Common use of Regulatory Approval in the Territory Clause in Contracts

Regulatory Approval in the Territory. 3.1 Licensee shall use Commercially Reasonable Efforts to obtain all required Regulatory Approvals for the Product for the Initial Indication as soon as reasonably possible following the Effective Date. 3.2 Licensee shall be responsible for all aspects of preparing, obtaining, and maintaining throughout the Term, at Licensee’s cost and expense, the Regulatory Approvals in Licensee’s name, including setting the overall regulatory strategy therefor and conducting communications with Governmental Authorities. Licensee shall determine what information or documentation may be required to complete any forms or applications necessary to file for the Regulatory Approvals for the Product. For the avoidance of doubt, Licensee shall be responsible for all commercially reasonable cost and expense associated with any further development which may be required in connection with securing the Regulatory Approvals, including any supplemental clinical trials. Subject to the foregoing, upon request from Licensee, Quoin will provide to Licensee reasonable assistance and information that is in the possession of Quoin as necessary for Licensee to obtain such Regulatory Approvals. Licensee will deliver to Quoin any data or information related to the Product generated for purposes of submission of the Regulatory Approvals, and a copy of the applications for Regulatory Approvals upon submission. 3.3 Licensee shall use Commercially Reasonable Efforts to file for the Regulatory Approvals for the Product for the Initial Indication in the Territory within six (6) months following the date of Quoin receiving regulatory approval for such Initial Indication in either the United States or European Union. In the event that Licensee determines that the Data Package is not sufficient to obtain the Regulatory Approvals, and the additional information and documentation required makes it unlikely that the Licensee will be able to file for the Regulatory Approvals within such six-month period, Licensee shall promptly notify Quoin and the Parties will discuss a reasonable timeline for Licensee to compile the necessary information and documentation and submit the filings for the Regulatory Approvals. 3.4 If Licensee does not file for the Regulatory Approvals (in a form reasonably likely to be approved) for the Initial Indication with applicable Governmental Authorities in the Territory within six (6) months following the date of Quoin receiving regulatory approval in either the United States or the European Union, or such later date as agreed upon by Quoin, Quoin may terminate this Agreement in accordance with Section 11.2.2 hereof. If the Regulatory Approvals for the Initial Indication have not been granted by the applicable Governmental Authorities in the Territory on or before such date which is 24 months after the date of filing such Regulatory Approvals or such later date as agreed upon by Quoin, Quoin may terminate this Agreement in accordance with Section 11.2.2 hereof. 3.5 In the event that Quoin obtains regulatory approval for any Additional Indication for the Product in the United States or the European Union, Licensee will use Commercially Reasonable Efforts to obtain, as promptly as practicable (but in any event within 6 months following such approval in the United State or the European Union), any Regulatory Approvals required to permit the Commercialization of the Product in the Territory for such Additional Indication. If the Regulatory Approvals for such Additional Indication have not been granted by the applicable Governmental Authorities in the Territory on or before such date which is 24 months after the date of filing such Regulatory Approvals or such later date as agreed upon by Quoin, Licensees rights to the Product for such Additional Indication may be terminated by Quoin in accordance with Section 11.2.2 hereof. Such termination will not apply to the Initial Indication or to any subsequent additional Indications, Licensee obtains approval for in the Territory.

Regulatory Approval in the Territory. 3.1 3.1. Licensee shall use Commercially Reasonable Efforts to obtain all required Regulatory Approvals for the Product for the Initial Indication as soon as reasonably possible following the Effective Date. 3.2 Licensee 3.2. Quoin shall be responsible for all aspects of preparing, obtaining, and maintaining throughout the Term, at LicenseeQuoin’s cost and expense, the Regulatory Approvals in Licensee’s name. Licensee shall perform all the ground work, including but not limited to setting the overall regulatory strategy therefor and conducting communications with Governmental Authorities. Licensee shall also determine what information or documentation may be required to complete any forms or applications necessary to file for the Regulatory Approvals for the Product. For the avoidance of doubt, Licensee Quoin shall be responsible for all commercially reasonable the cost and expense associated with any further development which may be required in connection with securing the Regulatory Approvals, including any supplemental clinical trials. Subject to the foregoing, upon request from Licensee, Quoin will provide to Licensee reasonable assistance and information that is in the possession of Quoin as necessary for Licensee to obtain such Regulatory Approvals. Licensee will deliver to Quoin any data or information related to the Product generated for purposes of submission of the Regulatory Approvals, and a copy of the applications for Regulatory Approvals upon submission. 3.3 3.3. Licensee shall use Commercially Reasonable Efforts to file for the Regulatory Approvals for the Product for the Initial Indication in the Territory within six (6) months following the date of Quoin receiving regulatory approval for such Initial Indication in either the United States or European Union. In the event that Licensee determines that the Data Package is not sufficient to obtain the Regulatory Approvals, and the additional information and documentation required makes it unlikely that the Licensee will be able to file for the Regulatory Approvals within such six-month period, Licensee shall promptly notify Quoin and the Parties will discuss a reasonable timeline for Licensee to compile the necessary information and documentation and submit the filings for the Regulatory Approvals. 3.4 3.4. If Licensee does not file for the Regulatory Approvals (in a form reasonably likely to be approved) for the Initial Indication with applicable Governmental Authorities in the Territory within six (6) months following the date of Quoin receiving regulatory approval in either the United States or the European Union, or such later date as agreed upon by Quoin, Quoin may terminate this Agreement in accordance with Section 11.2.2 hereof. If the Regulatory Approvals for the Initial Indication have not been granted by the applicable Governmental Authorities in the Territory on or before such date which is [24 months months] after the date of filing such Regulatory Approvals or such later date as agreed upon by Quoin, Quoin may terminate this Agreement in accordance with Section 11.2.2 hereof. 3.5 3.5. In the event that Quoin obtains regulatory approval for any Additional Indication for the Product in the United States or the European Union, Licensee will use Commercially Reasonable Efforts to obtain, as promptly as practicable (but in any event within 6 [6] months following such approval in the United State or the European Union), any Regulatory Approvals required to permit the Commercialization of the Product in the Territory for such Additional Indication. If the Regulatory Approvals for such Additional Indication have not been granted by the applicable Governmental Authorities in the Territory on or before such date which is [24 months months] after the date of filing such Regulatory Approvals or such later date as agreed upon by Quoin, Licensees rights to the Product for such Additional Indication Quoin may be terminated by Quoin terminate this Agreement in accordance with Section 11.2.2 hereof. Such termination will not apply to the Initial Indication or to any subsequent additional Indications, Licensee obtains approval for in the Territory.

Regulatory Approval in the Territory. 3.1 Licensee shall use Commercially Reasonable Efforts to obtain all required Regulatory Approvals for the Product for the Initial Indication as soon as reasonably possible following the Effective Date. Quoin shall be the applicant and owner of Regulatory Approvals in the Territory in the mainland China due to the restriction of the Applicable Laws and the Licensee shall serve as the domestic legal representative for the Product. Whenever and wherever Licensee or its Affiliate is allowed to hold the Regulatory Approval including the marketing authorization holder of the Product by Applicable Laws, Quoin shall support or transfer such holder of the Regulatory Approval, no matter in the application stage or being approved, to Licensee or its designated Affiliate. Notwithstanding above, in the regions where Licensee or its Affiliate is permitted to directly serve as the holder for the Regulatory Approval, including the marketing authorization holder, Quoin shall support Licensee to apply and hold such Regulatory Approval directly. 3.2 Licensee shall be responsible for all aspects of preparing, obtaining, and maintaining throughout the Term, at Licensee’s cost and expense, the Regulatory Approvals in Licensee’s name, including setting the overall regulatory strategy therefor and conducting communications with Governmental Authorities. Licensee shall determine what information or documentation may be required to complete any forms or applications necessary to file for the Regulatory Approvals for the Product. For the avoidance of doubt, Licensee shall be responsible for all commercially reasonable the cost and expense associated with any further development which may be required in connection with securing the Regulatory Approvals, including any supplemental clinical trials. Subject to the foregoing, upon request from Licensee, Quoin will provide to Licensee reasonable necessary assistance and information that is in the possession of Quoin as necessary for Licensee to obtain such Regulatory ApprovalsApprovals as below ("Necessay Support”): (a) Quoin shall provide any and all necessary regulatory support to Licensee for information required by the Regulatory Authorities, which may include, but is not limited to any and all technical documents, materials, data and information of the CMC, non-clinical studies and clinical studies of the product in accordance with the requirements and format under ICH M4 provided always that Quoin will only be able to provide such information to the extent that the said items are available to Quoin. Quoin shall use its commercially reasonable effort to facilitate that the suppliers of the API, excipients and packaging materials (container closure system) of the Product will provide assistance, such as conduct DMF filing in the Territory if and as required by the Regulatory Authorities. Quoin shall assist Licensee in solving any technical issues during the IND and/or NDA review once any deficiency letter is issued by the Regulatory Authority, provided that Quoin can only provide information which it has available. Quoin shall upon Licensee’s request participate in the communication meetings requested by the Regulatory Authority or other competent authorities in the Territory. Quoin shall on its cost provide all necessary samples and reference standards used for drug testing and clinical trials. (b) Once any deficiency letter is issued with regards to the manufacturing, specification, analytical procedure and stability of the product during IND and/or NDA review process in the Territories of Registration, Quoin shall use its commercially reasonable effort to conduct necessary manufacturing related studies in order to meet the authorities’ registration requirements in case that such studies have to be performed in the manufacturing sites. Quoin shall use commercially reasonable efforts to improve the manufacture process and quality control as per the Regulatory Authorities’ registration requirements accordingly. Licensee will deliver to Quoin any data or information related to the Product generated for purposes of submission of the Regulatory Approvals, and a an electronic copy of the applications for Regulatory Approvals upon submission. 3.3 Licensee shall use Commercially Reasonable Efforts to file for the Regulatory Approvals for the Product for the Initial Indication in the Territory within six eighteen (618) months following the date of Quoin receiving regulatory approval for such Initial Indication in either the United States or European Union, in the event that clinical trial waiver is issued by NMPA and the Product dossier provided by Quoin meets the requirements of NMPA. In the event that Licensee determines that the Data Package is not sufficient to obtain the Regulatory Approvals, and the additional information and documentation required makes it unlikely that the Licensee will be able to file for the Regulatory Approvals within such sixeighteen-month period, Licensee shall promptly notify Quoin and the Parties will discuss a reasonable timeline for Licensee to compile the necessary information and documentation and submit the filings for the Regulatory Approvals. 3.4 If Licensee does not file for the Regulatory Approvals (in a form reasonably likely to be approved) for the Initial Indication with applicable Governmental Authorities in the Territory within six eighteen (618) months following the date of Quoin receiving regulatory approval in either the United States or the European UnionUnion according to Section 3.3, or such later date as agreed upon by Quoin, Quoin may terminate this Agreement in accordance with Section 11.2.2 hereof, provided that Quoin has provided Necessary Support under Section 3.2. If the Regulatory Approvals for the Initial Indication have not been granted by the applicable Governmental Authorities in the Territory on or before such date which is 24 months [36 months] after the date of filing such Regulatory Approvals or such later date as agreed upon by Quoin,both Parties shall negotiate in good faith on the extension of such period, provided that Quoin may terminate this Agreement in accordance with has provided Necessary Support under Section 11.2.2 hereof3.2 and WinHealth has used Commercially Reasonable Efforts to acquire the Regulatory Approval. 3.5 In the event that Quoin obtains regulatory approval for any Additional Indication for the Product in the United States or the European Union, Licensee will use Commercially Reasonable Efforts to obtain, as promptly as practicable (but in any event within 6 [18] months following such approval in the United State or the European Union), any Regulatory Approvals required to permit the Commercialization of the Product in the Territory for such Additional Indication. If the Regulatory Approvals for such Additional Indication have not been granted by the applicable Governmental Authorities in the Territory on or before such date which is 24 months [36 months] after the date of filing such Regulatory Approvals or such later date as agreed upon by Quoin, Licensees rights both Parties shall negotiate in good faith on the extension of such period, provided that Quoin has provided Necessary Support under Section 3.2 and WinHealth has used reasonable efforts to acquire the Product for such Additional Indication may be terminated by Quoin in accordance with Section 11.2.2 hereof. Such termination will not apply to the Initial Indication or to any subsequent additional Indications, Licensee obtains approval for in the TerritoryRegulatory Approval.

Regulatory Approval in the Territory. 3.1 Licensee shall use Commercially Reasonable Efforts take the necessary steps to obtain all required Regulatory Approvals for the Product for the Initial Indication as soon as reasonably possible following the Effective Date. 3.2 Licensee shall be responsible for all aspects of preparing, obtaining, and maintaining throughout the Term, at Licensee’s cost and expense, the Regulatory Approvals in Licensee’s name, including setting the overall regulatory strategy therefor and conducting communications with Governmental Authorities. Licensee shall determine what information or documentation may be required to complete any forms or applications necessary to file for the Regulatory Approvals for the Product. For the avoidance of doubt, Licensee shall be responsible for all commercially reasonable cost and expense associated with any further development which may be required in connection with securing the Regulatory Approvals, including any supplemental clinical trials. Subject to the foregoing, upon request from Licensee, Quoin will provide to Licensee reasonable assistance and information information, at no charge, that is in the possession of Quoin as necessary for Licensee to obtain such Regulatory Approvals. Licensee will deliver to Quoin any data or information related to the Product generated for purposes of submission of the Regulatory Approvals, and a copy of the applications for Regulatory Approvals upon submission. 3.3 Licensee shall use Commercially Reasonable Efforts take the necessary steps to file for the Regulatory Approvals for the Product for the Initial Indication in the Territory within six (6) months following the date of Quoin receiving regulatory approval for such Initial Indication in either the FDA in the United States or the EMA in respect to the centralized license procedure for the European Union. In the event that Licensee determines that the Data Package is not sufficient to obtain the Regulatory Approvals, and the additional information and documentation required makes it unlikely that the Licensee will be able to file for the Regulatory Approvals within such six-month period, Licensee shall promptly within a reasonable period of time notify in writing Quoin and the Parties will discuss a reasonable timeline for Licensee to compile the necessary information and documentation and submit the filings for the Regulatory Approvals. 3.4 If Licensee does not file for the Regulatory Approvals (in a form reasonably likely to be approved) for the Initial Indication with applicable Governmental Authorities in the Territory within six (6) months following the date of Quoin receiving regulatory approval in either the FDA in the United States or the EMA in respect of the European Union, or such later date as agreed upon by Quoin, Quoin may terminate this Agreement in accordance with Section 11.2.2 hereof, subject to the provisions related to termination. If the Regulatory Approvals for the Initial Indication have not been granted by the applicable Governmental Authorities in the Territory on or before such date which is 24 twenty four (24) months after the date of filing such Regulatory Approvals or such later date as agreed upon by Quoin, Quoin may terminate this Agreement in accordance with Section 11.2.2 hereof. 3.5 . In the event that Quoin obtains regulatory approval for any Additional Indication for the Product in the FDA in the United States or the EMA for the European Union, the Parties will meet to discuss if the Licensee wishes to continue in Commercialization of the Additional Indication. If the Parties agree in writing to continue such Commercialization, then Licensee will use Commercially Reasonable Efforts take the necessary steps to obtain, as promptly soon as reasonbly practicable (but in any event within 6 months the agreed period of time following such approval in the FDA in the United State or the EMA in the European Union), any Regulatory Approvals required to permit the Commercialization of the Product in the applicable country in the Territory for such Additional Indication. If the Regulatory Approvals for such Additional Indication have not been granted by the applicable Governmental Authorities in the Territory on or before such date which is 24 months after the date of filing such Regulatory Approvals or such later date as agreed upon by Quoin, Licensees rights to the Product for such Additional Indication may be terminated by Quoin in accordance with Section 11.2.2 hereof. Such termination will not apply to the Initial Indication or to any subsequent additional Indications, Licensee obtains approval for in the Territory.

Regulatory Approval in the Territory. 3.1 Licensee shall use Commercially Reasonable Efforts to obtain all required Regulatory Approvals for the Product for the Initial Indication as soon as reasonably possible following the Effective Date. 3.2 Licensee shall be responsible for all aspects of preparing, obtaining, and maintaining throughout the Term, at Licensee’s cost and expense, Term the Regulatory Approvals in LicenseeQuoin’s name, name (where applicable),2 including setting the overall regulatory strategy therefor and conducting communications with Governmental Authorities. Quoin shall reimburse Licensee for all necessary costs to file for and obtain any required Regulatory Approvals in the Territory, provided that all such costs shall be approved in advance by Quoin. Licensee shall determine what information or documentation may be required to complete any forms or applications necessary to file for the Regulatory Approvals for the Product. For the avoidance of doubt, Licensee shall be responsible for all commercially reasonable cost and expense associated with notify Quoin if any further development which may be is required in connection with securing the Regulatory Approvals, including any supplemental clinical trialstrials and Quoin will determine whether to proceed or not, at Quoin’s expense. Subject to the foregoing, upon request from Licensee, Quoin will provide to Licensee reasonable assistance and information that is in the possession of Quoin as necessary for Licensee to obtain such Regulatory Approvals. Licensee will deliver to Quoin any data or information related to the Product generated for purposes of submission of the Regulatory Approvals, and a copy of the applications for Regulatory Approvals upon submission. 3.3 Licensee shall use Commercially Reasonable Efforts to file for the Regulatory Approvals for the Product for the Initial Indication in each jurisdiction in the Territory within six (6) months following the date of Quoin receiving regulatory approval for such Initial Indication in either the United States or European Union. In the event that Licensee determines that the Data Package is not sufficient to obtain the Regulatory Approvals, and the additional information and documentation required makes it unlikely that the Licensee will be able to file for the Regulatory Approvals within such six-month period, Licensee shall promptly notify Quoin and the Parties will discuss a reasonable timeline for Quoin and Licensee to compile the necessary information and documentation and submit the filings for the Regulatory Approvals. 3.4 If Licensee does not file for the Regulatory Approvals (in a form reasonably likely to be approved) for the Initial Indication with applicable Governmental Authorities in each jurisdiction in the Territory within six (6) months following the date of Quoin receiving regulatory approval in either the United States or the European Union, or such later date as agreed upon by Quoin, Quoin may terminate this Agreement in its entirety or with respect to any jurisdiction3 in accordance with Section 11.2.2 hereof. If the Regulatory Approvals for the Initial Indication have not been granted by the applicable Governmental Authorities in each jurisdiction in the Territory on or before such date which is 24 months after the date of filing such Regulatory Approvals or such later date as agreed upon by Quoin, Quoin may terminate this Agreement in its entirety or with respect to any jurisdiction in accordance with Section 11.2.2 hereof. Notwithstanding the foregoing, in the event that Product has been ordered under the Supply Agreement for sale on a named patient basis without Regulatory Approvals, Quoin shall not terminate this Agreement with respect to such orders. 3.5 In the event that Quoin obtains regulatory approval for any Additional Indication for the Product in the United States or the European Union, Licensee will use Commercially Reasonable Efforts to obtain, as promptly as practicable (but in any event within 6 months following such approval in the United State or the European Union), any Regulatory Approvals required to permit the Commercialization of the Product in each jurisdiction in the Territory for such Additional Indication. If the Regulatory Approvals for such Additional Indication have not been granted by the applicable Governmental Authorities in the Territory on or before such date which is 24 months after the date of filing such Regulatory Approvals or such later date as agreed upon by Quoin, Licensees rights to the Product for such Additional Indication may be terminated by Quoin in its entirety or with respect to any jurisdiction in accordance with Section 11.2.2 hereof. Such termination will not apply to the Initial Indication or to any subsequent additional Indications, Indications for which Licensee obtains approval for in the Territory. Notwithstanding the foregoing, in the event that Product has been ordered under the Supply Agreement for sale on a named patient basis without Regulatory Approvals, Quoin shall not terminate this Agreement with respect to such orders.