FDA Approval Milestone definition

FDA Approval Milestone means the approval by the FDA, during the FDA Approval Milestone Period, of a premarket approval application or a premarket approval application supplement for the use of any device in the Impella Product Family in patients presenting with STEMI, or Anterior STEMI, without cardiogenic shock.
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FDA Approval Milestone means the approval by the FDA by October 1, 2025 of a new drug application submitted to the FDA pursuant to 21 U.S.C § 355(b) and 21 C.F.R. Part 314 necessary for the commercial marketing and sale of the Product in the United States for the treatment of either (a) moderate-to-severe X-linked, or (b) moderate-to-severe lamellar (autosomal recessive congenital) ichthyosis subtypes, in each case in adults and pediatric patients 6 years of age and older.
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FDA Approval Milestone means the first achievement of regulatory approval by the FDA (including, for the avoidance of doubt, accelerated approval), on or prior to January 1, 2028, necessary for the commercial marketing and sale of tazemetostat in the United States as a second line treatment for relapsed or refractory follicular lymphoma in combination with lenalidomide and rituximab; provided, that the existing accelerated approvals of tazemetostat monotherapy, even if they become full monotherapy approvals, will not satisfy the foregoing requirements for the FDA Approval Milestone. For purposes of this definition, any regulatory approval by the FDA for the commercial marketing and sale of tazemetostat that allows for second line treatment in follicular lymphoma in combination with one or more products that contain lenalidomide and rituximab Table of Contents (including a generic or biosimilar thereof) shall be included, regardless of the precise language used in the FDA approval or full prescribing information. For illustrative purposes only, this language may include “previously treated follicular lymphoma” instead of “relapsed or refractory follicular lymphoma” or “second line follicular lymphoma.” • Ipsen will be obligated to pay an aggregate amount equal to approximately $53 million upon the achievement of annual Net Sales worldwide (except in, with respect to, or for sale in Japan, the People’s Republic of China, Taiwan, the Hong Kong Special Administrative Region and the Macau Special Administrative Region) for tazemetostat of at least $250.0 million during any four consecutive calendar quarters ending on or prior to December 31, 2026.
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Examples of FDA Approval Milestone in a sentence

  • For the avoidance of doubt, no publication of a Class I recommendation contemplated by the Clinical Recommendation Milestone or approval of a premarket approval application contemplated by the FDA Approval Milestone occurring after the end of the applicable Clinical Recommendation Milestone Period or the FDA Approval Milestone Period, as applicable, shall result in any Milestone Payment becoming due and payable.

  • In addition, following the Closing Date, this Agreement may be terminated by the Seller if the FDA Approval Milestone for the Bile Acid Indications is not paid by Buyer in full on or prior to the FDA Approval Milestone Payment Date (after expiration of the 7 day cure period).

  • If Buyer fails to deliver to Seller the full FDA Approval Milestone for the Bile Acid Indication on or before the FDA Approval Milestone Payment Date, Buyer shall have an additional seven (7) days in which cure such payment, during which time the late charges contemplated by Section 3.6(g) shall accrue and become payable to Seller.

  • The Sellers acknowledge and agree that any shares of Purchaser common stock received by the Sellers as the Contingent Equity Payment or FDA Approval Milestone Payment shall be subject to a lockup period through the second anniversary of the Closing Date, which shall be set forth in the subscription agreements for such shares to be entered into by the Sellers at the time of any such issuance.

  • If the FDA Approval Milestone for the Bile Acid Indications has not been achieved by December 31, 2017, the parties will mutually agree to either (i) further reductions in the FDA Approval Milestone for the Bile Acid Indications for later approvals or (ii) termination of this Agreement.

  • On a date no later than thirty (30) days following the date on which the Company or another Company Entity or any Affiliate thereof receives FDA Approval for New Ulesfia, Purchaser shall pay the FDA Approval Milestone Payment, allocated between the Sellers in proportion to their Percentage Interests, with any cash portion of such payment paid by wire transfer of immediately available funds to the account(s) designated in writing by the Sellers.

  • The remaining 50% of the unpaid principal amount of the Loans then outstanding, plus any interest accrued on such Loans through the Closing Date, shall be repaid from the FDA Approval Milestone (as defined in the CVR Agreement) and the Net Sales Milestone (as defined in the CVR Agreement), as set forth in the CVR Agreement to be entered into on the Closing Date between Holder and [●]).

  • Commencing upon the Closing, Parent shall use Commercially Reasonable Efforts to achieve (x) the Net Sales Milestone until December 31, 2026 and (y) the FDA Approval Milestone until January 1, 2028, in each case, unless earlier achieved.

  • The FDA Approval Milestone for the Bile Acid Indications will be equal to (i) twenty-seven million dollars ($27,000,000) if achieved on or before December 31, 2015, (ii) […***…] ($[…***…]) if achieved after December 31, 2015 but on or before December 31, 2016, (iii) […***…] ($[…***…]) if achieved after December 31, 2016 but on or before December 31, 2017.

  • Retrophin will pay Asklepion an additional FDA Approval Milestone of nine million dollars ($9,000,000) on the applicable FDA Approval Milestone Payment Date provided the approved labeling includes an indication statement for the treatment of children and adults for Cerebrotendindous Xanthomatosis (the “CTX ***Confidential Treatment Requested Indication”).


More Definitions of FDA Approval Milestone

FDA Approval Milestone is the receipt by Borrower, prior to September 15, 2024, of the approval from FDA for Borrower’s New Drug Application for Ensifentrine (NDA # 217389) with an Indications and Usage section of the label stating that Ensifentrine is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease, with no Boxed Warning.
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FDA Approval Milestone means the first achievement of
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FDA Approval Milestone means FDA Approval of a Product for use in the prevention of (a) any disease or condition caused by respiratory syncytial virus (RSV) and (b) any disease or condition caused by at least one of (x) human metapneumovirus or (y) human parainfluenza virus 3, and in each case of the foregoing ((a) and (b)), in an older adult population (by way of example, in adults 60 years of age or older or 65 years of age or older), regardless of whether such Product has FDA Approval as a combination product for use in the prevention of additional other diseases or conditions (e.g., influenza) beyond those recited in the foregoing clauses (a) and (b).
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FDA Approval Milestone means the Company receiving an approval letter from the U.S. Food and Drug Administration (“FDA”) evidencing licensure of inclisiran for an LDL-C (i.e., LDL cholesterol) lowering indication.
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FDA Approval Milestone means the first achievement of regulatory approval by the FDA (including, for the avoidance of doubt, accelerated approval), on or prior to January 1, 2028, necessary for the commercial marketing and sale of tazemetostat in the United States as a second line treatment for relapsed or refractory follicular lymphoma in combination with lenalidomide and rituximab; provided, that the existing accelerated approvals of tazemetostat monotherapy, even if they become full monotherapy approvals, will not satisfy the foregoing requirements for the FDA Approval Milestone. For purposes of this definition, any regulatory approval by the FDA for the commercial marketing and sale of tazemetostat that allows for second line treatment in follicular lymphoma in combination with one or more products that contain lenalidomide and rituximab (including a generic or biosimilar thereof) shall be included, regardless of the precise language used in the FDA approval or full prescribing information. For illustrative purposes only, this language may include “previously treated follicular lymphoma” instead of “relapsed or refractory follicular lymphoma” or “second line follicular lymphoma.”
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Related to FDA Approval Milestone

  • FDA Approval means the approval, license, clearance or authorization of the FDA necessary for the marketing and sale of a product for human use in the United States.

  • Development Milestone Event has the meaning set forth in Section 7.2.1.

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • Development Milestone is defined in Section 5.3.

  • Milestone Date means the date set against the relevant Milestone in the Implementation Plan;

  • Milestone 1 means achievement of annual Net Sales of at least $20,000,000 during the Calendar Year ending on December 31, 2021.

  • Milestone Event has the meaning set forth in Section 8.2.1.

  • Development Milestone Payment shall have the meaning set forth in Section 9.2(a).

  • Milestone 2 means achievement of annual Net Sales of at least $35,000,000 during any Calendar Year ending on or before December 31, 2024.

  • Milestone Events has the meaning set forth in Section 7.2.

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • Milestone means an event or task described in the Implementation Plan which must be completed by the corresponding date set out in such plan;

  • Sales Milestone Payment shall have the meaning set forth in Section 8.4.

  • Project Milestone means the project milestone set forth in Schedule-J;

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Regulatory Approval means any and all approvals (including MAA Approval, and Pricing and Reimbursement Approval, if applicable), licenses, registrations, permits, notifications and authorizations (or waivers) of any Regulatory Authority that are necessary for the manufacture, use, storage, import, transport, promotion, marketing, distribution, offer for sale, sale or other commercialization of a Product in any country or jurisdiction.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Project Milestones means the project milestones set forth in Schedule-G;

  • Milestone Payment has the meaning set forth in Section 4.2.