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
Right
