Positive Data Event definition

Positive Data Event is the receipt by Borrower on or before June 30, 2018 of positive data from the Phase 1/2 trials of Borrower’s drug candidate P-BCMA for the treatment of multiple myeloma, which data must be in such form and substance as is reasonably acceptable to Collateral Agent.
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Positive Data Event is publicly reporting of positive interim data by Borrower, on or before December 20, 2018, on at least 9 patients from the second patient cohort or higher in the ongoing Phase 1 trial of Borrower’s drug candidate P-BCMA-101 in multiple myeloma at a scientific conference, which data must be in such form and substance as is reasonably acceptable to Collateral Agent.
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Positive Data Event means that Borrower has delivered evidence to Agent, within 48 hours of disclosing such Positive Data to the Board, but in any event, prior to disclosure to the public by Borrower of such data, satisfactory to Agent in Agent’s sole but reasonable discretion, that Borrower has achieved Positive Data in Borrower’s ORCA-2 and ORCA-3 Phase 3 Studies.
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More Definitions of Positive Data Event

Positive Data Event means Borrower has provided Agent, on or prior to June 1, 2021, with evidence reasonably satisfactory to Agent in Agent’s reasonable discretion that Borrower has received positive data with respect to Borrower’s phase 3 clinical trial in both indications for Vonoprazan sufficient to file an NDA with the FDA.
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Positive Data Event means Collateral Agent’s and Lenders’ receipt, on or before March 31, 2018, of the following, in such form and substance as are acceptable to Collateral Agent and Lenders in their respective discretion: (i) evidence of meeting of primary endpoint within the overall group of SONICS (COR-2012-01) as described in Protocol Amendment #6 to SONICS dated 25 October 2016, filed with the US Food and Drug Administration to IND #115,968 on 22 November 2016 (Serial #047) along with evidence from the same study that COR-003 has an acceptable safety profile, in the opinion of the study’s Independent Data Safety Monitoring Board (as reflected in meeting minutes), which combined evidence supports continued development of the drug, (ii) a Responsible Officer’s certificate certifying that the primary endpoint within the overall group of SONICS (COR-2012-01) as described in Protocol Amendment #6 to SONICS dated 25 October 2016, filed with the US Food and CONFIDENTIAL TREATMENT REQUESTED UNDER C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. [****] INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST FILED SEPARATELY WITH THE COMMISSION. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION. Drug Administration to IND #115,968 on 22 November 2016 (Serial #047) has been met along with evidence from the same study that COR-003 has an acceptable safety profile, in the opinion of the study’s Independent Data Safety Monitoring Board (as reflected in meeting minutes), which combined evidence supports continued development of the drug and (iii) a copy of a press release issued by the Borrower announcing that the events described in clause (i) hereof have occurred.
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Positive Data Event means that Bxxxxxxx has delivered evidence to Agent, within 48 hours of disclosing such Positive Data to the Board, but in any event, prior to disclosure to the public by Borrower of such data, satisfactory to Agent in Agent’s sole but reasonable discretion, that Bxxxxxxx has achieved Positive Data in Borrower’s ORCA-2 and ORCA-3 Phase 3 Studies.
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Positive Data Event is the confirmation by Collateral Agent and Lenders that in Borrower’s pivotal trial in the United States of its Eversense continuous glucose monitoring system implant, the Eversense produced a MARD (mean absolute relative difference) score of 12.0% or less compared to lab testing in readings where glucose was greater than or equal to 75 mg/dL and the Eversense did not produce any safety issues that would prevent Company from filing for full PMA approval in the US, based on such evidence as is acceptable to Collateral Agent and each Lender in its sole and reasonable discretion.
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Positive Data Event occurs if and when (if ever) Bank confirms in writing that, it has received, on or prior to June 30, 2024, evidence satisfactory to Bank in its sole and absolute discretion (which evidence shall include satisfactory discussions between Bank and Xxxxxxxx’s investors), that Xxxxxxxx has received positive interim phase 2 data for ADX-097.”
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Related to Positive Data Event

  • Program change means any elimination, curtailment or reorganization of a curriculum offering, program or school operation or a reorganization or closing of a school or consolidation of two or more individual schools or school districts that is unrelated to financial exigency.

  • Benchmark Event means, with respect to an Original Reference Rate:

  • Positive Test Result means a finding of the presence of drugs, alcohol, or their metabolites in the sample tested in levels at or above the threshold detection levels contained in the standards of one of the programs listed in Minn. Stat. § 181.953, Subd. 1.

  • Potential Material Event means any of the following: (i) the possession by the Company of material information not ripe for disclosure in a Registration Statement, which shall be evidenced by determinations in good faith by the Board of Directors of the Company that disclosure of such information in the Registration Statement would be detrimental to the business and affairs of the Company, or (ii) any material engagement or activity by the Company which would, in the good faith determination of the Board of Directors of the Company, be adversely affected by disclosure in a Registration Statement at such time, which determination shall be accompanied by a good faith determination by the Board of Directors of the Company that the Registration Statement would be materially misleading absent the inclusion of such information.

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

  • Benchmark Transition Event means the occurrence of one or more of the following events with respect to the then-current Benchmark:

  • Expiry Date (Data di Scadenza) means the "Expiry Date" as specified in § 1 of the Product and Underlying Data.

  • Consultation Termination Event shall have the meaning assigned to such term or an analogous term in the Servicing Agreement.

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

  • Alternative nicotine product means any vaping product, whether or not it includes nicotine, including electronic smoking devices, that can be ingested into the body by chewing, smoking, absorbing, dissolving, inhaling, or by any other means. ‘Alternative nicotine product’ does not include:

  • Potential Termination Event means an event which, with the giving of notice and/or the lapse of time, would constitute a Termination Event.

  • Control Termination Event shall have the meaning given to such term or any one or more analogous terms in the Lead Securitization Servicing Agreement.

  • Gross beta particle activity means the total radioactivity due to beta particle emission as inferred from measurements on a dry sample.

  • Implementation Period means the period from the date of signing of the Agreement and up to the issuance of Final Acceptance Certificate for the project.

  • €STR Index Cessation Event means the occurrence of one or more of the following events:

  • Best available control technology (BACT means an emissions limitation (including a visible emission standard) based on the maximum degree of reduction for each pollutant subject to regulation under CAA which would be emitted from any proposed major stationary source or major modification which the Department, on a case-by-case basis, takes into account energy, environmental, and economic impacts and other costs, determines is achievable for such source or modification through application of production processes or available methods, systems, and techniques, including fuel cleaning or treatment or innovative fuel combustion techniques for control of such pollutant. In no event shall application of best available control technology result in emissions of any pollutant which would exceed the emissions allowed by any applicable standard under 7 DE Admin. Code 1120 and 1121. If the Department determines that technological or economic limitations on the application of measurement methodology to a particular emissions unit would make the imposition of an emissions standard infeasible, a design, equipment, work practice, operational standard, or combination thereof, may be prescribed instead to satisfy the requirement for the application of best available control technology. Such standard shall, to the degree possible, set forth the emissions reduction achievable by implementation of such design, equipment, work practice or operation, and shall provide for compliance by means which achieve equivalent results.

  • Program Period means the period of time which the department intends to support the program without requiring the recompetition for funds. The program period is specified within the grant application.

  • Change of Control Triggering Event means the occurrence of both a Change of Control and a Rating Event.

  • A "CHANGE IN CONTROL means an Ownership Change Event or a series of related Ownership Change Events (collectively, the "TRANSACTION") wherein the stockholders of the Company immediately before the Transaction do not retain immediately after the Transaction, in substantially the same proportions as their ownership of shares of the Company's voting stock immediately before the Transaction, direct or indirect beneficial ownership of more than fifty percent (50%) of the total combined voting power of the outstanding voting stock of the Company or the corporation or corporations to which the assets of the Company were transferred (the "TRANSFEREE CORPORATION(S)"), as the case may be. For purposes of the preceding sentence, indirect beneficial ownership shall include, without limitation, an interest resulting from ownership of the voting stock of one or more corporations which, as a result of the Transaction, own the Company or the Transferee Corporation(s), as the case may be, either directly or through one or more subsidiary corporations. The Board shall have the right to determine whether multiple sales or exchanges of the voting stock of the Company or multiple Ownership Change Events are related, and its determination shall be final, binding and conclusive.

  • Relevant Potential Change of Control Announcement means any public announcement or statement by the Issuer, any actual or potential bidder or any adviser acting on behalf of any actual or potential bidder relating to any potential Change of Control where within 180 days following the date of such announcement or statement, a Change of Control occurs.

  • Milestone Event has the meaning set forth in Section 8.4.

  • Potential Change of Control Announcement means any public announcement or statement by the Issuer or by any actual or potential bidder or any designated adviser thereto relating to any specific or any near-term potential Change of Control (whereby "near-term" shall mean that such potential Change of Control is reasonably likely to occur, or is publicly stated by the Issuer or by any such actual or potential bidder or any such designated adviser to be intended to occur, within four months of the date of such announcement or statement).

  • Potential Change of Control shall be deemed to have occurred if:

  • SOFR Index Cessation Event means the occurrence of one or more of the following events:

  • Adverse Event means any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.