BIOQUEST CORPORATION
SERVICE CONTRACT / CONFIDENTIALITY AGREEMENT
Contract No. C100-99-24p Revision 11-29-99
In order to protect the rights and, and proprietary information between BioQuest
Corp. (a Florida Corporation) and its affiliates (collectively "BioQuest") and
Ixion Biotechnology Inc. (a Delaware Corporation), and its affiliates
(collectively "Ixion"), the parties hereto, intending to be legally bound, agree
that:
1. The parties' representatives for providing, receiving and conducting
business activities are:
For BioQuest:▇▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇
Institution: BioQuest Corp.
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For Ixion: ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇
Institution: Ixion Biotechnology Inc.
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2. BioQuest Corp., hereinafter shall be known as BioQuest and Ixion,
hereinafter shall be known as Client.
3. The Services shall encompass the following: Quality Assurance, Regulatory
Assurance, and Product Development Management as set forth in the attached
Product Development Assessment Report.
4. The sole purpose of the Services is to support Client and provide
consulting information to Client regarding specific areas of interest to
Client as set forth in the attached Product Development Assessment Report.
5. BioQuest or one of its affiliated units (together BioQuest) will perform
the contracting services as set forth in the attached Product Development
Assessment Report.
6. As full consideration for the services provided hereunder, and Client's
agreement to the terms and conditions hereof, BioQuest will enroll Client
into its single rate Fast-Track Program and invoice Client monthly. In
addition, BioQuest will invoice Client for reimbursable expenses incurred
by BioQuest with the prior approval of Client.
7. This Agreement shall be effective, unless extended by written agreement of
the parties, beginning November 29, 1999, and ending November 29, 2002.
8. BioQuest represents that its staff has the requisite expertise, ability and
legal right to render the Services and will perform the Services in a
professionally responsible and efficient manner. BioQuest will abide by all
the laws, rules and regulations that apply to the performance of the
Services, Including applicable requirements regarding equal employment
opportunity and the provisions of Executive Order 11246 and related rules
(if applicable).
9. During the term of this Agreement and surviving the termination or
expiration thereof, BioQuest shall not disclose or use Confidential
Information, or allow it to be used, for its own benefit or the benefit of
others, and shall protect Confidential Information by using the same degree
of care, but not less than a reasonable degree of care, as it uses to
protect their own Confidential Information. Confidential Information shall
include all information disclosed by Client relating to Services provided
hereunder, except any portion thereof which: (a) is in BioQuest's
possession before receipt thereof under this Agreement, as evidenced by
BioQuest's written records; or (b) is disclosed or provided to BioQuest
after full execution of this Agreement by a third party who has a right to
make such disclosure; or (c) is or becomes part of the public domain
through no fault of BioQuest. Further, BioQuest agrees not to use
Confidential Information and/or Materials for any purpose other than that
indicated in this Agreement without prior written approval of Client.
BioQuest will require each of its employees performing Services to comply
with these requirements. Upon termination or expiration of this Agreement
BioQuest will return to Client all drawings, specifications, manuals and
other printed or reproduced material (including information stored on
machine readable media) provided by Client to BioQuest and all copies of
such information made by BioQuest.
10. In the event that BioQuest is required by judicial or administrative
process to disclose Confidential Information, BioQuest shall promptly
notify Client and allow Client a reasonable time to oppose such process.
11. Amendments shall be implemented according to the provisions of this
Agreement. The Agreement in its entirety and existing revision will remain
in force unless amended or otherwise permissible under this Agreement.
12. Either BioQuest or Client may terminate this Agreement with or without
cause upon thirty (30) days written notice following the agreed review of
this Agreement. Termination of this Agreement shall not affect any rights
or obligations which have accrued under the terms and conditions of this
Agreement prior thereto.
13. This Agreement may not be changed or terminated orally by or on behalf of
either party. In the event of the actual or threatened breach of any of the
terms of this Agreement by either party, the other party will have the
right to terminate the Agreement by providing thirty (30) days written
notice.
14. In event of the actual or threatened breach of any of the terms of this
Agreement, BioQuest will have the right to specific performance and
injunctive relief. The rights granted by this paragraph are in addition to
all other remedies and rights available at law or in equity. This Agreement
shall be construed according to the laws of Florida for contacts made
within that state and shall be enforceable by any court located in the
state.
15. This agreement supersedes all prior Agreements and understandings between
the parties hereto, respecting the subject matter of this Agreement.
16. All additions or modifications to this Agreement, including any attachment
referred to in paragraph 19 or amendments to this Agreement, must be made
in writing and executed by both parties.
17. Client undertakes to indemnify and hold harmless BIOQUEST from any and all
liability, loss, damage or expense (including attorney's fees) Client may
suffer as a result of any claims, demands, costs or judgements against it
arising out of services performed and carried out pursuant to this
Agreement, except where liability, loss damage, or expense is caused by, or
arises out of, the negligence of BIOQUEST or its officers, agents and
employees.
18. This Agreement is to be executed in duplicate. Please return one fully
executed copy to: Business Development, BioQuest Corp., ▇▇▇ ▇▇ ▇▇▇▇ ▇▇▇.,
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19. Attachment No X Yes. If Yes, number of pages 7.
Very Truly Yours, AGREED AND ACCEPTED:
BIOQUEST CORPORATION INSTITUTION
Name Ixion Biotechnology, Inc.
By /s/ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ Address 13709 Progress Blvd,
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇ ▇▇, ▇▇▇▇▇ ▇▇
Director, Business Development ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇
Authorized Signature
Date Nov. 29, 1999 /s/ ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇
Printed Name ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇
Title Chairman and CEO
Date 11/30/99
Ixion Biotechnology
Product Development Assessment Report
Contents
1. Objectives ------------------------------------- 2
2. Scope ------------------------------------- 2
3. Limitations ------------------------------------- 2
4. Roles and Responsibilities ------------------------------------ 2
4.1 Quality Assurance Management ----------------------------------- 2
4.2 Regulatory Assurance Management -------------------------------- 3
4.3 Product Development Management -------------------------------- 3
1. Objectives
1.1. Bring Ixion Biotechnology products to market
1.1.1. Establish Ixion Biotechnology Quality Policy and Quality
System
1.1.2. Guide Ixion Biotechnology Product Development Practices
1.1.3. Guide Ixion Biotechnology Regulatory Compliance
1.1.4. Prepare Ixion Biotechnology Regulatory submissions
1.1.5. Establish Ixion Biotechnology Risk Assessments
1.2. Provide value-added, cost effective services to Ixion
Biotechnology
1.2.1. Provide specialized services as needed
1.2.2. Optimize use of resources available
1.2.3. Provide access to BioQuest Corporation industry resources
1.2.4. Increase the overall value of Ixion Biotechnology for
investment prospects
2. Scope
2.1. Ixion operations administered from Alachua, FL
2.1.1. Quality Assurance Management
2.1.2. Regulatory Assurance Management
2.1.3. Product Development Management
2.2. Ixion Biotechnology development stage projects
2.2.1. XentrIX Monitor
2.2.2. Ox-Control(TM) (whole cell)
2.2.3. Ox-Control(TM) (extract)
2.2.4. IxC1-62/47
2.3. Movement of Ixion Biotechnology new technology (Feasibility)
stage projects into development
2.3.1. Clostridium difficile
2.3.2. Diabetes projects
2.4. Ixion Biotechnology holds patent position on a Kit, Materials and
Methods for detecting and quantitating oxalate. This merits
feasibility assessment for potential diagnostic product
development.
3. Limitations
3.1. Ixion Biotechnology does not possess manufacturing capabilities
3.2. Ixion Biotechnology does not possess marketing or distribution
resources
3.3. Ixion Biotechnology progress is dependent on their success at
raising capital
4. Roles and Responsibilities
4.1. Quality Assurance Management
4.1.1. BioQuest Corporation will act as Ixion Biotechnology's
Quality Systems Management entity. This responsibility will
require BioQuest Corporation to have the authority and power
to establish and maintain Ixion Biotechnology's quality
policies and procedures.
4.1.2. BioQuest Corporation will perform quality audits (including
vendor audits) and present findings in management reviews.
4.1.3. BioQuest Corporation will establish and maintain Ixion
Biotechnology's quality documentation.
4.2. Regulatory Assurance Management
4.2.1. BioQuest Corporation will develop an execute Regulatory
Approval Plans for Ixion Biotechnology's product offerings.
4.2.1.1.XentrIX Monitor will be classified as an RUO product to
support acquisition of data for NDA filing of IxC1-62/67.
4.2.1.2.IxC1-62/67 will require an NDA filing
4.2.1.3.Therapeutic diabetes products will require complex PMA
filings.
4.3. Product Development Management
4.3.1. XentrIX Monitor
4.3.1.1. XentrIX Monitor is a mature development project.
Formal product definition and manufacturing/
assembly procedures under design control will
qualify this product for initial market release as
a Research Use Only (RUO) test for identification
of Oxalobacter formigenes (a normal component of
human intestinal flora).
4.3.1.2. Although the market for XentrIX Monitor is limited,
the use of the assay will be elemental in
establishing the rest of the Oxalobacter/Oxalte
product line. Filing for a 510(k) is anticipated
with data gleaned from following the Ox-Control
products and in support of the IxC1-62/67 filing.
4.3.1.3. A Development Plan establishing Design Input and Project Schedule
will be established
* Business Plan
* Quality Plan
* Process Development Plan
* Verification Plan
* Regulatory Approval Plan
* Reliability Plan
* Service/Customer Service/Technical Service Plans
* Design Transfer and Manufacture
* Post Release Support
* Technical Service Plan
* Operating Plan
* Project Schedule
4.3.1.4. A Design Review will be performed as soon as possible to document
Design Output of the Feasibility Program.
4.3.1.4.1 Product formulation
* Patent/Literature Review
4.3.1.4.2. Animal study data
4.3.1.4.3. Preclinical trials data (300 samples)
* Protocols and Raw Data
4.3.1.4.4. CLIA lab data
* Protocols and Raw Data
4.3.1.4.5. Proposed testing of Ox-Control users
4.3.1.4.6. Labeling requirements
4.3.1.4.7. Vendor qualification status and plan
4.3.1.4.8. Manufacturing/Assembly plan
4.3.1.4.9. Risk Assessment
* Interviews and surveys
4.3.2. Ox-Control(TM)
4.3.2.1. Ox-Control(TM) (Oxalobacter formigenes whole cell).
Establishing the organism as safe, normal flora of the gut
should be straight forward with historical data. The
production of GMP material is essential.
4.3.2.2. A Development Plan establishing Design Input and Project Schedule
will be established
* Business Plan
* Quality Plan
* Process Development Plan
* Verification Plan
* Regulatory Approval Plan
* Reliability Plan
* Service/Customer Service/Technical Service Plans
* Design Transfer and Manufacture
* Post Release Support
* Technical Service Plan
* Operating Plan
* Project Schedule
4.3.2.3. A Design Review will be performed as soon as possible to document
Design Output of the Feasibility Program. The review may be
conducted in conjunction with the XentrIX Monitor as safety data
will be common to both.
* Product formulation
* Patent/Literature Review
* Animal study data
* Preclinical trials data
* Protocols and Raw Data
* CLIA lab data
* Protocols and Raw Data
* Proposed testing of Ox-Control users
* Protocol
* Regulatory Submission Plan
* Review probiotic products on the market
* Labeling requirements
* Vendor qualification status and plan
* Manufacturing plan
* Identify licensing partners and their roles should be given
priority
* Identify OEM vendors for fermentation and formulation
* Risk Assessment
* Interviews and surveys
4.3.2.4. Ox-Control(TM) (Oxalobacter formigenes extract). Establishing the
formulation as safe should be straight forward with historical
data, as well as, data from the whole cell product. The production
of GMP material is again essential.
4.3.2.5. A Development Plan establishing Design Input and Project Schedule
will be established
* Business Plan
* Quality Plan
* Process Development Plan
* Verification Plan
* Regulatory Approval Plan
* Reliability Plan
* Service/Customer Service/Technical Service Plans
* Design Transfer and Manufacture
* Post Release Support
* Technical Service Plan
* Operating Plan
* Project Schedule
4.3.2.6. A Design Review will be performed as soon as possible to document
Design Output of the Feasibility Program. The review may be
conducted in conjunction with the XentrIX Monitor and Ox-Control
(whole cell) as safety data will be common to all.
* Product formulation
* Patent/Literature Review
* Animal study data
* Preclinical trials data
* Protocols and Raw Data
* CLIA lab data
* Protocols and Raw Data
* Proposed testing of Ox-Control users
* Protocol
* Regulatory Submission Plan
* Review probiotic products on the market
* Labeling requirements
* Vendor qualification status and plan
* Manufacturing plan
* Identify licensing partners and their roles should be given
priority
* Identify OEM vendors for fermentation, purification and
formulation
* Risk Assessment
* Interviews and surveys
4.3.3. IxC1-62/47
4.3.3.1. IxC1-62/47 is the therapeutic product which will justify
filing a 510(k) for XentrIX Monitor.
4.3.3.2. A Development Plan establishing Design Input and Project
Schedule will be established. The schedule must integrate
the development of the XentrIX Monitor and Ox-Control
products.
* Business Plan
* Quality Plan
* Process Development Plan
* Fix formulation
* Verification Plan
* Regulatory Approval Plan
* Product claims
* IND requirements
* Clinical Protocols
* Reliability Plan
* Service/Customer Service/Technical Service Plans
* Design Transfer and Manufacture
* GMP manufacture
* Validation
* Post Release Support
* Technical Service Plan
* Operating Plan
* Project Schedule
4.3.4. Diabetes Division- Feasibility Project
4.3.4.1. Ixion has developed a technology for generating an unlimited
supply of functional islets from stem cells from both rodent
and human sources in vitro.
4.3.4.2. A Feasibility Plan establishing proof of concept and reduction
to practice will be established. The plan will address:
* Increased understanding of the biology of islet producing stem
cells
* Evaluation of proprietary encapsulation material(s) for
transplanted islets or islet producing cells
* Identification / definition of unique cell surface markers
expressed by islet producing cells for use in isolating islet
producing cells from the pancreas directly.
4.4. Costs for the Development Process are essentially recurring on a per
product basis with variations occurring mostly in the regulatory
submission activities required. An approximate cost breakdown under
the Fast Track Program for the XentrIX(TM)Oxalobacter formigenes
Monitor product follows. Concurrent Product Development of the
remainder of Ixion's product pipeline would be additive to this
estimate.
XentrIXTM Oxalobacter formigenes Monitor- Diagnostic
Assumptions and Calculations
Kit components provided will be OEM manufactured and assembled. These include:
-------------------------------------- -------------------------- --------------
Component Number of Constituents Source
-------------------------------------- -------------------------- --------------
Culture Swab Transport System 3 Vendor A
-------------------------------------- -------------------------- --------------
Culture Swab Specimen Preparation Kit 5 Vendor A
-------------------------------------- -------------------------- --------------
Amplification Kit 8
Sample Diluent Vendor B
10X PCR Buffer Vendor B
Magnesium Chloride Vendor B
Primers Vendor C
DNTP's Vendor C
(+) Control Vendor C
(-) Control Vendor C
DNA Polymerase Vendor D
-------------------------------------- -------------------------- --------------
Detection Kit 7
Probe Vendor C
Digoxigenin Conjugate Vendor E
Substrate A Vendor E
Substrate B Vendor E
Solution A (Blocking) Vendor B
Buffer A Vendor B
Buffer B Vendor B
------------------------------------ -------------------------- ---------------
Kit Summary Totals 23 5
----------------------------------- -------------------------- ---------------
Materials required but not provided;
Reagent Preparation - 6 (Standard Lab Supplies)
Specimen Preparation - 11 (Standard Lab Supplies)
Amplification and Detection - 50
* Formulations to be made - 9
* Additional OEM reagents/products - 4
* Specialized Equipment - 6
* Remaining Standard Lab Supplies - 31
