BLA Acceptance definition
BLA Acceptance means the written notification by the FDA that the BLA has met all the criteria for filing acceptance.
BLA Acceptance means the acceptance by the FDA of the BLA Filing.
BLA Acceptance means the written notification by the FDA or equivalent Governmental Authority for a country in the Territory that the BLA has met all the criteria for filing acceptance pursuant to 21 C.F.R. §314.101 or its foreign equivalent if such filing is outside the US. Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.
More Definitions of BLA Acceptance
BLA Acceptance means, with respect to a BLA for a Licensed Product submitted to FDA, the earlier of (a) the date on which FDA accepts such BLA for filing and review, or (b) the date that is sixty (60) days (or such other period as may be prescribed by FDA) following FDA’s receipt of such BLA, if the FDA has not issued a Refuse to File letter or other written communication refusing to file such BLA within such period.
BLA Acceptance means the receipt of written notice from the FDA that the filing of a BLA for the Product has been accepted pursuant to and in accordance with applicable Law, as the same may be amended from time to time.
BLA Acceptance means the receipt of notice from the relevant Governmental Authority that a BLA for the Product has met all the criteria for filing acceptance. ***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.