Pharmacovigilance; Safety Database Sample Clauses

Pharmacovigilance; Safety Database. Prior to IND transfer, designated staff from the respective Headquarter Pharmacovigilance Department shall be requested by the Joint Steering Committee to establish a detailed Safety Data Exchange Agreement (“SDEA”) for the Licensed Products to be in place prior to Sanofi starting any clinical development. Notwithstanding the foregoing, the Parties agree to the following principles:
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Pharmacovigilance; Safety Database. Promptly but in any circumstances within ninety (90) days following the first Initial Major Market IND Submission, the Parties shall negotiate and execute a detailed Safety Data Exchange Agreement (“SDEA”) setting forth the Parties responsibilities with respect to reporting of adverse events and maintaining a global safety database with respect to Lead Compounds and Products, which SDEA shall in any event be in place prior to AstraZeneca starting any clinical development. Notwithstanding the foregoing, the Parties agree to the following principles:
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Pharmacovigilance; Safety Database. Prior to [***], the Parties will enter into an agreement setting forth the Parties’ pharmacovigilance obligations with respect to the Licensed Products during Development (the “Pharmacovigilance Agreement”). The Pharmacovigilance Agreement shall define safety data exchange procedures concerning serious adverse events, including serious adverse drug reactions, with respect to any Licensed Products, sufficient to permit each Party and its Affiliates and Subcontractors or Sublicensees, as the case may be, to comply with applicable Law requirements pertaining to drug safety and pharmacovigilance. Gossamer (or its designee) shall be the global safety database holder and shall be responsible for all aspects of pharmacovigilance of the Licensed Product during Development in [***]. Chiesi will maintain its own safety database with regards to the data received during Clinical Trials sponsored by Chiesi and Chiesi will share with Gossamer such data, if any, in accordance with the Pharmacovigilance Agreement, which will allow both Parties to reasonably cooperate in order to comply with regulatory and pharmacovigilance obligations with respect to the Licensed Product. Not later than the [***] or such earlier date required by applicable Law, the Parties shall enter into a separate, written Pharmacovigilance Agreement containing specific terms, conditions and obligations of the Parties with respect to the collection, reporting and monitoring of all adverse events, risk management activities and other relevant drug safety matters with respect to the Licensed Product. The Pharmacovigilance Agreement shall require each Party to handle all serious adverse events information and other safety data that comes into its possession pursuant to the activities performed under this Agreement in accordance with all applicable Laws.
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Pharmacovigilance; Safety Database. Prior to transfer of the existing IND/CTA in accordance with Section 4.2.2, the Parties will enter into an agreement setting forth the Parties’ pharmacovigilance obligations with respect to the Licensed Products (the “Pharmacovigilance Agreement”). The Pharmacovigilance Agreement shall define safety data exchange procedures concerning adverse events, including adverse drug reactions, with respect to any Licensed Products, sufficient to permit each Party and its Affiliates and subcontractors or sublicensees, as the case may be, to comply with applicable Law requirements pertaining to drug safety and pharmacovigilance, including, to the extent applicable, those obligations contained in Health Care Laws. Xxxxxxx shall establish the global safety database of adverse events and relevant pharmacovigilance information for the Licensed Products. argenx shall transfer all safety information in its possession relating to the Licensed Compound or Licensed Product to the global safety database within an agreed time period, providing Xxxxxxx with sufficient time to enter all the data and to obtain validation of the database. The Pharmacovigilance Agreement shall require each Party to handle all serious adverse events information and other safety data that comes into its possession pursuant to the activities performed under this Agreement in accordance with all applicable Laws. The Pharmacovigilance Agreement shall require Xxxxxxx, in the event that argenx reasonably deems it necessary, to promptly make available to argenx such information from Xxxxxxx’x global safety database for the Licensed Compound or Licensed Product as may reasonably be required in order for argenx to comply with any pharmacovigilance reporting and other compliance obligations under applicable Law. * Confidential Information, indicated by [...***...], has been omitted from this filing and filed separately with the U.S. Securities and Exchange Commission.
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Pharmacovigilance; Safety Database. If Sanofi exercises its Option with respect to any POC Program, then prior to IND transfer with respect to any Product under such POC Program, designated staff from the respective Headquarter Pharmacovigilance Department shall be requested by the Joint Steering Committee to establish a detailed Safety Data Exchange Agreement (“SDEA”) for the Products to be in place prior to Sanofi starting any clinical development. Notwithstanding the foregoing, the Parties agree to the following principles:
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Related to Pharmacovigilance; Safety Database

  • Pharmacovigilance Licensee shall maintain until the termination of this Agreement (or, as applicable, until the rights and obligations intended to survive termination of this Agreement have been fulfilled) pharmacovigilance and risk management systems, procedures and documentation needed to perform and comply with its regulatory obligations and its related obligations under this Agreement. Licensee shall ensure that it will comply with all Applicable Law regarding Licensed Product in the Territory, including, without limitation, those laws and regulations relating to risk management, drug safety and pharmacovigilance. If Licensee becomes aware of any adverse reaction relating to Licenced Product in connection with this Agreement, Licensee shall inform MPP and Pfizer within twenty-four (24) hours of its becoming aware and cooperate with Pfizer in fulfilling Pfizer’s reporting responsibilities under Applicable Law. Licensee will be responsible for fulfilling all pharmacovigilance activities pursuant to the local regulations and requirements for the Licenced Products in the Territory and provide MPP and Pfizer with a report containing information regarding all such activities. Such report shall be provided annually, on February 1 of each year, and otherwise on reasonable request by MPP or Pfizer to both MPP and Pfizer’s pharmacovigilance contact as may be designated by Pfizer from time to time. Licensee shall notify MPP and Pfizer forthwith of the receipt of an enquiry from an Agency in the Territory relating to Licensed Product that concerns any safety issue. If Licensee becomes aware of any action that may be, will be or has been taken by an Agency for a safety reason connected with Licensed Product, it shall immediately, and in any event no later than twenty-four

  • 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.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • Quality Agreement Concurrently with execution of this Agreement, the Parties will enter into an agreement that details the quality assurance obligations of each Party with respect to the Manufacture and supply of Supplied Products under this Agreement (the “Quality Agreement”). Each Party shall perform its obligations under the Quality Agreement in accordance with the terms and conditions thereof. In the event of a conflict between the terms of the Quality Agreement and the terms of this Agreement, the provisions of the Quality Agreement shall govern.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to FDA or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Concession Area, including its abandonment.

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