Aprobación Condicional definition

Aprobación Condicional significa una autorización condicional de comercialización del Producto, otorgada por el INVIMA- Instituto Nacional de Vigilancia de Medicamentos y Alimentos, que permite poner el Producto en el mercado, en Colombia. 1.12. “Información Confidencial” significa toda la información confidencial o propia, distinta a Información Exceptuada, en cualquier forma, directa o indirectamente revelada al Receptor o sus Representantes, por la Parte Reveladora o en nombre suyo, en el marco de este Acuerdo, independientemente de la manera en que se revele, entregue, suministre, conozca u observe, ya sea que esté marcada como “Confidencial” o, de ser verbal, declarada confidencial en el momento de la revelación o confirmada dicha condición por escrito dentro de los treinta (30) días siguientes a la revelación. Información Confidencial incluye, sin limitación los términos y condiciones de este Acuerdo. La omisión de marcar como “Confidencial” la Información Confidencial revelada por escrito en el marco del CONFIDENTIAL- CONFIDENCIAL
Aprobación Condicional significa una autorización condicional para la comercialización del Producto, otorgada por (a) por (i) la Administración de Alimentos y Medicamentos de los Estados Unidos (“FDA”), incluyendo inicialmente bajo la autorización de uso de emergencia u otra forma de aprobación regulatoria para el Producto (“Aprobación Condicional de la FDA”), o (ii) la Comisión Europea (“Aprobación Condicional de la EC”), y (b) el Instituto de Salud Pública, que permite poner el Producto en el xxxxxxx, en Chile. 1.12.“Información Confidencial” significa toda la información confidencial o propia, distinta a Información Exceptuada, cualquiera que sea su forma, directa o indirectamente divulgada al Receptor o sus Representantes, por la Parte Divulgante o en nombre suyo, en el marco de este Acuerdo, independientemente de la manera en que se divulgue, entregue, suministre, conozca u observe, ya sea que esté marcada como “Confidencial” o, de ser verbal, declarada confidencial en el momento de la divulgación o confirmada dicha condición por escrito dentro de los treinta (30) xxxx siguientes a la divulgación. Información Confidencial incluye, sin limitar, los términos y condiciones de este Acuerdo. La omisión de marcar como “Confidencial” la Información Confidencial divulgada por escrito en el marco del presente, no llevará a considerarla no- confidencial, asumiendo la Parte Divulgante la carga de probar, inequívocamente, que esa información debería xxxxx sido conocida por una persona con experiencia razonable en la materia, con base en la naturaleza de la información y las circunstancias de su divulgación, para que sea Información Confidencial, siempre y cuando la

Examples of Aprobación Condicional in a sentence

  • If Conditional Approval is not received by -, Suppliers will have no obligation to deliver against the Adjusted Delivery Schedule.(i) No se enviarán dosis antes de que los Proveedores reciban la Aprobación Condicional.(ii) Si la Aprobación Condicional se recibe después, se modificará el Cronograma Provisional de Entregas y se ajustará para incluir el retraso entre -y la fecha de la Aprobación Condicional (" Cronograma de Entregas Ajustado").

Related to Aprobación Condicional

  • Abnormal Market Conditions means conditions contrary to Normal Markets Conditions e.g. when there is low liquidity in the market or rapid price movements in the market or Price Gaps.

  • Barrier Event means that R (final) is lower than the Barrier.

  • ICAO means the International Civil Aviation Organization.

  • Regulatory Capital Treatment Event means the good faith determination by the Corporation that, as a result of (i) any amendment to, or change in, the laws or regulations of the United States or any political subdivision of or in the United States that is enacted or becomes effective after the initial issuance of any share of Series F Preferred Stock, (ii) any proposed change in those laws or regulations that is announced after the initial issuance of any share of Series F Preferred Stock, or (iii) any official administrative decision or judicial decision or administrative action or other official pronouncement interpreting or applying those laws or regulations that is announced after the initial issuance of any share of Series F Preferred Stock, there is more than an insubstantial risk that the Corporation will not be entitled to treat the full liquidation value of the shares of Series F Preferred Stock then outstanding as “tier 1 capital” (or its equivalent) for purposes of the capital adequacy guidelines of the Board of Governors of the Federal Reserve System, Regulation Y, 12 CFR 225 (or, as and if applicable, the capital adequacy guidelines or regulations of any successor Appropriate Federal Banking Agency), as then in effect and applicable, for as long as any share of Series F Preferred Stock is outstanding.

  • DAS means digital addressable cable systems comprising of an electronic device (which includes hardware and its associated software) or more than one electronic device put in an integrated system through which signals of the network can be sent in encrypted form and decoded by the devices having an activated conditional access system at the premises of the subscriber within the limits of authorization made through CAS and SMS, by the cable operator to the subscriber on the explicit choice and request of such subscriber;

  • manoeuvring area means that part of an aerodrome to be used for the take-off, landing and taxiing of aircraft, excluding aprons;

  • Poor foundation conditions means those areas where features exist which indicate that a natural or man-induced event may result in inadequate foundation support for the structural components of an SWLF unit.

  • Anaerobic digestion ’ means a controlled process involving microbial decomposition of organic matter in the absence of oxygen ;

  • POPIA means the Protection of Personal Information Act, No 4 of 2013;

  • Insecticide fogger means any insecticide product designed to release all or most of its content, as a fog or mist, into indoor areas during a single application.

  • Primer means a coating labeled and formulated for application to a substrate to provide a firm bond between the substrate and subsequent coats.

  • Para means a Para of this Agreement;

  • DEL means the Department of Early Learning of the State of Washington; any division, section, office, unit or other entity of DEL; or any of the officers or other officials lawfully representing DEL.

  • Ambient air quality standard means an established concentration, exposure time, and frequency of occurrence of air contaminant(s) in the ambient air which shall not be exceeded.

  • National Ambient Air Quality Standards or “NAAQS” means national ambient air quality standards that are promulgated pursuant to Section 109 of the Act, 42 U.S.C. § 7409.

  • BAPPENAS means the Borrower’s National Development Planning Agency and any successor thereto;

  • Violent juvenile felony means any of the delinquent acts enumerated in subsection B or C of

  • AV means (in each case as at the last Valuation Date) such proportion of the Asset Value of the General Long Portfolio as is equal to the proportion that the Notes of the relevant General Long Series represent of the General Long Outstanding Note Liability as determined by the Administration Agent (or such other person as may be responsible for calculating the Asset Value with respect to the Notes in accordance with the Agency Agreement) in accordance with clause 17 of the Agency Agreement and in consultation with the Portfolio Manager, adjusted, in consultation with the Portfolio Manager, to account fully for any losses, expenses and costs to the Issuer of unwinding any underlying or related hedging and funding arrangements; and

  • Step Down Conditions As of any Distribution Date on which any decrease in any Senior Prepayment Percentage may apply, (i) the outstanding Principal Balance of all Mortgage Loans 60 days or more Delinquent (including Mortgage Loans in REO and foreclosure), averaged over the preceding six month period, as a percentage of the aggregate of the Class Certificate Principal Balances of the Classes of Subordinate Certificates on such Distribution Date, does not equal or exceed 50% and (ii) cumulative Realized Losses with respect to all of the Mortgage Loans do not exceed: · for any Distribution Date on or after the seventh anniversary until the eighth anniversary of the first Distribution Date, 30% of the aggregate Certificate Principal Balance of the Subordinate Certificates as of the Closing Date, · for any Distribution Date on or after the eighth anniversary until the ninth anniversary of the first Distribution Date, 35% of the aggregate Certificate Principal Balance of the Subordinate Certificates as of the Closing Date, · for any Distribution Date on or after the ninth anniversary until the tenth anniversary of the first Distribution Date, 40% of the aggregate Certificate Principal Balance of the Subordinate Certificates as of the Closing Date, · for any Distribution Date on or after the tenth anniversary until the eleventh anniversary of the first Distribution Date, 45% of the aggregate Certificate Principal Balance of the Subordinate Certificates as of the Closing Date, and · for any Distribution Date on or after the eleventh anniversary of the first Distribution Date, 50% of the aggregate Certificate Principal Balance of the Subordinate Certificates as of the Closing Date.

  • Banquet Event Order or “BEO” means a written order issued by the Contractor to the Judicial Council that confirms the Judicial Council’s specific instructions and orders with respect to the Program on any one or more of the following, but does not alter any of the Agreement’s terms and conditions: (i) meeting and/or function room(s) and set-up requirements and/or rental charges; (ii) meal menus and prices and set-up requirements; and/or (iii) audio-visual equipment and set-up requirements and/or rental charges. BEO’s will be approved and signed by the Judicial Council’s representative, as set forth in Exhibit B.

  • Waterborne disease outbreak means the significant occurrence of an acute infectious illness, epidemiologically associated with the ingestion of water from a public water system which is deficient in treatment, as determined by the Division.

  • Automated external defibrillator or “AED” means an external semiautomatic device that determines whether defibrillation is required.

  • Handgun means a firearm of any description, loaded or unloaded, from which any shot, bullet, or other missile can be discharged by an action of an explosive where the length of the barrel, not including any revolving, detachable, or magazine breech, does not exceed 12 inches; provided, however, that the term "handgun" shall not include a gun which discharges a single shot of .46 centimeters or less in diameter.

  • FOISA means the Freedom of Information (Scotland) Xxx 0000 and any subordinate legislation made under this Act from time to time or any superseding or amending enactments or regulations, together with any guidance and/or codes of practice issued by the Information Commissioner, the Scottish Information Commissioner and/or any relevant government department in relation to such legislation.

  • Violent felony means any offense that, if committed by an adult, would constitute a felony and:

  • ni , for any day “i”, means the number of calendar days from and including such day “i” up to but excluding the following London Banking Day;