Packaging and Labelling. (a) Biotronik will supply the Products ready for sale in accordance with the Product Specifications. Biotronik will, at its own cost and expense, provide the Products with instructions for use and labelling in accordance with the Product Specifications. (b) If for any country of the Territory the instructions for use are required in a different language, Acutus will arrange for translation at its own cost and expense and Biotronik will review and release the translation in accordance with the provisions of its quality management system at its own cost and expense prior to the distribution in accordance with Sections 3.6 and 3.12. (c) The Parties acknowledge that Acutus has the right to distribute the Bio Products under Biotronik branding or the Acutus private label in the Territory, provided that Biotronik shall obtain a Marketing Authorization Approval for such branding or label as soon as reasonably possible (if required). Upon Acutus’ request, the Parties will promptly discuss and agree upon the private label specifications for such Bio Products. Subject to an agreement by the Parties, Biotronik will adopt packaging, whereas Acutus agrees and acknowledges that for all packaging Biotronik will use white boxes, marking and labelling (including any box labels, pouch labels, instructions for use) of the respective Bio Products (but not the products themselves) to provide an Acutus “look-and-feel” by applying colors, Acutus’ Trademarks, labels, labelling styles and other visual elements of Acutus’ branding, subject to regulatory requirements in the respective countries and provided that Biotronik will act and will be labelled as the manufacturer of record of these Bio Products. Acutus will provide Biotronik its design requirements for the packaging, marking and labelling of the respective Bio Products and, subject to Biotronik’s approval, the respective design requirements will be integrated in the Product Specifications.
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Packaging and Labelling. (a) Biotronik Acutus will supply the ACM Products ready for sale in accordance with the Product Specifications. Biotronik Acutus will, at its own cost and expense, provide the ACM Products with instructions for use and labelling in accordance with the Product Specifications.
(b) If for any country of the Territory the instructions for use are required in a different language, Acutus Biotronik will arrange for translation at its own cost and expense and Biotronik Acutus will review and release the translation in accordance with the provisions of its quality management system at its own cost and expense prior to the distribution in accordance with Sections 3.6 and 3.12.
(c) The Parties acknowledge that Acutus has the right to distribute ACM Accessory Products and ACM Disposable Products will be distributed by Biotronik with the Bio Products under Biotronik branding or private label on the outer box (but the Acutus private label in branding still on the Territory, provided that Biotronik shall obtain a Marketing Authorization Approval for such branding disposable or label as soon as reasonably possible (if requiredaccessory itself and not obscured). Upon Acutus’ Biotronik’s request, the Parties will promptly discuss and agree upon the private label specifications for such Bio ProductsACM Products boxes. Subject to an agreement by the Parties, Biotronik Acutus will adopt packaging, whereas Acutus agrees and acknowledges that for all adapt packaging Biotronik will use white boxes, marking and labelling (including any box labels, pouch labels, instructions for use) of the respective Bio ACM Products boxes (but not excluding any relabelling of the products themselves) to provide an Acutus a Biotronik “look-and-feel” on the packaging by applying colorscolours, Acutus’ Biotronik’s Trademarks, labels, labelling styles and other visual elements of Acutus’ brandingBiotronik’s branding to the ACM Product boxes, subject to regulatory requirements in the respective countries and provided that Biotronik Acutus will act and will be labelled as the manufacturer Manufacturer of record Record of these Bio ACM Products. Notwithstanding the foregoing, the packaging of the ACM Console Product (and the console itself) shall maintain the Acutus original packaging and branding, including its external packaging and branding and any branding in any user interface. Biotronik will provide Biotronik Acutus its design requirements for the packaging, marking and labelling of the respective Bio ACM Products and, subject to Biotronik’s Acutus’ approval, the respective design requirements will be integrated in the Product Specifications.
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