Last updated: January 22, 2023
Please read and consider the terms of this Agreement carefully before signing the Test Requisition Form (TRF) and ordering a test. The Agreement includes important information about your legal rights, and covers areas such as warranty disclaimers, and limitations of liability. Please note that if you reside outside the United States of America, some of these terms may not apply to you, and you may be entitled to specific rights under the mandatory laws of the country in which you live.
YOU ACKNOWLEDGE AND AGREE THAT BY SIGNING THE TRF AND ORDERING A TEST, OR OTHERWISE ACCESSING, USING OR CONTRIBUTING TO THE SERVICES, YOU ARE INDICATING THAT YOU HAVE READ AND UNDERSTAND AND AGREE ON BEHALF OF YOUR ORGANIZATION TO BE BOUND BY THE TERMS OF THIS AGREEMENT.
Any use of the Services other than pursuant to the terms of this Agreement is a violation of U.S. and international copyright laws and conventions.
We have tried to make these Terms easy to understand and fair, but if you have any questions regarding these Terms, please feel free to contact us at email@example.com.
To order tests, you must follow the test ordering instructions written on the Test Requisition Form (TRF), complete all details set out in the TRF and attach all required documents. You need to instruct the patient to sign page 2 of the TRF. If the patient is not present at the time of ordering, please instruct the patient to sign the TRF at the time of blood draw. When the test is completed, OncoHost will send you an email (to the email address you provide) informing you that the PROphetR report is available and send the report via e-fax.
PROphetR is a liquid biopsy test for cancer patients that combines Al and plasma proteomic profiling to assign a PROphet® Score, a measure of the predicted clinical benefit from anti-PD-1/PD-L1 treatment. APROphet® Score between 5 and 10 is classified as POSITIVE, and a PROphet® Score between 0 and 5 is classified as NEGATIVE. The PROphetR test POSITIVE or NEGATIVE classification, together with PD-L1 levels (not provided by OH), is correlated to the patient's overall survival (OS) and clinical evidence-based treatment considerations are listed accordingly.
The test requires a blood sample withdrawn from the patient prior to commencement of therapy. Plasma is isolated from the blood sample and then profiled via the SomaScan® assay (developed by SomaLogic Inc.) at OncoHost's CLIA- certified laboratory. The assay is based on Slow-Off-Rate Modified Aptamers (SOMAmers) – chemically-modified single- stranded oligonucleotides that fold into molecular structures capable of binding to proteins with high affinity and specificity. The assay measures approximately 7,000 proteins in a single plasma sample. The proteomic profile is then analyzed by OncoHost's proprietary PROphetR algorithm to provide clinically relevant information that may be used to aid in patient management and treatment decisions.
PROphetR uses an internal dataset with data gathered from a variety of sources and, as such, the analyses may be subject to certain biases that restrict the generalizability or applicability to individual patients. The data that comprises the PROphetR dataset may not be representative of patient populations as a whole, nor relevant to this specific patient. Testing is performed at OncoHost's CLIA-certified lab located in the USA (CLIA ID no. 34D2250951). The test was developed, and its performance characteristics were determined by OH. The test has not been cleared or approved by the FDA.
The PROphetR test is intended for use by the physician as an aid for managing non-resectable stage III and IV non- small cell lung cancer (NSCLC) patients treated with first-line anti-PD-1/PD-L1-based therapy as a single agent or in combination with chemotherapy. The test is intended for patients aged 18 and above, with ECOG performance status of 0-2, normal hematologic, renal, and liver functions. The test is not intended for patients with any concurrent and/or other active malignancies that have required systemic treatment within 2 years of the first dose of therapy. OncoHost's authorized CLIA lab will evaluate the blood taken from the patient, perform the SomaScan® proteomic assay and send the report with the results to the requesting physician.
PROphetR test results should be evaluated in combination with the patient's medical history, clinical features, pathology reports, and other tests. Treatment management decisions are entirely at the discretion of the treating physician. PROphetR test results and information contained within this report are current as of the date provided and will not be updated by OH, even if subsequent changes would have led to additional or conflicting results. The patient's physician is responsible for considering all available information and options before making patient-specific management or treatment decisions. OH is not liable for medical judgment with regard to diagnosis, prognosis, or treatment.
By accepting receipt of the test results or any content derived from it, the ordering physician, institution of ordering physician, or any third parties to whom the results are transferred, agree that the results may only be used for the clinical management of the patient identified in the results by the physician. Any other use of the results including, without limitation, correlative studies, diagnostic development, derivative works, or other analyses, is expressly prohibited.
You may not, and you will not or enable others to: (a) use the Services for any purposes or in any manner except as consistent with these Terms, the Website, and applicable law; (b) modify, reverse engineer, or copy the Services; (c) alter any test results; (d) share any test results with any third parties except as expressly permitted by the patient via a valid written consent conforming to applicable law; (e) resell, redistribute, license, or in any way provide the Services to third parties; (f) remove any copyright, patent, trademark, proprietary rights, disclaimer or warning notice included on or embedded in any part of the Services; (g) forge headers or other elements of network transmissions to disguise the origin of any material transmitted through the Services to OH or to any third party; (h) override or attempt to override any security measure or component implemented in the Services; (i) create a user account purporting to describe a fictional person or character, any individual other than yourself, or any individual or entity other than one whom you have been authorized to represent; or (j) use any automated software or scripts to access or use the Services.
“Confidential Information” means any information, technical data, or know-how, including, but not limited to, that which relates to research, product plans, products, services, customers, markets, software, developments, inventions, processes, designs, drawings, engineering, hardware or software configuration information, marketing, organization, business, or finances of or relating to OH, or any information obtained by OH in confidence or in trust from a third party. Confidential Information shall also include, without limitation, the Services. Confidential Information does not include information, technical data, or know-how which (i) is already in your possession without obligations of confidentiality at the time of its disclosure by OH; (ii) is or becomes part of the public knowledge without breach of confidentiality obligations; or (iii) is approved by OH, in writing, for public release.
Confidentiality Obligations. Except as expressly set forth in this Agreement, you shall not use in any way for your own account or the account of any third party, nor disclose to any third party, any Confidential Information. You shall, at all times, maintain such Confidential Information in confidence in the same manner and to the same extent as you protect your own most confidential and/or proprietary information (which shall in no event be less than a reasonable degree of care). Upon the termination of this Agreement, you shall promptly return to OH or delete all copies of any Confidential Information in your possession.
You may, from time to time, provide suggestions, comments, or other feedback to OH regarding OH's current or future products and services, including the Services (collectively, "Feedback"). You agree that such Feedback, even if designated as confidential, shall not create any confidentiality obligation hereunder for or upon OH or its suppliers. You agree that OH shall be free to use, disclose, reproduce, license, or otherwise distribute and exploit any and all Feedback provided to it as it sees fit, entirely without obligation or restriction of any kind on account of intellectual property or otherwise, including after you stop using the Services.
The terms of this Section 5 will apply to you to the extent (i) you are or are employed by a Covered Entity and (ii) will create, transmit, receive, or maintain Protected Health Information in or through the Services.
The U.S. Department of Health and Human Services has issued regulations on "Standards for Privacy of Individually Identifiable Health Information" comprising 45 C.F.R. Parts 160 and 164, Subparts A and E (the "Privacy Standards"), "Security Standards for the Protection of Electronic Protected Health Information" comprising 45 C.F.R. Parts 160 and 164, Subpart C (the "Security Standards"), "Standards for Notification in the Case of Breach of Unsecured Protected Health Information" comprising 45 C.F.R. Parts 160 and 164, Subpart D (the "Breach Notification Standards"), and "Rules for Compliance and Investigations, Impositions of Civil Monetary Penalties, and Procedures for Hearings" comprising 45 C.F.R. Part 160, Subparts C, D, and E (the "Enforcement Rule"), promulgated pursuant to the Health Insurance Portability and Accountability Act of 1996 ("HIPAA"), the Health Information Technology for Economic and Clinical Health Act ("HITECH Act"), and the Genetic Information and Nondiscrimination Act of 2008 ("GINA") (the Privacy Standards, the Security Standards, the Breach Notification Standards, and the Enforcement Rule are collectively referred to herein as the "HIPAA Rules"). Capitalized terms not otherwise defined herein shall have the meaning set forth in the HIPAA Rules.
Among other things, HIPAA and the HIPAA Rules govern the use and disclosure of Protected Health Information ("PHI") by Covered Entities and their Business Associates. To the extent that you are or are employed by a Covered Entity and use the Services to create, transmit or maintain PHI, including but not limited to the communication of Your Content to other authorized users of the Services for purposes related to treatment of patients, you hereby acknowledge that you understand and agree as follows:
you agree to maintain full compliance with HIPAA and the HIPAA Rules and any other laws, now or hereafter existing, that are applicable to you, directly or indirectly, with respect to the collection, use, transmission, processing, receipt, reporting, disclosure, maintenance, or storage of personal information.
you understand and agree that information created, received, transmitted, or maintained as a result of your use of the Services are not intended to and do not constitute a Designated Record Set under HIPAA or the HIPAA Rules. You further acknowledge and agree that information created, received, or transmitted using the Services may be available to you for only a limited period of time as specified in these Terms. You acknowledge that it is your responsibility to properly record any information contained within or accessed via the Services that are used to make treatment decisions about a patient and that OH has no responsibility to maintain ongoing access to such content.
As between you and OH, OH and its licensors retain exclusive ownership of all rights, titles, and interests in and to the Services, including without limitation any and all worldwide copyrights, patents, trade secrets, trademarks, and intellectual property rights of any other kind related thereto. All rights not expressly granted herein are reserved and no implied licenses are granted hereunder. You hereby grant to OH a perpetual, irrevocable, royalty-free, fully paid up, transferable, sublicensable license to use, modify, create derivative works of, reproduce, distribute, disclose, publish, and otherwise exploit any of content or materials you provide to us as required for OH to provide the Services and as otherwise permitted pursuant to the Business Associate Agreement.
Disclaimers; Limitation of Liability.
DISCLAIMER OF WARRANTIES. AS BETWEEN YOU AND OH, OH MAKES NO WARRANTY OF ANY KIND, EXPRESS, IMPLIED OR STATUTORY, REGARDING THE SERVICES (INCLUDING WITHOUT LIMITATION THE TESTS), INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE AND NON-INFRINGEMENT AND ANY WARRANTIES OR CONDITIONS ARISING OUT OF COURSE OF DEALING OR USAGE OF TRADE. THE SERVICES AND THE USE THEREOF ARE ALSO SUBJECT TO THE RESTRICTIONS SET OUT IN SECTION 2 HEREOF.
LIMITATION OF LIABILITY. NOTWITHSTANDING ANYTHING ELSE IN THIS AGREEMENT OR OTHERWISE, AS BETWEEN YOU AND OH, OH SHALL NOT BE LIABLE OR OBLIGATED WITH RESPECT TO ANYTHING RELATING TO SUBJECT MATTER OF THIS AGREEMENT (INCLUDING WITHOUT LIMITATION FROM THE USE, INTERRUPTION IN USE, OR FAILURE OF THE SERVICES, AND/OR ANY HIPAA OR DATA SECURITY-RELATED MATTERS, SUCH AS BREACHES OF UNSECURED PHI) UNDER ANY BREACH OF CONTRACT, BREACH OF WARRANTY, TORT (INCLUDING NEGLIGENCE AND RELIANCE), STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY FOR ANY INDIRECT, SPECIAL, PUNITIVE, EXEMPLARY OR CONSEQUENTIAL DAMAGES (INCLUDING WITHOUT LIMITATION LOSS OF REVENUE OR GOODWILL, LOSS OF SAVINGS, LOSS OF DATA, LOSS OF USE, LOST BUSINESS, LOST PROFITS OR DATA BREACHES), EVEN IF OH HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES IN ADVANCE. AS BETWEEN YOU AND OH, YOUR SOLE AND EXCLUSIVE REMEDY FOR ANY CLAIM ARISING UNDER THIS AGREEMENT IS TO DISCONTINUE USE OF THE OH SERVICES.
IF APPLICABLE LAW RESTRICTS THE EXCLUSION OR LIMITATION OF DAMAGES, THEN THIS SECTION 6 SHALL BE DEEMED TO EXCLUDE AND LIMIT OH'S LIABILITY FOR ANY SUCH DAMAGES TO THE MAXIMUM EXTENT PERMITTED BY LAW. THE PROVISIONS OF THIS SECTION 6 ALLOCATE THE RISKS UNDER THIS AGREEMENT BETWEEN THE PARTIES, AND THE PARTIES HAVE RELIED ON THE LIMITATIONS SET FORTH HEREIN IN DETERMINING WHETHER TO ENTER INTO THIS AGREEMENT.
You agree to indemnify, defend and hold harmless OH, its subcontractors, licensors and suppliers, and their respective officers, directors, agents and employees, from and against any and all claims, losses, demands, liabilities, damages, costs and expenses (including reasonable attorneys' fees), arising out of or relating to your access to or use of the Services, your performance of any blood draws, your interactions with patients and third-party laboratories, and any advice or interventions you provide patients.
Term and Termination.
This Agreement shall commence as of the date when you accept this Agreement by signing the TRF and ordering a test and shall continue until terminated pursuant to the terms hereof.
OH reserves the right to suspend your access to the Services at any time and for any reason.
OH may terminate this Agreement at any time and for any reason or no reason upon notice to you. You may terminate this Agreement at any time by discontinuing all use of the Services. This Agreement shall automatically and immediately terminate without notice to you if you breach any term of this Agreement. Following termination for any reason, OH shall remove from the Services any Registration Information identifying you that would otherwise be accessible to other users of the Services.
Sections 1(d)-(f), 2-7, 8(d) and 9 shall survive any expiration or termination of this Agreement.
Equitable Relief. You hereby acknowledge that unauthorized disclosure or use of the Services would cause irreparable harm and significant injury to OH that may be difficult to ascertain. Accordingly, you agree that OH shall have the right to seek immediate injunctive relief, without posting a bond or other security, to enforce your obligations under this Agreement in addition to any other rights and remedies OH may have.
You may not and will not assign this Agreement or any portion of this Agreement without OH's prior written approval. Any purported assignment in violation of the foregoing shall be null and void. This Agreement shall be binding upon and accrue to the benefit of any permitted successors and assigns.
Governing Law. This Agreement shall be governed by the internal substantive laws of the State of Delaware, without regard to its conflict of laws provisions. Subject to Section 9(a), any disputes arising hereunder will be subject to the exclusive jurisdiction of the states and federal courts located in the State of Delaware and courts having jurisdiction to hear appeals therefrom.
All notices required under this Agreement shall be made in writing by email, if to OH, to the email address set forth in the preamble of this Agreement, and if to you, to the address submitted to OH during the Services registration process. Such email address for either party may be changed upon email notice delivered to the other party.
If any provision of this Agreement is determined by a court of competent jurisdiction to be unenforceable, the provision shall be deemed modified to the extent necessary to allow it to be enforced to the extent permitted by law, or if it cannot be modified, the provision shall be severed and deleted from the Agreement, and the remainder of the Agreement shall continue in effect.
Amendment; Waiver. No changes or modifications to this Agreement or waivers of any provision hereof shall be effective unless evidenced in a writing referencing this Agreement and signed by a duly authorized representative on behalf of each party. Failure by any party to enforce any term of this Agreement shall not be deemed a waiver of future enforcement of that or any other term in this Agreement or any other agreement that may be in place between the parties.
Force Majeure. OH shall be excused from any failure or delay in performing any obligation hereunder to the extent such failure results from a cause beyond the reasonable control of such party, including without limitation act of God, accident, earthquake, fire, flood, hurricane, tornado, storm or other weather condition, war, terrorism, cyberterrorism, hacking, sabotage, riot, civil disorder, act or decree of any governmental body, power or network failure, lockout, strike or other labor disturbance, illness, death or any other natural or artificial disaster. In the event of any such failure or delay, OH will use commercially reasonable efforts to perform as soon as practicable.
Entire Agreement. The terms and conditions set forth in this Agreement constitute the entire agreement between you and OH with respect to the Services which are the subject matter hereof, and merges and supersedes all prior and contemporaneous agreements, understandings, negotiations, and discussions. The section headings contained in this Agreement are for convenience of reference only and shall have no effect on the substantive interpretation hereof.