Positive Results means in relation to any Clinical Study that the results of such Clinical Study either (i) met their pre-determined primary end point, and (ii) were sufficient to enable such Licensed Product to advance to the next Clinical Study state (e.g. Phase II Clinical Study or Phase III Clinical Study) or to the next phase of regulatory approval (e.g. Market Approval).
Positive Results means, for an Additional Indication Pivotal Trial, (a) that [***] and (b) for an Additional Indication Pivotal Trial not being a Phase 3 study, that [***].
Positive Results has the meaning set forth in Section 3.1.3.
Examples of Positive Results in a sentence
Project Number: Project Name: Contractor/Subcontractor Name: Contractor/Subcontractor Address: Number of employees who worked on the jobsite during the report period: Number of employees subject to random testing during the report period: Number of Negative Results Number of Positive Results Action taken on employee(s) in response to a failed or positive random test: Date: This form is not required to be submitted to the Owner.
The Discharge Monitoring Report (DMR) form shall be submitted electronically by the required deadline.Determination of Positive Results: An acute toxicity test shall be considered positive if the Toxic Unit - Acute (TUa) is greater than 1.0 for either species.
P1.03-052 The Effect of Rounding on Rate of Positive Results on CT Screening for Lung Cancer.
All Positive Results Confirmatory Test will be maintained on the relevant Worker’s personnel records located at the workplace.
Interventions to Improve Follow-up of Positive Results on Fecal Blood Tests: A Systematic Review.
More Definitions of Positive Results
Positive Results means that, based on review of [**] (in the case of clause (i)) or [**] (in the case of clause (ii)), the primary endpoint of the study was achieved (or, in the case of the Initial Data, as applicable, the cardiovascular safety results supporting the filing of a New Drug Application for Regulatory Approval consistent with applicable FDA guidance for cardiovascular safety of diabetes drugs) with overall safety and efficacy supporting continued Development or application for Regulatory Approval. If Positive Results have not been achieved, then (a) Sanofi may elect to terminate this Agreement as set forth in Section 12.3.2(i)(b) or (b) the JSC may elect to immediately discontinue or cancel all or part of any Development activities under the Development Plan that are conditioned on the achievement of Positive Results with respect to the applicable Decision Point, including any ongoing or planned clinical studies or regulatory filings, or to modify the Development Plan as it deems appropriate in good faith, in the interest of securing Regulatory Approval for a Licensed Product in the Field in the Major Markets in the Territory.
Positive Results means the finalization of positive results from [***] sponsored or conducted by the Surviving Corporation. “Purchase Price” has the meaning set forth in S ection 3.2.
Positive Results. Means a confirmed positive test by the drug-testing laboratory that also has reviewed and certified as a positive by the Program Compliance Director in accordance with the guidelines set forth by the U.S. Department of Health and Human Services.
Positive Results means, based on review of [**] (in the case of clause (i)) or [**] (in the case of clause (ii)) the following, as applicable:
Positive Results means that there are no material observations that prevent 13485 certification for Licensed Product." All other terms and conditions of the Agreement shall remain in full force and effect. This Amendment Number One may be signed in counterparts, each of which when taken together shall constitute one fully executed document. Each individual executing this Agreement on behalf of a legal Entity does hereby represent and warrant to each other person so signing that he or she has been duly authorized to execute this Agreement on behalf of such Entity. Please indicate your agreement to the terms set forth in this letter by signing two copies of this letter, returning one signed to copy to me by email to following address: axxxxxxxxxxxxxxxxxxxxxxxxxxxxx.xxx; and by overnight courier to Jade Therapeutics, Inc., 600 Xxxxxxx Xxxxx, Xxxxx 000, Xxxx Xxxx Xxxx, XX 00000-0000, Attn: Chief Executive Officer, and retaining one copy for your records. Many thanks. Very truly yours, /s/ Axxxxx Xxxxxxxx Axxxxx Xxxxxxxx Chief Executive Officer Jade Therapeutics, Inc. Acknowledged and agreed by Licensor: BioTime, Inc. Name: Axx Xxxxxxx Signature: /s/ Axx Xxxxxxx Title: COO Date: Sept. 22, 2015
Positive Results means the finalization of positive results from [***] sponsored or conducted by the Surviving Corporation.
Positive Results means the final results of the Alcoholic ---------------- Cirrhosis Study, delivered to Interneuron in the form of the SAS original data listings that, in Interneuron's judgment, are supportive and sufficient to submit an NDA to the FDA without any additional clinical testing of Compound.