Drug Approval definition

Drug Approval means an approval granted by the appropriate Regulatory Authority to market the Product in the Field in any particular jurisdiction in the Licensed Territory.

Drug Approval means an approval granted by the appropriate Regulatory Authority to market the Product in the Field in any particular jurisdiction in the Licensed Territory; provided, “Drug Approval” shall include any and all marketing authorizations in the EU but exclude any and all Pricing Approvals and Reimbursement Approvals.

Drug Approval means an approval granted by the appropriate Regulatory Authority to market a Product in the Field in any particular jurisdiction in the Territory; provided, “Drug Approval” includes any and all marketing authorizations in the EU but excludes any and all Pricing and Reimbursement Approvals.

Examples of Drug Approval in a sentence

• The Parties intend that all Drug Approval Applications for the Product in the Field in the OUS Territory will be comprised of the Drug Approval Application submitted by Solvay to the FDA as described in Section 5.1(b), plus such additional data and reports not required to be submitted to the FDA but required to be submitted in the OUS Territory.

• The molecule has been submitted for New Drug Approval in the US and Europe.

• Drug Approval Process Regulation by governmental authorities in the United States and other countries is a significant factor in the development, production and marketing of cti's proposed drug products.

• Xxxxxx shall consult with Enanta in good faith in the preparation of all Drug Approval Applications for Candidates.

• In addition, Xxxxxx shall provide Enanta with initial IND filings or Drug Approval Applications sufficiently in advance of submission so that Enanta may review and comment on the substance of such Regulatory Filing or other document or correspondence.

More Definitions of Drug Approval

Drug Approval means an approval granted by the appropriate Regulatory Authority to market a Product in the Field in any particular jurisdiction in the Territory, excluding any required Pricing and Reimbursement Approval.

Drug Approval means an approval of a BLA, NDA, or of a MAA, or any corresponding Regulatory Approval for the Commercialization of a pharmaceutical product for a particular indication in any other country or region of the world, including other than the U.S. and the EU /European Economic Area.

Drug Approval means an approval granted by the appropriate Regulatory Authority to market a Licensed Product (as the context admits) in the Field of Use in any particular jurisdiction in the Licensed Territory; provided “Drug Approval” includes any and all marketing authorizations, but excludes any and all Pricing Approvals and Reimbursement Approvals.

Drug Approval means an approval granted by the appropriate Regulatory Authority to market a Product in the Field in any particular country or jurisdiction in the Licensed Territory; provided, “Drug Approval” includes any and all Marketing Authorizations but excludes any and all Pricing Approvals and Reimbursement Approvals. The term Drug Approval also includes an approval of (a) a drug/ device combination such as Aerosurf and (b) each of Drug and Device if required to be obtained separately.

Drug Approval means an approval, authorization or license (including, without limitation, an Investigational New Drug Application (“IND”) authorizing human testing of a drug, New Drug Application, conditional Marketing Authorization Application and Marketing Authorization Application) granted by a Governmental Authorities (including, without limitation, the FDA and the European Commission) to permit the use in human use, sale and marketing of a Product.

Drug Approval means the regulatory approval required before commercial sale or use of a Product as a drug in a regulatory jurisdiction, including, for purposes of Regulatory Approval in the US, a New Drug or a Biological License and all supplements filed pursuant to the requirements of the FDA (including all documents, data and other information concerning a Product that are necessary for, or included in, FDA approval to market a Product) and, for purposes of Regulatory Approval in the EU, all and any regulatory approval by the EMEA or any other applicable national regulatory authority.

Drug Approval shall have the meaning ascribed to it in the Mundipharma Collaboration Agreement.