BLA Supplement definition

BLA Supplement means a supplement to a BLA Application filed with the FDA pursuant to 21 C.F.R. § 601.2 et seq., (or any foreign equivalent) filed with the Regulatory Authorities in a country or territory to modify or amend the referenced BLA including, inter alia, to add a Baxter Facility to the BLA.
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Examples of BLA Supplement in a sentence

  • Kamada shall be responsible, as BLA holder, for reviewing, filing and holding the BLA Supplement.

  • There is no investment banker, broker, finder or other intermediary which has been retained by or is authorized to act on behalf of the Purchaser or any of its Affiliates who might be entitled to any fee or commission from the Seller or any of its Affiliates in connection with the transactions contemplated by this Agreement or the Ancillary Agreements.

  • BLA Supplement / MAA Variation - An application filed with the regulatory authorities (ie, FDA or EMA), to obtain approval for proposed manufacturing changes to drug product after approval.

  • Kamada shall reasonably cooperate, at its sole cost and expense, with ▇▇▇▇▇▇ in ▇▇▇▇▇▇’▇ efforts to prepare and/or maintain the US BLA Supplement.

  • The Company shall use commercially reasonable efforts to file the Retavase BLA Supplement to Qualify SCIL Proteins with the FDA as promptly as practicable on or after the date hereof.

  • B▇▇▇▇▇ shall be responsible, at its sole cost and expense for preparing and maintaining the BLA Supplement for all A1PI IV Product that is manufactured in a B▇▇▇▇▇ Facility, for sale and distribution in the United States, its territories and possessions (the “US BLA Supplement”).

  • Kamada shall reasonably cooperate, at its sole cost and expense, with B▇▇▇▇▇ in B▇▇▇▇▇’▇ efforts to prepare and/or maintain the US BLA Supplement.

Related to BLA Supplement

  • Country Supplement means a supplement to this Prospectus specifying certain information pertaining to the offer of Shares of the Company or a Fund or Class in a particular jurisdiction or jurisdictions.

  • mobility supplement means a supplement to which paragraph 9 of Schedule 4 refers;

  • Dietary supplement means a product, other than tobacco, that:

  • Asset Pool 1 Supplement means the Asset Pool 1 Supplement dated as of October 9, 2002, by and between the Issuer and the Indenture Trustee, as amended and supplemented from time to time.

  • the first supplementary agreement means the agreement of which a copy is set out in the Second Schedule;