Sharing of Information and Safety Reporting Sample Clauses

Sharing of Information and Safety Reporting. (i) Draxis and DAHI shall each use its reasonably diligent efforts to promptly investigate, collect and provide to Pfizer information concerning any complaints about the safety or effectiveness of any Product and information about any adverse events of any Product associated with the use or its safety or efficacy from any source throughout the world and any information that may be required from Pfizer by or for the U.S. Food and Drug Administration or other similar regulatory agencies outside the United States. (ii) Pfizer shall provide written notification to Draxis and DAHI of regulatory information relating to any Product, required by or for FDA and other regulatory agencies and the required reporting schedule(s). After receipt of any notification of any complaint described in Section 7(f)(i), including information about any adverse events associated with the use of any Product or other complaints or information about its safety or effectiveness, Draxis and DAHI shall provide the required regulatory information to Pfizer promptly so as to allow Pfizer a reasonable opportunity to assess, evaluate, and report the information to such regulatory agencies in a timely manner. Pfizer shall determine whether complaints and reports relating to any adverse drug experience must be reported to FDA or any other regulatory agency. (iii) Draxis and DAHI shall notify Pfizer immediately upon receiving information from FDA or any other regulatory authority or any other person concerning the possibility of a material problem with the safety or effectiveness of any Product, or any complaint concerning suspected or actual product tampering or the contamination or mix-up with or in the ingredients in any batch, package or container of Product. Further, Draxis and DAHI shall provide to Pfizer, immediately upon its receipt of such information, copies of all communications with or from a governmental regulatory authority about the manufacture, sale, promotion, distribution, or clinical investigation of any Product and any governmental review or inquiry about any Product, the need for a recall or withdrawal of one or more batches of any Product from the market, the initiation of a government investigation, detention, seizure or injunction of any Product, the initiation of a government inspection of the facilities used in conjunction with the manufacturing or distribution of any Product, or the receipt of any complaint concerning suspected or actual product tampering or the conta...
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Related to Sharing of Information and Safety Reporting

  • Information and Reporting The Adviser shall provide the Trust and its respective officers with such periodic reports concerning the obligations the Adviser has assumed under this Agreement as the Trust may from time to time reasonably request.

  • Freedom of Information and Transparency 20.1 The Recipient acknowledges that the Commissioner is subject to the provisions of the FOIA and agrees to assist and co-operate with the Commissioner (at the Recipient’s expense) where necessary to enable the Commissioner to comply with any requests received under the FOIA relating to this Agreement. This includes, but is not limited to, transferring to the Commissioner any request received by the Recipient under the FOIA relating to this Agreement as soon as practicable following receipt and in any event within three working days of receipt. 20.2 In no event shall the Recipient respond to a request under the FOIA relating to this Agreement without obtaining the prior written consent of the Commissioner. 20.3 The Recipient acknowledges that the Commissioner may be obliged to disclose information under the FOIA: 20.3.1 Without consulting the Recipient; or 20.3.2 Following consultation with the Recipient and having taken into account its views. Provided that where clause 20.3.1 applies the Commissioner shall, in accordance with the recommendations of the Secretary of State for Constitutional Affairs’ Code of Practice on the discharge of a public authorities’ functions under Part 1 of FOIA, take reasonable steps, to give the Recipient advanced notice or to draw the disclosure to the Recipient’s attention after any such disclosure. 20.4 The Recipient shall ensure it retains for disclosure all information (as defined in the FOIA) produced in the course of this Agreement or relating to this Agreement and shall allow the Commissioner to inspect such records from time to time upon request. 20.5 The Recipient acknowledges that the Commissioner is subject to certain transparency and disclosure obligations set out in the Elected Local Policing Bodies Specified Information Order 2011 (as amended) (“Transparency Obligations”) 20.6 The Recipient consents to the Commissioner publishing the contents of this Agreement and information regarding any tender process related to the Purpose of the Agreement to enable the Commissioner to comply with their Transparency Obligations. 20.7 The Recipient acknowledges that: 20.7.1 The Commissioner shall be responsible for determining, at their absolute discretion, whether any information is exempt from disclosure or should be disclosed pursuant to the FOIA and/or the Transparency Obligations and to what extent any information disclosed shall be redacted; and 20.7.2 Any lists or schedules provided by the Recipient outlining confidential information are of an indicative value only and that the Commissioner may be obliged to disclose confidential information in accordance with Clause 20.3 and/or Clause 20.5.

  • Information and Reports A. The Subadviser shall keep the Fund and the Adviser informed of developments relating to its duties as Subadviser of which the Subadviser has, or should have, knowledge that would materially affect the Designated Series. In this regard, the Subadviser shall provide the Fund, the Adviser and their respective officers with such periodic reports concerning the obligations the Subadviser has assumed under this Agreement as the Fund and the Adviser may from time to time reasonably request. In addition, prior to each meeting of the Trustees, the Subadviser shall provide the Adviser and the Trustees with reports regarding the Subadviser’s management of the Designated Series during the most recently completed quarter, which reports: (i) shall include Subadviser’s representation that its performance of its investment management duties hereunder is in compliance with the Fund’s investment objectives and practices, the Act and applicable rules and regulations under the Act, and the diversification and minimum “good income” requirements of Subchapter M under the Internal Revenue Code of 1986, as amended, and (ii) otherwise shall be in such form as may be mutually agreed upon by the Subadviser and the Adviser. B. Each of the Adviser and the Subadviser shall provide the other party with a list, to the best of the Adviser’s or the Subadviser’s respective knowledge, of each affiliated person (and any affiliated person of such an affiliated person) of the Adviser or the Subadviser, as the case may be, and each of the Adviser and Subadviser agrees promptly to update such list whenever the Adviser or the Subadviser becomes aware of any changes that should be added to or deleted from the list of affiliated persons. C. The Subadviser shall also provide the Adviser with any information reasonably requested by the Adviser regarding its management of the Designated Series required for any shareholder report, amended registration statement, or Prospectus supplement to be filed by the Fund with the SEC.

  • Freedom of Information and Protection of Privacy Act Any information provided on this contract may be subject to release under the Freedom of Information and Protection of Privacy Act. The Contractor may be consulted prior to release of any information.

  • CONFIDENTIALITY/SAFEGUARDING OF INFORMATION The CONTRACTOR shall not use or disclose any information concerning the AGENCY, or information that may be classified as confidential, for any purpose not directly connected with the administration of this contract, except with prior written consent of the AGENCY, or as may be required by law.

  • ERISA Information and Compliance The Obligors will promptly furnish and will cause the Subsidiaries and any ERISA Affiliate to promptly furnish to the Administrative Agent with sufficient copies to the Lenders (i) promptly after the filing thereof with the United States Secretary of Labor, the Internal Revenue Service or the PBGC, copies of each annual and other report with respect to each Plan or any trust created thereunder, (ii) immediately upon becoming aware of the occurrence of any ERISA Event or of any “prohibited transaction,” as described in section 406 of ERISA or in section 4975 of the Code, in connection with any Plan or any trust created thereunder, a written notice signed by a Responsible Officer specifying the nature thereof, what action the Obligors, the Subsidiary or the ERISA Affiliate is taking or proposes to take with respect thereto, and, when known, any action taken or proposed by the Internal Revenue Service, the Department of Labor or the PBGC with respect thereto, and (iii) immediately upon receipt thereof, copies of any notice of the PBGCs intention to terminate or to have a trustee appointed to administer any Plan. With respect to each Plan (other than a Multiemployer Plan), the Obligors will, and will cause each Subsidiary and ERISA Affiliate to, (i) satisfy in full and in a timely manner, without incurring any late payment or underpayment charge or penalty and without giving rise to any lien, all of the contribution and funding requirements of section 412 of the Code (determined without regard to subsections (d), (e), (f) and (k) thereof) and of section 302 of ERISA (determined without regard to sections 303, 304 and 306 of ERISA), and (ii) pay, or cause to be paid, to the PBGC in a timely manner, without incurring any late payment or underpayment charge or penalty, all premiums required pursuant to sections 4006 and 4007 of ERISA.

  • E5 Freedom of Information The Contractor acknowledges that the Authority is subject to the requirements of the FOIA and the Environmental Information Regulations and shall assist and cooperate with the Authority to enable the Authority to comply with its Information disclosure obligations.

  • RECORDS, INFORMATION AND REPORTS Contractor shall maintain full and accurate records with respect to all matters covered under this Agreement. To the extent permitted by law, County shall have free access at all proper times or until the expiration of four (4) years after the furnishing of services to such records, and the right to examine and audit the same and to make transcripts therefrom, and to inspect all data, documents, proceedings, and activities pertaining to this Agreement. To the extent permitted by law, Contractor shall furnish County such periodic reports as County may request pertaining to the work or services undertaken pursuant to this Agreement. The costs and obligations incurred or to be incurred in connection therewith shall be borne by the Contractor.

  • Inspection and Reporting Each Grantor shall permit the Collateral Agent, or any agent or representatives thereof or such professionals or other Persons as the Collateral Agent may designate, not more than once a year in the absence of an Event of Default, (i) to examine and make copies of and abstracts from such Grantor's records and books of account, (ii) to visit and inspect its properties, (iii) to verify materials, leases, Instruments, Accounts, Inventory and other assets of such Grantor from time to time, (iii) to conduct audits, physical counts, appraisals and/or valuations, examinations at the locations of such Grantor. Each Grantor shall also permit the Collateral Agent, or any agent or representatives thereof or such professionals or other Persons as the Collateral Agent may designate to discuss such Grantor's affairs, finances and accounts with any of its officers subject to the execution by the Collateral Agent or its designee(s) of a mutually agreeable confidentiality agreement.

  • INFORMATION AND NOTICES A. Unless otherwise expressly provided in this Agreement, all notices required or permitted hereunder shall be in writing and deemed sufficiently given for all purposes hereof if (i) delivered in person, by courier (e.g., by Federal Express) or by registered or certified United States Mail to the Party to be notified, with receipt obtained, or (ii) sent by facsimile or email transmission, with notice of receipt obtained, in each case to the appropriate address or number as set forth below. Each notice shall be deemed effective on receipt by the addressee as aforesaid; provided that, notice received by facsimile or email transmission after 5:00 p.m. at the location of the addressee of such notice shall be deemed received on the first business day following the date of such electronic receipt. B. Notices to the District shall be addressed to the District’s Authorized Representative as follows: Xx. Xxxxxxxx Xxxxxxx Superintendent of Schools Xxxxxxx-Portland Independent School District 000 Xxxxxxx Xxxxxx Portland, Texas 78374 Phone: (000) 000-0000 Facsimile: (000) 000-0000 Email: xxxxxxxx@x-xxxx.xxx or at such other address or to such other facsimile transmission number and to the attention of such other person as a Party may designate by written notice to the other. C. Notices to the Applicant shall be addressed to its Authorized Representative as follows: Xxxxxx Xxxx Property Tax Division Manager Exxon Mobil Corporation 0000 Xxxxxx Xxxxxxx Blvd. The Woodlands, Texas 77380 Phone: (000) 000-0000 Facsimile: (000) 000-0000 Email: xxxxxx.x.xxxx@xxxxxxxxxx.xxx or at such other address or to such other facsimile transmission number and to the attention of such other person as a Party may designate by written notice to the other.

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