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EXHIBIT 10.3
COST AND EVALUATION AGREEMENT
AHPharma, Inc. James L. McNaughton, Ph.D.
Food Safety & Animal Health Firm Chief Scientific Officer
Email: McNaughton@AHPharma.com
POULTRY SALMONELLA VACCINE PROJECT
COST AND EVALUATION AGREEMENT
GLOBAL GREEN, Inc. and AHPharma, Inc.
JULY 30, 2011
As mentioned in the initial Executive Summary, GLOBAL GREEN, Inc.
Vaccine USDA/FSIS regulatory approval is required. Generally, vaccine approvals
are relatively easier, less cumbersome and require much less scrutiny, and
therefore, less cost than with either FDA or EPA regulatory approval
requirements.
The entire project anticipated time frame includes:
- Final product evaluation of GLOBAL GREEN, Inc. GMP (Good Manufacturing
Practice, 21 CFR Part 110) material obtained from GLOBAL GREEN
(4-months required).
- Final vaccine product manufacturing (~8-12 months required).
- Approval time frame, including regulatory approval and commercial
field-testing (3 locations), we anticipate a 12-18 month time frame is
required.
- Consequently, the total timeframe is anticipated to be 12-18 months,
barring any unforeseen circumstances that may be out of our control
from either USDA/FSIS or the vaccine manufacturer.
Time frame variables include: time required for GLOBAL GREEN, Inc. to
produce GMP material, chosen manufacturing workload/production space
availability, and regulatory agency responses. Typically, with a vaccine,
AHPharma's experience has been that vaccine regulatory agencies are extremely
responsive and infrequently delays the process. AHPharma testing periods will
NOT be delayed and posed no treat to timing schedules. Anticipated time does not
include GLOBAL GREEN's time required to produce the final GMP material.
Project cost includes:
- Final product evaluation of GMP material
anticipated cost. A "Mock Study" will be tested
against Salmonella field strains throughout the
USA (at least three different locations and States
in three different regions). $ 60,000
- Final Marek's interference study on the final
product 20,000
- Final vaccine product manufacturing anticipated
cost (i.e., working with the manufacturer). 60,000
- Regulatory approval and field testing (3
locations) anticipated cost 160,000
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TOTAL $ 300,000
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AHPharma, Inc. Office Phone: 443-260-2499 Fax: 443-260-2476
Mailing Address: P.O. Box 3467, Salisbury, Maryland 21802
Shipping Address: 116 W. Chestnut Street, Salisbury, Maryland 21801
AHPharma, Inc. James L. McNaughton, Ph.D.
Food Safety & Animal Health Firm Chief Scientific Officer
Email: McNaughton@AHPharma.com
Cost does not include the GLOBAL GREEN's cost of development of GMP
material, actual manufacturing cost, initial batch-size field test material
and/or production cost. GMP guidelines are necessary to assure regulatory
agencies of the ability to create reproducible products, assure consistent
manufacturing practices, maintain appropriate record-keeping, ensure proper
storage, assure proper sanitation practices, etc. The vaccine manufacturing site
that is chosen must have the ability to work under the guidelines of GMP.
DISCLAIMER: Based on historical experience, AHPharma has attempted to evaluate
and anticipate ALL costs involved in obtaining final regulatory approval. Should
USDA require additional data collection, outside what is anticipated, factors
outside the control of either GLOBAL GREEN or AHPharma arise, additional funds
will be required to finish the final approval process. Until we obtain a final
bid from the product manufacturer, final manufacturing initial cost cannot be
fully finalized and is the cost area that may potential change. Anticipated
regulatory approval cost is a reasonably safe cost. At this time, we do not
anticipate that additional funds will be required.
AHPharma, Inc. GLOBAL GREEN, Inc.
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James L. McNaughton, Ph.D. Mehran Ghazvini, DC, NMD, CEO
President & CEO CEO of Global Green, Inc.
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Date Date
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AHPharma, Inc. Office Phone: 443-260-2499 Fax: 443-260-2476
Mailing Address: P.O. Box 3467, Salisbury, Maryland 21802
Shipping Address: 116 W. Chestnut Street, Salisbury, Maryland 2180
