Open Payments Program. The parties acknowledge that the U.S. program known as “Open Payments” (which is also referred to as the “Physician Payments Sunshine Act”) established by Section 1128G of the U.S. Social Security Act (42 U.S.C. 1320a-7h) and implemented by regulations at 42 C.F.R. Parts 402 and 403 requires “applicable manufacturers” to report direct and indirect payments and other transfers of value made to or at the request of, or designated on behalf of, “covered recipients,” including payments or transfers of value through a third party where the applicable manufacturer requires, instructs, directs, or otherwise causes the third party to provide the payment or transfer of value, in whole or in part, to a covered recipient. All Fees paid to Advarra under this Agreement are paid directly to Advarra as described in Section V. the Institution, whether or not it is an “applicable manufacturer” under the Open Payments program, cannot and will not require, instruct, direct, or otherwise cause Advarra to provide such payments for services, in whole or in part, to licensed physician members of the IRB. Therefore, payments from the Institution for services will not be considered payments or other transfers of value to licensed physicians who are employees or independent contractors of Advarra. Advarra represents and warrants that all review services will be conducted in such a manner as to satisfy 21 C.F.R. § 56.107(a) and other applicable laws.
Open Payments Program. The Parties acknowledge that the U.S. program known as “Open Payments” (which is also referred to as the “Physician Payments Sunshine Act”) established by Section 1128G of the U.S. Social Security Act (42 U.S.C. 1320a-7h) and implemented by regulations at 42 C.F.R. Parts 402 and 403 requires “applicable manufacturers” to report direct and indirect payments and other transfers of value made to or at the request of, or designated on behalf of, “covered recipients,” including payments or transfers of value through a third party where the applicable manufacturer requires, instructs, directs, or otherwise causes the third party to provide the payment or transfer of value, in whole or in part, to a covered recipient. All Fees paid to Advarra under this Agreement are paid directly to Advarra as described in Section V. Institution, whether or not it is an “applicable manufacturer” under the Open Payments program, cannot and will not require, instruct, direct, or otherwise cause Advarra to provide such payments for Services, in whole or in part, to licensed physician members of the IRB. Therefore, payments from Institution for Services will not be considered payments or other transfers of value to licensed physicians who are employees or independent contractors of Advarra. Advarra represents and warrants that all review services will be conducted in such a manner as to satisfy 21 C.F.R. § 56.107(a) and other applicable laws. Governing Law This Agreement shall be governed by the substantive law of the jurisdiction of the State of Delaware, without reference to that jurisdiction’s conflicts-of-law rules.
