Sanguine Corporation
SERVICE AGREEMENT
THIS SERVICES AGREEMENT is effective as of the latest signature date
by and between IriSys Research and Development LLC (hereinafter
"Contractor"), with its principal place of business at 0000
Xxxxxxxxxxx Xxxxx Xxxx, Xxxxx 000, Xxx Xxxxx, XX 00000-0000 and
Sanguine Corporation (hereinafter "Company") with its principal place
of business at 000 Xxxx Xxxxx Xxxxxx, Xxxxx 00, Xxxxxxxx, Xxxxxxxxxx
00000.
RECITALS
A. Sanguine Corporation is a public company (OTC BB: SGNC)
whose primary focus is the development of perfluorocarbon emulsions as
synthetic substitutes for human red blood cells with broad-based
medical applications. The Company has the resources necessary to
obtain product approval through FDA "fast track" approval, and capture
a significant share of the global human blood market.
Sanguine has a well-defined organization with leaders in the
field of synthetic blood chemistry and development including Xx.
Xxxxxx X. Xxxxx, who played a key role in the creation of Fluosol, the
only synthetic blood product ever approved for human use by the United
States Food and Drug Administration (FDA). Sanguine's management is
supported by recognized experts in the various fields of medicine
necessary for the development of viable products. PHER-O2 is
Sanguine's 2nd generation Red Blood Cell (RBC) substitute product.
Sanguine management has an impressive record of success in medical and
pharmaceutical development and the ability to accelerate PHER-O2product
development, test and FDA approval.
B. Contractor has expertise in preformulation development,
analytical chemistry and stability protocol design and testing
including preparation of regulatory reports required for new drug
applications and knowledge of regulatory standards required to achieve
regulatory compliance.
C. Sanguine has requested that Contractor perform the
services described in Attachment 1 to the Agreement.
D. Contractor desires to provide services to Sanguine on the
terms and conditions set forth in this Agreement
NOW THEREFORE, in consideration of the mutual covenants contained in
this Agreement, the parties, intending to be legally bound, agree as
follows.
ARTICLE I
BASIC OBLIGATIONS OF THE PARTIES
Section 1.1 The Contractor shall use commercially reasonable efforts to
perform the work stated in the Statement of Work at Attachment
l.
Section 1.2 Independent Contractor. Contractor shall perform all
work under this Agreement as an independent contractor.
Contractor is not an employee, legal partner,
representative, or joint venturer of or with Sanguine, and
nothing in this Agreement shall be construed to create such
a relationship. Neither party shall have the power or right
to bind or obligate the other.
Section 1.3 Scope of Work. Contractor agrees to provide Sanguine
with product development contract services to develop an
effective emulsification of perfluorodecalin, using
fluorosurfactants, as a red blood cell substitute that
carries oxygen and carbon dioxide from the lungs.
Section 1.4 Furnished Materials. Sanguine will provide the materials
listed in Enclosure 1 to Attachment 1 in a timely manner to
allow for completion of the work in accordance with the
performance schedule. Furnished materials will be provided
to Contractor on a no cost basis.
Section 1.5 Period of Performance. The work under this Agreement
shall begin immediately after contract award and be
completed in accordance with the schedule in Section 1.6.
Section 1.6 Deliverables and Schedule. Contractor deliverables and
schedule:
DELIVERABLE DATE
1. Preformulation analysis and recommendations Week 3
2. Test Plan for preliminary formulations
including criteria for droplet size, stability
(product half-life, shelf life, and
sterilization), and toxicity. Week 3
3. Progress Report Week 7
4. Progress Report Week 11
5. Results and recommendations of small-scale
experimental formulation studies Week 15
6. 4 liters of candidate emulsion for animal testing Week 17
7. Product development report (for use in regulatory
Filing) Week 20
Section 1.7 Review and Acceptance. Sanguine will review the
Contractor's deliverables and provide notification regarding
acceptability within five (5) working days of receipt.
ARTICLE II
PRICE AND PAYMENT
Section 2.1 Price. The price for performance of the work
(Attachment l) is Firm Fixed Price.
Section 2.2 Expenses. All costs identified as of the effective
date of this Agreement for performance of this effort are included
in the price shown in Section 2.1. Should unforeseen expenses
arise during performance of this Agreement, Sanguine shall be
immediately notified of the circumstance and expense. Sanguine
will review this information and consider amending the Agreement if
warranted.
Section 2.3 Payment. Payments will be made to Contractor in
accordance with the following schedule:
A. Contract award 15%
B. Deliverable # 1 & 2 15%
C. Deliverable # 3 15%
D. Deliverable # 4 15%
E. Deliverable # 5 15%
F Deliverable # 6 15%
G. Deliverable # 7 10%
ARTICLE III
MISCELLANEOUS
Section 3.1 Notices. Notices under this Agreement shall be in
writing and delivered either personally or by registered or
certified mail or prepaid overnight courier to the following
individuals:
Contractor: Sanguine Corporation:
Xx. Xxxx Xxxxx Xxxxxx X. Xxxxx, Ph.D.
0000 Xxxxxxxxxxx Xxxxx Xxxx 000 Xxxx Xxxxx Xx
Xxxxx 000 Xxxxx 00
Xxx Xxxxx, XX 00000-0000 Xxxxxxxx, XX 00000
Section 3.2 Force Majeure. If performance of any part of this
Agreement by either party is prevented, restricted, interfered with
or delayed by reason beyond the reasonable control of the party
liable to perform, the party so affected shall, upon written notice
to the other party, be excused from performance to the extent of
the prevention, restriction, interference or delay. When such
circumstances arise, the parties shall discuss what, if any,
amendment to the terms of this Agreement may be required in order
to arrive at an equitable solution.
Section 3.3 Termination. Either party shall have the right to
terminate this Agreement at any time by giving written notice to
the other party of that party's material default of any material
covenant or provision of this Agreement and if such default is not
corrected within 15 days after the party in default is in receipt
of the written notice from the other party with respect to such
default.
Section 3.4 Dispute resolution. All claims, disputes, or other
material matters in controversy ("disputes") arising out of or
relating to this Agreement shall be resolved exclusively before the
American Arbitration Association.
Section 3.5 Amendments. No change, modification, or amendment to
this Agreement shall be valid or binding unless such change or
modification shall be in writing signed by the party against whom
the same is sought to be enforced.
Section 3.6 Confidentiality. Contractor shall keep confidential
all information provided by or produced under this Agreement for
Sanguine, provided that this information (a) is not already in the
public domain, (b) is not already in the Contractor's possession at
the time of this Agreement, or (c) is not furnished by a third
party not bound to confidentiality by Sanguine. The terms of this
Section shall survive the termination or expiration of this
Agreement.
Section 3.7 Intellectual Property. All materials provided by
Sanguine under this Agreement are deemed to be owned by Sanguine
and shall be returned at the conclusion of the Agreement. All
information generated by Contractor under this Agreement shall be
the property of Sanguine. All information generated by the
Contractor shall be delivered to Sanguine at the completion of this
Agreement, one copy of which will be retained for archival
documentation by Contractor.
Contractor shall retain ownership to all methods, information,
ideas, data, concepts, and techniques proprietary to Contractor and
developed before or during this Agreement not related to the work
covered by this Agreement and not derived from information provided
by Sanguine under this Agreement.
Section 3.8 Indemnification. Both parties agree to defend
indemnify, and hold harmless the other party and its officers,
employees, and agents from any and all claims and liabilities of
any type or nature whatsoever arising out of any act, omission, or
negligence by the party, its officers, employees, and agents that
may arise out of or result from or in any way be related to the
effort pursuant to this Agreement.
Each party shall promptly notify the other party of any claim,
complaint, or lawsuit. The indemnifying party shall control the
defense of any third party claim, complaint, or lawsuit and the
indemnified party shall cooperate fully in the investigation and
defense of any such claim, complaint, or lawsuit.
Section 3.9 Assignment. Contractor may not assign this Agreement,
in whole or in part, without the prior written consent of Sanguine.
Section 3.10 Use of Materials. Contractor shall use the materials
provided by Sanguine solely for performing its efforts under this
Agreement. Contractor shall not sell, transfer, disclose, or
otherwise provide access to the materials to any person or entity
without the prior written consent of Sanguine except that
Contractor may allow access to the materials to employees and
agents for purposes consistent with this Agreement provided that
prior to such disclosure, such individuals shall have executed
written agreements consistent with the terms hereof. Contractor will
take all reasonable steps to ensure that such employees and agents
will use the materials in a manner that is consistent with federal,
state, and local laws and the terms of this Agreement. Contractor
understands that the materials may have biological and/or chemical
properties that are unpredictable and unknown at the time or
transfer, that they are to be used with caution and prudence, and are
not be used for testing in or treatment of humans.
Section 3.11 Applicable Law. This Agreement shall be construed
and enforced under the laws of the State of California, other than
those provisions governing conflicts of laws.
Section 3.12 Severability. In the event any provision, clause,
sentence, phrase, or word thereof, or the application thereof in
any circumstance, is held to be invalid or unenforceable, such
invalidity or unenforceability shall not affect the validity or
enforceability of the remainder thereof.
Section 3.13 Captions. Titles or captions of articles and
paragraphs contained in this Agreement are inserted only as a
matter of convenience and for reference, and in no way define,
limit, extend, or describe the scope of this Agreement or the
intent of any provision hereof.
Section 3.14 Entire agreement. This Agreement, together with
Attachments 1, constitutes the entire agreement between
Contractor and Sanguine with respect to the subject matter of this
Agreement and no representation or statement not contained in the
main body of this Agreement or Attachments 1 shall be binding
on Contractor or Sanguine as a warranty or otherwise.
IN WITNESS WHEROF, the parties hereto have caused this Agreement to
be executed by their duly authorized officers.
CONTRACTOR: Sanguine Corporation:
By: /s/Xxxx Xxxxx By:/s/Xxxxxx X. Xxxxx
Name: Xx. Xxxx Xxxxx Name: Xxxxxx X. Xxxxx
Title: Chief Operating Officer Title: Chairman & CEO
Date: Date:
ATTACHMENT 1 Statement of Work (SOW)
Contract shall use best commercial practices and reasonable efforts to
identify and recommend a fluorosufactant solution(s) for use with
perfluorocarbondecalin to produce an emulsion that can be used as an
effective RBC supplement in human whole blood.
1.1 Assess and recommend a matrix of stable perfluorocarbondecalin
emulsions based on preformulation analysis of
fluorosurfactants.
1.2 Determine optimum emulsion droplet size based on
functional requirements.
1.3 Prepare and test preliminary test emulsions using the
selected surfactant, additives, and stabilizers or various
injectable excepients based on the functional requirements
for PHER-O2 in order to determine candidate emulsions for
test. Quantity of preliminary test emulsions limited to
minimum required for further evaluation.
1.4 Perform stability testing against steam sterialization
1.5 Perform emulsion stability testing studies of the
emulsions at 5 degrees C and 25 degrees C with sample analysis
time points at 30, 60, and 90 days.
1.6 Recommend candidate emulsion formulation for animal
testing including test results.
1.7 Provide an Analytical Method Development Report for use in
a regulatory filing.
1.8 Provide a Formulation Development Report for use in a
regulatory filing.
1.9 Provide six (4) liters of candidate emulsion (BLP) for
further use in animal testing.
PHER-O2 FUNCTIONAL REQUIREMENTS
Intra-vascular half-life: minimum eight hours
Shelf life (storage): one year non-refrigerated
two years refrigerated
Toxicity: negligible
Acceptable tissue retention time (liver, spleen, etc.): Trace or
less (after 30 days)
Unit size of delivered product: 400 ML
Unit packaging: non-extractable plastic (Medidex) Glass
is acceptable alternative.
Primary application (FDA approval target): Angioplasty
PHER-O2 FORMULATION SPECIFICATIONS
Base: Perfluorocarbondecalin
Fluorosurfactant solution: To be determined
Droplet (particle) size: 0.1 micron or smaller
Percent of PFC in PHER O2 (W/V): minimum 70%
ENCLOSURE 1 to ATTACHMENT 1
MATERIALS TO BE FURNISHED BY SANGUINE
1.
2.
3.
ATTACHMENT 2
