Risks analysis Sample Clauses

Risks analysis. Risks related to NI-0501 NI-0501 is a monoclonal antibody of IgG1. Upon the administration of mAbs, which are proteins, acute infusion reactions can occur. These may happen during the infusion or in the subsequent hours (usually within the first 24 hours)29. These reactions are either IgE-mediated type I hypersensitivity reactions (anaphylactic reactions), or anaphylactoid reactions not mediated by IgE. True anaphylactic reactions usually do not occur upon initial infusion and require a certain sensitization. In contrast, the pathophysiology of anaphylactoid reactions appears to be secondary to the release of cytokines consequent to a mAb binding to circulating antigen-expressing cells. However, the clinical manifestations of anaphylactic and anaphylactoid reactions overlap, and both may lead to life-threatening conditions, involving cardiovascular, respiratory, central nervous, gastro-intestinal, and cutaneous systems. The management of anaphylactic and anaphylactoid reactions involves immediate administration of oxygen, epinephrine, vasopressors, bronchodilators, corticosteroids, and/or antihistamines. After 14 single infusions to HVs up to and including the dose of 3 mg/kg and more than 380 infusions administered to HLH patients (either in the context of the NI-0501-04 and NI-0501-05 studies or in patients who received NI-0501 in compassionate use) up to and including the dose of 10 mg/kg, no significant infusion related reaction has been observed. Only transient erythematous rashes localized to the extremities (feet and/or hands) resolving spontaneously have been observed in a few patients during the first infusions of NI-0501 in the NI-0501 study. On a few occasions, administration of NI-0501 has been performed through a peripheral venous access and all infusions were uneventful. • When administered to humans, most mAb therapeutics elicit some level of antibody response (anti-drug antibodies or ADAs) against the therapeutic product, as early as after the first exposure. No sign of immunogenicity has been reported in the NI-0501 study in healthy volunteers. The presence of ADAs will be measured throughout this study as per regulatory recommendations. The full analysis is planned to be performed at the end of the NI-0501-04 study. Data accumulated so far (in particular PK profiles and a negative ADA search performed in the only patient who developed hemolytic anemia during conditioning) have not led to suspect the presence of XXX. Risks related to the t...
Sample 1
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Risks analysis. In order to enable the Customer to test, assess and regularly evaluate the effectiveness of the technical and organizational measures of the Service to ensure the security of the Personal Data Processing and Personal Data, the Customer may request from the Service Provider or mandate an independent third party (not a direct competitor of the Service Provider, and subject to a confidentiality agreement) to make a risk analysis that takes into account the sensitivity of the Processing, Personal Data and the risks of accidental or fraudulent destruction, loss, alteration or unauthorized access to or disclosure of the Personal Data.
Sample 1
Risks analysis. As NI-0501 is a monoclonal antibody and is characterized by a long half-life, the Investigator should be aware of the risks reported below. 9.2.1 Risks related to the target 9.2.2 Risk related to the study population 9.2.3 Risk minimization measures
Sample 1

Related to Risks analysis

  • Risk Analysis The Custodian will provide the Fund with a Risk Analysis with respect to Securities Depositories operating in the countries listed in Appendix B. If the Custodian is unable to provide a Risk Analysis with respect to a particular Securities Depository, it will notify the Fund. If a new Securities Depository commences operation in one of the Appendix B countries, the Custodian will provide the Fund with a Risk Analysis in a reasonably practicable time after such Securities Depository becomes operational. If a new country is added to Appendix B, the Custodian will provide the Fund with a Risk Analysis with respect to each Securities Depository in that country within a reasonably practicable time after the addition of the country to Appendix B.

  • Quantitative Analysis Quantitative analysts develop and apply financial models designed to enable equity portfolio managers and fundamental analysts to screen potential and current investments, assess relative risk and enhance performance relative to benchmarks and peers. To the extent that such services are to be provided with respect to any Account which is a registered investment company, Categories 3, 4 and 5 above shall be treated as “investment advisory services” for purposes of Section 5(b) of the Agreement.”

  • Sampling and Analysis The Seller has sole responsibility for quality control of the coal and shall forward its “as loaded” quality to the Buyer as soon as possible. The sampling and analysis of the coal delivered hereunder shall be performed by Buyer and the results thereof shall be accepted and used for the quality and characteristics of the coal delivered under this Agreement. All analyses shall be made in Buyer’s laboratory at Buyer’s expense in accordance with ASTM standards where applicable, or using standards mutually acceptable to both parties. Samples for analyses shall be taken by any ASTM standards or standards mutually acceptable to both parties, and may be composited and shall be taken with a frequency and regularity sufficient to provide reasonably accurate representative samples of the deliveries made hereunder. Seller represents that it is familiar with Buyer’s sampling and analysis practices, and finds them to be acceptable. Buyer shall notify Seller in writing of any significant changes in Buyer’s sampling and analysis practices. Any such changes in Buyer’s sampling and analysis practices shall, except for ASTM or mutually agreeable changes in practices, provide for no less accuracy than the sampling and analysis practices existing at the time of the execution of this Agreement, unless the Parties otherwise mutually agree. (1) part shall be used for analysis by Buyer; one (l) part shall be used by Buyer as a check sample, if Buyer in its sole judgment determines it is necessary; one (1) part shall be retained by Buyer (LG&E) until the twenty-fifth (25th) of the month following the month of unloading (the “LG&E Disposal Date”) or Buyer (KU) until thirty (30) days after the sample is taken (the “KU Disposal Date”), the LG&E Disposal Date and the KU Disposal Date are collectively the “Disposal Date”), and shall be delivered to Seller for analysis if Seller so requests before the Disposal Date; and one part (“Referee Sample”) shall be retained by Buyer until the Disposal Date. Seller shall be given copies of all analyses made by Buyer by the tenth (10th) business day of the month following the month of unloading. Seller, on reasonable notice to Buyer shall have the right to have a representative present to observe the sampling and analyses performed by Buyer. Unless Seller requests a Referee Sample analysis before the Disposal Date, Buyer’s analysis shall be used to determine the quality of the coal delivered hereunder. The Monthly Weighted Averages shall be determined by utilizing the individual shipment analyses. If any dispute arises before the Disposal Date, the Referee Sample retained by Buyer shall be submitted for analysis to an independent commercial testing laboratory (“Independent Lab”) mutually chosen by Buyer and Seller. For each coal quality specification in question, a dispute shall be deemed not to exist and Buyer’s analysis shall prevail and the analysis of the Independent Lab shall be disregarded if the analysis of the Independent Lab differs from the analysis of Buyer by an amount equal to or less than: (i) 0.50% moisture (ii) 0.50% ash on a dry basis (iii) 100 Btu/lb. on a dry basis (iv) 0.10% sulfur on a dry basis. For each coal quality specification in question, if the analysis of the Independent Lab differs from the analysis of Buyer by an amount more than the amounts listed above, then the analysis of the Independent Lab shall prevail and Buyer’s analysis shall be disregarded. The cost of the analysis made by the Independent Lab shall be borne by Seller to the extent that Buyer’s analysis prevails and by Buyer to the extent that the analysis of the Independent Lab prevails.

  • Escrow Analysis If applicable, with respect to each Mortgage Loan, the Seller has within the last twelve months (unless such Mortgage was originated within such twelve month period) analyzed the required Escrow Payments for each Mortgage and adjusted the amount of such payments so that, assuming all required payments are timely made, any deficiency will be eliminated on or before the first anniversary of such analysis, or any overage will be refunded to the Mortgagor, in accordance with RESPA and any other applicable law;

  • Independent Analysis Each Party hereby confirms that its decision to execute this Agreement has been based upon its independent assessment of documents and information available to it, as it has deemed appropriate.

  • Investment Analysis and Implementation In carrying out its obligations under Section 1 hereof, the Advisor shall: (a) supervise all aspects of the operations of the Funds; (b) obtain and evaluate pertinent information about significant developments and economic, statistical and financial data, domestic, foreign or otherwise, whether affecting the economy generally or the Funds, and whether concerning the individual issuers whose securities are included in the assets of the Funds or the activities in which such issuers engage, or with respect to securities which the Advisor considers desirable for inclusion in the Funds' assets; (c) determine which issuers and securities shall be represented in the Funds' investment portfolios and regularly report thereon to the Board of Trustees; (d) formulate and implement continuing programs for the purchases and sales of the securities of such issuers and regularly report thereon to the Board of Trustees; and (e) take, on behalf of the Trust and the Funds, all actions which appear to the Trust and the Funds necessary to carry into effect such purchase and sale programs and supervisory functions as aforesaid, including but not limited to the placing of orders for the purchase and sale of securities for the Funds.

  • Fundamental Analysis The equity investment analysts provide independent research and analysis of specific companies within a sector. Typically, analysis includes review of published reports, interviews of company management, on-site observation of company operations, and the use of various financial models. In addition, analysts read trade journals, attend industry conferences, and focus on trends within the sector and industry. Based on this proprietary analysis, the analyst makes buy, sell or hold recommendations to the Adviser.

  • Investment Analysis and Commentary The Subadviser will provide quarterly performance analysis and market commentary (the “Investment Report”) during the term of this Agreement. The Investment Reports are due within 10 days after the end of each quarter. In addition, interim Investment Reports shall be issued at such times as may be mutually agreed upon by the Adviser and Subadviser; provided however, that any such interim Investment Report will be due within 10 days of the end of the month in which such agreement is reached between the Adviser and Subadviser. The subject of each Investment Report shall be mutually agreed upon. The Adviser is freely able to publicly distribute the Investment Report.

  • Statistical Sampling Documentation a. A copy of the printout of the random numbers generated by the “Random Numbers” function of the statistical sampling software used by the IRO.‌ b. A description or identification of the statistical sampling software package used by the IRO.‌

  • Financial testing The financial covenants set out in Clause 20.2 (Financial condition) shall be tested by reference to each of the financial statements and/or each Compliance Certificate delivered pursuant to Clause 19.2 (Compliance Certificate).

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