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Terms of Participation *
Licensed physicians who provide medical services to patients with (metastatic or unresectable) histologically-documented solid tumors and lymphomas are invited to request approval from Strata Oncology, Inc., (“Strata”) to refer certain of their qualified patients for participation in the Strata Trial. All referrals for participation in the Strata Trial are subject to, and conditioned upon compliance with, this Terms of Participation in Referrals for Screening for the Strata Trial (“Terms of Participation”). The Strata Trial is a multi-center, observational trial pursuant to which patients with certain mutation-positive solid tumors and lymphomas may be matched to a portfolio of clinical trials sponsored by clinical trial sponsors that have partnered with Strata, each covering distinct genomic alteration(s). Eligible patients who consent to participate in the Strata Trial pursuant to the Strata Trial protocol entitled, “An Observational Study Profiling Biospecimens from Cancer Patients to Screen for Molecular Alterations” (STR-001-001) are eligible for testing of their retained tumor tissue with a next-generation sequencing test capable of identifying genetic mutations from tumor tissue, conducted by the Strata’s CLIA-Certified Laboratory. William Gannon, MD (“Strata PI”) is the principal investigator for the performance of the Strata Trial through Strata’s virtual clinical trial site. In its sole and absolute discretion, upon submission by a referring physician of all information requested by Strata and upon acknowledgement and acceptance of these Terms of Participation, Strata may grant the physician (a “Referring Physician”) access to Strata’s electronic portal (“Portal”). A Referring Physician may use the Portal only for the purposes of ordering the Strata Test for the Referring Physician’s patients who qualify for and enroll in the Strata Trial and accessing Strata Test reports and other information provided by Strata through the Portal. Use of the Portal is subject in all respects to Strata’s Terms of Use (link below) and Privacy Policy (link below). In the event of any conflict with the Terms of Use or the Privacy Policy, this Terms of Participation controls. Acceptance of patient referrals and tissue specimens from any Referring Physician shall be determined by Strata in its sole and absolute discretion. Strata may refuse to accept any patient referral from any Referring Physician, and may discontinue a Referring Physician’s access to the Portal, at any time, for any reason or for no reason. Strata will not accept any tissue specimen from a Referring Physician except that of a subject properly enrolled in Strata Trial by the Strata PI. Strata will return any unauthorized specimens at the Referring Physician’s expense, and will not be responsible for any damage to or loss of the specimen. Authorized Strata Tests of tissue specimens submitted for subjects enrolled in the Strata Trial will be processed and reported by Strata at no cost to the Referring Physician or the Strata Trial subject. The Referring Physician will not receive any payment from Strata or any Strata partner clinical trial sponsor for the referral of any patient or for any activities of the Referring Physician under this Terms of Participation. The Referring Physician acknowledges and agrees that the items and services provided by Strata in connection with the Strata Trial are solely for the purposes of providing Referring Physician’s eligible patients with information regarding clinical trial options and encouraging efficient enrollment of eligible patients to the clinical trials sponsored by Strata’s partners. The authorization of the Referring Physician to refer eligible patients for participation in the Strata Trial was not determined based on the volume or value of any referrals or other business generated by the Referring Physician. No part of the provision of testing and other services by Strata in connection with the Strata Trial is intended to be for, nor shall be construed as, an offer or payment made in exchange for any explicit or implicit agreement to purchase, prescribe or recommend, or provide a favorable formulary status for, any Strata or Strata partner’s product or service. The authorization of a Referring Physician to refer eligible patients and submit tumor specimens and information to Strata is conditioned upon the Referring Physician’s agreement to the following representations and warranties. The Referring Physician represents and warrants that: (1) The Referring Physician will cooperate with Strata to provide all information requested by Strata in connection with the Strata Trial, and all information provided to Strata in connection with the Strata Trial will be complete and accurate at the time it is submitted. Any patient protected health information will be provided subject to the patient’s written authorization obtained in connection with the patient’s consent for participation in the Strata Trial or an IRB approved waiver. (2) The Referring Physician holds an unrestricted license to practice medicine in the state in which the physician treats each patient referred for screening for participation in the Strata Trial. (3) No government or commercial health plan, patient, or other person will be billed for the Strata Test or for any other laboratory or professional services provided by Strata. (4) The Referring Physician has obtained all required approvals, if any, of any professional practice or institution at which the Referring Physician practices to submit patient specimens for screening in the Strata Trial. (5) The Referring Physician will inform each patient for whom the Strata Test is performed of the results, including any match to a clinical trial sponsored by a Strata partner clinical trial, reflected on a Strata Test Report, and will cooperate with Strata to support eligible patients’ participation in Strata partners’ clinical trials to which patients and are matched and that are medically appropriate for the patient. (6) The Referring Physician will not use Strata’s name, symbols and/or marks in any publication or form of publicity without Strata’s prior approval. (7) The Referring Physician is not debarred under Section 306(a) or (b) of the Federal Food, Drug and Cosmetic Act, excluded from participation in any government healthcare program, convicted of any offense defined in 42 U.S.C. Section 1320a-7, or disqualified as a clinical investigator pursuant to 21 C.F.R Section 312.70 or 812.119. If Referring Physician becomes aware during his or her participation as a Referring Physician for the Strata Trial that he or she is, or is in the process of being, debarred, excluded or disqualified, Referring Physician will promptly notify Strata in writing. NOTWITHSTANDING ANY OTHER PROVISION HEREOF, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY OR ANY THIRD PARTY FOR ANY INDIRECT, CONSEQUENTIAL, INCIDENTAL, RELIANCE, SPECIAL, EXEMPLARY OR PUNITIVE DAMAGES (INCLUDING BUT NOT LIMITED TO DAMAGES FOR LOST PROFITS, LOST REVENUES OR COST OF PURCHASING REPLACEMENT SERVICES) ARISING OUT OF OR RELATING TO THESE TERMS OF PARTICIPATION. FURTHERMORE, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER, EITHER IN CONTRACT OR IN TORT, FOR PROTECTION FROM UNAUTHORIZED ACCESS OF PATIENT DATA OR FROM UNAUTHORIZED ACCESS TO OR ALTERATION, THEFT OR DESTRUCTION OF DATA FILES, PROGRAMS, PROCEDURES OR INFORMATION NOT CONTROLLED BY SAID PARTY, THROUGH ACCIDENT OR FRAUDULENT MEANS OR DEVICES. Disclosure for the Strata Test Report: The Strata Test was processed and reported by Strata at no cost to patient or his or her medical provider or any hospital, clinic or other health care entity associated with the provider. No government or commercial health plan, patient, or other person may be billed for the Strata Test or for any other laboratory or professional services provided by Strata.