LET ADPEN TAKE CARE OF
YOUR CONTRACT RESEARCH NEEDS
TERMS AND CONDITIONS
Effective Date: 06 October 2026
These Terms and Conditions apply to laboratory and related services provided by ADPEN Laboratories, Inc. (“ADPEN”), except as otherwise provided in an applicable written agreement.
For purposes of these Terms and Conditions, “Client” means the person or entity that contracts with or authorizes ADPEN to perform services. “Sponsor” means the person or entity for whose benefit the services are performed when different from the Client. References to the “Client or Sponsor” apply as appropriate to the particular project and do not, by themselves, establish responsibility for payment where separate billing arrangements have been agreed.
General Performance of Services
ADPEN provides contract analytical testing, method development, and related laboratory services in accordance with the scope and requirements agreed upon with each Client. Services will be performed in accordance with the agreed scope, applicable ADPEN procedures and quality systems, and project-specific requirements.
Quality Assurance oversight will be provided when required by the applicable regulatory framework, project protocol, quotation, agreement, or ADPEN quality system.
ADPEN will exercise a high standard of professional conduct and reasonable care in the performance of its services and preparation of resulting reports. If an error or omission attributable to ADPEN requires an affected portion of the work to be repeated, ADPEN will repeat the affected work at no additional charge to the Client. This remedy constitutes ADPEN’s sole responsibility with respect to such error or omission, except as otherwise provided in an applicable written agreement.
Confidentiality
ADPEN will maintain as confidential all non-public information received from or generated on behalf of the Client in connection with the performance of services, including, as applicable, information relating to samples, products, formulations, methods, study designs, analytical results, reports, specifications, and business or technical information (“Confidential Information”).
ADPEN will use Confidential Information solely as necessary to perform the agreed services and will disclose such information only to employees, contractors, consultants, or service providers who require access for the performance of those services and who are subject to appropriate confidentiality obligations.
Confidential Information does not include information that ADPEN can demonstrate: (a) was publicly available at the time of disclosure or subsequently becomes publicly available through no breach of an obligation by ADPEN; (b) was lawfully known to ADPEN without restriction prior to disclosure by the Client; (c) is lawfully received from a third party without a duty of confidentiality; or (d) is independently developed by ADPEN without use of the Client’s Confidential Information.
If disclosure of Confidential Information is required by law, regulation, court order, subpoena, or governmental authority, ADPEN may disclose the information to the extent legally required. To the extent legally permitted and reasonably practicable, ADPEN will notify the Client of such required disclosure.
Where a separate confidentiality agreement, nondisclosure agreement, master service agreement, or other written agreement governing confidentiality is in effect between ADPEN and the Client, the confidentiality provisions of that agreement will apply in accordance with its terms.
Quotations and Agreements
ADPEN quotations and proposals describe the scope of services, pricing, deliverables, assumptions, and project-specific terms applicable to the requested work. Unless otherwise stated, quotations are valid for the period specified in the quotation.
A quotation or proposal will be considered accepted upon the Client’s written approval, signature, issuance of a purchase order referencing the quotation, submission of samples with instructions to perform the accepted work, or other written authorization directing ADPEN to proceed. ADPEN’s commencement of authorized work will constitute performance under the accepted agreement.
Pricing and other commercial terms are based upon the scope of work described in the applicable quotation or proposal. If the Client requests a reduction, addition, modification, or other change to the accepted scope, ADPEN reserves the right to revise the scope, pricing, schedule, or other applicable terms before proceeding.
Where ADPEN and the Client have entered into an executed master service agreement or other governing written agreement applicable to the services, that agreement will control to the extent of any conflict with these Terms and Conditions, subject to any order-of-precedence provisions contained in that agreement.
Project-specific quotations, proposals, protocols, statements of work, change orders, and other written project documents will supplement these Terms and Conditions and may establish additional or different requirements for the applicable project. If a project-specific document conflicts with these Terms and Conditions, the project-specific document will control with respect to that project unless an applicable governing agreement provides otherwise.
Any material change to the agreed scope of work must be authorized by the Client and ADPEN before the additional or modified work is performed, except where immediate action is reasonably necessary to protect sample integrity, personnel safety, data integrity, or regulatory compliance.
Cancellation Policy
The Client may cancel an authorized project, study, or analytical testing order by providing written notice to ADPEN. The effective cancellation date will be the date ADPEN receives such notice.
Unless otherwise provided in the applicable quotation, proposal, master service agreement, or other written agreement, the following cancellation provisions will apply:
Contracted Projects and Studies
For projects and studies awarded to ADPEN through acceptance of a quotation, proposal, purchase order, or other written authorization, the Client will be responsible for cancellation charges based on the status and progress of the project at the time of cancellation:
- Following project award or authorization, before significant project activities have commenced: A minimum cancellation charge of 10% of the accepted project amount will apply.
- After project planning or preparation has substantially commenced, but before substantive laboratory or experimental activities have begun: A minimum cancellation charge 25% of the accepted project amount will apply.
- After substantive laboratory or experimental activities have commenced: A cancellation charge ranging from 25% to 100% of the accepted project amount will apply, with the final percentage determined by ADPEN based on the status and progress of the project.
- Following completion of the laboratory or experimental phase, but before issuance of the final report or completion of remaining deliverables: A cancellation charge ranging from 75% to 100% of the accepted project amount may apply, with the final percentage determined by ADPEN based on the status and progress of the project.
Routine Sample Testing
For individual sample submissions and routine analytical testing orders, cancellation charges will be based on the status of each affected analysis:
- Before sample receipt or initiation of testing activities: No standard cancellation fee will apply; however, the Client remains responsible for any project-specific or non-cancelable costs already incurred.
- Samples received and logged: 35% of the applicable analysis fee.
- Sample preparation initiated or completed: 50% of the applicable analysis fee.
- Instrumental analysis completed, but reporting not finalized: 95% of the applicable analysis fee.
Completed and reported analyses will be billed at the full applicable rate.
General Provisions
A material reduction in an accepted project scope may, at ADPEN’s discretion, be treated as a partial cancellation of the portion of work removed from scope. ADPEN also reserves the right to revise pricing for remaining work when a reduction materially changes the assumptions upon which the original quotation was based.
Where the value of work performed, materials purchased or committed, third-party charges, disposal obligations, closeout activities, or other project costs incurred by ADPEN exceeds the applicable cancellation charge above, the Client will be responsible for those additional amounts.
ADPEN reserves the right to waive or reduce a cancellation charge where circumstances warrant. Any such adjustment must be confirmed in writing by ADPEN.
Amounts previously paid by the Client will be applied toward amounts due under this cancellation policy. Any payment received in excess of the amount properly due following project reconciliation will be refunded to the Client or, by mutual agreement, applied as a credit toward future services.
Payment Terms
Unless otherwise stated in the applicable quotation, proposal, master service agreement, or other written agreement, payment terms are Net 30 days from the invoice date.
ADPEN may require an initial payment, deposit, milestone payment, partial prepayment, or full prepayment before work begins or before a subsequent phase of work is initiated. Any such payment requirement will be identified in the applicable quotation, proposal, agreement, or other written project terms.
Payment terms may vary based on the nature and scope of the services, project duration, Client credit history, or other commercial considerations. Extension of credit by ADPEN is subject to approval and may be modified or withdrawn if payment history or other circumstances warrant.
A service charge of 1.5% per month, or the maximum amount permitted by applicable law if lower, may be assessed on past-due undisputed balances.
If the Client disputes an invoice, the Client should notify ADPEN promptly in writing and identify the specific amount and basis of the dispute. Undisputed portions of an invoice remain payable in accordance with the applicable payment terms.
In the event of nonpayment of undisputed amounts when due, ADPEN may suspend or defer additional work, reporting, release of deliverables, or initiation of subsequent project phases until satisfactory payment arrangements have been made. The Client will be responsible for reasonable costs incurred by ADPEN in collecting past-due undisputed amounts, including reasonable attorneys’ fees and collection costs, to the extent permitted by applicable law.
Billing
Invoices will be issued to the party identified by the Client or Sponsor as responsible for payment. The invoiced party may be the Sponsor, a third-party management or consulting firm, or another authorized entity.
Where a third party is designated to receive or pay invoices, ADPEN may rely on the billing instructions provided in the applicable quotation, purchase order, study documentation, correspondence, or other written communication. If responsibility for payment is unclear or disputed, ADPEN may request written clarification before proceeding with additional work or releasing final deliverables.
Designation of a third party for billing purposes does not relieve the Client or Sponsor of responsibility for payment unless ADPEN expressly agrees in writing that the third party will have sole payment responsibility.
Invoices may include applicable charges for analytical services, project management, materials and consumables, third-party services, shipping, storage, disposal, rush services, additional work, and other charges authorized under the applicable quotation, proposal, agreement, or these Terms and Conditions.
Where project pricing is based on estimated quantities, hours, materials, third-party costs, or other variable expenses, final invoicing may be adjusted to reflect actual quantities or costs in accordance with the applicable quotation or agreement.
Rush and Expedited Services
ADPEN may offer rush or expedited services when laboratory capacity, instrumentation, personnel, method requirements, and sample conditions permit.
Rush or expedited services must be arranged in advance with an authorized ADPEN representative and may be subject to additional charges. Any applicable rush surcharge or expedited-service fee will be communicated to the Client or Sponsor before the expedited work is initiated.
Requested turnaround times are targets and are not guaranteed unless expressly agreed to in writing. Actual turnaround may be affected by sample condition, analytical complexity, required quality-control activities, instrument availability, unexpected technical issues, regulatory requirements, or other circumstances beyond ADPEN’s reasonable control.
ADPEN will make reasonable efforts to meet an agreed expedited schedule and will communicate material delays when they become known.
Sample Collection and Submission
The Client or Sponsor is responsible for the proper collection, identification, preservation, packaging, and shipment of samples in accordance with applicable requirements, the agreed analytical method or protocol, and appropriate industry practices.
Samples should be submitted with sufficient documentation to identify the samples and the requested work. As applicable, this information should include the sample description or identification, sample type or matrix, source, collection date and time, requested analyses, applicable specifications or reporting limits, known or expected concentration ranges, requested turnaround time, billing or purchase-order information, and any other information necessary for proper handling and analysis.
ADPEN will document receipt and custody of submitted samples in accordance with its applicable procedures. If a Client or Sponsor chain-of-custody record accompanies the samples, ADPEN will incorporate or reference that documentation as appropriate. If no chain-of-custody documentation is provided, ADPEN may initiate its own sample-receipt and custody documentation.
Upon receipt, ADPEN may evaluate samples for condition, quantity, identification, preservation, packaging integrity, temperature, holding-time requirements, and other factors relevant to the requested testing. ADPEN may place samples on hold, request additional information, reject samples, or proceed with testing subject to documented limitations when sample condition or documentation does not meet applicable requirements.
ADPEN is not responsible for sample degradation, contamination, loss of integrity, missed holding times, or other conditions occurring before ADPEN’s receipt and acceptance of the samples, except to the extent caused by ADPEN or its authorized carrier under a separate written arrangement.
Samples subject to hazardous, controlled, regulated, or other specialized handling requirements must be disclosed and approved in advance as described under Hazardous and Regulated Materials.
Incomplete, inaccurate, or late sample information may delay initiation or completion of testing. ADPEN will not be responsible for resulting delays where the required information or suitable samples were not provided in a timely manner.
Hazardous and Regulated Materials
The Client or Sponsor is responsible for informing ADPEN, before shipment or delivery, of any known or reasonably suspected hazardous, toxic, infectious, reactive, radioactive, highly concentrated, controlled, regulated, or otherwise unusual properties of samples, materials, or substances proposed for submission.
Hazardous or regulated materials, including DEA-controlled substances, radioactive materials, infectious materials, or other substances requiring specialized handling, custody, security, storage, transportation, or disposal, must not be shipped or delivered to ADPEN without prior written approval and coordination with ADPEN.
For materials accepted under special regulatory or security requirements, ADPEN may require additional documentation, chain-of-custody controls, shipping arrangements, receipt procedures, storage requirements, authorization records, or other measures before the material is accepted.
Appropriate safety and regulatory information, including Safety Data Sheets or other relevant hazard documentation when available, must be provided before shipment.
ADPEN reserves the right to refuse, quarantine, return, or impose special handling, storage, testing, transportation, custody, or disposal requirements for materials that present unusual safety, regulatory, environmental, security, or operational concerns.
The Client or Sponsor will be responsible for reasonable additional costs resulting from specialized regulatory, safety, security, handling, storage, transportation, or disposal requirements associated with the submitted material.
Sample Retention and Disposal
ADPEN will retain, return, or dispose of submitted samples in accordance with applicable regulatory requirements, approved protocols, project-specific instructions, ADPEN procedures, and the nature of the sample.
Unless otherwise agreed in writing, ADPEN may retain residual samples for a reasonable period following completion of testing or issuance of the applicable report. Specific retention periods may vary depending on the project, sample type, regulatory requirements, available storage capacity, and applicable agreement or protocol.
The Client or Sponsor must notify ADPEN in advance if samples must be returned, retained for a specified period, or handled under special storage or disposal requirements. Long-term storage, specialized storage conditions, sample return, shipping, and related handling may be subject to additional charges.
ADPEN may dispose of residual samples following the applicable retention period unless return or continued storage has been arranged in writing.
Samples or residual materials requiring special characterization, handling, transportation, treatment, or disposal because of hazardous, regulated, toxic, persistent, biohazardous, environmentally sensitive, or other unusual properties may be subject to additional charges. Such charges may include third-party waste characterization, profiling, transportation, packaging, treatment, disposal, documentation, and related handling costs.
Where disposal requirements or costs cannot reasonably be determined in advance, ADPEN may provide an estimated allowance and adjust the final charge to reflect actual third-party and related costs. ADPEN will notify the Client or Sponsor before incurring material disposal costs beyond an applicable quoted allowance when reasonably practicable.
ADPEN may require certain samples or materials to be returned to the Client or Sponsor rather than disposed of by ADPEN when appropriate based on the nature of the material, applicable requirements, or available disposal options. Applicable return shipping and handling costs will be the responsibility of the Client or Sponsor unless otherwise agreed in writing.
ADPEN will maintain applicable internal sample custody and disposition records in accordance with its procedures.
Quality Assurance
ADPEN performs laboratory services under its established quality systems, standard operating procedures, and applicable regulatory or accreditation requirements.
The specific quality or regulatory framework applicable to a project will be determined by the nature of the work and, where appropriate, will be identified in the applicable quotation, proposal, protocol, method, quality agreement, master service agreement, or other governing documentation.
Depending on the scope of work, services may be performed in accordance with Good Laboratory Practice (GLP), current Good Manufacturing Practice (cGMP), ISO/IEC 17025, applicable FDA or EPA requirements, or other agreed regulatory or quality frameworks. The applicability of any particular regulatory, quality, or accreditation framework should be established before work begins.
Where independent Quality Assurance oversight, inspections, audits, or review are required by the applicable framework or project agreement, such activities will be performed in accordance with ADPEN procedures and the agreed scope of work.
Requests for project-specific quality requirements, departures from ADPEN standard procedures, additional QA activities, or special documentation must be communicated and agreed upon before the affected work is performed. Such requirements may affect project scope, schedule, or pricing.
Ethics and Data Integrity
ADPEN is committed to conducting its laboratory and business activities with integrity, scientific objectivity, transparency, and professional responsibility.
ADPEN personnel are expected to generate, document, review, maintain, and report data in a manner consistent with applicable Good Documentation Practices and data-integrity principles, including ALCOA+ principles where applicable. Data should be attributable, legible, contemporaneous, original or a true copy, accurate, complete, consistent, enduring, and available throughout the applicable data lifecycle.
Laboratory records and reported results must accurately reflect the work performed. Fabrication, falsification, unauthorized alteration, concealment of data, improper data manipulation, or other practices that could compromise the integrity or reliability of laboratory records are prohibited.
ADPEN maintains policies, procedures, training, supervisory review, and quality oversight intended to support compliance with applicable regulatory and quality requirements, including FDA current Good Manufacturing Practice requirements where applicable to the work performed.
Employees are expected to promptly identify and appropriately document errors, deviations, atypical events, and other circumstances that may affect the integrity, quality, or interpretation of laboratory data. Such matters will be investigated, evaluated, and reported in accordance with applicable procedures and project requirements.
ADPEN will not knowingly compromise scientific integrity, data quality, or regulatory compliance in order to meet a requested schedule, reporting expectation, or desired analytical outcome.
Special Reports and Data Deliverables
Standard reports and data deliverables will be prepared in accordance with ADPEN’s applicable procedures and the requirements identified in the quotation, proposal, protocol, method, or other project documentation.
To be included within the original project scope and pricing, any special reporting requirements, custom templates, electronic data formats, portal submissions, client-specific forms, certificates, summaries, data packages, or other non-standard deliverables must be identified and agreed upon before work begins.
Requests made after testing or data review has commenced may require additional effort, reprocessing, reformatting, additional review, Quality Assurance involvement, or other activities not included in the original scope. Such work may result in additional charges and may affect the project schedule.
ADPEN will make reasonable efforts to accommodate post-project or late-stage reporting requests but cannot guarantee that all requested formats or deliverables can be produced if the necessary information was not captured, reviewed, or retained in the required manner during performance of the original work.
Record Retention
ADPEN will retain laboratory records, raw data, reports, and other project documentation in accordance with applicable regulatory requirements, approved protocols, governing agreements, and ADPEN record-retention procedures.
Retention periods may vary depending on the nature of the work, applicable cGMP, GLP, regulatory, accreditation, contractual, or project-specific requirements. Where a Client or Sponsor requires a specific retention period or record-retention arrangement beyond ADPEN’s standard practices, that requirement must be identified and agreed upon before work begins.
Records may be maintained in paper, electronic, or other controlled formats in accordance with ADPEN procedures and applicable requirements.
Requests for extended archival retention, special storage, retrieval of archived records, reproduction of historical records, or preparation of additional record packages may be subject to additional charges.
Following expiration of the applicable retention period and satisfaction of any regulatory, contractual, legal hold, or other applicable requirements, records may be destroyed in accordance with ADPEN procedures unless continued retention has been agreed upon in writing.
Litigation, Subpoenas, and Legal Proceedings
If ADPEN is required or requested to provide records, data, testimony, technical assistance, depositions, declarations, affidavits, document searches, record retrieval, sample storage, additional testing, or other services in connection with litigation, arbitration, regulatory proceedings, subpoenas, discovery requests, investigations, or other legal proceedings relating to work performed for the Client or Sponsor, the Client or Sponsor will be responsible for the reasonable costs incurred by ADPEN in responding to such requests, except to the extent such costs are finally determined to have resulted from ADPEN’s own misconduct or breach of its obligations.
Such costs may include personnel time, document and data retrieval, review and preparation, additional testing, copying or reproduction, storage, travel, mileage, lodging, meals, legal review, outside professional services, and other reasonable expenses associated with the response.
ADPEN personnel will provide testimony, depositions, or other participation at a mutually agreed location or by remote means when permitted and appropriate. Any required travel or appearance outside ADPEN’s facilities may be subject to additional charges.
Nothing in these Terms and Conditions requires ADPEN to provide expert opinions, expert-witness services, or testimony beyond factual information concerning work performed by ADPEN unless such services are separately agreed to in writing.
These Terms and Conditions will be governed by and construed in accordance with the laws of the State of Florida, except where another governing agreement between ADPEN and the Client or Sponsor provides otherwise.
ADPEN Laboratories | 11757 Central Parkway, Jacksonville, Florida 32224 USA | (904) 645-9169 | info@adpen.com