Safety Information Exchange Sample Clauses

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 [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. 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. 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. 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. Certain confidential information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment. 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.
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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.
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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 
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Related to Safety Information Exchange

  • KYC Information (i) Upon the reasonable request of any Lender made at least five (5) days prior to the Closing Date, the Borrowers shall have provided to such Lender, and such Lender shall be reasonably satisfied with, the documentation and other information so requested in connection with applicable “know your customer” and anti-money-laundering rules and regulations, including, without limitation, the PATRIOT Act, in each case at least five (5) days prior to the Closing Date.

  • Access to Company Information (a) The Company shall (and shall cause each Company Subsidiary to) permit representatives of the Parent to have full access (at all reasonable times, and in a manner so as not to interfere with the normal business operations of the Company and the Company Subsidiaries) to all premises, properties, financial and accounting records, contracts, other records and documents, and personnel, of or pertaining to the Company and each Company Subsidiary.

  • Client Information (2) Protected Health Information in any form including without limitation, Electronic Protected Health Information or Unsecured Protected Health Information (herein “PHI”);

  • 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:

  • Cost Basis Information (a) In the event of a cash exercise, the Company hereby instructs the Warrant Agent to record cost basis for newly issued shares in a manner to be subsequently communicated by the Company in writing to the Warrant Agent.

  • Confidentiality; Access to Information (a) The parties acknowledge that Company and Parent have previously executed a mutual nondisclosure agreement, dated as of March 5, 2000 (the "CONFIDENTIALITY AGREEMENT"), which Confidentiality Agreement will continue in full force and effect in accordance with its terms; provided, that nothing in this Agreement or the Confidentiality Agreement will restrict communications with parties to the Related Agreements.

  • Confidentiality/Protection of Customer Information The Company shall keep confidential and shall not divulge to any party, without the Purchaser's prior written consent, the price paid by the Purchaser for the Mortgage Loans, except to the extent that it is reasonable and necessary for the Company to do so in working with legal counsel, auditors, taxing authorities or other governmental agencies. Each party agrees that it shall comply with all applicable laws and regulations regarding the privacy or security of Customer Information and shall maintain appropriate administrative, technical and physical safeguards to protect the security, confidentiality and integrity of Customer Information, including maintaining security measures designed to meet the objectives of the Interagency Guidelines Establishing Standards for Safeguarding Customer Information, 66 Fed. Reg. 8616 (the "Interagency Guidelines"). For purposes of this Section, the term "Customer Information" shall have the meaning assigned to it in the Interagency Guidelines.

  • Inventions and Proprietary Information Prohibition on Third Party Information A. Proprietary Information Agreement. Executive acknowledges that he has signed and remains bound by the terms of the Company’s Proprietary Information and Inventions Agreement, which is attached as Exhibit B (“Proprietary Information Agreement”).

  • Company Information Subscriber understands that the Company is subject to all the risks that apply to early-stage companies, whether or not those risks are explicitly set out in the Offering Circular. Subscriber has had such opportunity as it deems necessary (which opportunity may have presented through online chat or commentary functions) to discuss the Company’s business, management and financial affairs with managers, officers and management of the Company and has had the opportunity to review the Company’s operations and facilities. Subscriber has also had the opportunity to ask questions of and receive answers from the Company and its management regarding the terms and conditions of this investment. Subscriber acknowledges that except as set forth herein, no representations or warranties have been made to Subscriber, or to Subscriber’s advisors or representative, by the Company or others with respect to the business or prospects of the Company or its financial condition.

  • Access to Information; Confidentiality (a) Upon reasonable advance written notice, subject to applicable logistical restrictions or limitations as a result of COVID-19 or any COVID-19 Measures and solely for purposes of furthering the Merger Transactions, the Company shall, and shall cause each of its Subsidiaries to, afford to Parent, Merger Sub and their respective representatives reasonable access during normal business hours during the period from the date of this Agreement until the earlier of the Effective Time or the valid termination of this Agreement pursuant to Article VII, to all their respective properties, assets, books, contracts, commitments, personnel and records and, during such period, the Company shall, and shall cause each of its Subsidiaries to, furnish promptly to Parent: (i) a copy of each report, schedule, registration statement and other document filed or received by it during such period pursuant to the requirements of federal or state securities Laws and (ii) all other information concerning its business, properties and personnel as Parent or Merger Sub may reasonably request (including Tax Returns filed and those in preparation and the workpapers of its auditors). Nothing herein (including, for the avoidance of doubt, this Section 5.2(a) and Section 5.2(b)) shall require the Company or any of its Subsidiaries to provide such access or information to the extent that such action (A) would reasonably be expected to result in a waiver of attorney-client privilege, work product doctrine or similar privilege, (B) specifically relates to the evaluation, deliberation or minutes of the Company Board (or any committee or subcommittee thereof) related to the Merger Transactions, the strategic and financial alternatives process leading thereto, or any information or materials provided to the Company Board (or any committee or subcommittee thereof) in connection therewith or (C) would reasonably be expected to violate any applicable Law or any confidentiality obligation owing to a third party so long as the Company shall promptly notify Parent of any such confidentiality obligations or access restrictions and use commercially reasonable efforts to obtain the consent of such third party to provide such information and otherwise provide such access to Parent, if requested and (b) generally describe the type of information that cannot be disclosed to Parent (to the extent not prohibited by law or the underlying document). No investigation pursuant to this Section 5.2 shall affect any representation or warranty in this Agreement of any party hereto or any condition to the obligations of the parties hereto. All requests for access pursuant to this Section 5.2 must be directed to the Chief Financial Officer of the Company or another person designated in writing by the Company. Notwithstanding anything herein to the contrary, Parent and Merger Sub shall not, and shall cause their respective representatives not to, contact any partner, licensor, licensee, customer or supplier of the Company in connection with the Offer, the Merger or any of the other Merger Transactions without the Company’s prior written consent (such consent not to be unreasonably withheld, conditioned or delayed), and Parent and Merger Sub acknowledge and agree that any such contact shall be arranged by and with a representative of the Company participating.

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