Safety Evaluation Sample Clauses

Safety Evaluation. 14.1 Celestial and BWTP shall notify GSK and shall supply to GSK any information, together with any supporting documentation, that it considers indicates a safety issue in relation to the Medicinal Product no later than twenty-four (24) hours from the identification by it of the safety issue.
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Safety Evaluation. Each Party shall provide the following information with respect to its Compound to be used in a Combined Therapy Study: (i) the latest investigator’s brochure and annual updates (with such updates to be provided within five (5) Business Days after being finalized), (ii) list of ongoing clinical studies, (iii) Aggregate Safety Information that emerge from all other clinical trials of the Party’s Compound within five (5) Business Days after general distribution within such Party, (iv) prompt notice of any material safety interactions with any Regulatory Authority and the substance thereof regarding any clinical trials of the Party’s Compound during the term of this Agreement; (v) a summary of all new clinically relevant toxicology study data on the Party’s Compound within five (5) Business Days after generation of such summary within such Party, (vi) safety analyses for the Combined Therapy Study in accordance with the applicable Statistical Analysis Plan, and (vii) such other safety data as set forth in the Pharmacovigilance Agreement. Except as permitted under Section 8.3(g) and Section 8.4, each Party shall use any such information provided by the other Party pursuant to this Section 2.1(g) solely to evaluate the safety of the Combined Therapy and the Compounds for use in the Combined Therapy Study.
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Safety Evaluation. Where there is a possible interface with / impact on safety related equipment, the Contractor‘s design complies with the applicable design codes as described in the KOU Safety Analysis Report (ASME, IEEE etc…). The Contractor’s design is such that it does not introduce any additional risk to the safety and/or operation of the plant and/or its people and/or the environment. Activity description Project Manager Contractor Requirements Planning Additional notes  Authorisation of individuals in accordance with KTA-001. X  All safety screenings, evaluations and justifications are performed by authorised individuals in accordance with KTA-001. N/A  Compilation of an Scheme Design document / Installation Design document and independent reviews X  Process in accordance with KAA-709. In accordance with Accepted Programme Although not obligatory, it is encouraged that the compiler of the design may not be the compiler of the Safety Evaluation documentation.  Probabilistic Safety Assessments (PSA) evaluation. X  The Employer performs the PSA. The Contractor to supply all relevant input information when requested to furnish information  Incorporate PSA results into safety evaluation and confirm applicability of PSA to detailed design X  The Contractor notifies the Project Manager of any discrepancies in the PSA study.  The Contractor corrects any safety concerns highlighted by the Safety Evaluation / PSA in its design. In accordance with Accepted Programme  Presentation of safety evaluations, justifications and cases to KORC for approval. X  The Project Manager arranges with KORC for an opportunity to present information at KORC.  Both the Project Manager and the Contractor attends the meeting.  The Project Manager performs the presentation. In accordance with Accepted Programme Regular meetings are scheduled every Monday but arrangement of special KORC meetings is possible for urgent issues.  Approval of safety evaluation documents. X  Project Manager acceptance is subject to the requirements of the safety evaluation process being met. In accordance with Accepted Programme Employer's KORC Chairman approves the documents.  Originals in Scheme Design and copies to TD & RM, copy to RRM, copy on LAN. X  The Project Manager submits the approved Safety Evaluation documentation to the Contractor. In accordance with Accepted Programme Activity description Project Manager Contractor Requirements Planning Additional notes  This activity group is 90% complete ...
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Safety Evaluation. Using the ODOT-calibrated crash prediction models, Kittelson will develop a safety evaluation of the recommended concept for the Greenwood West corridor, and summarize the findings of this evaluation in the Operations Analysis memorandum, above.
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Safety Evaluation. All safety data will be included in the subject data listings. Analyses and summary tables will be based upon the safety population. All AEs will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) (current version at the time of database lock), and will be classified by MedDRA preferred term and system organ class. AE listings will be presented by subject, system organ class and preferred term. Incidence of all reported AEs/treatment emergent AEs, AESIs, and SAEs will be tabulated by treatment group (600 U, 800 U, placebo for Treatment 1 and 600 U, 800 U for subsequent treatment(s)) and overall. In addition, summary tables will be presented by maximum intensity, drug relationship and AEs associated with premature withdrawal of IMP. A treatment emergent AE is defined as any AE that occurs during the active phase of the study if: • It was not present prior to receiving the first dose of IMP; or • It was present prior to receiving the first dose of IMP but the intensity increased at any point in the study following the first dose of IMP. Concomitant medication will be coded by using World Health Organisation Drug Dictionary (WHODRUG; current version at the time of database lock) and will be summarised by treatment group (600 U, 800 U, placebo for Treatment 1 and 600 U, 800 U for subsequent treatment(s)) and overall, with the number and percentage of subjects receiving concomitant medication by drug class and preferred drug name. Summary statistics (mean, median, standard deviation, standard error mean, and range as appropriate) by treatment group and overall will be presented for xxxxx xxxxx, laboratory safety tests, laboratory urinalysis/microscopy etc. at each assessment with change from Baseline. For laboratory safety data, abnormal values will be flagged in the data listings and a list of clinically significant abnormal values will be presented. Shift tables from Baseline of the number and percentage of subjects with low, normal or high values and normal or abnormal examinations will be presented by treatment group (600 U, 800 U, placebo for Treatment 1 and 600 U, 800 U for subsequent treatment(s)).
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Safety Evaluation. 1. Per NFAS 15.304(d), solicitations utilizing source selection procedures for procurements within the 50 United States, the District of Columbia, and outlying areas shall contain a standard “Safety” technical evaluation factor. This factor shall be included as a stand-alone evaluation factor and not as a sub-factor or an element of the Past Performance evaluation factor. This action will result in the selection of contractors that have consistently demonstrated a commitment to safety and the ability to properly manage and implement safety procedures for themselves and all tiers of subcontractors under their purview.
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Related to Safety Evaluation

  • Independent Evaluation Buyer is an experienced and knowledgeable investor in the oil and gas business. Buyer has been advised by and has relied solely on its own expertise and legal, tax, title, reservoir engineering, environmental and other professional counsel concerning this transaction, the Properties, the value thereof and title thereto.

  • Trust Evaluation As of the Evaluation Time (a) on the last Business Day of each year, (b) on the day on which any Unit is tendered for redemption and (c) on any other day desired by the Trustee or requested by the Depositor, the Trustee shall: Add (i) all moneys on deposit in a Trust (excluding (1) cash, cash equivalents or Letters of Credit deposited pursuant to Section 2.01 hereof for the purchase of Contract Securities, unless such cash or Letters of Credit have been deposited in the Interest and Principal Accounts because of failure to apply such moneys to the purchase of Contract Securities pursuant to the provisions of Sections 2.01, 3.03 and 3.04 hereof and (2) moneys credited to the Reserve Account pursuant to Section 3.05 hereof), plus (ii) the aggregate Evaluation of all Securities (including Contract Securities and Reinvestment Securities) on deposit in such Trust as is determined by the Evaluator (such evaluations shall take into account and itemize separately (i) the cash on hand in the Trust or moneys in the process of being collected from matured interest coupons or bonds matured or called for redemption prior to maturity, (ii) the value of each issue of the Securities in the Trust on the bid side of the market as determined by the Evaluator pursuant to Section 4.01, and (iii) interest accrued thereon not subject to collection and distribution). For each such Evaluation there shall be deducted from the sum of the above (i) amounts representing any applicable taxes or governmental charges payable out of the respective Trust and for which no deductions shall have previously been made for the purpose of addition to the Reserve Account, (ii) amounts representing estimated accrued fees of the Trust and expenses of such Trust including but not limited to unpaid fees and expenses of the Trustee, the Evaluator, the Supervisor, the Depositor and bond counsel, in each case as reported by the Trustee to the Evaluator on or prior to the date of evaluation, (iii) any moneys identified by the Trustee, as of the date of the Evaluation, as held for distribution to Unitholders of record as of a Record Date or for payment of the Redemption Value of Units tendered prior to such date and (iv) unpaid organization costs in the estimated amount per Unit set forth in the Prospectus. The resulting figure is herein called a "Trust Fund Evaluation." The value of the pro rata share of each Unit of the respective Trust determined on the basis of any such evaluation shall be referred to herein as the "Unit Value."

  • Tests and Preclinical and Clinical Trials The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • No Reverse Engineering You may not, and you agree not to or enable others to, copy (except as expressly permitted by this License or by the Usage Rules if they are applicable to you), decompile, reverse engineer, disassemble, attempt to derive the source code of, decrypt, modify, or create derivative works of the Apple Software or any services provided by the Apple Software, or any part thereof (except as and only to the extent any foregoing restriction is prohibited by applicable law or to the extent as may be permitted by the licensing terms governing use of open-sourced components included with the Apple Software).

  • Sampling and Analysis The sampling and analysis of the coal shall be performed by Seller upon loading of the coal, and the results thereof shall be accepted and used as defining the quality and characteristics of the coal under this Agreement and as the Payment Analysis. All analyses shall be made in Seller’s laboratory at Seller’s expense in accordance with ASTM standards where applicable, or industry-accepted standards in other cases. Samples for analyses shall be taken in accordance with ASTM standards or other methods mutually acceptable to both parties. Seller shall transmit its quality analysis to Buyer as soon as possible. Each sample taken by Seller shall be divided into four (4) parts and put into airtight containers, properly labeled and sealed. One (1) part shall be used for analysis by Seller. One (1) part shall be used by Seller as a check sample, if Seller in its sole judgment determines it is necessary. One (1) part shall be retained by Seller until thirty (30) days after the sample is taken (“Disposal Date”), and shall be delivered to Buyer for analysis if Buyer so requests before the Disposal Date. One (1) part (the “Referee Sample”) shall be retained by Seller until the Disposal Date. Buyer, on reasonable notice to Seller, shall have the right to have a representative present to observe the sampling and analyses performed by Seller. Unless Buyer requests an analysis of the Referee Sample before the Disposal Date, Seller’s analysis shall be used to determine the quality of the coal under this Agreement and shall be the Payment Analysis. The Monthly Weighted Averages of specifications referenced in §6.1 shall be based on the individual Shipment analyses. If any dispute arises with regard to the analysis of any sample before the Disposal Date for such sample, the Referee Sample retained by Seller 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, if the analysis of the Independent Lab differs by more than the applicable ASTM reproducibility standards, the Independent Lab results will govern, and the prior analysis shall be disregarded. All testing of the Referee Sample by the Independent Lab shall be at requestor’s expense unless the Independent Lab results differ from the original Payment Analysis for any specification by more than the applicable ASTM reproducibility standards as to that specification. In such case, the cost of the analysis made by the Independent Lab shall be borne by the party who provided the original Payment Analysis.

  • Quality Assurance The parties endorse the underlying principles of the Company’s Quality Management System, which seeks to ensure that its services are provided in a manner which best conforms to the requirements of the contract with its customer. This requires the Company to establish and maintain, implement, train and continuously improve its procedures and processes, and the employees to follow the procedures, document their compliance and participate in the improvement process. In particular, this will require employees to regularly and reliably fill out documentation and checklists to signify that work has been carried out in accordance with the customer’s specific requirements. Where necessary, training will be provided in these activities.

  • Reverse Engineering The Customer must not reverse assemble or reverse compile or directly or indirectly allow or cause a third party to reverse assemble or reverse compile the whole or any part of the software or any products supplied as a part of the Licensed System.

  • ANALYSIS AND MONITORING The Custodian shall (a) provide the Fund (or its duly-authorized investment manager or investment adviser) with an analysis of the custody risks associated with maintaining assets with the Eligible Securities Depositories set forth on Schedule B hereto in accordance with section (a)(1)(i)(A) of Rule 17f-7, and (b) monitor such risks on a continuing basis, and promptly notify the Fund (or its duly-authorized investment manager or investment adviser) of any material change in such risks, in accordance with section (a)(1)(i)(B) of Rule 17f-7.

  • Forecasts and Orders 4.1 Customer shall provide IBM’s customer account representative with a Product demand forecast, which shall cover a minimum of twelve (12) months broken out by Product and month. By the fifth (5th) day of every month during the term of this Attachment, Customer will provide IBM’s customer account representative with an updated Product demand forecast covering a rolling twelve (12) month period (not to extend beyond the term of this Attachment), which will be reviewed for approval by IBM within ten (10) days of receipt by IBM. Forecasts shall constitute good faith estimates of Customer’s anticipated requirements for Products but shall not contractually obligate IBM to supply, nor contractually obligate Customer to purchase, the quantities of Product set forth in such forecasts.

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