Reporting to Government Authorities Sample Clauses

Reporting to Government Authorities. Each Party shall, and shall cause its respective Affiliates to, furnish timely notice as required by Applicable Law (i.e., currently not later than [***] for deaths and immediately life-threatening Adverse Events and not later than [***] for Serious Adverse Events) to all competent governmental agencies in the Territory of all Adverse Events identified or suspected with respect to any Licensed Product administered, distributed, marketed and sold under authority of any IND or Regulatory Approval. Each Party shall provide the other Party with all necessary assistance in complying with all Adverse Event reporting requirements established by, or required under, any applicable IND and/or Regulatory Approval in the Territory. Accordingly, each Party shall provide the other with timely information, in accordance with the time frames set forth below, on any Serious Adverse Events relating to any Licensed Product to the extent that such Serious Adverse Events could affect the Regulatory Approval for the Product, or relate to the safety, efficacy or potency of the Licensed Product.
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Reporting to Government Authorities. Each Party shall, and shall cause its respective Affiliates to, furnish timely notice as required by Applicable Law (i.e., currently not later than [***] calendar days for deaths and immediately life threatening Adverse Events and not later than [***] calendar days for Serious Adverse Events) to all competent governmental agencies in those parts of the Territory in which it is the Lead Regulatory Party of all Adverse Events identified or suspected with respect to any Collaboration Products administered, distributed, marketed and sold under authority of any IND or Marketing Approval. Each Party shall provide the other Party with all necessary assistance in complying with all Adverse Event reporting requirements established by, or required under, any applicable IND and/or Marketing Approval in the Territory. Accordingly, each Party shall provide the other with timely information, in accordance with the time frames set forth below, on any Serious Adverse Events relating to any Collaboration Product to the extent that such Serious Adverse Events could affect the Marketing Approval for the Collaboration Product, or relate to the safety, efficacy or potency of the Collaboration Product. The Parties agree that with regards to the Unilateral Products, the obligations set forth in this Section 5.5a shall only apply to the Continuing Party.
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Reporting to Government Authorities. Each Party shall, and shall cause its respective Affiliates to, furnish timely notice as required by Applicable Law (i.e., currently not later than [ * ] for deaths and immediately life-threatening Adverse Events and not later than [ * ] for Serious Adverse Events) to all competent governmental agencies in the Territory of all Adverse Events identified or suspected with respect to any Licensed Product administered, distributed, marketed and sold under authority of any IND or Regulatory Approval. Each Party shall provide the other Party with all necessary assistance in complying [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. with all Adverse Event reporting requirements established by, or required under, any applicable IND and/or Regulatory Approval in the Territory. Accordingly, each Party shall provide the other with timely information, in accordance with the time frames set forth below, on any Serious Adverse Events relating to any Licensed Product to the extent that such Serious Adverse Events could affect the Regulatory Approval for the Product, or relate to the safety, efficacy or potency of the Licensed Product.
Sample 1Sample 2
Reporting to Government Authorities. Each Party shall, and shall cause its respective Affiliates to, furnish timely notice as required by Applicable Law (i.e., currently not later than [ * ] for deaths and immediately life-threatening Adverse Events and not later than [ * ] for Serious Adverse Events) to all competent governmental agencies in the Territory of all Adverse Events identified or suspected with respect to any Licensed Product administered, distributed, marketed and sold under authority of any IND or Regulatory Approval. Each Party shall provide the other Party with all necessary assistance in complying -37-
Sample 1

Related to Reporting to Government Authorities

  • Reports to Government Entities Nothing in this Agreement shall prohibit or restrict the Executive from initiating communications directly with, responding to any inquiry from, providing testimony before, providing confidential information to, reporting possible violations of law or regulation to, or filing a claim or assisting with an investigation directly with a self-regulatory authority or a government agency or entity, including the Equal Employment Opportunity Commission, the Department of Labor, the National Labor Relations Board, the Department of Justice, the Securities and Exchange Commission, Congress, any agency Inspector General or any other federal, state or local regulatory authority (collectively, the “Regulators”), or from making other disclosures that are protected under the whistleblower provisions of state or federal law or regulation. The Executive does not need the prior authorization of the Company to engage in conduct protected by this subsection, and the Executive does not need to notify the Company that the Executive has engaged in such conduct. Please take notice that federal law provides criminal and civil immunity to federal and state claims for trade secret misappropriation to individuals who disclose trade secrets to their attorneys, courts, or government officials in certain, confidential circumstances that are set forth at 18 U.S.C. §§ 1833(b)(1) and 1833(b)(2), related to the reporting or investigation of a suspected violation of the law, or in connection with a lawsuit for retaliation for reporting a suspected violation of the law.

  • Authorization of Governmental Authorities No action by (including any authorization, consent or approval), in respect of, or filing with, any governmental authority or regulatory body is required for, or in connection with, the valid and lawful authorization, execution, delivery and performance by it of this Agreement, subject to, in the case of the Debtors, the entry by the Bankruptcy Court of the Approval Order.

  • Compliance with Government Regulations The Company covenants that if any share of Common Stock required to be reserved for purposes of exercise or conversion of Warrants require, under any federal or state law or applicable governing rule or regulation of any national securities exchange, registration with or approval of any governmental authority, or listing on any such national securities exchange, before such shares may be issued upon exercise, the Company will use its commercially reasonable efforts to cause such shares to be duly registered, approved or listed on the relevant national securities exchange, as the case may be.

  • Actions Before Governmental Authorities There are no actions, suits or proceedings at law or in equity or by or before any governmental authority now pending or, to the knowledge of Borrower, threatened against or affecting Borrower or its property, that is reasonably expected to result in a Material Adverse Effect.

  • Approvals of Governmental Bodies As promptly as practicable after the date of this Agreement, Buyer will, and will cause each of its Related Persons to, make all filings required by Legal Requirements to be made by them to consummate the Contemplated Transactions (including all filings under the HSR Act). Between the date of this Agreement and the Closing Date, Buyer will, and will cause each Related Person to, cooperate with Sellers with respect to all filings that Sellers are required by Legal Requirements to make in connection with the Contemplated Transactions, and (ii) cooperate with Sellers in obtaining all consents identified in Part 3.2 of the Disclosure Letter; provided that this Agreement will not require Buyer to dispose of or make any change in any portion of its business or to incur any other burden to obtain a Governmental Authorization.

  • Compliance; Governmental Authorizations The Seller has complied in all material respects with all applicable Federal, state, local or foreign laws, ordinances, regulations and orders. The Seller has all Federal, state, local and foreign governmental licenses and permits necessary in the conduct of the Subject Business the lack of which would have a material adverse effect on the Buyer's ability to operate the Subject Business after the Closing on substantially the same basis as presently operated, such licenses and permits are in full force and effect, no violations are or have been recorded in respect of any thereof and no proceeding is pending or threatened to revoke or limit any thereof. None of such licenses and permits shall be affected in any material respect by the transactions contemplated hereby.

  • 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.

  • Compliance with Federal and State Work Authorization and Immigration Laws The Contractor and all subcontractors, suppliers and consultants must comply with all federal and state work authorization and immigration laws, and must certify compliance using the form set forth in Section 7 (“Georgia Security and Immigration Compliance Act Affidavits”). The required certificates must be filed with the Owner and copied maintained by the Contractor as of the beginning date of this contract and each subcontract, supplier contract, or consultant contract, and upon final payment to the subcontractor or consultant. State officials, including officials of the Georgia Department of Audits and Accounts, officials of the Owner, retain the right to inspect and audit the Project Site and employment records of the Contractor, subcontractors and consultants without notice during normal working hours until Final Completion, and as otherwise specified by law and by Rules and Regulations of the Georgia Department of Audits and Accounts.

  • Competent Authorities The Parties shall inform each other about the structure, organisation and division of competences of their competent authorities during the first meeting of the Sanitary and Phytosanitary Sub-Committee referred to in Article 65 of this Agreement ("SPS Sub-Committee"). The Parties shall inform each other of any change of the structure, organisation and division of competences, including of the contact points, concerning such competent authorities.

  • Compliance with Governmental Regulations Landlord and Tenant shall comply with all rules, regulations and requirements promulgated by national, state or local governmental agencies or utility suppliers concerning the use of utility services, including any rationing, limitation or other control. Tenant shall not be entitled to terminate this Lease nor to any abatement in rent by reason of such compliance.

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