Bio-specimen Purchase and Data Use Agreement

Biospecimen Purchase and Data Use Agreement

PLEASE READ THIS AGREEMENT CAREFULLY BEFORE SUBMITTING ORDER.

This Biospecimen Purchase and Data Use Agreement (the “Agreement”) is between you and Applied Pathology Systems, LLC (“APS”). You must have a current approved account with APS to place an order. You, your employees and collaborators (collectively, the “Purchaser”) agree to use the clinical data and associated biospecimen material, progeny and derivatives (collectively, the “Materials”) in accordance with this Agreement, and the Terms and Conditions found on APS’s website (http://www.appliedpathology.com). If the Purchaser intends to distribute the Materials, the Purchaser agrees to require the end user to agree and comply with the terms of this Agreement.

 Scope of Use

The Purchaser may use the Materials for research use only. The Materials are not for use in humans. The Purchaser shall not distribute, sell, lend or otherwise transfer the Materials for any reason unless approval is obtained from APS. Any commercial use of the Materials requires a license from APS and APS is not obligated to grant a commercial license.

The Purchaser assumes all risk and responsibility in connection with the receipt, handling, storage, disposal, transfer and use of the Materials including without limitation taking all appropriate safety and handling precautions to minimize health or environmental risk.  The Materials are to be handled as if potentially infectious at all times. The Purchaser will ensure that its employees or others who handle the Materials on its behalf are made aware of the hazards and risks involved in handling potentially infectious human biological materials.

The Purchaser agrees that any activity undertaken with the Materials will be conducted in compliance with all applicable guidelines, laws and regulations. Unless prohibited by law, the Purchaser assumes all liability for claims for damages against it by third parties that may arise from its use, storage, or disposal of the Materials, except that, to the extent permitted by law, APS shall be liable to the Purchaser when the damage is caused by the gross negligence or willful misconduct of APS.

 Intellectual Property

The Purchaser retains all right, title and interest in and to any and all results, inventions, ideas, methods, concepts, processes, formulas, protocols, data, results, works of authorship, process or design improvements, discoveries, developments, design, techniques and other know-how, whether or not patentable, developed by Client from use of the Materials.

APS retains all right, title, and interest in and to the Materials and all processes, methodologies or capabilities that are used or developed during or related to the provision of the Materials.

 

Identification

The Materials are coded or otherwise de-identified.  Any widely used identifying information is removed.

The Purchaser will not in any way identify or contact, attempt to identify or contact, or aid any person or entity in identifying or contacting any donor, donor family and/or source of the Materials.  Furthermore, the Purchaser will not attempt to obtain or otherwise acquire any private identifiable information associated with the Materials.  However, it is acknowledged that, due to scientific advances such as DNA analyses or human errors, there is a small risk that the identity of the person who was the source of the Materials could become known.

If the Purchaser discovers the identity of any donor, donor family, and/or source of the Materials, the Purchaser will ensure that it will not make use of such knowledge, will advise APS of such discovery, will safe-guard or destroy such information as requested by APS, and will inform no other person or entity of such discovered identity (except as may be required by applicable law).

The Purchaser will have the right to disclose non-individually identifiable information regarding the Materials in a summary form that aggregates more than one individual’s clinical information for scientific journal publication and regulatory filing purposes, in all events to the extent permitted under applicable law (provided, however, that any such disclosures for patent filing purposes need not be on an aggregate basis if such information so disclosed is de-identified and such disclosures abide by applicable law). Please see additional terms concerning the use of the clinical data below.

Indemnification

The Purchaser agrees to indemnify, defend and hold harmless to APS and its contributors against all third party claims, demands, losses, costs, damages and expenses (including reasonable attorneys' fees) arising out of or relating to the use, receipt, handling, storage, transfer, disposal and other activities relating to the Materials.  All settlements will be subject to APS’s consent.

Data use general term

APS (or its suppliers) is a covered entity as defined in the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”). APS is providing the Purchaser with a Limited Data Set of Protected Health Information (“PHI”) as defined in 45 C.F.R. §164.514(e)(2) (the “Limited Data Set”).  Both APS and the Purchaser agree to the provisions of this Agreement in order to address the requirements of HIPAA and to protect the interest of both parties.

Restrictions on Use and Disclosure

The Purchaser shall have the right to use all PHI provided to it by APS for research purposes only. The Purchaser agrees that it will not use or further disclose the PHI other than as permitted by this AGREEMENT, or as otherwise required by law or regulation. The Purchaser shall use appropriate safeguards to protect the PHI from misuse or inappropriate disclosure and to prevent any use or disclosure of the PHI.

The Purchaser will have the right to disclose non-individually identifiable information regarding the Data in a summary form that aggregates more than one individual’s clinical information for scientific journal publication and regulatory filing purposes, in all events to the extent permitted under applicable law (provided, however, that any such disclosures for patent filing purposes need not be on an aggregate basis if such information so disclosed is de-identified and such disclosures abide by applicable law). The Purchaser shall report to APS any use or disclosure of the PHI that is not provided for in this Agreement of which the Purchaser becomes aware. Purchaser will take reasonable steps to limit any further such use or disclosure.

Term and Termination

Term. The Term of this Agreement shall be effective as of the receipt of the data by the Purchaser, and shall terminate when all the PHI provided by APS to Purchaser is destroyed or returned, or, if it is infeasible to return or destroy PHI, protections are extended to such information, in accordance with this Agreement. The annotated clinical data is for information purpose. Even though APS strives for details and accuracy of the clinical data, APS holds no liability for its absolute accuracy due to the complexity of each experimental condition and the subjective nature of some evaluations.

Termination. Should the Purchaser commit a material breach of this Agreement, which is not cured within ten (10) days after the Purchaser receives notice of such breach from APS, then APS will discontinue disclosure of PHI. Within ten (10) days upon termination of this Agreement, the Purchaser shall return or destroy all PHI received from APS.  Purchaser shall retain no copies of the PHI.   In the event that that Purchaser determines that returning or destroying the PHI is infeasible and upon mutual agreement of both parties, the Purchaser shall extend the protections of this Agreement to such PHI and limit further uses and disclosures of such PHI to those purposes that make the return or destruction infeasible, for so long as Purchaser maintains PHI.

Ambiguities

The parties agree that any ambiguity in this Agreement shall be resolved in favor of a meaning that complies and is consistent with applicable law protecting the privacy, security and confidentiality of PHI and the Limited Data Set, including, but not limited to HIPAA.  

Limitation of Liability

In no event will APS be liable for special, incidental, consequential, punitive, multiple, exemplary or other indirect damages or for lost profits, lost data or loss of use damages arising in connection with this Agreement, whether based upon warranty, contract, tort, strict liability or otherwise, even if APS has been advised of, or is aware of, the possibility of such damages. In no event will APS’s aggregate liability for any and all claims arising from any services and/or materials provided hereunder exceed the aggregate amount paid by client pursuant to this Agreement. APS’s licensors and contributors shall have no liability under this Agreement. The Purchaser agrees that the limitations of liability set forth in this Agreement shall apply even if a limited remedy provided hereunder fails of its essential purpose.

 Miscellaneous

APS shall have no obligation to provide the Purchaser with updates to the clinical information after the date of the acceptance of the Purchaser’s order. Both APS and the Purchaser intend that the Purchaser is not making payment for the biospecimen materials themselves, but rather for the service of providing the Materials and for any related services.

The Purchaser agrees to acknowledge the source of the Materials as “Applied Pathology Systems” in any publications or disclosures reporting use of it.