Common use of Drug Registration Clause in Contracts

Drug Registration. 9.1 The Parties agree to fully cooperate in good faith under this Agreement in connection with the Marketing Authorization(s), supplying and commercialization of Product in the Territory in the Field to the extent permitted by any applicable laws. For purposes thereof, each Party shall provide (or request its Affiliates to provide) to the other Party and/or the JSC any necessary Information and such other information as may be reasonably required under this Agreement. 9.2 During the Term, AEON, at its sole cost and expense, shall use Commercially Reasonable Efforts to (i) obtain Regulatory Approvals required by Governmental Authorities in relation to the Commercial Plan of Product in Territory in the Field, including but not limited to preparing and filing all necessary applications and (ii) maintain any such Regulatory Approvals. 9.3 During the Term, AEON agrees to use Commercially Reasonable Efforts to achieve all Regulatory Approvals necessary for Products to be marketed in the Territory in the Field. AEON shall be responsible for preparing, submitting requirements and prosecuting any study for the Marketing Authorization in the Territory in the Field. AEON shall be responsible for completing all technical non-clinical studies and Clinical Trials required for such Marketing Authorization Application(s). DAEWOONG will provide all materials and documentations requested by AEON to register the Product in the Territory. [***]. For avoidance of doubt, any documents, study results and reports made pursuant to this Article 9 or otherwise communicated between the Parties will be subject to the confidentiality provisions of Article 14. Further, AEON and its consultants shall exercise Commercially Reasonable Efforts to achieve Marketing Authorization for a Product in the Territory in the Field. 9.4 Each Party shall provide the other Party with reasonable prior notice of all material meetings, conferences and discussions scheduled with any relevant Governmental Authority concerning any Regulatory Approval relating to Products to the extent such notice is practicable and in any event shall use its reasonable efforts to provide such notice as promptly as practicable. At all such meetings, conferences or discussions, such other Party shall have the right to attend and participate (accompanied by a translator, consultants or advisors, if so decided by such Party), either in person or by telephone, to the extent permitted by the applicable Governmental Authority at such other Party’s sole cost and expense; provided, further that such other Party shall have the right to comment in timely fashion on any such approval applications or communication with Governmental Authorities, which comments such Party shall reasonably consider. 9.5 Subject to [***], AEON shall provide DAEWOONG with complete and accurate record of the dossier related to all Regulatory Approvals obtained by AEON or its Affiliates or sub-licensees that relate to Product, including copies of: (a) all the correspondence exchanged with Governmental Authorities; (b) any certificate of Marketing Authorizations in the Territory related to Product within fourteen (14) days of completion of such registration; (c) subsequent amendments or supplements thereto; and (d) any regulatory documents and certificates relating to the foregoing that DAEWOONG requests. [***]. 9.6 [***].

Drug Registration. 9.1 The Parties agree to fully cooperate in good faith under this Agreement in connection with the Marketing Authorization(s)Authorization, supplying and commercialization of Product in the Territory in the Field to the extent permitted by any applicable laws. For purposes thereof, each Party shall provide (or request its Affiliates to provide) to the other Party and/or the JSC any necessary Information and such other information as may be reasonably required under this Agreement. 9.2 During the TermTerm of this Agreement, AEONEVOLUS, at its sole cost and expense, shall use Commercially Reasonable Efforts to (i) obtain Regulatory Approvals required by Governmental Authorities in relation to the Commercial Plan of Product in Territory in the FieldTerritory, including but not limited to preparing and filing all necessary applications and (ii) maintain any such Regulatory Approvals. 9.3 During the TermTerm of this Agreement, AEON EVOLUS agrees to use Commercially Reasonable Efforts to achieve all Regulatory Approvals necessary for Products to be marketed in the Territory in the FieldTerritory. AEON EVOLUS shall be responsible for preparing, submitting requirements and prosecuting any study for the Marketing Authorization in the Territory in the FieldTerritory. AEON EVOLUS shall be responsible for completing all technical non-clinical studies and Clinical Trials required for such Marketing Authorization Application(s)Application. DAEWOONG will provide all materials and documentations requested by AEON EVOLUS to register the Product in the Territory. [***]. For avoidance of doubt, any documents, study results and reports made pursuant to this Article 9 or otherwise communicated between the Parties will be subject to the confidentiality provisions of Article 14. Further, AEON EVOLUS and its consultants shall exercise Commercially Reasonable Efforts to achieve Marketing Authorization for a Product in the Territory in the FieldAuthorization. 9.4 Each Party EVOLUS shall provide the other Party DAEWOONG with reasonable prior notice of all material meetings, conferences and discussions scheduled with any relevant Governmental Authority concerning any Regulatory Approval relating to Products to the extent such notice is practicable and in any event shall use its reasonable efforts to provide such notice as promptly as practicable. At all such meetings, conferences or discussions, such other Party DAEWOONG shall have the right to attend and participate (accompanied by a translator, consultants or advisors, if so decided by such PartyDAEWOONG), either in person or by telephone, to the extent permitted by the applicable Governmental Authority at such other Party’s DAEWOONG’S sole cost and expense; provided, further that such other Party DAEWOONG shall have the right to comment in timely fashion on any such approval applications or communication with Governmental Authorities, which comments such Party EVOLUS shall reasonably consider. 9.5 Subject to [***]the EVOLUS Regulatory Right, AEON EVOLUS shall provide DAEWOONG with complete and accurate record of the dossier related to all Regulatory Approvals obtained by AEON or its Affiliates or sub-licensees that relate to ProductApprovals, including copies of: (a) all the correspondence exchanged with Governmental Authorities; (b) any certificate of Marketing Authorizations Drug Registrations in the Territory related to Product within fourteen (14) days of completion of such registration; (c) subsequent amendments or supplements thereto; and (d) any regulatory documents and certificates relating to the foregoing that DAEWOONG requestsrequest. [***]. 9.6 [***].

Drug Registration. 9.1 The Parties agree to fully cooperate in good faith under this Agreement in connection with the Marketing Authorization(s), supplying and commercialization of Product in the Territory in the Field to the extent permitted by any applicable laws. For purposes thereof, each Party shall provide (or request its Affiliates to provide) to the other Party and/or the JSC any necessary Information and such other information as may be reasonably required under this Agreement. 9.2 During the Term, AEON, at its sole cost and expense, shall use Commercially Reasonable Efforts to (i) obtain Regulatory Approvals required by Governmental Authorities in relation to the Commercial Plan of Product in Territory in the Field, including but not limited to preparing and filing all necessary applications and (ii) maintain any such Regulatory Approvals. 9.3 During the Term, AEON XXXX agrees to use Commercially Reasonable Efforts to achieve all Regulatory Approvals necessary for Products to be marketed in the Territory in the Field. AEON shall be responsible for preparing, submitting requirements and prosecuting any study for the Marketing Authorization in the Territory in the Field. AEON shall be responsible for completing all technical non-clinical studies and Clinical Trials required for such Marketing Authorization Application(s). DAEWOONG will provide all materials and documentations requested by AEON to register the Product in the Territory. [***]The Parties agree to share and freely use all relevant documents and study results that both Parties retain and will develop in the future. Subject to Article 9.6, AEON shall have sole ownership rights to any ​ Marketing Authorization Application(s) and Regulatory Approval(s) for Products in the Territory in the Field (“AEON Regulatory Right”), but DAEWOONG shall have the right to reference such Marketing Authorization Application(s) and Regulatory Approval(s) in DAEWOONG’s regulatory filings outside of the Territory, if required. For avoidance of doubt, any documents, study results and reports made pursuant to this Article 9 or otherwise communicated between the Parties will be subject to the confidentiality provisions of Article 14. Further, AEON and its consultants shall exercise Commercially Reasonable Efforts to achieve Marketing Authorization for a Product in the Territory in the Field. 9.4 Each Party shall provide the other Party with reasonable prior notice of all material meetings, conferences and discussions scheduled with any relevant Governmental Authority concerning any Regulatory Approval relating to Products to the extent such notice is practicable and in any event shall use its reasonable efforts to provide such notice as promptly as practicable. At all such meetings, conferences or discussions, such other Party shall have the right to attend and participate (accompanied by a translator, consultants or advisors, if so decided by such Party), either in person or by telephone, to the extent permitted by the applicable Governmental Authority at such other Party’s sole cost and expense; provided, further that such other Party shall have the right to comment in timely fashion on any such approval applications or communication with Governmental Authorities, which comments such Party shall reasonably consider. 9.5 Subject to [***]the AEON Regulatory Right, AEON shall provide DAEWOONG with complete and accurate record of the dossier related to all Regulatory Approvals obtained by AEON or its Affiliates or sub-licensees that relate to Product, including copies of: (a) all the correspondence exchanged with Governmental Authorities; (b) any certificate of Marketing Authorizations in the Territory related to Product within fourteen (14) days of completion of such registration; (c) subsequent amendments or supplements thereto; and (d) any regulatory documents and certificates relating to the foregoing that DAEWOONG requests. Following Regulatory Approval, and subject to the AEON Regulatory Right, DAEWOONG shall have the right to freely use all information and documentation relating to all record of Regulatory Approvals of Product worldwide, subject to the prior written approval of AEON, which approval shall not be unreasonably withheld. 9.6 In the event of (i) [***], or (ii) upon the termination of this Agreement by [***], then, effective upon such expiration or termination, AEON shall [***]. 9.6 [***].

Drug Registration. 9.1 The Parties agree to fully cooperate in good faith under this Agreement in connection with the Marketing Authorization(s)Authorization, supplying and commercialization of Product in the Territory in the Field to the extent permitted by any applicable laws. For purposes thereof, each Party shall provide (or request its Affiliates to provide) to the other Party and/or the JSC any necessary Information and such other information as may be reasonably required under this Agreement. 9.2 During the TermTerm of this Agreement, AEONEVOLUS, at its sole cost and expense, shall use Commercially Reasonable Efforts to (i) obtain Regulatory Approvals required by Governmental Authorities in relation to the Commercial Plan of Product in Territory in the FieldTerritory, including but not limited to preparing and filing all necessary applications and (ii) maintain any such Regulatory Approvals. 9.3 During the TermTerm of this Agreement, AEON XXXXXX agrees to use Commercially Reasonable Efforts to achieve all Regulatory Approvals necessary for Products to be marketed in the Territory in the FieldTerritory. AEON XXXXXX shall be responsible for preparing, submitting requirements and prosecuting any study for the Marketing Authorization in the Territory in the FieldTerritory. AEON XXXXXX shall be responsible for completing all technical non-clinical studies and Clinical Trials required for such Marketing Authorization Application(s)Application. DAEWOONG will provide all materials and documentations requested by AEON EVOLUS to register the Product in the Territory. [***]. For avoidance of doubt, any documents, study results and reports made pursuant to this Article 9 or otherwise communicated between the Parties will be subject to the confidentiality provisions of Article 14. Further, AEON EVOLUS and its consultants shall exercise Commercially Reasonable Efforts to achieve Marketing Authorization for a Product in the Territory in the FieldAuthorization. 9.4 Each Party EVOLUS shall provide the other Party DAEWOONG with reasonable prior notice of all material meetings, conferences and discussions scheduled with any relevant Governmental Authority concerning any Regulatory Approval relating to Products to the extent such notice is practicable and in any event shall use its reasonable efforts to provide such notice as promptly as practicable. At all such meetings, conferences or discussions, such other Party XXXXXXXX shall have the right to attend and participate (accompanied by a translator, consultants or advisors, if so decided by such PartyXXXXXXXX), either in person or by telephone, to the extent permitted by the applicable Governmental Authority at such other Party’s DAEWOONG’S sole cost and expense; provided, further that such other Party DAEWOONG shall have the right to comment in timely fashion on any such approval applications or communication with Governmental Authorities, which comments such Party EVOLUS shall reasonably consider. 9.5 Subject to [***]the EVOLUS Regulatory Right, AEON EVOLUS shall provide DAEWOONG with complete and accurate record of the dossier related to all Regulatory Approvals obtained by AEON or its Affiliates or sub-licensees that relate to ProductApprovals, including copies of: (a) all the correspondence exchanged with Governmental Authorities; (b) any certificate of Marketing Authorizations Drug Registrations in the Territory related to Product within fourteen (14) days of completion of such registration; (c) subsequent amendments or supplements thereto; and (d) any regulatory documents and certificates relating to the foregoing that DAEWOONG requestsrequest. [***]. 9.6 [***].