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. 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.

Marketing Approval. Final approval of an Application by the FDA, or comparable 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, decentralized process or mutual recognition or member state national authorization), without regard to any other marketing approvals such as pricing and reimbursement approvals; provided, that if a First Commercial Sale for use or consumption by a member of the general... public of a Licensed Product has occurred in any country in compliance with that country's applicable laws, it shall be conclusively deemed for purposes of this Agreement that such approval in such country has been obtained View More

Marketing Approval. With respect to the Product in a particular country, all approvals, licenses, registrations or authorizations of any Regulatory Authority, necessary for the manufacturing, use, storage, import, transport and sale of such Product in such country, together with pricing or reimbursement approval in countries where governmental approval is required for pricing or for the Product to be reimbursed by national health insurance.

Marketing Approval. Means all approvals from the relevant Regulatory Authority of a Major Country necessary to market and sell a Product in such country or territory.