Examples of BLA Filing 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.
Ray further argues that Lynass’s declaration about their relationship does not “offer any proof that Lynass relied on Ray for ‘moral, financial, or personal support and guidance.’” Id. The undersigned agrees.
In addition, prior to the first BLA Filing, the Roche Alliance Director shall be available upon Eleven’s request to answer questions about the status of the Roche Group’s development activities once per each Calendar Quarter (except for such Calendar Quarter that Roche provides Eleven with the annual summary report).
The expenses charged by either Party to its R&D Account in accordance with Section 5.3.2 shall not, subject to Section 7.1.4, be an amount in excess of [***] the amount included for such expenses in the then current Annual Research Budget, Annual Development Budget or Post BLA Filing Annual Budget, as appropriate, unless the JSC recommends and each Party approves such excess expenses.