Immunological and Safety Endpoints Sample Clauses

Immunological and Safety Endpoints. Immunological endpoints will be [**]. The [**] will be evaluated [**] will also be evaluated. Emergent will be responsible for ensuring suitable clinical assays exist that have been qualified and may be performed within Emergents’s clinical assay laboratory or at a suitable contractor that is skilled in the testing of clinical samples that possess suitable experience in the techniques proposed. Safety endpoints will be adverse events, incidence of flu-like illnesses (myalgia, fever, muscle/joint aches, general malaise and headache), serious adverse events and injection site reactions assessed by the modified Draize score. Schedule 1 Appendix 2 9
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Related to Immunological and Safety Endpoints

  • Environmental Health and Safety i. Environment, Health and Safety Performance. Seller acknowledges and accepts full and sole responsibility to maintain an environment, health and safety management system ("EMS") appropriate for its business throughout the performance of this Contract. Buyer expects that Seller’s EMS shall promote health and safety, environmental stewardship, and pollution prevention by appropriate source reduction strategies. Seller shall convey the requirement of this clause to its suppliers. Seller shall not deliver goods that contain asbestos mineral fibers.

  • Environmental, Health and Safety Matters (a) Comply in all material respects with all applicable Environmental Laws, including, without limitation, obtaining and complying with and maintaining any and all licenses, approvals, notifications, registrations or permits required by applicable Environmental Laws. For purposes of this Section 5.12(a), material noncompliance by the Company, any of its Subsidiaries or any tenant or subtenant, with any applicable Environmental Law shall be deemed not to constitute a breach of this covenant provided that, upon learning of any actual or suspected material noncompliance, the Company and the relevant Subsidiaries shall promptly undertake all reasonable efforts to achieve material compliance (or contest in good faith by appropriate proceedings the alleged violation or applicable Environmental Law at issue and (to the extent required by GAAP) provide on the books of the Company or any of its Subsidiaries, as the case may be, reserves in accordance with GAAP with respect thereto), and provided further that, in any case, such noncompliance, and any other noncompliance with applicable Environmental Law, individually or in the aggregate, could not reasonably be expected to have a Material Adverse Effect. (b) Promptly comply in all material respects with all lawful orders and directives of all Governmental Authorities regarding applicable Environmental Laws, except to the extent that the validity thereof is currently being contested in good faith by appropriate proceedings and (to the extent required by GAAP) reserves in accordance with GAAP with respect thereto have been provided on the books of the Company or any of its Subsidiaries, as the case may be. (c) Defend, indemnify and hold harmless the Administrative Agent and the Lenders, and their respective parents, subsidiaries, affiliates, employees, agents, officers and directors, from and against any claims, demands, penalties, fines, liabilities, settlements, damages, costs and expenses of whatever kind or nature, known or unknown, contingent or otherwise, arising out of, or in any way relating to the violation of, noncompliance with or liability under any Environmental Laws applicable to the Company or any of its Subsidiaries or any of their respective operations or properties, or any orders, requirements or demands of Governmental Authorities related thereto, including, without limitation, attorney’s and consultant’s fees, investigation and laboratory fees, response costs, court costs and litigation expenses, except to the extent that any of the foregoing arise out of the gross negligence or willful misconduct of (or, as determined pursuant to a claim initiated by the Company, breach in bad faith of its express obligations under the applicable Loan Documents by) the party seeking indemnification therefor, in each case, as determined by a final non-appealable judgment by a court of competent jurisdiction. This indemnity shall continue in full force and effect regardless of the termination of this Agreement.

  • Environment, Health, and Safety (a) To the Knowledge of AIDEA and the Acquired Companies, except as disclosed in Disclosure Schedules 3.16(b), (d), and (e), the Acquired Companies have complied with all Environmental, Health, and Safety Laws. No action, suit, proceeding, hearing, investigation, charge, complaint, claim, demand, or notice has been filed or commenced against any of the Acquired Companies alleging any failure to so comply. Without limiting the generality of the preceding sentence, the Acquired Companies, to the Knowledge of AIDEA and the Acquired Companies, have obtained and been in compliance with all of the terms and conditions of all permits, licenses, and other authorizations that are required under, and have complied with all other limitations, restrictions, conditions, standards, prohibitions, requirements, obligations, schedules, and timetables that are contained in, all Environmental, Health, and Safety Laws. (b) Except as disclosed in Disclosure Schedule 3.16(b), neither the Acquired Companies nor AIDEA with respect to the Acquired Companies, to the Knowledge of AIDEA and the Acquired Companies, has any Liability arising out of events or circumstances occurring under any Environmental, Health, and Safety Laws for contamination of, damage to, or polluting any site, location, property, natural resources, the air, or any body of water (surface or subsurface), or for any illness of, or personal injury to, or death of, any employee or other individual related to the foregoing. (c) To the Knowledge of AIDEA and the Acquired Companies, all equipment and personal property owned, leased, or used in the Operations are and have been free of hydrocarbon contamination, asbestos, PCBs, dioxins, and any other hazardous, toxic, radioactive, or dangerous substances, except for the liquefied natural gas and compressed natural gas the Acquired Companies produce, store, and handle, and except for the fuel, lubricants, refrigerants, and solvents that are used in the ordinary course of business in conducting the Operations. The liquefied natural gas and compressed natural gas of the Acquired Companies, and the fuel, lubricants, refrigerants, and solvents used in its Operations, have all been stored, handled, transported, used, and disposed of in accordance with all Environmental, Health, and Safety Laws and consistent with all standard industry practices. (d) Except as disclosed on Disclosure Schedule 3.16(d), all real property the Acquired Companies owns is, to the Knowledge of AIDEA and the Acquired Companies, free from contamination by any substance regulated under, or defined as or considered “hazardous” or “toxic” or “radioactive” or “contamination” or “pollution” under, any Environmental, Health, and Safety Laws, including but not limited to hydrocarbons, asbestos, PCBs, and dioxins. AIDEA has provided IGU with true and complete copies of all environmental assessments, studies, and reports (1) of which AIDEA and the Acquired Companies have Knowledge and (2) that reference the real property any of the Acquired Companies owns, leases, or uses. Although neither AIDEA nor the Acquired Companies has conducted any environmental assessments regarding the leased real property used by the Acquired Companies, neither AIDEA nor the Acquired Companies has Knowledge of any environmental contamination on or under the portions of any leased or used real property where any of the Operations have been conducted. (e) Except as disclosed on Disclosure Schedule 3.16(e), neither the Acquired Companies nor AIDEA has Knowledge of any leak, spill, release, discharge, or disposal of any substance regulated under, or defined as or considered “hazardous” or “toxic” or “radioactive” or “contamination” or “pollution” under any Environmental, Health, and Safety Laws that has occurred on, in, or under the real property any of the Acquired Companies owns, leases, or uses, or has ever owned, leased, or used, in conducting the Operations, that was reportable or should have been reported to any government or governmental agency, or that was or could have been subject to clean up or remediation, under any Environmental, Health, and Safety Laws. (f) Except as disclosed on Disclosure Schedule 3.16(f), to the Knowledge of AIDEA and the Acquired Companies, there is no underground storage tank present on any real property any of the Acquired Companies owns, leases, or uses or has owned, leased or used, in conducting the Operations.

  • Health and Safety Plan Consultant shall prepare and submit a Health and Safety Plan (“HASP”) for the portion of Consultant’s work that will involve field work, assessments, or investigations of certain Project elements. The HASP shall describe how Consultant plans to complete field work, assessments, and/or investigations at the RWF. Consultant’s HASP must comply with the CIP HASP and shall be updated as new conditions are encountered.

  • WORKPLACE HEALTH AND SAFETY The parties to this Agreement are committed to providing a safe and healthy workplace and work practices. The parties recognise that illness or injury at the workplace is costly to the employer and the employees and also disruptive to the respective parties. To facilitate healthy and safe work practices, the parties to the Agreement are committed to discussing health and safety issues as they apply to the operations of the employer as part of the consultative measures under this Agreement. The employer and employees under this agreement may refer to their respective industrial representatives for appropriate advice or expertise in enhancing performance with due regard to health and safety initiatives. The parties also recognise the importance of conducting regular audits of the employer's operations, policies and procedures including the employees' skills, knowledge, qualifications and application of healthy and safe work practices.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, 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, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies 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.

  • D5 Health and Safety The Contractor shall promptly notify the Authority of any health and safety hazards which may arise in connection with the performance of its obligations under the Contract. The Authority shall promptly notify the Contractor of any health and safety hazards which may exist or arise at the Authority’s Premises and which may affect the Contractor in the performance of its obligations under the Contract.

  • OCCUPATIONAL HEALTH AND SAFETY 34.01 The parties recognize the need for a safe and healthy workplace. The Employer shall be responsible for providing safe and healthy working conditions. The Employer and Employees will take all reasonable steps to eliminate, reduce or minimize all workplace safety hazards. Occupational health and safety education, training and instruction provided by the Employer, shall be paid at the Basic Rate of Pay, to fulfill the requirements for training, instruction or education set out in the Occupational Health and Safety Act, Regulation or Code. (a) There shall be an Occupational Health and Safety Committee (Committee), which shall be composed of representatives of the Employer and representatives of the Local and may include others representing recognized functional bargaining units. This Committee shall meet once a month, and in addition shall meet within 10 days of receiving a written complaint regarding occupational health or safety. An Employee shall be paid the Employee’s Basic Rate of Pay for attendance at Committee meetings. A request to establish separate committees for each site or grouping of sites shall not be unreasonably denied. The Employer shall provide training at no cost to all Employees on the Committee to assist them in performing their duties on the Committee. Training shall be paid at the Employee’s Basic Rate of Pay. (b) Minutes of each meeting shall be taken and shall be approved by the Employer, the Local, and other bargaining groups, referred to in (a), prior to circulation. (c) The purpose of the Committee is to consider such matters as occupational health and safety and the Local may make recommendations to the Employer in that regard. (d) If an issue arises regarding occupational health or safety, the Employee or the Local shall first seek to resolve the issue through discussion with the applicable immediate supervisor in an excluded management position. If the issue is not resolved satisfactorily, it may then be forwarded in writing to the Committee. (e) The Committee shall also consider measures necessary to ensure the security of each Employee on the Employer’s premises and the Local may make recommendations to the Employer in that regard. (f) (i) Should an issue not be resolved by the Committee, the issue shall be referred to the Chief Executive Officer (CEO). A resolution meeting between the Local and the CEO, or designate(s), shall take place within 21 calendar days of the issue being referred to the CEO. The CEO or designate(s) shall reply in writing to the Local within seven (7) calendar days of the resolution meeting.

  • HEALTH AND SAFETY 25.01 The Employer is subject to the provisions of the Occupational Health and Safety Act of the Province of Ontario and its regulations, including the provision that calls for a worker representative selected by the Union on the University Joint Health and Safety Committees. It is agreed that the University and the Union will cooperate to the fullest possible extent in the prevention of accidents and the promotion of safety and health at University workplaces. To this end, the parties acknowledge and agree that all University Employees on University and third-party premises where Employees work, are required to comply with work- site specific policies, procedures, regulations, and standards relating to health and safety. 25.02 The Employer recognizes the right of workers to be informed about hazards in the workplace, to be provided with appropriate training, and the right to refuse unsafe work in accordance with the Occupational Health and Safety Act where there is an immediate danger to the Employee’s health and safety or to the health and safety of others. 25.03 The Union will select a worker representative for each applicable Joint Health and Safety Committee formed under the Occupational Health and Safety Act. Time spent attending meetings of the Committee or carrying out duties as a worker representative shall be considered time worked. 25.04 A worker representative on a Joint Health and Safety Committee may become a certified worker representative on the Committee. The University will provide the required training for certification at no cost to the Employee or the Union. Time spent in such training shall be considered time worked, as outlined in Article 13 – Hours of Work and Overtime. 25.05 When a worker representative on a Joint Health and Safety Committee ceases to be employed in the Bargaining Unit, he/she will cease to be a worker representative on the Committee. 25.06 The University will supply, and Employees will wear and/or utilize, personal protective equipment and the other devices that the University requires Employees to wear and/or utilize. 25.07 The Employer shall provide information, training and supervision to an Employee to protect the health and safety of that Employee. With reference to Article 13, time spent in such training shall be considered time worked, as outlined in Article 13 – Hours of Work and Overtime. 25.08 The name and contact information of the Health and Safety Officer in each Academic Unit shall be posted in the Department/Academic Unit. 25.09 In accordance with the Occupational Health and Safety Act, persons with authority in the workplace, including any Employees, shall ensure that persons under their authority are informed of health and safety hazards, and advised of policies and procedures associated with the safe handling of materials and equipment.

  • Environmental and Safety Matters (a) The Company and its Subsidiaries have at all times complied in all material respects with all applicable Environmental and Safety Requirements, which compliance has included obtaining and complying in all material respects at all times with all material permits, licenses and other authorizations required pursuant to Environmental and Safety Requirements for the occupation of their facilities and the operation of their respective businesses. (b) Except as set forth in Section 4.27(b) of the Disclosure Schedule, since February 19, 2008, neither the Company nor any of its Subsidiaries has received any notice, report, order, or directive regarding any, and is not subject to any litigation, proceedings or order regarding any, actual or alleged violation of Environmental and Safety Requirements, or any liability or potential liability arising under Environmental and Safety Requirements, in effect prior to and as of the date of the applicable Closing, relating to the business, the Owned Real Property or Leased Real Property. (c) Except as set forth in Section 4.27(c) of the Disclosure Schedule, neither the Company nor any of its Subsidiaries has treated, stored, disposed of, arranged for or permitted the disposal of, transported, handled, released, or exposed any Person to, any substance (including without limitation any hazardous substance), owned or operated any property or facility which is or has been contaminated by any substance, so as to give rise to any current or future liabilities under any Environmental and Safety Requirements in effect at the time of such treatment, storage, disposal, transportation, handling, release or exposure. (d) Except as set forth in Section 4.27(d) of the Disclosure Schedule, neither the Company nor any of its Subsidiaries has assumed, undertaken, or provided any indemnity with respect to, any liability of any other Person relating to Environmental and Safety Requirements. (e) The Company has furnished to Investor true and correct copies of all environmental audits, reports, assessments and all other documents materially bearing on environmental, health or safety liabilities relating to the past or current operations or facilities of the Company and all of its Subsidiaries, in each case which are in its possession or under its reasonable control.

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