Workplan Items Sample Clauses

Workplan Items. (i) As soon as practicable following execution and delivery of this Agreement by the Parties, New Commons and BMAHC will undertake the preparation of the Feasibility Study. (ii) The Feasibility Study will be prepared in accordance with the Terms of Reference attached at Schedule B and for certainty will include the following: (A) a preliminary Project Design reflecting the values, aspirations and requirements of BMAHC; (B) the review and if necessary augmentation of the existing phase 1 environmental site assessment; (C) a preliminary Capital Budget and Pro Forma and financing strategy; (D) Securing funding and financing as required to undertake subsequent phases of development work; and (E) A high level assessment of possible green build components that should be included in the Project, including managing the Green Municipal Fund grant and attendant deliverables including revision of a workplan and reporting to Federation of Canadian Municipalities for the conduct of a feasibility study assessing energy requirements and outcomes of the Project using an evaluative process, cost benefit analysis, and recommendations for actions.
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Workplan Items. During the Pre-Development Phase, New Commons and BMAHC will use commercially reasonable efforts to carry out, or cause to be carried out, the following: (i) the terms and conditions on which the Lands, if any, will be acquired; (ii) updating and refining the Project Design on a schematic basis; (iii) preparing a Project Schedule in accordance with the information created or obtained during the Pre-Development Phase; (iv) Facilitate and manage the procurement of a design/builder with BMAHC (including the drafting and issuance of a request for qualifications and a request for proposals and supporting the evaluation processes of both) resulting in the execution of a Design-Build Stipulated Price Contract; (v) updating and refining the Capital Budget and Pro Forma to reflect the Project Design, financing and operating model, site conditions and other information created or obtained during the Pre- Development Phase; (vi) Produce and manage a business plan consisting of Project budget and cashflow, schedule and development plan; (vii) Support and engage in zoning/rezoning and other planning approvals if needed, in coordination with BMAHC and Town staff including management of all required pre-development studies and participation in related open house and public meetings, as required; (viii) review the public and private financing options and deal structure and submit any necessary financing applications, obtain financing letters of interest; and (ix) Securing funding and financing as required to undertake subsequent phases of development work.
Workplan Items. During the Permitted Phase, New Commons and BMAHC will use commercially reasonable efforts to carry out, or cause to be carried out, the following: (i) if applicable, entering into definitive, binding agreements by which the Lands will be acquired, subject to no conditions other than the declaration of Construction Green Light, unless otherwise agreed by the parties; (ii) supporting stakeholder and community engagement and updating and refining the Project Design to a level sufficient to obtain the Official Plan, Zoning and Site Plan Approvals, as applicable; (iii) obtaining the Official Plan, Zoning and Site Plan Approvals, subject (where applicable) to conditions within the control of BMAHC and/or New Commons; (iv) meeting all conditions specified in connection with any Official Plan, Zoning, and Site Plan approvals that are capable of being met during the Permitting Phase; (v) obtaining letters of interest or expressions of interest for capital funding, construction financing and permanent financing sufficient to complete and operate the Project in accordance with the Pro Forma; (vi) conducting a phase 2 environmental site assessment if recommended in the phase 1 environmental assessment obtained during the Feasibility Phase; (vii) obtaining expressions of interest in respect of Third Party Components, if the parties agree that the Project may contain such components; (viii) obtaining the Building Permits; (ix) if applicable, securing contracts for the purchase and sale of any Third Party Components, subject to no conditions other than the declaration of Construction Green Light, unless otherwise agreed by the parties; (x) if applicable, securing commitments from Project Equity Investors, subject to no conditions other than the declaration of Construction Green Light, unless otherwise agreed by the parties; (xi) securing conditional commitments in respect of the Debt Financing; (xii) meeting all conditions specified by lenders of the Debt Financing which are capable of being met during the Permitting Phase; (xiii) facilitate and manage the procurement of qualified design builder; (xiv) if applicable, finalizing any plans related to the relocation of residents and occupants of the Lands, and obtaining commitments in respect of any alternative accommodations in connection with such relocation; (xv) updating and refining the Project Schedule in accordance with the information created or obtained during the Permitting Phase; and (xvi) updating and refining ...
Workplan Items. During the Construction Phase, New Commons will use commercially reasonable efforts to carry out, or cause to be carried out, the following: (i) if applicable, complete the acquisition of the New Lands and, if necessary, consolidate the Lands and the New Lands; (ii) updating the Project Design as required in accordance with the issued Building Permits; (iii) work with BMAHC to finalize and execute a Design Build Stipulated Price Contract; (iv) updating and refining the Project Schedule in accordance with the information created or obtained during the Permitting Phase; (v) updating the Pro Forma based on competitive pricing of the Project; (vi) work with BMAHC to grant, register and perfect such security as may be required to secure the Debt Financing; and (vii) ensuring that construction of the Project is carried out and completed in compliance with this Agreement, the Design_Build Stipulated Price Contract, industry best practices, the Development Permits, the Building Permits, lending agreements, and any applicable requirements of Governmental Authorities.

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  • Participant Responsibilities You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, as determined by the study investigator, that may put your safety at risk or could have an effect on the study results • Optional Japanese participants must have 4 Japanese biological grandparents who were born in Japan • You must weigh more than 110 lb (99 lb if a Japanese participant) • Your body mass index (BMI) must be between: o Part A, B, and C – 20 -33 kg/m2 o Japanese participants – 16 – 33 kg/m2 • You may be asked to provide documentation of your childbearing status • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, minerals, or vitamins) within 7 days before the first dose or at any time during the study o You must not take hormone replacement therapy (HRT) within 28 days before the first dose or at any time during the study ▪ Depo-Provera® must be discontinued at least 6 months before the first dose o Before taking any drugs other than the study drugs, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study • You must not have taken any medications, dietary or herbal supplements that are inhibitors or inducers of certain enzymes or proteins within 14 days or 5 half-lives (which is drug dependent); before the first dose or at any time during the study o The study investigator or study staff will review a list of these medications and substances with you • You must not take any investigational product (drug or vaccine) within 30 days before the first dose of this study • You must not have a history of sensitivity reactions to midazolam or any of the components of the liquid formulation • You may only participate in one part of this study • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done to check for such drugs. o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day • You must not use tobacco- or nicotine-containing products for 24 hours before the first dose and while confined to the CRU • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study • You will need to stay in the CRU for up to 12 days (Part A) starting with each check-in o Japanese participants will need to stay in the CRU for 12 days starting with check-in o Participants in Group 4 will need to stay in the CRU for 26 days starting with check-in • You will need to stay in the CRU for 19 days (Part B) • You will need to stay in the CRU for 13 days (Part C) • All participants: you may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You may be asked to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You will be confined to the procedure room for the first 4 hours during each continuous cardiac monitoring, except to use the bathroom (Part A only) • You cannot lie down for 4 hours after dosing on days when blood samples for study drug levels are collected, unless needed for study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses • You must not eat or drink anything except water for at least 10 hours before each safety laboratory test • You must not eat or drink anything except water for at least 10 hours before collection of the pre- dose blood sample for study drug and other pre-dose blood samples o Except for 1 hour before and 1 hour after dosing (Part A only), you may drink water freely o You can drink water freely if you are in Part B or C • If dosing under fasting conditions (Part A), you must not eat or drink anything (except water) for at least 10 hours before dosing • If dosing under fed conditions (Part A), you must not eat or drink anything except water for at least 10 hours before eating breakfast • If dosing when an OGTT will be done (Parts A and B), you must not eat or drink anything (except water) for at least 10 hours before dosing and/or OGTT • If dosing with a standard breakfast (Part B and C), you must not eat or drink anything (except water) for at least 10 hours before eating breakfast • You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, Xx. Xxxxxx®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Lunch will be provided about 4–5 hours after dosing • Dinner will be provided about 9-10 hours after dosing • An evening snack may be allowed about 12-13 hours after dosing • If it is necessary to split doses and dose twice a day, the timing of meals or snacks may be changed during • Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. This study is for research purposes only. Your alternative is to not take part in the study.

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