Positive Results definition

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.

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Positive Results has the meaning set forth in Section 3.1.3.

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 [***].

Examples of Positive Results in a sentence

• All Positive Results Confirmatory Test will be maintained on the relevant Worker’s personnel records located at the workplace.

• Drug Screening – Positive Results Sergeants who are tested and test positive for the presence of drugs under the Drug Screening Policy shall be suspended from duty immediately without pay, pending a due process hearing for dismissal from employment.

• At each Decision Point, within [**] after the earlier of (i) [**] and (ii) [**], the JSC shall determine whether or not Positive Results have been achieved.

• If Positive Results are not achieved with respect to a given Decision Point, as determined in accordance with Section 3.1.3,and if elected by Sanofi, then the Parties shall promptly meet to negotiate in good faith to alter the financial terms provided for under this ARTICLE 7 to address such failure to achieve Positive Results, and if an agreement is reached among the Parties, the Agreement shall be amended to give effect to such agreement.

• Positive Results The MRO shall notify employees of positive test results.

More Definitions of Positive Results

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. The MRO will contact any employee or contractor testing positive for the presence of a prohibited substance. The individual will be allowed to present medical documentation to explain any permissible use of a drug or prescription medication. All such discussions between the individual and the MRO will be confidential. Owner will not be a party to or have access to matters discussed between the individual and the MRO. Until the individual contacts the MRO or five (5) days have lapsed after the individual was asked to contact the MRO, Owner will not be advised of the test result. If legitimate, medically supportable reasons exist to explain the positive result, the MRO will report the test result to Owner as a negative. If there is no legitimate, medically supportable reason for the positive test result, the MRO will report the test result as positive.

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."

Positive Results means the finalization of positive results from [***] sponsored or conducted by the Surviving Corporation. “Purchase Price” has the meaning set forth in Section 3.2.

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.

Positive Results means the finalization of positive results from [***] sponsored or conducted by the Surviving Corporation.