The terms and conditions stated below are effective for all divisions of Consumer Product Testing Company, Inc. (CPTC) performing services for the Sponsor. This document provides a basic outline of our standard terms and conditions, counterparts of which are provided to the Sponsor as additional documentation and are included by reference as part of this document.
CPTC is operating as an independent contractor, and not as an agent or employee of Sponsor in its performance of any and all services hereunder.
CPTC maintains strict standards of confidentiality in regards to all services and consultation provided to the Sponsor. CPTC 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 CPTC. In addition, Sponsor agrees to withhold from using the name, image, logo or other identifying items of Consumer Product Testing Company, Inc. or any of its officers, employees or agents in any marketing or advertising without our express prior written consent.
Standard of Performance
All studies shall be performed in accordance with CPTC Standard Operating Procedures, approved protocols, and standards of conduct consistent with 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 17025:2005 Quality Practices; where applicable.
Sponsor shall provide CPTC with all test products and other documentation, which will be required to perform the Protocols in a timely manner, so as not to delay performance by CPTC. A study schedule shall be agreed upon between Sponsor and CPTC, especially as it pertains to the initiation of clinical bio-phase. Project delays which are based upon changes to the protocol requested by the Sponsor after the initiation of testing, or unavailability of sufficient test product, shall have those direct costs billed to the Sponsor in full. These costs are in addition to the Cost of Study.
Sponsor shall provide, without charge, all finished products to be studied under this Agreement. The product(s) shall be in appropriately marked containers. Sponsor guarantees that no dosage form constituting or being part of any shipment now or hereafter made to CPTC in connection with the project covered by this Agreement will be adulterated or mislabeled. Sponsor attests that the products (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 article. Necessary or expedient changes to the Protocol 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, CPTC will provide reasonable, on-site technical consultation, as needed, to properly evaluate the products to be investigated in the study. There will be no additional charge for this service. CPTC will provide additional personnel for a reasonable number of project-related FDA and/or other regulatory agency meetings at a daily cost equal to CPTC hourly consulting rates, based on an eight hour working day at the time such meeting attendance is requested of CPTC. In addition, Sponsor will compensate CPTC for reasonable travel expenses and other reasonable out-of-pocket expenses related to such regulatory agency meeting attendance.
We highly recommend that “Priority”, “Rush” and “Stat” requests 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 the current laboratory resources and prior commitments. Priority, Rush or Stat requests must be indicated on the laboratory sample submission form. Please note that there are upcharges for Priority, Rush and Stat services if available for that testing division.
Any delays in performance by CPTC, shall be excused if and to the extent caused by occurrence beyond the control of CPTC including but not limited to, decrees of the government, Act of God, strikes or other concerted actions of workmen, fires, floods, explosions, riots, war, rebellion and sabotage, but the foregoing shall not be considered a waiver by Sponsor of its right to enforce the obligations of CPTC. In the event that there is such a delay in performance, Sponsor shall have the option to terminate this Agreement. In the event Sponsor elects not to terminate this Agreement, CPTC shall, at Sponsor’s option, either continue with the study or initiate a repeat study, which shall be completed at no additional cost to Sponsor beyond the cost agreed upon in this Agreement.
Neither Sponsor nor CPTC 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. However, should the Sponsor terminate any study after acceptance of initial contractual documentation, CPTC reserves the right to invoice the Sponsor for any direct costs associated with the setup of such study, providing the Sponsor with proof of such expenses.
Upon written notification of such termination, CPTC reserves the right to invoice the Sponsor a minimum cancellation fee of 20% of study cost, or aggregate amount of direct costs incurred through date of termination of that study, whichever is greater, but not more than the original cost of study. Sponsor may terminate a method development project after acceptance of final contractual documentation, and CPTC reserves the right to invoice the Sponsor any direct costs associated with the setup of such study, and costs associated with allocation of resources directly related to the project. CPTC reserves the right to bill the Sponsor in full, for any clinical study cancelled after initiation, as resources have been specifically assigned to that project which cannot be reassigned to any other project. Unless prior written notification is given by CPTC, such cancellation fee is due and payable immediately. Final accounting summary shall accompany final invoice of services/costs accumulated to date, including payments applied.
CPTC may terminate a clinical or photobiology study immediately upon notification to Sponsor if requested to do so by the responsible IRB or if such termination is required to protect the health and safety of study subjects.
CPTC standard protocols, test methods, concepts, know how, techniques, improvements, or software shall remain the intellectual property (IP) of CPTC; and its assigns shall be the sole owner of all patents, copyrights, trademarks and other rights in connection therewith. Custom designed study protocols remain the intellectual property (IP) of CPTC until the study is paid in full.
Warranty and Limits of Liability
In providing services for Sponsors, CPTC 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, express or implied. In no event, shall CPTC 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.
The Sponsor must inform CPTC of the desired regulatory status, under which a study shall be conducted, or any intention of Regulatory Agency submission 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 dependent upon such status.
Based upon information provided by the Sponsor, CPTC may offer formal (under a consultation services contract) or informal recommendations as to the performance of a study and/or the level of compliance at 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 CPTC in a professional manner, and the official records of such inspections shall be made available to any client of CPTC upon request. In the event that a Regulatory Agency inspection of CPTC 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. Preapproval Inspections) 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.
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. CPTC shall be solely responsible for responding to non-conformance findings in the manner and timeframe that is required by the applicable regulations.
The Sponsor agrees to indemnify, and to save and hold harmless CPTC, 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 products or processes manufactured or furnished by the Sponsor, or the user of any products of processes developed by CPTC for the Sponsor.
CPTC agrees to notify the Sponsor 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 negligence of CPTC, or its employees, agents or representatives, during the actual performance of services under this agreement, including, but not limited to, any failure to follow specific instructions for the use of the product or failure to follow the agreed upon protocols; or unauthorized warranties made by CPTC or its employees with respect to the product furnished to CPTC by the Sponsor; or alteration of the composition of the product furnished to CPTC by the Sponsor without the prior consent of the Sponsor as to the alteration. However, CPTC’s damages shall be limited in the aggregate, to an amount equal to the lesser of either damages suffered by the Sponsor as the direct result thereof; or the total amount paid by the Sponsor to CPTC for the work herein covered.
A Letter of Indemnification can be supplied to the Sponsor upon request if no Sponsor prepared documentation is available.
CPTC shall provide the Sponsor with at least one original Final Report, in the form preferred by Sponsor (hard copy, or PDF), which becomes the property of Sponsor.
To ensure the quality of the Work product, CPTC has employed certain security measures, which are considered essential to the Sponsor/CPTC 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”). Clients must create an account in the CPTC Client Access System (CAS) for secured and traceable transmission of PDF reports and Invoices. Only Final Reports in PDF format, will be deemed to be the accurate and defensible Work product, for which CPTC 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 CPTC, or any unique identifying images of CPTC, 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 CPTC.
CPTC Information Technology shall be defined as those devices, networks and related infrastructure that CPTC owns, operates, contracted or has obtained for use, to conduct CPTC business. Devices include but are not limited to, CPTC owned or managed servers, storage, processing, communications devices and related infrastructure, and contracted secure cloud service providers on which CPTC data is accessed, processed, stored, or communicated, and may include personally owned devices. Data includes, but is not limited to, non-public information, other CPTC created Proprietary Information or managed business and research data, metadata, and credentials created by or issued on behalf of CPTC.
In any circumstance when a Sponsor is provided access to CPTC Information Technology, it is solely Sponsor’s responsibility to ensure that its access does not result in any access by unauthorized individuals to CPTC Information Technology. This includes conformance with minimum security standards in effect at the CPTC location(s) where access is provided.
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 program 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.
No less than annually, Sponsor shall evaluate and document whether Sponsor’s practices accessing CPTC Information Technology complies with these terms. Documentation of such evaluation shall be made available to CPTC upon CPTC’s request. Regardless of whether CPTC requests a copy of such evaluation, Sponsor shall immediately inform CPTC 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 CPTC archives for a minimum of ten (10) years. At any time prior to the completion of the tenth archival year, a Sponsor may submit a written request to the CPTC Quality Assurance Department, to obtain custody of these records and documents once the CPTC 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 CPTC archive period, with no further notice to the Sponsor, in a manner that renders them useless.
Payment Terms; Fee Schedule
The Sponsor shall be supplied with a contract price concurrent with initial, authorizing contractual documents. Revisions to final contract price shall be made in writing and be executed by the signature of both Sponsor and CPTC.
Advance payments are required in certain situations, and these situations are delineated within each division’s initial contractual documents. Payment in full, in advance, may be required of new clients until a credit limit and payment history have been established by the accounting department of CPTC.
Some projects require the generation of a billing schedule, which includes a cancellation and re-scheduling matrix. The studies, for which this generally applies, are those studies that are greater than 8 weeks in duration, and/or $25,000 in sales.
CPTC reserves the right to terminate any study in which the Sponsor does not pay its initial invoice for that study. Non-payment of interim summary fees will be deemed an abandonment of the project, and therefore the project will be terminated. In the event of default of a payment for services rendered, the Sponsor shall assume all reasonable fees associated with the remedy for securing such payment. Issuance of final report, or an interim report of data accumulated to that date, will be withheld until both parties in writing have agreed upon satisfactory terms.
Invoices for which payment exceeds six months from date of invoice shall be immediately turned over to a Collection Service for proper remedy, unless other terms have been accepted by CPTC in writing prior to the six-month date.
Third Party Billings
All fees and charges shall be invoiced directly to Sponsor. Third party billing will only be accepted with prior written acknowledgement of the third party.
Agreements between Sponsor and CPTC shall be governed by, and construed in accordance with the laws of the State of New Jersey and the United States of America.