BLA Filing Date definition

BLA Filing Date means the date of the filing of a Biologic Licensing Application, including all supplements and amendments thereto, for the approval to market a Product by the FDA.
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BLA Filing Date shall have the meaning assigned to such term in Section 4.1.
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Examples of BLA Filing Date in a sentence

  • As soon as practicable after the BLA Filing Date, and consistent with the transition plan adopted by the PDC and contained in the initial Clinical Development Plan, the Company shall transition such clinical and other studies ongoing with respect to the Products which have been identified in such Clinical Development Plan as being transferred to ERS in such transition plan from the Company's sole control to the control of the Party(ies) set forth in the initial Clinical Development Plan.

  • Therefore, until the Initial Regulatory Filing is made (the "BLA Filing Date"), the Company shall be primarily responsible for conducting the clinical studies and all other regulatory matters, manufacturing matters and/or pre-clinical studies necessary to support, prepare and file the Initial Regulatory Filing until the BLA Filing Date, and the Company shall use all commercially reasonable efforts necessary to make the Initial Regulatory Filing.

  • No later than [***] prior to the Target BLA Filing Date, GSK will prepare a reasonably detailed written plan for the Licensed Product with respect to the [***] plans for the Licensed Product that sets out the [***] with respect to Licensed Products throughout the Territory, which plan will include at a minimum: (a) [***] (the “Global Strategic Launch Plan”).

  • Therefore, until the Initial Regulatory Filing is made (the "BLA FILING DATE"), the Company shall be primarily responsible for conducting the clinical studies and all other regulatory matters, manufacturing matters and/or pre-clinical studies necessary to support, prepare and file the Initial Regulatory Filing until the BLA Filing Date, and the Company shall use all commercially reasonable efforts necessary to make the Initial Regulatory Filing.