Examples of Marketing Application in a sentence
Again, similar to the FDA, each country will mandate a specific financial consideration for the Marketing Application dossiers being submitted.
Should Lilly elect to sublicense, or to co-market or co-promote Licensed Product with a Third Person in the Territory, Lilly shall have the right to provide appropriate access to such Clinical Trial data or information, Clinical Trial databases, all data generated in support of any Marketing Application, Regulatory Approval other regulatory commitment, or Regulatory Document to such Third Person, subject to payment of the compensation amounts as agreed for any such access and use by such Third Person.
No later than [***] prior to the anticipated First Commercial Sale of any Cost Share Product and in any event no later than the first filing of a Marketing Application for a BLA for such Cost Share Product, the Parties shall form a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”).
Nothing in this Article 5 shall be deemed to require Genzyme to file Marketing Applications and obtain Marketing Application Approvals in each country in the Territory; Genzyme shall determine in good faith where and when to file and maintain such applications and approvals in a manner consistent with its obligation to use its commercially reasonable and diligent efforts to commercialize Aldurazyme.
A submission for European Marketing Application Authorisation is planned by the end of 2015.