Standard Terms and Conditions

The terms and conditions stated herein are effective for all divisions of Consumer Product Testing Company, Inc. (CPT℠) performing services and/or consultation for the study Sponsor.  This document provides a basic outline of our standard terms and conditions, counterparts of which may be provided to the Sponsor as additional documentation and are included by reference as part of this document.

CPT℠ is operating as an independent contractor, and not as an agent or employee of Sponsor in its performance of any, and all services hereunder.

Confidentiality

CPT℠ maintains strict standards of confidentiality in regard to all services and consultation (“Project”) provided to the Sponsor.  CPT℠ can provide a standard Non-Disclosure Agreement to the Sponsor if they do not have a Sponsor-prepared document.  This agreement shall be signed by the appropriate authorizing agent within the Sponsor’s organization and shall be kept on file by the Legal Department of CPT℠.

The phrase ” Confidential Information” shall include, but not be limited to, any and all trade secrets, data, designs, drawings, documentation, software (regardless of form or media, including cloud applications), hardware, machinery, prototypes, formulations, compounds, compositions, materials, processes, methods, concepts, facilities, research, development, quotations, protocols, marketing and business activities, intellectual property, workforce and any other non-public information, whether obtained, or disclosed verbally, or in writing, or through observation, which one party (the “Disclosing Party”) discloses to the other party (the “Receiving Party”) including the existence of any Sponsor/CPT℠ business relationship.

Each Party agrees that it shall not remove, or otherwise alter, any of the other Party’s trademarks or service marks, serial numbers, logos, copyrights, notices or other proprietary notices or indicia, if any are fixed or attached to any Confidential Information or any part thereof.

The Projects shall be considered confidential, and the reported results of these Projects shall be the exclusive and sole property of Sponsor.  Sponsor shall hold the sole proprietary right to publication, but shall not, except as legally required, divulge, or make public the fact that CPT℠ has furnished or contracted to furnish to Sponsor, the studies performed under this Agreement, or attribute to CPT℠ any abstract or interpretation of any such report so long as CPT℠ involvement is not generally known to the public, without the prior written consent of CPT℠.  For the avoidance of doubt, the Work Product generated and known as “Interim Report”, “Draft Report”, or “Final Report” contains the data which is the direct result of the work made for hire, however, these reports (Work Product) are submitted for the exclusive use of the person, partnership, or corporation to whom it is addressed, and neither the report nor the name of CPT℠ nor any member of its staff, may be used in connection with the advertising or sale of any product or process without written authorization of a duly authorized agent of CPT℠. The degree of care utilized to protect Sponsor information shall not be less than as CPT℠ utilizes to protect its own proprietary or confidential information of same nature.

CPT℠ and study Sponsor, including their Affiliates, and any of its employees, consultants, business partners or outside professionals, will not originate any publicity, news release, technical article or other public announcement, written or oral, whether to the public, press or otherwise, relating to the Projects or the existence of an arrangement between CPT℠ and study Sponsor without the prior written consent of the other party.

Standard of Performance

All studies shall be performed in accordance with CPT℠ Standard Operating Procedures, approved protocols, methods, and standards of conduct consistent with the regulatory status selected by the Sponsor under which testing will be conducted, i.e., Good Clinical Practices (GCP), Current Good Manufacturing Practice for Finished Pharmaceuticals (cGMP) and Good Laboratory Practice for Non-Clinical Laboratory Studies (GLP), including conduct of studies for EPA and OECD, as promulgated by the Food and Drug Administration, and ISO/IEC 17025:2017 Quality Practices; where applicable.

Wherever possible, these Standard Terms & Conditions shall be read in such a manner so as to avoid conflict with the quotation, and other related agreements, but in the event of an unavoidable conflict, the terms and definitions defined herein, shall control over the terms and conditions of the quotation as well as all other related agreements and amendments.

CPT℠ represents that it shall conduct all testing with the prior approval and ongoing review of all appropriate and necessary review authorities, and in accordance with all applicable laws and regulations. Furthermore, CPT℠ represents that it shall conduct testing services in a professional and competent manner by suitable personnel, in accordance with generally accepted sound scientific research techniques, methods and principles.

Individuals provided by CPT℠ to perform services are CPT℠’s employees, consultants, or agents.    The manner and means by which CPT℠ chooses to select, hire, assign, compensate, correct, transfer or dismiss such individuals will be at the sole discretion of CPT℠.  Sponsor will not have the right to, and will not, control the manner or determine the method of accomplishing the services provided by CPT℠.

Sponsor shall provide CPT℠ with all test materials and other documentation, which will be required to perform the Protocols and/or Methods in a timely manner, so as not to delay performance by CPT℠.  A sample submission form, purchase order, letter of authorization, or signed quotation, detailing the total study cost is required to initiate testing projects and must accompany the samples when submitted.

For any Project in which a Purchase Order is required by the study Sponsor as part of the authorizing documentation, CPT℠ will initiate a ‘hold’ on submission of any Draft, Interim or Final report, pending receipt of such Purchase Order.  In the event that Sponsor changes the terms of the original PO, such change will have no bearing as to the original agreed payment and terms of such payment. It shall be the responsibility of the study Sponsor to ensure that any Purchase Order issued to CPT℠ complies with the Sponsor’s availability of funds for payment for services rendered.  All invoices which cannot be paid by the Sponsor’s non-compliance with this section, shall incur a fee of 2% per month beyond terms, until payment is received by CPT℠.

Project delays which are based upon changes to the protocol requested by the Sponsor after the initiation of testing, or unavailability of sufficient test material, shall have those direct costs billed to the Sponsor in full.  These costs are in addition to the Cost of Study.

CPT℠ schedules clinical trials only after all information and materials have been received, including a signed quotation, an accepted (standard) or signed (custom) protocol, authorizing Purchase Order number if required, and arrival of the test material.  Protocol development begins once a signed quotation is received. 

Ingredient lists, including percentage of actives (for OTC drug products), are to be submitted with authorizing documents for review by CPT℠ department Management.  Depending upon the nature of the test material, Sponsor may also be required to provide a Safety Data Sheet (SDS), a Certificate of Analysis, or Certification of Origin/Sourcing.

Sponsor shall provide, without charge, all test material(s) to be studied under this Agreement. The test material(s) shall be in appropriately marked containers. Sponsor guarantees that no test material constituting or being part of any shipment now or hereafter made to CPT℠ in connection with a project covered by this Agreement will be adulterated or mislabeled. Sponsor attests that the test material(s) (including any reference product used in the Study) provided by Sponsor are identical in content to the description provided in the Protocol if blinded formulations are to be used or are identical to the label description for open-label formulations if they are to be used.  It is the responsibility of Sponsor to define the stability and/or other relevant characteristics of the test material.  A study schedule for testing shall be agreed upon between Sponsor and CPT℠.  Necessary or expedient changes to the Protocol or Test Method during the course of the study may be verbally agreed upon, but any such changes must be documented in writing to (or from) Sponsor within 72 hours of such change.  Changes which result in any increase in study cost, as well as any other changes must be authorized in writing by Sponsor, prior to implementation.

During the course of the study, CPT℠ will provide reasonable, limited, on-site technical consultation, as needed, to properly evaluate the test material(s) to be investigated in the study.  There will be no additional charge for this service. Additional consulting services can be contracted with CPT℠ staff for in-depth discussions, research, planning, and audits as needed.

“Priority”, “Rush”, “STAT”, and “CRITICAL” requests are to be made by the Sponsor in advance of sample submission, as they are accepted by the laboratory only if the desired date of report submission can be met, based on current laboratory resources and prior commitments. Priority, Rush, STAT, and “CRITICAL” requests must be indicated on the laboratory sample submission form, where available.  Please note that there are upcharges for Priority, Rush, STAT, and CRITICAL services if available for that testing division.

Any delays in performance by CPT℠ shall be excused, if and to the extent caused by occurrence beyond the control of CPT℠ including but not limited to, decrees of the government, Act of God, strikes or other concerted actions of workmen, pandemics, fires, floods, explosions, riots, war, rebellion and sabotage (collectively, “Force Majeure Events”), but the foregoing shall not be considered a waiver by Sponsor of its right to enforce the obligations of CPT℠ as contracted.  Notwithstanding the foregoing, if a Force Majeure Event continues for ten (10) consecutive days or more, Sponsor shall have the option to terminate this Agreement on five (5) days written notice to CPT℠.  In the event Sponsor elects not to terminate this Agreement, CPT℠ shall continue with the Project; or at Sponsor’s request, initiate a repeat Project, which terms shall be negotiated with Sponsor in good faith. If there is a delay caused by the acts or omissions of CPT℠, CPT℠ shall be liable for any reasonable costs that Sponsor can demonstrate incurred as a direct result of such delay.

Neither Sponsor nor CPT℠ shall unreasonably withhold access to the other, to study materials, wherever located, if such access is required for validation of laboratory results or procedures to comply with U.S. government regulatory agency request or applicable law.

Termination of Project

The Sponsor may terminate any study, and for any reason, by providing at least thirty (30) days notice to CPT℠.  However, should the Sponsor terminate any study after acceptance of initial contractual documentation but prior to the initiation of testing, CPT℠ reserves the right to invoice the Sponsor a cancellation fee, as denoted in the quotation, or for any pass through expenses associated with the setup of such study, through the date of termination of that study, whichever is greater, but not more than the original cost of study.  CPT℠ shall provide the Sponsor with proof of pass through expenses.  CPT℠ shall, on a pro rata basis, repay to the study Sponsor all fees and expenses paid in advance for any Projects not performed or reports not provided.

CPT℠ reserves the right to bill the Sponsor in full, for any study cancelled after initiation of testing, as resources have been specifically assigned to that Project which cannot be reassigned to any other project.  Unless prior written notification is given by CPT℠, such cancellation fee is due and payable immediately.  Final accounting summary shall accompany the final invoice of services/costs accumulated to date, including payments applied and be sent to the study Sponsor.

CPT℠, in its sole discretion, may terminate any human clinical Project, in whole or in part, at any time, if the Principal Investigator for a clinical trial deems that clinical trial subjects are placed at risk, based upon the test material, protocol, or process.  Such notice shall be provided to Sponsor in a timely manner, to allow the Sponsor to review Project data, provided that such review is performed within 72 hours of CPT℠ notification.

Test Material Retention Period and Disposal or Return to Sponsor

Test materials not consumed in testing, shall be retained for a period of 15 days upon completion of testing, or longer at CPT℠’s discretion, after which they will be disposed of in an appropriate manner unless the Sponsor has provided a written request for their return prior to initiation of testing.  Hazardous test materials will be returned to the study Sponsor at Sponsor’s cost.  If the study Sponsor requests that CPT℠ dispose of test materials at the completion of testing, a quote for disposal of test materials, including administrative fees will be obtained for Sponsor approval.  In order for test materials to be returned to the Sponsor, the project must be completed and reported, and a release must be provided by the Department Director.

The Sponsor is to provide their preferred courier, and their shipper number for CPT℠ to return the test materials to them. Controlled substance shipping fees (if applicable) are in addition to these costs.  If the Sponsor does not provide their shipping information, CPT℠ will charge shipping fees at prevailing rates at the time of request.

CPT℠ is not responsible for U.S. Customs processing or clearance, and scheduling, or fees, associated with U.S. Customs and/or courier services. 

Regulatory Status of Testing

Each Sponsor must decide upon the regulatory status under which the testing of their sample(s) will be conducted.  That being said, Consumer Product Testing Company, Inc. urges Sponsors to choose the regulatory status of testing that corresponds to the regulatory category to which their sample(s) is assigned.

Good Manufacturing Practices (GMP) – The testing of therapeutic products (e.g., drugs and dietary supplements) for ‘release’ and ‘stability’, the raw materials that are used to manufacture such products, and the primary container system in which such products are packaged.

Good Clinical Practices (GCP) – All human clinical testing is conducted by CPT℠ under GCP requirements for the protection of subjects. This is what CPT℠ describes as GCP Category 2 status.  Any study intended for submission to a Regulatory Agency or for publishing should be conducted under what CPT℠ describes as GCP Category 1 status.

Good Laboratory Practices (GLP) – Nonclinical testing of medical devices, food additives, FD &C colors intended for submission to FDA for approval.  Early-stage nonclinical safety testing during drug development. Nonclinical testing of materials intended for submission to EPA for approval.

Research – Testing conducted for the Sponsor’s information only.  Testing of cosmetic/personal care products however many Sponsors now choose GMP status for testing such products for the reason stated below.

For example:

The Analytical or Microbiological testing of Rx or OTC drugs, the raw materials used in their manufacture, and the components used in their packaging should always be conducted under “GMP” status, unless the testing is for research purposes only.  Testing under “GMP” status requires the use of verified compendial methods or validated non-compendial methods which have undergone Method Transfer to CPT℠.  Additional requirements may apply and shall be discussed with each Sponsor on a project-by-project basis.

The Analytical or Microbiological testing of Cosmetic/Personal Care products may currently be tested under a “Research” status, however many Sponsors choose to conduct such testing under “GMP” status since the results are generated under a more tightly controlled testing scheme.

Human Clinical testing that is intended for submission to a Regulatory Agency or intended for publication should always be conducted under what CPT℠ terms “GCP Category I” status.  Clinical testing not intended for submission or publication may be conducted at a lower regulatory status and shall be discussed with each Sponsor on a project-by-project basis.

In Vitro Toxicological testing that is intended for submission to a Regulatory Agency should always be conducted under “GLP” status.  Testing conducted under “GLP” status requires the generation of a Protocol, and other elements that shall be discussed with each Sponsor on a project-by-project basis.  In Vitro Toxicological testing not intended for submission may be conducted under a “Research” status, however many Sponsors choose to conduct such testing under “GLP” status since the results are generated under a more tightly controlled testing scheme.   

Regulatory Compliance

The Sponsor must inform CPT℠ of the desired regulatory status, under which a study shall be conducted, or any intention of Regulatory Agency submission or publication prior to the initiation of a study.  This will ensure the laboratory maintains the proper compliance with agency requirements based upon the regulatory status chosen.  Additional fees may apply depending upon such status.

Based upon information provided by the Sponsor, CPT℠ may offer formal (under a consultation services contract) or informal recommendations as to the performance of a study and/or the level of compliance under which it should be conducted.  The ultimate decisions on such matters, however, and responsibility for their impact rests solely with the Sponsor.

Regulatory Agency inspections of pharmaceutical testing facilities are both common and expected occurrences.  General inspections made by Regulatory Agencies shall be hosted by CPT℠ in a professional manner, and the official records of such inspections shall be made available to any client of CPT℠ upon request.  In the event that a Regulatory Agency inspection of CPT℠ is directed towards testing that was performed for a specific client, that client shall be notified immediately and periodically updated as to the progress of the inspection.  Directed inspections of testing that was performed for a specific client, e.g. Pre-Approval Inspections (PAI) will be subject to a regulatory inspection support fee based upon the time and staff needed to host and comply with Agency requests during the inspection.

Support Services for Sponsor Submissions to Governmental Agencies:

CPT℠ may provide staff support (Quality Assurance, Regulatory, or Laboratory) for FDA/EPA/Regulatory Agency Inspection of client-owned test materials. The client will be invoiced a daily fee, per staff member required, at current rates at time of request. This is prorated for actual amount of time (rounded to the half hour) spent with inspectors, gathering information and preparing responses.

Regulatory Agency requests to review client-specific test records/documents shall be promptly forwarded (in writing) to that client for response within twenty-four (24) hours.  Client refusals of inspection shall be relayed to the Regulatory Agency for direct resolution with the client.  The lack of a response within the allotted time-period shall be interpreted as agreement to allow for the inspection of client records/documents. Any findings of non-conformance by a Regulatory Agency that directly relate to testing performed for a specific client shall be promptly provided to that client.  CPT℠ shall be solely responsible for responding to non-conformance findings in the manner and timeframe that is required by the applicable regulations.

Reports

CPT℠ shall provide the Sponsor with at least one original Final Report which becomes the property of Sponsor. To ensure the quality of the Work Product, CPT℠ has employed certain security measures, which are considered essential to the Sponsor/CPT℠ relationship.  To that end, and to ensure the integrity of the data provided to the Sponsor, all Final Reports are provided in a secured and password-protected Adobe Portable Document Format (“PDF”).   Sponsors must create an account in the CPT℠ Client Portal (eCPT^℠) for secured and traceable transmission of PDF reports and Invoices.  Only Final Reports in this secured PDF format will be deemed to be the accurate and defensible Work Product, for which CPT℠ will provide support to the Sponsor. For the avoidance of doubt, the Work Product generated and known as “Interim Report”, “Draft Report”, or “Final Report” contains the data which is the direct result of the work made for hire, however, these reports are submitted for the exclusive use of the person, partnership, or corporation to whom it is addressed, and neither the report nor the name of CPT℠, or any unique identifying images of CPT℠, nor any member of its staff, may be used in connection with the advertising, marketing, or sale of any product or process with prior written authorization by a duly authorized agent of CPT℠.

All reports and invoices will be provided to the study Sponsor (or designee) through our secure online eCPT^℠ Client Portal which will remain available for 2 years from study initiation date, except for stability studies which will reside in the system for the length of the study plus 1 year.  Hard copies will only be provided upon request at an additional cost at prevailing rates at time of request, and not in lieu of online access to those documents.

Sponsors may review the CPT℠ User Agreement and Privacy Policy for the eCPT^℠ Client Portal on our website.

Data Security

CPT℠ Information Technology shall be defined as those devices, networks and related infrastructure that CPT℠ owns, operates, contracted or has obtained for use, to conduct CPT℠ business. Devices include but are not limited to, CPT℠ owned or managed servers, storage, processing, communications devices and related infrastructure, and contracted secure cloud service providers on which CPT℠ data is accessed, processed, stored, or communicated, and may include personally owned devices. Data includes, but is not limited to, non-public information, other CPT℠ created Proprietary Information or managed business and research data, metadata, and credentials created by or issued on behalf of CPT℠.

In any circumstance when a Sponsor is provided access to CPT℠ Information Technology, it is solely the Sponsor’s responsibility to ensure that its access does not result in any access by unauthorized individuals to CPT℠ Information Technology. This includes conformance with minimum security standards in effect at the CPT℠ location(s) where access is provided. It is the Sponsor’s responsibility to inform CPT℠ in writing when personnel have left their company and their access to CPT℠ data is to be terminated.

Sponsor will develop, implement, and maintain a comprehensive Information Security Plan that is written in one or more readily accessible parts and contains administrative, technical, and physical safeguards. The safeguards contained in such programs must be consistent with the safeguards for protection of Protected Information and information of a similar character set forth in any state or federal regulations by which the person who owns or licenses such information may be regulated.

Not less than annually, Sponsor shall evaluate and document whether Sponsor’s practices accessing CPT℠ Information Technology complies with these terms. Documentation of such evaluation shall be made available to CPT℠ upon CPT℠’s request. Regardless of whether CPT℠ requests a copy of such evaluation, Sponsor shall immediately inform CPT℠ of any findings of noncompliance and certify when findings of non-compliance have been addressed.

Document Retention Policy

All records and documents pertaining to the conduct of studies, shall be retained in the CPT℠ archives for a minimum of  five (5) years.  At any time prior to the completion of the fifth archival year, a Sponsor may submit a written request to the CPT℠ Quality Assurance Department, to obtain custody of these records and documents, based upon the study Sponsor’s company policy, once the CPT℠ archive period has been completed.  This transfer shall be performed at the Sponsor’s expense.  In the absence of such written requests, study-related records and documents shall be destroyed at the end of the CPT℠ archive period, with no further notice to the Sponsor, in a manner that renders them useless.

Financial Terms

The Sponsor shall be supplied with a contract price concurrent with the initial, authorizing contractual documents.  Revisions to final contract price, including costs of any re-tests performed at the Sponsor’s request, shall be made in writing and be executed by the signature of both Sponsor and CPT℠.

CPT℠ reserves the right to request a prepayment of up to 100% in advance of services being performed. In some cases, CPT℠ may require a partial prepayment and/or interim payments with the remaining balance due upon presentation of a written draft, or final report. Some studies require an initiation fee of the total estimated cost to cover the initial cost of performing the test, supplies, and/or to establish credit. Prepayment will be indicated in the quotation, if applicable, and invoiced upon acceptance of the quotation.

Some projects require the generation of a billing schedule based upon operational milestones, which includes a cancellation and re-scheduling matrix.  Projects placed on hold prior to initiation of testing, which are appropriately authorized by the study sponsor, for which samples are in house, will incur a maintenance fee for every 30-day period, at the rate of $150.00 per month, until such time as the project is released for initiation of testing.  These costs are in addition to the quoted cost of study.

CPT℠ reserves the right to terminate any study in which the Sponsor does not pay its initial invoice for that study. Non-payment of initiation or interim summary fees will be deemed an abandonment of the project, and therefore the project will be terminated.  In the event of default on a payment for services rendered, the Sponsor shall assume all reasonable fees associated with the remedy for securing such payment, including collection and legal fees.  Issuance of a Summary of Findings, an Interim Report of data accumulated to that date, or Final Report, will be withheld until both parties have agreed in writing upon satisfactory terms.

Fees (initial and annual fees) which are incurred by CPT℠ due to a Sponsor’s requisite enrollment in any online payment platform will be charged to the Sponsor upon CPT℠’s enrollment, and maintenance invoice.

Invoices that are outstanding for a period exceeding three months beyond terms shall be immediately turned over to either a collection service, or CPT℠ General Counsel for proper remedy unless other terms have been accepted by CPT℠ in writing. CPT℠ may elect to bring an action for the collection of unpaid fees in any court having competent jurisdiction. The Sponsor shall pay all CPT℠’s collection costs, including attorney’s fees, court costs, and related costs.

Financial terms may be altered at any time by our Accounting Department based upon factors such as payment history and D&B credit advisory reports. Changes in payment terms made by Sponsor/Client without prior agreement in writing by an authorized agent of CPT℠, will result in voiding of previously signed contracts, quotations or other instruments authorizing testing.  As such, pricing and/or finance terms may be adjusted. 

CPT℠ accepts wire transfers, checks drawn on US Banks, or Visa, Master Card and American Express credit cards. Payments made by credit card authorization will incur a 3.5% processing fee.  Payors may process credit transactions by contacting our accounting department at accountingstaff@cptclabs.com, or by following directions provided on CPT℠ invoices under payment options.

Sponsor shall not be entitled to retain or defer payment of any sums due to CPT℠ based upon any dispute, counter claim or set off which it may allege against CPT℠.  Services rendered shall be in compliance with regulatory requirements, Standard Operating Procedures, Protocols, Methods and Sponsor directives.  Results obtained are specific to each Project, and Sponsor may not withhold payment based upon disputed results.  Final Reports are the direct result of the work-for-hire, however; should a Sponsor/Client/Payor withhold payment, or delay payment equal to or greater than 30 days beyond previously agreed terms, the Final Report for that work-for-hire shall be removed from our eCPT^℠ Client Portal, and shall not be supported by CPT℠.

Sponsor payments made beyond agreed upon terms for any thirty-day period, for which the Sponsor/Client/Payor fails to cure within seven (7) days of CPT℠ providing notice of delinquent payment, may result in the financial terms for the Sponsor/Client/Payor being revised to Prepayment prior to initiation of any future testing.  Further, any Sponsor/Client/Payor whose payment history for the previous calendar year, consistently exceeds terms by 90 days or more, will be subject to a review of annual pricing rates, and may incur an increase in pricing structure, based upon the length of delinquency of payments.

Third Party Billings

All fees and charges shall be invoiced directly to the study Sponsor.  Third party billing will only be accepted by CPT℠, with prior written acknowledgment by such Third Party Payor of financial responsibility for all study costs associated with the Project by the third party.  Projects shall be placed on hold status, until such Third Party Payor acceptance has been received.

Intellectual Property

CPT℠ quotations, standard protocols, test methods, test procedures, concepts, materials, know how, techniques, improvements, software (regardless of form or media), hereafter known as ‘Technical Information’ which CPT℠ has discovered, or developed, independent of Sponsor’s Confidential Information shall remain the intellectual property (IP) of CPT℠; and its assigns shall be the sole owner of all patents, copyrights, trademarks, service marks and other rights in connection therewith. Custom designed study protocols remain the intellectual property (IP) of CPT℠ until the Project is paid in full.

CPT℠ will be free to utilize any Technical Information CPT℠ has discovered or adapted in the performance of the testing services.  For the avoidance of doubt, CPT℠’s residual rights include the right to use the Technical Information in the creation of any Work Product, but such residual rights shall not include the Work Product itself.  For all purposes, Technical Information is considered confidential, and shall not be disclosed without the prior written consent of a duly authorized agent of CPT℠.  This Technical Information shall be protected by Sponsor with at least the same diligence, care and precaution that Sponsor uses to protect its own confidential and trade secret information.

Warranty and Limits of Liability

In providing services to study Sponsors, CPT℠ warrants the accuracy of test results for the samples submitted.  This warranty is the sole warranty given to the Sponsor.  We disclaim any other warranties, expressed or implied.  In no event shall CPT℠ be liable for indirect, special, consequential, or incidental damages including, but not limited to, damages for loss of profit or goodwill.  We accept no legal responsibility for the purposes for which the Sponsor uses the test results.

Any liability incurred by the Sponsor due to the falsification or adulteration of any Final Report, or data used to compile such report, which has occurred post submission to the Sponsor, shall be the Sponsor’s sole responsibility, and will result in voiding the Sponsor’s access to the eCPT^℠ Client Portal.

Indemnification

The Sponsor agrees to indemnify, and to save and hold harmless CPT℠, its officers, directors, agents, and employees against all claims for injury to persons or damage to property and all related expenses, including but not limited to costs of litigation, arising out of and during the course of client submitted studies, where there is testing, or evaluation, or use of any test materials or processes manufactured or furnished by the Sponsor, or the user of any test materials of processes developed by CPT℠ for the Sponsor.

Each party agrees to notify the other party promptly of such claims.

This indemnification shall not apply in any instance where the injury to person or damage to property is caused by the willful negligence of CPT℠, or its employees, agents or representatives, during the actual performance of services, including, but not limited to, any failure to follow specific instructions for the use of the test material or failure to follow the agreed upon protocols; or unauthorized warranties made by CPT℠ or its employees with respect to the test material furnished to CPT℠ by the Sponsor; or alteration of the composition of the test material furnished to CPT℠ by the Sponsor without the prior consent of the Sponsor as to the alteration.  However, CPT℠’s damages shall be limited in the aggregate, to an amount equal to the lesser of either damage suffered by the Sponsor as the direct result thereof; or the total amount paid by the Sponsor to CPT℠ for the work herein covered.

A Letter of Indemnification can be supplied to the Sponsor upon request if no Sponsor prepared documentation is available.

Support Services

CPT℠ will provide additional personnel for a reasonable number of project-related FDA and/or other regulatory agency meetings at a daily cost equal to current CPT℠ hourly consulting rates, based on an eight hour working day at the time such meeting attendance is requested of CPT℠.  In addition, Sponsor will compensate CPT℠ for reasonable travel expenses and other reasonable out-of-pocket expenses related to such regulatory agency meeting attendance.

Governing Law

Agreements between Sponsor and CPT℠ shall be governed by and construed in accordance with the laws of the State of New Jersey and the United States of America, without regard to conflicts-of-laws principles.