Common use of Regulatory Authority Clause in Contracts

Regulatory Authority. The term “Regulatory Authority” shall mean any national, supranational (e.g., the European Commission, the Council of the European Union, the European Medicines Agency), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity including the FDA, in each country involved in the granting of Regulatory Approval for the Product.

Appears in 8 contracts

Samples: Confidential Treatment Requested (Pieris Pharmaceuticals, Inc.), Option and License Agreement (Magenta Therapeutics, Inc.), Asset Purchase Agreement (Evotec AG)

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Regulatory Authority. The term “Regulatory Authority” shall mean Authority means any nationalnational (e.g., supranational the FDA), supra-national (e.g., the European Commission, the Council of the European Union, or the European Medicines AgencyEMA), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity including the FDA, in each country authority involved in the granting of Regulatory Approval Approvals or Price Approvals for the Productpharmaceutical products in such country or countries.

Appears in 2 contracts

Samples: License Agreement (Organovo Holdings, Inc.), License Agreement (Aldeyra Therapeutics, Inc.)

Regulatory Authority. The term “Regulatory Authority” shall mean any national, supranational (e.g., the European Commission, the Council of the European Union, the European Medicines Agency), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity including the FDA, in each country involved in the granting of Regulatory Approval for the Collaboration Product.

Appears in 2 contracts

Samples: Collaboration and License Agreement (C4 Therapeutics, Inc.), Collaboration and License Agreement (C4 Therapeutics, Inc.)

Regulatory Authority. The term “Regulatory Authority” shall mean any national, supranational (e.g., the European Commission, the Council of the European Union, the European Medicines Agency), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity entity, including the FDA, in each country involved in the granting of Regulatory Approval for the Product.

Appears in 2 contracts

Samples: License Agreement (Global Blood Therapeutics, Inc.), License Agreement (Global Blood Therapeutics, Inc.)

Regulatory Authority. The term “Regulatory Authority” shall mean mean, with respect to a country in the Territory, any nationalnational (e.g., supranational the FDA), supra-national (e.g., the European Commission, the Council of the European Union, or the European Medicines AgencyAgency for the Evaluation of Medicinal Products), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity including the FDA, in each country involved in the granting of a Regulatory Approval for the Productsuch country or countries.

Appears in 1 contract

Samples: License and Development Agreement (Inovio Biomedical Corp)

Regulatory Authority. The term “Regulatory Authority” shall mean any nationalnational (e.g., supranational the FDA), supra-national (e.g., the European Commission, the Council of the European Union, or the European Medicines Agency), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity including the FDA, in each country of the world involved in the granting of Regulatory Approval for the Product.

Appears in 1 contract

Samples: Development and License Agreement (SCOLR Pharma, Inc.)

Regulatory Authority. The term “Regulatory Authority” shall mean any nationalnational (e.g., supranational the FDA), supra-national (e.g., the European Commission, the Council of the European Union, or the European Medicines AgencyAgency for the Evaluation of Medicinal Products), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity including the FDA, in each country Governmental Body involved in the granting of a Regulatory Approval for the Productsuch country or countries.

Appears in 1 contract

Samples: Agreement and Plan of Merger (Onyx Pharmaceuticals Inc)

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Regulatory Authority. The term “Regulatory Authority” shall mean any national, supranational (e.g., the European Commission, the Council of the European Union, the European Medicines Agency), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity including the FDA, in each country involved in the granting of Regulatory Approval for the Producta Companion Diagnostic.

Appears in 1 contract

Samples: Collaboration and License Agreement (Rules-Based Medicine Inc)

Regulatory Authority. The term “Regulatory Authority” shall mean any national, supranational (e.g., the European Commission, the Council of the European Union, the European Medicines Agency), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity including the FDAFDA and EMA, in each country involved in the granting of Regulatory Approval for the Product.

Appears in 1 contract

Samples: License Agreement (Dermira, Inc.)

Regulatory Authority. The term “Regulatory Authority” shall mean means, with respect to a country in the Territory, any nationalnational (e.g., supranational the FDA), supra-national (e.g., the European Commission, the Council of the European Union, or the European Medicines AgencyAgency for the Evaluation of Medicinal Products), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity including the FDA, in each country involved in the granting of a Regulatory Approval for the Productsuch country or countries.

Appears in 1 contract

Samples: Development Agreement (Progenics Pharmaceuticals Inc)

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