lisa.peterson@OhioAttorneyGeneral.gov) Director Gary Mohr Ohio Department of Rehabilitation and Correction 770 West Broad Street Columbus, Ohio 43222 614-752-1150 CIO Executive Assistant Melissa Adkins (melissa adkins@odrc state.oh.us) Dear Governor Kasich, Attorney General DeWine, and Director Clarke: Ithas been brought to our attention that in December of 2016 the Ohio Department of Rehabilitation and Correction (ODRC) acquired quantities of the drug rocuronium bromide from an as-yet undisclosed supplier, with the intention of using this product in lethal injection executions beginning on July 26, 2017, ‘Sandoz Inc. is an FDA-approved manufacturer of rocuronium bromide for the US market, ‘Sandoz, @ division of Novartis, is a global leader in generic, biosimilar and other value added ‘medicines which we develop, manufacture and distribute with the intention of saving and improving people's lives,We write to communicate in the clearest possible terms that Sandoz objects to the use of ‘Sandoz rocuronium bromide or any other Sandoz product in the administration of capital punishment. To ensure our products are not purchased for this purpose, Sandoz has imposed a system of strict distribution controls designed to prohibit the sale of its medicines to correctional facilites or otherwise for use in connection with lethal injection executions. These Controls align with prevailing industry standards in the pharmaceutical sector and reflect our ‘company's strict palicy on ensuring the appropriate use of our medicines. Specifically, Sandoz has entered into contractual agreements with our distributors which stipulate that the products in question are to be sold exclusively to medical users such as hospitals, consistent with approved product labeling. VWe also prohibit resale to parties such as correctional facilities or any other party intending to use or distribute the product for purposes. of lethal injection. Thus, if OCDRC has obtained rocuronium bromide manufactured by Sandoz with the intent to use it in executions, ths isin clear breach of the contracts Sandoz has. entered into with its customers, ‘The uncertainty surrounding whether our products have been acquired by Ohio for these executions impedes our ability to enforce our company policies, protect our contractual rights, and preserve the integrity of our business relationships. On behalf of Sandoz, | request that the ODRC immediately confirm whether it has acquired Sandoz rocuronium bromide for use in lethal injection executions. Further, if Ohio has purchased Sandoz’s rocuronium bromide, we request immediate return ofthis and any other Sandoz products that have been obtained for this purpose, in exchange for a full refund. Given the gravity and urgency of this matter, we respectfully request a reply to this letter no later than the close of business on July 19, 2017, We look forward to receiving your response. Sincerely, Michelle T. Quinn Vice President, General Counsel, North America Sandoz Inc. Ceo Peter Goldschmidt President, Sandoz US, Head, North America Wendy Sussman Vice President, Public AffairsSANDOZ 3!" {eo cotege Road West Pincton, NJ 08540 USA Phone +.609-6278800 July 10,2017 fee oF tna dovsenor i RECEWED MIA EMAIL and FEDEX: JUL 112017 Governor John. Kasich Governor John Kasich 77 South High Street 30th Floor Columbus, OH 43215 Fax: 614/468-0354 CIO Chief of Staff Beth Hansen (beth hansen@governor.chio.gov); Assistant to the Chief of ‘Staff Margaret Rochon (margaret rochon@governor.chio.gov) ‘Attorney General Mike DeWine State Office Tower 30. Broad St. Columbus, OH 43266-0410 C/O Communications Director Lisa Peterson: (isa peterson@OhioAttorneyGeneral gov) Director Gary Mohr Ohio Department of Rehabilitation and Correction 770 West Broad Street Columbus, Ohio 43222 614-752-1150 C/O Executive Assistant Melissa Adkins (melissa.adkins @odre. state oh.us) ‘Dear Governor Kasich, Attorney General DeWine, and Director Clarke: Ithas been brought to our attention that in December of 2016 the Ohio Department of Rehabilitation and Correction (ODRC) acquired quantities of the drug rocuronium bromide: from an as-yet undisclosed supplier, withthe intention of using this product in lethal injection executions beginning on July 26, 2017. ‘Sandoz Inc. is an FDA-approved manufacturer of racuronium bromide for the US market Sandoz, a division of Novartis, is a global leader in generic, biosimilar and other value added ‘medicines which we develop, manufacture and distribute with the intention of saving and improving people's lives,We write to communicate in the clearest possible terms that Sandoz objects to the use of Sandoz rocuronium bromide or any other Sandoz product in the administration of capital Punishment. To ensure our products are not purchased for this purpose, Sandoz has imposed 2 system of strict distribution controls designed to prohibit the sale ofits medicines to correctional faciities or otherwise for use in connection with lethal injection executions. These controls align with prevailing industry standards in the pharmaceutical sector and reflect our company's strict policy on ensuring the appropriate use of our medicines, Specifically, Sandoz has entered into contractual agreements with our distributors which stipulate that the products in question are to be sold exclusively to medical users such as hospitals, consistent with approved product labeling. We also prohibit resale to parties such as Correctional facilities or any other party intending to use or distribute the product for purposes. Of lethal injection. Thus, if ODRC has obtained rocuronium bromide manufactured by Sandoz with the intent to use it in executions, this is in clear breach of the contracts Sandoz has centered into with its customers, ‘The uncertainty surrounding whether our products have been acquired by Ohio for these ‘executions impedes our abilty to enforce our company policies, protect our contractual rights, and preserve the integrity of our business relationships. On behalf of Sandoz, | request that the ODRC immediately confirm whether ithes acquired Sandoz rocuronium bromide for use in lethal injection executions. Further, if Ohio has purchased Sandoz’s rocuronium bromide, we request immediate return of this and any other Sandoz products that have been obtained for this purpose, in exchange for a full refund, Given the gravity and urgency of this matter, we respectfully request a reply to ths letter no later than the close of business on July 19, 2017. We ok nuendo acon ya ipa Sinerty Abb lhe (iclablé : ite T Guan Vice President, General Counsel, North America Sandoz Inc. we Ce: Peter Goldschmidt President, Sandoz US, Head, North America Wendy Sussman’ Vice President, Public Affairspiveu on Lll/Mylan Better Hes DIT JUL 17 AN 9:54 fore Boer tons on an aden Soest et use Sr? au es me Teacies ene Via Federal Express July 14, 2017 Gary C. Mohr, Director Ohio Department of Rehabilitation & Corrections 770 West Broad Street Columbus, OH 43222 RE: Acquisition and Use of Rocuronium Bromide Dear Director Mohr: Mylan is a pharmaceutical manufacturer that markets and sells hundreds of pharmaceutical products in the United States, including a small number of products that have been sought by state departments of corrections for use in lethal injection procedures, Mylan distributes its products ‘only for prescription or administration by healthcare providers consistent with their approved labeling and applicable standards of care. We do not market our products for unapproved or off label use, of which lethal injection would constitute an extreme example, Indeed, Mylan has taken proactive steps to prevent its products from being sold or acquired for such purposes. Mylan has been informed that the Ohio Department of Rehabilitation & Corrections (“DRC’) has obtained a quantity of rocuronium bromide for use in lethal injections, though we do not know whether it is Mylan-manufactured product. As one of the manufacturers approved to sell that product in the U.S., Mylan takes seriously the possibility that one of its products may have been diverted for a use that is inconsistent with its approved labeling. We certainly appreciate that the DRC may purchase Mylan products for therapeutic purposes, Nevertheless, we request your assurances that the DRC has not acquired Mylan’s rocuronium bromide or any other Mylan product for the purpose of administering lethal injections. If the DRC has, in fact, obtained a Mylan product for use in lethal injection (whether rocuronium bromide or any other product), we insist that you (a) refrain from making such use of ur products and (b) contact us immediately to arrange for the retum of all such products in your possession (at our cost and expense). ‘A prompt reply would be appreciated. Sincerely, oS Brian S. Roman Global General Counsel