EXHIBIT 10.16
LETTER OF ACCEPTANCE
CLIENT: Michael Wilhelm DATE: 2-Oct-03
ImmuneRegen Biosciences, Inc.
Corporate Offices OUR REF: Q3451
8655 Via de Ventura Blvd., Suite E-155
Scottsdale, AZ 85258
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STUDY NUMBER: To be issued FEE: $95,000*
STUDY TYPE: A 2-Week Inhalation Toxicity Study in Rats (GLP)
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METHOD OF PAYMENT:
Payment Payment
No. Amount Date Payment Due
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Analytical Method
Feasibility* 1 $ 8,000 (1 week) Upon Completion
Additional
Feasibility* 2 $ 1,500/day Upon Completion
In-Life Study 3 $ 23,750 Upon Authorization
In-Life Study 4 $ 42,750 Completion of In-Life
In-Life Study 5 $ 19,000 Submission of Draft Report
In-Life Study 6 $ 9,500 Submission of Final Report
* Price includes one week of feasibility. Additional feasibility intervals, if
required, will be at $1,500/day.
** Or 30 days after submission of draft report if no comments are received from
the client.
TERMS: Net 7 Days (See Section 8 in "Attachment A")
If Client postpones the study, a weekly fee of $6,000 will be incurred
to retain room (See Section 14 in "Attachment A")
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To confirm your acceptance of this contract, please
return one copy, duly signed, to the Contracts Dept.
Issued on behalf of Huntingdon Life Sciences, Inc.
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Name: Arpad J. Madarasz, DVM
Date: 2-Oct-03
Signed:
Please apply for instructions regarding consignment of samples.
Accepted on behalf of Client
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Name:
Date:
Signed:
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THIS LETTER OF ACCEPTANCE IS VALID FOR A PERIOD OF THREE MONTHS FROM DATE OF
ISSUE. THIS LETTER OF ACCEPTANCE AND ANY CONTRACT BETWEEN HUNTINGDON LIFE
SCIENCES AND THE CLIENT FOR THE CONDUCT OF THE ABOVE STUDY ARE SUBJECT TO THE
STANDARD CONDITIONS PRINTED IN ATTACHMENT A.
Huntington
Life Sciences
ATTACHMENT A
CONDITIONS
Any study (the study') undertaken by Huntingdon Life Sciences Inc (hereinafter
referred to as the Company) will be carried out subject to the following
conditions.
Confidentiality
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1. The Client shall not, without the prior written consent of the Company,
make any use of or disclose to any third party the quotation any subsequent
quotation, any correspondence between the parties or any experimental data and
reports arising as a result of the study save that (but subject to the
provisions of paragraph 3 below):
(i) the Client may use the experimental data and reports arising as a
result of the study for the purpose of its own evaluation',
(ii) the Client may make disclosure of such correspondence, data and reports
on a confidential basis to regulatory authorities, the Client's licensees or
members of the Client's consortium sponsoring the study', and
(iii) the Client may disclose to third parties complete copies of the reports
arising as result of the study or factual and complete extracts from such
reports provided that such extracts give a true and fair view of the results set
out in such reports.
2. The Company shall keep confidential and shall not disclose to any third
party without the prior written consent of the Client any information related to
any work done in connection with the study or any information acquired from the
Client unless in the Company's opinion the health and well being of a patient
(or patients) or the public interest is prejudiced thereby. No disclosure shall
be made without the Company having first informed the Client.
3. Any public disclosure by the Client of any information or document
relating to or arising as a result of the study (including information and
documents referred to in paragraph 1 above) shall not without the prior written
consent of the Company directly or indirectly identify or otherwise refer to the
Company (whether under its corporate or any other name) in connection therewith
save that the Client may refer to the Company when making disclosure pursuant to
subparagraph (iii) of paragraph 1 above provided that no reference shall be made
to the Company in connection with any conclusion or opinion of the Client and no
report or extract from such a report or reference to the Company shall be used
to endorse or imply approval of any compound or product of the Client or the use
or proposed use of any compound or product of the Client.
Health and Safety
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4. It is a condition of the Company undertaking the study that the Client
shall provide the Company with all information available to it regarding known
or potential hazards associated with the use of any substances supplied to the
Company by the Client and that the Client shall comply with all current
legislation and regulations concerning shipment of substances by road, sea or
air.
Prices
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5. The prices shown in the Letter of Acceptance, the terms of which form
an integral part of the contract, are based on our best understanding of the
services required at the time this document was prepared. Additional charges may
be made based on a review of the final signed protocol. In addition, minor
deviations from the work to be performed under the contract may become necessary
(i) for veterinary services to protect the health and well being of study
animals (ii) because of results observed during the course of the study which
require additional services to be performed or (iii) because services have to be
performed during holiday or overtime periods. Such additional charges will not
exceed $10,000 without the Client's written consent. The contract study price
excludes all costs associated with the shipment of raw data, specimens or test
materials, for which the Client is wholly responsible.
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6. Any major changes to the work to be performed under the contract
required by the Client shall be notified by the Client to the Company in writing
and will be subject of a mutually agreed exchange in scope'' or additional work
notice'' amendment applying under the existing contract, which may be taken in
substitution for or as an addition to the original price quoted in the contract
(but without prejudice to the Company's right to payment for work already
carried out under the original contract).
Consultancy and Scientific Services
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7. Professional and scientific advice provided by the company leading to
the construction of a protocol for a study is included in the prices shown in
the Letter of Acceptance. In the event that the Company is not asked to
undertake the work involved in such a study a charge based on our normal hourly
rates and not to exceed $5,000 shall be paid by the Client. If, during the
sparse of the study, consultants services provided at the request of the Client
by the Study Director or other scientific personnel are over and above the hours
normally included as part of the study, then the Company will advise the Client
of this fact and notify the Client of the estimated additional charge which will
be made.
Payment Terms
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8. Charges for the study, as specified in the 'letter of Acceptance'' and
traditional Work notices, are due upon completion of each milestone. The company
will periodically submit to the Client an misapplication for Payment'' listing
the Study Number, Study Title, and the applicable milestone payment. Milestone
payments are due and payable by the Client within seven days of the milestone
completion date.
9. Should payment not be received, the Company reserves the right after
giving due notice to the Client, to stop all work on the study and to dispose of
any salable stock or other items employed in connection therewith and the
Company shall be entitled to hold or apply the proceeds of such disposal against
unpaid accounts, but without prejudice to any other rights or remedies available
to the Company under law.
Good Laboratory Practice
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10. Unless otherwise agreed in the study protocol, the Company will conduct
the study in compliance with all relevant and officially declared good
laboratory practice regulations and standards. 11. Client agrees to allow
government regulatory inspections free and ready access to data, reports,
specimens and other materials during GLP directed or surveillance inspections.
Clients who wish to make their own GLP or quality assurance inspections may be
subject to an additional charge.
Reports
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12. On completion of the study as set out in the quotation the Company will
provide, in suitable form, a report of the study.
Commencement of Study
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13. The Commencement of the study is defined as the first day a member of
the Company staff begins to work on the protocol or once the Client has approved
this Letter of Acceptance. In the event of delay by the Client the Company
reserves the right to implement a charge and to re-schedule such work to
commence on a later date. The Company will use its best endeavors to ensure that
such re-scheduling is to the earliest available date.
Study Postponement
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14. In the event the Client postpones initiation of the study, the Company
will make every effort to reschedule the study at minimal cost to the Client.
However, any study postponed by the Client within 28 calendar days prior to
receipt of animals will be subject to a weekly fee, which will allow the Client
to retain the room and delay dose initiation. In addition, the Client will be
billed for all costs incurred and irrevocably committed up to the point of
postponement, including but not limited to time, resources and materials, such
as the cost of animal maintenance, study procedures that have to be repeated or
materials purchased for the study that expire or have to be re-purchased, and
any other study specific costs incurred on behalf of the Client due to the
postponement. Should the period of postponement be uncertain or lengthy, the
Client may cancel the study, as described in paragraph 16.
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Time
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15. The Company will use its best endeavors to ensure that all study time
schedules which are agreed with the Client shall be met. However, any time
schedules agreed for a study or delivery of a report are of necessity best
estimates only and are not of the essence.
Early Termination of Study
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16. Once the study has commenced, as defined in paragraph 13 above, the
Client may by notice in writing to the he Company to terminate the study prior'
to completion. On receipt of such notification by the Company request t Company,
all work will terminate as expeditiously as possible in accordance with the
Client's instructions. Any study cancelled by the Client will be subject to the
following fees: Direct expenses only, if cancelled 28 or more days prior to
receipt of animals', direct expenses + 10% of the value of the study, if
cancelled 21-27 days prior to receipt of 1 animals', direct expenses + 20% of
the value; of the study, if cancelled 14-20 days prior to receipt of animals',
direct expenses + 30% of the total value of the study, if cancelled less than 14
days prior to receipt of animals', direct expenses + 30% of the total value of
the study remaining at the time the Company receives notification of early
termination, if cancelled after receipt of animals, Direct expenses include all
costs and expenses incurred and irrevocably committed to the point of
termination of the study, including but not limited to costs of animals and
their maintenance and any other study specific costs incurred on behalf of the
Client. Payment of the said charge will be due on presentation of the account.
17. Should the Company be prevented from carrying out or continuing to
carry out the study or any part thereof by reason of legislation, Government
prohibition, fire, storm, explosion, war hostilities, the deliberate sabotage of
the study by any person, civil commotion, industrial disputes, cessation or
failure of public services or any other supplier to the Company, of goods or
services, disease, Act of God, or any other event beyond the control of the
Company, the Client or the Company will be entitled to terminate the study by
giving notice to that effect to the other party. All costs, expenses and charges
associated with the termination of the study in these circumstances will be
dealt with as in paragraph 16 above and the Company shall be under no liability
whatsoever to the Client by reason of the occurrence of any such event or the
termination of the study as provided in paragraph 19 below.
Liability and Indemnity
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18. Except as may be the direct result of gross negligence or willful
misconduct by the Company, the Company shall be under no liability whatsoever
for all or any losses, damages, claims, costs, charges or expenses suffered or
incurred by the Client or any third party resulting directly or indirectly from:
(i) negligence, arts, defaults or omissions of any suppliers to the Company
of equipment, services, feeds or goods or any other supplies of whatsoever
nature or from any defect or deficiency in any supplies or from the negligence,
ants, defaults or omissions of any correspondents, consultants, agents or
independent contractors of the Company',
(ii) the occurrence of any of the events described in paragraph 17 above or
the termination of the study following any such event;
(iii) all or any actions, proceedings, demands or claims made against the
Client or any third party by any person whatsoever.
19. The Client shall indemnify the Company, and the Company shall be under
no liability whatsoever, for all or any consequential or indirect losses or
damages or loss of profit suffered or incurred by the Client or customer of the
Client, or any third party howsoever caused.
20. In any event and notwithstanding the terms contained herein, the
Company's liability will not in any circumstances exceed the value of the study.
21. Except as may be the direct result of gross negligence or willful
misconduct by the Company, the Client shall indemnify and hold the Company
harmless against all actions, proceedings, demands, claims, losses, damages,
costs, charges, expenses and all liability whatsoever which may be made against
the Company or which the Company may sustain, pay or incur arising out of or in
connection with all or any actions, proceedings, demands or claims made against
the Client or any customer of the Client or any person or persons dealing with
the Client by any person whatsoever.
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Patents
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22. The Client warrants to the Company that the Client owns all relevant
rights or has obtained all necessary licenses from the owner/ owners of such
rights to enable the Company to keep and/or use the test material or other
materials to be used by the Company in the conduct of the study without
infringing any third party intellectual property rights.
23. The Client shall indemnify and keep the Company indemnified against any
and all losses damages costs and expenses suffered or incurred by the Company by
reason of the breach of the foregoing warranty.
Retention of Study Data
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24. A1l experimental data arising from performance of the study by the
Company (including documentary raw data, specimens, records and other materials,
collectively materials) will remain the property of the Client. However, the
Client agrees that the Company shall retain the materials resulting from the
performance of a study and the Company so agrees to retain said materials upon
completion of a study, for a period of one year. After such period of time, the
Company will make reasonable efforts to contact the Client at the last known
address of the Client giving them the opportunity for the return of the
materials to the Client. Al1 materials remaining at the Company six months after
the initial attempt to contact the Client may be destroyed at the option of the
Company. The Client agrees to keep the Company fully informed of any changes in
circumstances which would impede or prevent the Company from contacting the
Client pursuant to this paragraph, including but not limited to a change of
address or a change in corporate status for the Client.
Notice
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25. Any notice required to be given by either party in accordance with
these conditions shall be deemed to be sufficiently given if sent to the other
party at the address of such party shown on the quotation by facsimile or telex
and confirmed by prepaid post.
Arbitration
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26. If any difference or dispute shall arise between the parties hereto
concerning any matter arising out of the study or any of these conditions, such
difference or dispute shall be resolved in accordance with the expedited
Commercial Arbitration Rules of the American Arbitration Association, by a
single arbitrator appointed in accordance with such Rules. The decision of the
arbitrator shall be conclusive and binding upon the parties, and judgment on any
award rendered in such arbitration may be entered in any court of competent
jurisdiction. The costs of such arbitration shall be borne equally by the
parties hereto.
Governing Law
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27. These conditions and any contract between the Company and the Client
shall be governed and construed in accordance with laws of the State of New
Jersey.
Complete Agreement
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28. This agreement represents the complete agreement between the Company
and the Client in relation to the performance of the study. A1l preceding
correspondence, either written or oral and express or implied conditions, or
agreements are hereby expressly excluded from this contract, the acceptance of
which is indicated by both parties on execution of this contract.
Severability
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29. If any provision of these conditions is determined by an arbitrator or
a court of competent jurisdiction to be illegal or unenforceable, such provision
may be reformed and construed so as to be valid, operative and enforceable to
the maximum extent permitted by law or equity while preserving its original
intent. The invalidity or unenforceability of any provisions of these conditions
shall not render invalid the remainder of these conditions or any contract
between the parties.
Non-solicitation of Employees
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30. The Client agrees that for a period of one year after the termination
of this agreement, the Client will not solicit or encourage employees of the
Company to leave the employment of the Company for the purpose of becoming
employed or otherwise affiliated with the Client.
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