Relating to the Review of External Speaker Programs Sample Clauses

Relating to the Review of External Speaker Programs. In connection with the review of External Speaker Programs: i. A description of each External Speaker Program Reviewed, including the identity of the External Speaker, an identification of the Government Reimbursed Product associated with the program, the date of the program, and a description of the format of the program (e.g., whether the program occurred in a virtual format, whether the program included a question and answer session; whether the program was recorded, etc.); ii. For each Government Reimbursed Product and/or new indication approved by the FDA for which External Speaker Programs occurred, the total amount of remuneration expended by Novartis relating to External Speaker Programs; iii. For each External Speaker, the total amount of remuneration paid to the External Speaker in connection with External Speaker Programs for each Government Reimbursed Product and the total amount incurred or paid by Novartis for travel and travel- related expenses for the External Speaker; iv. For each External Speaker, a description of any other Payments provided by Novartis to the External Speaker. This description shall include the total amount of other Payments, the nature/purpose of each Payment, and the date of each such Payment; v. The IRO’s findings and supporting rationale as to whether: a. Novartis complied with the requirements relating to the format of External Speaker Programs (including requirements that External Speaker Programs be conducted in a virtual format and requirements that Novartis not organize or facilitate group gatherings of HCPs outside of the individual HCP’s office setting for purposes of participating in or viewing External Speaker Programs);