Safety Information Exchange Sample Clauses

Safety Information Exchange. 15.1 In order to allow FRI and AAA to exercise a proper pharmacovigilance activity in compliance with any applicable law and regulations, by signing the present Agreement and the SDEA, FRI and AAA concur to report to each other in the English language all safety information concerning the Product via a mutually agreed way. The SDEA describes procedures and time frames, and defines responsibilities that the Parties shall employ to protect patients and promote their well-being. The requirements set forth in the SDEA shall serve to: · Define responsibilities, format, content, methods of transmission and timelines for safety data collection, processing and exchange for the Product; · Enable AAA and FRI and their respective affiliates/third parties, to comply with all pharmacovigilance obligations, as amended from time to time, in the Territory for which they have safety reporting obligations; · Ensure the completeness and accuracy of safety information (including, without limitation, Company Core Data Sheet (“CCDS”), Company Core Safety Information (CCSI), Investigator Brochure (“IB”), Risk Management Plan (if applicable) and/or Product Labeling (including, without limitation, Local Prescribing Information), as appropriate); · Ensure global harmonization and consistency of safety information; · Prevent premature dissemination of non-validated or unapproved safety information; · Ensure the timely detection and investigation of potential safety signals by AAA and FRI; · Expedite the decision making process in the event that an Adverse Event is likely to have an impact on the benefit/risk balance of the Product; · Facilitate pharmacovigilance/risk management programs. · Ensure responses to the Local Competent Regulatory Authority in the Territory in accordance with the applicable regulatory requirements in liaison with FRI. Local Agreements consistent with this global SDEA may need to be set up in the future to define a specific local safety data exchange in case of local co-marketing/co-promotion situation. 15.2 FRI commits itself to support AAA in performing local pharmacovigilance activities in strict compliance with applicable legislation and regulations. For this FRI shall immediately inform AAA of any clinical trials that FRI intends to sponsor or support or that come to FRI’s knowledge, e.g. the investigator initiated studies, sponsored by any other Third Parties.
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Safety Information Exchange. Prior to the first Licensed Product entering clinical Development, the Parties will negotiate in good faith and agree on processes and procedures for sharing safety information and ensuring compliance with reporting requirements to Regulatory Authorities relating to Licensed Products. The agreed upon processes and procedures will be set forth in a pharmacovigilance agreement containing mutually agreed terms and conditions that are customary for agreements of this type.
Sample 1
Safety Information Exchange. Pharmacovigilance Agreement (/clause/safety-information- exchange-pharmacovigilance-agreement). The Parties will initiate negotiations and use Commercially Reasonable Efforts to execute a pharmacovigilance agreement (“ Pharmacovigilance Agreement”) within [**] after the Effective Date. The executed Pharmacovigilance Agreement shall be in an appropriate format to enable the Parties to fulfill local and international regulatory reporting obligations and to facilitate appropriate safety reviews. The Pharmacovigilance Agreement will include safety data exchange procedures governing the coordination of collection, monitoring, investigation, reporting, and exchange of information, consistent with Applicable Law. Such guidelines and procedures shall be in accordance with, and enable the Parties and their Affiliates to fulfill, local and international regulatory reporting obligations to Governmental Authorities. Among other things, the Pharmacovigilance Agreement shall require MacroGenics and any Collaborators to submit safety data concerning any adverse experiences and any other safety information arising from or related to the use of the Licensed Compound as a single agent or as a component of any Combination Regimen in any MacroGenics Combination Study or Collaborator Combination Study, as applicable, as necessary for Incyte to maintain the Global Safety Database.
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Safety Information Exchange. Apellis will report to the JSC any Serious Safety Issue for which reporting is required under this provision. Such Serious Safety Issues are to be reported for (i) Subjects who receive the Product or (ii) individuals otherwise exposed to the Product. Apellis shall promptly report Serious Safety Issues to the JSC.
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Safety Information Exchange. 4.1 Dexcel shall be responsible for the following with respect to all suspected Adverse Drug Reactions associated with the Products (including all spontaneous serious and non-serious reports, both expected and unexpected), occurring in the Territory:
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Safety Information Exchange. Each Party will fulfill its requirements for pharmacovigilance regulatory compliance. A mutually agreed pharmacovigilance agreement will be signed between the Parties, detailing each Party’s responsibilities. This will be done at the latest before the start of the Collaboration Trial. For the avoidance of doubt, for any pharmacovigilance matters (including in relation to safety data) the pharmacovigilance agreement shall take precedence over this Agreement.
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Safety Information Exchange. 7.1 The following terms, when used herein, shall have the meaning as defined in the ICH E2A guideline: (i) [*]
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Safety Information Exchange 
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Related to Safety Information Exchange

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

  • 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].

  • - 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.

  • 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.

  • Confidential System Information HHSC prohibits the unauthorized disclosure of Other Confidential Information. Grantee and all Grantee Agents will not disclose or use any Other Confidential Information in any manner except as is necessary for the Project or the proper discharge of obligations and securing of rights under the Contract. Grantee will have a system in effect to protect Other Confidential Information. Any disclosure or transfer of Other Confidential Information by Xxxxxxx, including information requested to do so by HHSC, will be in accordance with the Contract. If Grantee receives a request for Other Confidential Information, Xxxxxxx will immediately notify HHSC of the request, and will make reasonable efforts to protect the Other Confidential Information from disclosure until further instructed by the HHSC. Grantee will notify HHSC promptly of any unauthorized possession, use, knowledge, or attempt thereof, of any Other Confidential Information by any person or entity that may become known to Grantee. Grantee will furnish to HHSC all known details of the unauthorized possession, use, or knowledge, or attempt thereof, and use reasonable efforts to assist HHSC in investigating or preventing the reoccurrence of any unauthorized possession, use, or knowledge, or attempt thereof, of Other Confidential Information. HHSC will have the right to recover from Grantee all damages and liabilities caused by or arising from Grantee or Grantee Agents’ failure to protect HHSC’s Confidential Information as required by this section.

  • 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.

  • Budget Information Funding Source Funding Year of Appropriation Budget List Number Amount

  • Client Information Protected Health Information in any form including without limitation, Electronic Protected Health Information or Unsecured Protected Health Information (herein “PHI”);

  • Access to Information Systems Access, if any, to DXC’s Information Systems is granted solely to perform the Services under this Order, and is limited to those specific DXC Information Systems, time periods and personnel as are separately agreed to by DXC and Supplier from time to time. DXC may require Supplier’s employees, subcontractors or agents to sign individual agreements prior to access to DXC’s Information Systems. Use of DXC Information Systems during other time periods or by individuals not authorized by DXC is expressly prohibited. Access is subject to DXC business control and information protection policies, standards and guidelines as may be modified from time to time. Use of any other DXC Information Systems is expressly prohibited. This prohibition applies even when an DXC Information System that Supplier is authorized to access, serves as a gateway to other Information Systems outside Supplier’s scope of authorization. Supplier agrees to access Information Systems only from specific locations approved for access by DXC. For access outside of DXC premises, DXC will designate the specific network connections to be used to access Information Systems.

  • Data Access and Proprietary Information 6.1 The Fund acknowledges that the databases, computer programs, screen formats, report formats, interactive design techniques, and documentation manuals furnished to the Fund by the Transfer Agent as part of the Fund’s ability to access certain Fund Confidential Information maintained by the Transfer Agent on databases under the control and ownership of the Transfer Agent or other third party (“Data Access Services”) constitute copyrighted, trade secret, or other proprietary information of substantial value to the Transfer Agent or other third party (collectively, “Transfer Agent Proprietary Information”). In no event shall Transfer Agent Proprietary Information be deemed Fund Confidential Information. The Fund agrees to treat all Transfer Agent Proprietary Information as proprietary to the Transfer Agent and further agrees that it shall not divulge any Transfer Agent Proprietary Information to any person or organization except as may be provided hereunder. Without limiting the foregoing, the Fund agrees for itself and its employees and agents to: (a) Use such programs and databases (i) solely on the Fund’s computers or on computers of Federated Services Company or its affiliates (collectively, “Fund Computers”), or (ii) solely from equipment at the location agreed to between the Fund and the Transfer Agent and (iii) solely in accordance with the Transfer Agent’s applicable user documentation; (b) Refrain from copying or duplicating in any way (other than in the normal course of performing processing on the Fund Computers), the Transfer Agent Proprietary Information; (c) Refrain from obtaining unauthorized access to any portion of the Transfer Agent Proprietary Information, and if such access is inadvertently obtained, to inform Transfer Agent in a timely manner of such fact and dispose of such information in accordance with the Transfer Agent’s instructions; (d) Refrain from causing or allowing information transmitted from the Transfer Agent’s computer to the Fund’s terminal to be retransmitted to any other computer terminal or other device except as expressly permitted by the Transfer Agent (such permission not to be unreasonably withheld); (e) Allow the Fund to have access only to those authorized transactions as agreed to between the Fund and the Transfer Agent; and (f) Honor all reasonable written requests made by the Transfer Agent to protect at the Transfer Agent’s expense the rights of the Transfer Agent in the Transfer Agent Proprietary Information at common law, under federal copyright law and under other federal or state law. 6.2 The Fund shall take reasonable efforts to advise its employees of their obligations pursuant to this Section 6. The obligations of this Section shall survive any earlier termination of this Agreement. 6.3 If the Fund notifies the Transfer Agent that any of the Data Access Services do not operate in material compliance with the most recently issued user documentation for such services, the Transfer Agent shall use its best efforts in a timely manner to correct such failure. Organizations from which the Transfer Agent may obtain certain data included in the Data Access Services are solely responsible for the contents of such data and the Fund agrees to make no claim against the Transfer Agent arising out of the contents of such third-party data, including, but not limited to, the accuracy thereof; provided, however, that the Fund shall be entitled to insist that the Transfer Agent, and the Transfer Agent for the benefit of the Fund shall, enforce any and all rights under applicable contracts for the Data Access Services. SUBJECT TO THE FOREGOING OBLIGATIONS OF THE TRANSFER AGENT, DATA ACCESS SERVICES AND ALL COMPUTER PROGRAMS AND SOFTWARE SPECIFICATIONS USED IN CONNECTION THEREWITH ARE PROVIDED ON AN AS IS, AS AVAILABLE BASIS. EXCEPT AS OTHERWISE PROVIDED HEREIN TO THE CONTRARY, THE TRANSFER AGENT EXPRESSLY DISCLAIMS ALL WARRANTIES INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. 6.4 If the transactions available to the Fund include the ability to originate Proper Instructions through electronic instructions to the Transfer Agent in order to: (i) effect the transfer or movement of cash or Shares; or (ii) transmit Shareholder information or other information, then in such event the Transfer Agent shall be entitled to rely on the validity and authenticity of such Proper Instructions without undertaking any further inquiry as long as such Proper Instruction is undertaken in conformity with applicable security procedures.

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