Agreement and Safety Data Exchange Sample Clauses

Agreement and Safety Data Exchange. Within one hundred twenty (120) days after the Effective Date, or as soon as possible thereafter, the parties shall execute a Pharmacovigilance Agreement (or “PVA”) that will define the responsibilities of the parties in respect of pharmacovigilance in relation to the Product in the framework of this Agreement, including with regard to the process for the transfer and exchange of safety data and contacts with Regulatory Authorities, in accordance with Applicable Laws. The parties shall enter into the PVA on terms no less stringent than those required by ICH or other applicable guidelines. From the Effective Date of this Agreement, parties shall exchange safety data relating to the Product within appropriate timeframes and in an appropriate format to ensure compliance with the reporting requirements of all applicable Regulatory Authorities on a worldwide basis. In no case shall exchange of Adverse Events (or “AEs”) occur later than five (5) calendar days for fatal/life threatening AEs, nine (9) calendar days for other related serious AEs, twenty-four (24) calendar days for non-serious AEs for post marketing cases, and in addition to the timelines for fatal and related serious AEs, twelve (12) calendar days for other serious, unrelated AE cases, twenty-four (24) calendar days for pregnancy and overdose with no AE, and twenty-seven (27) calendar days for serious ICSR following the end of study unblinding for clinical trials.
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Agreement and Safety Data Exchange 
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Related to Agreement and Safety Data Exchange

  • Environment, Health, and Safety (i) The Seller, and its predecessors and Affiliates has complied with all Environmental, Health, and Safety Laws, and no action, suit, proceeding, hearing, investigation, charge, complaint, claim, demand, or notice has been filed or commenced against any of them alleging any failure so to comply. Without limiting the generality of the preceding sentence, each of the Seller, and its predecessors and Affiliates has obtained and been in compliance with all of the terms and conditions of all permits, licenses, and other authorizations which are required under, and has complied with all other limitations, restrictions, conditions, standards, prohibitions, requirements, obligations, schedules, and timetables which are contained in, all Environmental, Health, and Safety Laws.

  • Environmental, Health and Safety The Policy Board shall review, approve and monitor environmental and workplace health and safety guidelines, the goal of which is to achieve compliance with current national, state and local laws and regulations regarding environmental and workplace health and safety.

  • Environmental, Health and Safety Matters (a) The Company has complied and is in compliance with all Environmental, Health, and Safety Requirements.

  • Health and Safety All employees and workers have a duty in law to act responsibly and to take reasonable care for the health and safety at work of both themselves and their colleagues. This duty can be carried out by:

  • Environmental, Health and Safety Laws There does not exist any violation by the Borrower or any Subsidiary of any applicable federal, state or local law, rule or regulation or order of any government, governmental department, board, agency or other instrumentality relating to environmental, pollution, health or safety matters which will or threatens to impose a material liability on the Borrower or a Subsidiary or which would require a material expenditure by the Borrower or such Subsidiary to cure. Neither the Borrower nor any Subsidiary has received any notice to the effect that any part of its operations or properties is not in material compliance with any such law, rule, regulation or order or notice that it or its property is the subject of any governmental investigation evaluating whether any remedial action is needed to respond to any release of any toxic or hazardous waste or substance into the environment, the consequences of which non-compliance or remedial action could constitute an Adverse Event.

  • Environmental and Safety Matters Except as disclosed in Schedule 4.13:

  • Global Safety Database Licensee shall establish, hold and maintain (at Licensee’s sole cost and expense) the global safety database for Licensed Products.

  • Environmental and Safety Laws To its knowledge, the Company is not in violation of any applicable statute, law or regulation relating to the environment or occupational health and safety, and to its knowledge, no material expenditures are or will be required in order to comply with any such existing statute, law or regulation.

  • Anti-Money Laundering Program Services BNYM will perform one or more of the services described in subsections (1) through (7) of this Section 3(b) if requested by the Fund and the Fund agrees to pay the fees applicable to the service as set forth in the Fee Agreement (“AML Services”).

  • COMPLIANCE WITH GOVERNMENTAL RULES AND REGULATIONS; RECORDS The Trust assumes full responsibility for its compliance with all securities, tax, commodities and other laws, rules and regulations applicable to it.

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