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Französisch > Englisch: Microbiological Protocol General field: Medizin
Ausgangstext - Französisch Les conditions operatoires ainsi que les contr6Ies sont selectionnes de maniere a demontrer que la modification du procede n'altere en rien la qualite du produit et n'a pas d'impact notamment en terme de sterilite et d'endotoxines (cf prelevements et analyses de routine), de purete et de dosage.
Les aspects purete, dosage sont controles au paragraphe ci-dessus de validation de !'aspect physicochimique.
La validation de l'aspect purement microbiologique consistera a fabriquer et a contr6Ier trois lots consecutifs de mediafill fabriques selon les parametres decrits au paragraphe suivant.
D'un point de vue microbiologique, pour les memes operations, la fabrication est d'autant plus a risque qu'elle dure longtemps. C'est pourquoi le pire des cas sera controls a trois reprises et visera les temps maximum de chaque etape et inter-etape.
Übersetzung - Englisch The operating conditions as well as inspections are selected in such a way as to demonstrate that the modification of the process does not alter the quality of the product in any way whatsoever and has no impact, in particular in terms of sterility and endotoxins (cf. routine sampling and analyses), purity, and dosage.
The purity and dosage aspects are inspected according to the above paragraph on the validation of physiochemical appearance.
Validation of purely microbiological appearance will consist of manufacturing and inspecting three consecutive media fill test batches manufactured according to the parameters described in the following paragraph.
From a microbiological viewpoint, for the same operations, manufacture becomes riskier the longer it takes. As a result, the worst case scenario will be inspected three times and will respect the maximum durations of each stage and inter-stage interval.
Spanisch > Englisch: COURT RULING General field: Rechts- und Patentwesen
Ausgangstext - Spanisch Dispone el artículo 96.4 que de impugnarse el inventario o la lista de acreedores acompañados al informe inicial de la administración concursal, si tales impugnaciones afectaran a menos del 20 por ciento del activo o del pasivo del concurso, el juez podrá ordenar la finalización de la fase común y la apertura de la fase de convenio o liquidación, sin perjuicio del reflejo que las impugnaciones puedan tener en los textos definitivos y las medidas cautelares que pueda adoptar para su efectividad. En este caso, basándonos en el informe emitido por la Administración concursal y obrante en las actuaciones, concurre el supuesto legal que permite anticipar la finalización de la fase común, tal como autoriza el precepto invocado.
Finalizada la fase común, y no estando solicitada la liquidación, procede abrir la fase de convenio y ordenar la formación de la sección quinta, con los efectos legalmente previstos, conforme a lo dispuesto en los artículos 111 y siguientes de la LC.
La administración concursal ha solicitado, en su escrito de fecha 25 de junio de 2019, presentado en fecha 1 de julio de 2019, que se conceda para la celebración de la Junta de acreedores un plazo más amplio del fijado en el artículo 111.2 de la Ley Concursal. Alega como motivos que justifican la adopción de esa excepcional medida: a) el elevado número de acreedores, que supera los 20.000; b) la tramitación de este procedimiento bajo el régimen de los concursos conexos, lo que fuerza a coordinar la situación procesal de siete sociedades distintas, todas ellas de gran dimensión, bajo los autos 700/2017; c) la complejidad del presente expediente en atención especialmente a su carácter transfronterizo, que resulta de la actividad empresarial desplegada por la concursada en más de cuarenta países (Argentina, Brasil, Bangladesh, Bolivia, Colombia, India, Kenia, Méjico, Perú, Ruanda, Senegal, Uganda, Uzbekistán, etc.), a través de múltiples filiales y sucursales extranjeras y en diferentes áreas tales como la ingeniería, la construcción de infraestructuras, las concesiones y la energía; d) la dispersión de los acreedores en un elevado número de jurisdicciones extranjeras ubicadas hasta en cuatro continentes, incluyendo Portugal, Méjico, Angola, Italia, Marruecos, Colombia, Kenia, Bangladesh, Uruguay, Uganda, Kuwait, Tanzania, Honduras, Francia, Etiopia, Argentina, Argelia, Perú, Chile, Brasil, Bolivia, Armenia, Uzbekistán, Senegal, India, Túnez, Omán, Eslovaquia, Gambia, Emiratos árabes, Rumanía y Paraguay; y e) las especiales dificultades de información y comunicación con una masa pasiva tan compleja y dispersa, debido al profuso reconocimiento de créditos que se ha efectuado partiendo de la propia contabilidad de la concursada y sin que se disponga de un cauce de notificación electrónica masiva a los acreedores.
Übersetzung - Englisch In accordance with article 96.4 of the Spanish Law on Bankruptcy Proceedings, in the event that the inventory or list of creditors accompanying the Bankruptcy Administrator’s initial report is challenged, if these challenges affect at least 20% of the assets or liabilities subject to bankruptcy proceedings, the judge will be permitted to decree the closing of the common phase of the proceedings and the opening of the agreement or liquidation phase, without prejudice to the effects that these challenges may have on the definitive texts and precautionary measures that may be adopted in order to make them effective. In this case, based on the report issued by the Bankruptcy Administrator and as observed in the case files, sufficient legal grounds exist to conclude the common phase early, as authorized in the above-mentioned law.
Considering that the common phase has been concluded and liquidation is not being requested, we hereby proceed to open the agreement phase and order the establishment of the fifth stage of the proceedings, with the legally established effects, in accordance with the provisions of articles 111 and the following articles of the LC.
The Bankruptcy Administrator requested, in its letter from June 25, 2019, submitted on July 1, 2019, an extension to the deadline established in article 111.2 of the LC for setting the date for holding the meeting of creditors. The following are the motives that it states to justify the adoption of this exceptional measure: a) the large number of creditors, which exceeds 20,000; b) the processing of these proceedings under the regime of interconnected bankruptcy proceedings, which makes it necessary to coordinate the proceedings of seven different companies, all of which are very large, under case number 700/2017; c) the complexity of the present file, in particular with regards to its international nature, as a result of the business activities carried out by the insolvent company in more than forty countries (Argentina, Brazil, Bangladesh, Bolivia, Colombia, India, Kenya, Mexico, Peru, Rwanda, Senegal, Uganda, Uzbekistan, etc.), through the intermediary of multiple foreign subsidiaries and branches, and via different business units such as engineering, infrastructure construction, dealerships, and energy; d) the dispersion of creditors across a large number of foreign jurisdictions located across four continents, including Portugal, Mexico, Angola, Italy, Morocco, Kenya, Bangladesh, Uruguay, Uganda, Kuwait, Tanzania, Honduras, France, Ethiopia, Argentina, Algeria, Peru, Chile, Brazil, Bolivia, Armenia, Uzbekistan, Senegal, India, Tunisia, Oman, Slovakia, Gambia, the United Arab Emirates, Romania, and Paraguay; and e) the particular difficulties of reporting and communicating with such a complex and distributed group of debtors, due to the profuse acknowledgment of the debts that have been granted based on the accounting of the insolvent company itself combined with the absence of a channel enabling the mass electronic notification of these creditors.
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