REDACTED - AS FILED

REDACTED - AS FILED

Exhibit 10.26

 

CONFIDENTIAL

Prepared for Rose C. Perri, Generex Biotechnology Corporation

 

Table 1:  QAR Version History

 

QAR Number		Additional Cost ($)
01		[REDACTED]
Revised Total Estimated Project Cost		[REDACTED]

 

Section 6.  Reasons for Amendment

 

 

In order to expedite the project initiation, the project related activities and analytical methods transfer will be performed subject to the Standard Terms and Conditions (STC), effective June 20, 2006, between Cardinal Health and Generex Biotechnology Corporation. All other activities (Engineering Batch Production and Evaluation, Process Qualification, and Production of Clinical Supplies) will be performed per the Master Development and Clinical Services Agreement (MDCSA), pending negotiation, as specified in the original quotation. Should the MDCSA become fully executed prior to the completion of the project related activities and analytical methods transfer, the MDCSA will become the applicable legal agreement and will supercede the STC.

 

 

Generex Biotechnology Corporation has requested that Cardinal Health include full release testing of clinical batches of the Ora-lyn drug product produced at Cardinal Health’s RTP, NC facility. The original quotation included reduced release testing by “Identification by HPLC” (GNX-005), “Leak Rate/Net Content” (GNX-017), and “Fill Weight Finished Product” (GNX-024), “Microbial Limits” (USP <61>). Additional activities to be included are:

 

–	Cardinal Health will transfer in-house Generex’s Particle Size Distribution by Cascade Impaction method (assumed to be performed using an eight-stage cascade impactor)

–	It is assumed that the transfers included in the original quotation for GNX-005 and GNX-020 bulk product methodology will be sufficient for the transfer of GNX-006 and GNX-021 finished product methodology.

–	Full release analyses will be performed as listed in Table 2.

 

 

 

 

 

Table 2:  Full Release Methods for Reference

 

Reference		Method		Replicates per Batch Release
GNX-002		Physical Appearance of Finished Product (Oral-lyn)		[REDACTED]
GNX-004		pH of Finished Product for Aerosol can		[REDACTED]
GNX-006		HPLC Potency and Identity Determination for Insulin in Buccal Formulations (Finished Product Oral-lyn by Un-Crimped Method)		[REDACTED]
GNX-017		Leak Rate/Net Content (Aerosol Finished Product)		[REDACTED]
GNX-021		High Molecular Weight Protein (HMWP) Content of Insulin Drug Substance and Drug Product by Size Exclusion HPLC (Oral-lyn Finished Product)		[REDACTED]
GNX-022		HPLC Assay (Potency) and Identity Determination for Insulin in Buccal Formulations (Finished Product Oral-lyn by Actuation Method)1		[REDACTED]
GNX-024		Fill Weight Finish Product		[REDACTED]
TBD		Particle Size Distribution by Cascade Impaction		[REDACTED]
USP <61> & <1227>		Microbial Limits		[REDACTED]

 

¹ It is assumed that this HPLC Assay method will be used as the dose content analytical method.

 

Table 3:  Amended Cost Detail

 

Analysis		Cost ($)
Method Transfer		[REDACTED]
Batch Release (Per the methods listed in Table 2)		[REDACTED] per batch of [REDACTED] Units1  ([REDACTED] per unit)

 

¹ With full batch release, the total clinical supplies production cost for three batches is $[REDACTED], or $[REDACTED] above the $[REDACTED] cost quoted for reduced release testing in the original quotation.

 

Section 7.  Comments

 

This QAR, revised to include method transfer and full release testing activities, supercedes the “00” version issued June 21, 2006.

 

Section 8.   Approvals

 

Generex Biotechnology Corporation		Cardinal Health PTS, LLC
/s/ Rose C. Perri Signature		/s/ Annette Shanley Signature
Rose C. Perri Printed Name		Annette Shanley Printed Name
Chief Operating Officer Title		Manager, Contract Management Title
_______________ Date		_______________ Date

 

 

Contract Management: Project Coordination: Date: CAH Reference:

Wally Heritage David Shirley August 17, 2006 QAR-GFV-0001.01

 

 

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