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.
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.
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
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.
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.