exh_10-24.htm


Ehxibit 10-24


 






  





  











  



PROJECT AGREEMENT AND LETTER OF AUTHORIZATION




















FORMATECH, Inc.


200 Bulfinch Drive


Andover, MA 01810


Attention: Jeff Clement







Pursuant to the terms and conditions of a Contract Aseptic Fill Manufacturing Agreement MA-102-10 (the “Manufacturing Agreement”) by and between FORMATECH, INC. (hereinafter, FORMATECH) and Cellceutix, Inc., (hereinafter, “CLIENT”), CLIENT hereby authorizes FORMATECH to perform the services identified herein:








	
·  

	
using the components and excipients identified in Exhibit I, and








	
·  

	
in accordance with the Pricing Schedule identified in Exhibit II.












 



	
General Information


	
Product Name

	
Kevetrin


	
Product use and/or indication

	
Oncology


	
Molecule Type

	
Small Molecule


	
Batch Size (# of vials)

	
<3,500 Vials


	
Formulation

	
30.0 mg/mL


	
Fill volume:

	
1.0mL


	
Clinical Phase of Lot to be Manufactured

	
Phase I


	
Countries in which studies will be held

	
USA


	
Bulk Drug Substance Storage Conditions

	
CRT


	
Drug Product Storage Conditions

	
2-8°C

































































































If you agree to the aforementioned terms and conditions, please sign and return one copy of


this letter to the undersigned.







CELLCEUTIX, INC.












By: _______________________________












Date: ______________________________












Accepted and agreed to:







FORMATECH, INC.












By: ______________________________________












Date: _____________________________________












Disposition of product tailings, weight check vials, process and testing reject materials







Note: Formatech will dispose of all product tailings, weight check vials, process and testing reject vials within four (4) weeks of completion of manufacturing activities for this batch.







In the event that CLIENT wishes to reclaim these materials, please designate as such below and provide shipping information.







      Return to CLIENT or CLIENT designee







Ship to:                 _____________________________________________


_____________________________________________


_____________________________________________


_____________________________________________















FORMATECH, Inc., 200 Bulfinch Drive, Andover, MA  01810


FTI#: PA-036-10JC                                                                   Page  of [INSERT PAGE NUMBER]                            Confidential









  





  











  



PROJECT AGREEMENT AND LETTER OF AUTHORIZATION





















	
 


Exhibit I: Components, Excipients & Reagents


 


	
Components


	
Vials


	
Type

	
Size / Neck Size

	
Mfg. & Part #

	
Supplied / Released by


	
Type 1 Glass

	
2mL / 13mm

	
 TBD

	
Formatech


	
Stoppers


	
Style

	
Formulation / Coating

	
Mfg. & Part #

	
Supplied / Released by


	
Lyo

	
FluroTec

	
West; TBD

	
Formatech


	
Aluminum Seals


	
Style

	
Color

	
Mfg. & Part #

	
Supplied / Released by


	
13mm flip-off crimp seals

	
TBD

	
TBD

	
 Formatech


	
Sterile Filters


	
Mfg.

	
Type

	
Part #

	
Supplied / Released by


	
TBD

	
TBD

	
TBD

	
Formatech


	
Excipients & Reagents


	
Description

	
Grade

	
Mfg. & Part #

	
Supplied / Released by


	
API is formulated in WFI only.



























FORMATECH’s Component, Excipient and Reagent allowance is $2,000.00 per Project Agreement and CLIENT will be invoiced for all component, excipient, reagent and/or ID testing charges in excess of that amount.







*Please note that the following items will be addressed in the batch record with CLIENT input:







· Specifications regarding container closure and excipients/reagents manufacturers


· Catalog numbers and grades associated with container closure and excipients/reagents


· Numbers of reserve samples for testing required


· Filling tolerances and label claims








	
Exhibit II: MANUFACTURING SERVICES


	
Activity

	
Pricing

	
Notes


	
Disposable Manufacturing Equipment


· Glass Formulation & Filling Vessels, filling assemblies, sterilizing filters


 

	
 


$

	
 


 


	
Batch Record Development & Issuance

	
$

	  
	
Cleaning Qualification Study & Initial Cleaning Verification of Manufacturing Equipment


 

	  	
Verified using TOC Note: additional charges will be incurred if an alternate detection method is required i.e. RP-HPLC


	
Formulation:


·Formulation suite usage


·Continuous sparging with inert gas


·Other special services (UF/DF, etc.)


 

	
 


Incl.


N/A


N/A

	
 


 


 


 


	
Aseptic Manufacturing:


·Liquid Filling: ≤3,500  vials


(1 day process)


·Overtime charges, GMP suite


·Lyophilization: ≤48 hours


·Nitrogen gas overlay


·Other special services

	
 


$


 


TBD


$


N/A


N/A


 

	
 


Note: Formulation & filling in GMP suite not to exceed 8 continuous hours. If filtering/fill time is extended, the following overtime rates will apply:


· 1-4 hours: $/hour


· Over 4 hours: $/hour


· Additional day: $/day


 


	
Label Production and Drug Product Labeling

	
TBD

	
 Vial labeling required


  Box labels required


 Inkjet lot # on overseal


	
Bulk packaging


 

	
Included

	
Bulk pack into tamper-evident containers per Formatech SOP.


	
Shipping

	
TBD*

	
*Shipping and handling will be billed back to CLIENT separately


 


	
Total Cost of Manufacturing Services:             $ + TBD


























































	
Exhibit II (cont.): ANALYTICAL SERVICES


	
Activity

	
Pricing

	
Notes


	
 


 Bulk Drug Substance ID


	
Note: ID test material must be delivered to Formatech in a satellite container accompanying the API


 

	
TBD

	
 


	
 


Bulk Formulated Drug / In-process Testing


	
Density

	
$

	  
	
Bioburden (includes preparatory test)

	
$

	
Upon completion of the preparatory test,  the cost of this assay is $ for each subsequent fill


	
 


Sterile Filtered Bulk Drug


	
Bulk Sterility by membrane filtration

	
***

	
*** Outsourced – costs to be billed back to client.


	
 


Drug Product Release Testing


	
pH (3 samples)

	
$

	  
	
Osmolality (3 samples)

	
$

	  
	
Appearance (3 samples)

	
$

	  
	
Karl Fischer, Moisture Content (3 samples)

	
$

	  
	
Particulate Analysis (USP<788>)

	
***

	
*** Outsourced – costs to be billed back to client.


	
Sterility (and Bacteriostasis & Fungistasis if required)

	
***

	
*** Outsourced – costs to be billed back to client.


	
Bacterial Endotoxin (and inhibition & Enhancement if required)

	
***

	
*** Outsourced – costs to be billed back to client.


	
Total Cost of Analytical Services:                   $+ TBD & ***


 


	  
	
 


Final Project Cost:                                        $ USD + TBD & ***


	  










NOTE: Formatech will provide CLIENT with one (1) copy of the completed batch record for this fill and the cost is included in the total project cost.  Any additional documentation requested by CLIENT including but not limited to copies of raw data, additional copies of batch records, etc., will be provided if requested by CLIENT and additional charges will be applied.







All separate invoices for shipping and testing services include a 20% surcharge for handling and processing.
















  





  














FORMATECH, Inc., 200 Bulfinch Drive, Andover, MA  01810


FTI#: PA-036-10JC                                                                   Page  of [INSERT PAGE NUMBER]                            Confidential