Regulatory Approval

Regulatory Approval. Shall mean any and all approvals (including price and reimbursement approvals), licenses, registrations, or authorizations of the United States or European Union or any country, federal, state or local regulatory agency, department, bureau or other government entity that is necessary for the manufacture, use, storage, import, transport and/or sale of an Collaboration Specialty Laboratories Product in such jurisdiction.

Regulatory Approval. Shall mean (i) approval of an NDA by the FDA permitting commercial sale of a Product or (ii) any comparable approval permitting commercial sale of a Product granted by the applicable Regulatory Agency in any other country or jurisdiction.

Regulatory Approval. Shall mean any approvals (including supplements, amendments, pre-marketing and post-marketing approvals, labeling approval, and pricing and reimbursement approvals), licenses, registrations or authorizations of any national, supra-national (e.g., the European Commission or the Council of the European Union), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, necessary for the manufacture, distribution, use or sale of Product in a... regulatory jurisdiction. View More

Regulatory Approval. Means, with respect to the Product, any approval (notwithstanding the indication), registration, license or authorization from the FDA to market and sell such Product in the Territory.

Regulatory Approval. In a particular country means all approvals (including any applicable governmental price and reimbursement 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 for the marketing and sale of a Licensed Product in a country.

Regulatory Approval. Shall mean, with respect to a particular Product and country or jurisdiction in the Territory, all approvals, registrations, licenses, and authorizations (but excluding pricing and reimbursement approvals) that are required by the applicable Regulatory Authority to market and sell such Product in such country or jurisdiction.

Regulatory Approval. Means any and all filings and approvals (including pricing and reimbursement approvals only in those jurisdictions requiring reimbursement approval required before marketing can commence), product and establishment licenses, registrations or authorizations of any kind of the FDA or any Foreign Regulatory Authority necessary for the development, pre-clinical and/or human clinical testing, manufacture, quality testing, supply, use, storage, importation, export, transport, marketing and sale of a... pharmaceutical product (or any component thereof) in any country or other jurisdiction in the Territory. "Regulatory Approval" shall include, without limitation, any INDs, NDAs and drug master files. View More

Regulatory Approval. Means all approvals, licenses, registrations or authorizations of any national or international or local regulatory agency, department, bureau or other governmental entity, necessary for the commercial sale of the Product.

Regulatory Approval. Any governmental or regulatory approval, consent or authorization or waiver required to be obtained from or any filing required to be made with or notice required to be given to any governmental or Regulatory Authority, commission, tribunal, ministry, official or agency.

Regulatory Approval. Means all governmental approvals and authorizations necessary for the manufacture and commercial sale of the Product in a country of the Territory, including, but not limited to, marketing authorization, pricing approval and pricing reimbursement, as applicable.