Severity Assessment Sample Clauses

Severity Assessment. 3.1 Each force PSD will nominate a single point of contact (SPOC). The SPOCs will under take a severity assessment of the complaint or incident.
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Severity Assessment. The investigator will assess the severity of all adverse events using the ***,***, or *** to describe the maximum intensity of each adverse event. For purposes of consistency, these intensity grades are defined as follows: · ***; · ***; · ***. Note the distinction between the severity and the seriousness of an adverse event. A *** is not necessarily a ***. For example, a headache may be *** but would not be classified as serious unless it met one of the criteria for ***.
Severity Assessment. ‌ Investigators will assess the severity of all adverse events using the adjectives MILD, MODERATE, or SEVERE to describe the maximum intensity of each adverse event. For purposes of consistency, these intensity grades are defined as follows: • MILD: Does not interfere with the subject’s usual function; • MODERATE: Interferes to some extent with the subject’s usual function; or • SEVERE: Interferes significantly with the subject’s usual function. Note the distinction between the severity and the seriousness of an adverse event. A severe event is not necessarily a serious event. For example, a headache may be severe (interferes significantly with subject’s daily function) but would not be classified as serious unless it met one of the criteria for SAEs listed in Section 11.1.5.
Severity Assessment. The investigator will assess the severity of all adverse events using the ***, ***, or *** to describe the maximum intensity of each adverse event. For purposes of consistency, these intensity grades are defined as follows: · ***; · ***; · ***. *** 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. Note the distinction between the severity and the seriousness of an adverse event. A *** is not necessarily a ***. For example, a headache may be *** but would not be classified as serious unless it met one of the criteria for ***.

Related to Severity Assessment

  • Joint Assessment If the Building is not separately assessed, Real Property Taxes allocated to the Building shall be an equitable proportion of the Real Property Taxes for all of the land and improvements included within the tax parcel assessed, such proportion to be determined by Lessor from the respective valuations assigned in the assessor's work sheets or such other information as may be reasonably available. Lessor's reasonable determination thereof, in good faith, shall be conclusive.

  • No Joint Assessment Borrower shall not suffer, permit or initiate the joint assessment of the Property (a) with any other real property constituting a tax lot separate from the Property, and (b) which constitutes real property with any portion of the Property which may be deemed to constitute personal property, or any other procedure whereby the lien of any taxes which may be levied against such personal property shall be assessed or levied or charged to such real property portion of the Property.

  • Phase II A small portion of the work for the Phase II modifications to the Plattsburgh Substation will be performed by Transmission Owner, and the remainder will be performed by Clinton and Xxxxxxxxx. A detailed definition of the specific scope for Transmission Owner and Clinton and Xxxxxxxxx including interface points shall be defined during the design phase and, as such documents become available, copies will be delivered to the NYISO, Transmission Owner, Noble Altona Windpark, LLC and Marble River, LLC. The full scope includes the installation of wave traps, CCVT’s and modifications and/or additions to relaying on the MWP-1 and MWP- 2 lines. These lines will be reconfigured at the completion of Phase II to connect to Xxxxx and Xxxxxxx Substations on MWP-1 and the Xxxx Substation on MWP-2. Clinton and Xxxxxxxxx will design the upgrades and purchase the materials based on the outline specification that was prepared and issued by Transmission Owner. The work to be performed by Clinton and Xxxxxxxxx will include both the materials for the exterior and interior installations and items for Transmission Owner installation inside the control building in existing relay panels and communication racks. In addition, Clinton and Xxxxxxxxx will be responsible for the exterior and interior construction work and will provide construction management services in coordination with Transmission Owner. The civil design for the foundations and the electrical design for the cable runs to the control room will be designed by, as approved by Transmission Owner, and installed under the supervision and control of Clinton and Xxxxxxxxx. The equipment will be selected and procured in accordance with the specifications developed during the detailed engineering phase, copies of which shall be furnished to the NYISO, Transmission Owner, Noble Altona Windpark, LLC and Marble River, LLC. The construction of the foundations, structures, wave traps, CCTV and cable runs into the control building to the termination cabinets will be completed by Clinton and Xxxxxxxxx. The work at the Plattsburgh Substation will be installed under Transmission Owner’s CPP-1. Transmission Owner will provide Protection and Controls Engineering, install and terminate wiring from the termination cabinets to the control panels and relays, install relays and equipment in the existing panels, and will commission such work inside the 230kV control building. Transmission Owner will develop the communications protocols and data flow over the circuits.

  • 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.

  • Risk Assessments a. Risk Assessment - Transfer Agent 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 occurring and the impact of those threats upon the Transfer Agent organization to evaluate and analyze the appropriate level of information security safeguards (“Risk Assessments”).

  • Assessment 29) The Secretary of State will notify the appropriate body for assessment purposes about the Academy.

  • Phase I a. In Phase I, the project will be connected as a tap to the Transmission Owner’s 230kV transmission line MWP-2 via one 230kV circuit breaker in series with one of two ring bus breakers for stuck breaker protection (one in each direction) and a tie-line breaker, as shown on the one-line diagram labeled CL-E-IA-01 attached to this Appendix A as Figure 1. The changes to the existing MWP-2 line protection for this arrangement are described in Phase I System Upgrades in Section II of this Appendix A.

  • Stability Testing Patheon may be requested to conduct stability testing on the Products in accordance with the protocols set out in the Specifications for the separate fees and during the time periods set out in Schedule C to a Product Agreement. Patheon will not make any changes to these testing protocols without prior written approval from Client. If a confirmed stability test failure occurs, Patheon will notify Client within one Business Day, after which Patheon and Client will jointly determine the proceedings and methods to be undertaken to investigate the cause of the failure, including which party will bear the cost of the investigation. Patheon will not be liable for these costs unless it has failed to perform the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws. Patheon will give Client ail stability test data and results at Client’s request.

  • 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.

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