Global Safety Database and Safety Reporting Sample Clauses

Global Safety Database and Safety Reporting. Subject to Section 9.2.7, Pfizer shall maintain the global safety database for the Candidates and Products pursuant to this Agreement and the Commercialization Agreement. Provided that (a) BioNTech (subject to Section 9.1) will be the Lead Development Party with respect to Clinical Trials conducted in the EU, (b) BioNTech will hold a safety database to meet its sponsor responsibilities and regulatory responsibilities in the EU and to hold safety data reports received from China; (c) information shall be exchanged between Pfizer and BioNTech as described in the Pharmacovigilance Agreement to ensure alignment of information between the databases and (d) BioNTech will delegate its responsibilities for the collection, processing, assessment and safety reporting to Regulatory Authorities for all Clinical Trial(s) conducted pursuant to the Research and Development Plan in the Territory upon the approval of the IND for Candidate(s) with FDA. Notwithstanding the foregoing, such responsibility can only be delegated to and Pfizer can only accept this responsibility if the Clinical Trial sites for the Candidates and Products are reporting the safety data, including all individual Serious Adverse Events, translated into English, to Pfizer and for so long as Pfizer has access to all safety data, including all individual Serious Adverse Events, translated into English for any and all active Clinical Trials for the Candidates and Products, including products identical to Candidates or Products conducted under the terms and conditions of the Fosun Agreement (or subsequent agreements with other development partners) to allow Pfizer to meet its regulatory obligations as Lead Development Party in the Territory.
Sample 1Sample 2
AutoNDA by SimpleDocs
Global Safety Database and Safety Reporting. Subject to the Pharmacovigilance Agreement entered into as described in Section 8.3.3 as amended from time, Pfizer shall maintain the global safety database for the Candidates and Products pursuant to this Agreement, provided that (a) BioNTech will hold a safety database to meet its sponsor responsibilities and regulatory responsibilities in the EU and any other countries or markets in the BioNTech Commercialization Territory and to hold safety data reports received from the Fosun Territory; (b) information shall be exchanged between Pfizer and BioNTech as described in the Pharmacovigilance Agreement to ensure alignment of information between the databases; and (c) BioNTech will delegate to Pfizer its responsibilities for the collection, processing, assessment and safety reporting to Regulatory Authorities for (i) all Clinical Trial(s) conducted pursuant to this Agreement and the Research and Development Plan thereunder in the Territory upon the approval of the IND for Candidate(s) with FDA and (ii) upon Regulatory Approval of the Marketing Authorization Applications or grant of Emergency Use Authorization, adverse event and other safety information relating to the Candidates or Products. Notwithstanding the foregoing, such responsibility can only be delegated to and Pfizer can only accept this responsibility if, with respect to safety information arising from clinical trials, the Clinical Trial sites for the Candidates and Products are reporting the safety data and, with respect to safety information from Commercialization Activities and Medical Activities, BioNTech and its Affiliates are reporting the safety data, in each case, including all individual Serious Adverse Events, translated into English, to Pfizer and for so long as Pfizer has access to all safety data, including all individual Serious Adverse Events, translated into English for any and all active Clinical Trials for the Candidates and Products, including products identical to Candidates or Products conducted under the terms and conditions of the Fosun Agreement (or subsequent agreements with other development partners) and for all Commercialization Activities and Medical Activities conducted by or on behalf of BioNTech to allow Pfizer to meet its regulatory obligations as Lead Regulatory Party in the Territory.
Sample 1

Related to Global Safety Database and Safety Reporting

  • CERTIFICATION REGARDING DRUG-FREE WORKPLACE REQUIREMENTS 1. The Contractor certifies that it will provide a drug-free workplace by: a. Publishing a statement notifying employees that the unlawful manufacture, distribution, dispensing, possession or use of a controlled substance is prohibited in the Contractor’s workplace and specifying the actions that will be taken against employees for violation of such prohibition;

  • Function of Joint Health and Safety Committee All incidents involving aggression or violence shall be brought to the attention of the Joint Health and Safety Committee. The Employer agrees that the Joint Health and Safety Committee shall concern itself with all matters relating to violence to staff.

  • 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.

  • COMPLIANCE WITH HEALTH, SAFETY, AND ENVIRONMENTAL REGULATIONS The Contractor, it’s Subcontractors, and their respective employees, shall comply fully with all applicable federal, state, and local health, safety, and environmental laws, ordinances, rules and regulations in the performance of the services, including but not limited to those promulgated by the City and by the Occupational Safety and Health Administration (OSHA). In case of conflict, the most stringent safety requirement shall govern. The Contractor shall indemnify and hold the City harmless from and against all claims, demands, suits, actions, judgments, fines, penalties and liability of every kind arising from the breach of the Contractor’s obligations under this paragraph.

  • 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.

  • Contract Work Hours and Safety Standards Act The following clauses apply to any Federal-aid construction contract in an amount in excess of $100,000 and subject to the overtime provisions of the Contract Work Hours and Safety Standards Act. These clauses shall be inserted in addition to the clauses required by 29 CFR 5.5(a) or 29 CFR 4.6. As used in this paragraph, the terms laborers and mechanics include watchmen and guards.

  • Work Health and Safety (a) The employer and employee acknowledge their responsibilities under the Work Health and Safety Act 2011 and Work Health and Safety Regulations 2012. (b) Where there is a Work Health and Safety Representative they must be elected and will carry out the tasks associated with the role of Work Health and Safety Representative set out within the Work Health and Safety Act 2011.

  • 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.

  • HEALTH, SAFETY AND ENVIRONMENT In the performance of this Contract, Contractor and Operator shall conduct Petroleum Operations with due regard to health, safety and the protection of the environment (“HSE”) and the conservation of natural resources, and shall in particular:

  • CONTRACT WORK HOURS AND SAFETY STANDARDS As per the Contract Work Hours and Safety Standards Act (40 U.S.C. 3701-3708), where applicable, all Customer Purchase Orders in excess of ,000 that involve the employment of mechanics or laborers must include a provision for compliance with 40 U.S.C. 3702 and 3704, as supplemented by Department of Labor regulations (29 CFR Part 5). Under 40 U.S.C. 3702 of the Act, each contractor must be required to compute the wages of every mechanic and laborer on the basis of a standard work week of 40 hours. Work in excess of the standard work week is permissible provided that the worker is compensated at a rate of not less than one and a half times the basic rate of pay for all hours worked in excess of 40 hours in the work week. The requirements of 40 U.S.C. 3704 are applicable to construction work and provide that no laborer or mechanic must be required to work in surroundings or under working conditions which are unsanitary, hazardous or dangerous. These requirements do not apply to the purchases of supplies or materials or articles ordinarily available on the open market, or contracts for transportation or transmission of intelligence.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!