BLA. The term “BLA” shall mean a Biologics License Application, or similar application, that is submitted to the FDA, or a foreign equivalent of the FDA, for marketing approval of a Licensed Product in a jurisdiction.
Appears in 2 contracts
Samples: Research Funding and Option Agreement (aTYR PHARMA INC), Research Funding and Option Agreement (aTYR PHARMA INC)
BLA. The term “BLA” shall mean means a Biologics License Applicationbiologics license application submitted to FDA to obtain license approval for a biologic product, or similar application, that is submitted to the FDA, any successor application or a foreign equivalent of the FDA, for marketing approval of a Licensed Product in a jurisdictionequivalent.
Appears in 1 contract
Samples: Development and Exclusive Distribution Agreement (Akorn Inc)
BLA. The term “BLA” shall mean a Biologics License Application, or similar applicationapplication for marketing approval, that is of a Product for use in the Field submitted to the FDA, or a foreign equivalent of the FDA, for marketing approval of a Licensed Product in a jurisdiction.
Appears in 1 contract
