Document:

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]                            Confidentialexh_10-25.htm

 

Exhibit 10-25

 

$237,310.00              DEMAND UNSECURED NOTE

 

 

 

November 3, 2009

 

 

 

 

 

              FOR VALUE RECEIVED, the undersigned, CELLCEUTIX CORPORATION (the “Maker”), promises to pay to the order of Leo Ehrlich (“Lender”), at 100 Cummings Center, Suite 151-B, Beverly, MA 01915, or at such other location as Lender shall designate, the principal sum of Two Hundred Thirty Seven Thousand Three Hundred Ten and 00/100 Dollars ($237,310.00).  The aggregate unpaid principal and interest of such loan shall be paid by the Maker on demand.

 

 

 

              1.              Interest.  This Note shall bear interest from the date hereof on the aggregate unpaid principal amount hereof at the rate of six per cent (6.00%) per annum until September 30, 2009 and at the rate of nine per cent (9%) per annum thereafter.  All payments under this Note shall be treated first as payments of interest accrued as of the date of payment and then as payments of principal.

 

 

 

              2.              Repayment.  The Maker, from time to time, may repay this Note in whole or in part without premium or penalty, but with accrued interest to the date of repayment on the amount repaid. Each partial repayment of this Note shall be applied first to accrued interest, then to principal.

 

 

 

              3.              Cost of Collection.  The Maker agrees to pay the costs and expenses of collection incurred in connection with the enforcement by Lender or any other holder hereof of any of its rights under this Note, including, without limitation, reasonable attorneys' fees and disbursements.

 

 

 

              4.              Indemnity.  The Maker agrees to indemnify and hold harmless Lender and each of Lender’s agents, affiliates and advisors from and against all claims, damages, losses, liabilities and expenses (including, without limitation, fees and disbursements of counsel) that may be incurred by or asserted against Lender or any such agent, affiliate or advisor in connection with or arising out of any investigation, litigation or proceeding related to or arising out of this Note or any transaction contemplated hereby, excluding any such claims, damages, losses, liabilities or expenses incurred by reason of the gross negligence or willful misconduct of the indemnitee.  The obligations of the Maker under this indemnity shall survive the payment in full of this Note.

 

 

 

              5.              Waiver.  The Maker hereby waives presentment for payment, demand, notice of dishonor, and protest of this Note.  The Maker also hereby waives any and all existing and future claims and offsets against amounts due under this Note and agrees to pay in accordance with the terms of this Note all amounts due under this Note regardless of any claim which may be asserted by or on behalf of the Maker.

 

 

 

              6.              Governing Law.              THIS NOTE SHALL BE GOVERNED BY, AND CONSTRUED IN ACCORDANCE WITH, THE LAWS OF THE STATE OF MASSACHUSETTS WITHOUT REGARD TO CONFLICT OF LAWS PRINCIPLES.

 

 

 

              7.              Amendment.  No term or provision of this Note may be waived, altered, modified, or amended, except as Lender may consent thereto in writing.

 

 

 

              8.              Transfer.  Lender may transfer this Note, in whole or in part, and deliver to the transferee all or any part of the property then held by it as security hereunder, and the transferee shall thereupon become vested with all the powers and rights of Lender with respect to the property under this Note and the Financing Statements.  Lender thereafter shall be forever relieved and fully discharged from any liability or responsibility in the matter, but Lender shall retain all rights and powers given with respect to interests in this Note and to property not so transferred.

 

 

 

                    9.                  This Note replaces all earlier notes issued to Leo Ehrlich.

 

 

 

                   

 

              IN WITNESS WHEREOF, the undersigned has executed this Note as of the date first above written.

 

 

 

 

 

  CELLCEUTIX CORPORATION

 

 

 

 

 

   By: _______________________________

 

   Name:               George W. Evans

 

   Title:              Chief Executive Officer

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