Common use of Regulatory Interface Clause in Contracts

Regulatory Interface. Distributor shall be responsible for obtaining Registration of the Product in the Territory and shall exercise commercially reasonable efforts to obtain and Maintain any Product Registrations in the Territory during the Term. As between the Parties hereto, it is agreed that the Product Registrations shall be held in the name of Distributor, who shall be the beneficial owner of all Product Registrations and Ampio may not use the Product Registrations, or any of them, on or in respect of any product other than the Product or use any authorization other than one or more of the Product Registrations on or in respect of the Product, except as may be approved in writing by Distributor. Ampio agrees to use its commercially reasonable efforts to assist Distributor, at Distributor’s costs, in obtaining and Maintaining the Product Registrations. All costs to obtain or Maintain the Product Registrations shall be borne by Distributor. If any Governmental Authority gives notice to Distributor that its Product Registration may be invalid or may be revoked, limited, or conditioned, Distributor shall promptly inform Ampio, but in any case not more than 5 Business Days following Distributor’s receipt of such notice. In support of Distributor’s Registration of the Product, Ampio will (a) shall supply to Distributor efficacy, quality and safety data as specified by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), (b) perform or cause to be performed and will supply to Distributor data from Zone 4 stability testing of the Product, and (c) will provide suitable evidence that the site at which the Product is manufactured complies with the Agency requirements (ANVISA), including, if required, inspection by the Brazilian Regulatory Authorities at manufacturing site.