Trial Master File Clause Samples
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Trial Master File. Promptly following the Effective Date, OPKO will establish and maintain a trial master file (to the extent they not already established and maintained for any applicable Trial) for any Trials in the format as agreed upon by the JDC (each a “Trial Master File”). Notwithstanding anything to the contrary herein, OPKO will not be permitted to delegate its rights and obligations pursuant to this Section 4.5.4 to any Third Parties without the prior approval of the JDC, except OPKO may delegate its rights and obligations pursuant to this Section 4.5.4 to any of its Affiliates provided that OPKO retains accountability following such delegation.
Trial Master File. Notwithstanding any other provision in this Agreement regarding the return or transfer of Confidential Information or clinical trial data or documents, any Party that is a sponsor of a Clinical Trial involving the Products shall retain all documents and data, including, but not limited to the Trial Master File, to the extent required to be retained under Applicable Laws. [***].
Trial Master File. “TMF”). For each Joint Global Study, as between the Parties, the Sponsor Party shall be responsible for the set up and maintenance of the Trial Master File and collection of documents for Regulatory Filings from its Sponsored Territory. The TMF shall contain all documentations related to the Joint Global Study. It must be set up in compliance with Good Clinical Practice (GCP) standards and applicable local regulatory requirements.
Trial Master File. Upon Biogen’s written request, Ionis will provide to Biogen or its designated Affiliate a copy of ▇▇▇▇▇’ trial master file for such Collaboration Program (such trial master file, the “Trial Master File”) promptly, and in any event within [***] days after ▇▇▇▇▇’ receipt of such written request. Within [***] days after receipt of the Trial Master File, Biogen or an Affiliate may notify Ionis of any omissions or deficiencies that Biogen or its Affiliate believes in good faith cause the Trial Master File to be incomplete (such notice, a “Trial Master File Deficiency Notice”). Ionis will promptly, and in any event within [***] days after receipt of the Trial Master File Deficiency Notice, resubmit a complete Trial Master File to Biogen or its designated Affiliate, including any information required to be included in a Trial Master File that Biogen requests be included in the Trial Master File. If the Parties do not agree as to whether the Trial Master File is complete, the matter will be referred to the Executives for resolution. The Executives will meet promptly and negotiate in good faith to resolve the dispute and agree upon a complete Trial Master File. If ▇▇▇▇▇ is the Commercializing Party of a Discontinued Collaboration Product, this Section 4.9.2(d) will apply to such Discontinued Collaboration Product mutatis mutandis such that Biogen will transfer to Ionis Biogen’s trial master file for such Discontinued Collaboration Product.