Causality Assessment Sample Clauses

Causality Assessment. ‌ The Investigator is to assess the causal relationship (causality) between an adverse event and the investigational product and/or the clinical trial procedure according to the following definitions (Decision of 25 November 2013 on Guideline on Annex I to Regulation (EC) No 1223/2009 (2013/674/EU) - Causality assessment of undesirable effect caused by cosmetic products): • Very likely • Likely • Not clearly attributable • Unlikely • Excluded Medical judgment should be used to determine the relationship, considering all relevant factors including the pattern of reaction, temporal relationships, positive de-challenge or re-challenge, relevant medical history, and confounding factors such as co-medication or concurrent diseases.
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Causality Assessment. Trial investigators are required to provide an assessment of causality for all adverse events (serious and non-serious) observed during this trial. This assessment will provide a determination of whether, in the investigator’s judgment, there exists a reasonable possibility that the investigational product caused or contributed to an adverse event. For this assessment, investigators must categorize the causality as either “related” or “not related.” For an adverse event to be considered “related” to the trial treatment, there should be evidence that the event follows a reasonable temporal sequence from the administration of trial treatment or that the event follows a known response pattern to the drug. Causality would be further confirmed by improvement in the adverse event upon stopping the trial treatment and reappearance of the event upon rechallenge.
Sample 1
Causality Assessment. Trial investigators are required to provide an assessment of causality for all adverse events (serious and non-serious) observed during this trial. This assessment will provide a determination of whether, in the investigator’s judgment, there exists a reasonable possibility that the investigational product caused or contributed to an adverse event. For this assessment, investigators must categorize the causality as either “related” or “not related.” For an adverse event to be considered “related” to the trial treatment, there should be evidence that the event follows a reasonable temporal sequence from the administration of trial treatment or that the event follows a known response pattern to the drug. Causality would be further confirmed by *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. improvement in the adverse event upon stopping the trial treatment and reappearance of the event upon rechallenge.
Sample 1
Causality Assessment. Generally the reporter's causality assessment will be accepted. Supplier and Teva may however express another opinion. The most conservative opinion will determine further reporting.
Sample 1
Causality Assessment. ‌ Investigators are required to provide an assessment of causality for all adverse events (serious and non-serious) observed during this study. This assessment will provide a determination of whether, in the investigator’s judgment, there exists a reasonable possibility that the investigational product caused or contributed to an adverse event. For this assessment, investigators must categorize the causality as either “related” or “not related”. For an adverse event to be considered “related” to the study treatment, there should be evidence that the event follows a reasonable temporal sequence from the administration of study treatment, or that the event follows a known response pattern to the drug. Causality would be further confirmed by improvement in an adverse event upon stopping the study treatment and reappearance of the event upon rechallenge.
Sample 1

Related to Causality Assessment

  • Risk Assessments a. Risk Assessment - DST shall, at least annually, perform risk assessments that are designed to identify material threats (both internal and external) against Fund Data, the likelihood of those threats Schedule 10.2 p.2 occurring and the impact of those threats upon DST organization to evaluate and analyze the appropriate level of information security safeguards (“Risk Assessments”).

  • Environmental Review (a) Buyer shall have the right to conduct or cause a consultant (“Buyer’s Environmental Consultant”) to conduct an environmental review of the Assets and Seller’s records pertaining to the Assets (as set forth in Section 3.01) prior to the expiration of the Examination Period (“Buyer’s Environmental Review”). The cost and expense of Buyer’s Environmental Review, if any, shall be borne solely by Buyer. The scope of work comprising Buyer’s Environmental Review shall not include any intrusive test or procedure without the prior written consent of Seller. Buyer shall (and shall cause Buyer’s Environmental Consultant to): (i) consult with Seller before conducting any work comprising Buyer’s Environmental Review, (ii) perform all such work in a safe and workmanlike manner and so as to not unreasonably interfere with Seller’s operations and (iii) comply with all applicable laws, rules, and regulations. Seller shall use commercially reasonable efforts to obtain any Third Party consents and otherwise cooperate with Buyer in conducting Buyer’s Environmental Review and any activities related thereto. Seller shall have the right to have a representative or representatives accompany Buyer and Buyer’s Environmental Consultant at all times during Buyer’s Environmental Review. With respect to any samples taken in connection with Buyer’s Environmental Review, Buyer shall take split samples, providing one of each such sample, properly labeled and identified, to Seller. The Parties shall execute a “common undertaking” letter regarding the confidentiality for the Environmental Review where appropriate. Buyer hereby agrees to release, defend, indemnify and hold harmless Seller from and against all claims, losses, damages, costs, expenses, causes of action and judgments of any kind or character (INCLUDING THOSE RESULTING FROM SELLER’S SOLE, JOINT, COMPARATIVE OR CONCURRENT NEGLIGENCE OR STRICT LIABILITY) to the extent arising out of Buyer’s Environmental Review. Buyer hereby covenants and agrees that it will have at least $2,000,000 of general liability insurance to cover its indemnification hereunder prior to the commencement of the Environmental Review.

  • Feasibility Study Buyer will, at Buyer's expense and within ____ days from Effective Date ("Feasibility Study Period"), determine whether the Property is suitable, in Buyer's sole and absolute discretion, for ___________________ use. During the Feasibility Study Period, Buyer may conduct a Phase I environmental assessment and any other tests, analyses, surveys and investigations ("Inspections") that Buyer deems necessary to determine to Buyer's satisfaction the Property's engineering, architectural and environmental properties; zoning and zoning restrictions; subdivision statutes; soil and grade; availability of access public roads, water, and other utilities; consistency with local, state and regional growth management plans, availability of permits, government approvals, and licenses; and other inspections that Buyer deems appropriate to determine the Property's suitability for the Buyer's intended use. If the Property must be rezoned, Buyer will obtain the rezoning from the appropriatx xxxernment agencies. Seller will sign all documents Buyer is required to file in connection with development or rezoning approvals. Seller gives Buyer, its agents, contractors and assigns, the right to enter the Property at any time during the Feasibility Study Period for the purpose of conducting inspections; provided, however, that Buyer, its agents, contractors and assigns enter the Property and conduct inspections at their own risk. Buyer will indemnify and hold Seller harmless from xxxxes, damages, costs, claims and expenses of any nature, including attorney's fees, expenses and liability incurred in application for rezoning or related proceedings, and from liability to any person, arising from the conduct of any and all inspections of any work authorized by Buyer. Buyer will not engage in any activity that xxxxx result in a construction lien being filed against the Property without Seller's prior written consent. If this transaction does not close, Buyer will, at Buyer's expense, (1) repair all damages to the Property resulting from the Inspections and return the Property to the condition it was in prior to conduct of the Inspections, and (2) release to Seller all reports and other work generated as a result of the Inspections. Buyer will deliver written notice to Seller prior to the expiration of the Feasibility Study Period of Buyer's determination of whether or not the Properxx xx acceptable. Buyer's failure to comply with this notice requirement will constitute acceptance of the Property as suitable for Buyer's intended use in its "as is" condition. If the Property is unacceptable to Buyer and written notice of this fact is timely delivered to Seller, this Contract will be deemed terminated as of the day after the Feasibility Study period ends and Buyer's deposit(s) will be returned after Escrow Axxxx receives proper authorization form all interested parties.

  • Periodic Review of Costs of Environmental Compliance In the ordinary course of its business, the Company conducts a periodic review of the effect of Environmental Laws on the business, operations and properties of the Company and its subsidiaries, in the course of which it identifies and evaluates associated costs and liabilities (including, without limitation, any capital or operating expenditures required for clean-up, closure of properties or compliance with Environmental Laws or any permit, license or approval, any related constraints on operating activities and any potential liabilities to third parties). On the basis of such review and the amount of its established reserves, the Company has reasonably concluded that such associated costs and liabilities would not, individually or in the aggregate, result in a Material Adverse Change.

  • Environmental Assessment Buyer shall have the right for a period commencing upon execution of this Agreement by both parties and ending on November 28, 2012, to conduct an environmental assessment of the Assets, at Buyer’s sole risk, liability and expense. Seller shall make available to Buyer, during the environmental assessment period described above, Seller’s historical files regarding prior operations on the Assets, and provide Buyer and its representatives with reasonable access to the Assets to conduct the environmental assessment. Buyer shall provide Seller three (3) days prior written notice of a desired date(s) for such assessment and Seller shall have the right to be present during any assessment and, if any testing is conducted pursuant to Seller’s express prior written consent, Seller may require splitting of all samples. Notwithstanding any other provision of this Agreement to the contrary, Buyer shall not have the right to drill any test, monitor or other xxxxx or to extract samples of any air, soil, water or other substance from the Assets without Seller’s express prior written consent. If Buyer proposes a reasonable request to drill a test well or extract a sample pursuant to a systematic and customary procedure for the assessment of the environmental condition of the Assets and Seller refuses to grant its consent to such a well or sampling, then Buyer shall have the right, for a period of seventy-two (72) hours following notification of Seller’s refusal to consent, to deliver written notice to Seller of Buyer’s election to exclude from this transaction the portion of the Assets affected by such proposed test well or sample, and the Purchase Price shall be adjusted accordingly by the Allocated Value of such portion of the Assets so excluded. Under no circumstances whatsoever shall Seller ever be obligated to grant its consent to any such test xxxxx or sampling proposed by Buyer, and Buyer’s sole and exclusive remedy for any refusal by Seller to grant its consent shall be the limited right contained in the preceding sentence to exclude the affected Assets from the transactions contemplated by this Agreement. If Buyer fails to exercise the right to exclude such Assets by written notice to Seller delivered prior to the expiration of the seventy-two hour period described above, then Buyer shall be conclusively deemed to have waived such right and shall be obligated to purchase the affected Assets without conducting such testing or sampling or any adjustment of the Purchase Price unless otherwise provided in this Agreement.

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