Regulatory and Safety Information Sample Clauses

Regulatory and Safety Information. Each Party agrees to provide the other with all reasonable assistance and take all actions reasonably requested by the other Party that are necessary or desirable to enable the other Party to comply with any Applicable Law with respect to Ivory, including reporting obligations of Amgen related to Ivory. Such assistance and actions will include, among other things, GSK keeping Amgen informed, commencing immediately upon notification of any action by, or notification or other information which it receives (directly or indirectly) from any Governmental Authority that: (i) raises any concerns regarding the safety or efficacy of Ivory; (ii) indicates or suggests a potential liability for either Party to Third Parties arising in connection with Ivory; or (iii) is reasonably likely to lead to a recall or market withdrawal of Ivory. Concurrently with entry into this Agreement, or promptly after the Effective Date of the Agreement, but not later than sixty (60) days thereafter, the Parties will enter into an agreement pertaining to safety, pharmacovigilance, product complaints and/or the like.
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Regulatory and Safety Information. On or as reasonably practicable following the Effective Date, Regeneron will use Commercially Reasonable Efforts to provide Kiniksa or its designee with access to (a) Regulatory Documentation and Approvals, in all cases, specifically and exclusively relating to the Development of the Product in the Regeneron Field, and (b) the global safety database for the Product and copies of all material safety data and other product data and information related to the Product in the Regeneron Field, in each of clauses (a) and (b), in Regeneron’s possession and Control.
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Regulatory and Safety Information. No later than [***] days after the U.S. BLA Transfer Date, and subject to Kiniksa’s reasonable assistance, to the extent legally permissible (including to the extent permitted under Regeneron’s obligations to Third Parties on the U.S. BLA Transfer Date), Regeneron shall (a) transfer and assign to Kiniksa or Kiniksa’s designee Regeneron’s rights, title, and interests in and to all Regulatory Documentation and Approvals [***] related to the Development of the Product in the Regeneron Field in the Territory, and (b) subject to an audit reasonably satisfactory to Regeneron as set forth in Section 7.6.2 (Pharmacovigilance Audit), transfer to Kiniksa or Kiniksa’s designee the global safety database for the Product and copies of all such material safety data and other product data and information, in each case, in Regeneron’s possession and Control. In the event of (i) failure to obtain assignment, or (ii) with respect to regulatory items that would otherwise fall within the foregoing clauses (i) or (ii), but for such materials not [***] related to a Product, but nonetheless that are necessary for the Development or Commercialization of such Product in the Kiniksa Field, in each case ((i) and (ii)), Regeneron hereby consents and grants to Kiniksa the right to reference any such item solely with respect to the Development or Commercialization of such Product in the Kiniksa Field.
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Related to Regulatory and Safety Information

  • Safety Information Any other bulletins may only be posted by mutual agreement between the Union and designated Management.

  • Third-Party Information; Privacy or Data Protection Laws Each Party acknowledges that it and its respective Subsidiaries may presently have and, after the Effective Time, may gain access to or possession of confidential or proprietary Information of, or personal Information relating to, Third Parties: (i) that was received under confidentiality or non-disclosure agreements entered into between such Third Parties, on the one hand, and the other Party or the other Party’s Subsidiaries, on the other hand, prior to the Effective Time or (ii) that, as between the two parties, was originally collected by the other Party or the other Party’s Subsidiaries and that may be subject to and protected by privacy, data protection or other applicable Laws. Each Party agrees that it shall hold, protect and use, and shall cause its Subsidiaries and its and their respective Representatives to hold, protect and use, in strict confidence the confidential and proprietary Information of, or personal Information relating to, Third Parties in accordance with privacy, data protection or other applicable Laws and the terms of any agreements that were either entered into before the Effective Time or affirmative commitments or representations that were made before the Effective Time by, between or among the other Party or the other Party’s Subsidiaries, on the one hand, and such Third Parties, on the other hand.

  • Labor Law Information You acknowledge that if you continue to hold shares of Common Stock acquired under the Plan after an involuntary termination of your employment, you may not be eligible to receive unemployment benefits in Russia. Anti-Corruption Information. Anti-corruption laws prohibit certain public servants, their spouses and their dependent children from owning any foreign source financial instruments (e.g., shares of foreign companies such as the Company). Accordingly, you should inform the Company if you are covered by these laws because you should not hold shares of Common Stock acquired under the Plan.

  • Third Party Information I understand, in addition, that the Company has received and in the future will receive from third parties confidential or proprietary information (“Third Party Information”) subject to a duty on the Company’s part to maintain the confidentiality of such information and to use it only for certain limited purposes. During the term of my employment and thereafter, I will hold Third Party Information in the strictest confidence and will not disclose to anyone (other than Company personnel who need to know such information in connection with their work for the Company) or use, except in connection with my work for the Company, Third Party Information unless expressly authorized by an officer of the Company in writing.

  • Access to Company Information (a) During the period from the date of this Agreement to the Effective Time, the Company shall permit representatives of the Parent to have reasonable access (at all reasonable times, and in a manner so as not to interfere with the normal business operations of the Company) to all premises, properties, financial and accounting records, contracts, other records and documents, and personnel, of or pertaining to the Company. (b) The Parent and each of its Subsidiaries (i) shall treat and hold as confidential any Company Confidential Information (as defined below), (ii) shall not use any of the Company Confidential Information except in connection with this Agreement, and (iii) if this Agreement is terminated for any reason whatsoever, shall return to the Company all tangible embodiments (and all copies) thereof which are in its possession. For purposes of this Agreement, “Company Confidential Information” means any information of the Company that is furnished to the Parent or any of its Subsidiaries by the Company in connection with this Agreement; provided, however, that it shall not include any information (A) which, at the time of disclosure, is available publicly other than as a result of non-permitted disclosure by the Parent, any of its Subsidiaries or their respective directors, officers, or employees, (B) which, after disclosure, becomes available publicly through no fault of the Parent, any of its Subsidiaries or their respective directors, officers, or employees, (C) which the Parent or any of its Subsidiaries knew or to which the Parent or any of its Subsidiaries had access prior to disclosure, as demonstrated by competent evidence, provided that the source of such information is not known by the Parent or any of its Subsidiaries to be bound by a confidentiality obligation to the Company, or (D) which the Parent or any of its Subsidiaries rightfully obtains from a source other than the Company, provided that the source of such information is not known by the Parent or any of its Subsidiaries to be bound by a confidentiality obligation to the Company.

  • Contractor Information The Contractor will provide up to date information for each of the following in the form and manner specified by OGS:

  • KYC Information (i) Upon the reasonable request of the Lender made at least 1 day prior to the Closing Date, the Borrower shall have provided to the Lender the documentation and other information so requested in connection with applicable “know your customer” and anti-money-laundering rules and regulations, including the PATRIOT Act, in each case at least five days prior to the Closing Date. (ii) [reserved].

  • Insurance and Fingerprint Requirements Information Insurance If applicable and your staff will be on TIPS member premises for delivery, training or installation etc. and/or with an automobile, you must carry automobile insurance as required by law. You may be asked to provide proof of insurance. Fingerprint It is possible that a vendor may be subject to Chapter 22 of the Texas Education Code. The Texas Education Code, Chapter 22, Section 22.0834. Statutory language may be found at: xxxx://xxx.xxxxxxxx.xxxxx.xxxxx.xx.xx/ If the vendor has staff that meet both of these criterion: (1) will have continuing duties related to the contracted services; and (2) has or will have direct contact with students Then you have ”covered” employees for purposes of completing the attached form. TIPS recommends all vendors consult their legal counsel for guidance in compliance with this law. If you have questions on how to comply, see below. If you have questions on compliance with this code section, contact the Texas Department of Public Safety Non-Criminal Justice Unit, Access and Dissemination Bureau, FAST-FACT at XXXX@xxxxx.xxxxx.xx.xx and you should send an email identifying you as a contractor to a Texas Independent School District or ESC Region 8 and TIPS. Texas DPS phone number is (000) 000-0000. See form in the next attribute to complete entitled: Texas Education Code Chapter 22 Contractor Certification for Contractor Employees

  • Patient Information Each Party agrees to abide by all laws, rules, regulations, and orders of all applicable supranational, national, federal, state, provincial, and local governmental entities concerning the confidentiality or protection of patient identifiable information and/or patients’ protected health information, as defined by any other applicable legislation in the course of their performance under this Agreement.

  • - CLEC INFORMATION 3.1 Except as otherwise required by law, CenturyLink will not provide or establish Interconnection, Unbundled Network Elements, ancillary services and/or resale of Telecommunications Services in accordance with the terms and conditions of this Agreement prior to CLEC's execution of this Agreement. The Parties shall complete CenturyLink's "New Customer Questionnaire," as it applies to CLEC's obtaining of Interconnection, Unbundled Network Elements, ancillary services, and/or resale of Telecommunications Services hereunder. 3.2 Prior to placing any orders for services under this Agreement, the Parties will jointly complete the following sections of CenturyLink's "New Customer Questionnaire:" General Information Billing and Collection (Section 1) Credit Information Billing Information Summary Billing OSS and Network Outage Notification Contact Information System Administration Contact Information Ordering Information for LIS Trunks, Collocation, and Associated Products (if CLEC plans to order these services) Design Layout Request – LIS Trunking and Unbundled Loop (if CLEC plans to order these services) 3.2.1 The remainder of this questionnaire must be completed within two (2) weeks of completing the initial portion of the questionnaire. This questionnaire will be used to: Determine geographical requirements; Identify CLEC identification codes; Determine CenturyLink system requirements to support CLEC's specific activity; Collect credit information; Obtain Billing information; Create summary bills; Establish input and output requirements; Create and distribute CenturyLink and CLEC contact lists; and Identify CLEC hours and holidays. 3.2.2 CLECs that have previously completed a Questionnaire need not fill out a New Customer Questionnaire; however, CLEC will update its New Customer Questionnaire with any changes in the required information that have occurred and communicate those changes to CenturyLink. Before placing an order for a new product, CLEC will need to complete the relevant New Product Questionnaire and amend this Agreement.

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