SWOG Clinical Trials Initiative Purchased Service Agreement

1. Clinical Trial Services. 1.1 INVESTIGATOR, when engaging in a Designated Clinical Trial, will enter those patients of INVESTIGATOR into the Designated Clinical Trial who are eligible under the criteria specified in the protocol of the Designated Clinical Trial. INVESTIGATOR shall furnish on a timely basis to the GROUP’s Statistical Center in Seattle, Washington (“Statistical Center”) the data and follow-up information as outlined in the protocol in each of the Designated Clinical Trials. 1.2 Patients/participants of a Designated Clinical Trial will be followed by INVESTIGATOR according to the protocol whether or not treatment is completed under the protocol. 1.3 INVESTIGATOR acknowledges and agrees that (i) GROUP conducts many Clinical Trials and that the services of INVESTIGATOR are only being engaged in connection with Designated Clinical Trials, and (ii) Clinical Trials may be initiated by the GROUP without the prior approval of the INSTITUTION or INVESTIGATOR. 1.4 INVESTIGATOR and INSTITUTION acknowledge that funding received to implement this Agreement may include federal funding programs awarded or transferred to SWOG-CTI. Notwithstanding the source of funding, INVESTIGATOR and INSTITUTION agree to comply with all obligations typically required by NIH funding as a condition to engaging in the Designated Clinical Trial. 2. Fees and Payments. As compensation for the services provided by INVESTIGATOR under the terms of this Agreement, SWOG-CTI shall pay to INVESTIGATOR the fees set forth below. 2.1 Fees. Under this agreement, the INVESTIGATOR/INSTITUTION would be eligible for payment in the following areas: 2.1.a. Clinical Trial Registration Supplement (CTRS) for Designated Clinical Trials with NCI Funding: For each Designated Clinical Trial with governmental funding initiated by GROUP, additional funding may be obtained by SWOG-CTI to supplement clinical trial costs incurred by the INVESTIGATOR/ INSTITUTION. This Supplement is in addition to governmental funding distributed by the GROUP to the INVESTIGATOR or by the government to the INVESTIGATOR through a U10 Grant. 2.1.b. Clinical Trial Registration Payment (CTRP) for Designated Clinical Trials without NCI Funding: Due to reduction in the Federal budget, some trials may be initiated by GROUP that are not eligible for per capita reimbursement from GROUP, and for which eligible registrations will not be applicable to the SWOG U10 Grant accrual baseline. In such situations, the entire payment for clinical trial registration will be provided by SWOG-CTI to INVESTIGATOR. 2.2 Acceptance of Payment The Funding Memorandum issued with the initiation of the GROUP’S Designated Clinical Trial will delineate the source, amount, and intended purpose of all supplemental payments related to registrations on the Designated Clinical Trial. Activation of the trial by the INVESTIGATOR/INSTITUTION indicates acceptance by the INVESTIGATOR/INSTITUTION of the reimbursement plan. 2.3 Use of Funds The compensation to be paid by SWOG-CTI to the INVESTIGATOR for the CTRS and CTRP programs may be directed to regulatory support, data management, translational medicine components of trials such as specimen collection and shipping, or other expenses related to performance of clinical trial research on the Designated Clinical Trial. Each Designated Clinical Trial initiated by GROUP will describe in the Funding Memorandum the amount, source (federal or private), and purpose of CTRS/CTRP to be supplied by SWOG-CTI to INVESTIGATOR/INSTITUTION. 2.4 If funds from any future funding programs b