Balton Sp. z o.o., with its registered office in Warsaw, is a manufacturer of medical devices, the advertising of which may be subject to restrictions under Polish law, European law, laws of other member states and laws of third countries.
 

[In PL]

A significant proportion of Baltons sp. z o.o. medical devices are devices that are both implantable devices and devices intended for use by users other than laypersons, i.e. for use by professionals. Advertising of such devices in the territory of the Republic of Poland may be directed only to professionals, i.e.:

1. persons with the appropriate specialized education
2. persons professionally engaged in the trade of medical devices
3. persons constituting administrative and managerial personnel in entities providing health care services

All materials about the products distributed in the territory of Poland are intended only for the abovementioned categories of persons (professionals), unless a representative of Balton sp. z o.o. expressly indicates that given material is advertising material intended for the public or that the material is not of an advertising nature. It is the responsibility of the distributor to ensure that materials provided to it intended for professionals are not directed to entities other than professionals. In practice, this means, among others, that:

1. leaflets, posters and other physical visual materials may not be displayed in venues with unrestricted access, such as pharmacies, waiting rooms in outpatient clinics, hospitals, as well as during publicly accessible events (fairs or conferences)
2. audio or audiovisual advertisements may not be broadcast on radio, television or publicly available streaming services and the like
3. advertisements placed on websites may be available only after registration on the website, which requires a declaration at the time of creating an account that you are a professional with relevant education, person professionally engaged in the trade of medical devices, a member of administrative or managerial staff of a healthcare provider. The distributor should clearly indicate that it is the entity carrying out the advertising, and when it subcontracts advertising to third parties, it should approve the advertisement in writing in accordance with relevant regulations and ensure that it is indicated that the advertisement is carried out on behalf of the distributor.
    

[In UE]

While using Baltons sp. z o.o. materials or advertising or otherwise informing about its products, the distributor is required to independently ensure that its advertising activities comply with all applicable laws (Polish, European or laws of other member states or third countries). In particular, it is obliged to ensure that the manner in which it conducts these activities does not mislead the user (including a professional) or the patient with regard to the device's intended purpose, safety and performance by:

1. a) ascribing functions and properties to the device which the device does not have;
2. creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
3. failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;
4. suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.
    

[all over the world]

The distributor may not interfere with Balton Sp. z o.o.'s materials or its trademarks. It may use them only for purposes related to the distribution of its medical devices, in a manner that complies with all legal regulations, takes into account the good name of Balton Sp. z o.o. and its products, and does not expose the company to any liability.

In any case, the Distributor shall comply with the provisions of the agreements concluded with Balton Sp. z o.o. regarding the rules of advertising and use of the company's materials