Regulatory Agency
Regulatory Agency. Means the EMEA, the FDA and any other governmental regulatory authority or agency involved in regulating any aspect of the development, manufacture, market approval, sale, distribution, packaging or use of the Product.
Found in
BIOMARIN PHARMACEUTICAL INC contract
Regulatory Agency. Shall mean any regulatory agency or other body, governmental or private, including but not limited to agencies regulating product safety and/or electromagnetic emissions, the approval of which is required for sale in North America and Europe with other regions to be added by mutual consent.
Found in
PRESSTEK INC contract
Regulatory Agency. Means any governmental regulatory authority responsible for granting health or pricing approvals, registrations, import permits and other approvals required before the Licensed Product may be tested or marketed in any country. Regulatory Agency shall include the FDA, EMEA and any analogous agency in any other country or region.
Regulatory Agency. Means the FDA or any other similar governmental agency or agencies in countries other than the United States.
Found in
DELTAGEN INC contract
Regulatory Agency. Shall mean the FDA or equivalent agency or government body of another country.
Regulatory Agency. Means any governmental agency having regulatory or supervisory jurisdiction over either of the Employers at the time of reference.
Found in
QUAINT OAK BANCORP INC contract
Regulatory Agency. Means any federal or state agency charged with the supervision or regulation of depository institutions or holding companies of depository institutions, or engaged in the insurance of depository institution deposits, or any court, administrative agency or commission or other authority, body or agency having supervisory or regulatory authority with respect to the Company, the Bank or any of their Subsidiaries.
Found in
BCB BANCORP INC contract
Regulatory Agency. Means any national, supranational, regional, state, provincial or local regulatory agency or other governmental entity that has authority, responsibility or jurisdiction with regard to the manufacture, marketing and sale of the Product within the Territory.
Found in
AEROGEN INC contract
Regulatory Agency. The United States Food and Drug Administration ("FDA") or any successor agency with responsibilities comparable to those of the FDA or any comparable agency in a country outside the United States.
Regulatory Agency. Any national (e.g., the FDA), supra-national (e.g., the European Commission, the Council of the European Union), or other governmental entity with authority over the development, manufacture, use, marketing, sale, or pricing of any CyberHeart Product or CyberKnife System in any jurisdiction
Found in
ACCURAY INC contract
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