Exhibit 10.7
VISTA BIOLOGICALS STATEMENT OF WORK
The following information, production outline and specifications will be used in
completing the contractual obligations between Vista Biologicals Corporation
(VISTA) and CytoDyn, Inc. (CytoDyn).
VISTA Information
Company: Vista Biologicals Corporation
2120-C Las Palmas Drive
Carlsbad, CA 92009-1523
(760) 438-5058
(760) 438-0229 FAX
Contacts (s): Robert Fleischaker, PhD, President
CUSTOMER Information
Company: CytoDyn, Inc.
P.O. Box 66
Glorieta, NM 87535
(505) 577-1636
(800) 417-7252 FAX
Contact (s): Mr. Allen D Allen
Shipping Source: Federal Express
________________________________________________________________________________
Vista Biologicals Corporation proprietary rights are included in the information
disclosed herein. Recipient by accepting this document agrees that neither this
document nor the information herein nor any part thereof shall be reproduced or
transferred to other documents or used or disclosed to others for manufacturing
or for any other purpose except as specifically authorized in writing by Vista
Biologicals Corporation. Unpublished - created on preparation of this document.
All rights reserved under copyright laws.
VISTA BIOLOGICALS CORPORATION Page 1
SOW for CytoOyn
June 2008
____________________
Contract Objectives
Phase I: Review current manufacturing directions and SOP's, prepare
summary of production work to date and help in preparation
of CMC section of new IND.
Phase Ib: Clone and produce CDlla
Phase II: Evaluate growth and productivity using several different
commercial media. Purify material using the three previous
purification methods. Show equivalency of material produced
by three methods in terms of an activity assay.
Phase III: Bring in Materials.
Phase IV: Prepare S6FIAntibody.
Review of Manufacturing Directions and SOP's, and support of preparation of new
IND (CMC section)
The original DMF for the production of S6Fl will be
reviewed. In addition the CMC section of the material
produced by Amerimmune will also be reviewed. The proposed
production and purification protocol will be compared and
contrasted to the two previous methods. Additionally the
response to questions previously asked by the FDA for a
phase II trial will be addressed.
________________________________________________________________________________
Vista Biologicals Corporation proprietary rights are included in the information
disclosed herein. Recipient by accepting this document agrees that neither this
document nor the information herein nor any part thereof shall be reproduced or
transferred to other documents or used or disclosed to others for manufacturing
or for any other purpose except as specifically authorized in writing by Vista
Biologicals Corporation. Unpublished - created on preparation of this document.
All rights reserved under copyright laws.
VISTA BIOLOGICALS CORPORATION Page 2
SOW for CytoOyn
June 2008
____________________
Demonstration of Equivalency of Material Produced by the Different Methods.
A small study will be initiated to compare growth and
production by several of the now commercially available
media. In addition material will be produced and purified
by the two previous methods and the purity and activity
will be compared.
Production of S6Fl
Ordering and Preparing Materials
Materials, such as media, chromatography gels, UF filters,
and chemicals for buffer preparation will be ordered,
quarantined, and tested for identity.
Cell Line
Cell Description: Murine hybridoma
Cell Designation: S6Fl
Starting Seed Train
Vessel(s): T-75cm2, T-150cm2, & T-225cm2 polystyrene flasks, spinner
flasks, and 10L bioreactor.
Cell resurrection: Rapidly thaw vial in warm water, dilute into 30ml growth
medium, centrifuge and decant supernatant. Resuspend cell
pellet in 30ml growth medium. Initiate culture in 75cm2
flask.
________________________________________________________________________________
Vista Biologicals Corporation proprietary rights are included in the information
disclosed herein. Recipient by accepting this document agrees that neither this
document nor the information herein nor any part thereof shall be reproduced or
transferred to other documents or used or disclosed to others for manufacturing
or for any other purpose except as specifically authorized in writing by Vista
Biologicals Corporation. Unpublished - created on preparation of this document.
All rights reserved under copyright laws.
VISTA BIOLOGICALS CORPORATION Page 3
SOW for CytoOyn
June 2008
____________________
Plant:
Roughly 2 X 105 cells/mL. or roughly 1:5 split ratio from confluent cultures.
Subculture: By dilution when cell density roughly 1 X 106 cells/mL
every 2 days in order to expand culture to a final density
of roughly 2-4 X 108 cells.
Special Handling: Do not allow cell density to significantly exceed 1 X 106
cells/mL as this effects culture viability and/or
productivity.
Growth Medium: Gibco CHO-SFM
Production in Bioreactor
Culture System
Required Runs: One (1)
Configuration: 1001 working volume Bioreactor
Planting Density: 2-3 X 105 cells/mL
Agitation: 30-60 rpm
Temperature: 37-38 C
Sampling: Cell number and viability is determined 3 times per week.
Perfusion System: Media is perfused through the system at a rate dependent
upon the culture density. The conditioned media is
collected into sterile bags
________________________________________________________________________________
Vista Biologicals Corporation proprietary rights are included in the information
disclosed herein. Recipient by accepting this document agrees that neither this
document nor the information herein nor any part thereof shall be reproduced or
transferred to other documents or used or disclosed to others for manufacturing
or for any other purpose except as specifically authorized in writing by Vista
Biologicals Corporation. Unpublished - created on preparation of this document.
All rights reserved under copyright laws.
VISTA BIOLOGICALS CORPORATION Page 4
SOW for CytoOyn
June 2008
____________________
and held at 2-8(degree)C until further processing is
completed.
Purification of Product
The S6F1 antibody is purified from the conditioned media
using a series of chromatographic and UF steps. Viral
inactivation is provided for by a low pH hold and via UF
filtration through a Milipore Virasolve membrane.
Analysis of Product
The S6F1 antibody is analyzed for purity using gel
electrophoresis. Concentration is determined using OD28oo
Activity is determined using an ELISA type assay. Endotoxin
is determined by LAL.
Additional Testing of Product
Vista will arrange to have an outside lab provide the
additional safety testing required for the release of the
product for clinical trial use.
Final Product Specifications
Description Acceptance Criteria
Bulk Product Not less than 10 grams of purified S6F1 antibody as
determined via OD28o
Final Product Volume Determined by weight (1.0 gram equals 1.0 mL.)
________________________________________________________________________________
Vista Biologicals Corporation proprietary rights are included in the information
disclosed herein. Recipient by accepting this document agrees that neither this
document nor the information herein nor any part thereof shall be reproduced or
transferred to other documents or used or disclosed to others for manufacturing
or for any other purpose except as specifically authorized in writing by Vista
Biologicals Corporation. Unpublished - created on preparation of this document.
All rights reserved under copyright laws.
VISTA BIOLOGICALS CORPORATION Page 5
SOW for CytoOyn
June 2008
____________________
Purity Greater than 95 % as determined via SDS-PAGE
Endotoxin Less than lEU / mg as determined via LAL.
Shipping Conditions Single shipment following harvest.
Product sent via Federal Express.
Batch Record Review
Upon completion of the work Vista will provide CytoDyn with
a report summarizing the trial run study and the assay
results. In addition Vista will provide CytoDyn copies of
all batch records and supporting documents. CytoDyn will
review those batch records and make requests for any
additional documents or clarification within 1 week of
receiving those documents. Vista will provide additional
documents and clarification within 1 week following
CytoDyn's review.
General Terms and Conditions
Taxes: Services subject to taxes will be itemized on the invoice
Costs: The fees are:
Starting review of DMF, (SOP's and manufacturing
directions) 40,000
Ordering and Preparing Materials, 80,000
Beginning Cloning effort 15,000
Continuing document review (2nd month) 40,000
Continuing cloning (2nd month) 15,000
Evaluation of media and comparison of
purification methods 30,000
Starting Seed Train, 55,000
Production in Bioreactor, 50,000
Starting Purification of Product, 50,000
________________________________________________________________________________
Vista Biologicals Corporation proprietary rights are included in the information
disclosed herein. Recipient by accepting this document agrees that neither this
document nor the information herein nor any part thereof shall be reproduced or
transferred to other documents or used or disclosed to others for manufacturing
or for any other purpose except as specifically authorized in writing by Vista
Biologicals Corporation. Unpublished - created on preparation of this document.
All rights reserved under copyright laws.
VISTA BIOLOGICALS CORPORATION Page 6
SOW for CytoOyn
June 2008
____________________
Continuing Production (2nd month) 50,000
Analysis of Product, 40,000
Batch Record Review and Analysis 40,000
Subtotal $505,000.
Payment: In addition, the cost of outside tests, such as the end of
production viral testing, LAL, etc ... will be paid by
CytoDyn directly. Also, as in previous agreements CytoDyn
will indemnify Vista against liabilities arising from the
use or production of the S6Fl antibody, Vista will provide
CytoDyn with S6Fl for research use only.
Confidential Information
The Parties recognize and acknowledge that in the course of providing the
Services under this Agreement, each Party may acquire from the other
information that is confidential or proprietary and the disclosure of
which may cause irreparable injury to the disclosing Party. All such
confidential or proprietary information disclosed hereunder shall be
treated and protected as Confidential Information.
Intellectual Property Ownership
Vista Biological Corporation understands and agrees that the underlying
rights to the intellectual property and materials that are the subject of
each Price Contract (including, without limitation, all intellectual
property rights in Company Confidential Information, Materials and/ or
any proteins or protein products under development by CytoDyn), are owned
solely by CytoDyn. Neither Vista Biological Corporation nor any
Company-approved subcontractor shall acquire any rights of any kind
whatsoever with respect to any of the foregoing as a result of conducting
the Services.
________________________________________________________________________________
Vista Biologicals Corporation proprietary rights are included in the information
disclosed herein. Recipient by accepting this document agrees that neither this
document nor the information herein nor any part thereof shall be reproduced or
transferred to other documents or used or disclosed to others for manufacturing
or for any other purpose except as specifically authorized in writing by Vista
Biologicals Corporation. Unpublished - created on preparation of this document.
All rights reserved under copyright laws.
VISTA BIOLOGICALS CORPORATION Page 7
SOW for CytoOyn
June 2008
____________________
Physical property created under this Statement of Work, including but
without limitation, batch records, communications with the FDA, cell
banks and bulk product will become the property of CytoDyn, Inc.
It is anticipated that new intellectual property will be created during
the work to be done under this Statement of Work. CytoDyn, Inc. will pay
for the prosecution of one or more patents protecting such intellectual
property, listing Robert Fleischaker as the inventor. In consideration of
a reasonable royalty, Dr. Fleischaker will assign all such patent
applications and patents to CytoDyn, Inc. Dr. Fleischaker will cooperate
with the prosecution and assignment of patents, promptly providing all
necessary information to CytoDyn, Inc. and promptly executing all
necessary documents.
_____________________________________
President, Vista Biologicals Corp.
Robert Fleischaker, PhD
_____________________________________
CytoDyn, Inc.
Allen D Allen
________________________________________________________________________________
Vista Biologicals Corporation proprietary rights are included in the information
disclosed herein. Recipient by accepting this document agrees that neither this
document nor the information herein nor any part thereof shall be reproduced or
transferred to other documents or used or disclosed to others for manufacturing
or for any other purpose except as specifically authorized in writing by Vista
Biologicals Corporation. Unpublished - created on preparation of this document.
All rights reserved under copyright laws.
VISTA BIOLOGICALS CORPORATION Page 8