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SEC Filings

10-Q
ATHENEX, INC. filed this Form 10-Q on 05/09/2019
Entire Document
 

Athenex GMP - Process Equipment List

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*The equipment listed below identifies the process equipment to be procured via the GMP. With the exception of equipment packages listed on the "Pending Procurement" sheets, under division 41, equiment which is not listed or funded below, is not included in the GMP

 

Div.

Description

BOD Estimate

 

Status (Deferred, Athenex, Exyte, Other Package)

GMP Value

41

Utility Panel for Portable Tank

$

19,397

 

Deferred

$

-

41

API Benchtop Powder Hood #1

$

23,387

 

Deferred

$

-

41

API Benchtop Scale #1

$

7,997

 

Deferred

$

-

41

Utility Panel for Portable Tank

$

19,397

 

Deferred

$

-

41

API Benchtop Powder Hood #2

$

23,387

 

Deferred

$

-

41

API Benchtop Scale #2

$

7,997

 

Deferred

$

-

41

IV/Syringe Used-to-clean EQ Pass through

$

20,327

 

Deferred

$

-

41

Walkie Lift

$

4,192

 

Athenex

$

-

41

Isolated Filling Line (2- 100mL) 30 unit/min

$

219,122

 

Deferred

$

-

41

Automated Tub Cover and liner removal

$

38,259

 

Deferred

$

-

41

Syringe Filler #2 30 unit/min

$

38,259

 

Deferred

$

-

41

Plunger Insertion

$

38,259

 

Deferred

$

-

41

Isolator TBD

$

38,259

 

Deferred

$

-

41

VHP Unit for Isolator TBD

$

38,259

 

Deferred

$

-

41

Wash Station

$

4,795

 

Deferred

$

-

41

Utility Carts

$

2,096

 

Deferred

$

-

41

Automated Denester

$

310,685

 

Deferred

$

-

41

Machine Inspection (cosmetic, particulate)

$

1,550,774

 

Deferred

$

-

41

Automated Renester

$

310,149

 

Deferred

$

-

41

Manual Syringe Inspection system in lieu of Automated

$

(1,750,000)

 

Deferred

$

-

41

Placeholder for EQ Line items

$

5,843,675

 

Deferred

$

-

41

Summarized Packaging utility use

$

2,096

 

Deferred

$

-

41

Utility Carts

$

15,206

 

Deferred

$

-

41

Manual Quality Checking Station

$

6,957

 

Deferred

$

-

41

Hand Packing Station

$

6,957

 

Deferred

$

-

41

Case Taper Machine MISC-007

$

4,527

 

Deferred

$

-

41

Label Dispenser MISC-008

$

4,527

 

Deferred

$

-

41

Isolated Filling System 10 unit/min

$

78,798

 

Deferred

$

-

41

Bag Filler (2 head custom filler)

$

12,575

 

Deferred

$

-

41

Isolator TBD

$

21,125

 

Deferred

$

-

41

VHP Unit for Isolator TBD

 

0

 

Deferred

$

-

41

Manual Quality Checking Station

$

3,806

 

Deferred

$

-

41

Hand Packing Station

$

3,806

 

Deferred

$

-

41

Case Taper Machine MISC-009

$

3,806

 

Deferred

$

-

41

Label Dispenser MISC-010

$

5,332

 

Deferred

$

-

41

ISO 5 Laminar Flow Bench #1 8 ft.

$

7,427

 

Athenex

$

-

41

ISO 5 Laminar Flow Bench #2 8 ft.

$

7,427

 

Athenex

$

-

41

ISO 5 Laminar Flow Bench #3 8 ft.

$

9,523

 

Athenex

$

-

41

ISO 5 Laminar Flow Bench #4 8 ft.

$

9,523

 

Athenex

$

-

41

ISO 5 Laminar Flow Bench #5 8 ft.

$

13,715

 

Athenex

$

-

41

ISO 5 Laminar Flow Bench #6 8 ft.

$

4,192

 

Athenex

$

-

41

Terminal Sterilizer #1 (Air/Steam) 380 cf

$

933,551

 

Deferred

$

-

41

Homogenizer 50 L MX-001

$

25,685

 

Athenex

$

-

41

Top-loading balance (Isolator) WS-006

$

12,575

 

Athenex

$

-

41

Process Water POU

$

4,192

 

PQ10 (WFI Coolers)

$

-

41

Sachet Filler 120 unit/min

$

45,468

 

Athenex

$

-

41

Discharge Conveyor

$

2,096

 

Athenex

$

-

41

Ointment Ultrasonic cleaner 10 gal

$

9,791

 

Athenex

$

-

41

Process Water POU

$

26,606

 

PQ10 (WFI Coolers)

$

-

41

Wash Sink

$

32,893

 

Exyte

$

32,893.00

41

Ointment Used-to-clean EQ Pass through MISC-036

$

8,138

 

Deferred

$

-

41

Checkweigher CW-001

$

17,017

 

Athenex

$

-

41

Hand Packing Station

$

3,806

 

Athenex

$

-

41

Case Taper Machine MISC-013

$

3,806

 

Athenex

$

-

41

Label Dispenser MISC-014

$

3,806

 

Athenex

$

-

41

Excipient Bench Scale #1

$

26,606

 

Deferred

$

-

41

Excipient Portable Floor Scale #1 3300 lbs.

$

22,063

 

Deferred

$

-

41

Down flow Booth Solvent or Powder 10 ft.

$

200,876

 

Deferred

$

-

41

3 lab sinks, glassware washer

$

17,302

 

Exyte provide Lab Sinks, Athenex provide Glass

Washers

$

 

17,302.00

41

Misc. Lab Sinks, Benchtop EQ

$

4,192

 

Exyte provide Lab Sinks, Athenex provide Benchtop

Eq.

$

 

4,192.00

41

Misc. Lab Sinks, Benchtop EQ

$

15,206

 

Exyte provide Lab Sinks, Athenex provide Benchtop

Eq.

$

 

15,206.00

41

Decontamination Sterilizer 35 cf AUTO-004

$

376,574

 

PQ2 (Autoclave)

$

-

41

Pallet Washer, Automatic

$

103,187

 

Athenex

$

-

41

Isco Sampler

$

4,376

 

Athenex

$

-

41

Incubators (3)

$

141,750

 

Exyte

$

141,750

41

ISO 5 Laminar Flow Bench #1 - Diana, flow, balances

$

36,500

 

Exyte - Athenex Estimate

$

36,500.00

41

ISO 5 Laminar Flow Bench #2 - Diana, flow, balances

$

36,500

 

Exyte - Athenex Estimate

$

36,500.00

41

ISO 5 Laminar Flow Bench #3 - Diana, flow, balances

$

36,500

 

Exyte - Athenex Estimate

$

36,500.00

41

ISO 5 Laminar Flow Bench #4 - Diana, flow, balances

$

36,500

 

Exyte - Athenex Estimate

$

36,500.00

41

ISO 5 Laminar Flow Bench #5 - Diana, flow, balances

$

36,500

 

Exyte - Athenex Estimate

$

36,500.00

41

ISO 5 Laminar Flow Bench #6 - Diana, flow, balances

$

36,500

 

Exyte - Athenex Estimate

$

36,500.00

41

Carts / Totes / Balance Cable 15 / 100 / 8

$

17,650

 

Exyte - Athenex Estimate

$

17,650.00

 

 

Exhibit 1 - Page 4 of 14

March 1, 2019