Strategy Sample Clauses

Strategy. As an organization without operational services (fuel, maintenance, etc.), and in consideration that the majority of potential issues come from boat maintenance whereby the boats are personal property, the predominant strategy will be the minimization of on-site waste. With this approach, the organization will have minimal potential impact on the environment and reduce regulatory risk. To accomplish this, requirements will be established by policy, periodic communications shall occur, and audits will be utilized to provide feedback for improvement.
Strategy. The strategy is to complete a minimal additional amount of preclinical safety in parallel with the clinical development program. [**]. The filing will be based on a [**]. We note that the current phase 2 study has no control group, and can give only general information about safety and tolerability, and no real information on efficacy in humans. For this reason the [**] will be designed with a ‘vanguard’ cohort of approximately [**] patients. Once the vanguard has completed 6 months of follow up, and interim analysis will be performed, assessing the study for 1) safety, 2) efficacy or futility and 3) performance of the endpoint. Specific, detailed and comprehensive criteria will be established to allow for stopping or continuation, or adjustments in sample size or inclusion criteria. The rules for the interim analysis will be agreed with regulatory authorities in advance of any unblinding, and appropriate adjustments will be made for type 1 error. Following the interim analysis the number of participating centers will be increased to speed enrollment, and the study will continue to completion. Endpoint and sample size We will define [**] and then power the study to show at least a [**] with BL-1040 compared to placebo. This difference is clinically meaningful. To give maximum power we want to define an endpoint that has a [**] after treatment, which would be reduced to [**]. We will design a [**] that ensures an event rate that is [**] in the control arm. Failure could include [**] Any one of these events and the patient is [**]; none of these events and the patient is considered [**]. It is possible that other clinically relevant events may be added to the composite. Next we will estimate how often each of these events will happen. [**]. Control Group Event Rate Treatment Group Event Rate Sample size per arm 90% power and type 1 error < 5% Total [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] Although not required under device approval regulations, approximately [**] patients would be desirable for a safety database. If we assume that the placebo event rate will be approximately [**], we would estimate the sample size of the pivotal study to be approximately [**] patients, including the [**] patients in the vanguard cohort. Budget 2009 2010 2011 2012 2013 2014 2015 2016 TOTAL [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] TOTAL [**] [**] [**] [**] [**] [**] [**] [**] [**] Phase III Study Budget will assume [**]...
Strategy. The CHARMe Project Team is placing great emphasis on the dissemination of the project results. The CHARMe concept has been developed following the recognition that in order to exploit climate change datasets to the maximum extent, and to encourage their use by non-experts, it was necessary to develop a standardised method of managing Commentary data. Furthermore, it was noted that CHARMe cannot be developed in isolation from other organisations working in climate change and data management. To this end a comprehensive communication strategy will be developed and made available in a first version at the start of the project. The strategy will identify other initiatives and organisations that should be taken account of and how they should be approached. Existing relationships will provide the basis for this strategy, however, the objective will be to develop a comprehensive network of organisations that will acknowledge, and potentially adopt, the CHARMe concept and thereby ensuring the legacy of the project. The project team members involved will be tasked with building the necessary relationships with specific national and international organisations as defined in the strategy. For CHARMe to continue as a resource beyond the end of this project, it must be taken up by the wider user community. The science applications in WP700 are chosen to showcase some of the tools that can be built on the core system once it is adopted in archives. An assessment of the impact of adopting CHARMe procedures will be carried out (WP620) to determine the total likely implementation and operational running costs of the CHARMe system. Thus the two work packages together (WP600 and WP700) will describe both the costs and benefits to data providers of adopting CHARMe in their archives. WP800 describes the dissemination activities within the project, informing key relevant parties on the results of the research activities undertaken in both the IT and environmental part of the project. The target group includes those that produce, use or deal with climate datasets, scientists of various disciplines, policy makers, even the general public. The outcomes of the project will be disseminated at European and international level, as climate change is a global phenomenon that is affected by activities worldwide. Special emphasis of course will be given to end-users of climate data (scientists & agencies), for whom the use of reliable data is of utmost importance. Links with existing high...
Strategy. The Area Tourism Plan for the Outer Hebrides was the first one to be completed in Scotland and is commended as a good example of best practice in area tourism planning and partnership working. A number of meetings of the Area Tourism Partnership Group comprising CnES, VisitScotland, HIEIG, and the Outer Hebrides Tourism Industry Association have taken place with the venue for these meetings being rotated throughout the islands. Good progress has been made towards delivery of the Area Tourism Plan to 2009. An advisory paper on use of Gaelic within and by VisitScotland was also produced. TOURIST INFORMATION SERVICES VisitScotland operated five Tourist Information Centres in Castlebay, Lochboisdale, Lochmaddy, Tarbert, and Stornoway during the tourism season employing 14 staff. The TIC’s had over 80,000 visitor customers (an increase of 24%), dealt with over 10,000 telephone enquiries, over 3,000 email enquiries, 500 letter enquiries and also transacted 1,156 accommodation bookings (an increase of 6.5%). VisitScotland also provide information via a number of unmanned Tourist Information Points throughout the islands as well as at inter-island ferry waiting rooms and libraries. VisitScotland undertook a £10,000 refurbishment of Stornoway TIC and Castlebay and Lochboisdale TIC’s are currently having upgrading work done. Brochures were also distributed at CalMac offices at mainland ferry ports to foot passengers and car drivers. A bid has been made for funding to introduce Plasma information screens to all TIC’s.
Strategy. The Exposure will be calculated based on the current and projected outstanding principal balances of Advances, the Borrower’s existing interest rate derivatives portfolio, the Borrower’s cash balances held in the Liquidity Reserve Account, and the maturity profile of the Borrower’s Lease portfolio. · At least 70% of the Exposure (the “Hedge Requirement”) will be hedged through the use of Eligible Hedge Agreements. · If any Eligible Hedge Agreement constituting interest rate caps are used, the spread above the then “at-the-money” strike rate shall not exceed 1.50%. Eligible Hedge Agreements constituting interest rate swaps will require the Borrower to pay a fixed rate and receive a monthly floating rate, against the notional amount stated therein. · The Borrower will evaluate monthly whether it is in compliance with the Hedge Requirement and if its determination concludes that it is not in compliance, the Borrower will promptly make adjustments to its portfolio of Eligible Hedge Agreements to restore compliance.
Strategy. Medgenics will develop a regulatory strategy for the Field for the Territory (subject to Section 6.1.1 in the case of terminated countries in the European Union and Section 6.1.2 in the case of Canada), that is consistent with the terms of this Agreement. Pursuant to and in accordance with such regulatory strategy, Medgenics will use Commercially Reasonable Efforts to prepare Regulatory Approval Applications or other submissions to Regulatory Authorities that are suitable in content and format for use in all geographies in the applicable Territory (e.g., use of ICH eCTD format).
Strategy. The deployment of the PPB Officers will be accomplished to provide the best direct support of the Clean & Safe Safety Coordinators and other personnel. They will be on a common radio frequency allowing the PPB Officers to use the Safety Coordinators as "eyes and ears". The PPB Officers will also monitor the BOEC police dispatch channel. They will focus on order maintenance, high visibility patrol, and fixing chronic problems (problem solving). The PPB Officers will generally be deployed on bicycles to better facilitate this strategy. Day to day deployment and coordination of the PPB Officers will be the joint responsibility of the Clean & Safe security vendor and a Central Precinct Sergeant as designated by the Central Precinct Commander. To ensure objective #2, the PPB officers will attend the Clean and Safe Security roll call at the start of their shift as well as the Central Precinct afternoon pre-relief roll call at mid-shift. The PPB Officers assigned to the District will be available to Central Precinct Patrol Officers for high priority cover situations but will not normally be available for dispatched calls. Priorities:
Strategy. As the term is used in its application to prevention, it encompasses broad-based approaches or generalized activities to be used in attempts to delay the onset, reduce, or cause the cessation of the use of alcohol among minors and/or the use and abuse of legal and illegal drugs and substances by all members of a given population.
Strategy. For each product, develop a detailed description of the offering, identify all direct costs to fulfill/deliver, establish mutually agreeable service levels, and identify additional terms as appropriate. The parties have agreed to split the income, after all direct costs, 60% to the seller and 40% to the non-selling party unless the parties agree otherwise. The parties will pursue each of the products/services described below in the priorities indicated by the commence-activity dates and shall work to develop the required detailed description of each offering by the indicated decision-date. The parties recognize that in light of the detailed descriptions the launch dates may change. For each product that the parties mutually agree to pursue they shall enter into an addendum to this Agreement in the form of Exhibit D-4 or such other writing mutually agreed to and Executed by the Parties that at a minimum contains the information required by Section 6.1.1 of the Agreement and Exhibit D-4. Project details and timeline: