Regulatory Approval

Regulatory Approval. With respect to a state, nation or multinational jurisdiction, (i) any approvals, licenses, registrations or authorizations necessary for the manufacture (where relevant), marketing and sale of a Licensed Product or Licensed Service in such state, nation or jurisdiction, and (ii) where relevant, pricing approvals necessary to obtain reimbursement from a Government Authority

Regulatory Approval. With respect to a regulatory jurisdiction, any and all approvals, product and/or establishment licenses, registrations or authorizations of any Governmental Authority, necessary for the commercial manufacture, use, storage, import, export, transport, or Commercialization of a product in such regulatory jurisdiction, including, where applicable, (i) pricing and reimbursement approval in such regulatory jurisdiction, (ii) pre- and post-approval marketing authorisations (including any prerequisite... manufacturing approval or authorisation related thereto), (iii) labelling approval and (iv) technical, medical and scientific licences. With regard to an IVD, Regulatory Approval would occur upon FDA approval of a Premarket Approval Application or de novo classification or premarket authorization for the IVD, and similar approvals of Governmental Authorities in other jurisdictions View More

Regulatory Approval. Any technical, medical and scientific license, registration, authorization or approval (including, without limitation, any approval of an NDA or BLA or foreign counterpart, supplement or amendment, pre- and post- approval, pricing approval, or labeling approval) of any national, supra-national regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, necessary for the commercial manufacture, distribution, marketing, promotion, offer for... sale, use, import, export and sale of a Marketed Product in a regulatory jurisdiction View More

Regulatory Approval. Means receipt of final written approval from the United States Food and Drug Administration or final written registration or approval for a CE Mark allowing the marketing and sale of products covered by Licensed Patents by Licensor in the Retained Field.

Regulatory Approval. With respect to a particular Covered Product, any and all approvals, licenses, registrations, or authorizations of a relevant Regulatory Authority (including price approvals) necessary for the Development, Manufacture and/or Commercialization of such Covered Product in a particular country or jurisdiction. For the avoidance of doubt, Regulatory Approval in the United States shall be deemed to occur upon approval of the applicable NDA (as defined above) in the United States, and shall not be... construed to require a determination or approval of reimbursements of any type. View More

Regulatory Approval. Any approvals, licenses, registrations or authorizations of any federal, state, provincial or local regulatory agency, department, bureau or other governmental entity necessary for the manufacture and sale of a product in a regulatory jurisdiction

Regulatory Approval. Any and all approvals (including pricing and reimbursement approvals), licenses, registrations or authorizations by any Regulatory Authority that are necessary for the Commercialization of a therapeutic Product in a country in the Territory, including any approval for a Product clearance, new drug application, or pre-marketing authorization

Regulatory Approval. Means any applicable and all approvals from Regulatory Authorities in a country which are required to market and sell Development Products in such country

Regulatory Approval. Any approvals (including supplements, amendments, pre- and post-approvals and price approvals), licenses, registrations or authorizations (including any designations of an indication for a Product as an 'Orphan Product' under the Orphan Drug Act), howsoever called, of any Regulatory Authority, which are necessary for the distribution, importation, exportation, manufacture, production, use, storage, transport or clinical testing and/or sale of a product or process in a regulatory jurisdiction.... Regulatory Approval will not include any site license for a LICENSEE manufacturing facility. View More

Regulatory Approval. Shall mean any approval, licenses, registrations, or authorizations of any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government Regulatory Authority regulating or otherwise exercising authority with respect to the Product in the Territory and required for the manufacture, use, storage, import, transport or sale of any such Product in any country of the Territory, including but not... limited Pre-Market Notifications ("510(k)") European Commission ("EC") Annex II CE Mark certifications, Doctor and Dentist Exemption Certificates ("DDX"), Clinical Trials in Marketed Products ("CTMP"), Drug Master Files ("DMF"), national filings, Manufacturing Authorization Applications ("MAA"), MAA dossiers, MAA renewals, MAA variations and Clinical Trials Exemptions ("CTX"). View More