No Harmful Actions. If either Party believes that the other Party, as the case may be, is taking or intends to take any action with respect to the Product that could reasonably be expected to have a material adverse impact upon the regulatory status of the Product in the Retained Territory or the Territory, such Party shall have the right to bring the matter to the attention of the JSC. Without limiting the foregoing, unless the Parties otherwise agree: (a) Daewoong shall not communicate with any Regulatory Authority having jurisdiction in the Retained Territory, unless so ordered by such Regulatory Authority, in which case Daewoong shall provide immediately to Ampio notice of such order; and (b) Daewoong shall not submit any Regulatory Filings or seek Regulatory Approvals for the Products in the Retained Territory.
Appears in 3 contracts
Sources: License, Development and Commercialization Agreement, License, Development and Commercialization Agreement (Aytu Bioscience, Inc), License, Development and Commercialization Agreement (Ampio Pharmaceuticals, Inc.)