-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, C7OB6a0upoSEk81Cr2Dj161pY/J/2p1VeksWIHkui/XeM8kK1XTq5eT6i67Xibqe 1FxMNSziB3L3tPAM84vMtQ== 0001144204-07-007652.txt : 20070214 0001144204-07-007652.hdr.sgml : 20070214 20070214120148 ACCESSION NUMBER: 0001144204-07-007652 CONFORMED SUBMISSION TYPE: 10-K/A PUBLIC DOCUMENT COUNT: 6 CONFORMED PERIOD OF REPORT: 20060731 FILED AS OF DATE: 20070214 DATE AS OF CHANGE: 20070214 FILER: COMPANY DATA: COMPANY CONFORMED NAME: GENEREX BIOTECHNOLOGY CORP CENTRAL INDEX KEY: 0001059784 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 820490211 STATE OF INCORPORATION: DE FISCAL YEAR END: 0731 FILING VALUES: FORM TYPE: 10-K/A SEC ACT: 1934 Act SEC FILE NUMBER: 000-25169 FILM NUMBER: 07616178 BUSINESS ADDRESS: STREET 1: 33 HARBOUR SQ STREET 2: STE 202 CITY: TORONTO ONTARIO CANADA STATE: A1 ZIP: M5J 2G2 BUSINESS PHONE: 4163642551 MAIL ADDRESS: STREET 1: 33 HARBOUR SQ STREET 2: STE 202 CITY: TORONTO ONTARIO CA STATE: A1 ZIP: M5J 2G2 10-K/A 1 v065783_10ka.htm
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 10-K
Amendment No. 2

(Mark One)
x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended July 31, 2006

o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from _______ to _______

Commission file number 000-25169
 
GENEREX BIOTECHNOLOGY CORPORATION
(Exact name of registrant as specified in its charter)

Delaware
 
98-0178636
(State or other jurisdiction of
 
(I.R.S. Employer
incorporation or organization)
 
Identification No.)
     
33 Harbour Square, Suite 202, Toronto, Canada
 
M5J 2G2
(Address of principal executive offices)
 
(Zip Code)

(416) 364-2551
(Registrant’s telephone number, including area code)

N/A
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
 
Title of each class
 
Name of each exchange on which registered
Common Stock, $.001 par value per share
 
The NASDAQ Stock Market LLC

Securities registered pursuant to Section 12(g) of the Act: None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.      
Yes o    No þ

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act.    Yes o    No þ

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes þ      No o

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. o No þ

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act.    
 
Large accelerated filer o      Accelerated filer þ       Non-accelerated filer o

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    
Yes o    No þ

As of January 31, 2006, the aggregate market value of the registrant’s common stock held by non-affiliates of the registrant was $82,310,308 based on the closing sale price as reported on the NASDAQ Capital Market. Generex Biotechnology Corporation has no non-voting common equity. At October 10, 2006, there were 107,616,478 shares of common stock outstanding.

DOCUMENTS INCORPORATED BY REFERENCE: Portions of the Proxy Statement for the registrant’s Annual Meeting of Stockholders, or an amendment to this Annual Report on Form 10-K, to filed within 120 after the end of the fiscal year ended July 31, 2006, are incorporated by reference into Part III of this Annual Report on Form 10-K.


 
 
 Generex Biotechnology Corporation
Form 10-K/A
July 31, 2006

Index

 
 
Page
Part IV
 
 
 
 
Item 15.
 
Exhibits and Financial Statement Schedules.
 
2
 
 
 
 
 
Signatures
 
 
 
3
 

 
Explanatory Note

This Amendment No. 2 (“Amendment”) to the Company’s Annual Report on Form 10-K for the year ended July 31, 2006 (the “Form 10-K”) is being filed solely to include a revised version of Exhibit 10.25, which is the subject of the Company’s request for confidential treatment submitted on October 16, 2006. In response to comments of the Staff relating to the Company’s request for confidential treatment, the Company has revised Exhibit 10.25 to include the following items that were redacted in the previously filed version of Exhibit 10.25: the estimated aggregate production period (found in the Executive Summary on page 2) and the termination notice requirement (found in Section 8.1 on page 12). Except as described above, no other change has been made to the Form 10-K, and this Form 10-K/A does not amend, update or change the any other Item or the disclosures in the Form 10-K in any way. This Form 10-K/A does not reflect events occurring after the filing of the Form 10-K or modify or update those disclosures, including any exhibits to the Form 10-K affected by subsequent events.

1


PART IV
 
Item. 15  Exhibits and Financial Statements and Schedules.

(a)  
3.   Exhibits
Exhibit
Number
 
Description of Exhibit (1)
 
 
 
10.25
 
Quotation for Contract Manufacturing of Oral-lyn™ entered into between Generex Biotechnology Corporation and Cardinal Health PTS, LLC on June 20, 2006 (subject to confidential treatment)*
 
 
 
31.1
 
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*
 
 
 
31.2
 
Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*
 
 
 
32
 
Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*
 

*Filed herewith.
 
2


Signatures

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized this 14th day of February 2007.

 
 
 
 
GENEREX BIOTECHNOLOGY CORPORATION
 
 
 
 
 
 
 
By:  
/s/ Anna E. Gluskin  
 

Name:   Anna E. Gluskin
 
Title:   Chief Executive Officer and President

3

 
EXHIBIT INDEX 

Exhibit
Number
 
Description of Exhibit (1)
 
 
 
10.25
 
Quotation for Contract Manufacturing of Oral-lyn™ entered into between Generex Biotechnology Corporation and Cardinal Health PTS, LLC on June 20, 2006 (subject to confidential treatment)*
 
 
 
31.1
 
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*
 
 
 
31.2
 
Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*
 
 
 
32
 
Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*
 

*Filed herewith.
 
4

 
EX-10.25 2 v065783_ex10-25.htm
REDACTED - AS FILED

THE MARKED PORTIONS OF THIS AMENDMENT HAVE BEEN OMITTED
AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO
A REQUEST FOR CONFIDENTIAL TREATMENT
 
Quotation

Contract Manufacturing of Ora-lyn™ 

 
June 5, 2006


 
Customer Contact: Rose C. Perri
33 Harbour Square
   
Account Manager: Tom Clark
Phone: 919-465-8319
Contract Manager: Wally Heritage
Phone: 919-465-8284 
 
 
BioPharmaceutical Product Development
   
 
 Pharmaceutical Product Development
   
cardinalhealth logo
Clinical Packaging Services
 
Analytical Chemistry and Microbiology Services
 
 
Scientific and Regulatory Consulting
   
 
Pulmonary and Nasal Product Development
   
 
 Clinical and Small Scale Commercial Manufacturing
 
CONFIDENTIAL
 

 
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Executive Summary

Cardinal Health, Pharmaceutical Development (Cardinal Health) will perform a technical transfer for the production of Oral-lyn™ for Generex Biotechnology Corporation (Generex). Following the technical transfer, Cardinal Health will produce Phase III clinical supplies of the Oral-lyn drug product. The estimated cost for the technical transfer and Phase III clinical batch production is $[REDACTED] over a period of approximately seven months. If the three process qualification batches are used as the Phase III clinical supplies, the total estimated cost will be $[REDACTED].

Section 1. Version History

Table 1: Revisions
 
Version
 
Date Issued
 
Reason(s)
00
 
May 11, 2006
 
New Issue
         
01
 
June 5, 2006
 
1. Reduced the total number of clinical supplies needed to [REDACTED] (Table 4)
2. Reduced the amount of in-process testing required per batch. (Tables 2 and 4)
3. Removed full raw materials release and included release by Identification and Certificates of Analysis. (Table 4)
4. Removed finished product full release testing from the scope of work. (Tables 2 and 4)
5. Included invoicing schedule. (Table 11)

Section 2. Scope of Work

Cardinal Health will perform a technical transfer for the production of Oral-lyn drug product for Generex. The technical transfer will include the transfer of analytical methods, the production of an engineering batch, and then production of three process qualification batches. If appropriate, all three process qualification batches will serve as Phase III clinical trial materials. Otherwise, Cardinal Health will produce additional batches for Phase III clinical supplies to support Generex’s clinical studies. All activities will be conducted according to cGMPs.

2.1. Safety

2.1.1. Cardinal Health’s Responsibilities

Cardinal Health will assess all vendor and Generex MSDSs and all handling data for the samples/materials associated with this project. When samples/materials are categorized as a Controlled Drug Substance (CDS) and/or Class 4 and above, the samples/materials will require special handling precautions and procedures.
 

 160 Cardinal Health Way • Morrisville, NC 27560 • PO Box 13341 • RTP, NC 27709
Direct: (919) 481-4855 • Facsimile: (919) 481-4908 • www.cardinal.com/pts
 
 

 
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If categorized as a CDS, Cardinal Health will invoice Generex a CDS Handling Surcharge for all project activities. If categorized as a Class 4 or above, Cardinal Health will invoice Generex for compound specific monitoring, supplies, or equipment purchased specifically for this project to ensure safe handling of Generex‘s samples and materials. It is not anticipated that Generex’s product will be categorized as a CDS or Class 4 compound.

2.1.2. Generex’s Responsibilities

Generex will provide an MSDS and all sample/material handling data for the samples/materials associated with this project. If samples/materials have any special handling considerations, Generex will notify Cardinal Health prior to the initiation of the project.

2.2. Methods/Documentation

Table 2: Methods for Reference 
 
       
Replicates per Analysis
Reference
 
Method
 
In-process Testing 
 
Batch Release
GNX-001
 
Physical Appearance of Oral-lyn Bulk Drug Product
 
1
 
-
             
GNX-003
 
pH Test For Bulk
 
1
 
-
             
GNX-005
 
HPLC Potency and Identity Determination for Insulin in Bulk Product
 
1
 
1
             
GNX-017
 
Leak Rate/Net Content (Aerosol Finished Product)
 
-
 
10
             
GNX-020
 
High Molecular Weight Protein (HMWP) Content of Oral-lyn Drug Substance and Drug Product by Size Exclusion HPLC (Oral-lyn Bulk Drug Product)
 
1
 
-
             
GNX-024
 
Fill Weight Finish Product
 
-
 
3
             
USP <61> & <1227>
 
Microbial Limits
 
1
 
1
             
SOP-MC-019-002
 
Cleaning Verification
 
-
 
-

2.2.1. Cardinal Health’s Responsibilities

Cardinal Health will review all project-related documentation and methods received from Generex associated with this project.

2.2.2. Generex’s Responsibilities

Generex will provide all available project-related documentation and methods to be used for this project.
 

160 Cardinal Health Way • Morrisville, NC 27560 • PO Box 13341 • RTP, NC 27709
Direct: (919) 481-4855 • Facsimile: (919) 481-4908 • www.cardinal.com/pts
 

 
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2.3. Sample/Materials

Table 3: Raw Materials
 
Raw Material
 
Supplier
[REDACTED]
 
[REDACTED]
[REDACTED]
 
[REDACTED]
[REDACTED]
 
[REDACTED]
[REDACTED]
 
[REDACTED]
[REDACTED]
 
[REDACTED]
[REDACTED]
 
[REDACTED]
[REDACTED]
 
[REDACTED]
[REDACTED]
 
[REDACTED]
[REDACTED]
 
[REDACTED]
[REDACTED]
 
[REDACTED]
[REDACTED]
 
[REDACTED]
[REDACTED]
 
[REDACTED]

2.3.1. Cardinal Health’s Responsibilities

Cardinal Health will, as necessary, log in all samples/materials according to current Standard Operating Procedures. Upon issuance of the final report or Certificate of Analysis, samples/materials will be stored in quarantine at Cardinal Health for a period of 30 days. After the 30-day quarantine, samples/materials will be disposed of at Cardinal Health unless notified otherwise by Generex.

2.3.2. Generex’s Responsibilities

If available, Generex will provide all samples/materials necessary to perform this project. The samples/materials should arrive at Cardinal Health with all proper documentation. If samples/materials are not available, Generex will request Cardinal Health to purchase all necessary samples/materials needed to perform this project. If return shipment is requested, Generex will notify Cardinal Health prior to the disposition of samples/materials.
 

160 Cardinal Health Way • Morrisville, NC 27560 • PO Box 13341 • RTP, NC 27709
Direct: (919) 481-4855 • Facsimile: (919) 481-4908 • www.cardinal.com/pts
 

 
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Section 3. Project Activities

3.1. Cardinal Health’s Responsibilities

Cardinal Health will transfer analytical methods in-house from Generex, produce engineering and process qualification batches, and produce clinical supplies as indicated in Table 4.

Table 4: Project Activities and Costs
 
Study Phase
 
Activities
Project Related Activities
 
Cardinal Health will carry out project related activities that include initial project discussions with Generex, project team selection, agreement to and approval of project activities, and program management activities.
     
Analytical Methods Transfer
 
Transfer of Generex’s analytical methods listed in Table 21 .
     
Raw Materials Release
 
Cardinal Health will release the raw materials listed in Table 3 for use with the engineering, process qualification, and clinical batches. It is assumed that Generex will perform full release of all raw materials and Cardinal Health will release raw materials based on Identification and Certificates of Analysis. 2 
     
Engineering Batch
 
· Preparation of product inventory specifications
· Preparation of batch records
· Production of one [REDACTED]-canister placebo batch
· Production of one [REDACTED]-canister active batch
· Process evaluation analysis consisting of:
· In-process and finished product analysis by the methods listed in Table 2
· Check weighing
· Automatic valve function (spray testing)
· Cleaning verification
 

1 It is assumed that analytical methods are validated to a level sufficient for Phase III activities. Cardinal Health requests that a report detailing the validation of the all methodology be provided prior to transfer activities.
 
2 It is assumed that Cardinal Health will perform Identification and CoA release testing once for the engineering batches, once for the three process qualification batches, and once for the Phase III clinical supply batches.
 

160 Cardinal Health Way • Morrisville, NC 27560 • PO Box 13341 • RTP, NC 27709
Direct: (919) 481-4855 • Facsimile: (919) 481-4908 • www.cardinal.com/pts
 

 
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Table: 4  Project Activities and Costs (continued)

Study Phase
 
Activities
Process Qualification
 
Production of process qualification batches will consist of the following activities for each of the three batches:
· Pre-production activities
· Preparation of product specifications
· Preparation of batch records
· Production activities
· Filling up to [REDACTED] canisters with the Oral-lyn drug product
· In-process control analysis (post-production analysis) of bulk and finished drug product
· Release of finished drug product per methods listed in Table 2
· Cleaning verification after the manufacture of each batch
It is proposed that if the production and release analysis of the process qualification batches is acceptable, the process qualification batches may serve as clinical supplies. If process qualification batches are to be used as clinical supplies, the following additional activities will be performed:
· Bulk packaging and labeling1 
· Shipment of samples to a clinical packaging and services facility3 
     
Clinical Supplies Production
 
If necessary (based on the use of Process Qualification batches as clinical supplies) Cardinal Health will produce up to three batches of the Oral-lyn drug product for use in clinical studies. Activities will include:
· Pre-production activities
· Receipt and release of API, valves, canisters, and actuators1
· Preparation of batch records
· Production activities
· Filling up to [REDACTED] canisters per batch with the Oral-lyn drug product
· In-process control analysis (post-production analysis) of bulk drug product and finished product
· Release of finished drug product per methods listed in Table 2
· Bulk packaging and labeling1,2
· Shipment of samples to a clinical packaging and services facility (e.g. Cardinal Health’s Clinical Packaging Services facility in Philadelphia4 
 
The costs associated with stability studies (storage and analysis) to support Phase III clinical studies are not included in this quotation. Cardinal Health has the experience, capabilities, and facilities to provide stability study services if requested by Generex.
 

1 The costs associated with long-term storage of bulk product is not included in this quotation.
 
2 The costs associated with assembly of the canisters into actuators and dust caps is not included in this quotation. It is assumed that assembly will occur at the clinical packaging and labeling facility.
 
3 The costs associated with shipment to the clinical packaging and labeling facility is not included in this quotation but will be invoiced to Generex at cost. Packaging and labeling of clinical supplies is not included in this quotation.
 
4 The costs associated with shipment to the clinical packaging and labeling facility is not included in this quotation but will be invoiced to Generex at cost. Packaging and labeling of clinical supplies is not included in this quotation.
 

160 Cardinal Health Way • Morrisville, NC 27560 • PO Box 13341 • RTP, NC 27709
Direct: (919) 481-4855 • Facsimile: (919) 481-4908 • www.cardinal.com/pts
 

 
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3.2. Generex’s Responsibilities

Generex will sign the protocol and provide a technical contact that will be available for technical discussions and to make decisions that are needed in reference to this project. Generex will not use any samples/materials shipped from Cardinal Health for this project in a manner that is inconsistent with the scope of this project.

Section 4. Specifications

4.1. Cardinal Health’s Responsibilities

Cardinal Health will document the specifications, if applicable, in the protocol.
 
4.2. Generex’s Responsibilities

Generex will provide all specifications necessary to perform this project.

Section 5. Scheduling/Deliverables

5.1. Scheduling

Cardinal Health must receive a signed Quotation with a Purchase Order number, a signed protocol, all samples/materials, and must have on file a signed and effective terms and conditions and Quality Agreement (if applicable) in order for this project to be scheduled. Once scheduled, Cardinal Health will notify Generex of the anticipated start and completion date of the project activities.

Rush services are available at Generex’s request. If rush services are requested, additional costs will be incurred, ranging from [REDACTED] to [REDACTED]% of the project cost and depending upon the lead-time provided and Generex-requested turnaround time.

A proposed timeline based on the clinical supplies requirements and raw materials constraints as anticipated at the time of quotation issuance is included in Table 5.
 

160 Cardinal Health Way • Morrisville, NC 27560 • PO Box 13341 • RTP, NC 27709
Direct: (919) 481-4855 • Facsimile: (919) 481-4908 • www.cardinal.com/pts
 

 
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Table 5: Anticipated Project Timelines
 
[REDACTED]
 

160 Cardinal Health Way • Morrisville, NC 27560 • PO Box 13341 • RTP, NC 27709
Direct: (919) 481-4855 • Facsimile: (919) 481-4908 • www.cardinal.com/pts
 

 
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5.2. Communication

In order to establish a collaborative relationship between Generex and Cardinal Health, Cardinal Health will appoint a project management representative to serve as a point of contact for Generex and to oversee progress on this project. Upon initiation of the project, Cardinal Health and Generex will establish a communication plan to include primary points of contact for both Cardinal Health and Generex. In addition, Cardinal Health and Generex will establish project meeting schedule(s), with scope, frequencies and durations to be mutually agreed upon by both parties.

5.3. Deliverables

Table 6: Tasks/Deliverables
 
Task
 
Deliverable
     
Technical Transfer
 
Analytical method transfer activities
· Analytical methods transfer report
Pre-production activities
· Product inventory specifications
· Master batch records
Engineering Batch
· Production batch records
· [REDACTED] placebo canisters
· [REDACTED] active canisters
Process Qualification
· Production batch records
· [REDACTED] canisters per process qualification batch (three batches total)
· Process qualification report
Technical transfer report
     
Phase III Clinical Supply Production
 
· Production batch records
· [REDACTED] canisters per Phase III clinical batch (3 total batches for a total of [REDACTED] canisters)
· Certificates of Analysis for each batch
· Bulk packaged and labeled supplies shipped to Cardinal Health’s clinical packaging and labeling facility in Philadelphia, PA
 

160 Cardinal Health Way • Morrisville, NC 27560 • PO Box 13341 • RTP, NC 27709
Direct: (919) 481-4855 • Facsimile: (919) 481-4908 • www.cardinal.com/pts
 

 
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Section 6. Cost Proposal

6.1 Project Cost

Table 7: Project Related Activities Costs1 
 
Activity
 
Estimated Cost ($)
Project Related Activities
 
[REDACTED]
 
Table 8: Technical Transfer Costs
 
Technical Transfer Activity
 
Cost ($)
Analytical Methods Transfer
 
REDACTED
     
Engineering Batch Production and Evaluation of
One Active and One Placebo Batch
 
[REDACTED]
     
Process Qualification (Three Batches of [REDACTED])
 
[REDACTED]
     
Total Technical Transfer Cost
 
[REDACTED]

Table 9: Phase III Clinical Supply Production Costs
 
Activity
 
Cost ($)
Production of Clinical Supplies
 
[REDACTED]/batch of [REDACTED] units
($[REDACTED] per canister)
     
Total Clinical Supplies Production Costs for Three Batches
 
[REDACTED]
 
Table 10: Total Project Costs
 
Activity
 
Cost ($)
Project Related Activities
 
[REDACTED]
     
Technical Transfer
 
[REDACTED]
     
Phase III Clinical Supply Production
 
[REDACTED]
     
Total Project Costs
 
[REDACTED]2 
 

1 Project Related Activities, as detailed in Section 3.1, will be performed over the course of the program and will include frequent communications with Generex during technical transfer activities and project management of the technical transfer and subsequent Phase III batch productions.
2 The total project cost, excluding project related activities, will be $[REDACTED] if all three Process Qualification batches are used for Phase III clinical supplies and no additional batches are produced. Project related activities will be invoiced as accrued.
 

160 Cardinal Health Way • Morrisville, NC 27560 • PO Box 13341 • RTP, NC 27709
Direct: (919) 481-4855 • Facsimile: (919) 481-4908 • www.cardinal.com/pts
 

 
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6.2. Additional Fees

If copies of raw data are requested in the course of an active project, Generex will be invoiced at $[REDACTED]/hour for time required to generate and compile the data.

All requested samples/materials purchased by Cardinal Health for this project will be invoiced to Generex, at cost.

Non-standard or special instrumentation or equipment required solely for Generex’s project will be invoiced to Generex following Generex approval.

6.3. Revisions to Pricing

Cardinal Health reserves the right to revise quoted costs for any project as a result of initial scope change, revisions in protocols, modifications of test methods, final review of test methods, undocumented requirements, retesting or resynthesis, or any unforeseen difficulty in executing the project. The additional work will be performed based on written agreement from Generex and will be documented on a Cardinal Health Quotation Amendment Request (QAR).

All required investigational work (such as OOS investigations, troubleshooting chromatographic methods, etc.) may be conducted without prior approval from Generex, for up to [REDACTED] scientist hours per occurrence. If the additional work requires going beyond [REDACTED] hours, Generex will be contacted prior to continuation. All investigational retesting performed that is not directly due to a Cardinal Health error will be invoiced to Generex.
 

160 Cardinal Health Way • Morrisville, NC 27560 • PO Box 13341 • RTP, NC 27709
Direct: (919) 481-4855 • Facsimile: (919) 481-4908 • www.cardinal.com/pts
 

 
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Section 7. Invoicing and Payment Terms

7.1. Invoicing
 
Cardinal Health will [REDACTED]. Cardinal Health will issue invoices as detailed below. Costs for activities, not including any pass-through costs, will not exceed those listed in Section 6 without Generex’s approval.
 
Table 11: Invoicing Schedule
 
Activity
 
Invoice Schedule/Amount
Quotation Acceptance
by Generex
 
 $[REDACTED] (deposit to be made by Generex)1 
     
Project Related Activities
 
Invoiced monthly as accrued
     
Analytical Method Transfer
 
Invoiced monthly until completion
     
Engineering Batch Production
and Evaluation
 
Invoiced monthly until completion
     
Process Qualification
 
Invoiced upon batch completion [REDACTED]2 
     
Production of Clinical Supplies
 
Invoiced upon batch completion [REDACTED]2
     
Generex’s Regulatory Submission to the Canadian Agency
 
Invoiced upon submission [REDACTED]

7.2. Payment Terms

Payments toward all invoices are due within [REDACTED] days of receipt of invoice and are non-refundable. Any applicable wire transfer fee must be included in the payment issued to Cardinal Health. Remit all payments to:

Cardinal Health, Pharmaceutical Development, RTP
4673 Collections Center Drive
Chicago, IL 60693

Section 8. Additional Project Terms

8.1. Termination / Cancellation

Either party may terminate the Project or any portion thereof at any time by providing forty-five (45) days written notice. In the event of a termination by Generex, Cardinal Health will promptly scale down the affected portion of the Project to avoid (or minimize, where non-cancellable) any further related expenses. On the effective date of termination, Generex will make payment to Cardinal Health in an amount equal to the costs incurred by Cardinal Health for all work performed prior to the effective date, any costs necessary to scale-down the Project, any non-cancellable commitments made by Cardinal Health prior to notice of termination, and any cancellation fees pursuant to the details below. Additionally, Cardinal Health will invoice Generex the cost of any sample/materials, reference materials, equipment, and supplies purchased by Cardinal Health specifically for this project.
 
1 The $[REDACTED] deposit will be applied to the final invoice for Process Qualification activities (or Clinical Supplies production if performed).
2 Batch completion will be marked by release of materials to Generex for analysis.
 

160 Cardinal Health Way • Morrisville, NC 27560 • PO Box 13341 • RTP, NC 27709
Direct: (919) 481-4855 • Facsimile: (919) 481-4908 • www.cardinal.com/pts
 

 
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CONFIDENTIAL
Page  13
 
In addition to costs already incurred, Cardinal Health reserves the right to invoice Project Cancellation fees according to the following calendar day schedule: Batch Cancellation notice of 20 to 29 days - [REDACTED]% of cost for Batch Manufacture, 10 to 19 days - [REDACTED]% of cost for Batch Manufacture, 4 to 9 days - [REDACTED]% of cost for Batch Manufacture and 0 to 3 days - [REDACTED]% of cost of Batch Manufacture.
 
8.2. Project Notes and Assumptions

Generex acknowledges that the results of experimental/development work and the outcome of prevalidated manufacturing are not predictable and agrees that Generex shall pay for all work conducted and for all product batches produced in accordance within this quotation regardless of outcome.

Costs assume that raw material vendors will not be qualified by Cardinal Health. Qualification of vendors may represent a potential opportunity for cost savings and may be discussed with Generex in greater detail, if requested.

It is assumed that a single cleaning verification will be performed after the production of each two-batch campaign.
 
Costs assumes high yields (>[REDACTED]%).
 

160 Cardinal Health Way • Morrisville, NC 27560 • PO Box 13341 • RTP, NC 27709
Direct: (919) 481-4855 • Facsimile: (919) 481-4908 • www.cardinal.com/pts
 

 
QTE-GFV-0001.01 
CONFIDENTIAL
Page  14
 
8.3. Standard Terms and Conditions

All work performed under this quotation is subject to the Master Development and Clinical Services Agreement, pending negotiation, between Cardinal Health and Generex.

Section 9. Project Approval and Authorization

By signing below, Generex Biotechnology Corporation agrees to the project details as set forth in this Quotation.
 
Generex Biotechnology Corporation     Cardinal Health PTS, LLC
       
       
/s/ Rose C. Perri     /s/ Troy M. Young

Signature
   
Signature
   
Rose C. Perri    
Troy M. Young

Printed Name
   

Printed Name
       
Chief Operating Officer
   
Director, Business Services

Title
   

Title
       
June 20, 2006
   
6/5/2006

Date
   

Date
       

PO Number
     
 
Please sign and return a copy of the Quotation Approval Page via fax to Wally Heritage at
(919) 481-4908 or email at wally.heritage@cardinal.com.
 

160 Cardinal Health Way • Morrisville, NC 27560 • PO Box 13341 • RTP, NC 27709
Direct: (919) 481-4855 • Facsimile: (919) 481-4908 • www.cardinal.com/pts
 

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Exhibit 31.1
 
CERTIFICATION

I, Anna E. Gluskin, certify that:

 
1.
 
I have reviewed this Amendment No. 2 to Annual Report on Form 10-K of Generex Biotechnology Corporation;
 
     
 
2.
 
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
 
     
 
3.
 
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
 
     
 
4.
 
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 
a)
 
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
 
     
 
b)
 
Designed such internal control over financial reporting or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
       
 
c)
 
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
 
     
 
d)
 
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 
5.
 
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 
a)
 
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
 
     
 
b)
 
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

     
DATE: February 14, 2007 By:   /s/ Anna E. Gluskin
 
Anna E. Gluskin, Chief Executive Officer
  (Principal Executive Officer)
 

EX-31.2 5 v065783_ex31-2.htm
Exhibit 31.2

CERTIFICATION

I, Rose C. Perri, certify that:

 
1.
 
I have reviewed this Amendment No. 2 to Annual Report on Form 10-K of Generex Biotechnology Corporation;
 
     
 
2.
 
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
 
     
 
3.
 
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
 
     
 
4.
 
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 
a)
 
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
 
     
 
b)
 
Designed such internal control over financial reporting or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
       
 
c)
 
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
 
     
 
d)
 
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 
5.
 
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 
a)
 
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
 
     
 
b)
 
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
 
     
DATE: February 14, 2007 By:   /s/ Rose C. Perri
 
Rose C. Perri, Chief Financial Officer
  (Principal Financial and Accounting Officer)
 

EX-32 6 v065783_ex32.htm
Exhibit 32

CERTIFICATIONS

Pursuant to Section 906 of the Public Company Accounting Reform and Investor Protection Act of 2002 (18 U.S.C. ss. 1350, as adopted), Anna E. Gluskin, Chief Executive Officer and President of Generex Biotechnology Corporation (the "Company"), and Rose C. Perri, Chief Financial Officer of the Company, each hereby certifies that, to the best of her knowledge:

1.  The Company's Amendment No. 2 to its Annual Report on Form 10-K for the period ended July 31, 2006, and to which this Certification is attached as Exhibit 32 (the "Report") fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

2.  The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company at the end of the period covered by the Report.
 
     
DATE: February 14, 2007 By:   /s/ Anna E. Gluskin
 
Anna E. Gluskin, Chief Executive Officer
  (Principal Executive Officer)
 
     
DATE: February 14, 2007 By:   /s/ Rose C. Perri
 
Rose C. Perri, Chief Financial Officer
  (Principal Financial and Accounting Officer)
 
 
 

 
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