definiens: means, with respect to a Product in any regulatory jurisdiction, approval from the applicable RegulatoryAuthority sufficient for the manufacture, distribution, use, marketing and sale of such Product in such jurisdiction inaccordance with Applicable Laws . In jurisdictions where the applicable Regulatory Authority sets the pricing orreimbursement authorizations necessary for the general marketing and sale of such Product in the marketplace, Approval willnot be deemed to have occurred if the final approval to market and sell such Product is being withheld because [COMPANY] Idec(or its Affiliate or Sublicensee ) and the Regulatory Authority have not yet determined pricing or reimbursement even if allother approvals, licenses, registrations or 118 authorizations necessary for marketing, sale or use of such Product in such jurisdiction have been obtained . doesnot include authorization by a Regulatory Authority to conduct named patient, compassionate use or other similar activities