NDA Transfer Date definition

NDA Transfer Date means ten (10) Business Days after receipt by Titan of the milestone payment set forth in Section 6.1(b)(i).

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NDA Transfer Date means the NDA Transfer Date as such term is defined in the Titan Agreement.

NDA Transfer Date has the meaning set forth in Section 3.5.2.

Examples of NDA Transfer Date in a sentence

During the period commencing on May 28, 2013 and ending on the NDA Transfer Date, Braeburn shall be solely responsible for all costs associated with, or required for approval of, the Product by the FDA in the Territory with the exception of legal and consulting fees and expenses incurred by Titan.
Subject to the terms and conditions of this Agreement, Braeburn hereby grants to Knight, for the Term, an exclusive, fully paid, right and license to use the Braeburn Marks and Sublicensed Product Trademarks on or in connection with the Commercialization of Sublicensed Products in the Territory following the NDA Transfer Date.
Notwithstanding the foregoing, the Parties agree and acknowledge that following the Effective Date, Knight may, to the extent permitted under the Titan Agreement, undertake such activities as are reasonably necessary to prepare for the NDA Transfer Date, provided that Knight shall keep Braeburn reasonably informed with respect to any such activities, and Braeburn shall reasonably cooperate with and assist Knight in any such activities.
All rights not specifically granted to Knight herein are reserved and retained by Braeburn, including, without limitation, with respect to the period between the Effective Date and the NDA Transfer Date.
This Agreement shall be effective as of the Effective Date, but the Parties agree and acknowledge that certain rights and obligations under this Agreement shall not become effective until the NDA Transfer Date.
On the NDA Transfer Date, Titan shall submit to the FDA a letter authorizing the transfer of ownership from Titan to Braeburn of the Product NDA.
After the NDA Transfer Date, at Braeburn’s request, Titan shall provide reasonable assistance in conducting any such Recall, including providing all pertinent records that Braeburn may reasonably request to assist in effecting such action, subject to reimbursement of Titan’s Fully Burdened Costs associated with providing such cooperation, and any other documented, direct, out-of-pocket costs incurred (paid or accrued) with respect to such Recall shall be borne by Braeburn.
Before the NDA Transfer Date, Titan shall make all decisions with respect to any Recall related to a Product in the Territory.
After the NDA Transfer Date, Braeburn shall make all decisions with respect to any Recall related to a Product in the Territory.
Additionally, to the extent not disbanded pursuant to the preceding sentence, the Development Committee shall be automatically disbanded effective upon the sixth anniversary of the NDA Transfer Date.

More Definitions of NDA Transfer Date

NDA Transfer Date means as soon as reasonably practicable after November 1, 2011, and on a date mutually agreed by the parties, which, unless otherwise agreed by the parties, shall be the same date as the Manufacture Transfer Date for the 500mg Product.

NDA Transfer Date means, with regard to a particular Product NDA, the date identified by Purchaser or Purchaser’s Affiliate or designate in its submission to the FDA under 21 C.F.R. §314.72(a)(2) as the date on which the change in ownership of the Product NDA is effective.

NDA Transfer Date means the earlier of (a) September 30, 2012 and (b) at Esprit’s sole election, the date, if any, that Indevus assigns its rights or obligations under this Agreement to another person or entity in connection with the transfer or sale of Indevus’ business or all or substantially all of its assets or in the event of a merger, consolidation, change in control or similar corporate transaction.

NDA Transfer Date means, for each Product NDA, the effective date of NDA transfer specified by TXMD and Purchaser in letters submitted to FDA notifying the agency that ownership of such Product NDA is transferring from TXMD (or the applicable TXMD Group member or TXMD Affiliate) to Purchaser. Where transfer of NDA ownership requires FDA approval due to certain types of labelling, manufacturing or other changes to be implemented in conjunction with the NDA transfer, NDA Transfer Date means the date upon which the FDA approves the transfer naming Purchaser or Purchaser’s Affiliate or designate as the holder of such Product NDA.

NDA Transfer Date means the date [****] that the role of MA Holder in the United States transfers from the Current MA Holder to the New MA Holder.

NDA Transfer Date has the meaning set forth in the Transition Services Agreement.