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Compliance Clauses

Compliance Clauses

1. Pharmacovigilance

  • We have a regulatory reporting duty to monitor pharmacovigilance. To comply with this, you agree to carry out following obligations for the duration and in scope of the Agreement:

  • You will provide information to us regarding:

    • All Adverse Events* of a BI product

    • Such AE* includes:

      • Suspected lack of efficacy of a BI product,

      • harmful reactions in humans after being exposed to a BI product,

      • a suspected violation of the approved maximum residue limits or a potential insufficient withdrawal period,

      • a potential environmental problem, or

      • a suspected transmission of an infectious agent

    • Asymptomatic human exposures, which are human exposures of a BI product that are not related to an AE.

  • You will provide the above information to us:

    • no later than 1 calendar days of the date you first receive it

    • exactly as received, without screening, selection, or further processing

    • by sending a secure e-mail indicating the date of receipt.

    If you do not receive our PV Data confirmation receipt within one (1) business day, you must contact us for clarification.

  • You are responsible for training and informing your staff to comply with the obligations given here and for documenting this training.

  • If there are any changes to the PV contact details for either Party, the other Party will be informed in writing. In such cases, a formal amendment to this contract is not required.

2. Data Privacy

  • BI collects and processes your personal data according to the GDPR and any relevant local regulation and/or legislation, as also specified in this Agreement. BI is the data controller of such personal data. We will process your data only for the purposes described under this Agreement. We may process your data for other purposes if the law requires or if you give your consent. Please visit our privacy policy to learn more about how we handle your personal data.

3. Export Control

  • The Parties confirm that they are neither a Sanctioned Party in terms of UN, U.S., EU or any national Sanctioned Party List nor Controlled by a Sanctioned Party. The Parties notify each other without delay in case of any changes of this status.

4. ABAC

  • You represent and warrant that you, your employees, sub-contractors and agents will act in compliance with any applicable anti-bribery/anti-corruption laws and regulations in connection with BI’s business operations or this Agreement and will not, directly or indirectly, offer, promise or give any benefit or other advantage to any public official or any other third party in exchange for an improper advantage.

 

*‘Adverse Events’ or ‘AE' means any untoward medical reflection(s) in animals that is observed after any use (including label use, off-label use, and misuse) of a veterinary product, regardless its connection to the product.