Common use of Serialization Clause in Contracts

Serialization. The Parties agree and acknowledge that the Falsified Medicines Directive (Directive 2011/62/EU) as amended by Directive 2001/83/EC and the European Commission delegated regulation (EU) 2016/161 of 2 October 2015 (“Delegated Regulation”) supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (“Serialization”), are applicable on the sale and distribution of the Product in the Territory. The Parties shall adhere to the legal requirements applicable in the Territory in connection with Serialization. SUPPLIER shall provide DISTRIBUTOR with Product with a unique identifier, tamper-evident seals and all other mandatory master data as further detailed in the Delegated Regulation (e.g. 2D-Data matrix Code, Human readable). DISTRIBUTOR shall register and pay any and all fees, [***] where necessary, associated with the Serialization of the Product at the German Medicines Verification System (securPharm e.V.), the ACS PharmaProtect GmbH, the Informationsstelle für Arzneispezialitäten (IFA) GmbH and any other relevant agency for Serialization in the Territory, [***]. SUPPLIER or its designated onboarding partner with EMVO (the European Medicines Verification Organisation) shall upload the relevant master data relating to DISTRIBUTOR and its Designated Wholesaler.

Serialization. The Parties agree and acknowledge that the Falsified Medicines Directive (Directive 2011/62/EU) as amended by Directive 2001/83/EC and the European Commission delegated regulation (EU) 2016/161 of 2 October 2015 (“Delegated Regulation”) supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (“Serialization”), are applicable on the sale and distribution of the Product in the Territory. The Parties shall adhere to the legal requirements applicable in the Territory in connection with Serialization. SUPPLIER shall provide DISTRIBUTOR with Product with a unique identifier, tamper-evident seals and all other mandatory master data as further detailed in the Delegated Regulation (e.g. 2D-Data matrix Code, Human readable). DISTRIBUTOR shall register and pay any and all fees, [***] where necessary, associated with the Serialization of the Product at the German Medicines Verification System (securPharm e.V.), the ACS PharmaProtect GmbH, the Informationsstelle für Arzneispezialitäten Informationsstel le fir Arzneispezialitaten (IFA) GmbH and any other relevant agency for Serialization in the Territory, [***]. SUPPLIER or its designated onboarding partner with EMVO (the European Medicines Verification Organisation) shall upload the relevant master data relating to DISTRIBUTOR and its Designated Wholesaler.