Additional Responsibilities of the Parties. 6.8.1 Impax and Wyeth shall keep each other advised of significant market, economic, regulatory and other developments which may affect the Promotion or Detailing of the Product in the Territory during the Term. 6.8.2 Impax shall report promptly to Wyeth all other significant information concerning any complaint of any kind regarding any Detailed Product, its labeling, quality or packaging, including, but not limited to, any adverse drug experience not reported pursuant to Section 6.4 above. 6.8.3 It is understood and agreed that the reporting requirements set forth in this Article 6 are based on Wyeth policies and procedures and regulatory reporting requirements. Accordingly, in the event of changes to regulatory requirements or Wyeth policies and procedures, Impax agrees to comply with all reasonable revised notification procedures as requested in writing by Wyeth. Wyeth shall promptly advise Impax in the event of the change of the person or phone number for any of the contacts specified above. 6.8.4 Wyeth shall retain sole responsibility for communicating with all government agencies, including, without limitation, the FDA, and satisfying all requirements regarding maintenance of approvals to Market any Detailed Product in the Territory.
Appears in 4 contracts
Sources: Copromotion Agreement (Impax Laboratories Inc), Copromotion Agreement (Impax Laboratories Inc), Copromotion Agreement (Impax Laboratories Inc)