Breakthrough Designation definition

Breakthrough Designation means designation of a drug as a breakthrough therapy by the NMPA.

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Breakthrough Designation means the designation of a drug as a breakthrough therapy by the FDA pursuant to Section 506(a) of the Federal Food Drug and Cosmetic Act (21 U.S.C. §356(a)), as amended by Section 902 of the Food and Drug Administration Safety and Innovation Act and as may be amended further from time to time.

Breakthrough Designation means, with respect to a Product, that such Product satisfies the requirements for a “breakthrough therapy”, as set forth in 21 U.S.C. § 356, as amended by § 902 of the Food and Drug Administration Safety and Innovation Act.

Examples of Breakthrough Designation in a sentence

In addition, if this Agreement expires prior to the payment of the Breakthrough Designation Milestone, then Section 2.12 of the Merger Agreement shall survive such expiration.
For clarity, and notwithstanding the foregoing, following the expiration of the License Agreement, if Company or its Affiliate or sublicensee ever achieves the Breakthrough Designation Milestone with a subsequent or future Licensed Product, then Parent shall pay the corresponding milestone payment for achievement of the Breakthrough Designation Milestone pursuant to this Section 2.12.
In addition, except with respect to the Breakthrough Designation Milestone, if for any reason any other Development Milestone corresponding to a Milestone payment does not occur prior to the occurrence of Regulatory Approval, then such prior non-occurring Development Milestone shall be deemed to occur concurrently with Regulatory Approval, and the applicable Milestone payments for the applicable Development Milestones shall become due and payable in accordance with this Section 8.2.
Brigatinib – a new ALK TKI with Breakthrough Designation from the FDA – is ARIAD’s next cancer medicine in development.
For avoidance of doubt, Company is not obligated to achieve the Breakthrough Designation Milestone.
Notwithstanding the foregoing, if the Breakthrough Designation Milestone was not achieved but all other Merger Consideration was paid, then the Term shall expire provided that if Company or its Affiliate or sublicensee ever achieves the Breakthrough Designation Milestone with a subsequent or future Licensed Product, then Parent shall pay the corresponding milestone payment for achievement of the Breakthrough Designation Milestone pursuant to Section 2.12 of the Merger Agreement.
Treatment of [**] cumulative subjects across all Incyte Clinical Studies (including Incyte Monotherapy Studies and Incyte Combination Studies) in a single Indication for greater than [**] continuously at a recommended Phase II or Phase III defined dose and schedule [**] [**] [**] Initiation of a Pivotal Study [**] [**] [**] Breakthrough Designation Granted [**] N/A N/A (c) Regulatory Filing Milestones.

More Definitions of Breakthrough Designation

Breakthrough Designation means designation by the FDA as a breakthrough therapy pursuant to 21 U.S.C. section 356 (or its successor).

Breakthrough Designation means a designation by the FDA of a drug as a breakthrough therapy as set forth in 21 U.S.C. § 356(a) and related FDA guidance, and equivalent rules, regulations and guidance outside of the United States, for example, PRIority MEdicine designation granted by EMA.

Breakthrough Designation means a Compound has received “breakthrough therapy designation” by the FDA as contemplated by Title IX of the United States Food and Drug Administration Safety and Innovation Act of 2012.

Breakthrough Designation means a drug as defined by FDASIA Section 902 that: (a) intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition and (b) preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development;