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INCY » Topics » Regulatory Approval

This excerpt taken from the INCY 10-K filed Mar 3, 2006.
Regulatory Approval” means any and all approvals, excluding any INDs, but including supplements and amendments, licenses, registrations or authorizations (other than Price Approvals) 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,

 

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*** Confidential material redacted and filed separately with the Commission.

 

commission, council or other Governmental Authority, that are necessary for the manufacture, distribution, use, marketing or sale of a pharmaceutical product in a regulatory jurisdiction.

 

"Regulatory Approval" elsewhere:

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BioMarin Pharmaceutical (BMRN)
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Emergent Biosolutions (EBS)
Enzon Pharmaceuticals (ENZN)
Obagi Medical Products (OMPI)
Optimer Pharmaceuticals (OPTR)
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