Exchange of Data and Regulatory Information Sample Clauses

Exchange of Data and Regulatory Information. 9.3.1 Each Party shall provide copies, without charge, to the other Party all (a) [*], when and as [*] are issued, (b) [*], and (c) [*] promptly upon the other Party’s request, but in no event later than [*] days after receipt of such request, provided that Salix shall be obligated to provide such [*] (y) with respect to the Salix Designated Indication Product, only if and when Salix and Alfa have agreed on the terms of a license for the Salix Designated Indication Product, including the compensation payable by Alfa to Salix, pursuant to Section 4.2.2(b) or (z) with respect to an Other New Formulation Product, only if and when Salix and Alfa have agreed on the compensation payable by Alfa to Salix for such Other New Formulation Product, pursuant to Section 4.2.3(b). All such [*] shall be subject to the confidentiality provisions set forth in Article 12. For clarification, (i) the designation by Salix of any information as confidential which is based on or derived from source information provided by Alfa shall not result in any transfer of the ownership of or right to the underlying information from Alfa to Salix and (ii) the designation by Alfa of any information as confidential which is based on or derived from source information provided by Salix shall not result in any transfer of the ownership of or right to the underlying information from Salix to Alfa. 9.3.2 Each Party shall continue to have access to (a) [*] and (b) [*] following the granting of Marketing Approvals by the relevant Regulatory Authorities, provided that under either subsection (a) or (b), Alfa’s right to access such [*] may be exercised (y) with respect to the Salix Designated Indication Product, only if and when Salix and Alfa have agreed on the terms of a license for the Salix Designated Indication Product, including the compensation payable by Alfa to Salix, pursuant to Section 4.2.2(b) or (z) with respect to an Other New Formulation Product, only if and when Salix and Alfa have agreed on the compensation payable by Alfa to Salix for such Other New Formulation Product, pursuant to Section 4.2.3(b). * Confidential treatment requested; certain information omitted and filed separately with the SEC. 9.3.3 Alfa’s obligations under Sections 9.3.1 and 9.3.2 are limited to information submitted to Regulatory Authorities in [*] and [*]. 9.3.4 The respective rights and obligations of the Parties granted under this Section 9.3 shall terminate when the Agreement terminates.
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Related to Exchange of Data and Regulatory Information

  • Regulatory Information (a) All the notaries at De Pinna LLP are regulated through the Faculty Office of the Archbishop of Canterbury. Its address is The Faculty Office, 0 Xxx Xxxxxxxxx, Xxxxxxxxxxx, Xxxxxx XX0X 0XX, its telephone: 000 0000 0000, and it can be reached by email at xxxxxxx.xxxxxx@0xxxxxxxxxxxx.xxx. It also has a website at xxx.xxxxxxxxxxxxx.xxx.xx. (b) We are required to comply with the rules of professional conduct and other regulatory arrangements of the Master of the Faculties, the sole regulator of notarial activities under the Legal Services Act 2007. Information about those rules and regulations may be found at xxxx://xxx.xxxxxxxxxxxxx.xxx.xx/notary/i-am-a-notary/notaries-rules-regulations/. (c) We comply with the Code of Practice published by the Master of the Faculties: xxxx://xxx.xxxxxxxxxxxxx.xxx.xx/notary/code-of-practice.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

  • Books, Records and Regulatory Filings (a) The Sub-Adviser agrees to maintain and to preserve for the applicable periods any such records as are required to be maintained by the Sub-Adviser with respect to the Fund by the 1940 Act and rules adopted thereunder, and by any other applicable laws, rules and regulations. The Sub-Adviser further agrees that all records that it maintains for the Fund are the property of the Fund and it will promptly surrender any of such records upon request; provided, however, that the Sub-Adviser may retain copies of such records for the applicable periods they are required by law to be retained, and thereafter shall destroy such records. (b) The Sub-Adviser agrees that it shall furnish to regulatory authorities having the requisite authority any information or reports in connection with its services hereunder that may be requested in order to determine whether the operations of the Fund are being conducted in accordance with applicable laws, rules and regulations. (c) The Sub-Adviser shall make all filings with the SEC required of it pursuant to Section 13 of the 1934 Act with respect to its duties as are set forth herein. The Sub-Adviser also shall make all required filings on Schedule 13D or 13G and Form 13F (as well as other filings triggered by ownership in securities under other applicable laws, rules and regulations) in respect of the Portfolio as may be required of the Fund due to the activities of the Sub-Adviser. The Sub-Adviser shall be the sole filer of Form 13F with respect to the Portfolio of the Fund.

  • Customer Data 5.1 The Customer shall own all rights, title and interest in and to all of the Customer Data and shall have sole responsibility for the legality, reliability, integrity, accuracy and quality of the Customer Data. 5.2 The Supplier shall follow its archiving procedures for Customer Data as set out in its Back-Up Policy available at XxxxxXXX.xxx or such other website address as may be notified to the Customer as such document may be amended by the Supplier in its sole discretion from time to time the current version of which is set out at Schedule 3 of this Agreement. In the event of any loss or damage to Customer Data, the Customer's sole and exclusive remedy shall be for the Supplier to use reasonable commercial endeavours to restore the lost or damaged Customer Data from the latest back-up of such Customer Data maintained by the Supplier in accordance with the archiving procedure described in its Back-Up Policy. The Supplier shall not be responsible for any loss, destruction, alteration or disclosure of Customer Data caused by any third party (except those third parties sub-contracted by the Supplier to perform services related to Customer Data maintenance and back-up). 5.3 The Supplier shall, in providing the Services, comply with its Privacy and Security Policy as such document may be amended from time to time by the Supplier in its sole discretion. 5.4 If the Supplier processes any personal data on the Customer’s behalf when performing its obligations under this agreement, the parties record their intention that the Customer shall be the data controller and the Supplier shall be a data processor and in any such case: (a) the Customer shall ensure that the Customer is entitled to transfer the relevant personal data to the Supplier so that the Supplier may lawfully use, process and transfer the personal data in accordance with this agreement on the Customer's behalf; (b) the Customer shall ensure that the relevant third parties have been informed of, and have given their consent to, such use, processing, and transfer as required by all applicable data protection legislation; (c) the Supplier shall process the personal data only in accordance with the terms of this agreement and any lawful instructions reasonably given by the Customer from time to time; and (d) each party shall take appropriate technical and organisational measures against unauthorised or unlawful processing of the personal data or its accidental loss, destruction or damage. 5.5 The Supplier and the Customer shall comply with their respective obligations as set out in Schedule 4 of this Agreement

  • Sensitive data Where the transfer involves personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, genetic data, or biometric data for the purpose of uniquely identifying a natural person, data concerning health or a person’s sex life or sexual orientation, or data relating to criminal convictions and offences (hereinafter ‘sensitive data’), the data importer shall apply the specific restrictions and/or additional safeguards described in Annex I.B.

  • Client Data The Subrecipient shall maintain client data demonstrating client eligibility for services provided. Such data shall include, but not be limited to, client name, address, income level or other basis for determining eligibility, and description of service provided. Such information shall be made available to Grantee monitors or their designees for review upon request.

  • Third Party Proprietary Data The Disclosing Party's Third Party Proprietary Data, if any, will be identified in a separate technical document.

  • Exchange Control Information Exchange control reporting is required for cash transactions exceeding AUD10,000 and for international fund transfers. The Australian bank assisting with the transaction will file the report for you. If there is no Australian bank involved in the transfer, you will have to file the report.

  • Product Information EPIZYME recognizes that by reason of, inter alia, EISAI’s status as an exclusive licensee in the EISAI Territory under this Agreement, EISAI has an interest in EPIZYME’s retention in confidence of certain information of EPIZYME. Accordingly, until the end of all Royalty Term(s) in the EISAI Territory, EPIZYME shall keep confidential, and not publish or otherwise disclose, and not use for any purpose other than to fulfill EPIZYME’s obligations, or exercise EPIZYME’s rights, hereunder any EPIZYME Know-How Controlled by EPIZYME or EPIZYME Collaboration Know-How, in each case that are primarily applicable to EZH2 or EZH2 Compounds (the “Product Information”), except to the extent (a) the Product Information is in the public domain through no fault of EPIZYME, (b) such disclosure or use is expressly permitted under Section 9.3, or (c) such disclosure or use is otherwise expressly permitted by the terms and conditions of this Agreement. For purposes of Section 9.3, each Party shall be deemed to be both the Disclosing Party and the Receiving Party with respect to Product Information. For clarification, the disclosure by EPIZYME to EISAI of Product Information shall not cause such Product Information to cease to be subject to the provisions of this Section 9.2 with respect to the use and disclosure of such Confidential Information by EPIZYME. In the event this Agreement is terminated pursuant to Article 12, this Section 9.2 shall have no continuing force or effect, but the Product Information, to the extent disclosed by EPIZYME to EISAI hereunder, shall continue to be Confidential Information of EPIZYME, subject to the terms of Sections 9.1 and 9.3 for purposes of the surviving provisions of this Agreement. Each Party shall be responsible for compliance by its Affiliates, and its and its Affiliates’ respective officers, directors, employees and agents, with the provisions of Section 9.1 and this Section 9.2.

  • Product Data Illustrations, standard schedules, performance charts, instructions, brochures, diagrams, and other information furnished by Developer to illustrate a material, product, or system for some portion of the Work.

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