Anatomy Act Compliance Form

ANATOMY ACT COMPLIANCE AGREEMENT

This Anatomy Act Compliance Agreement (the Agreement) is made and entered into as of Effective Date: by and between Provider Name: with principal address: ("Provider"), and Compliance Consultant Name: with principal address: ("Consultant"). Provider and Consultant are referred to collectively as the Parties.

RECITALS

WHEREAS, Provider conducts activities that involve the receipt, use, storage, or disposition of human anatomical material and desires to maintain continuous compliance with applicable Anatomy Act requirements governing procurement, recordkeeping, donor consent, transportation, and disposition; and

WHEREAS, Consultant represents that it has the training, experience, and resources necessary to advise, audit, and assist Provider in implementing and documenting operational and regulatory controls necessary to comply with the Anatomy Act and related regulatory obligations; and

WHEREAS, the Parties desire to set forth herein the scope of services, payment terms, confidentiality obligations, and other terms governing Consultant's engagement to support Provider's Anatomy Act compliance program.

SCOPE OF WORK

Consultant shall perform the services described above, which may include but are not limited to: review of Provider policies and procedures, audit of specimen sources and chain-of-custody records, staff training on donor consent and identification procedures, assistance with registration and permitting required under the Anatomy Act, and preparation of corrective action plans where non-compliances are identified. Consultant shall exercise professional skill and care consistent with industry standards.

COMPLIANCE CHECKLIST & CERTIFICATIONS

Provider represents and warrants that the following statements are true as of the Effective Date (check applicable boxes and provide additional detail where requested):

Permit, registration, or authorization required by applicable Anatomy Act is on file with Provider.

Specimen tracking and chain-of-custody procedures are maintained and available for audit.

Donor consent documentation is maintained in accordance with Anatomy Act requirements.

PAYMENT TERMS

All fees are exclusive of applicable taxes. If Provider fails to pay any amount when due, Consultant may suspend services after providing written notice as set forth in Term and Termination and shall be entitled to recover collection costs, including reasonable attorneys' fees.

TERM AND TERMINATION

This Agreement commences on Start Date: and shall continue until End Date: unless earlier terminated in accordance with this Section.

Either Party may terminate this Agreement for material breach by the other Party if such breach remains uncured for a period of thirty (30) days after receipt of written notice specifying the breach. Termination shall not relieve Provider of its obligation to pay for services performed and costs incurred prior to termination.

CONFIDENTIALITY

Consultant acknowledges that during the course of the engagement it may obtain access to confidential information of Provider, including donor records, consent forms, internal policies, and other proprietary or personally identifiable information. Consultant agrees to hold such information in strict confidence, to use it solely for the performance of this Agreement, and not to disclose it except as required to perform the services or as required by law. Consultant shall implement reasonable administrative, technical, and physical safeguards to protect confidential information.

The obligations of confidentiality shall survive termination of this Agreement for a period of five (5) years, except for personally identifiable information or donor records where a longer retention is required by law, in which case applicable retention obligations shall control.

INSURANCE AND LIABILITY

Consultant shall maintain professional liability and general liability insurance appropriate to the scope of services. Except for liability arising from willful misconduct or gross negligence, neither Party shall be liable to the other for consequential, incidental, or punitive damages. Each Party's aggregate liability under this Agreement shall be limited to direct damages up to the total fees paid by Provider to Consultant under this Agreement.

GOVERNING LAW

This Agreement shall be governed by and construed in accordance with the laws of the State of without regard to conflicts of law principles.

ENTIRE AGREEMENT

This Agreement, including all attachments and schedules executed by the Parties, constitutes the entire agreement between the Parties with respect to the subject matter hereof and supersedes all prior and contemporaneous agreements, understandings, negotiations, and discussions, whether written or oral. Any amendment to this Agreement must be in writing and signed by authorized representatives of both Parties.

CERTIFICATION

By signing below, each Party certifies that it has authority to enter into this Agreement, that the information provided in this form is true and accurate to the best of its knowledge, and that it will promptly notify the other Party of any change that materially affects compliance with the Anatomy Act.

Sign Now