Provision Language
2. License Grants
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2.4 AbbVie shall provide, upon MPP’s request, a Sublicensee with NCE Exclusivity or other regulatory exclusivity waivers to the extent required by the applicable regulatory authorities in order to manufacture or sell Licensed Product(s) in the Territory in accordance with the terms of the Sublicense.
3. Sublicense
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3.4 Regulatory Authorities. MPP shall cause Sublicensees to obtain from the relevant authorities in the Territory and maintain in force all required health registrations, permissions, consents and regulatory authorisations relating to the importation, manufacture and sale of the Licensed Products which are necessary to enable the Licensed Products and Licensed Compounds to be sold or supplied in the Territory in accordance with this Agreement.
3.5 Pharmacovigilance. MPP shall cause Sublicensees to agree to cooperate with AbbVie in fulfilling any pharmacovigilance reporting responsibilities AbbVie may have under applicable laws and regulations, as specified by Abbvie and as arising out of this agreement; provided, Sublicensee must be responsible for fulfilling all pharmacovigilance activities as per the local regulations and requirements for the Licensed Products in the Territory. If MPP or any Sublicensee becomes aware of any adverse reaction relating to the Licensed Products in connection with this Agreement or a Sublicense Agreement, MPP or the relevant Sublicensee shall inform AbbVie within 24 hours of its becoming aware and cooperate with AbbVie in fulfilling AbbVie’s reporting responsibilities under applicable laws and regulations.