Global Cure Medicine LLC v. Alfa Pharma LLC

Filing 68

PRETRIAL ORDER signed by Judge Marsha J. Pechman. (PM)

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Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 1 of 30 1 Hon. Marsha J. Pechman 2 3 4 UNITED STATES DISTRICT COURT WESTERN DISTRICT OF WASHINGTON 5 6 7 GLOBAL CURE MEDICINE, LLC A foreign limited liability company, 8 Plaintiff 9 Case No: 19-cv-00588-MJP v. 10 11 12 PRETRIAL ORDER ALFA PHARMA, LLC, a Washington limited liability company, and Suliman AlFayoumi, a Washington resident, Defendants. 13 14 JURISDICTION 15 Jurisdiction is vested in this court by virtue of: 28 U.S.C. §1332, diversity of citizenship, and the matter in controversy exceeds the sum of $75,000.00 exclusive of interest and costs. The 16 Plaintiff is a foreign limited liability company and has its principal place of business in the Sultanate of Oman. The owners of Plaintiff are all citizens and domiciliaries of the Sultanate of 17 Oman. The Defendant limited liability company AlfaPharma is a State of Washington entity. AlFayoumi is a U.S. citizen domiciled in Washington State in King County, and the sole owner and 18 Manager of AlfaPharma. 19 CLAIMS AND DEFENSES 20 21 22 23 The plaintiff will pursue at trial the following claims: 1. Defendant Alfa Pharma, LLC is liable to Plaintiff for breach of contract and breach of express and implied warranties. 2. Both Defendants are liable to Plaintiff for fraud. PRETRIAL ORDER - 1 Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 2 of 30 1 The Defendants will pursue the following defenses 2 1. Defendants will contend that Plaintiff has not met its burden of proof. 3 2. Defendants will pursue an affirmative defense of failure to mitigate damages. 4 ADMITTED FACTS 5 6 7 8 9 10 11 The following facts are admitted by the parties: 1. Plaintiff Global Cure Medicine, LLC (“GCM”) seeks to recover damages stemming from the purchase of pharmaceuticals from Defendants Alfa Pharma LLC (“AlfaPharma”) and Suliman Al-Fayoumi. GCM is a pharmaceutical importer located in Oman. AlfaPharma is a pharmaceutical wholesaler/distributor located in Renton, Washington—wholly owned and solely operated by Defendant Al-Fayoumi. 2. In September 2016, the Ministry of Health of the Sultanate of Oman requested proposals 12 to supply the Royal Hospital with vials of injectable solution Eculizumab from Alexion 13 Pharmaceuticals, Inc., headquartered in Boston, Massachusetts. 14 3. The brand name for the drug is “Soliris.” Alexion developed, manufactures, and markets 15 the drug, which is protected by patent. It is the first and only therapy for the treatment of 16 atypical hemolytic uremic syndrome (“aHUS”), a blood disease characterized by low 17 levels of circulating red blood cells. Soliris is a life-saving medication for aHUS, but a 18 single dose containing an impurity, or an improper quantity of the active ingredient could 19 pose immediate life-threatening danger. Soliris was the most expensive drug in the world 20 in 2010 and the fourth most expensive medication in the United States in 2015. 21 22 23 PRETRIAL ORDER - 2 Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 3 of 30 1 4. On November 5, 2016, Alfa Pharma sent a quotation to provide GCM with 150 units of 2 Soliris 300 mg vials at a cost of $705,000.00 USD, for the Royal Hospital. The quotation 3 contains a “Guarantee that all items will be delivered to destination in excellent 4 condition,” and that “Original Certificates of Analysis [‘COA’] & Certificates of Origin 5 [‘COO’] will be supplied.” The COA establishes authenticity and manufacturing date of 6 the product and the COO establishes its origin. 7 5. Both parties were aware of counterfeit Soliris medications in the market at that time. 8 6. Defendants sent a formal quotation for 75 vials of Soliris and requested a Purchase Order 9 from GCM. The email stated, “We guarantee delivery within 2-3 weeks of order 10 confirmation as we currently have most of the order volume in stock (i.e., around 60 11 vials). We can’t however continue to hold the stock for much longer without a firm 12 order.” 13 14 15 7. Although AlfaPharma had a warehouse in Renton, it did not hold any of the vials of Soliris physically at its warehouse in Renton. 8. GCM issued purchase orders to AlfaPharma for collectively 200 units of Myozyme for 16 $126,000.00 and 75 units of Soliris for $352,500 (two shipments at $178,600+$173,900) 17 to be sourced respectively from Genzyme, U.S.A and Alexion, U.S.A., with minimum 18 expiration dates of 1 year, and to be accompanied by their COA and COO. 19 9. AlfaPharma confirmed the order with an Order Confirmation for 75 units of Soliris that 20 again stated “Original Certificates of Analysis & Certificates of Origin will be supplied” 21 and that the expiry dates would be “Min 1 year from delivery.” The order confirmation 22 was sent with a document called “General Terms & Conditions” and dated February 24, 23 2017. PRETRIAL ORDER - 3 Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 4 of 30 1 10. AlfaPharma invoiced GCM in accordance with the purchase orders and again stated on 2 its invoice that “Original Certificates of Analysis & Certificates of Origin will be 3 supplied” and that the Expiry Date would be “Min 1 year from delivery.” 4 11. GCM through its affiliate Global Industrial Services, LLC paid AlfaPharma $353,850 5 (which included a $1,350 shipping fee) for the Soliris plus $12,400 for stainless steel 6 containers for the medication for a total $366,250 USD. 7 12. A first shipment of Soliris in fulfillment of a majority of the 75 vials ordered by GCM 8 arrived in Oman on or around April 23, 2017, from a source in Turkey. Another shipment 9 arrived in Oman to complete fulfillment of the order for 75 vials on or around May 11, 10 11 2017 from the same source in Turkey. 13. The vials of Soliris provided to fulfill GCM’s order did not come with adequate 12 documentation. For example, some of the batches delivered had no Certificate of 13 Analysis while others had inconsistencies and irregularities. 14 14. Soliris must be used before its expiration date. 15 15. GCM supplied 40 units of the Soliris to the Royal Hospital at the end of April 2017. The 16 Royal hospital used two of the vials of Soliris supplied to it by GCM. GCM sent the 17 documentation it received from AlfaPharma, including the certificates of analysis, to the 18 Royal Hospital. The Royal Hospital rejected the documentation that was supplied by 19 20 GCM as inadequate to authenticate the Soliris according to its requirements and withheld payment to GCM of the $448,500 contract price for the 75-vial order. 21 16. On July 6, 2017 the Royal Hospital formally rejected the Soliris supplied to it by GCM 22 and instructed GCM to retrieve the vials in the Royal Hospital’s possession. GCM 23 forwarded the rejection letter to AlfaPharma. PRETRIAL ORDER - 4 Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 5 of 30 1 2 3 4 5 17. GCM requested AlfaPharma to authenticate the Soliris. AlfaPharma was unable to provide documentation sufficient to authenticate the Soliris delivered. 18. AlfaPharma did not provide replacement Soliris and did not provide any other form of authentication. 19. GCM made additional requests from AlfaPharma for assistance in proving authenticity. 6 On July 20, 2017, GCM sent an email notifying AlfaPharma that the Royal Hospital had 7 rejected the pharmaceuticals and asking AlfaPharma for documentation that Alpha’s 8 source in Turkey, a company called Xerox Pharma, had obtained the Soliris from Alexion 9 or an authorized Alexion distributor. 10 20. By email dated August 3, 2017 GCM informed AlfaPharma that the Royal Hospital had 11 now tendered the supply order to others after rejecting the delivery from GCM. GCM 12 requested that AlfaPharma attempt to get fresh documentation to authenticate the Soliris, 13 and if fresh documentation could not be provided, to take back the Soliris at issue, and for 14 AlfaPharma to refund GCM the money paid together with payment of the penalties that 15 the Royal Hospital would assess. AlfaPharma did not take back the pharmaceuticals and 16 did not pay any money to GCM. 17 21. The Royal Hospital obtained 75 vials of Soliris from another source and formally 18 canceled the OMR 172,500 ($448,500 USD) GCM contract on April 30, 2018. The Royal 19 Hospital imposed its administrative fees and cancelation penalty in the amount of OMR 20 20,624.475, or approximately $53,624 USD. 21 22 22. The parties do not know whether the drugs supplied by AlfaPharma are chemically identical to Soliris or not. 23 ISSUES OF LAW PRETRIAL ORDER - 5 Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 6 of 30 1 The following are the issues of law to be determined by the court: 2 1. Whether the Court has determined that the Soliris shipment in this case was not 3 merchantable? GCM’s position is that the Court determined in the Order on Cross- 4 Motions for Summary Judgment that defendants breached both express warranties 5 and the implied warranty of merchantability. Defendants position is that this issue 6 was neither briefed nor decided in the Motions for Summary Judgment and that 7 “merchantability” is a question of fact that depends on whether the goods fit the 8 definition in the UCC at 62A.2-314. This issue relates to defendants’ mitigation 9 affirmative defense. 10 2. If the parties are not agreed on damages, whether GCM is precluded from arguing as 11 part of consequential damages, the value of its loss of its license to import 12 pharmaceuticals into Oman? 13 3. Whether defendants’ proposed exhibits and testimony related to the FDA and 14 Washington State Department of Health investigations should be excluded? 15 4. Whether prejudgment interest should be allowed and the amount of prejudgment 16 interest on each claim? The parties stipulate that this issue should be decided by the 17 Court after receipt of post-verdict briefs, if appropriate. 18 19 EXPERT WITNESSES 20 There are no expert witnesses. 21 OTHER WITNESSES 22 The names and addresses of witnesses, other than experts, to be used by each party at the 23 time of trial and the general nature of the testimony of each are: PRETRIAL ORDER - 6 Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 7 of 30 1 (a) On behalf of plaintiff: Mahmoud Hamouda, Manager, GCM, will testify concerning formation of the parties’ 2 contract, performance, breach and damages to plaintiff. 3 T.K. Vijayan, Manager, GCM, will testify concerning formation of the parties’ contract, performance, breach and damages to plaintiff. 4 Sajeev V. Kumaran, Manager, GCM, will testify concerning formation of the parties’ contract, performance, breach and damages to plaintiff. 5 Rakesh Kumar, Liaison Manager, Global Source Trading LLC, may testify concerning 6 formation of the parties’ contract, performance, breach and damages to plaintiff Ahmed Al Sherbini, Medicure Sales, GCM, may testify concerning formation of the 7 parties’ contract, performance, breach and damages to plaintiff; possible witness only. Suliman Al-Fayoumi may be called as an adverse witness. 8 9 (b) On behalf of defendant: Suliman Al-Fayoumi, will testify regarding defendants’ background, experience, history of parties’ dealings, contract formation, performance, allegations of breach, and allegations of 11 damages. 10 Dima Al-Fayoumi, will testify regarding her knowledge of emails between GCM and 12 Defendant, her knowledge of the transaction at issue, GCM’s lawsuit in Oman, and result of that lawsuit. 13 14 EXHIBITS 15 Identify each exhibit with a number, which becomes the number for the exhibit at the trial and appears on the exhibit tag with the following information in table format: 16 17 18 Ex. # 1 19 20 21 Description Xerox Proforma Invoice. April 28, 2020 5:14 pm. (Disclosed via email from defense counsel Michael Whitticar to GCM counsel Mel Simburg.) ALF001191 Joint Exhibits Authenticity Admissibility Objection Admitted X X 2 X X X X AlfaPharma price quote. November 5, 2016. Alfa to GCM. GCM000195. 22 23 3 PRETRIAL ORDER - 7 Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 8 of 30 1 Letter and item list. January 29, 2017. Royal Hospital, Ministry of Health, Sultanate of Oman to GCM. GCM000002 – GCM000003 2 3 4 4 6 X X X 5 X X X X X X X X X Email. February 10, 2017 at 9:23 pm. AlfaPharma to Global Cure Medicine; email from GCM to Alfa, dated February 10, 2017 at 06:59. GCM000197 8 9 10 11 X Email. February 10, 2017 at 12:42 am. AlfaPharma to Global Cure Medicine. GCM000196. 5 7 X 6 Purchase orders. February 20, 2017. Global Cure Medicine to AlfaPharma. GCM000006 Withdrawn. Duplicate of Ex. 132 12 13 14 7 15 Purchase order. March 1, 2017. Global Cure Medicine to AlfaPharma. GCM000007. 16 17 8 18 19 20 9 10 21 22 23 11 Invoice. March 17, 2017. AlfaPharma to Global Cure. GCM000198. Invoice. May 11, 2017. AlfaPharma to Global Cure. GCM000009. Letter dated March 21, 2017, from Global Industrial Service, on behalf of Global Cure to the Oman Arab Bank. GCM000010. Email dated April 23, 2017 at 3:26 pm, from AlfaPharma to Global Cure confirming PRETRIAL ORDER - 8 Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 9 of 30 1 2 12 3 4 5 13 6 14 7 15 8 9 delivery of 66 vials of Soliris. GCM0000199. [Invoice dated May 17, 2017, from AlfaPharma to Global Cure, confirming 66 vials of Soliris. GCM000012.] Withdrawn. Duplicate of Ex. 8. Alfa packing list, dated April X 23, 2017. ALF 000038. DHL shipping labels/waybill, X dated April 25, 2017. GCM000014 –15. [Photocopy of identification badge for Ahmet Tarhan Bleda. No date. GCM000016.] Withdrawn. X X Authentic ity (FRE 901) Relevanc y (FRE 401/402) 10 11 16 12 13 17 14 15 16 17 18 18 19 20 19 20 21 22 23 21 22 Delivery Note, April 27, 2017, for Soliris from Global Cure to the Royal Hospital of Oman with receipt stamp, GCM000017. Email dated May 11, 2017 at 1:08 p.m., from AlfaPharma to Global Cure; Email, dated May 10, 2017, from Global Cure to AlfaPharma. GCM000200. Withdrawn. Duplicate of Ex. 9. AlfaPharma packing list, dated May 11, 2017, Alfa to Global Cure. ALF 000039. Email dated May 11, 2017 at 10:13 am, from Dima (GCM) to GCM. GCM000201. DHL shipping labels/waybill, dated May 9, 2017. GCM000022 – 23. [Photocopy of identification badge for Ahmet Tarhan Bleda. No date. GCM000024] Withdrawn PRETRIAL ORDER - 9 X X X X X X X X X X Authentic ity (FRE 901) Relevanc y (FRE 401/402) Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 10 of 30 1 23 2 3 24 4 Letter dated May 23,2017, from the Royal Hospital of Oman to Global Cure Medicine. ALF 1189. Letter, dated May 17, 2017, from Alexion to the Royal Hospital. GCM000026. X X Hearsay (FRE801/ 802) Relevanc y/Prejudi ce (FRE 401/402/ 403) Hearsay (FRE801/ 802) Relevanc y/Prejudi ce (FRE 401/402/ 403) 5 6 7 25 Letter dated June 13, 2017, from Almac to Alexion. GCM000202 - GCM000203. 26 Letter dated July 6, 2017, from the Royal Hospital to Global Cure GCM000029. Email dated July 26, 2017 at 5:33 pm., from Vijay (GCM) to Mstone (Alfa). GCM000034. Email dated August 3, 2017 at 4:23 pm, from Vijayan (GCM) to Customer service at Alfa & Suliman (Alfa). GCM000035. Email dated August 4, 2017 at 11:05 pm., from Vijayan (GCM) to “Vijaykumarkr (GCM) cc: Customerservice at Alfa & Suliman & Mstone (Alfa). GCM000036 Letter dated November 18, 2018, from the Ministry of Health, Republic of Turkey to Global Cure Medicine. GCM00037 – GCM000038 [37 is certified English translation of 38.]. X X X X X X X X Letter dated April 30, 2018, from the Ministry of Health in X 8 9 10 11 12 27 13 14 28 15 16 29 17 18 19 30 20 21 22 23 31 PRETRIAL ORDER - 10 Hearsay (FRE801/ 802) Relevanc y/Prejudi ce (FRE 401/402/ 403) X Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 11 of 30 1 2 32 3 4 Oman to Global Cure Medicine. GCM00039. [Email, dated July 24, 2017 from Promek Export to Global Cure Medicine, and email from GCM to Promek, GCM000040 – 41.] Withdrawn. Hearsay (FRE 801/802) Relevanc y/Prejudi ce (FRE 401/402/ 403) 5 6 33 7 8 9 34 10 Email dated December 20, 2017 and email chain from December 11 to December 20, 2017, from Global Cure to Muscat Government Agency. GCM00042 – 55. Letter dated April 12, 2018, from Alexion to Global Cure Medicine, GCM000060. X X Digital copies of identification of members of Global Cure Medicine, LLC. No date. GCM000061 - GCM000063. Digital copy of Global Cure’s Commercial Registration Certificate with the Sultanate of Oman. No date. GCM000064 – GCM000070. Email dated November 14, 2017, from Global Cure Medicine to Ministry of Health of Turkey with embedded letter dated January 15, 2017, from the Omani Embassy in Turkey GCM000071. Apostille, Secretary of State, Washington State, dated December 20, 2016. GCM000075 – GCM000077. Document titled ALMAC Certificate of Analysis, for X X X X X X X X X X Hearsay (FRE 801/802) Relevanc y/Prejudi ce (FRE 401/402/ 403) 11 12 13 35 14 15 36 16 17 18 37 19 20 21 38 22 23 39 PRETRIAL ORDER - 11 Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 12 of 30 1 2 3 40 4 5 6 7 41 8 9 10 42 11 12 13 14 15 43 44 16 17 18 19 20 21 22 23 45 46 47 Soliris Batch No. P0004801, dated June 9, 2016, bearing signature identified as Trevor Clarke, June 13, 2016. GCM000078 – GCM000079. Screenshot of text messages via WhatsApp between Dima and Mahmoud with partial COA and PDF attachments labeled “Varsayilan” and “Varsayilan 2” at 3:14 PM. Undated. GCM000080. Screenshot of text message via WhatsApp from Mima with partial COA and PDF attachments labeled “Varsayilan 1” and “Varsayilan 8,” dated April 9 & 23, 2017. GCM000081. [Emails exchanged between Global Cure Medicine and Ministry of Health of Turkey dated December 11-20, 2017. GCM000082 – GCM00095.] Withdrawn. Duplicate of Ex. 33. Withdrawn. See Ex. 205. Letter to M. Stone at AlfaPharma from Global Cure Medicine, dated May 25, 2018. GCM000098 – GCM000099. Photocopy of Suliman AlFayoumi business card. No date. GCM000100. Withdrawn. See Ex. 206. Email from customerservice@alfapharma.n et to alfayoumi@hotmail.com to customerservice@alfapharma.n et to medicure.marketing@gstoman. com re: “Soliris CoAs” and attachments, dated November 23, 2016. GCM000105 – GCM000106. PRETRIAL ORDER - 12 X X X X X X X X X X Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 13 of 30 1 48 2 3 4 5 49 6 7 8 9 10 50 11 12 13 14 15 51 16 17 18 52 19 20 21 22 23 53 [Document titled ALMAC Certificate of Analysis, for Soliris Batch No. P0004202, dated January 5, 2016, bearing signature identified as Trevor Clarke, January 7, 2016. GCM000107 – GCM000108.] Withdrawn. Duplicate of Ex. 115. [Document titled ALMAC Certificate of Analysis, for Soliris Batch No. P0004707, dated April 8, 2016, bearing signature identified as Trevor Clarke, April 11, 2016. GCM000109 – GCM000110.] Withdrawn. Duplicate of Ex. 116. [Document titled ALMAC Certificate of Analysis, for Soliris Batch No. P0004708, dated April 8, 2016, bearing signature identified as Trevor Clarke, April 11, 2016. GCM000111 – GCM000112.] Withdrawn. Duplicate of Ex. 117. Document titled ALMAC Certificate of Analysis, for Soliris Batch No. P0005002R, dated May 2, 2016, bearing signature identified as Trevor Clarke, May 4, 2016. GCM000115 – GCM000116. Document titled ALMAC Certificate of Analysis, for Soliris Batch No. 1000028, dated May 2, 2016, bearing signature identified as Trevor Clarke, May 3, 2016. GCM000117 – GCM000118. Document titled ALMAC Certificate of Analysis, for Soliris Batch No. P0004801, dated April 4, 2016, bearing PRETRIAL ORDER - 13 X X X X X X Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 14 of 30 1 2 54 3 4 5 6 7 55 8 9 10 11 12 56 13 14 57 15 16 17 18 58 19 20 21 22 23 59 signature identified as Trevor Clarke, April 5, 2016. GCM000119 – GCM000120. [Document titled ALMAC Certificate of Analysis, for Soliris Batch No. P0004906, dated March 16, 2016, bearing signature identified as Trevor Clarke, March 14, 2016. GCM000121 – GCM000122.] Withdrawn. Duplicate of Ex. 111. [Document titled ALMAC Certificate of Analysis, for Soliris Batch No. P0004907, dated March 16, 2016, bearing signature identified as Trevor Clarke, March 14, 2016. GCM000123 – GCM000124.] Withdrawn. Duplicate of Ex. 112. Emails between Global Cure Medicine and AlfaPharma, dated February 26, 2017. GCM000125 – GCM000126. [Document titled General Terms & Conditions, Invoice ALF-154-2017, dated February 24, 2017. GCM000127 – GCM000128.] Withdrawn. Duplicates of Ex. 87. / ALF 01-02. [Quotation dated February 25, 2017, Invoice # ALFA-1542017 for 75 vials of Eculizumab for $353,850 including shipping. GCM000129.] Withdrawn. Duplicate of Ex. 92. (Dup ALF 07). [Email from Vijayan (GCM) to Dima (GCM) cc: Ahmed (GCM), customer service at Alfa (Alfa), GCM000130.] PRETRIAL ORDER - 14 X X Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 15 of 30 1 2 Withdrawn. Duplicate of Ex. 66. 60 X X X X X X X X X X X X X X X X X X Email dated July 8, 2017 at 9:34 a.m. from Sam A (Alfa) to Vijayan (GCM) cc: Dima (GCM), Ahmed (GCM), GCM000131. 3 4 5 61 6 7 8 62 9 10 63 11 12 64 13 14 15 65 16 17 66 18 19 67 20 21 22 23 68 Email dated July 8, 2017 at 2:07 p.m. from Vijayan (GCM) to Sam A (Alfa), cc: Dima (GCM), Ahmed (GCM), GCM000132. Email July 9, 2017 at 5:25 PM from Vijayan (GCM) to Sam A. (Alfa), cc: Dima (GCM), Ahmed (GCM). GCM000133. Email July 11, 2017 at 8:50 PM. from Vijayan (GCM) to Sam A (Alfa), cc: Ahmed (GCM), GCM000134. Email July 12, 2017 at 6:51 AM. from Vijayan (GCM) to Dima (GCM), Customer service at Alfa (Alfa), cc: GCM parties, GCM000135. Email dated July 12, 2017 at 6:59 AM. from Vijayan (GCM) to Dima (GCM), Customer Service at Alfa (ALFA), cc: GCM team, GCM000136. Emails between AlfaPharma and GCM July 3, 2017 to July 12, 2017. GCM000137 GCM000138. Email dated July 12, 2017 at 8:54 am with password for attachment previously sent, and email string. from customer service at Alfa to Vijayan (GCM), cc: GCM team. GCM000139 – GCM000140. Emails July 19, 2017 to July 20, 2017, between Vijayan PRETRIAL ORDER - 15 Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 16 of 30 1 2 69 3 4 70 5 6 7 8 71 9 10 72 11 12 73 13 14 15 16 74 17 18 19 75 20 21 22 23 76 (GCM) and MStone (Alfa). GCM000141 – GCM000142. Email dated July 24, 2017 at 8:47 AM. from Vijayan (GCM) to MStone (Alfa), cc: GCM team, GCM000143. Email dated July 24, 2017 at 9:40 PM from Mstone (Alfa) to Vijayan (GCM), cc: GCM team, and email dated July 23, 2017 at 23:47 from Vijayan (GCM) to Mstone/Sam/Suliman (Alfa), Dima (GCM). GCM000144. Email dated August 4, 2017 at 11:50 PM. from Vijayan (GCM) to MStone (Alfa), cc: GCM team, GCM000145. Email dated August 8, 2017 at 6:42 AM. from Vijayan (GCM) to MStone (Alfa), cc: GCM team, GCM000146. Email dated August 23, 2017 at 1:18 PM. from Aysha (GCM) to Vijayan (GCM), cc: M Stone, customer service at AlfaPharma, and Salfayoumi (hotmail) (Alfa), GCM team, GCM000147 – 148. Digital copy of Xerox Pharmaceutical invoice (partially redacted) to Global Cure Medicine for 75 Solaris 300mg manufactured by Alexion. Undated. GCM0000149. Email dated March 29, 2017 from Global Cure Medicine to various personnel at Global Cure Medicine. GCM000158. Letter dated March 28, 2017 from Global Cure Medicine to Royal Hospital, with annotation “Rejected” and faxed back March 29, 2017. GCM000159. PRETRIAL ORDER - 16 X X X X X X X X X X X X X X X X Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 17 of 30 77 Alexion Letter. GCM000162 – GCM000163. Duplicate of Ex. 83. Withdrawn 78 Email dated July 17, 2017 from X Global Cure Global Cure Medicine to AlfaPharma with attached Invoice dated November 28, 2016 from AlfaPharma to Global Cure Global Cure Medicine, Deposition of Al-Fayoumi, Ex. 40, GCM 162 – 166. 79 1 [Digital copy of “XELJANZ” tablet box. Undated. GCM000165.] Withdrawn. Duplicate of Ex. 78. [Invoice dated March 1, 2017 from AlfaPharma to Global Cure Medicine, GCM000166.] Withdrawn. Duplicate of Ex. 78. Email dated April 19, 2017 from Global Cure Medicine to various personnel at Global Cure Medicine re Tofacitinib, GCM000167. Letter dated April 17, 2017 from Ministry of Health, Sultanate of Oman to Managing Director at GCM, GCM000168, attachment to GCM000167. Letter dated May 22, 2017 from Alexion to Royal Hospital of Oman, GCM000172 – GCM000173. 2 Hearsay (FRE801/ 802) Relevanc y/Prejudi ce (FRE 401/402/ 403) 3 4 5 6 7 8 9 X 10 11 12 80 13 14 15 81 16 17 18 82 19 20 21 22 83 23 PRETRIAL ORDER - 17 X X X X Hearsay (FRE801/ 802) Relevanc y/Prejudi ce (FRE Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 18 of 30 1 2 401/402/ 403) 84 85 Royal Hospital letter to Global Cure Medicine, undated. GCM000174. Withdrawn. 86 Withdrawn. 87 AlfaPharma general terms and conditions, dated February 24, 2017. ALF000001-2. Document titled Alexion Certificate of Analysis, for Soliris Batch # P0004202. Undated. ALF000003. Document titled Alexion Certificate of Analysis, for Soliris Batch # P0004002. Undated. ALF000004. Document titled Alexion Certificate of Analysis, for Soliris Batch # P0004708. Undated. ALF000005. Certificate of Origin. Undated. ALF000006. AlfaPharma price quote to Global Cure Medicine, dated February 25, 2017. ALF000007. Withdrawn. See Ex. 208 Email chain dated October 30, 2016, from Xerox Pharmaceutical Warehouse to ‘Suliman’, with imbedded attachments. ALF000010 -14. Forwarded email chain dated July 6 to August 8, 2017 between AlfaPharma and 3 X X Relevanc y/Prejudi ce (FRE 401/402/ 403) Relevanc y/Prejudi ce (FRE 401/402/ 403) 4 5 6 7 8 9 10 88 11 12 89 13 14 90 15 16 91 17 92 18 19 20 93 94 21 22 23 95 PRETRIAL ORDER - 18 X X X X X X X X X X X X X X X X Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 19 of 30 1 2 96 3 4 5 97 98 6 7 8 99 9 10 11 12 100 13 14 15 101 16 17 18 19 20 102 21 22 23 103 Global Cure Medicine. ALF000019 – 23. Forwarded email exchange dated July 19 – July 20, 2017 between AlfaPharma and Global Cure Medicine. ALF000024 – 25. Withdrawn. See Ex. 2010. Email dated October 5, 2016 from Xerox Pharmaceutical to AlfaPharma re: P0004708 03/2018 with 1 attachment labeled “CCF05102016.pdf”. ALF000029. Email exchange dated October 4, 2016 to April 23, 2017 between Xerox Pharmaceutical to AlfaPharma, with 1 attachment labeled “Pack List SOLIRIS 300mg..pdf”. ALF000030 – 31. Email dated October 4, 2016 from Xerox Pharmaceutical to AlfaPharma, with 2 attachments labeled “CCF04102016_0001.pdf” and “CCF04102016.pdf”. ALF000032. Email exchange dated September 30, 2016 between Xerox Pharmaceutical and AlfaPharma, with 4 attachments labeled “SOLIRIS-3601.pdf”, “SOLIRIS- 3704.pdf”, “SOLIRIS-4801.pdf”, and “SOLIRIS-4707.pdf”. ALF000033 – 36. Packing list dated October 3, 2016 from AlfaPharma to Global Cure Medicine. ALF000037. Packing lists. ALF 38:4/23/2017. Withdrawn. Duplicate of Ex.13. PRETRIAL ORDER - 19 X X X X X X X X X X X X Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 20 of 30 1 2 104 ALF 39. 5/11/2017. Withdrawn. Duplicate of Ex. 19. 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 105 Document dated May 2, 2016 titled ALMAC Certificate of Analysis, for Soliris Batch No. 1000081, page 1 of 2. ALF000040. 106 Document dated May 3, 2016 titled ALMAC Certificate of Analysis, for Soliris Batch No. 1000020, page 2 of 2, dated May 2, 2016, with signature identified as Trevor Clarke. ALF000041. 107 Document titled Alexion Certificate of Analysis, for Soliris Batch No. P0003601, undated. ALF000042. 108 Document titled Alexion Certificate of Analysis, for Soliris Batch No. P0003704, undated. ALF000043 109 Document titled Alexion Certificate of Analysis, for Soliris Batch No. P0004707, undated. ALF000044. 110 Document titled Alexion Certificate of Analysis, for Soliris Batch No. P0004801 undated. ALF000045. 111 Document dated March 14, 2016 titled ALMAC Certificate of Analysis, for Soliris Batch No. P0004906, dated March 16, 2016, with signature identified as Trevor Clarke. ALF000046. ALF000047. 112 Document dated March 14, 2016 titled ALMAC Certificate of Analysis, for Soliris Batch No. P0004907, dated March 1?, 2016 (date not fully discernable), with signature PRETRIAL ORDER - 20 X X X X X X X X X X X X X X X X Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 21 of 30 1 2 113 3 4 114 5 6 115 7 8 9 116 10 11 12 13 117 14 15 16 17 118 18 19 20 21 119 22 23 120 identified as Trevor Clarke. ALF000048. ALF000049. Purchase order dated September 28, 2016 from Global Cure Medicine to AlfaPharma. ALF000050. Invoice dated September 28, 2016 from AlfaPharma to Global Cure Medicine. ALF000051. Document dated January 5, 2016, titled ALMAC Certificate of Analysis, for Soliris Batch # P0004202, with signature identified as Trevor Clarke dated January 7, 2016. ALF000052 – 53. Document dated April 7, 2016, titled ALMAC Certificate of Analysis, for Soliris Batch # P0004707, with signature identified as Trevor Clarke dated April 11, 2016. ALF000054 – 55. Document dated April 8, 2016, titled ALMAC Certificate of Analysis, for Soliris Batch # P0004708, with signature identified as Trevor Clarke dated April 11, 2016. ALF000056 – 57. Document dated May 2, 2016, titled ALMAC Certificate of Analysis, for Soliris Batch # P0005002R with signature identified as Trevor Clarke dated May 4, 2016. ALF000060 – 61. Withdrawn. Duplicate of Ex. 51 Xerox Pharmaceutical Proforma Invoice dated September 29, 2016. ALF000062. AlfaPharma Invoice dated September 28, 2016 to Global PRETRIAL ORDER - 21 X X X X X X X X X X X X Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 22 of 30 1 2 3 4 121 5 6 7 122 8 9 123 10 124 11 12 13 125 14 15 126 16 17 18 127 19 20 21 22 23 128 129 Cure Medicine for 20 unit of Soliris for Batch Nos. P0003601, P0003704, P0004707, P0004801 and P0005002R. ALF000063. Withdrawn. Duplicate of Ex. 114. AlfaPharma Order confirmation to Global Cure Medicine dated March 20, 2017 for 75 units of Soliris, with handwritten note in lower right corner. ALF000064. AlfaPharma Certificate of Origin as France for 20 vials of Soliris, undated. ALF000065. Bank of America printout of payments, dated March 1 to March 31, 2017. ALF000067. Screenshot of ALMAC Certificates of Analysis list of batch numbers P0004202, P0004707, P0004708, P0004801. ALF000068. Picture of Copy of shipping label dated May 9, 2017 from AlfaPharma to Global Cure Medicine. ALF000069. Wire transfer request, dated March 22, 2017 from Global Cure Medicine to Oman Arab Bank for payment to AlfaPharma. ALF000070. Promissory note for $366,250.00 from Global Cure Medicine to Oman Arab Bank. No date. ALF000071. Trust Receipt from Oman Arab Bank to Global Cure Medicine. No date. ALF000072. Order Confirmation dated March 17, 2017 from AlfaPharma to Global Cure Medicine, for stainless steel double ended TPED-compliant PRETRIAL ORDER - 22 X X X X X X X X X X X X X X X X X X Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 23 of 30 1 2 130 3 4 131 5 6 132 7 8 133 9 10 11 12 134 13 14 15 135 16 17 136 18 19 20 137 21 22 23 138 sample cylinder for $12,400. ALF000073. Letter dated October 18, 2016 from AlfaPharma, Michael Stone, JD to Global Cure Medicine. ALF00075- 76. Purchase Order dated March 1, 2017 from Global Cure Medicine to AlfaPharma for 37 units of Soliris. ALF000077. Purchase Order dated February 20, 2017 from Global Cure Medicine to AlfaPharma, for 38 units of Soliris and 200 of Myozyme. ALF000078. National Bank of Oman Application dated March 2, 2017 for open account letter from Global Cure Medicine to AlfaPharma for payment of $14,895. ALF000079 [Letter dated October 18, 2016 from Alfa to GCM. ALF000075-76 and ALF0011811182.] Withdrawn. Duplicate of Ex. 130. Bank of Baroda delivery report of payment by Global Cure Medicine to AlfaPharma. October 10, 2016. ALF000080. National Bank of Oman Application for open account letter from Global Cure Medicine to AlfaPharma for payment of $62,300, dated March 2. 2017. ALF000081. National Bank of Oman Application for open account letter dated February 5, 2017 from Global Cure Medicine to AlfaPharma for payment of $9016.68. ALF000082. Global Cure Medicine purchase order, dated March 5, PRETRIAL ORDER - 23 X X X X X X X X X X X X X X X X Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 24 of 30 1 2 139 140 3 4 5 141 6 7 8 142 9 10 11 12 143 13 14 15 144 16 17 18 19 145 20 21 22 23 146 2017 for $8,590.32. ALF000083 – ALF000084. Withdrawn. See Ex. 209. Email dated August 4, 2017 with earlier email chain dated, July 3 to July 24, 2017 from Global Cure Medicine to Michael Stone AlfaPharma. ALF000308 – 312. Email dated July 23, 2017 with earlier email chain dated, July 3 to July 20, 2017 from Global Cure Medicine to Michael Stone AlfaPharma. ALF000314 – 317. Email dated July 19, 2017 with earlier email chain dated, July 3 to July 20, 2017 from Global Cure Medicine to Michael Stone AlfaPharma. ALF000318 – 320. Email dated August 23, 2017 with earlier email chain dated, July 3 to August 8, 2017 from Global Cure Medicine to Global Cure Medicine and AlfaPharma. ALF000322 – 328. Email dated August 29, 2017 with earlier email chain dated April 2 to August 11, 2017 from Global Cure Medicine to Global Cure Medicine and AlfaPharma. ALF000330 – 339. Email dated August 9, 2017 with earlier email chain dated July 25 to July 28, 2017 from Global Cure Medicine to AlfaPharma. ALF000342 – 343. Email dated August 3, 2017 with earlier email chain dated July 26, 2017 from Global Cure Medicine to AlfaPharma PRETRIAL ORDER - 24 X X X X X X X X X X X X X X Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 25 of 30 1 2 147 3 4 5 148 6 7 8 149 9 150 10 11 12 151 13 14 15 152 16 17 18 153 19 20 21 22 23 154 155 and Global Cure Medicine. ALF000382 – 383. Email dated August 23, 2017 with email chain dated August 8, 2017 from Global Cure Medicine to Global Cure Medicine and AlfaPharma. ALF000386 – 387. Email dated March 24, 2017 with email chain dated March 22 to March 24, 2017. from Global Cure Medicine to Global Cure Medicine. ALF000410 – 412. Email dated July 5, 2017 from Global Cure Medicine to AlfaPharma. ALF000415. Email dated April 6, 2017 with email chain dated March 14 to April 6, 2017 from Global Cure Medicine to AlfaPharma. ALF000417 – 422. Email dated March 18, 2017 with email chain dated March 14 to March 17, 2017 from Global Cure Medicine to AlfaPharma. ALF000428 – 429. Email dated April 11, 2017 at 12:15 pm with email chain from April 4, 2017 from Alfa to GCM. ALF000431ALF000432. Email dated March 7, 2017 at 10:42 PM with email chain from Alfa to GCM. ALF000442. Email dated March 7, 2017 from Sam to GCM. ALF000497. Email dated July 11, 2017 with email chain dated July 3 to July 9, 2017 from Global Cure Medicine to AlfaPharma. ALF000539 – 541. PRETRIAL ORDER - 25 X X X X X X X X X X X X X X X X X X Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 26 of 30 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 156 Email dated July 9, 2017 with email chain dated from July 3 to July 8, 2017 from Global Cure Medicine to AlfaPharma. ALF000542 – 544. 157 Email dated July 8, 2017 with email china dated July 3 to July 8, 2017 from Global Cure Medicine to AlfaPharma. ALF000545 – 547. 158 Email dated July 7, 2017 with email chain dated July 3 to July 6, 2017 from AlfaPharma to Global Cure Medicine. ALF000548 – 549. 159 Email dated October 4, 2016 with chain email from September 29 to October 4 2016 from Global Cure Medicine to AlfaPharma. ALF000552 – 560. 160 Email dated October 4, 2016 with email chain dated September 29 to October 4, 2016 from Global Cure Medicine to Global Cure Medicine and AlfaPharma. ALF000569 - 577. 161 Email dated March 30, 2017 with email chain from March 27 – March 30, 2017 from AlfaPharma to Dr. Mohammed Al-Sabbari CEO Albittar International. ALF000616 – 618. 162 Email dated March 18, 2017 with email chain dated from March 14 to March 17, 2017 from Global Cure Medicine to AlfaPharma. ALF000684 – 686. 163 Email dated February 1, 2017 from Sam to M. Hamouda at GCM. Bates No. ALF000734. 164 Email dated April 4, 2017 with email chain dated from March PRETRIAL ORDER - 26 X X X X X X X X X X X X X X X X X X Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 27 of 30 1 2 3 165 4 5 6 7 166 8 9 10 11 167 12 13 14 168 15 16 169 17 18 19 170 171 20 21 22 23 172 27 to March 30, 2017 from AlfaPharma to Dr. Mohammed Al-Sabbari CEO Albittar International. ALF001045 – 1047. Email dated October 3, 2016 from Xerox Pharma to AlfaPharma re: COO with 2 attachments labeled “CCF03102016_0001.pdf” and “CCF03102016_0002.pdf”. ALF001130. Email dated November 22, 2016 from Xerox Farma to AlfaPharma sre: Counterfeit Soliris in the market, with 3 attachments labeled “IMG_5086.JPG”, “IMG_5087.JPG” and “IMG_5088.JPG”. ALF001131. Email dated May 10, 2017 from Xerox Farma to AlfaPharma with attachment labeled “Pack list SOLIRIS 300mg 11 vials.docx”. ALF001132. Emails dated November 22, 2016 from Xerox Farma to AlfaPharma. ALF001133. Email dated November 22, 2016 from AlfaPharma to Xerox Farma. ALF001135. Email dated November 22, 2016 from AlfaPharma to Xerox Farma. ALF001136. Email dated October 2, 2016 from Xerox Pharmaceutical to AlfaPharma, re batch P0005002R, with attachment labeled “CCF02102016.pdf”. ALF001176. Scan copy of annotated copy of AlfaPharma Invoice. Dated March 17, 2017. ALF001177. PRETRIAL ORDER - 27 X X X X X X X X X X X X X X X X Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 28 of 30 1 173 Stipulated Facts 2 3 Ex. # 201 4 5 6 202 7 8 9 203 10 11 204 12 13 205 14 15 16 206 17 18 19 20 21 22 23 207 208 X X Defendant’s Exhibits Description Authenticity Admissibility Letter from Dr. Ibrahim Disputed Disputed Alrashidi dated July 6, 2017 (ALF00193) plus translation. Withdrawn. See Ex. 26. Decision of Public Disputed Disputed Prosecution Office, Sultanate of Oman) Case # 2017/15495 (ALF00194-199) plus translation Summary Judgement Disputed Disputed by The Court of Appeals (ALF00200202) plus translation Notification from Disputed Disputed Omani Labor Court (ALF00203) Letter to U.S. FDA Disputed from Global Cure Medicine, dated April 18, 2018. GCM000096 – GCM000097. Emails exchanged Disputed between Global Cure Medicine and U.S. FDA, April 18 – May 16, 2018. GCM000101 – GCM0000104. Withdrawn. See Ex. 78 Forwarded email chain Disputed dated April 24, 2018 from AlfaPharma to Chris Humberson at the Washington State department of Health. ALF000008ALF000009. PRETRIAL ORDER - 28 Disputed Disputed Disputed Objection FRE 902(3) authenticity ; 401-2 relevance FRE 902(3) authenticity ; 401-2 relevance FRE 902(3) authenticity ; 401-2 relevance FRE 902(3) authenticity ; 401-2 relevance FRE 401-2 relevance, not probative of any issue Hearsay. FRE 401-2 relevance, not probative of any issue. FRE 401-2 relevance, not probative of any issue. Hearsay Admitted Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 29 of 30 1 209 2 3 4 5 6 210 7 8 9 10 11 Scan print out dated Disputed April 24, 2018, of partial communication from Chris Humberson, P.PH. Washington State Department of Health with acknowledgement signature of Suliman al-Fayoumi. ALF000112. Forwarded emails Disputed dated February 22 and March 1, 2018, with 9 attachments between AlfaPharma and Sangeeta Vaswani Chaerjee and Michael Cummins or the U.S. Food and Drug Administration. ALF000027 – 28. Disputed FRE 401-2 relevance, not probative of any issue. Hearsay. Disputed Hearsay. FRE 401-2 relevance, not probative of any issue. 12 In the Authenticity and Admissibility columns, indicate “Stipulated” or “Disputed”. If “Disputed”, identify the objection in the Objection column. An objection based on a Fed. R. 14 Evid. should reference the rule number; additional objections should be referenced by a code that the parties include with the exhibit list. The “Admitted” column is for use by the Court. 15 (No party is required to list any exhibit which is listed by another party, or any exhibit to 16 be used for impeachment only. See LCR 16 for further explanation of numbering of exhibits). 13 17 18 19 ACTION BY THE COURT (a) This case is scheduled for trial before a jury on December 14, 2020 (b) Trial briefs shall be submitted to the court on or before November 30, 2020. (c) Jury instructions requested by either party shall be submitted to the court on or before 20 November 30, 2020. Suggested questions of either party to be asked of the jury by the court on voir dire shall be submitted to the court on or before November 30, 2020. 21 (d) (Insert any other ruling made by the court at or before pretrial conference.) 22 This order has been approved by the parties as evidenced by the signatures of their 23 counsel. This order shall control the subsequent course of the action unless modified by a PRETRIAL ORDER - 29 Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 30 of 30 1 subsequent order. This order shall not be amended except by order of the court pursuant to agreement of the parties or to prevent manifest injustice. 2 DATED this 3rd day of December, 2020. 3 A 4 5 Marsha J. Pechman United States District Judge 6 FORM APPROVED: 7 SIMBURG, KETTER, SHEPPARD & PURDY, LLP s/Melvyn J. Simburg Melvyn J. Simburg, WSBA #4773 msimburg@sksp.com 999 Third Avenue, Suite 2525 Seattle, WA 98101 T: 206.382.2600 Attorney for Plaintiff 8 9 10 11 12 LOWE GRAHAM JONES PLLC s/ Mark P. Walters Mark P. Walters, WSBA No. 30819 Walters@LoweGrahamJones.com 701 Fifth Avenue, Suite 4800 Seattle, Washington 98104 T: 206.381.3300 F:206.381.3301 Attorney for Defendant 13 14 15 16 17 18 19 20 21 22 23 PRETRIAL ORDER - 30

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