definiens: as such term is defined under Applicable Laws in the United States and equivalent Applicable Laws in other jurisdictio ns ), including material compliance with applicable Privacy and Information Security Laws and Health Laws . Neither Seller nor any of its Affiliates have received any notifications or other communications from any institutional review board ( IRB ), ethics com mittee or safety monitoring committee raising any issues, including from any Regulatory Authority in any jurisdiction requiring the termination delay, suspension or investigation of any clinical trials conducted by, or on behalf of, Seller or any of its Af filiates, or in which Seller or any of its Affiliates have participated and, to knowledge of Seller, no such action has been threatened . Further, no clinical investigator, researcher, or clinical staff participating in any clinical trial conducted by, or o n behalf of, Seller or any of its Affiliates, or in which Seller or any of its Affiliates have participated, has been disqualified from participating in studies involving the Product, and to the knowledge of Seller, no such administrative action to disqual ify such clinical investigators, researchers or clinical staff has been threatened or is pending . Accurate and complete copies of all material scientific, pre -clinical and clinical data of Seller or any of its Affiliates with respect to the Product or the Program have been made available to Purchaser