aBLA definition

aBLA means an abbreviated Biologics License Application filed with the FDA in the United States, as defined in Section 351(k) of the Public Health Services Act (42 U.S.C. 262(k)).
aBLA has the meaning set forth in Section 10.3. 1.2 “Abandonment” means that (i) prior to [***], none of AnaptysBio, its Affiliates or any Sublicensee has initiated or conducted (or caused to be initiated or conducted) any Development or Manufacturing activity during a continuous period of twenty-four (24) months (which period shall be tolled for the duration of any Force Majeure Event, for periods of delay due to Manufacturing or supply issues and for periods during which AnaptysBio, any of its Affiliates or any Sublicensee is waiting for a response from the FDA or other Regulatory Authority), or (ii) AnaptysBio has undergone a Change of Control transaction during the Term and the Acquirer in connection with such Change of Control, after the closing date of such transaction, has publicly declared its intention to cease Development of all Compounds and Products. In such event of Abandonment, ▇▇▇▇▇▇▇▇▇▇ agrees to notify Centessa promptly in writing. 1.3 “Acquiree” has the meaning set forth in Section 3.5.3. 1.4 “Adverse Ruling” has the meaning set forth in Section 11.3. 1.5 “Affiliate” means, with respect to any Person, any other Person which directly or indirectly controls, is controlled by, or is under common control with, such Person. For purposes of this Section 1.5 and Section 1.24, a Person shall be regarded as in control of another Person if it owns, directly or indirectly, more than fifty percent (50%) of the voting stock or other ownership

Related to aBLA

  • orphan means a child who has no surviving parent caring for him or her;

  • in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Medical cannabis pharmacy agent means the same as that term is defined in Section 26-61a-102.