SOPs and Sample Accountability Program Clause Samples

SOPs and Sample Accountability Program. Cardinal Health has established and shall maintain internal SOPs relating to drug sampling which shall ensure that all of its Representatives receive, store, handle, track and distribute drug samples in compliance with Laws (including but not limited to the PDMA) and with prudent management practices. The SOPs comply with all Laws and include, among other things, its Sample Materials Distribution Instructions and sample accountability program. Cardinal Health shall conduct ongoing training of its Representatives and Managers to familiarize them with its SOPs, and monitor their compliance therewith. The SOPs (including the sample accountability program) require, among other things, compliance with the following procedures: (a) all samples are stored and handled in a clean, secure environment at room temperature (or as otherwise required by Product Labeling); (b) Cardinal Health maintains appropriate inventory tracking records and controls; (c) all damaged, expired or shop-worn samples are returned or destroyed (at Acorda’s instruction); (d) Acorda and its distributor are informed in writing within 72 hours of receipt of any sample shipment that contains damaged, expired, unusable or missing items (specifying the number of such affected items); Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission. (e) Cardinal Health and its Representatives distribute samples only upon receipt of an Authorized Request; (f) Cardinal Health and its Representatives maintain sample distribution records, including retaining a hard copy of each Authorized Request bearing the requestor’s signature, as well as a copy of the corresponding receipt of the sample (recording the name, address, professional title and signature of the person receiving the sample); (g) Cardinal Health and its Representatives monitor all Authorized Requests in order to ensure that no practitioner receives (whether pursuant to one or more requests) an aggregate number of samples in excess of any monthly or other limitation imposed by Law, or any SOP; provided that Acorda will be contacted on a case-by-case basis if a request is received which, if fulfilled, would exceed any such applicable limit, and Acorda’s instructions followed with respect thereto; (h) Cardinal Health and its Representatives refrain from selling or trading, or offering to sell ...