No Reference Filing Clause Samples

No Reference Filing. 6.3.1 In the event that the Pfizer Licensors, their Affiliates and their Sublicensees or the Company Licensees and their Affiliates (as applicable) have not submitted a Reference Filing as described in Sections 6.1 or 6.2 (as applicable) to the applicable Regulatory Authorities, but have submitted such a Reference Filing to another Regulatory Authority, such Pfizer Licensor or Company Licensee (as applicable) or its applicable Affiliate shall prepare and if allowable by Applicable Law, submit a proprietary dossier of the CMC Information and quality, nonclinical and clinical information (the “Regulatory Dossier”) to the applicable Regulatory Authority to the extent necessary for such Regulatory Authority to approve, with respect to a Company Licensee, its Affiliates and its Sublicensees, the Company Submissions and, with respect to a Pfizer Licensor and its Affiliates, the Pfizer Submissions (each of a Pfizer Licensor and a Company Licensee, a “Filing Party”); provided that, if a Company Licensee is a Filing Party, the applicable Pfizer Licensor has submitted the applicable Reference Filing, and the information contained in the Regulatory Dossier exists, as of the Effective Date. 6.3.2 If submission of a Regulatory Dossier as described in Section 6.3.1 is not permitted by Applicable Law, then the Filing Party will provide the applicable Pfizer Licensor (if the Filing Party is a Company Licensee) or the applicable Company Licensee (if the Filing Party is a Pfizer Licensor) (such Pfizer Licensor and Company Licensee, the “Dossier Controlling Party”) with a copy of the Regulatory Dossier solely for disclosure to the applicable Regulatory Authorities to the extent necessary for the applicable Regulatory Authorities to approve, with respect to a Company Licensee, the Company Submissions and, with respect to a Pfizer Licensor, the Pfizer Submissions. For clarity, the Dossier Controlling Party shall disclose the Regulatory Dossier to the Regulatory Authorities without any modifications except for translations to the local language required by Applicable Law. 6.3.3 Notwithstanding anything to the contrary in this Section 6.3, in the event that a Dossier Controlling Party has a reasonable, good faith belief that the Regulatory Authority to whom the applicable Regulatory Dossier will be disclosed will not maintain the confidentiality of any Confidential Information of the Dossier Controlling Party, the Dossier Controlling Party shall notify the other Party and (a) th...