Investigator Safety Letters Sample Clauses

Investigator Safety Letters. Each Party shall promptly (but in no event later than 72 hours before expiration of the earliest deadline to provide notice to clinical investigators pursuant to all relevant guidelines of Regulatory Authorities governing the conduct of clinical trials worldwide) provide a copy of all investigator safety letters generated by it or its Affiliates or licensees in connection with worldwide clinical studies of products containing AP23573 to the Principal Liaison of other Party. Upon receipt thereof, the Party receiving such investigator safety letter shall (i) timely (in accordance with all relevant guidelines of Regulatory Authorities) disseminate or cause to be disseminated such investigator safety letters to each clinical investigator conducting clinical trials in any patient population worldwide with any product containing AP23573 on behalf of it or its Affiliates or licensees, and (ii) within 24 hours thereafter, confirm in writing to the Principal Liaison of the Party disclosing such investigator safety letter that it has complied with its obligation in clause (i) of this sentence.
Sample 1
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Investigator Safety Letters. Each Party shall promptly (but in no event later than 72 hours before expiration of the earliest deadline to provide notice to clinical investigators pursuant to all relevant guidelines of Regulatory Authorities governing the conduct of Clinical Trials worldwide) provide a copy of all investigator safety letters generated by it or its Affiliates, licensees or sublicensees in connection with worldwide Clinical Trials of products containing AP23573 to the Principal Liaison of other Party. Upon receipt thereof, the Party receiving such investigator safety letter shall (i) timely (in accordance with all relevant guidelines of Regulatory Authorities) disseminate or cause to be disseminated such investigator safety letters to each clinical investigator conducting Clinical Trials in any patient population worldwide with any product containing AP23573 on behalf of it or its Affiliates, licensees or sublicensees, and (ii) within 24 hours thereafter, confirm in writing to the Principal Liaison of the Party disclosing such investigator safety letter that it has complied with its obligation in clause (i) of this sentence.
Sample 1

Related to Investigator Safety Letters

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

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

  • Copies of policies; letters of undertaking Each Borrower shall ensure that all approved brokers provide the Security Trustee with pro forma copies of all policies relating to the obligatory insurances which they are to effect or renew and of a letter or letters of undertaking in a form required by the Security Trustee and including undertakings by the approved brokers that:

  • 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.

  • Quality Assurance Licensee agrees that all use of the Licensed Subject Matter shall be only upon the Products manufactured by or for Licensee in accordance with quality standards approved by Licensor prior to the commencement of manufacturing of the Products. Licensee shall submit for Licensor's sole and absolute approval the type of cereal, the name of cereal, the packaging design, advertising material, and all other materials to be used in connection with the Products subject to the sole and absolute approval of Licensor which shall not be unreasonably delayed or withheld.

  • Periodic Review of Compliance Policies and Procedures During the Term, Transfer Agent shall periodically assess its compliance policies and procedures (the “Policies”). Transfer Agent shall provide, (i) no less frequently than annually, electronic access to its Policies to the chief compliance officer of the Fund (the “Chief Compliance Officer”), and/or any individual designated by the Fund or such Chief Compliance Officer, including but not limited to members of the internal compliance and audit departments of Federated Investors, Inc., and any advisory board constituted by the Fund provided that the Transfer Agent may reasonably require any members of such advisory board that are not employees of the Fund or its Affiliates to execute a confidentiality agreement with respect to such information; (ii) at such reasonable times as he or she shall request, access by such Chief Compliance Officer to such individuals as may be necessary for the Chief Compliance Officer to conduct an annual review of the operation of such Policies for purposes of making his or her annual report to the Board of the Fund (the “Annual Report”), (iii) promptly upon enactment, notification of, and a copy of, any material change in such Policies, and (iv) promptly upon request, such other information as may be reasonably requested by such Chief Compliance Officer for purposes of making such Annual Report.

  • Review Scope The parties confirm that the Asset Representations Review is not responsible for (a) reviewing the Receivables for compliance with the representations and warranties under the Transaction Documents, except as described in this Agreement or (b) determining whether noncompliance with the representations and warranties constitutes a breach of the Eligibility Representations. For the avoidance of doubt, the parties confirm that the review is not designed to determine why an Obligor is delinquent or the creditworthiness of the Obligor, either at the time of any Asset Review or at the time of origination of the related Receivable. Further, the Asset Review is not designed to establish cause, materiality or recourse for any Test Fail (as defined in Section 3.05).

  • Environmental Compliance and Reports Borrower shall comply in all respects with any and all Environmental Laws; not cause or permit to exist, as a result of an intentional or unintentional action or omission on Borrower's part or on the part of any third party, on property owned and/or occupied by Borrower, any environmental activity where damage may result to the environment, unless such environmental activity is pursuant to and in compliance with the conditions of a permit issued by the appropriate federal, state or local governmental authorities; shall furnish to Lender promptly and in any event within thirty (30) days after receipt thereof a copy of any notice, summons, lien, citation, directive, letter or other communication from any governmental agency or instrumentality concerning any intentional or unintentional action or omission on Borrower's part in connection with any environmental activity whether or not there is damage to the environment and/or other natural resources. Additional Assurances. Make, execute and deliver to Lender such promissory notes, mortgages, deeds of trust, security agreements, assignments, financing statements, instruments, documents and other agreements as Lender or its attorneys may reasonably request to evidence and secure the Loans and to perfect all Security Interests.

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