SDEA Clause Samples

An SDEA, or Supply and Distribution Agreement, is a contractual clause that outlines the terms under which one party supplies goods or services to another for distribution. It typically details the rights and obligations of both the supplier and distributor, including delivery schedules, pricing, territory, and exclusivity arrangements. By clearly defining these aspects, the SDEA helps prevent disputes, ensures a reliable supply chain, and allocates responsibilities between the parties.
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SDEA. Within ninety (90) days after the Effective Date, the Parties shall enter into an agreement to initiate the process for the exchange of pharmacovigilance data in a mutually agreed format to ultimately be reflected in a definitive safety data exchange agreement (“SDEA”), including post-marketing spontaneous reports received by a Party or its Affiliates in order to monitor the safety of the Product and to meet reporting requirements with any applicable Governmental Authority. The Parties agree that there shall only be one SDEA with respect to this Agreement and the Asset Purchase Agreement.
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SDEA. (i) The Parties will cooperate in the collection, review, assessment, tracking and filing of information related to adverse events associated with the Licensed Products, including in accordance with applicable FDA regulations, including 21 CFR §§ 312.32, 314.80, and with comparable Laws in countries within and outside the Territory. As soon as reasonably practicable after the Original Agreement Effective Date, but in no event later than [*] days thereafter, the pharmacovigilance departments of both Parties shall meet and determine the approach to be taken for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Licensed Products, which shall be documented in a separate mutually acceptable safety data exchange agreement (the “Safety Data Exchange Agreement”) between the Parties; provided, however, that this Agreement shall control in the event of any conflict between the terms of this Agreement and such Safety Data Exchange Agreement. Until such time as the Parties have entered into the Safety Data Exchange Agreement, the Parties will exchange safety information, regardless of causality, involving or associated with the use of the Licensed Products, on the following schedule: (A) All serious adverse event information will be exchanged within [*] days after the receipt of such information by a Party or by any of the Party’s Affiliates, agents or Sublicensees. (B) Non-serious adverse event information will be exchanged on either Party’s reasonable request. (ii) The Parties acknowledge that an initial Safety Data Exchange Agreement has been entered into by them effective as of May 6, 2011. Simultaneously with the execution of this Agreement, the Parties are entering into an additional Safety Data Exchange Agreement; provided, however, that this Agreement shall control in the event of any conflict between the terms of this Agreement and either the initial or such additional Safety Data Exchange Agreement. All references to the “Safety Data Exchange Agreement” herein shall be deemed to be references to both the initial and such additional Safety Data Exchange Agreement, as applicable.
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SDEA. The Parties shall enter into a Safety Data Exchange Agreement (SDEA) describing the procedures which Kitov and Coeptis shall implement, and the responsibilities of each Party thereunder to ensure that relevant safety information relating to the Product is exchanged in a timely manner and that Parties can fulfill their respective pharmacovigilance obligations under applicable laws
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SDEA. Within 30 days after the Execution Date but in no event later than the day on which the first Business Permit (i.e., relevant product registration) in respect of any Product will be effectively transferred from the relevant Selling Person to Purchaser in accordance with the Asset Purchase Agreement, the Service Provider (or its relevant Affiliate) and the Service Recipient shall in good faith negotiate and agree in writing a Safety Data and Exchange Agreement (“SDEA”). Such SDEA shall be on terms and conditions customary for similar transactions, and shall govern the transition of pharmacovigilance activities from the relevant Selling Person (and/or its Affiliates) to the Purchaser and the transfer of the safety database at a mutually agreed date. The SDEA shall enable worldwide safety surveillance and risk management and allow each Party to comply with its legal and regulatory obligations as legal manufacturer or holder of the relevant Business Permit (i.e., relevant product registration). The SDEA will be signed by authorized departments of the Parties and shall be considered part of this Agreement, provided however that it can be amended separately without the need to amend this Agreement as a whole.
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Related to SDEA

  • Pharmacovigilance Agreement Subject to the terms of this Agreement, and at a date to be determined by the JDC, Facet and Trubion shall define and finalize the actions the Parties shall employ to protect patients and promote their well-being in a written agreement (hereinafter referred to as the “Pharmacovigilance Agreement”). These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any Collaboration Product. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations to Governmental Authorities. Furthermore, such agreed procedures shall be consistent with relevant ICH guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirements, in which case local reporting requirements shall prevail. The Pharmacovigilance Agreement will provide for a worldwide safety database to be maintained by the Party appointed by the JDC. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement (as the Parties may agree to modify it from time to time) and to cause its Affiliates and permitted sublicensees to comply with such obligations.

  • 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

  • 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.

  • Confidentiality Agreement As an employee of the Company, you will continue to have access to certain confidential information of the Company and you may, during the course of your employment, develop certain information or inventions that will be the property of the Company. To protect the interests of the Company, your acceptance of this Agreement confirms that the terms of the Company’s Employee Confidentiality, Inventions and Non-Interference Agreement you previously signed with the Company (the “Confidentiality Agreement”) still apply.

  • Confidentiality Agreements The parties hereto agree that this Agreement supersedes any provision of the Confidentiality Agreements that could be interpreted to preclude the exercise of any rights or the fulfillment of any obligations under this Agreement, and that none of the provisions included in the Confidentiality Agreements will act to preclude Holder from exercising the Option or exercising any other rights under this Agreement or act to preclude Issuer from fulfilling any of its obligations under this Agreement.