Common use of Complaints and Recalls Clause in Contracts

Complaints and Recalls. If Alliant receives a complaint or information regarding a Licensed Product which it would be required under applicable Law to disclose to a Regulatory Agency, it shall promptly, but in any event not later than twenty-four (24) hours after receipt, advise BioMarin in writing of the details of such complaint or information. Promptly thereafter, Alliant shall report such complaint or information to the appropriate Regulatory Agencies in the countries in North America, respectively, in which such Licensed Product is being commercialized, each as may be required by, and in accordance with, the appropriate Laws of the relevant countries and Regulatory Agencies. Alliant shall provide to BioMarin with all available follow-up information related to such incident (including any information in such Party’s possession as may be reasonably required by the other Party to satisfy its regulatory filing obligations).

Appears in 2 contracts

Sources: License Agreement, License Agreement (Biomarin Pharmaceutical Inc)