Global Cure Medicine LLC v. Alfa Pharma LLC
Filing
68
PRETRIAL ORDER signed by Judge Marsha J. Pechman. (PM)
Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 1 of 30
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Hon. Marsha J. Pechman
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UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF WASHINGTON
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GLOBAL CURE MEDICINE, LLC
A foreign limited liability company,
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Plaintiff
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Case No: 19-cv-00588-MJP
v.
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PRETRIAL ORDER
ALFA PHARMA, LLC, a Washington
limited liability company, and Suliman AlFayoumi, a Washington resident,
Defendants.
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JURISDICTION
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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
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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
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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
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Manager of AlfaPharma.
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CLAIMS AND DEFENSES
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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
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The Defendants will pursue the following defenses
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1. Defendants will contend that Plaintiff has not met its burden of proof.
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2. Defendants will pursue an affirmative defense of failure to mitigate damages.
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ADMITTED FACTS
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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
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to supply the Royal Hospital with vials of injectable solution Eculizumab from Alexion
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Pharmaceuticals, Inc., headquartered in Boston, Massachusetts.
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3. The brand name for the drug is “Soliris.” Alexion developed, manufactures, and markets
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the drug, which is protected by patent. It is the first and only therapy for the treatment of
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atypical hemolytic uremic syndrome (“aHUS”), a blood disease characterized by low
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levels of circulating red blood cells. Soliris is a life-saving medication for aHUS, but a
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single dose containing an impurity, or an improper quantity of the active ingredient could
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pose immediate life-threatening danger. Soliris was the most expensive drug in the world
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in 2010 and the fourth most expensive medication in the United States in 2015.
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PRETRIAL ORDER - 2
Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 3 of 30
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4. On November 5, 2016, Alfa Pharma sent a quotation to provide GCM with 150 units of
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Soliris 300 mg vials at a cost of $705,000.00 USD, for the Royal Hospital. The quotation
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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
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[‘COO’] will be supplied.” The COA establishes authenticity and manufacturing date of
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the product and the COO establishes its origin.
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5. Both parties were aware of counterfeit Soliris medications in the market at that time.
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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
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confirmation as we currently have most of the order volume in stock (i.e., around 60
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vials). We can’t however continue to hold the stock for much longer without a firm
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order.”
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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
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$126,000.00 and 75 units of Soliris for $352,500 (two shipments at $178,600+$173,900)
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to be sourced respectively from Genzyme, U.S.A and Alexion, U.S.A., with minimum
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expiration dates of 1 year, and to be accompanied by their COA and COO.
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9. AlfaPharma confirmed the order with an Order Confirmation for 75 units of Soliris that
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again stated “Original Certificates of Analysis & Certificates of Origin will be supplied”
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and that the expiry dates would be “Min 1 year from delivery.” The order confirmation
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was sent with a document called “General Terms & Conditions” and dated February 24,
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2017.
PRETRIAL ORDER - 3
Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 4 of 30
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10. AlfaPharma invoiced GCM in accordance with the purchase orders and again stated on
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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.”
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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
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containers for the medication for a total $366,250 USD.
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12. A first shipment of Soliris in fulfillment of a majority of the 75 vials ordered by GCM
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arrived in Oman on or around April 23, 2017, from a source in Turkey. Another shipment
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arrived in Oman to complete fulfillment of the order for 75 vials on or around May 11,
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2017 from the same source in Turkey.
13. The vials of Soliris provided to fulfill GCM’s order did not come with adequate
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documentation. For example, some of the batches delivered had no Certificate of
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Analysis while others had inconsistencies and irregularities.
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14. Soliris must be used before its expiration date.
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15. GCM supplied 40 units of the Soliris to the Royal Hospital at the end of April 2017. The
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Royal hospital used two of the vials of Soliris supplied to it by GCM. GCM sent the
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documentation it received from AlfaPharma, including the certificates of analysis, to the
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Royal Hospital. The Royal Hospital rejected the documentation that was supplied by
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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.
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16. On July 6, 2017 the Royal Hospital formally rejected the Soliris supplied to it by GCM
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and instructed GCM to retrieve the vials in the Royal Hospital’s possession. GCM
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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
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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.
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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
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source in Turkey, a company called Xerox Pharma, had obtained the Soliris from Alexion
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or an authorized Alexion distributor.
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20. By email dated August 3, 2017 GCM informed AlfaPharma that the Royal Hospital had
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now tendered the supply order to others after rejecting the delivery from GCM. GCM
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requested that AlfaPharma attempt to get fresh documentation to authenticate the Soliris,
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and if fresh documentation could not be provided, to take back the Soliris at issue, and for
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AlfaPharma to refund GCM the money paid together with payment of the penalties that
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the Royal Hospital would assess. AlfaPharma did not take back the pharmaceuticals and
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did not pay any money to GCM.
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21. The Royal Hospital obtained 75 vials of Soliris from another source and formally
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canceled the OMR 172,500 ($448,500 USD) GCM contract on April 30, 2018. The Royal
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Hospital imposed its administrative fees and cancelation penalty in the amount of OMR
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20,624.475, or approximately $53,624 USD.
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22. The parties do not know whether the drugs supplied by AlfaPharma are chemically
identical to Soliris or not.
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ISSUES OF LAW
PRETRIAL ORDER - 5
Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 6 of 30
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The following are the issues of law to be determined by the court:
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1. Whether the Court has determined that the Soliris shipment in this case was not
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merchantable? GCM’s position is that the Court determined in the Order on Cross-
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Motions for Summary Judgment that defendants breached both express warranties
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and the implied warranty of merchantability. Defendants position is that this issue
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was neither briefed nor decided in the Motions for Summary Judgment and that
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“merchantability” is a question of fact that depends on whether the goods fit the
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definition in the UCC at 62A.2-314. This issue relates to defendants’ mitigation
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affirmative defense.
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2. If the parties are not agreed on damages, whether GCM is precluded from arguing as
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part of consequential damages, the value of its loss of its license to import
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pharmaceuticals into Oman?
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3. Whether defendants’ proposed exhibits and testimony related to the FDA and
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Washington State Department of Health investigations should be excluded?
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4. Whether prejudgment interest should be allowed and the amount of prejudgment
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interest on each claim? The parties stipulate that this issue should be decided by the
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Court after receipt of post-verdict briefs, if appropriate.
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EXPERT WITNESSES
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There are no expert witnesses.
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OTHER WITNESSES
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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
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(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.
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Sajeev V. Kumaran, Manager, GCM, will testify concerning formation of the parties’
contract, performance, breach and damages to plaintiff.
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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.
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(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.
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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.
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EXHIBITS
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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:
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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.
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23
3
PRETRIAL ORDER - 7
Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 8 of 30
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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
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13
14
7
15
Purchase order. March 1, 2017.
Global Cure Medicine to
AlfaPharma. GCM000007.
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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
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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
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14
15
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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
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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
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9
10
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27
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28
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29
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18
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30
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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
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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
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21
38
22
23
39
PRETRIAL ORDER - 11
Case 2:19-cv-00588-MJP Document 68 Filed 12/03/20 Page 12 of 30
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40
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41
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9
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42
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43
44
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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
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48
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49
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50
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51
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52
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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
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13
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15
16
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58
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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
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X
X
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X
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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
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7
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62
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10
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64
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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.
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(d) (Insert any other ruling made by the court at or before pretrial conference.)
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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
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5
Marsha J. Pechman
United States District Judge
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FORM APPROVED:
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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
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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
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PRETRIAL ORDER - 30
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