Common use of Regulatory Submissions Clause in Contracts

Regulatory Submissions. With respect to the Governmental Approvals of the Agreement Products in the Territory: (a) Unless otherwise required by Applicable Law, any Governmental Approvals and any Regulatory Submissions relating to Agreement Products in the Territory shall be filed, owned and held in the name of EVOLUS or its Affiliates. (b) EVOLUS shall be solely responsible, at its expense, and shall use commercially reasonable efforts to timely prepare, file, prosecute, and maintain all Regulatory Submissions relating to Agreement Products in the Territory, including any reports or amendments necessary to maintain Governmental Approvals, and for seeking any revisions of the conditions of each Governmental Approval. (c) EVOLUS shall have sole authority and responsibility and shall use commercially reasonable efforts to develop, modify, seek and/or obtain any necessary Governmental Approvals of any Labeling, packaging, advertising or other promotional or informational materials used in connection with Agreement Products in the Territory, and Promotional Materials and for determining whether the same requires Regulatory Approval. (d) EVOLUS will be the primary contact with the Regulatory Authorities in the Territory and shall be solely responsible for all communications with such Regulatory Authorities that relate to any Regulatory Submission relating to Agreement Products in the Territory prior to and after any Governmental Approval. (e) Subject to the terms and conditions of this Agreement, EVOLUS may file any submissions that are intended to change or modify Labeling or prescribing information approved by Health Canada for the Agreement Products in the field for the Territory; provided that, except as required by Applicable Laws, EVOLUS will provide to the DISTRIBUTOR a draft of such submission at least ten (10) business days prior to a planned submission to the applicable Regulatory Authority and EVOLUS will give reasonable consideration to any comments the DISTRIBUTOR may have. For greater certainty it is acknowledged and agreed that the labeling with respect to Products for distribution in Canada will be different than labeling for Products for distribution in the United States, as a result of among other things, the requirement in Canada to have the label in both English and French languages.

Regulatory Submissions. With respect to the Governmental Approvals Commercialization of the Agreement Sublicensed Products in the Territory: (a) Unless otherwise required by Applicable Law, any Governmental Regulatory Approvals and any all Regulatory Submissions relating to Agreement Sublicensed Products in the Territory shall be filed, owned and held in the name of EVOLUS or its AffiliatesKnight. (b) EVOLUS Knight shall be solely responsible, at its expense, and shall use commercially reasonable efforts Commercially Reasonable Efforts to timely prepare, file, prosecute, and maintain all Regulatory CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Submissions relating to Agreement Sublicensed Products in the Territory, including any reports or amendments necessary to maintain Governmental Regulatory Approvals, and for seeking any revisions of the conditions of each Governmental Regulatory Approval. (c) EVOLUS Knight shall have sole authority and responsibility and shall use commercially reasonable efforts Commercially Reasonable Efforts to develop, modify, seek and/or obtain any necessary Governmental Regulatory Approvals of any Sublicensed Product Labeling, packaging, advertising or other promotional or informational materials used in connection with Agreement Sublicensed Products in the Territory, and Promotional Materials and for determining whether the same requires Regulatory Approval. Braeburn shall provide to Knight copies of all material FDA Regulatory Submissions in its possession and Control reasonably related to the Sublicensed Products. (d) EVOLUS Knight will be the primary contact with the Regulatory Authorities in the Territory and shall be solely responsible for all communications with such Regulatory Authorities that relate to any Regulatory Submission relating to Agreement Sublicensed Products in the Territory prior to and after any Governmental Regulatory Approval. (e) Subject to the terms and conditions of this Agreement, EVOLUS Knight may file any submissions that are intended to change or modify Sublicensed Product Labeling or prescribing information approved by Health Canada for the Agreement applicable Regulatory Authority for, or the Indications of, Sublicensed Products in the field for the Territory; Territory provided that, except as required by Applicable Laws, EVOLUS will provide it provides to the DISTRIBUTOR Braeburn a draft of such submission at least ten (10) business days [***] Business Days prior to a planned submission to the applicable Regulatory Authority and EVOLUS will give gives prompt and reasonable consideration to any comments the DISTRIBUTOR Braeburn may have. (f) To the extent Braeburn reasonably believes that a filing or submission relating to Sublicensed Products in the Territory is required by Applicable Laws in order to sell or continue selling the Sublicensed Products, Braeburn shall notify Knight in writing. For greater certainty If Knight decides not to prepare such filing or submission, it is acknowledged shall promptly notify Braeburn of such decision and agreed Braeburn shall, acting reasonably, be entitled to prepare such filing or submission, [***], to be filed or submitted by Knight; provided that Braeburn shall use good faith efforts to include any comments of Knight in such filing or submission. (g) Knight shall permit Braeburn to access, and shall provide Braeburn on a timely basis with the labeling right to cross-reference and use in exercising its rights and performing its obligations hereunder with respect to Sublicensed Products for distribution in Canada will be different than labeling for Products for distribution in the United StatesTerritory and for Braeburn to use in connection with the development and commercialization of Sublicensed Products outside of the Territory, any and all Regulatory Submissions related to the Sublicensed Products Controlled by Knight. At the request of Braeburn and to the extent legally permitted and in accordance with the terms and conditions of this Agreement, Knight shall notify the appropriate Regulatory Authorities, as applicable, of Braeburn’s right to CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. reference such Regulatory Submissions in regulatory submissions filed by Braeburn in accordance with this Agreement. (h) Braeburn shall permit Knight to access, and shall provide Knight on a result timely basis with the right to cross-reference and use in exercising its rights and performing its obligations hereunder with respect to Sublicensed Products in the Territory (including for Knight to use in connection with its Commercialization of among other thingsSublicensed Products in the Territory), any and all Regulatory Submissions related to the requirement Sublicensed Products Controlled by Braeburn. At the request of Knight and to the extent legally permitted and in Canada accordance with the terms and conditions of this Agreement, Braeburn shall notify the appropriate Regulatory Authorities in the Territory of Knight’s right to have the label reference such Regulatory Submissions in both English and French languagesregulatory submissions filed by Knight in accordance with this Agreement.

Regulatory Submissions. With respect to the Governmental Approvals Commercialization of the Agreement Sublicensed Products in the Territory: (a) Unless otherwise required by Applicable Law, any Governmental Regulatory Approvals and any all Regulatory Submissions relating to Agreement Sublicensed Products in the Territory shall be filed, owned and held in the name of EVOLUS or its AffiliatesKnight. (b) EVOLUS Knight shall be solely responsible, at its expense, and shall use commercially reasonable efforts Commercially Reasonable Efforts to timely prepare, file, prosecute, and maintain all Regulatory Submissions relating to Agreement Sublicensed Products in the Territory, including any reports or amendments necessary to maintain Governmental Regulatory Approvals, and for seeking any revisions of the conditions of each Governmental Regulatory Approval. (c) EVOLUS Knight shall have sole authority and responsibility and shall use commercially reasonable efforts Commercially Reasonable Efforts to develop, modify, seek and/or obtain any necessary Governmental Regulatory Approvals of any Sublicensed Product Labeling, packaging, advertising or other promotional or informational materials used in connection with Agreement Sublicensed Products in the Territory, and Promotional Materials and for determining whether the same requires Regulatory Approval. Braeburn shall provide to Knight copies of all material FDA Regulatory Submissions in its possession and Control reasonably related to the Sublicensed Products. (d) EVOLUS Knight will be the primary contact with the Regulatory Authorities in the Territory and shall be solely responsible for all communications with such Regulatory Authorities that relate to any Regulatory Submission relating to Agreement Sublicensed Products in the Territory prior to and after any Governmental Regulatory Approval. (e) Subject to the terms and conditions of this Agreement, EVOLUS Knight may file any submissions that are intended to change or modify Sublicensed Product Labeling or prescribing information approved by Health Canada for the Agreement applicable Regulatory Authority for, or the Indications of, Sublicensed Products in the field for the Territory; Territory provided that, except as required by Applicable Laws, EVOLUS will provide it provides to the DISTRIBUTOR Braeburn a draft of such submission at least ten fifteen (1015) business days Business Days prior to a planned submission to the applicable Regulatory Authority and EVOLUS will give gives prompt and reasonable consideration to any comments the DISTRIBUTOR Braeburn may have. (f) To the extent Braeburn reasonably believes that a filing or submission relating to Sublicensed Products in the Territory is required by Applicable Laws in order to sell or continue selling the Sublicensed Products, Braeburn shall notify Knight in writing. For greater certainty If Knight decides not to prepare such filing or submission, it is acknowledged shall promptly notify Braeburn of such decision and agreed Braeburn shall, acting reasonably, be entitled to prepare such filing or submission, at Knight’s sole cost and expense (provided that such costs and expenses are commercially reasonable given such filing requirements), to be filed or submitted by Knight; provided that Braeburn shall use good faith efforts to include any comments of Knight in such filing or submission. (g) Knight shall permit Braeburn to access, and shall provide Braeburn on a timely basis with the labeling right to cross-reference and use in exercising its rights and performing its obligations hereunder with respect to Sublicensed Products for distribution in Canada will be different than labeling for Products for distribution in the United StatesTerritory and for Braeburn to use in connection with the development and commercialization of Sublicensed Products outside of the Territory, any and all Regulatory Submissions related to the Sublicensed Products Controlled by Knight. At the request of Braeburn and to the extent legally permitted and in accordance with the terms and conditions of this Agreement, Knight shall notify the appropriate Regulatory Authorities, as applicable, of Braeburn’s right to reference such Regulatory Submissions in regulatory submissions filed by Braeburn in accordance with this Agreement. (h) Braeburn shall permit Knight to access, and shall provide Knight on a result timely basis with the right to cross-reference and use in exercising its rights and performing its obligations hereunder with respect to Sublicensed Products in the Territory (including for Knight to use in connection with its Commercialization of among other thingsSublicensed Products in the Territory), any and all Regulatory Submissions related to the requirement Sublicensed Products Controlled by Braeburn. At the request of Knight and to the extent legally permitted and in Canada accordance with the terms and conditions of this Agreement, Braeburn shall notify the appropriate Regulatory Authorities in the Territory of Knight’s right to have the label reference such Regulatory Submissions in both English and French languagesregulatory submissions filed by Knight in accordance with this Agreement.

Regulatory Submissions. With respect to To the Governmental Approvals of the Agreement Products in the Territory: (a) Unless otherwise required extent permitted by Applicable Law, each Party’s regulatory team shall reasonably cooperate with the other Party’s regulatory team regarding Drug Approval Applications and other material Regulatory Submissions for Products in all markets for which such Party is the Regulatory/Reimbursement Responsible Party. In addition, to the extent permitted by Applicable Law, each Party shall provide the other Party with a reasonable opportunity to review and comment on all material Regulatory Submissions for any Governmental Approvals Product to be submitted to any Regulatory Authority in the Apellis Territory or any Major Market by or on behalf of such Party (including Drug Approval Applications, material correspondence, meeting requests, briefing materials, and minutes) throughout the process of preparing such Regulatory Submissions and, in particular, shall provide such other Party with drafts of all such Regulatory Submissions on the timeline agreed to by the Parties in good faith in writing prior to the date such Regulatory Submissions are to be finalized to allow for such other Party’s review and comment. Each Party shall consider in good faith (and, with respect to the EMA PNH Regulatory Approval, Apellis shall not unreasonably decline to implement) all timely, reasonable comments from the other Party regarding such Party’s Regulatory Submissions for Products in the Apellis Territory or any Major Market and, within [**] after submitting any Regulatory Submission for any Product to any Regulatory Authority in the Apellis Territory or any Major Market provide a copy of such final Regulatory Submission to the other Party. Each Party shall cooperate with the other Party as reasonably requested by such other Party to assist such other Party’s efforts to prepare and submit any Regulatory Submissions relating to Agreement for Products in the Territory shall be filed, owned and held in the name of EVOLUS or its Affiliates. (b) EVOLUS shall be solely responsible, at its expense, and shall use commercially reasonable efforts to timely prepare, file, prosecute, and maintain all Regulatory Submissions relating to Agreement Products in the Territory, including any reports or amendments necessary to maintain Governmental Approvals, and for seeking any revisions of the conditions of each Governmental Approval. (c) EVOLUS shall have sole authority and responsibility and shall use commercially reasonable efforts to develop, modify, seek and/or obtain any necessary Governmental Approvals of any Labeling, packaging, advertising or other promotional or informational materials used in connection with Agreement Products in the Territory, and Promotional Materials and for determining whether the same requires Regulatory Approval. (d) EVOLUS will be the primary contact with the Regulatory Authorities in the Territory and shall be solely responsible for all communications with such Regulatory Authorities that relate to any Regulatory Submission relating to Agreement Products in the Territory prior to and after any Governmental Approval. (e) Subject to the terms and conditions of under this Agreement, EVOLUS may file including by providing all such supporting documentation for INDs, CTAs, Drug Approval Applications, and other Regulatory Submissions to such other Party as are reasonably requested by such other Party with reasonably sufficient time to allow such other Party to review and incorporate such documentation and timely submit such Regulatory Submissions in accordance with Applicable Law or any submissions that are intended to change other requirements or modify Labeling or prescribing information approved by Health Canada for the Agreement Products in the field for the Territory; provided that, except as required by Applicable Laws, EVOLUS will provide to the DISTRIBUTOR a draft requests of such submission at least ten (10) business days prior to a planned submission to the any applicable Regulatory Authority and EVOLUS will give reasonable consideration to any comments the DISTRIBUTOR may have. For greater certainty it is acknowledged and agreed that the labeling with respect to Products for distribution in Canada will be different than labeling for Products for distribution in the United States, as a result of among other things, the requirement in Canada to have the label in both English and French languagesAuthority.

Regulatory Submissions. With respect to the Governmental Approvals of the Agreement Products in the Territory: (a) Unless otherwise required by Applicable Law, any Governmental Approvals and any Regulatory Submissions relating to Agreement Products in the Territory shall be filed, owned and held in the name of EVOLUS or its Affiliates. (b) EVOLUS shall be solely responsible, at its expense, and shall use commercially reasonable efforts to timely prepare, file, prosecute, and maintain all Regulatory Submissions relating to Agreement Products in the Territory, including any reports or amendments necessary to maintain Governmental Approvals, and for seeking any revisions of the conditions of each Governmental Approval.commercially (c) EVOLUS shall have sole authority and responsibility and shall use commercially reasonable efforts to develop, modify, seek and/or obtain any necessary Governmental Approvals of any Labeling, packaging, advertising or other promotional or informational materials used in connection with Agreement Products in the Territory, and Promotional Materials and for determining whether the same requires Regulatory Approval. (d) EVOLUS will be the primary contact with the Regulatory Authorities in the Territory and shall be solely responsible for all communications with such Regulatory Authorities that relate to any Regulatory Submission relating to Agreement Products in the Territory prior to and after any Governmental Approval. (e) Subject to the terms and conditions of this Agreement, EVOLUS may file any submissions that are intended to change or modify Labeling or prescribing information approved by Health Canada for the Agreement Products in the field for the Territory; provided that, except as required by Applicable Laws, EVOLUS will provide to the DISTRIBUTOR a draft of such submission at least ten (10) business days prior to a planned submission to the applicable Regulatory Authority and EVOLUS will give reasonable consideration to any comments the DISTRIBUTOR may have. For greater certainty it is acknowledged and agreed that the labeling with respect to Products for distribution in Canada will be different than labeling for Products for distribution in the United States, as a result of among other things, the requirement in Canada to have the label in both English and French languages.. 4. DISTRIBUTOR OBLIGATIONS 4.1