Review iSpecimen Purchase Terms
Online Purchase Terms – October 17, 2022
These online purchase terms (“Purchase Terms”) apply to all iSpecimen quotes, statement(s) of work, work orders, and purchase orders (collectively, “Purchase Documents”) placed by customer (“Customer”) for the procurement of certain specimen(s), services, and/or data (collectively the “Specimens” and/or the “Services”) from iSpecimen Inc. (“iSpecimen” or “Company”). Customer’s placement of a Purchase Document constitutes Customer’s acceptance of these Purchase Terms, as of the date of such placement (the “Effective Date”). iSpecimen and Customer may also be referred to herein individually as a “Party” and collectively as the “Parties”. Capitalized terms in the Purchase Terms that are defined in Exhibit A – Definitions shall have the meaning ascribed in Exhibit A – Definitions, which exhibit is attached hereto and incorporated herein.
Specimens and Services
iSpecimen shall use commercially reasonable efforts to provide the Specimens and/or Services as specified in any Purchase Document accepted by the Company. iSpecimen shall not guarantee that Specimens are suited for any particular research or experiment performed by the Customer or by any third party on the Customer’s behalf. Unless otherwise specified in writing by Customer, iSpecimen may select alternate Specimens that meet Order criteria when fulfilling inventory-based Orders if Customer-selected Specimens are unavailable. If no alternate Specimens are available that meet Order criteria or the Customer has specified that alternate Specimens are not allowed, the applicable Order may be closed in a partially-filled state.
Scope of Use
Unless specifically marked for clinical purposes, the Specimens shall be used solely as Research-Use Only Specimens. Such Research-Use Only Specimens, or any modified or unmodified derivatives of Research-Use Only Specimens, shall not be used: (i) in human subjects; (ii) for the treatment or diagnosis of humans; (iii) for testing in animals intended for human consumption; (iv) as a component in a manufactured product not generally used in research and development; or (v) to create immortalized cell lines for commercial distribution. Customer shall not sell Research-Use Only Specimens to any third-party person or entity without the express written consent of iSpecimen.
Clinical Grade Specimens may be used for labeled purposes only. Customer shall be solely responsible for the use, distribution and/or resale of any Clinical Grade Specimens and/or any Clinical Grade Derivative Products.
All individuals who use the Specimens, including any third parties contracted by Customer, shall be bound under a written agreement with iSpecimen and material and data use requirements at least as stringent as these Purchase Terms. Customer and all individuals working with the Specimens agree to use, handle, retain, and destroy (if applicable) the Specimens in accordance with the terms of these Purchase Terms as well as all applicable federal, state, and international laws, statutes, and regulations, as such may be amended, revised, restated, or replaced from time to time.
The Specimens are provided in a non-identifiable form. In the event Customer discovers the identity of any donor and/or donor family who provided the Specimens or generates data from the Specimens that may permit such discovery, Customer shall not make use of such knowledge, shall safeguard or destroy such information, and shall advise iSpecimen of such discovery in accordance with all applicable laws and regulations at the time of such discovery. Customer further agrees to never use the Specimens, provided data, or any material or data derived from the Specimens to attempt to ascertain the identity of the individual(s) from whom they were obtained.
Limited Data Sets
In the event a Specimen is provided with a Limited Data Set, Customer agrees to: (i) limit the use and disclosure of any Limited Data Set solely to conduct Customer’s internal research, as permitted herein; (ii) comply with all applicable federal and state laws and regulations relating to the maintenance of the PHI included with the Limited Data Set and; (iii) safeguard the confidentiality of the PHI and the use and disclosure of the PHI. Customer shall limit the disclosure of any Limited Data Set to those members of its workforce, including any agents or subcontractors, who have a legitimate business need to access such Limited Data Set for purposes of Customer’s permitted research. Prior to disclosing any Limited Data Set to its workforce members, Customer shall ensure that such workforce members have agreed to the same restrictions and conditions that apply under these Purchase Terms and shall comply with HIPAA. Customer agrees to report to iSpecimen any use or disclosure of a Limited Data Set not provided for in these Purchase Terms of which it becomes aware, including, without limitation, any disclosure of PHI to an unauthorized subcontractor, within ten (10) days of Customer’s discovery.
Ownership and IP
Customer retains all right, title, and interest in and to any and all information, ideas, methods, data, inventions, works, rights, properties, technology, and know-how that is conceived, created, discovered, developed, or invented solely by Customer from use of the Specimens and/or Services. At all times each Party maintains ownership in its pre-existing intellectual property.
Customer acknowledges that the Specimens may have hazardous properties and may carry transmissible infectious agents. Except to the extent prohibited by law, Customer assumes all risks and responsibility in connection with the handling, storage, disposal, internal transfer, and/or use of the Specimens and any modifications thereto. Customer shall take appropriate safety and handling precautions to minimize health or environmental risk to all individuals who use or come in contact with the Specimens.
No Debarment, Exclusion or Convictions
As of the Effective Date, each Party represents and warrants that neither it nor its management personnel nor any personnel involved in the performance of its obligations herein has been debarred or is proposed for debarment, under Section 306 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. Section 335(a), or otherwise disqualified or suspended from performing research or otherwise subject to any restrictions or sanctions by any regulatory authority, has been convicted of any criminal offense related to health care, or been debarred, sanctioned, excluded or otherwise made ineligible for participation in a federal or state health care program by any federal or state agency. Each Party will immediately notify the other if any of the representations ceases to be true. In the event any of the foregoing representations cease to be true or a Party otherwise breaches this subsection, the applicable Order may be terminated in writing with immediate effect by the non-breaching Party.
Should Customer become aware of the identity of any iSpecimen supplier as a direct result of Specimens or Services delivered under these Purchase Terms, Customer shall not knowingly solicit or contract for the supply of Specimens directly with any such supplier for a period of one (1) year from the Effective Date. Should Customer circumvent iSpecimen and procure substantially similar Services or Specimens directly from any such supplier during the one (1)-year period following the Effective Date, Customer agrees to pay iSpecimen an amount equal to twenty-five percent (25%) of the actual purchase price Customer paid to procure such Services or Specimens from the supplier(s) during such period.
iSpecimen reserves the right to remove Customer from the iSpecimen Marketplace should Customer repeatedly request Specimens and/or Services and subsequently does not make purchases through the iSpecimen Marketplace.
All Specimens are shipped in accordance with Incoterms®2020 FCA Shipping Point. Shipments may be insured for their value. Shipping and any insurance costs shall be the responsibility of Customer. Domestic Specimen Orders may be shipped using either the Customer’s carrier account number or iSpecimen’s carrier account number. International Specimen Orders are shipped using the Customer’s carrier account number only. All shipments, whether domestic or international, must include a contact name and phone number for the Customer and the recipient of the shipment. Customer assumes all risk for losses and damages associated with the Specimens during transit.
iSpecimen reserves the right to ship Specimens to Customer once collected or procured unless otherwise specified in a Purchase Document or Change Order. If iSpecimen ships or delivers the Specimens erroneously as a result of incorrect information supplied by Customer or Customer fails to accept shipped Specimens for any reason, iSpecimen may immediately invoice Customer for any Services performed (including, but not limited to, contracting, kit building, site recruitment, site set-up, site training, donor recruitment, and/or donor consenting) and/or Specimens shipped under the Order. Customer agrees to pay iSpecimen for all charges set forth herein.
Acceptance and Returns
Customer has fourteen (14) days from receipt of Specimens to inspect the Specimens to ensure compliance with the specifications set forth in the applicable Purchase Document. Should any Specimens be Rejected Specimens, Customer shall promptly notify iSpecimen by sending an e-mail message to the following e-mail address: [email protected]. Within such message, Customer shall specify whether it chooses to receive replacement Specimens or receive invoice credit. iSpecimen shall determine whether the Rejected Specimens are to be returned to iSpecimen (at iSpecimen’s cost) or destroyed by Customer. If Rejected Specimens are to be returned, iSpecimen shall provide the shipping address for Customer to return the Rejected Specimens.
Order Changes, Pauses, and Cancellations
Change Orders shall only be deemed accepted if approved in writing by iSpecimen. Change Orders may also require re-quoting of the applicable Purchase Document.
Change Orders for prospectively collected hematopoietic cell product (e.g., fresh bone marrow aspirate, fresh Leukopacks, fresh whole blood units) require fifteen (15) days’ written notice. Customer shall be invoiced: (i) fifty percent (50%) of the purchase price for Change Orders requested between one (1) and five (5) days prior to the scheduled mobilization or collection date, whichever is earlier; or (ii) twenty-five percent (25%) of the purchase price for Change Orders requested between six (6) and fifteen (15) days prior to the scheduled mobilization or collection date, whichever is earlier.
Change Orders, pauses, and cancellations for products other than prospectively collected hematopoietic cell products require thirty (30) days’ written notice. Notwithstanding the foregoing, Shipment Delays require seven (7) days’ written notice. Customer shall be invoiced for any Services performed (including, but not limited to, contracting, kit building, site recruitment, site set-up, site training, donor recruitment, and/or donor consenting) and/or Specimens collected and/or procured under an Order prior to any Change Order, pause, or cancellation.
Customer agrees to pay iSpecimen for all charges set forth herein.
iSpecimen shall invoice for all Specimens upon shipment of the Specimens to the Customer unless otherwise agreed to in writing by both Parties. Customer shall pay iSpecimen within thirty (30) days of Customer’s receipt of an iSpecimen invoice. Customers may be charged one percent (1%) per month, not to exceed the maximum amount by law, on any overdue balances.
Each Party shall maintain Confidential Information in strict confidence and shall not at any time or for any reason disclose any Confidential Information of the other Party to any unauthorized third party without the disclosing Party’s prior written consent. Neither Party shall use any Confidential Information of the other Party for any purpose whatsoever except in performing its duties and exercising its rights under these Purchase Terms. Notwithstanding the foregoing, the receiving Party may disclose the Confidential Information of the disclosing Party if it believes in good faith that any applicable law, rule, or regulation requires the disclosure; provided that the receiving Party makes a reasonable effort to give the disclosing Party as much advance notice as is practicable of such requirement; and, provided further, that any such disclosure is limited in content and manner to that which is so required.
Confidential Information does not include any information or development: (i) which is or subsequently becomes available to the general public other than through a breach by the receiving Party; (ii) which is already known to the receiving Party before disclosure by the disclosing Party and can be evidenced as such; (iii) which is independently developed by the receiving Party without use of or reference to the Confidential Information of the other; or (iv) which the receiving Party rightfully receives from third parties not under a duty of confidentiality owed to the disclosing Party.
The term of this MDUA shall be from the Effective Date and shall continue for a period of one (1) year (the “Initial Term”). Thereafter, this MDUA shall automatically renew with successive one (1)-year periods (each a “Renewal Term” and the Renewal Term(s) together with the Initial Term constitute the “Term”). Either Party may terminate this MDUA during a Renewal Term by providing the other Party with thirty (30) days’ advance written notice.
Each Party shall be liable for any loss, claim, damage, or liability that such Party incurs as a result of its activities under these Purchase Terms, except that the Parties assume liability only to the extent as provided under the applicable laws and regulations. Notwithstanding the foregoing, Customer shall, except to the extent prohibited by law, indemnify, defend, and hold harmless the iSpecimen Indemnitees from and against any and all Third-Party Claims arising from Customer’s use of the Specimens or Customer’s failure to comply with the Purchase Terms, Customer’s wrongful act or negligence, or Customer’s failure to comply with any applicable federal, state, national, local, or international law. This paragraph shall survive expiration or termination of the Purchase Terms.
iSpecimen shall ensure that an iSpecimen Indemnitee agrees to notify Customer as soon as it becomes aware of any Third-Party Claim for which it is entitled to indemnification and agrees to cooperate with and authorize Customer to carry out the sole management and defense of any such Third-Party Claim. Customer may not compromise or settle any such Third-Party Claim without the prior written approval of the iSpecimen Indemnitee, such approval not to be unreasonably withheld. Customer agrees, at its own expense, to provide attorneys to defend against any Third-Party Claims brought or filed against an iSpecimen Indemnitee with respect to the indemnity contained in this subsection, whether or not such Third-Party Claims are rightfully brought or filed.
Limitation of Liability
EXCEPT TO THE EXTENT PROHIBITED BY LAW, CUSTOMER ASSUMES ALL LIABILITY FOR DAMAGES WHICH MAY ARISE FROM ITS USE, STORAGE, TRANSFER, OR DISPOSAL OF THE SPECIMENS. iSPECIMEN SHALL NOT BE LIABLE TO CUSTOMER FOR ANY LOSS, CLAIM, OR DEMAND MADE BY CUSTOMER, OR MADE AGAINST CUSTOMER BY ANY OTHER PARTY, DUE TO OR ARISING FROM CUSTOMER’S USE OF THE SPECIMENS, EXCEPT TO THE EXTENT REQUIRED BY LAW WHEN CAUSED BY THE GROSS NEGLIGENCE OR WILLFUL MISCONDUCT OF iSPECIMEN. This paragraph shall survive expiration or termination of the Purchase Terms.
DISCLAIMER OF Warranties
Customer acknowledges and agrees the SPECIMENS may have been subject to changes in temperature as part of the storage and shipping process. SPECIMENS may have been tested using equipment or methodologies that are different from those of Customer AND ARE PROVIDED TO CUSTOMER WITH THE ORIGINAL CLINICAL TEST RESULTS, OTHER MEDICAL RECORD DATA, AND/OR SUBJECT-PROVIDED DATA. SUBSEQUENT CUSTOMER TESTING OF SPECIMENS MAY YIELD DIFFERENT RESULTS BASED ON THE SPECIFIC EQUIPMENT OR METHODOLOGIES UTILIZED BY CUSTOMER. Customer acknowledges, agrees, and accepts that all SPECIMENS are provided “as is” and that there are no express or implied warranties of any sort including, BUT NOT LIMITED TO, warranties of merchantability and fitness for a particular purpose, or that the use of the SPECIMENS SHALL not infringe on any patent, copyright, trademark, or other proprietary rights. without limiting the foregoing, iSpecimen makes no representations or warranty as to the identity, purity, safety, or activity of the SPECIMENS.
Except as otherwise provided herein, should the performance of the Purchase Terms or any obligation under the Purchase Terms be prevented, restricted, or interfered with by reason of any event, act, or condition beyond iSpecimen’s reasonable control (including, but not limited to, pandemics, fire, labor disturbance, endemic failures, telecommunications disruptions of the World Wide Web or the Internet, telecommunication failures, denial of service attacks, acts of God, financing difficulties, or any similar cause beyond iSpecimen’s reasonable control), iSpecimen, upon written notice to Customer, shall be excused from such performance to the extent of such prevention, restriction, or interference.
All notices, requests, or other communications to iSpecimen must be in writing and sent to the address set forth below or to any other address as iSpecimen may designate by notice hereunder and must be: (a) delivered by hand; (b) sent by recognized overnight courier; or (c) sent by certified mail, return receipt requested, postage prepaid.
450 Bedford Street
Lexington, Massachusetts 02420
Attention: General Counsel
Customer shall acknowledge “iSpecimen Inc.” as the provider of biospecimens in any publications or public disclosures that report results obtained from the use of the Specimens.
Customer may not assign the Purchase Terms, nor delegate its rights or duties, without the express written consent of iSpecimen, which consent shall not be unreasonably withheld or delayed. The Purchase Terms shall be binding upon the Parties or their authorized respective successors and assigns.
The Purchase Terms will be governed, construed, and in enforced according to the laws of the Commonwealth of Massachusetts without giving effect to any principles of conflicts of laws.
In the event that any provision contained in the Purchase Terms is held to be invalid or unenforceable, all other provisions of the Purchase Terms will be deemed severable and will remain enforceable to the full extent permitted by law.
Use of a Party's Name
Customer may not, without the prior written consent of iSpecimen, use in advertising, publicity, or otherwise, the name, trademark, logo, symbol, or other image of iSpecimen. iSpecimen shall be permitted to use Customer’s logo on the iSpecimen website for marketing purposes only.
All section headings are for reference only and will not be used to interpret the Purchase Terms.
Customer and iSpecimen specifically acknowledge and agree that any other purchase terms varying from or adding to these Purchase Terms, whether contained in any purchase order or other electronic, written, or oral communication made by Customer to iSpecimen, are rejected and shall be null and void and of no force or effect, unless expressly agreed to in writing by both Parties. Variance from or addition to these Purchase Terms in any written notification or documentation, from Customer or otherwise, shall be of no effect unless expressly agreed to in writing by both Parties. In the event of any conflict between these Purchase Terms and any other document or agreement, the terms of the Purchase Terms shall prevail and control.
“Applicable Laws” means all applicable federal, state, national and local laws, regulations and guidelines, as well as any other applicable compliance requirements, including but not limited to the International Anti-Bribery & Fair Competition Act of 1998, HIPAA and HITECH (both as defined below).
“Change Order” means any Customer-initiated changes to any Purchase Document, including pauses or cancellation of Orders, Shipment Delays, or changes to Specimen collection, processing requirements, donor criteria, Specimen quantities, data requirements, documentation, packaging, labeling, and/or delivery date(s).
“Clinical Grade Derivative Products” are products or derivatives created from Clinical Grade Specimens in accordance with labeled uses.
“Clinical-Grade Specimens” means Specimens collected and marked for clinical purposes in accordance with the FDA or other governing bodies.
“Confidential Information” means information disclosed by one Party to the other Party that is marked as confidential, or which by its nature is confidential and would be judged so under a reasonable standard or is disclosed or provided under circumstances reasonably indicating that it is confidential or proprietary.
“Data Use Agreement” shall have the same meaning as set forth in HIPAA (as defined below) and its subsequent amendments thereto.
“Domestic Specimen Orders” are shipments sent to a U.S. based address.
“FDA” means the Food and Drug Administration.
“HCT/Ps” means human cells, tissues, and cellular and tissue-based products.
“HIPAA” means the Health Insurance Portability and Accountability Act of 1996 and the regulations implementing HIPAA, all as may be modified and/or restated from time to time.
“HITECH” means the Health Information Technology for Economic and Clinical Health Act, and the regulations implementing HITECH, all as may be amended, modified and/or restated from time to time.
“International Specimen Orders” are shipments sent to a non-U.S. based address.
“iSpecimen Indemnitees” means iSpecimen and its officers, directors, employees, contractors, consultants and agents.
“Limited Data Set” shall have the same meaning as set forth in HIPAA and its subsequent amendments thereto.
“Order” means an accepted request for Specimens or Services as specified in a Purchase Document.
“Protected Health Information” or “PHI” shall have the same meaning as set forth in HIPAA.
“Rejected Specimen” means shipped Specimens that are unsuitable for Customer’s use because the Specimen(s) do not meet the requirements stated in the applicable Purchase Document.
“Research-Use Only Specimens” means Specimens that are to be used solely for scientific research purposes.
“Services” means the services iSpecimen may provide Customer as detailed in an Order.
“Shipment Delay” means the postponement of the delivery date of collected or procured Specimens.
“Specimen” means any tissue, blood, fluid, other biological material, and derivatives or combinations of those materials that represent the physical cell makeup of an organism, in whole or in part, and expressly excludes any biological materials derived from fetal or embryonic tissues, which iSpecimen may provide Customer.
“Term” means the Renewal Term(s) together with the Initial Term.
“Third-Party Claims” means any and all third-party claims and damages.