PROJECT AGREEMENT AND LETTER OF AUTHORIZATION
Ehxibit 10-24
PROJECT AGREEMENT AND LETTER OF AUTHORIZATION
FORMATECH, Inc.
000 Xxxxxxxx Xxxxx
Xxxxxxx, XX 00000
Attention: Xxxx Xxxxxxx
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:
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using the components and excipients identified in Exhibit I, and
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in accordance with the Pricing Schedule identified in Exhibit II.
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General Information
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Product Name
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Kevetrin
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Product use and/or indication
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Oncology
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Molecule Type
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Small Molecule
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Batch Size (# of vials)
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<3,500 Vials
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Formulation
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30.0 mg/mL
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Fill volume:
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1.0mL
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Clinical Phase of Lot to be Manufactured
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Phase I
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Countries in which studies will be held
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USA
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Bulk Drug Substance Storage Conditions
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CRT
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Drug Product Storage Conditions
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2-8°C
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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.
Ship to: _____________________________________________
_____________________________________________
_____________________________________________
_____________________________________________
FORMATECH, Inc., 000 Xxxxxxxx Xxxxx, Xxxxxxx, XX 00000
FTI#: PA-036-10JC Page of [INSERT PAGE NUMBER] Confidential
PROJECT AGREEMENT AND LETTER OF AUTHORIZATION
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Exhibit I: Components, Excipients & Reagents
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Components
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Vials
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Type
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Size / Neck Size
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Mfg. & Part #
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Supplied / Released by
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Type 1 Glass
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2mL / 13mm
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TBD
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Formatech
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Stoppers
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Style
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Formulation / Coating
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Mfg. & Part #
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Supplied / Released by
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Lyo
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FluroTec
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West; TBD
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Formatech
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Aluminum Seals
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Style
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Color
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Mfg. & Part #
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Supplied / Released by
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13mm flip-off crimp seals
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XXX
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XXX
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Formatech
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Sterile Filters
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Mfg.
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Type
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Part #
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Supplied / Released by
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XXX
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XXX
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TBD
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Formatech
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Excipients & Reagents
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Description
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Grade
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Mfg. & Part #
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Supplied / Released by
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API is formulated in WFI only.
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FORMATECH’s Component, Excipient and Reagent allowance is $2,000.00 per Project Agreement and CLIENT will be invoiced for all component, excipient, reagent and/or ID testing charges in excess of that amount.
*Please note that the following items will be addressed in the batch record with CLIENT input:
· Specifications regarding container closure and excipients/reagents manufacturers
· Catalog numbers and grades associated with container closure and excipients/reagents
· Numbers of reserve samples for testing required
· Filling tolerances and label claims
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Exhibit II: MANUFACTURING SERVICES
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Activity
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Pricing
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Notes
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Disposable Manufacturing Equipment
· Glass Formulation & Filling Vessels, filling assemblies, sterilizing filters
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$
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Batch Record Development & Issuance
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$
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Cleaning Qualification Study & Initial Cleaning Verification of Manufacturing Equipment
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Verified using TOC Note: additional charges will be incurred if an alternate detection method is required i.e. RP-HPLC
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Formulation:
·Formulation suite usage
·Continuous sparging with inert gas
·Other special services (UF/DF, etc.)
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Incl.
N/A
N/A
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Aseptic Manufacturing:
·Liquid Filling: ≤3,500 vials
(1 day process)
·Overtime charges, GMP suite
·Lyophilization: ≤48 hours
·Nitrogen gas overlay
·Other special services
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$
TBD
$
N/A
N/A
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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
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Label Production and Drug Product Labeling
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TBD
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Bulk packaging
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Included
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Bulk pack into tamper-evident containers per Formatech SOP.
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Shipping
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TBD*
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*Shipping and handling will be billed back to CLIENT separately
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Total Cost of Manufacturing Services: $ + TBD
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Exhibit II (cont.): ANALYTICAL SERVICES
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Activity
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Pricing
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Notes
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Bulk Drug Substance ID
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Note: ID test material must be delivered to Formatech in a satellite container accompanying the API
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TBD
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Bulk Formulated Drug / In-process Testing
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Density
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$
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Bioburden (includes preparatory test)
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$
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Upon completion of the preparatory test, the cost of this assay is $ for each subsequent fill
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Sterile Filtered Bulk Drug
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Bulk Sterility by membrane filtration
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***
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*** Outsourced – costs to be billed back to client.
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Drug Product Release Testing
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pH (3 samples)
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$
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Osmolality (3 samples)
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$
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Appearance (3 samples)
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$
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Xxxx Xxxxxxx, Moisture Content (3 samples)
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$
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Particulate Analysis (USP<788>)
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***
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*** Outsourced – costs to be billed back to client.
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Sterility (and Bacteriostasis & Fungistasis if required)
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***
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*** Outsourced – costs to be billed back to client.
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Bacterial Endotoxin (and inhibition & Enhancement if required)
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***
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*** Outsourced – costs to be billed back to client.
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Total Cost of Analytical Services: $+ TBD & ***
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Final Project Cost: $ USD + TBD & ***
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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., 000 Xxxxxxxx Xxxxx, Xxxxxxx, XX 00000
FTI#: PA-036-10JC Page of [INSERT PAGE NUMBER] Confidential
