Common use of No Reference Filing Clause in Contracts

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) the Parties shall promptly discuss how to address such issue and (b) in no event will such Confidential Information be disclosed to the applicable Regulatory Authority against the reasonable, good faith objection of the Dossier Controlling Party.

No Reference Filing. 6.3.1 In the event that the Pfizer LicensorsLicensees, their Affiliates and their Sublicensees Sublicensees, or the Company Licensees Licensors 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 Licensee or Company Licensee Licensor (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 to the extent Controlled by the applicable Party (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 SublicenseesLicensor, the Company Submissions and, with respect to a Pfizer Licensor and its AffiliatesLicensee, the Pfizer Submissions (each of a Pfizer Licensor Licensee and a Company LicenseeLicensor, a “"Filing Party”"); provided that, if a Company Pfizer Licensee is a Filing Party, the applicable Pfizer Licensor Reference Filing has submitted the applicable Reference Filingbeen submitted, 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 Company Licensor (if the Filing Party is a Company Pfizer Licensee) or the applicable Company Pfizer Licensee (if the Filing Party is a Pfizer Company Licensor) (such Pfizer Company Licensor and Company Pfizer 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 LicenseeLicensor, the Company Submissions and, with respect to a Pfizer LicensorLicensee, the Pfizer Submissions. For clarity, the Dossier Controlling Party shall disclose ensure that the Regulatory Dossier is disclosed 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 6.36.3.3, 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) the Parties shall promptly discuss how to address such issue and (b) in no event will such Confidential Information be disclosed to the applicable Regulatory Authority against the reasonable, good faith objection of the Dossier Controlling Party.

No Reference Filing. 6.3.1 In the event that the Pfizer LicensorsLicensees, their Affiliates and their Sublicensees or the Company Licensees Licensors 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 Licensee or Company Licensee Licensor (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 Licensor and its SublicenseesAffiliates, the Company Submissions and, with respect to a Pfizer Licensor Licensee, its Affiliates and its AffiliatesSublicensees, the Pfizer Submissions (each of a Pfizer Licensor Licensee and a Company LicenseeLicensor, a “Filing Party”); provided that, if a Company Pfizer Licensee is a Filing Party, the applicable Pfizer Company 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 Company Licensor (if the Filing Party is a Company Pfizer Licensee) or the applicable Company Pfizer Licensee (if the Filing Party is a Pfizer Company Licensor) (such Pfizer Company Licensor and Company Pfizer 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 LicenseeLicensor, the Company Submissions and, with respect to a Pfizer LicensorLicensee, 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 6.36.3.3, 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) the Parties shall promptly discuss how to address such issue and (b) in no event will such Confidential Information be disclosed to the applicable Regulatory Authority against the reasonable, good faith objection of the Dossier Controlling Party.

No Reference Filing. 6.3.1 In the event that the Pfizer LicensorsLicensors and their Affiliates, or the Company Licensees, their Affiliates and their Sublicensees or the Company Licensees and their Affiliates Sublicensees, (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 to the extent Controlled by the applicable Party (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 AffiliatesLicensor, 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 Reference Filing has submitted the applicable Reference Filingbeen submitted, 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 ensure that the Regulatory Dossier is disclosed 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) the Parties shall promptly discuss how to address such issue and (b) in no event will such Confidential Information be disclosed to the applicable Regulatory Authority against the reasonable, good faith objection of the Dossier Controlling Party.

No Reference Filing. 6.3.1 In the event that the Pfizer LicensorsLicensors and their Affiliates, or the Company Licensees, their Affiliates and their Sublicensees or the Company Licensees and their Affiliates Sublicensees, (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 to the extent Controlled by the applicable Party (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 AffiliatesLicensor, 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 Reference Filing has submitted the applicable Reference Filingbeen submitted, 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) the Parties shall promptly discuss how to address such issue and (b) in no event will such Confidential Information be disclosed to the applicable Regulatory Authority against the reasonable, good faith objection of the Dossier Controlling Party.the