exh10-18.htm


     

    Exhibit 10-18

     

    
 

    MASTER
PRE-CLINICAL SERVICES AGREEMENT

    


    This
Master Service Agreement (the “Agreement”), made this 22 day of October, 2009
(the “Effective Date”) by and between Toxikon Corporation (“Toxikon”), a
Massachusetts corporation with its principal executive offices located at 15
Wiggins Avenue, Bedford, Massachusetts 01730 and Cellceutix Corporation
(“Sponsor”), a Nevada corporation with its principal executive offices located
at 100 Cummings Center , Suite 151-B, Beverly, MA 01915.

    Background.
Toxikon and Sponsor have agreed to establish a relationship under which Toxikon
will render Services (defined below) specified in Study Quotations attached to
this Agreement.

    Definitions.                                The
following terms have the meanings set forth below:

    “Project
Order” means the services rendered as detailed in the documents required for
placement and performance of study, including study quotation, protocol, and
test request form.

    


    “Quotation”
means the pricing and payment terms for a study. Each Service shall be more
completely described in a study quotation. An example form is attached hereto as
Exhibit A.

    


    “Change
Order” means the Project Order addendum summarizing the costs for additional or
modified services that are requested by Sponsor after the Quotation has been
signed.

    


    “Materials”
means any data, documentation, biological materials, chemical compounds, and
reagents, together with all derivatives thereof or other materials or
information held by Sponsor and furnished to Toxikon in connection with
Toxikon’s rendering of the Services, including without limitation, all materials
identified in the applicable Project Order.

    “Confidential
Information” means any confidential or other proprietary information disclosed
by one party to the other under this Agreement, except information that: (a) is
public knowledge at the time of disclosure, (b) was known by the other party
before disclosure by the disclosing party, or becomes public knowledge or
otherwise known to the other party after such disclosure, other than by breach
of a confidentiality obligation, or (c) is independently developed by the other
party.

    


    “Services”
means those services which Toxikon is engaged to provide to Sponsor pursuant to
the terms of this Agreement, as set forth in the specific Project
Order.

    


    “Results”
means all results of Services including, but not limited to, information, data,
documentation, reports, protocols, and any other deliverables, as defined in the
applicable Project Order.

    


    “Study
Delay” shall mean delay of agreed upon start date.

    


    Project
Order.

    


    Description.  All
work delivered or performed hereunder shall be in accordance with this Agreement
and the applicable Project Order.  Each Project Order shall set forth
a description of the specific Services to be provided, any Materials being
provided by Sponsor for the Services, delivery and performance schedules,
Toxikon personnel responsible for performing and/or supervising the Services
(the “Project Leader”), the Sponsor contact, the budget/compensation and other
details relating to the Services.  In the event of a conflict between
this Agreement and any Project Order, unless otherwise identified as a conflict
and agreed to in writing, the terms of this Agreement shall govern.

    


    Performance
of Services

    


    Project
Leader.   Toxikon will designate a Project Leader under each
Project Order, who will be Sponsor’s primary contact at Toxikon for the Services
being rendered.  Project Leaders shall communicate with a
representative designated by Sponsor (“Sponsor
Representative”).  Sponsor Representative shall have responsibility
over all matters relating to performance of the study on behalf of
Sponsor.

    


    Reporting.  All
reports will be prepared in Toxikon’s standard format unless otherwise requested
by Sponsor.

    


    Draft
Report. A draft report will be issued when requested by Sponsor and agreed upon
by the Project Leader.  Additional charges may apply for issuance of
draft report.  Sponsor will have up to 30 days to submit comments in
writing regarding the draft report. If after 30 days, no comments or other
remarks regarding the draft report are received, Toxikon shall issue the final
report. Modifications after final report submission may be subject to additional
fees.  Modification of a final report will be completed upon written
request/acceptance by Sponsor of a study amendment.

    


    Affiliates.  Toxikon
shall have the right to provide all or any part of the Services for a Project
Order through an Affiliate of Toxikon, in which case the Affiliate shall execute
the applicable portion of the Project and shall be deemed to have executed this
Agreement and agreed to be bound by the terms and conditions
hereof.

    


    Absence
of Debarment.  Toxikon represents that neither it, nor any of its
employees, subcontractors, consultants, or advisors performing the Services
under this Agreement, have been debarred, and to the best of its knowledge, are
not under consideration to be debarred, by the Food and Drug Administration from
working in or providing services to any pharmaceutical or biotechnology company
under the Generic Drug Enforcement Act of 1992 and any amendments
thereof.

    


    Compliance
with Policies and Regulations.  In performing Services, Toxikon shall
comply with all applicable business conduct, regulatory, and health and safety
guidelines or regulations established by any relevant governmental authority.
Toxikon acknowledges that the Materials may be of an experimental nature and
will comply with all laws and regulations applicable to their handling and
use.  If applicable, Toxikon will perform the Services in material
compliance with the current standards promulgated by the FDA applicable thereto,
including, but not limited to, current Good Manufacturing Practices (21 CFR
Parts 210 and 211), Good Laboratory Practice for Non-Clinical Laboratory Studies
(21 CFR Parts 58), and the General Biological Products Standards (21 CFR Part
610).  In addition, Toxikon shall comply with all applicable Sponsor
guidelines, of which Toxikon is made aware by Sponsor.

    


    Compensation

    Charge
for Services. As full consideration for Services provided under a Project Order,
Sponsor shall pay Toxikon the sum set forth in Toxikon’s invoices forwarded to
Sponsor on the terms and conditions set forth in the applicable Quotation within
thirty (30) days of receipt of invoice by Sponsor. Toxikon will issue invoices
to Sponsor as follows:

    Attention:
Accounts Payable

    Address:
_____________________________

    City:
____________________________

    State:
____________________________

    Zip:
_____________________________

    


    7.1.1
Additional Services. During the course of the Project, should Sponsor request
services or deliverables not set forth in the Project Order a Change Order with
additional charges will be issued to Sponsor. Sponsor will return written
acceptance of the charges to Toxikon.  All additional charges will be
invoiced under the terms of the Quotation.

    


    7.1.2
Currency. All prices listed are stated in U.S. Dollars and do not include any
international taxes or duties (i.e. VAT or TDS).

    


    Study
Delay/Cancellation.  Toxikon may apply charges for Sponsor-initiated
delay or project cancellation.  Such delay charges will be governed
and invoiced under the terms of the Quotation.

    


    Additional
Costs.

    


    Amended
Reports. Sponsor-specific amendments to a final report will incur additional
charges; Charges will be determined on a study-to-study basis based on scope of
change.

    


    Rush
Service. If Sponsor requests a test and/or report be completed in less time than
our standard turnaround time, then the client will be charged a surcharge
dependent on current availability and as agreed in writing by the
Sponsor. Turnaround time and expedite processing fees are determined on a
study-to-study basis and based on the scope of work. Sponsor must contact an
appropriate Toxikon representative to confirm scheduling, availability, and
applicable charges.  Toxikon will make every effort to accommodate all
Sponsor requests, however scheduling will be dependent on current lab
resources.

    


    Consulting
Services. Consulting Services will be determined based on scope of work
requested.

    


    Laboratory
Audits – Visits.  Sponsor representatives may visit Toxikon at
reasonable times within reasonable frequency during normal business hours to
discuss or observe the progress of a project.  Toxikon will assist
Sponsor in scheduling such visits in advance.  Additional charges may
apply for Sponsor visits.

    


    FDA or
Other Regulatory Audits. Toxikon will assess a nominal charge of $1,000 per day
to our Sponsors for all directed regulatory inspections to support an
application for market approval or data review.  All Sponsors will be
notified in advance of the inspection whenever possible.

    


    Client
Quality Audits. Toxikon will assess a nominal charge of $1,000 per day if the
Quality Audit extends beyond one business day.  Each audit shall be at
mutually agreed upon times and dates.

    


    Report
Replacement. Replacement of an original report will incur a fee, as
appropriate.

    


    Interim /
Draft Report Fees. Available upon request and in agreement with the Project
Leader. Additional charges may apply.

    


    Protocol
Development. Toxikon has standard protocols, which are consistent with current
regulatory guidelines.  If Sponsor-specific modifications are
requested extra charges may apply and will be quoted in the Project Order or as
a Change Order of an executed Project Order.

    


    Freight.
All client product, test articles, returned archived reports, and data are
shipped F.O.B. Toxikon.   All claims for freight damage should be
made directly with freight carrier responsible for such
damage.  Toxikon shall have no liability for any damage that occurs
while any shipment is in the possession of carrier.  International
clients are responsible for all paperwork and payment of all US Customs
brokerage fees.

    


    Shipping.
Unless noted otherwise in the Project Order, charges for shipment of Sponsor
test materials or project samples (blood, serum, tissue, dose verification,
etc.) are the responsibility of the Sponsor.  Sponsor account numbers
for shipment may be provided to Toxikon for third-party billing.

    


    Proprietary
Rights.

    


    Materials.  All
Materials provided to Toxikon by Sponsor for the performance of Services and all
associated intellectual property rights shall remain the exclusive property of
Sponsor. Sponsor shall provide Toxikon with sufficient amounts of all Materials
to perform Project Order.  Toxikon shall use Materials provided by
Sponsor under any Project Order solely for rendering the Services under the
applicable Project Order.  Sponsor will provide Toxikon with any
relevant occupational safety information known by Sponsor, including a Material
Safety Data Sheet (MSDS).  Any Materials remaining upon completion of
the Services under a Project Order shall be, at Sponsor’s direction, either
returned to Sponsor or destroyed.  Toxikon does not warrant or
guarantee the condition of any returned material.

    


    Results.  Toxikon
hereby assigns and agrees to assign to Sponsor title to the Results, including
any intellectual property rights embodied in or derived from such Results
(whether or not protectable under patent, copyright, trade secret or similar
laws).

    


    Records.  Toxikon
shall maintain all materials and all other data and documentation obtained or
generated by Toxikon in the course of providing Services hereunder, including
all computerized records and files (the “Records”) in a secure area reasonably
protected from fire, theft and destruction.  These Records shall be
“works made for hire” and shall remain the exclusive property of
Sponsor.

    


    Record
Retention.   All Records shall be (i) retained by Toxikon for a
period of five (5) years, or as a matter of law or regulation or (ii) disposed
of, at the direction and written request of Sponsor, unless such Records are
otherwise required to be stored or maintained by Toxikon as a matter of law or
regulation.  In no event shall Toxikon dispose of any such Records
without first giving Sponsor sixty (60) days’ prior written notice of its intent
to do so.   Notwithstanding the foregoing, Toxikon may retain
copies of any such Records as are reasonably necessary for regulatory or
insurance purposes, subject to Toxikon’s obligation of
confidentiality.

    


    Confidentiality.

    


    Nondisclosure
of Confidential Information.  During the Term (defined below) and
thereafter, Toxikon shall not directly or indirectly publish, disseminate or
otherwise disclose, deliver or make available to any person outside its
organization any Confidential Information. Toxikon may disclose Confidential
Information to persons within its organization who/which have a need to receive
such Confidential Information in order to further the purposes of this Agreement
and who/which are bound to protect the confidentiality of such Confidential
Information.  If required, Toxikon may disclose Confidential
Information to a governmental authority or by order of a court of competent
jurisdiction, provided that such disclosure is subject to all applicable
governmental or judicial protection available for like material and reasonable
advance notice is given in writing to Sponsor.

    


    Use of
Sponsor Confidential Information.  During the Term and thereafter,
Toxikon shall use Sponsor’s Confidential Information solely for the purposes
contemplated in the applicable Project Order, or for such other purpose as may
be agreed upon in writing by the parties.

    


    Physical
Protection of Confidential Information.  During the Term and
thereafter, Toxikon shall exercise all commercially reasonable precautions to
physically protect the integrity and confidentiality of Confidential
Information.

    


    Publication.  Sponsor
shall have the right to publish, and disclose the publication and disclosure of,
the Results, provided that the role of Toxikon is properly acknowledged in the
publication.  Toxikon may, with prior written consent, publish
articles or make presentation relating to the service provided to
Sponsor.

    


    Indemnification.

    


    By
Toxikon.  Toxikon will defend, indemnify, and hold Sponsor harmless
from and against any third party claims, demands, suits, actions, causes of
actions, losses, damages, fines and liabilities, including reasonable attorneys’
fees, arising out of the Services or breach of this Agreement (“Sponsor
Losses”), and will pay any costs and damages which, by final judgment, after
exhaustion of all reasonable appeals, may be assessed against Sponsor, except
that Toxikon shall not be obligated to indemnify Sponsor for Sponsor Losses to
the extent they result from the negligence or willful misconduct of Sponsor. The
foregoing indemnification shall be contingent upon Sponsor promptly notifying
Toxikon of a Sponsor Loss and providing reasonable cooperation (at Toxikon’s
expense) and tendering to Toxikon, and its insurer, full authority to defend or
settle the claim or suit. Sponsor has the right to participate (at its own
expense) in the claim or suit and in selecting counsel
therefore.  Notwithstanding the foregoing, Toxikon shall not settle
any claim hereunder without Sponsor’s written consent, which consent shall not
be unreasonably withheld.

    


    By
Sponsor.  Sponsor will defend, indemnify, and hold Toxikon harmless
from and against any third party claims, demands, suits, actions, causes of
actions, losses, damages, fines and liabilities, including reasonable attorneys’
fees, arising out of (i) Sponsor’s negligence or willful misconduct in
connection with this Agreement, or (ii) Sponsor’s use of the Results, and will
pay any costs and damages which, by final judgment, after exhaustion of all
reasonable appeals, may be assessed against Toxikon, except that Sponsor shall
not be obligated to indemnify Toxikon for “Toxikon Losses” to the extent they
result from the negligence or willful misconduct of Toxikon or the breach of
this Agreement by Toxikon. The foregoing indemnification shall be contingent
upon Toxikon promptly notifying Sponsor of a Toxikon Loss and providing
reasonable cooperation (at Sponsor’s expense) and tendering to Sponsor (and/or
its insurer) full authority to defend or settle the claim or suit.

    


    Term and
Termination.

    


    Term.  This
Agreement will commence on the Effective Date and shall expire on the later of
(a) five (5) years from the Effective Date or (b) the completion of all Services
under the last Project Order executed by the parties prior to the fifth
anniversary of the Effective Date. The Term may be extended by mutual agreement
of the parties or earlier terminated in accordance with Section 11.2 or 11.3
below.

    


    Termination
for Cause.

    


    By
Toxikon. Toxikon may terminate this Agreement upon ninety (90) days prior
written notice to Sponsor.  Toxikon may terminate this Agreement in
the event of Sponsor’s material breach of the terms of this Agreement, which
breach is not cured within thirty (30) days after Sponsor’s receipt of written
notice of said breach from Toxikon.

    


    By
Sponsor.  Sponsor may terminate this Agreement with cause upon ninety
(90) days prior written notice to Toxikon.  Sponsor may terminate this
Agreement in the event of Toxikon’s material breach of the terms of this
Agreement, which breach is not cured within thirty (30) days after Toxikon’s
receipt of written notice of said breach from Sponsor.  Upon
termination of this Agreement, Sponsor shall pay Toxikon for all Services and
incurred expenses through the termination date.

    


    By Either
Party.  Either party may terminate this Agreement or any Project
Order(s) for cause at any time upon ninety (90) days’ prior written notice to
the other party.  “Cause” shall mean (i) material breach by either
party of this Agreement or of a Project Order where such breach, if curable, is
not remedied to the other party’s reasonable satisfaction within such thirty
(30) day period, or (ii) a material change unacceptable to either party in the
other party's ability to function as a going concern, to conduct its operations
in the normal course of business or to perform its obligations under this
Agreement or under any Project Order.

    


    Termination
without Cause

    By
Sponsor. Sponsor may terminate this Agreement without cause upon (90) days prior
written notice to Toxikon. Upon termination of this Agreement, Sponsor shall pay
Toxikon for all Services and incurred expenses through to the termination
date.

    


    Effect of
Termination or Expiration.  Upon termination or expiration of this
Agreement, neither Service Provider nor Sponsor shall have any further
obligations under this Agreement, or in the case of termination or expiration of
a Project Order, under such Project Order, except that (a) Toxikon shall
terminate all Services in progress in an orderly manner as soon as practical and
in accordance with a schedule agreed to by Sponsor, unless Sponsor specifies in
the notice of termination that Services in progress should be completed, (b)
Toxikon shall deliver to Sponsor any Materials in its possession or control and
all Results developed through termination or expiration, (c) Sponsor shall pay
Service Provider any monies due and owing Service Provider, up to the time of
termination or expiration, for Services actually performed, all authorized
expenses actually incurred (as specified in the applicable Project Order) and
any additional fees associated with the termination including but not limited to
incurred costs plus penalties, and (d) Toxikon shall immediately return to
Sponsor all Sponsor Confidential Information and copies thereof provided to
Toxikon under this Agreement or under any Project Order which has been
terminated or has expired, (e) Sponsor has immediately returned to Toxikon all
Toxikon Confidential Information and copies thereof provided to Sponsor under
this Agreement or under any Project Order which has been terminated or has
expired.

    


    Miscellaneous.

    


    Independent
Contractor.  All Services will be rendered by Toxikon as an
independent contractor and this Agreement does not create an employer-employee
relationship between Sponsor and Toxikon. Toxikon shall have complete and
exclusive control over its employees and agents.

    


    Use of
Name.  Neither party shall use the other party’s name in any form of
advertising, promotion or publicity, including press releases, without the prior
written consent of the other party.

    


    Notice.  All
communications and notices from one party to the other shall be in writing and
shall be given by addressing the same to the other at the address or facsimile
number set forth in this Agreement, or at such other address or facsimile number
as either may specify in writing to the other.  All notices shall
become effective when deposited in the United States mail with proper postage
for first class Registered or Certified Mail prepaid, return receipt requested,
or commercial courier or when delivered personally, or, if promptly confirmed by
mail or commercial courier as provided above, when dispatched by
facsimile.

    


    With
regard to Toxikon:

    Toxikon
Corporation

    15
Wiggins Avenue

    Bedford,
MA 01730

    Attn:
President

    


    With
Regard to Sponsor:

    _______________________________

    _______________________________

    _______________________________

    Attention:
_______________________

    


    Assignment.  This
Agreement, and the rights and obligations hereunder, may not be assigned or
transferred by either party without the prior written consent of the other party
provided however, that either party may assign its rights or obligations under
this Agreement, without the prior written consent of the other party, in
connection with the transfer or sale of all or substantially all of its assets,
stock or business, or its merger consolidation or combination with another
entity and such assignment shall be binding upon and inure to the benefit of the
assignee.

    


    Entire
Agreement.  This Agreement constitutes the entire agreement of the
parties with regard to its subject matter, and supersedes all previous written
or oral representations, agreements and understandings between Toxikon and
Sponsor.

    


    No
Modification.  This Agreement and/or any Project Order may be changed
only by a signed authorization by representatives of both parties.

    


    Dispute
resolution. Any dispute arising out of, concerning, or related to either
parties' performance under this agreement, the test protocols, or any other
agreement between these parties, shall be settled in the courts of the
Commonwealth of Massachusetts, or in a federal court sitting in Massachusetts,
provided federal jurisdiction applies.

    


    Attorneys
Fees and Costs. In the event that Sponsor fails to pay for laboratory and or the
testing services contracted for, and said past due account is referred to legal
counsel for collection, Sponsor agrees to pay reasonable attorneys' fees and
costs incurred in collection of any past due invoices.

    


    Insurance.
Toxikon shall secure and maintain in full force and effect throughout the
performance of the project policies of insurance for (a) Workmen’s Compensation,
(b) General Liability including completed operations coverage, (c) Professional
liability insurance including errors and omissions coverage and (d) Automobile
Liability having policy limits, deductibles and other terms appropriate to the
conduct of Toxikon’s business in Toxikon’s sole and exclusive
judgement.  Certificates of Insurance will be made available upon
Sponsor’s request.

    


    Force
Majeure.  Neither party shall be liable in damages or have the right
to terminate this Agreement for any delay or default in performing hereunder if
such delay or default is caused by conditions beyond their control including,
but not limited to Acts of God, Government restrictions, wars, weather, disease,
civil strife, power failure, insurrections and/or any other cause beyond the
reasonable control (each a “Disability”) of the party whose performance is
affected.  Any timelines affected by a Disability shall be extended
for a period equal to that of the Disability and each Project Order budget shall
be adjusted to reflect cost increases resulting from the
Disability.  The party incurring the Disability shall provide notice
to the other of the commencement and termination of the Disability.

    


    Severability.  In
the event that any one or more of the provisions contained in this Agreement
shall, for any reason, be held to be invalid, illegal or unenforceable in any
respect, such invalidity, illegality or unenforceability shall not affect any
other provisions of this Agreement, and all other provisions shall remain in
full force and effect.  If any of the provisions of this Agreement are
held to be excessively broad, it shall be reformed and construed by limiting and
reducing it so as to be enforceable to the maximum extent permitted by
law.

    


    Applicable
Law.  This Agreement shall in all events and for all purposes be
governed by, and construed in accordance with, the law of the Commonwealth of
Massachusetts, without regard to any choice of law principle that would dictate
the application of the law of another jurisdiction.

    


    Document
Hierarchy. In the event of a conflict between Master Pre-Clinical Services
Agreement and Project Order; the Master Pre-Clinical Services Agreement is the
superior document over the Project Order.

    


    


    TOXIKON:

    


    Signature:
_____________________________________ Date_____________________

    Nancy
DiGiulio

    VP,
Regulatory Affairs

    TOXIKON
CORPORATION

    


    


    


    SPONSOR:

    


    Signature:________/s/________________________      Date___10/29/2009

    


    Name:_____Krishna
Menon___________________

    


    Title:______President________________________

    


    Company:__CELLCEUTIX,CORPORATION