Regulatory Approval
Regulatory Approval. Means all authorizations by the competent Regulatory Authorities which are required for the manufacture, marketing, promotion, pricing and sale of a Product in a given country or regulatory jurisdiction in the Territory.
Regulatory Approval. Means, with respect to a Product, all approvals, licenses, registrations or authorizations necessary for the commercialization of such Product in a particular jurisdiction.
Found in
Forty Seven, Inc. contract
Regulatory Approval. The approval, registration, license or authorization of a Governmental Authority necessary for the manufacturing, distribution, use, promotion or sale of a Product for one or more indications in a country or other regulatory jurisdiction, including approval of Biologics License Applications (as defined by applicable Law) in the United States and Marketing Authorizations in the European Union or other European countries.
Found in
Elanco Animal Health Inc contract
Regulatory Approval. With respect to any jurisdiction, those approvals or authorizations of a regulatory authority that are necessary for the commercial marketing and sale of a pharmaceutical product in such jurisdiction.
Found in
Novus Therapeutics, Inc. contract
Regulatory Approval. All approvals, licenses, registrations, and authorizations of any federal, national, multinational, state, provincial, or local Regulatory Authority, department, bureau, and other governmental entity that are necessary and sufficient for the marketing and sale of a product in a country or group of countries
Found in
ProPhase Labs, Inc. contract
Regulatory Approval. The approvals (including any applicable governmental price and reimbursement approvals), licenses, registrations or authorizations of Regulatory Authorities necessary for the development, manufacture, use, offer for sale, sale or importation of a product in a country or territory
Found in
Curative Biotechnology Inc contract
Regulatory Approval. All authorizations by the appropriate Regulatory Authority necessary for commercial sale of Finished Product in a jurisdiction
Found in
Flexion Therapeutics Inc contract
Regulatory Approval. Shall mean the technical, medical and scientific licenses, registrations, authorizations and approvals of any national (e.g., the FDA), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, necessary for the Research, Development, Manufacture and Commercialization of Licensed Product(s) in the Territory, including, without limitation, INDs and other submissions and approvals necessary to conduct clinical studies, approvals of ND As, •...
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Regulatory Approval. Means receipt of all approvals, licenses, registrations, or authorizations of any country, federal, supranational, state or local regulatory agency, ministry, department, bureau or other government entity that are necessary for the use or sale of a particular Product in the jurisdiction for a particular indication, including any approvals for importation, manufacture, pricing, and/or reimbursement where necessary for effective market entry.
Regulatory Approval. Means, for a particular country, approval by the applicable Regulatory Authority of any and all filings required for the commercial marketing or sales of any product (or component thereof) in such country, along with satisfaction of any related applicable regulatory requirements.
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Found in
Lucira Health, Inc. contract