definiens: means, with respect to a Product in any regulator y jurisdiction, approval from the applicable Regulatory Authority sufficient for the manufacture, distribution, use, marketing and sale of such Pro duct in such jurisdiction in accordance with Applicable Laws . In jurisdictions where the applicable Regulatory Auth ority sets the pricing or reimbursement authorizations necessa ry for the general marketing and sale of such Produ ct in the marketplace, Approval will not be deemed to have oc curred if the final approval to market and sell suc h Product is being withheld because [COMPANY] ( or its Affiliate or Sublicensee ) and the Regulatory Authority have n ot yet determined pricing or reimbursement even if all oth er approvals, licenses, registrations or authorizat ions necessary for marketing, sale or use of such Product in such jurisdiction have been obtained . does not include authorization by a Regulatory Authority to conduct named patient, compassionate use or other similar a ctivities