1. Any distributor, importer, deployer or other third party shall be considered a provider of a high-risk AI system for the purposes of this Regulation and shall be subject to the obligations of the provider under Article 16, in any of the following circumstances:
(a) they put their name or trademark on a high-risk AI system already placed on the market or put into service, without prejudice to contractual arrangements stipulating that the obligations are allocated otherwise;
(b) they make a substantial modification to a high-risk AI system that has already been placed on the market or has already been put into service and in a way that it remains a high-risk AI system in accordance with Article 6;
(ba) they modify the intended purpose of an AI system, including a general purpose AI system, which has not been classified as high-risk and has already been placed on the market or put into service in such manner that the AI system becomes a high risk AI system in accordance with Article 6;
2. Where the circumstances referred to in paragraph 1, point (a) to (ba) occur, the provider that initially placed the AI system on the market or put it into service shall no longer be considered a provider of that specific AI system for the purposes of this Regulation. This former provider shall closely cooperate and shall make available the necessary information and provide the reasonably expected technical access and other assistance that are required for the fulfilment of the obligations set out in this Regulation, in particular regarding the compliance with the conformity assessment of high-risk AI systems. This paragraph shall not apply in the cases where the former provider has expressly excluded the change of its system into a high-risk system and therefore the obligation to hand over the documentation.
2a. For high-risk AI systems that are safety components of products to which the legal acts listed in Annex II, section A apply, the manufacturer of those products shall be considered the provider of the high-risk AI system and shall be subject to the obligations under Article 16 under either of the following scenarios:
(i) the high-risk AI system is placed on the market together with the product under the name or trademark of the product manufacturer; (ii) the high-risk AI system is put into service under the the name or trademark of the product manufacturer after the product has been placed on the market.
2b. The provider of a high risk AI system and the third party that supplies an AI system, tools, services, components, or processes that are used or integrated in a high-risk AI system shall, by written agreement, specify the necessary information, capabilities, technical access and other assistance based on the generally acknowledged state of the art, in order to enable the provider of the high risk AI system to fully comply with the obligations set out in this Regulation. This obligation shall not apply to third parties making accessible to the public tools, services, processes, or AI components other than general-purpose AI models under a free and open licence. The AI Office may develop and recommend voluntary model contractual terms between providers of high-risk AI systems and third parties that supply tools, services, components or processes that are used or integrated in high-risk AI systems. When developing voluntary model contractual terms, the AI Office shall take into account possible contractual requirements applicable in specific sectors or business cases. The model contractual terms shall be published and be available free of charge in an easily usable electronic format.
2b. Paragraphs 2 and 2a are without prejudice to the need to respect and protect intellectual property rights and confidential business information or trade secrets in accordance with Union and national law.