Marketing Approval

Marketing Approval. Means final approval of an NDA by the FDA, or final approval of a comparable document filed with an equivalent health regulatory authority in any other country or in the European Union (using the centralized process or mutual recognition), including all required marketing, pricing or reimbursement approvals.

Marketing Approval. Shall mean the final approval in a country from all necessary regulatory agencies to market the Product in such country including any requisite pricing approvals.

Marketing Approval. Shall mean, with respect to a particular Licensed Product in a particular country, the date upon which the last of all governmental or regulatory approvals required for the sale of such Licensed Product in that country has been granted.

Marketing Approval. Means, with respect to a Product in a particular jurisdiction, all approvals or authorizations necessary for the commercialization of such Product in such jurisdiction, including, in each case, Pricing Approval.

Marketing Approval. Means approval of an MAA in a country of the Territory.

Marketing Approval. Any and all approvals, licenses, registrations or authorizations of any federal, state, provincial or local regulatory agency, department, bureau or other governmental entity, necessary to permit the marketing, distribution and sale of a Collaboration Product in a country or regulatory jurisdiction in the Territory

Marketing Approval. Final approval of an NDA by the FDA, or final approval of a comparable document filed with an equivalent health regulatory authority in any other country or in the European Union (using the centralized process or mutual recognition), including all required marketing, pricing or reimbursement approvals; provided, that if a First Commercial Sale has occurred in any country (or within any country within a region), it shall be conclusively deemed for purposes of this Agreement that all required... marketing, pricing and reimbursement approvals in such country and in such (entire) region have been obtained View More

Marketing Approval. Approval received from the FDA or any comparable approval in any non-US jurisdiction with any relevant Regulatory Authority granting the right to commercialize QS-21 Vaccines (but specifically independent of pricing or reimbursement considerations, where applicable).

Marketing Approval. The approval of a NDA or a New Drug Application filed with the United States Food & Drug Administration prior to sale of a pharmaceutical product to humans, which grants a sponsor company of the NDA approval for the sale and marketing of a new pharmaceutical in the United States; or the approval of an analogous application with any analogous agency or Regulatory Authority outside of the United States under any analogous foreign law for the purposes of approval of the sale and marketing of a new... pharmaceutical in the respective country View More

Marketing Approval. With respect to any country, the approval of any marketing application for the Finished Product by the appropriate Regulatory Authority in such country, including (a) FDA Approval, (b) approval of a marketing authorization application by the EU Medicines Agency and (c) approval of other product registration application with respect to any other territory.