Common use of Regulatory Submissions Clause in Contracts

Regulatory Submissions. With respect to the Commercialization of the Sublicensed Products in the Territory: (a) Unless otherwise required by Applicable Law, any Regulatory Approvals and all Regulatory Submissions relating to Sublicensed Products in the Territory shall be filed, owned and held in the name of Knight. (b) Knight shall be solely responsible, at its expense, and shall use 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 Sublicensed Products in the Territory, including any reports or amendments necessary to maintain Regulatory Approvals, and for seeking any revisions of the conditions of each Regulatory Approval. (c) Knight shall have sole authority and responsibility and shall use Commercially Reasonable Efforts to develop, modify, seek and/or obtain any necessary Regulatory Approvals of any Sublicensed Product Labeling, packaging, advertising or other promotional or informational materials used in connection with 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) 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 Sublicensed Products in the Territory prior to and after any Regulatory Approval. (e) Subject to the terms and conditions of this Agreement, Knight may file any submissions that are intended to change or modify Sublicensed Product Labeling or prescribing information approved by the applicable Regulatory Authority for, or the Indications of, Sublicensed Products in the Territory provided that, except as required by Applicable Laws, it provides to Braeburn a draft of such submission at least [***] Business Days prior to planned submission to the applicable Regulatory Authority and gives prompt and reasonable consideration to any comments 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. If Knight decides not to prepare such filing or submission, it shall promptly notify Braeburn of such decision and 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 right to cross-reference and use in exercising its rights and performing its obligations hereunder with respect to Sublicensed Products in the Territory 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 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 Sublicensed Products in the Territory), any and all Regulatory Submissions related to the Sublicensed Products Controlled by Braeburn. At the request of Knight and to the extent legally permitted and in accordance with the terms and conditions of this Agreement, Braeburn shall notify the appropriate Regulatory Authorities in the Territory of Knight’s right to reference such Regulatory Submissions in regulatory submissions filed by Knight in accordance with this Agreement.

Regulatory Submissions. With respect to the Commercialization Governmental Approvals of the Sublicensed Agreement Products in the Territory: (a) Unless otherwise required by Applicable Law, any Regulatory Governmental Approvals and all any Regulatory Submissions relating to Sublicensed Agreement Products in the Territory shall be filed, owned and held in the name of KnightEVOLUS or its Affiliates. (b) Knight EVOLUS 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 Sublicensed Agreement Products in the Territory, including any reports or amendments necessary to maintain Regulatory Governmental Approvals, and for seeking any revisions of the conditions of each Regulatory Governmental Approval. (c) Knight EVOLUS shall have sole authority and responsibility and shall use Commercially Reasonable Efforts commercially reasonable efforts to develop, modify, seek and/or obtain any necessary Regulatory Governmental Approvals of any Sublicensed Product Labeling, packaging, advertising or other promotional or informational materials used in connection with Sublicensed Agreement 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) Knight 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 Sublicensed Agreement Products in the Territory prior to and after any Regulatory Governmental Approval. (e) Subject to the terms and conditions of this Agreement, Knight EVOLUS may file any submissions that are intended to change or modify Sublicensed Product Labeling or prescribing information approved by Health Canada for the applicable Regulatory Authority for, or the Indications of, Sublicensed Agreement Products in the Territory field for the Territory; provided that, except as required by Applicable Laws, it provides EVOLUS will provide to Braeburn the DISTRIBUTOR a draft of such submission at least [***] Business Days ten (10) business days prior to a planned submission to the applicable Regulatory Authority and gives prompt and EVOLUS will give reasonable consideration to any comments Braeburn the DISTRIBUTOR may have. (f) To . For greater certainty it is acknowledged and agreed that 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. If Knight decides not to prepare such filing or submission, it shall promptly notify Braeburn of such decision and 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 right to cross-reference and use in exercising its rights and performing its obligations hereunder labeling with respect to Sublicensed Products for distribution in Canada will be different than labeling for Products for distribution in the Territory 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 AuthoritiesUnited States, as applicablea result of among other things, of Braeburn’s right the requirement in Canada 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 have the label in regulatory submissions filed by Braeburn in accordance with this Agreementboth English and French languages. (h) Braeburn shall permit Knight to access, and shall provide Knight on a 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 Sublicensed Products in the Territory), any and all Regulatory Submissions related to the Sublicensed Products Controlled by Braeburn. At the request of Knight and to the extent legally permitted and in accordance with the terms and conditions of this Agreement, Braeburn shall notify the appropriate Regulatory Authorities in the Territory of Knight’s right to reference such Regulatory Submissions in regulatory submissions filed by Knight in accordance with this Agreement.

Regulatory Submissions. With respect to the Commercialization Governmental Approvals of the Sublicensed Agreement Products in the Territory: (a) Unless otherwise required by Applicable Law, any Regulatory Governmental Approvals and all any Regulatory Submissions relating to Sublicensed Agreement Products in the Territory shall be filed, owned and held in the name of KnightEVOLUS or its Affiliates. (b) Knight EVOLUS shall be solely responsible, at its expense, and shall use 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 Sublicensed Products in the Territory, including any reports or amendments necessary to maintain Regulatory Approvals, and for seeking any revisions of the conditions of each Regulatory Approval.commercially (c) Knight EVOLUS shall have sole authority and responsibility and shall use Commercially Reasonable Efforts commercially reasonable efforts to develop, modify, seek and/or obtain any necessary Regulatory Governmental Approvals of any Sublicensed Product Labeling, packaging, advertising or other promotional or informational materials used in connection with Sublicensed Agreement 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) Knight 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 Sublicensed Agreement Products in the Territory prior to and after any Regulatory Governmental Approval. (e) Subject to the terms and conditions of this Agreement, Knight EVOLUS may file any submissions that are intended to change or modify Sublicensed Product Labeling or prescribing information approved by Health Canada for the applicable Regulatory Authority for, or the Indications of, Sublicensed Agreement Products in the Territory field for the Territory; provided that, except as required by Applicable Laws, it provides EVOLUS will provide to Braeburn the DISTRIBUTOR a draft of such submission at least [***] Business Days ten (10) business days prior to a planned submission to the applicable Regulatory Authority and gives prompt and EVOLUS will give reasonable consideration to any comments Braeburn the DISTRIBUTOR may have. (f) To . For greater certainty it is acknowledged and agreed that 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. If Knight decides not to prepare such filing or submission, it shall promptly notify Braeburn of such decision and 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 right to cross-reference and use in exercising its rights and performing its obligations hereunder labeling with respect to Sublicensed Products for distribution in Canada will be different than labeling for Products for distribution in the Territory 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 AuthoritiesUnited States, as applicablea result of among other things, of Braeburn’s right the requirement in Canada to CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”have the label in both English and French languages. 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 AMENDED4. 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 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 Sublicensed Products in the Territory), any and all Regulatory Submissions related to the Sublicensed Products Controlled by Braeburn. At the request of Knight and to the extent legally permitted and in accordance with the terms and conditions of this Agreement, Braeburn shall notify the appropriate Regulatory Authorities in the Territory of Knight’s right to reference such Regulatory Submissions in regulatory submissions filed by Knight in accordance with this Agreement.DISTRIBUTOR OBLIGATIONS 4.1

Regulatory Submissions. With respect to the Commercialization of the Sublicensed Products in the Territory: (ai) Unless otherwise required The Parties acknowledge that no Licensed Product has been reviewed or approved for sale or use as a human therapeutic product by Applicable Law, any Regulatory Approvals and all Regulatory Submissions relating to Sublicensed Products in the Territory shall be filed, owned and held in the name of Knight. (b) Knight shall be solely responsible, at its expense, and Governmental Authority. BDSI shall use Commercially Reasonable Efforts to timely prepareprepare and file in the United States all required application(s) for Governmental Approval of the Fentanyl Product for the First Indication, file, prosecute, and maintain all Regulatory CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[including the ***]”. 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 1934Subject to Section 2.03(c), AS AMENDED. Submissions relating BDSI shall prepare, or cause to Sublicensed Products in the Territory, including any reports or amendments necessary to maintain Regulatory Approvalsbe prepared by a Third Party, and for seeking any revisions file simultaneously with the filing of the conditions NDA, a proposed final draft RiskMAP with respect to the First Indication of each Regulatory Approval. (c) Knight shall have sole authority and responsibility and the Fentanyl Product. Notwithstanding anything to the contrary in this Agreement, Meda shall use Commercially Reasonable Efforts to developprepare and file, modifyand be responsible for the preparation and filing of, seek and/or obtain any necessary Regulatory Approvals all required application(s) for Governmental Approval of any Sublicensed Product Labeling, packaging, advertising or other promotional or informational materials used in connection with Sublicensed the Licensed 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) Knight will be the primary contact with the Regulatory Authorities other countries in the Territory and shall be solely responsible (including, on a Licensed Product-by-Licensed Product basis, Governmental Approvals for all communications with indications approved by FDA in the United States), provided that (i) Meda shall not, by act or omission, in the course of exercising such Regulatory Authorities that relate rights and satisfying such obligations, create any circumstance reasonably likely to materially adversely affect the development or Commercialization of any Regulatory Submission relating Licensed Product in any country of the Territory without BDSI’s prior written consent and, in the event Meda intends to Sublicensed file any application(s) for Governmental Approval for Licensed Products in such other jurisdictions in the Territory prior to receipt of Governmental Approval thereof in the United States, (ii) the form and after content of any Regulatory Approvalsuch application (and any related correspondence) shall, notwithstanding anything to the contrary herein, be subject to BDSI’s prior written consent. (eii) Subject At all times, the Party responsible for preparing and filing applications for Governmental Approval in a particular country of the Territory (i.e. BDSI in the United States, Meda in Mexico and Canada) shall (i) inform the other Party of all material communications with the relevant Competent Authority(ies) in such country concerning the Licensed Product and (ii) provide copies of proposed material submissions to the terms relevant Competent Authority(ies) in such country concerning the Licensed Product to the Development Committee and conditions the other Party prior to their submission to such Competent Authority. At all times, the responsible Party in a particular country of this Agreement, Knight may file the Territory will not respond substantively to any material communication with a particular Competent Authority or otherwise make any submissions that are intended to change or modify Sublicensed Product Labeling or prescribing information approved by a Competent Authority concerning, in either case, the applicable Regulatory Authority forLicensed Product, or without first giving the Indications ofother Party a reasonable opportunity to review and comment, Sublicensed Products in the Territory provided that, except as such opportunity not to be required by Applicable Laws, it provides to Braeburn a draft of such submission at least [exceed ***] Business Days prior , unless the urgency of such matter and its related response reasonably precludes providing the other Party such an opportunity, in which case the responsible Party shall be entitled to planned respond as it determines in its reasonable discretion. The Party responsible for filing an application for Governmental Approval in a particular country of the Territory shall review and consider in good faith any reasonable comments received from the other Party related to material communications or material submissions to and from the relevant Competent Authority(ies) in such country related to any Licensed Product and any reasonable comments or suggestions from the other Party otherwise related to any of the Governmental Approvals for any Licensed Product in such country. In the event the other Party raises any reasonable, material objection to any such submission to a Competent Authority, including the applicable Regulatory proposed label or any formulation changes, such matters shall be subject to resolution by the Development Committee unless timing constraints make submission of the matter to the Development Committee reasonably impracticable or the Development Committee becomes deadlocked with respect to such matters, in which case such matters shall be as determined by BDSI, in its reasonable discretion, except that, in such case, BDSI may not, without Meda’s consent (such consent not to be unreasonably withheld), so determine any matter in a manner that (i) is reasonably likely to materially increase any Development Costs to be paid by Meda, (ii) materially changes the intended indications for which a Licensed Product is developed, or (iii) is reasonably likely to materially adversely affect the Commercialization of a Licensed Product, including changes to labeling and RiskMAP procedures that are reasonably likely to have such an effect. The Parties shall cooperate in good faith with respect to obtaining, and each Party shall use its Commercially Reasonable Efforts to enable an employee of the other Party to attend, if and as requested by the other Party, all formal meetings with any Competent Authority relating to, Governmental Approval of any Licensed Product. The Parties shall cooperate in good faith with respect to the conduct of any inspections by any regulatory authority of a Party’s site and gives prompt and reasonable consideration facilities related to any comments Braeburn may have. (f) Licensed Product. To the extent Braeburn reasonably believes that a filing either Party receives material written or submission material oral communication from the FDA or any other Competent Authority relating to Sublicensed Products in any Governmental Approval process with respect to any Licensed Product, the Territory is required by Applicable Laws in order to sell or continue selling the Sublicensed Products, Braeburn shall notify Knight in writing. If Knight decides not to prepare Party receiving such filing or submission, it communication shall promptly notify Braeburn the other Party and provide a copy of such decision and 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 submissionwritten communication as soon as reasonably practicable. (g) Knight shall permit Braeburn to access, and shall provide Braeburn on a 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 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 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 Sublicensed Products in the Territory), any and all Regulatory Submissions related to the Sublicensed Products Controlled by Braeburn. At the request of Knight and to the extent legally permitted and in accordance with the terms and conditions of this Agreement, Braeburn shall notify the appropriate Regulatory Authorities in the Territory of Knight’s right to reference such Regulatory Submissions in regulatory submissions filed by Knight in accordance with this Agreement.

Regulatory Submissions. With respect to To the Commercialization of the Sublicensed 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 Product to be submitted to any Regulatory Approvals 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 all minutes) throughout the process of preparing such Regulatory Submissions relating and, in particular, shall provide such other Party with drafts of all such Regulatory Submissions on the timeline agreed to Sublicensed 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 shall be filedor any Major Market and, owned and held in the name of Knight. (b) Knight shall be solely responsible, at its expense, and shall use Commercially Reasonable Efforts to timely prepare, file, prosecute, and maintain all Regulatory CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “within [***]”. 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 Sublicensed Products in the Territory, including ] after submitting any reports or amendments necessary to maintain Regulatory Approvals, and Submission for seeking any revisions of the conditions of each Regulatory Approval. (c) Knight shall have sole authority and responsibility and shall use Commercially Reasonable Efforts to develop, modify, seek and/or obtain any necessary Regulatory Approvals of any Sublicensed Product Labeling, packaging, advertising or other promotional or informational materials used in connection with 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) 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 Sublicensed Products Authority in the Apellis Territory prior 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 after submit any Regulatory Approval. (e) Subject to the terms and conditions of Submissions for Products under this Agreement, Knight may file any submissions that are intended to change or modify Sublicensed Product Labeling or prescribing information approved including by the applicable Regulatory Authority forproviding all such supporting documentation for INDs, or the Indications ofCTAs, Sublicensed Products in the Territory provided that, except as required by Applicable Laws, it provides to Braeburn a draft of such submission at least [***] Business Days prior to planned submission to the applicable Regulatory Authority and gives prompt and reasonable consideration to any comments 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. If Knight decides not to prepare such filing or submission, it shall promptly notify Braeburn of such decision and 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 accessDrug Approval Applications, and shall provide Braeburn on a 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 and for Braeburn to use in connection with the development and commercialization of Sublicensed Products outside of the Territory, any and all other Regulatory Submissions related to the Sublicensed Products Controlled such other Party as are reasonably requested by Knight. At the request of Braeburn such other Party with reasonably sufficient time to allow such other Party to review and to the extent legally permitted incorporate such documentation 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 timely submit such Regulatory Submissions in regulatory submissions filed by Braeburn in accordance with this AgreementApplicable Law or any other requirements or requests of any applicable Regulatory Authority. (h) Braeburn shall permit Knight to access, and shall provide Knight on a 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 Sublicensed Products in the Territory), any and all Regulatory Submissions related to the Sublicensed Products Controlled by Braeburn. At the request of Knight and to the extent legally permitted and in accordance with the terms and conditions of this Agreement, Braeburn shall notify the appropriate Regulatory Authorities in the Territory of Knight’s right to reference such Regulatory Submissions in regulatory submissions filed by Knight in accordance with this Agreement.