Common use of Regulatory Clause in Contracts

Regulatory. 6.1 Holder of Regulatory Approvals and Regulatory Submissions. NVCR shall initially be the holder of Regulatory Approvals and Regulatory Submission for Licensed Products in the Territory. At Zai’s request during the Term, (a) the JSC will discuss in good faith whether to transfer manufacturing responsibilities for Licensed Products for the Territory to Zai, and (b) the Parties will discuss in good faith whether to enable Zai to hold Regulatory Approvals and Regulatory Submissions in the Territory, including any pricing or reimbursement approvals, whether by transfer to Zai of such Regulatory Approvals and Regulatory Submissions or through the submission of a new application for Regulatory Approval in the Territory submitted by Zai, in each case ((a) or (b)), to the extent permitted by Applicable Law and in accordance therewith. If agreed by the Parties, NVCR shall reasonably cooperate with Zai, at Zai’s expense, to enable Zai to hold any or all such Regulatory Approvals and Regulatory Submissions. 6.2 Zai’s Responsibilities. (a) Zai shall be responsible [***] for all regulatory activities leading up to and including the obtaining of Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products from Regulatory Authorities in the Field and in the Territory, provided that, Zai shall conduct such regulatory activities (and any and all regulatory activities delegated to Zai in this Agreement or by NVCR during the Term in connection with the Development and Commercialization of the Licensed Product in the Territory during such time that NVCR is the holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory) as the express, exclusive, and authorized legal agent of record for NVCR in the Territory, and provided further, that such actions shall be taken on behalf of NVCR and for the benefit of Zai in the Territory. Promptly after the Effective Date and from time to time during the Term, the Parties shall conduct such actions and execute such documents as are required for Zai to act as NVCR’s express, exclusive, and authorized legal agent of record in the Territory. Notwithstanding the foregoing, to the extent permitted under Applicable Laws, Zai may file, obtain and maintain (on behalf of NVCR, which will be the holder of) Regulatory Submissions, Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products in the Territory. (b) Zai shall promptly provide to NVCR for review and comment drafts of all Regulatory Submissions prepared by or on behalf of Zai, including English summaries thereof. NVCR shall have the right to review and comment on such Regulatory Submissions and Zai shall consider in good faith any comments received from NVCR and incorporate all comments that are reasonable or necessary for protecting NVCR’s interest as licensor of the Licensed Product or holder of the Regulatory Submission or Regulatory Approval in the Territory. In addition, each Party shall promptly notify the other Party of any Regulatory Submissions and any comments or other correspondences related thereto submitted to or received from any Regulatory Authority in the Territory and shall provide the other Party with copies thereof as soon as reasonably practicable. If any such Regulatory Submission, comment or correspondence is not in English, Zai shall also promptly provide NVCR with a written English summary of any comments or other correspondences received from a Regulatory Authority with respect to a Regulatory Submission. (c) Each Party shall promptly provide the other Party with notice after receiving notice of any meeting or discussion with any Regulatory Authority in the Territory related to any Licensed Product in the Field. Zai shall lead any such meeting or discussion, provided, however, that NVCR or its designee shall have the right, but not the obligation, to attend and participate in such meeting or discussion. If NVCR elects not to attend such meeting or discussion, Zai shall provide NVCR with a written summary thereof in English promptly following such meeting or discussion.

Regulatory. 6.1 Holder B.1 At E*TRADE locations, Broadridge shall use its commercially reasonable efforts to ensure that Broadridge employees, subcontractors, contractors, consultants or other similar third parties or personnel under the control of Regulatory Approvals Broadridge (collectively, “Broadridge Personnel”), will comply with all E*TRADE policies and Regulatory Submissionsprocedures, including, but not limited to, security procedures, information security requirements, rules, regulations, policies, holiday and similar schedules (“E*TRADE Policies”) which have been provided to Broadridge and the Broadridge Personnel in writing. NVCR Such E*TRADE Policies are subject to change at E*TRADE’s sole discretion at anytime, but such change must be communicated in writing to Broadridge and the Broadridge Personnel. Broadridge shall initially be use its commercially reasonable efforts to minimize any disruption to E*TRADE’s normal business operations in performing the holder Services. B.2 Broadridge acknowledges that all Broadridge Personnel will comply with Broadridge’s information security policy (or if applicable, E*TRADE’s information security policy if any Broadridge Personnel is on E*TRADE’s premises, so long as such policy has been provided in writing to such Personnel). Further, Broadridge agrees that certain Broadridge Personnel, as determined by E*TRADE and Broadridge jointly, shall complete information security awareness training reasonably acceptable to E*TRADE. B.3 Broadridge acknowledges and understands that E*TRADE (any of Regulatory Approvals its parent, subsidiaries and Regulatory Submission for Licensed Products in Affiliates) is subject to examination and oversight by various federal and state regulators and governmental administrative agencies, including, without limitation, the Territory. At Zai’s request during Office of the Term, (a) Comptroller of the JSC will discuss in good faith whether to transfer manufacturing responsibilities for Licensed Products for the Territory to ZaiCurrency, and (b) the Parties will discuss in good faith whether that by entering into this Schedule with E*TRADE, Broadridge may be subject to enable Zai to hold Regulatory Approvals examination and Regulatory Submissions in the Territoryoversight by such regulators and agencies. Broadridge hereby agrees, including any pricing or reimbursement approvals, whether by transfer to Zai of such Regulatory Approvals and Regulatory Submissions or through the submission of a new application for Regulatory Approval in the Territory submitted by Zai, in each case ((a) or (b)), but solely to the extent permitted that such examination relates to the Services provided by Applicable Law Broadridge to E*TRADE hereunder, to submit to and in accordance therewith. If agreed by the Parties, NVCR shall reasonably cooperate with Zaiin any such examination, at ZaiE*TRADE’s expense, and oversight proceeding or in E*TRADE’s efforts to enable Zai respond to hold any audit, inquiry or all such Regulatory Approvals review, whether formal or informal, which may include, but may not be limited to, granting E*TRADE or federal or state regulatory authorities access to Broadridge’s: (i) overviews of its disaster recovery and Regulatory Submissions. 6.2 Zai’s Responsibilities. business continuity plans; (aii) Zai shall be responsible [disaster ***] * Confidential treatment has been requested for all regulatory activities leading up to and including the obtaining of Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products from Regulatory Authorities in the Field and in the Territory, provided that, Zai shall conduct such regulatory activities (and any and all regulatory activities delegated to Zai in this Agreement or by NVCR during the Term in connection redacted portions. The Confidential Information redacted has been filed separately with the Development Securities and Commercialization Exchange Commission. recovery test results; (iii) an overview of the Licensed Product in the Territory during such time that NVCR is the holder of Regulatory Approvals Broadridge’s information security program, (iv) books and Regulatory Submissions for the Licensed Product in the Territoryrecords; and (v) as the expressfacilities, exclusivesystems, and authorized legal agent of record for NVCR in the Territory, equipment on supervised visits and provided further, that such actions shall be taken on behalf of NVCR and for the benefit of Zai in the Territory. Promptly after the Effective Date and from time without actual access to time during the Term, the Parties shall conduct such actions and execute such documents as are required for Zai to act as NVCRBroadridge’s express, exclusive, and authorized legal agent of record in the Territory. Notwithstanding the foregoing, to the extent permitted under Applicable Laws, Zai may file, obtain and maintain (on behalf of NVCR, which will be the holder of) Regulatory Submissions, Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products in the Territorysystems. (b) Zai shall promptly provide to NVCR for review and comment drafts of all Regulatory Submissions prepared by or on behalf of Zai, including English summaries thereof. NVCR shall have the right to review and comment on such Regulatory Submissions and Zai shall consider in good faith any comments received from NVCR and incorporate all comments that are reasonable or necessary for protecting NVCR’s interest as licensor of the Licensed Product or holder of the Regulatory Submission or Regulatory Approval in the Territory. In addition, each Party shall promptly notify the other Party of any Regulatory Submissions and any comments or other correspondences related thereto submitted to or received from any Regulatory Authority in the Territory and shall provide the other Party with copies thereof as soon as reasonably practicable. If any such Regulatory Submission, comment or correspondence is not in English, Zai shall also promptly provide NVCR with a written English summary of any comments or other correspondences received from a Regulatory Authority with respect to a Regulatory Submission. (c) Each Party shall promptly provide the other Party with notice after receiving notice of any meeting or discussion with any Regulatory Authority in the Territory related to any Licensed Product in the Field. Zai shall lead any such meeting or discussion, provided, however, that NVCR or its designee shall have the right, but not the obligation, to attend and participate in such meeting or discussion. If NVCR elects not to attend such meeting or discussion, Zai shall provide NVCR with a written summary thereof in English promptly following such meeting or discussion.

Regulatory. 6.1 Holder of 5.1 Regulatory Approvals Matters with Respect to Licensed Compounds and Regulatory Submissions. NVCR shall initially be the holder of Regulatory Approvals and Regulatory Submission for Licensed Products in the Co-Promotion Territory. At Zai’s request during . 5.1.1 Subject to the Termterms and conditions of this Agreement, (a) until such time as responsibility for regulatory matters in the JSC will discuss in good faith whether to transfer manufacturing responsibilities Co-Promotion Territory for Licensed Compounds and Licensed Products are transferred to Bayer pursuant to Sections 5.1.2 and 5.3, in the Co-Promotion Territory, Loxo shall be responsible for: (i) determining, planning and implementing the regulatory plans and strategies for Licensed Compounds and Licensed Products in the Co-Promotion Territory; (ii) either directly or through its Affiliates, making all regulatory filings with respect to Licensed Compounds and Licensed Products in the Co-Promotion Territory including NDA/XXXx; (iii) holding all IND/CTAs and Marketing Authorizations for Licensed Compounds and Licensed Products throughout the Co-Promotion Territory in the name of either itself or its Affiliates until the transfer of such IND/CTAs and Marketing Authorizations as contemplated by Section 5.1.2; and (iv) subject to Sections 5.6 and 5.7, handling all interactions with Regulatory Authorities in the Co-Promotion Territory with respect to Licensed Compounds and Licensed Products, including all submissions, meetings and discussions in all cases. 5.1.2 As soon as practical after receipt of the Marketing Authorization for the Territory to ZaiCo-Promotion Territory, on a Licensed Product-by-Licensed Product basis but no later than, in the case of a LOXO-101 Product, [***], and (b) the Parties will discuss in good faith whether to enable Zai to hold Regulatory Approvals and Regulatory Submissions in the case of a LOXO-195 Product, [***] for such LOXO-195 Product for the Co-Promotion Territory, including Loxo shall do all things reasonably necessary or useful to transfer, and Bayer shall provide Loxo reasonable assistance in connection thereto, as well as do all things reasonably necessary or useful to assume and take over, any pricing or reimbursement approvalsRegulatory Documentation, whether by transfer to Zai of such Regulatory Approvals and Regulatory Submissions or through the submission of a new application for Regulatory Approval in the Territory submitted by Zai, in each case ((a) or (b))including, to the extent permitted by Applicable Law Law, all IND/CTAs and Marketing Authorizations related to the applicable Licensed Product Controlled by Loxo or any of its Affiliates for the Co-Promotion Territory into the name of Bayer or its designated Affiliate. Loxo shall, and shall cause its Affiliates to, duly execute and deliver, or cause to be duly executed and delivered such instruments and shall do and cause to be done such acts and things, including the filing of such assignments, agreements, documents and instruments as Bayer may reasonably request from time to time in accordance therewithconnection with Bayer’s rights under this Section 5.1.2. If agreed by the Parties, NVCR shall reasonably cooperate with Zai, at Zai’s expense, to enable Zai to hold any or all such Regulatory Approvals and Regulatory Submissions. 6.2 Zai’s Responsibilities. (a) Zai shall be responsible [***] for all regulatory activities leading up Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to and including Rule 406 of the obtaining Securities Act of Regulatory Approvals and any pricing or reimbursement approvals1933, as applicable, for Licensed Products from Regulatory Authorities in the Field and in the Territory, provided that, Zai shall conduct such regulatory activities (and any and all regulatory activities delegated to Zai in this Agreement or by NVCR during the Term in connection with the Development and Commercialization of the Licensed Product in the Territory during such time that NVCR is the holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory) as the express, exclusive, and authorized legal agent of record for NVCR in the Territory, and provided further, that such actions shall be taken on behalf of NVCR and for the benefit of Zai in the Territoryamended. Promptly after the Effective Date and from time to time during the Term, the Parties shall conduct such actions and execute such documents as are required for Zai to act as NVCR’s express, exclusive, and authorized legal agent of record in the Territory. Notwithstanding the foregoing, to the extent permitted under Applicable Laws, Zai may file, obtain and maintain (on behalf of NVCR, which will be the holder of) Regulatory Submissions, Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products in the Territory. (b) Zai shall promptly provide to NVCR for review and comment drafts of all Regulatory Submissions prepared by or on behalf of Zai, including English summaries thereof. NVCR shall have the right to review and comment on such Regulatory Submissions and Zai shall consider in good faith any comments received from NVCR and incorporate all comments that are reasonable or necessary for protecting NVCR’s interest as licensor of the Licensed Product or holder of the Regulatory Submission or Regulatory Approval in the Territory. In addition, each Party shall promptly notify the other Party of any Regulatory Submissions and any comments or other correspondences related thereto submitted to or received from any Regulatory Authority in the Territory and shall provide the other Party with copies thereof as soon as reasonably practicable. If any such Regulatory Submission, comment or correspondence is not in English, Zai shall also promptly provide NVCR with a written English summary of any comments or other correspondences received from a Regulatory Authority Confidential treatment has been requested with respect to a Regulatory Submissionthis information. (c) Each Party shall promptly provide the other Party with notice after receiving notice of any meeting or discussion with any Regulatory Authority in the Territory related to any Licensed Product in the Field. Zai shall lead any such meeting or discussion, provided, however, that NVCR or its designee shall have the right, but not the obligation, to attend and participate in such meeting or discussion. If NVCR elects not to attend such meeting or discussion, Zai shall provide NVCR with a written summary thereof in English promptly following such meeting or discussion.

Regulatory. 6.1 Holder Regulatory Responsibilities of Regulatory Approvals and Regulatory SubmissionsClearside. NVCR shall initially be the holder of Regulatory Approvals and Regulatory Submission for Licensed Products in the Territory. At Zai’s request during the Term, (a) the JSC will discuss in good faith whether to transfer manufacturing responsibilities for Licensed Products for the Territory to Zai, and (b) the Parties will discuss in good faith whether to enable Zai to hold Regulatory Approvals and Regulatory Submissions in the Territory, including any pricing or reimbursement approvals, whether by transfer to Zai of such Regulatory Approvals and Regulatory Submissions or through the submission of a new application for Regulatory Approval in the Territory submitted by Zai, in each case ((a) or (b)), Prior to the extent permitted by Applicable Law and in accordance therewith. If agreed by the PartiesXIPERE NDA Approval Date, NVCR shall reasonably cooperate with Zai, at Zai’s expense, to enable Zai to hold any or all such Regulatory Approvals and Regulatory Submissions. 6.2 Zai’s Responsibilities. (a) Zai Clearside shall be solely responsible [***] for all regulatory activities leading up to and including the obtaining of Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products from all interactions with Regulatory Authorities necessary to obtain Regulatory Approval of the XIPERE Product in the Field United States and in the Territoryshall bear all costs and expenses relating thereto, provided that, Zai shall conduct such regulatory activities (and any and all regulatory activities delegated to Zai in this Agreement or by NVCR during the Term including in connection with the Development and Commercialization of items set out in Exhibit 5.1 (“Additional Clearside Regulatory Matters”). Clearside shall use Commercially Reasonable Efforts to obtain Regulatory Approval for the Licensed XIPERE Product in the Territory during such time that NVCR is United States. Clearside shall (a) promptly provide Bausch Health with copies of any communications which Clearside receives from the holder of applicable Regulatory Approvals and Regulatory Submissions for Authority concerning the Licensed Product in the Territory) as the expressXIPERE Product, exclusive, and authorized legal agent of record for NVCR in the Territory, and provided further, that such actions shall be taken on behalf of NVCR and for the benefit of Zai in the Territory. Promptly after the Effective Date and from time to time during the Term, the Parties shall conduct such actions and execute such documents as are required for Zai to act as NVCR’s express, exclusive, and authorized legal agent of record in the Territory. Notwithstanding the foregoing, to the extent permitted under Applicable Laws, Zai may file, obtain and maintain (on behalf of NVCR, which will be the holder of) Regulatory Submissions, Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products in the Territory. (b) Zai shall promptly provide to NVCR for review and comment drafts Bausch Health with draft copies of all proposed communications from Clearside to the applicable Regulatory Submissions prepared by or on behalf Authority with respect to the XIPERE Product (including any Additional Clearside Regulatory Matters ) prior to Clearside’s submission thereof, and (c) permit Bausch Health with a reasonable period of Zai, including English summaries thereof. NVCR shall have the right time to review and comment on such Regulatory Submissions communications and Zai Clearside shall consider in good faith any such reasonable comments, provided that Clearside shall not submit any such communications to the Regulatory Authority without the prior consent of Bausch Health, such consent not to be unreasonably withheld (for greater certainty, if Clearside incorporates any and all comments received from NVCR Bausch Health into such communications, then Bausch Health shall be deemed to have provided such prior written consent). Clearside shall promptly (and incorporate all comments in any event within [***]) inform Bausch Health of any material regulatory developments with respect to the XIPERE Product in the Territory that are reasonable or necessary may negatively affect the timeline for protecting NVCR’s interest as licensor the First Commercial Sale of the Licensed XIPERE Product or holder of the Regulatory Submission or Regulatory Approval in the Territory. In addition, each Party shall promptly notify the other Party of any Regulatory Submissions and any comments or other correspondences related thereto submitted to or received from any Regulatory Authority in the Territory and shall promptly respond to Bausch Health’s reasonable questions or requests for information relating thereto. In addition, within [***] following the end of each calendar quarter until the XIPERE NDA Approval Date, Clearside shall provide the other Party with copies thereof as soon as reasonably practicable. If any such Regulatory Submission, comment or correspondence is not in English, Zai shall also promptly provide NVCR with a written English summary report to Bausch Health setting forth in reasonable detail the status of any comments or other correspondences received from a Regulatory Authority with respect its then-current regulatory activities in relation to a Regulatory Submission. (c) Each Party shall promptly provide the other Party with notice after receiving notice of any meeting or discussion with any Regulatory Authority in the Territory related to any Licensed XIPERE Product in the FieldTerritory. Zai Clearside shall lead promptly respond to Bausch Health’s reasonable questions or requests for information relating to any such meeting or discussion, provided, however, that NVCR or its designee shall have the right, but not the obligation, to attend and participate in such meeting or discussion. If NVCR elects not to attend such meeting or discussion, Zai shall provide NVCR with a written summary thereof in English promptly following such meeting or discussionreport.

Regulatory. 6.1 Holder 7.4.1 PeerStream acknowledges and agrees that YouNow’s performance of Regulatory Approvals its obligations under this Agreement may be subject to and Regulatory Submissionscontingent on the resolution of any regulatory considerations relating to such obligations. NVCR Neither YouNow nor PeerStream shall initially be liable or responsible to the holder other, nor be deemed to have defaulted under or breached this Agreement, for any failure or delay in fulfilling or performing any terms of Regulatory Approvals the Agreement, when and Regulatory Submission for Licensed Products to the extent such failure or delay is caused by or results from the application of any law or regulation, a change in the Territoryany law or regulation or any action by any Governmental Authority, based on a reasonable determination by YouNow or PeerStream that any such law or regulation applies. At Zai’s request during the TermFurther, (a) the JSC YouNow and PeerStream will discuss work in good faith whether to transfer manufacturing responsibilities address any such regulatory considerations and structure the integration of the PeerStream Apps into the Platform, as well as execute their respective obligations under this Agreement, in a manner that minimizes the regulatory burdens and expenses on the operation of the Platform. 7.4.2 PeerStream covenants and agrees to deliver materials and information necessary for Licensed Products YouNow to obtain all approvals, consents, or qualifications of any Governmental Authority reasonably necessary for the Territory PeerStream Apps to Zaicomply with applicable law. Notwithstanding any provisions of this Agreement to the contrary, (i) Peerstream consents to YouNow’s reasonable or required disclosure of information regarding this Agreement, the relationship contemplated hereunder, and the Peerstream Apps in any filings or submissions to the U.S. Securities and Exchange Commission (b) the Parties will discuss in good faith whether to enable Zai to hold Regulatory Approvals and Regulatory Submissions in the Territory“SEC”), including any pricing such YOUNOW MASTER SERVICES AGREEMENT 7 CONFIDENTIAL filings or reimbursement approvalssubmissions relating to an offering pursuant to Regulation A of the Securities Act of 1933, whether as amended (“Regulation A”), or periodic and other reports required to be filed by transfer YouNow with the SEC and (ii) YouNow consents to Zai PeerStream’s reasonable or required disclosure of such Regulatory Approvals information regarding this Agreement, the relationship contemplated hereunder, and Regulatory Submissions the Platform in any filings or through submissions to the submission SEC, including periodic and other reports required to be filed by PeerStream with the SEC. 7.4.3 Any alterations that YouNow makes to the structuring of a new application for Regulatory Approval the integration of the PeerStream Apps that YouNow deems necessary in order to address regulatory considerations that would restrict the integration of the PeerStream Apps and performance of this Agreement from being consummated, or that would cause performance to be unduly expensive in light of costs and regulatory burdens on YouNow or the Platform, shall be deemed to constitute good faith performance under this Agreement. 7.4.4 While PeerStream may become eligible to receive Props Tokens from the Protocol Rewards Engine in the Territory submitted by Zaifuture, in each case ((a) or (b)), to the extent permitted by Applicable Law and in accordance therewith. If agreed by the Parties, NVCR shall reasonably cooperate with Zai, at Zai’s expense, to enable Zai to hold any or all such Regulatory Approvals and Regulatory Submissions. 6.2 Zai’s Responsibilities. (a) Zai shall be responsible [***] for all regulatory activities leading up to and including the obtaining of Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products from Regulatory Authorities in the Field and in the Territory, provided that, Zai shall conduct such regulatory activities (and any and all regulatory activities delegated to Zai in PeerStream acknowledges that this Agreement does not contemplate any payments to PeerStream from the Protocol Rewards Engine. Further, PeerStream and YouNow acknowledge and agree that: (i) No money or by NVCR during the Term other consideration is being solicited in connection with any YouNow offering from the Development and Commercialization of the Licensed Product in the Territory during such time that NVCR is the holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory) as the express, exclusiveProtocol Rewards Engine, and authorized legal agent if sent in response, will not be accepted; (ii) No offer to buy Props Tokens can be accepted and no part of record for NVCR any purchase price can be received in connection with any YouNow offering from the TerritoryProtocol Rewards Engine until an offering statement is qualified pursuant to the Securities Act of 1933, and provided furtheras amended (the “Securities Act”); (iii) Any such offer may be withdrawn or revoked, that such actions shall be taken on behalf without obligation or commitment of NVCR and for the benefit any kind, at any time before notice of Zai in the Territory. Promptly its acceptance given after the Effective Date and from time to time during the Term, the Parties shall conduct such actions and execute such documents as are required for Zai to act as NVCR’s express, exclusive, and authorized legal agent of record in the Territory. Notwithstanding the foregoing, to the extent permitted under Applicable Laws, Zai may file, obtain and maintain (on behalf of NVCR, which will be the holder of) Regulatory Submissions, Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products in the Territory. (b) Zai shall promptly provide to NVCR for review and comment drafts of all Regulatory Submissions prepared by or on behalf of Zai, including English summaries thereof. NVCR shall have the right to review and comment on such Regulatory Submissions and Zai shall consider in good faith any comments received from NVCR and incorporate all comments that are reasonable or necessary for protecting NVCR’s interest as licensor of the Licensed Product or holder of the Regulatory Submission or Regulatory Approval in the Territory. In addition, each Party shall promptly notify the other Party of any Regulatory Submissions and any comments or other correspondences related thereto submitted to or received from any Regulatory Authority in the Territory and shall provide the other Party with copies thereof as soon as reasonably practicable. If any such Regulatory Submission, comment or correspondence is not in English, Zai shall also promptly provide NVCR with a written English summary of any comments or other correspondences received from a Regulatory Authority with respect to a Regulatory Submission. (c) Each Party shall promptly provide the other Party with notice after receiving notice of any meeting or discussion with any Regulatory Authority in the Territory related to any Licensed Product in the Field. Zai shall lead any such meeting or discussion, provided, however, that NVCR or its designee shall have the right, but not the obligation, to attend and participate in such meeting or discussion. If NVCR elects not to attend such meeting or discussion, Zai shall provide NVCR with a written summary thereof in English promptly following such meeting or discussion.qualification date; and

Regulatory. 6.1 Holder of Regulatory Approvals and Regulatory Submissions. NVCR shall initially be the holder of Regulatory Approvals and Regulatory Submission for Licensed Products in the Territory. At Zai’s request during the Term, (a) the JSC will discuss in good faith whether to transfer manufacturing responsibilities for Licensed Products for the Territory to Zai, and (b) the Parties will discuss in good faith whether to enable Zai to hold Regulatory Approvals and Regulatory Submissions in the Territory, including any pricing or reimbursement approvals, whether by transfer to Zai of such Regulatory Approvals and Regulatory Submissions or through the submission of a new application for Regulatory CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. 21 Approval in the Territory submitted by Zai, in each case ((a) or (b)), to the extent permitted by Applicable Law and in accordance therewith. If agreed by the Parties, NVCR shall reasonably cooperate with Zai, at Zai’s expense, to enable Zai to hold any or all such Regulatory Approvals and Regulatory Submissions. 6.2 Zai’s Responsibilities. (a) Zai shall be responsible [***] for all regulatory activities leading up to and including the obtaining of Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products from Regulatory Authorities in the Field and in the Territory, provided that, Zai shall conduct such regulatory activities (and any and all regulatory activities delegated to Zai in this Agreement or by NVCR during the Term in connection with the Development and Commercialization of the Licensed Product in the Territory during such time that NVCR is the holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory) as the express, exclusive, and authorized legal agent of record for NVCR in the Territory, and provided further, that such actions shall be taken on behalf of NVCR and for the benefit of Zai in the Territory. Promptly after the Effective Date and from time to time during the Term, the Parties shall conduct such actions and execute such documents as are required for Zai to act as NVCR’s express, exclusive, and authorized legal agent of record in the Territory. Notwithstanding the foregoing, to the extent permitted under Applicable Laws, Zai may file, obtain and maintain (on behalf of NVCR, which will be the holder of) Regulatory Submissions, Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products in the Territory. (b) Zai shall promptly provide to NVCR for review and comment drafts of all Regulatory Submissions prepared by or on behalf of Zai, including English summaries thereof. NVCR shall have the right to review and comment on such Regulatory Submissions and Zai shall consider in good faith any comments received from NVCR and incorporate all comments that are reasonable or necessary for protecting NVCR’s interest as licensor of the Licensed Product or holder of the Regulatory Submission or Regulatory Approval in the Territory. In addition, each Party shall promptly notify the other Party of any Regulatory Submissions and any comments or other correspondences related thereto submitted to or received from any Regulatory Authority in the Territory and shall provide the other Party with copies thereof as soon as reasonably practicable. If any such Regulatory Submission, comment or correspondence is not in English, Zai shall also promptly provide NVCR with a written English summary of any comments or other correspondences received from a Regulatory Authority with respect to a Regulatory Submission. (c) Each Party shall promptly provide the other Party with notice after receiving notice of any meeting or discussion with any Regulatory Authority in the Territory related to any Licensed Product in the Field. Zai shall lead any such meeting or discussion, provided, however, that NVCR or its designee shall have the right, but not the obligation, to attend and participate in such meeting or discussion. If NVCR elects not to attend such meeting or discussion, Zai shall provide NVCR with a written summary thereof in English promptly following such meeting or discussion.. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. 22

Regulatory. 6.1 Holder 7.4.1 PeerStream acknowledges and agrees that YouNow’s performance of Regulatory Approvals its obligations under this Agreement may be subject to and Regulatory Submissionscontingent on the resolution of any regulatory considerations relating to such obligations. NVCR Neither YouNow nor PeerStream shall initially be liable or responsible to the holder other, nor be deemed to have defaulted under or breached this Agreement, for any failure or delay in fulfilling or performing any terms of Regulatory Approvals the Agreement, when and Regulatory Submission for Licensed Products to the extent such failure or delay is caused by or results from the application of any law or regulation, a change in the Territoryany law or regulation or any action by any Governmental Authority, based on a reasonable determination by YouNow or PeerStream that any such law or regulation applies. At Zai’s request during the TermFurther, (a) the JSC YouNow and PeerStream will discuss work in good faith whether to transfer manufacturing responsibilities address any such regulatory considerations and structure the integration of the PeerStream Apps into the Platform, as well as execute their respective obligations under this Agreement, in a manner that minimizes the regulatory burdens and expenses on the operation of the Platform. 7.4.2 PeerStream covenants and agrees to deliver materials and information necessary for Licensed Products YouNow to obtain all approvals, consents, or qualifications of any Governmental Authority reasonably necessary for the Territory PeerStream Apps to Zaicomply with applicable law. Notwithstanding any provisions of this Agreement to YOUNOW MASTER SERVICES AGREEMENT 6 CONFIDENTIAL the contrary, (i) Peerstream consents to YouNow’s reasonable or required disclosure of information regarding this Agreement, the relationship contemplated hereunder, and the Peerstream Apps in any filings or submissions to the U.S. Securities and Exchange Commission (b) the Parties will discuss in good faith whether to enable Zai to hold Regulatory Approvals and Regulatory Submissions in the Territory“SEC”), including any pricing such filings or reimbursement approvalssubmissions relating to an offering pursuant to Regulation A of the Securities Act of 1933, whether as amended (“Regulation A”), or periodic and other reports required to be filed by transfer YouNow with the SEC and (ii) YouNow consents to Zai PeerStream’s reasonable or required disclosure of such Regulatory Approvals information regarding this Agreement, the relationship contemplated hereunder, and Regulatory Submissions the Platform in any filings or through submissions to the submission SEC, including periodic and other reports required to be filed by PeerStream with the SEC. 7.4.3 Any alterations that YouNow makes to the structuring of a new application for Regulatory Approval the integration of the PeerStream Apps that YouNow deems necessary in order to address regulatory considerations that would restrict the integration of the PeerStream Apps and performance of this Agreement from being consummated, or that would cause performance to be unduly expensive in light of costs and regulatory burdens on YouNow or the Platform, shall be deemed to constitute good faith performance under this Agreement. 7.4.4 While PeerStream may become eligible to receive Props Tokens from the Protocol Rewards Engine in the Territory submitted by Zaifuture, in each case ((a) or (b)), to the extent permitted by Applicable Law and in accordance therewith. If agreed by the Parties, NVCR shall reasonably cooperate with Zai, at Zai’s expense, to enable Zai to hold any or all such Regulatory Approvals and Regulatory Submissions. 6.2 Zai’s Responsibilities. (a) Zai shall be responsible [***] for all regulatory activities leading up to and including the obtaining of Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products from Regulatory Authorities in the Field and in the Territory, provided that, Zai shall conduct such regulatory activities (and any and all regulatory activities delegated to Zai in PeerStream acknowledges that this Agreement does not contemplate any payments to PeerStream from the Protocol Rewards Engine. Further, PeerStream and YouNow acknowledge and agree that: (i) No money or by NVCR during the Term other consideration is being solicited in connection with any YouNow offering from the Development and Commercialization of the Licensed Product in the Territory during such time that NVCR is the holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory) as the express, exclusiveProtocol Rewards Engine, and authorized legal agent if sent in response, will not be accepted; (ii) No offer to buy Props Tokens can be accepted and no part of record for NVCR any purchase price can be received in connection with any YouNow offering from the TerritoryProtocol Rewards Engine until an offering statement is qualified pursuant to the Securities Act of 1933, and provided furtheras amended (the “Securities Act”); (iii) Any such offer may be withdrawn or revoked, that such actions shall be taken on behalf without obligation or commitment of NVCR and for the benefit any kind, at any time before notice of Zai in the Territory. Promptly its acceptance given after the Effective Date and from time to time during the Term, the Parties shall conduct such actions and execute such documents as are required for Zai to act as NVCR’s express, exclusive, and authorized legal agent of record in the Territory. Notwithstanding the foregoing, to the extent permitted under Applicable Laws, Zai may file, obtain and maintain (on behalf of NVCR, which will be the holder of) Regulatory Submissions, Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products in the Territory. (b) Zai shall promptly provide to NVCR for review and comment drafts of all Regulatory Submissions prepared by or on behalf of Zai, including English summaries thereof. NVCR shall have the right to review and comment on such Regulatory Submissions and Zai shall consider in good faith any comments received from NVCR and incorporate all comments that are reasonable or necessary for protecting NVCR’s interest as licensor of the Licensed Product or holder of the Regulatory Submission or Regulatory Approval in the Territory. In addition, each Party shall promptly notify the other Party of any Regulatory Submissions and any comments or other correspondences related thereto submitted to or received from any Regulatory Authority in the Territory and shall provide the other Party with copies thereof as soon as reasonably practicable. If any such Regulatory Submission, comment or correspondence is not in English, Zai shall also promptly provide NVCR with a written English summary of any comments or other correspondences received from a Regulatory Authority with respect to a Regulatory Submission. (c) Each Party shall promptly provide the other Party with notice after receiving notice of any meeting or discussion with any Regulatory Authority in the Territory related to any Licensed Product in the Field. Zai shall lead any such meeting or discussion, provided, however, that NVCR or its designee shall have the right, but not the obligation, to attend and participate in such meeting or discussion. If NVCR elects not to attend such meeting or discussion, Zai shall provide NVCR with a written summary thereof in English promptly following such meeting or discussion.qualification date; and

Regulatory. 6.1 Holder (i) The Company and each of Regulatory Approvals and Regulatory Submissions. NVCR shall initially be the holder of Regulatory Approvals and Regulatory Submission for Licensed Products Company’s subsidiaries that is engaged in the Territory. At Zai’s request during business of insurance or reinsurance (each such subsidiary, an “Insurance Subsidiary”) is duly licensed or registered as an insurance holding company, insurer or as a reinsurer, as the Termcase may be, under the laws (aincluding, without limitation, laws that relate to companies that control insurance companies) and the JSC will discuss rules, regulations and interpretations of the insurance regulatory authorities thereunder (collectively, the “Insurance Laws”) of each jurisdiction in good faith whether to transfer manufacturing responsibilities for Licensed Products for which the Territory to Zai, and (b) the Parties will discuss in good faith whether to enable Zai to hold Regulatory Approvals and Regulatory Submissions conduct of its business as described in the TerritoryRegistration Statement, including any pricing the Pricing Disclosure Package and the Prospectus requires such licensing or reimbursement registration (each such license or registration, an “Insurance License”), except where the failure to be so licensed or registered would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect. The Company and each of the Insurance Subsidiaries has made all required filings under applicable Insurance Laws in each jurisdiction where such filings are required, except for such filings the failure of which to make would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect. The Company and each of the Insurance Subsidiaries has all other necessary authorizations, approvals, whether by transfer orders, consents, certificates, permits, registrations and qualifications of and from all insurance regulatory authorities necessary to Zai of such Regulatory Approvals and Regulatory Submissions or through the submission of a new application for Regulatory Approval conduct its business as described in the Territory submitted by ZaiRegistration Statement, the Pricing Disclosure Package and the Prospectus (together with the Insurance Licenses, the “Insurance Licenses and Authorizations”) and all of the foregoing are in each case ((a) full force and effect, except where the failure to have such Insurance Licenses and Authorizations in full force and effect would not reasonably be expected to have a Material Adverse Effect. To the Company’s knowledge there is no threatened action, suit, proceeding or (b))investigation that would, individually or in the aggregate, result in the revocation, termination or suspension of any of the Insurance Licenses and Authorizations that would reasonably be expected to have a Material Adverse Effect. Neither the Company nor any of the Insurance Subsidiaries has received any notification from any insurance regulatory authority or other governmental entity to the extent permitted by Applicable Law effect that any additional Insurance Licenses and in accordance therewith. If agreed Authorizations are needed to be obtained by the PartiesCompany or any of the Insurance Subsidiaries in any case where it would be reasonably expected that the failure to obtain such additional Insurance Licenses and Authorizations would, NVCR shall reasonably cooperate with Zaiindividually or in the aggregate, at Zai’s expense, to enable Zai to hold any or all such Regulatory Approvals and Regulatory Submissions. 6.2 Zai’s Responsibilitiesresult in a Material Adverse Effect. (aii) Zai shall be responsible [***] for The Company and each of its subsidiaries are in compliance in all material respects with all applicable laws administered by, and all rules, regulations, directives, orders and decrees of any federal, state, local or foreign regulatory activities leading up or supervisory authority, self-regulatory organization or governmental agency or body having jurisdiction over the Company or any of its subsidiaries (each, a “Regulatory Authority”) (including, without limitation, state insurance regulatory authorities), including applicable regulatory capital requirements, except where the failure to and including the obtaining of Regulatory Approvals and any pricing so comply would not, individually or reimbursement approvals, as applicable, for Licensed Products from Regulatory Authorities in the Field and aggregate, result in the Territory, provided that, Zai shall conduct such regulatory activities (and any and all regulatory activities delegated to Zai in this Agreement or by NVCR during the Term in connection with the Development and Commercialization of the Licensed Product in the Territory during such time that NVCR is the holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory) as the express, exclusive, and authorized legal agent of record for NVCR in the Territory, and provided further, that such actions shall be taken on behalf of NVCR and for the benefit of Zai in the Territory. Promptly after the Effective Date and from time to time during the Term, the Parties shall conduct such actions and execute such documents as are required for Zai to act as NVCR’s express, exclusive, and authorized legal agent of record in the Territory. Notwithstanding the foregoing, to the extent permitted under Applicable Laws, Zai may file, obtain and maintain (on behalf of NVCR, which will be the holder of) Regulatory Submissions, Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products in the Territorya Material Adverse Effect. (biii) Zai shall promptly provide Except as described in the Registration Statement, Pricing Disclosure Package and the Prospectus, or as would not, individually or in the aggregate, reasonably be expected to NVCR for review and comment drafts have a Material Adverse Effect, neither the Company nor any of all its subsidiaries is a party to or otherwise subject to any order, decree, agreement, memorandum of understanding, or other regulatory enforcement action, proceeding or order with or by, or is a party to or recipient of a commitment letter, supervisory letter or similar undertaking to or from, any Regulatory Submissions prepared by Authority (whether or on behalf of Zai, including English summaries thereof. NVCR shall have the right to review and comment on not such Regulatory Submissions and Zai shall consider in good faith Authority has determined that publication would be contrary to the public interest) or has adopted any comments received from NVCR and incorporate all comments that are reasonable or necessary for protecting NVCR’s interest as licensor of board resolutions at the Licensed Product or holder of the Regulatory Submission or Regulatory Approval in the Territory. In addition, each Party shall promptly notify the other Party request of any Regulatory Submissions and Authority. Neither the Company nor any comments or other correspondences related thereto submitted to or received from any Regulatory Authority in the Territory and shall provide the other Party with copies thereof as soon as reasonably practicable. If of its subsidiaries has been advised by any such Regulatory SubmissionAuthority that it is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any such order, comment decree, agreement, memorandum of understanding, commitment letter, supervisory letter or correspondence similar undertaking; and there is not in Englishno unresolved violation, Zai shall also promptly provide NVCR with a written English summary of criticism or exception by any comments or other correspondences received from a Regulatory Authority with respect to a Regulatory Submission. (c) Each Party shall promptly provide any examination of the other Party with notice after receiving notice of any meeting or discussion with any Regulatory Authority Company and its subsidiaries which, in the Territory related reasonable judgment of the Company, is expected to any Licensed Product result in the Field. Zai shall lead any such meeting or discussion, provided, however, that NVCR or its designee shall have the right, but not the obligation, to attend and participate in such meeting or discussion. If NVCR elects not to attend such meeting or discussion, Zai shall provide NVCR with a written summary thereof in English promptly following such meeting or discussionMaterial Adverse Effect.

Regulatory. 6.1 Holder (i) The Company and each of Regulatory Approvals and Regulatory Submissions. NVCR shall initially be the holder of Regulatory Approvals and Regulatory Submission for Licensed Products Company’s subsidiaries that is engaged in the Territory. At Zai’s request during business of insurance or reinsurance (each such subsidiary, an “Insurance Subsidiary”) is duly licensed or registered as an insurance holding company, insurer or as a reinsurer, as the Termcase may be, under the laws (aincluding, without limitation, laws that relate to companies that control insurance companies) and the JSC will discuss rules, regulations and interpretations of the insurance regulatory authorities thereunder (collectively, the “Insurance Laws”) of each jurisdiction in good faith whether to transfer manufacturing responsibilities for Licensed Products for which the Territory to Zai, and (b) the Parties will discuss in good faith whether to enable Zai to hold Regulatory Approvals and Regulatory Submissions conduct of its business as described in the TerritoryRegistration Statement, including any pricing the Pricing Disclosure Package and the Prospectus requires such licensing or reimbursement registration (each such license or registration, an “Insurance License”), except where the failure to be so licensed or registered would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect. The Company and each of the Insurance Subsidiaries has made all required filings under applicable Insurance Laws in each jurisdiction where such filings are required, except for such filings the failure of which to make would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect. The Company and each of the Insurance Subsidiaries has all other necessary authorizations, approvals, whether by transfer orders, consents, certificates, permits, registrations and qualifications of and from all insurance regulatory authorities necessary to Zai of such Regulatory Approvals and Regulatory Submissions or through the submission of a new application for Regulatory Approval conduct its business as described in the Territory submitted by ZaiRegistration Statement, the Pricing Disclosure Package and the Prospectus (together with the Insurance Licenses, the “Insurance Licenses and Authorizations”) and all of the foregoing are in each case ((a) full force and effect, except where the failure to have such Insurance Licenses and Authorizations in full force and effect would not reasonably be expected to have a Material Adverse Effect. To the Company’s knowledge there is no threatened action, suit, proceeding or (b))investigation that would, individually or in the aggregate, result in the revocation, termination or suspension of any of the Insurance Licenses and Authorizations that would reasonably be expected to have a Material Adverse Effect. Neither the Company nor any of the Insurance Subsidiaries has received any notification from any insurance regulatory authority or other governmental entity to the extent permitted by Applicable Law effect that any additional Insurance Licenses and in accordance therewith. If agreed Authorizations are needed to be obtained by the PartiesCompany or any of the Insurance Subsidiaries in any case where it would be reasonably expected that the failure to obtain such additional Insurance Licenses and Authorizations would, NVCR shall reasonably cooperate with Zai, at Zai’s expense, to enable Zai to hold any individually or all such Regulatory Approvals and Regulatory Submissions. 6.2 Zai’s Responsibilities. (a) Zai shall be responsible [***] for all regulatory activities leading up to and including the obtaining of Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products from Regulatory Authorities in the Field and aggregate, result in the Territory, provided that, Zai shall conduct such regulatory activities (and any and all regulatory activities delegated to Zai in this Agreement or by NVCR during the Term in connection with the Development and Commercialization of the Licensed Product in the Territory during such time that NVCR is the holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory) as the express, exclusive, and authorized legal agent of record for NVCR in the Territory, and provided further, that such actions shall be taken on behalf of NVCR and for the benefit of Zai in the Territory. Promptly after the Effective Date and from time to time during the Term, the Parties shall conduct such actions and execute such documents as are required for Zai to act as NVCR’s express, exclusive, and authorized legal agent of record in the Territory. Notwithstanding the foregoing, to the extent permitted under Applicable Laws, Zai may file, obtain and maintain (on behalf of NVCR, which will be the holder of) Regulatory Submissions, Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products in the Territorya Material Adverse Effect. (b) Zai shall promptly provide to NVCR for review and comment drafts of all Regulatory Submissions prepared by or on behalf of Zai, including English summaries thereof. NVCR shall have the right to review and comment on such Regulatory Submissions and Zai shall consider in good faith any comments received from NVCR and incorporate all comments that are reasonable or necessary for protecting NVCR’s interest as licensor of the Licensed Product or holder of the Regulatory Submission or Regulatory Approval in the Territory. In addition, each Party shall promptly notify the other Party of any Regulatory Submissions and any comments or other correspondences related thereto submitted to or received from any Regulatory Authority in the Territory and shall provide the other Party with copies thereof as soon as reasonably practicable. If any such Regulatory Submission, comment or correspondence is not in English, Zai shall also promptly provide NVCR with a written English summary of any comments or other correspondences received from a Regulatory Authority with respect to a Regulatory Submission. (c) Each Party shall promptly provide the other Party with notice after receiving notice of any meeting or discussion with any Regulatory Authority in the Territory related to any Licensed Product in the Field. Zai shall lead any such meeting or discussion, provided, however, that NVCR or its designee shall have the right, but not the obligation, to attend and participate in such meeting or discussion. If NVCR elects not to attend such meeting or discussion, Zai shall provide NVCR with a written summary thereof in English promptly following such meeting or discussion.

Regulatory. 6.1 Holder (a) Licensee shall be responsible for all regulatory activities related to the development and commercialization of the Product in the Field in the Territory, at Licensee’s own cost and expense. Licensee shall prepare and file all Regulatory Approvals Materials necessary to obtain and maintain the Regulatory Submissions. NVCR Approval of the Product in the Field in the Territory and shall initially be responsible for all communication and interaction with Regulatory Authorities with respect thereto. (b) At Licensee’s request and expense, Licensor shall provide Licensee with reasonable assistance in connection with the holder of Regulatory Approvals and Regulatory Submission regulatory activities for Licensed Products the Product in the Field in the Territory. At ZaiLicensor shall provide Licensee access to all material preclinical and clinical data, results, communications and other information Controlled by Licensor and relating to or resulting from any of Licensor’s request during the Term, (a) the JSC will discuss in good faith whether to transfer manufacturing responsibilities for Licensed Products for the Territory to Zai, and (b) the Parties will discuss in good faith whether to enable Zai to hold Regulatory Approvals and Regulatory Submissions in the Territory, including any pricing clinical trials or reimbursement approvals, whether by transfer to Zai of such Regulatory Approvals and Regulatory Submissions or through the submission of a new application for Regulatory Approval in the Territory submitted by Zai, in each case ((a) or (b)), regulatory filings relating to the extent permitted by Applicable Law and in accordance therewith. If agreed by the Parties, NVCR shall reasonably cooperate with Zai, at Zai’s expense, to enable Zai to hold any or all such Regulatory Approvals and Regulatory Submissions. 6.2 Zai’s Responsibilities. (a) Zai shall be responsible [***] for all regulatory activities leading up to and including the obtaining of Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products from Regulatory Authorities Virus in the Field and (the “Licensor Data”) for use by Licensee in obtaining Regulatory Approval for the Territory, provided that, Zai shall conduct such regulatory activities (and any and all regulatory activities delegated to Zai in this Agreement or by NVCR during the Term in connection with the Development and Commercialization of the Licensed Product in the Territory during such time that NVCR is the holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory) as the express, exclusive, and authorized legal agent of record for NVCR Field in the Territory, and provided furtherLicensee shall have a right of access, that a right of reference and a right to use and incorporate all such actions shall be taken on behalf Licensor Data for purposes of NVCR and for obtaining Regulatory Approval of the benefit of Zai Product in the Territory. Promptly after the Effective Date and from time to time during the Term, the Parties shall conduct such actions and execute such documents as are required for Zai to act as NVCR’s express, exclusive, and authorized legal agent of record in the Territory. Notwithstanding the foregoing, to the extent permitted under Applicable Laws, Zai may file, obtain and maintain (on behalf of NVCR, which will be the holder of) Regulatory Submissions, Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products Field in the Territory. (bc) Zai Licensee shall promptly provide to NVCR for review and comment Licensor with drafts of all Regulatory Submissions prepared by or on behalf of Zai, including English summaries thereof. NVCR shall have Materials relating to the right Product a reasonable time prior to submission for review and comment on such Regulatory Submissions comment, and Zai shall consider and implement in good faith any comments received from NVCR Licensor. Without limiting the foregoing, upon Licensor’s request, Licensee shall remove from such Regulatory Materials any information that Licensor reasonably believes would materially and incorporate all comments that are reasonable adversely affect the development or necessary for protecting NVCR’s interest as licensor commercialization of any Therapeutic Virus outside the Licensed Product or holder of Field, to the Regulatory Submission or Regulatory Approval in the Territoryextent allowed by applicable laws and regulations. In addition, each Party Licensee shall promptly notify the other Party provide Licensor with copies of any Regulatory Submissions and any comments or other correspondences related thereto Materials relating to the Product submitted to or received from any Regulatory Authority in the Territory within ten (10) days after submission or receipt, and shall provide the other Party with copies thereof as soon as reasonably practicable. If any such Regulatory Submission, comment or correspondence is not in English, Zai shall also promptly provide NVCR with a written English summary notify Licensor of any comments or other correspondences received from a Regulatory Authority with respect material communication relating to a Regulatory Submission. (c) Each Party shall promptly provide the other Party with notice after receiving notice of any meeting or discussion Product with any Regulatory Authority in the Territory related to within ten (10) days after such communication. (d) If any Licensed Regulatory Exclusivity is available for any Product in the Fieldany country or jurisdiction, Licensee shall, at its own cost and expense, use Commercially Reasonable Efforts to seek and maintain such Regulatory Exclusivity protection for such Product. Zai shall lead any If Licensee does not seek or maintain such meeting or discussionRegulatory Exclusivity protection, provided, however, that NVCR or its designee then Licensor shall have the right, right (but not the obligation) to do so at Licensor’s own cost and expense; provided that if Licensor successfully obtains such Regulatory Exclusivity protection, Licensee shall reimburse Licensor for all cost and expense incurred. (e) Licensee shall keep Licensor informed with respect to attend any adverse event or safety issues relating to the development or commercialization of the Product in the Field in the Territory. The Parties may enter into a pharmacovigilance agreement setting forth the procedures for the reporting of adverse event or safety issues of the Product in order for the Parties to comply with its reporting obligations under applicable Laws. (f) Each Party shall notify the other immediately, and participate promptly confirm such notice in writing, if it obtains information indicating that the Product may be subject to any recall, corrective action or other regulatory action by any Regulatory Authority (a “Remedial Action”). The Parties shall assist each other in gathering and evaluating such meeting or discussioninformation as is necessary to determine the necessity of conducting a Remedial Action. If NVCR elects not Licensee shall be responsible for all Remedial Actions for the Product in the Field in the Territory, including the decision to attend commence such meeting or discussionRemedial Action, Zai and shall provide NVCR with a written summary thereof bear all cost and expense thereof. Licensee shall, and shall ensure that its Affiliates and sublicensees will, maintain adequate records to permit Licensee to trace the distribution, sale and use of the Product in English promptly following such meeting or discussionthe Field in the Territory.

Regulatory. 6.1 Holder (i) The Company and each of Regulatory Approvals and Regulatory Submissions. NVCR shall initially be the holder of Regulatory Approvals and Regulatory Submission for Licensed Products Company’s subsidiaries that is engaged in the Territory. At Zai’s request during business of insurance or reinsurance (each such subsidiary, an “Insurance Subsidiary”) is duly licensed or registered as an insurance holding company, insurer or as a reinsurer, as the Termcase may be, under the laws (aincluding, without limitation, laws that relate to companies that control insurance companies) and the JSC will discuss rules, regulations and interpretations of the insurance regulatory authorities thereunder (collectively, the “Insurance Laws”) of each jurisdiction in good faith whether to transfer manufacturing responsibilities for Licensed Products for which the Territory to Zai, and (b) the Parties will discuss in good faith whether to enable Zai to hold Regulatory Approvals and Regulatory Submissions conduct of its business as described in the TerritoryRegistration Statement, including any pricing the Time of Sale Information and the Prospectus requires such licensing or reimbursement registration (each such license or registration, an “Insurance License”), except where the failure to be so licensed or registered would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect. The Company and each of the Insurance Subsidiaries has made all required filings under applicable Insurance Laws in each jurisdiction where such filings are required, except for such filings the failure of which to make would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect. The Company and each of the Insurance Subsidiaries has all other necessary authorizations, approvals, whether by transfer orders, consents, certificates, permits, registrations and qualifications of and from all insurance regulatory authorities necessary to Zai of such Regulatory Approvals and Regulatory Submissions or through the submission of a new application for Regulatory Approval conduct its business as described in the Territory submitted by ZaiRegistration Statement, the Time of Sale Information and the Prospectus (together with the Insurance Licenses, the “Insurance Licenses and Authorizations”) and all of the foregoing are in each case ((a) full force and effect, except where the failure to be so licensed or (b))registered would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect. To the Company’s knowledge there is no threatened action, suit, proceeding or investigation that would, individually or in the aggregate, result in the revocation, termination or suspension of any of the Insurance Licenses and Authorizations that would reasonably be expected to have a Material Adverse Effect. Neither the Company nor any of the Insurance Subsidiaries has received any notification from any insurance regulatory authority or other governmental entity to the extent permitted by Applicable Law effect that any additional Insurance Licenses and in accordance therewith. If agreed Authorizations are needed to be obtained by the PartiesCompany or any of the Insurance Subsidiaries in any case where it would be reasonably expected that the failure to obtain such additional Insurance Licenses and Authorizations would, NVCR shall reasonably cooperate with Zaiindividually or in the aggregate, at Zai’s expense, to enable Zai to hold any or all such Regulatory Approvals and Regulatory Submissions. 6.2 Zai’s Responsibilitiesresult in a Material Adverse Effect. (aii) Zai shall be responsible [***] for The Company and each of its subsidiaries are in compliance in all material respects with all applicable laws administered by, and all rules, regulations, directives, orders and decrees of any federal, state, local or foreign regulatory activities leading up or supervisory authority, self-regulatory organization or governmental agency or body having jurisdiction over the Company or any of its subsidiaries (each, a “Regulatory Authority”) (including, without limitation, state insurance regulatory authorities), including applicable regulatory capital requirements, except where the failure to and including the obtaining of Regulatory Approvals and any pricing so comply would not, individually or reimbursement approvals, as applicable, for Licensed Products from Regulatory Authorities in the Field and aggregate, result in the Territory, provided that, Zai shall conduct such regulatory activities (and any and all regulatory activities delegated to Zai in this Agreement or by NVCR during the Term in connection with the Development and Commercialization of the Licensed Product in the Territory during such time that NVCR is the holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory) as the express, exclusive, and authorized legal agent of record for NVCR in the Territory, and provided further, that such actions shall be taken on behalf of NVCR and for the benefit of Zai in the Territory. Promptly after the Effective Date and from time to time during the Term, the Parties shall conduct such actions and execute such documents as are required for Zai to act as NVCR’s express, exclusive, and authorized legal agent of record in the Territory. Notwithstanding the foregoing, to the extent permitted under Applicable Laws, Zai may file, obtain and maintain (on behalf of NVCR, which will be the holder of) Regulatory Submissions, Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products in the Territorya Material Adverse Effect. (biii) Zai shall promptly provide Except as described in the Registration Statement, the Time of Sale Information and the Prospectus, or as would not, individually or in the aggregate, reasonably be expected to NVCR for review and comment drafts have a Material Adverse Effect, neither the Company nor any of all its subsidiaries is a party to or otherwise subject to any order, decree, agreement, memorandum of understanding, or other regulatory enforcement action, proceeding or order with or by, or is a party to or recipient of a commitment letter, supervisory letter or similar undertaking to or from, any Regulatory Submissions prepared by Authority (whether or on behalf of Zai, including English summaries thereof. NVCR shall have the right to review and comment on not such Regulatory Submissions and Zai shall consider in good faith Authority has determined that publication would be contrary to the public interest) or has adopted any comments received from NVCR and incorporate all comments that are reasonable or necessary for protecting NVCR’s interest as licensor of board resolutions at the Licensed Product or holder of the Regulatory Submission or Regulatory Approval in the Territory. In addition, each Party shall promptly notify the other Party request of any Regulatory Submissions and Authority. Neither the Company nor any comments of its subsidiaries has been advised or other correspondences related thereto submitted to or received from any Regulatory Authority in the Territory and shall provide the other Party with copies thereof as soon as reasonably practicable. If notified by any such Regulatory SubmissionAuthority that it is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any such order, comment decree, agreement, memorandum of understanding, commitment letter, supervisory letter or correspondence similar undertaking; and there is not in Englishno unresolved violation, Zai shall also promptly provide NVCR with a written English summary of criticism or exception by any comments or other correspondences received from a Regulatory Authority with respect to a Regulatory Submission. (c) Each Party shall promptly provide any examination of the other Party with notice after receiving notice of any meeting or discussion with any Regulatory Authority Company and its subsidiaries which, in the Territory related reasonable judgment of the Company, is expected to any Licensed Product result in the Field. Zai shall lead any such meeting or discussion, provided, however, that NVCR or its designee shall have the right, but not the obligation, to attend and participate in such meeting or discussion. If NVCR elects not to attend such meeting or discussion, Zai shall provide NVCR with a written summary thereof in English promptly following such meeting or discussionMaterial Adverse Effect.

Regulatory. 6.1 Holder of Regulatory Approvals and Regulatory Submissions. NVCR shall initially be the holder of Regulatory Approvals and Regulatory Submission for Licensed Products in the Territory. At Zai’s request during the Term, (a) The JDC will approve all regulatory plans and strategies and the JSC schedule for regulatory submissions. Pursuant to Section 4.1, Licensor will discuss in good faith whether to transfer manufacturing responsibilities for Licensed Products for the Territory to Zaiprovide Novartis with copies of any correspondence or other documentation it has submitted to, and (b) the Parties will discuss in good faith whether to enable Zai to hold or received from, any Regulatory Approvals and Regulatory Submissions in the Territory, including any pricing or reimbursement approvals, whether by transfer to Zai of such Regulatory Approvals and Regulatory Submissions or through the submission of a new application for Regulatory Approval in the Territory submitted by Zai, in each case ((a) or (b)), Authority relating to the extent permitted by Applicable Law and in accordance therewith. If agreed by the Parties, NVCR shall reasonably cooperate with Zai, at Zai’s expense, to enable Zai to hold any Compound or all such Regulatory Approvals and Regulatory Submissions. 6.2 Zai’s Responsibilities. (a) Zai shall be responsible [***] for all regulatory activities leading up to and including the obtaining of Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products from Regulatory Authorities in the Field and in the Territory, provided that, Zai shall conduct such regulatory activities (and any and all regulatory activities delegated to Zai in this Agreement or by NVCR during the Term in connection with the Development and Commercialization of the Licensed Product in the Territory during such time that NVCR is the holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory) as the express, exclusive, and authorized legal agent of record for NVCR in the Territory, and provided further, that such actions shall be taken on behalf of NVCR and for the benefit of Zai in the Territory. Promptly after the Effective Date and from time to time during the Term, the Parties shall conduct such actions and execute such documents as are required for Zai to act as NVCR’s express, exclusive, and authorized legal agent of record in the Territory. Notwithstanding the foregoing, to the extent permitted under Applicable Laws, Zai may file, obtain and maintain (on behalf of NVCR, which will be the holder of) Regulatory Submissions, Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products in the TerritoryProduct. (b) Zai Licensor shall be solely responsible, at its sole expense, for obtaining Regulatory Approvals for Products in the Territory prior to the exercise by Novartis of its Development Rights. Prior to the Novartis Development Commencement Date, all Regulatory Filings submitted in any country in the Territory in connection with obtaining Regulatory Approvals to test or market the Compound or Product, including all IND, NDA and MAA submissions and other Regulatory Filings relating to the Compound or Product, shall be owned by, and submitted by and in the name of, Licensor or its Affiliates. Licensor will promptly provide deliver to NVCR for Novartis copies of all relevant regulatory correspondence or other documents received by Licensor or its Affiliates with respect to the Compound or Product. Prior to making any Regulatory Filing or submitting any correspondence or other documentation to any Regulatory Authority with respect to the Compound or Product, Licensor shall deliver to Novartis a copy thereof in draft form. Novartis will have the opportunity to review and comment drafts provide comments thereon and Licensor will reasonably take into account Novartis’ comments. Novartis will have the right to be present at all meetings with Regulatory Authorities. (c) Within thirty (30) days after Novartis’ exercise of its Development Rights, Licensor or its Affiliates, without additional consideration, will transfer to Novartis or its designated Affiliate all Regulatory Approvals and Regulatory Filings in the Territory and provide complete copies of the same to Novartis or its designated Affiliates. Following the Novartis Development Commencement Date, (i) Novartis shall be solely responsible, at its sole expense (subject to Section 5.3(b)), for obtaining any Regulatory Approvals for Product in the Territory and (ii) all Regulatory Filings submitted in any country in the Territory in connection with obtaining Regulatory Approvals to test or market the Compound or Product, including all IND, NDA and MAA submissions and other Regulatory Filings relating to the Compound or Product, shall be owned by, and submitted by and in the name of, Novartis, its Affiliates or designees. (d) Licensor shall fully cooperate with and provide reasonable assistance to Novartis in connection with Regulatory Filings in the Territory relating to the Compound or Product, including by executing any required documents, providing access to personnel and providing Novartis with copies of all reasonably required documentation. (e) To the extent required, Licensor shall grant or cause to be granted to Novartis and its Affiliates or sublicensees cross-reference rights to any relevant drug master files and other filings submitted by Licensor or its Affiliates with any Regulatory Submissions prepared Authority with respect to the Compound or Product. Licensor also shall use commercially reasonable efforts to assist Novartis and its Affiliates or sublicensees in obtaining cross-reference rights to any relevant drug master files and other filings submitted by Third Parties with any Regulatory Authority with respect to the Compound or on behalf Product. If Novartis exercises the Development Rights, Novartis shall grant or cause to be granted to Licensor and its Affiliates or sublicensees cross-reference rights to the portions of Zai, including English summaries thereof. NVCR any drug master files and other filings submitted by Novartis or its Affiliates with any Regulatory Authority in regard to the Compound or Product that specifically relate to Licensor’s polymer technology. (f) Novartis shall have the right to review disclose the existence of, and comment on such Regulatory Submissions and Zai shall consider the results from, any clinical trials conducted under this Agreement in good faith any comments received from NVCR and incorporate all comments that are reasonable or necessary for protecting NVCR’s interest as licensor of the Licensed Product or holder of the Regulatory Submission or Regulatory Approval in the Territoryaccordance with its standard policies. In addition, each Party shall promptly notify the other Party of any Regulatory Submissions and any comments or other correspondences related thereto submitted to or received from any Regulatory Authority in the Territory and shall provide the other Party with copies thereof as soon as reasonably practicable. If any such Regulatory Submission, comment or correspondence is not in English, Zai shall also promptly provide NVCR with a written English summary of any comments or other correspondences received from a Regulatory Authority with respect to a Regulatory Submission. (c) Each Party shall promptly provide the other Party with notice after receiving notice of any meeting or discussion with any Regulatory Authority in the Territory related to any Licensed Product in the Field. Zai shall lead any such meeting or discussion, provided, however, that NVCR or its designee Licensor shall have the rightright to disclose the existence of, but not and the obligationresults from, to attend any clinical trials conducted under this Agreement upon prior review and participate in such meeting approval by the JDC or discussion. If NVCR elects not to attend such meeting or discussion, Zai shall provide NVCR with a written summary thereof in English promptly following such meeting or discussionas otherwise permitted by Section 17.

Regulatory. 6.1 Holder of 6.1. Zai’s Responsibilities. Zai shall use Commercially Reasonable Efforts to obtain Regulatory Approvals and Regulatory Submissions. NVCR shall initially be the holder of Regulatory Approvals pricing and Regulatory Submission reimbursement approvals for Licensed Products in the Territory. At Zai’s request during Territory in accordance with the Term, (a) the JSC will discuss Development Plan and Zai shall be solely responsible for all costs and expenses incurred in good faith whether to transfer manufacturing responsibilities for Licensed Products for the Territory to Zai, and (b) the Parties will discuss in good faith whether to enable Zai to hold Regulatory Approvals and Regulatory Submissions connection with performing such activities in the Territory, including any pricing or reimbursement approvals, whether by transfer to Zai of such Regulatory Approvals and Regulatory Submissions or through the submission of a new application for Regulatory Approval in the Territory submitted by Zai, in each case ((a) or (b)), to the extent permitted by Applicable Law and in accordance therewith. If agreed by the Parties, NVCR shall reasonably cooperate with Zai, at Zai’s expense, to enable Zai to hold any or all such Regulatory Approvals and Regulatory Submissions. 6.2 Zai’s Responsibilities. (a) Zai shall be responsible [***] for all regulatory activities leading up to and including the obtaining of the Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products from Regulatory Authorities in the Field and in the Territory, provided that, Zai shall conduct such regulatory activities (and any and all regulatory activities delegated to Zai in this Agreement or by NVCR during the Term in connection with the Development and Commercialization of the a Licensed Product in from the Territory during such time that NVCR is the holder of Regulatory Authority on a region-by-region basis, at its sole cost and expense. Zai or its designee shall own, hold and maintain all Regulatory Approvals and Regulatory Submissions for the a Licensed Product in the Territory) as the express, exclusive, and authorized legal agent of record for NVCR ; provided however that [***]; provided that in the Territory, and provided further, that such actions event [***]. Zai shall be taken on behalf keep Deciphera promptly informed of NVCR and for the benefit of Zai in the Territory. Promptly after the Effective Date and from time to time during the Term, the Parties shall conduct such actions and execute such documents as are required for Zai to act as NVCR’s express, exclusive, and authorized legal agent of record in the Territory. Notwithstanding the foregoing, regulatory developments related to the extent permitted under Applicable Laws, Zai may file, obtain and maintain (on behalf of NVCR, which will be the holder of) Regulatory Submissions, Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products in the TerritoryTerritory and shall promptly notify Deciphera in writing of any decision by any Regulatory Authority in the Territory regarding a Licensed Product. (ba) Zai Review of Regulatory Submissions. Each Party shall promptly provide to NVCR Deciphera for review and comment drafts of all Regulatory Submissions prepared by or on behalf of Zai, including English summaries thereofin the Territory for the Licensed Products no later than [***] prior to the planned submission. NVCR Each Party shall have incorporate any comments received from the right to review and comment other Party on such Regulatory Submissions where required under any Applicable Law and Zai shall consider in good faith any other comments received from NVCR and incorporate all comments that are reasonable or necessary for protecting NVCR’s interest as licensor of the Licensed Product or holder of the other Party on such Regulatory Submission or Regulatory Approval in the TerritorySubmissions. In addition, each Party shall promptly notify the other Party of any material Regulatory Submissions for the Licensed Products and any other material documents, comments or other correspondences related thereto submitted to or received from any Regulatory Authority in the Territory and shall provide the such other Party with copies thereof as soon as reasonably practicable, but in all events within [***] after submission or receipt thereof. If any such Regulatory Submission, comment comment, or correspondence is not in English, Zai then, at the other Party’s request and expense, the Party providing such copies shall also promptly provide NVCR with a written English summary of any comments or other correspondences received from a Regulatory Authority with respect to a Regulatory Submission. (c) Each Party shall promptly provide the other Party with notice after receiving notice of any meeting or discussion with any Regulatory Authority in the Territory related to any Licensed Product in the Field. Zai shall lead any such meeting or discussion, provided, however, that NVCR or its designee shall have the right, but not the obligation, to attend and participate in such meeting or discussion. If NVCR elects not to attend such meeting or discussion, Zai shall provide NVCR with a written summary thereof English translation within the corresponding timelines as set forth in English promptly following such meeting or discussionthis ARTICLE 6.

Regulatory. 6.1 Holder of 10.2.1 DSM will provide AMAG with standard regulatory support as identified under the heading “Regulatory Approvals and Regulatory SubmissionsSupport” in ANNEX 4 attached hereto. NVCR DSM shall initially be the holder of Regulatory Approvals and Regulatory Submission for Licensed Products in the Territory. At Zaialso make available to AMAG, at AMAG’s request during and expense, additional regulatory consulting services as identified under the Termheading “Regulatory Consulting” in ANNEX 4 attached hereto. Regulatory support services, (a) as identified in ANNEX 4, shall be at no additional charge to AMAG; regulatory consulting services shall be billed at DSM’s standard hourly rates and payable pursuant to Section 7.4 of this Agreement. Additional regulatory services and/or documentation may be provided by DSM, subject to the JSC will discuss in good faith whether to transfer manufacturing responsibilities for Licensed Products for the Territory to Zai, and (b) agreement of the Parties will discuss in good faith whether and subject to enable Zai to hold Regulatory Approvals and Regulatory Submissions in the Territory, including any pricing or reimbursement approvals, whether additional charges. 10.2.2 AMAG shall provide DSM with all documents reasonably requested by transfer to Zai of such Regulatory Approvals and Regulatory Submissions or through the submission of a new application for Regulatory Approval in the Territory submitted by Zai, in each case ((a) or (b)), DSM relating to the extent permitted by Applicable Law and in accordance therewith. If agreed by the Parties, NVCR shall reasonably cooperate with Zai, at ZaiFDA’s expense, to enable Zai to hold any or all such Regulatory Approvals and Regulatory Submissions. 6.2 Zai’s Responsibilities. (a) Zai shall be responsible [***] for all regulatory activities leading up to and including the obtaining of Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products from Regulatory Authorities in the Field and in the Territory, provided that, Zai shall conduct such regulatory activities (and any and all regulatory activities delegated to Zai in this Agreement or by NVCR during the Term in connection with the Development and Commercialization pre-approval inspection of the Licensed Product in the Territory during such time that NVCR is the holder Facility, including, but not limited to, development reports, CMC sections of AMAG’s NDA or other Regulatory Approvals Documentation and Regulatory Submissions for the Licensed Product in the Territory) as the express, exclusive, and authorized legal agent of record for NVCR in the Territory, and provided further, that such actions shall be taken on behalf of NVCR and for the benefit of Zai in the Territory. Promptly after the Effective Date and from time to time during the Term, the Parties shall conduct such actions and execute such documents as are required for Zai to act as NVCR’s express, exclusive, and authorized legal agent of record in the Territory. Notwithstanding the foregoing, to the extent permitted under Applicable Laws, Zai may file, obtain and maintain (on behalf of NVCR, which will be the holder of) Regulatory Submissions, Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products in the Territory. (b) Zai shall promptly provide to NVCR for review and comment drafts of all Regulatory Submissions prepared by or on behalf of Zai, including English summaries thereof. NVCR shall have the right to review and comment on such Regulatory Submissions and Zai shall consider in good faith any comments received from NVCR and incorporate all comments that are reasonable or necessary for protecting NVCR’s interest as licensor of the Licensed Product or holder of the Regulatory Submission or Regulatory Approval in the Territorystability data. In addition, each Party AMAG shall promptly notify provide to DSM a copy of AMAG’s annual report filed with the other Party FDA with respect to the manufacture and control of the Product; and AMAG shall take into consideration any Regulatory Submissions and DSM comments to such annual report solely to the extent applicable to the manufacture of the Product as performed by DSM. DSM shall provide comments on the Annual Report to AMAG within three (3) business days after receipt. Notwithstanding the foregoing or anything in this Agreement to the contrary, AMAG shall be solely responsible for all regulatory filings for the Product, including the CMC regulatory strategy. 10.2.3 DSM will not change or modify any comments of the master batch records or other correspondences related thereto submitted to manufacturing SOPs, or received from otherwise make any Regulatory Authority change in the Territory and shall provide the other Party materials, equipment, process or procedures used to manufacture or test any Product in AMAG’s judgment that would require a filing with copies thereof as soon as reasonably practicable. If any such Regulatory Submission, comment or correspondence is not in English, Zai shall also promptly provide NVCR with a written English summary of any comments or other correspondences received from a Regulatory Authority and/or that would reasonably be expected to or affects DSM’s ability to manufacture the Product in accordance with respect the Specifications or the terms of this Agreement, without first obtaining AMAG’s prior written approval. DSM will disclose all proposed changes in such manufacturing and testing materials, equipment, process or procedure to AMAG at a Regulatory Submissionlevel that would be sufficient to allow AMAG to understand and reproduce such changes and comply with regulatory standards. If AMAG agrees to allow any such change requiring AMAG’s approval to be implemented, then the Parties will revise manufacturing SOPs, master batch records and the relevant Specifications in writing accordingly, if applicable. (c) Each Party shall promptly provide 10.2.4 DSM will keep complete, accurate and authentic accounts, notes, data and records pertaining to the other Party manufacture, processing, testing, storage, and delivery/shipment of the Product from the Facility, including without limitation master production and control records in accordance with notice after receiving notice of any meeting or discussion regulatory standards and with any Regulatory Authority the terms set forth in the Territory related to any Licensed Product Quality Agreement. DSM will retain such documentation in accordance with DSM’s record retention policy and in accordance with the retention schedule specified in the FieldQuality Agreement, which shall at least be the period required by applicable law. Zai shall lead any such meeting or discussion, provided, however, that NVCR or its designee shall have the right, but not the obligation, to attend Electronic records will be backed up and participate in such meeting or discussion. If NVCR elects not to attend such meeting or discussion, Zai shall provide NVCR with stored at a written summary thereof in English promptly following such meeting or discussionsecure offsite storage facility.

Regulatory. 6.1 Holder of Regulatory Approvals and Regulatory Submissions. NVCR shall initially be the holder of Regulatory Approvals and Regulatory Submission for Licensed Products in the Territory. At Zai’s request during the Term, (a) Novartis will (i) determine the JSC will discuss in good faith whether regulatory plans and strategies for any Licensed Products; (ii) make all Regulatory Filings with respect to transfer manufacturing responsibilities the Licensed Products, either itself or through its Affiliates or sublicensees; and (iii) be responsible for Licensed Products for the Territory to Zai, obtaining and (b) the Parties will discuss in good faith whether to enable Zai to hold maintaining Regulatory Approvals and Regulatory Submissions throughout the world in the Territory, including any pricing name of Novartis or reimbursement approvals, whether by transfer to Zai of such Regulatory Approvals and Regulatory Submissions its Affiliates or through the submission of a new application for Regulatory Approval in the Territory submitted by Zai, in each case ((a) or (b)), to the extent permitted by Applicable Law and in accordance therewith. If agreed by the Parties, NVCR shall reasonably cooperate with Zai, at Zai’s expense, to enable Zai to hold any or all such Regulatory Approvals and Regulatory Submissions. 6.2 Zai’s Responsibilities. (a) Zai shall be responsible [***] for all regulatory activities leading up to and including the obtaining of Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products from Regulatory Authorities in the Field and in the Territory, provided that, Zai shall conduct such regulatory activities (and any and all regulatory activities delegated to Zai in this Agreement or by NVCR during the Term in connection with the Development and Commercialization of the Licensed Product in the Territory during such time that NVCR is the holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory) as the express, exclusive, and authorized legal agent of record for NVCR in the Territory, and provided further, that such actions shall be taken on behalf of NVCR and for the benefit of Zai in the Territory. Promptly after the Effective Date and from time to time during the Term, the Parties shall conduct such actions and execute such documents as are required for Zai to act as NVCR’s express, exclusive, and authorized legal agent of record in the Territory. Notwithstanding the foregoing, to the extent permitted under Applicable Laws, Zai may file, obtain and maintain (on behalf of NVCR, which will be the holder of) Regulatory Submissions, Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products in the Territorysublicensees. (b) Zai shall promptly Cerulean will reasonably cooperate with and provide assistance to NVCR for review Novartis in connection with filings to any Regulatory Authority relating to the Licensed Products, including by executing any required documents, providing access to personnel, and comment drafts providing Novartis with copies of all Regulatory Submissions prepared reasonably required documentation, and will cause its vendors and service providers to transfer any such filings that are in their control. To cooperate and assist pursuant to this Section, Cerulean will provide, at its expense, up to [**] hours of working time by Cerulean employees; Novartis will bear all reasonable costs and expenses associated with any additional hours required from Cerulean employees hereunder, as well as any reasonable costs associated with cooperation or on behalf of Zai, including English summaries thereofassistance required from Cerulean’s vendors or service providers. NVCR shall Cerulean will have the right to review and comment attend CMC-specific meetings with Regulatory Authorities, provided that this will not prevent the attendance of required Novartis personnel, as determined by Novartis, due to limitations on the number of attendees imposed by such Regulatory Submissions Authorities, and Zai to provide comments (which will be reasonably considered by Novartis) on Regulatory Filings and other communications with Regulatory Authorities that are directly related to the Cerulean platform as implemented in a Licensed Product; and provided, further that any such activities conducted at Cerulean’s election (and not at Novartis’ request) shall consider in good faith be at Cerulean’s own cost and expense (and will not be counted toward the [**] hours of assistance described above). Novartis will share any comments guidance received from NVCR and incorporate all comments Regulatory Authorities that are reasonable or necessary for protecting NVCR’s interest as licensor specifically relates to the Cerulean platform. Any information arising from such activities will be deemed to be the Proprietary Information of the Licensed Product or holder of the Regulatory Submission or Regulatory Approval in the Territory. In addition, each Party shall promptly notify the other Party of any Regulatory Submissions and any comments or other correspondences related thereto submitted to or received from any Regulatory Authority in the Territory and shall provide the other Party with copies thereof as soon as reasonably practicable. If any such Regulatory Submission, comment or correspondence is not in English, Zai shall also promptly provide NVCR with a written English summary of any comments or other correspondences received from a Regulatory Authority with respect to a Regulatory SubmissionNovartis. (c) Each Party shall promptly provide To the extent necessary, Cerulean will grant or cause to be granted to Novartis and its Affiliates or sublicensees cross-reference rights to any relevant drug master files and other Party with notice after receiving notice of any meeting filings submitted by Cerulean or discussion its Affiliates with any Regulatory Authority Authority. (d) Novartis will have the right to disclose the existence of, and the results from, any clinical trials conducted under this Agreement in accordance with its standard policies. (e) When and as deemed necessary or appropriate by Novartis, the Territory related Parties will enter into a commercially reasonable pharmacovigilance agreement with respect to any Licensed Product in the Field. Zai shall lead any such meeting or discussion, provided, however, that NVCR being Developed by Novartis or its designee shall have the right, but not the obligation, to attend and participate in such meeting or discussion. If NVCR elects not to attend such meeting or discussion, Zai shall provide NVCR with a written summary thereof in English promptly following such meeting or discussionAffiliates.

Regulatory. 6.1 Holder 5. 1Holder of Regulatory Approvals and Regulatory Submissions; Regulatory Responsibilities. NVCR shall initially A Marinus Affiliate located in the European Union, Marinus Pharmaceuticals Emerald Limited, limited liability company formed corporation incorporated and existing under the laws of Ireland, registration number 688211, having a principal registered address place of business at 00 Xxxxxxxxx Xxxxxxx, Xxxxxx 0, X00 X000, Ireland, or another Marinus Affiliate located in the European Union will be the initial marketing authorization holder of for all Regulatory Approvals and Regulatory Submission for of Licensed Products in the Territory. At Zai’s request during Marinus shall have the Termright to transfer the Regulatory Approvals to other Marinus wholly owned subsidiaries located in the Territory for tax or other corporate purposes. Additionally, (a) should Marinus be required to hold local Regulatory Approvals within specific countries in the JSC Territory, Marinus shall set up such local subsidiaries as are required within such countries in the Territory. Marinus will be ​ ​ responsible for the conduct of all regulatory activities with respect to Licensed Products. Marinus shall promptly inform Licensee in writing of any plan to transfer the Regulatory Approvals and the Parties shall discuss in good faith whether to transfer manufacturing responsibilities for Licensed Products implications of such transfer. Marinus will be responsible for the Territory to Zai, and (b) the Parties will discuss in good faith whether to enable Zai to hold Regulatory Approvals and Regulatory Submissions in the Territory, including any pricing or reimbursement approvals, whether by transfer to Zai conduct of such Regulatory Approvals and Regulatory Submissions or through the submission of a new application for Regulatory Approval in the Territory submitted by Zai, in each case ((a) or (b)), to the extent permitted by Applicable Law and in accordance therewith. If agreed by the Parties, NVCR shall reasonably cooperate with Zai, at Zai’s expense, to enable Zai to hold any or all such Regulatory Approvals and Regulatory Submissions. 6.2 Zai’s Responsibilities. (a) Zai shall be responsible [***] for all regulatory activities leading up with respect to and including the obtaining of Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products from Regulatory Authorities in the Field and in the Territory, provided thatincluding (i) developing regulatory plans, Zai strategies and interactions with Regulatory Authorities in the Field in the Territory in support of obtaining such Regulatory Approvals, and (ii) preparing, obtaining, submitting, engaging and maintaining Regulatory Submissions for Licensed Products and obtaining and maintaining Regulatory Approvals of Licensed Products in the Field in any country in the Territory and Licensee shall provide such information, data and support to Marinus (including information and data with respect to Licensee’s conduct of Post-Regulatory Approval Studies) as may be reasonably requested by Marinus from time to time, provided, however, that details of such regulatory activities (and support shall be subject to a separate written agreement by the Parties. Marinus shall promptly inform Licensee about any and all regulatory activities delegated to Zai in this Agreement or by NVCR during the Term in connection with the Development and Commercialization Regulatory Approvals of the Licensed Product in the Territory during such time that NVCR is the holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory) as the express, exclusive, and authorized legal agent of record for NVCR in the Territory, and provided further, that such actions shall be taken on behalf of NVCR and for the benefit of Zai in the Territory. Promptly after the Effective Date and from time to time during the Term, the Parties shall conduct such actions and execute such documents as are required for Zai to act as NVCR’s express, exclusive, and authorized legal agent of record Products in the Territory. Notwithstanding the foregoing, to the extent permitted under Applicable Lawsas part of its Commercialization activities, Zai may file, obtain Licensee shall be responsible for using Commercially Reasonable Efforts for obtaining all pricing and maintain (on behalf of NVCR, which will be the holder of) Regulatory Submissions, Regulatory Approvals and any pricing or reimbursement approvals, as applicable, approvals for Licensed Products in the Territory. (b) Zai shall promptly provide to NVCR for review and comment drafts of all Regulatory Submissions prepared by or on behalf of Zai, including English summaries thereof. NVCR shall have the right to review and comment on such Regulatory Submissions and Zai shall consider in good faith any comments received from NVCR and incorporate all comments that are reasonable or necessary for protecting NVCR’s interest as licensor of the Licensed Product or holder of the Regulatory Submission or Regulatory Approval Field in the Territory. In addition, each Party shall promptly notify the other Party of any Regulatory Submissions and any comments or other correspondences related thereto submitted to or received from any Regulatory Authority in the Territory and shall provide the other Party with copies thereof as soon as reasonably practicable. If any such Regulatory Submission, comment or correspondence is not in English, Zai shall also promptly provide NVCR with a written English summary of any comments or other correspondences received from a Regulatory Authority with respect to a Regulatory Submission. (c) Each Party shall promptly provide the other Party with notice after receiving notice of any meeting or discussion with any Regulatory Authority in the Territory related to any Licensed Product in the Field. Zai shall lead any such meeting or discussion, provided, however, that NVCR or its designee shall have the right, but not the obligation, to attend and participate in such meeting or discussion. If NVCR elects not to attend such meeting or discussion, Zai shall provide NVCR with a written summary thereof in English promptly following such meeting or discussion.

Regulatory. 6.1 Holder of Regulatory Approvals 1.1.1 As between the Parties, Licensee will have responsibility for and Regulatory Submissions. NVCR shall initially be decision-making over regulatory activities for the holder of Regulatory Approvals and Regulatory Submission for Licensed Products in the Territory. At Zai’s request during the Term, (a) the JSC will discuss in good faith whether to transfer manufacturing responsibilities for Licensed Products for the Territory to Zai, and (b) the Parties will discuss in good faith whether to enable Zai to hold Regulatory Approvals and Regulatory Submissions Indications in the Territory, including any pricing or reimbursement approvals, whether by transfer to Zai Field of such Regulatory Approvals and Regulatory Submissions or through the submission of a new application for Regulatory Approval in the Territory submitted by Zai, in each case ((a) or (b)), to the extent permitted by Applicable Law and in accordance therewithUse. If agreed by As between the Parties, NVCR shall reasonably cooperate with Zai, at Zai’s expense, to enable Zai to hold any or all such Regulatory Approvals and Regulatory Submissions. 6.2 Zai’s Responsibilities. (a) Zai shall be responsible [***] for all regulatory activities leading up to and including the obtaining of Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products from Regulatory Authorities in the Field and in the Territory, provided that, Zai shall conduct such regulatory activities (and any and all regulatory activities delegated to Zai in this Agreement or by NVCR during the Term in connection with the Development and Commercialization of the Licensed Product in the Territory during such time that NVCR is the holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory) as the express, exclusive, and authorized legal agent of record for NVCR in the Territory, and provided further, that such actions shall be taken on behalf of NVCR and for the benefit of Zai in the Territory. Promptly after the Effective Date and from time to time during the Term, the Parties shall conduct such actions and execute such documents as are required for Zai to act as NVCR’s express, exclusive, and authorized legal agent of record in the Territory. Notwithstanding the foregoing, to the extent permitted under Applicable Laws, Zai may file, obtain and maintain (on behalf of NVCR, which Licensee will be the holder of) Regulatory Submissions, Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products in the Territory. (b) Zai shall promptly provide to NVCR for review and comment drafts of all Regulatory Submissions prepared by or on behalf of Zai, including English summaries thereof. NVCR shall have the right to review conduct all communications with Regulatory Authorities, including all meetings, conferences and comment on such Regulatory Submissions discussions (including advisory committee meetings), with regard to Licensed Products for the Indications in the Field of Use. Licensee will lead and Zai shall consider in good faith any comments received from NVCR have control over preparing and incorporate submitting all comments that are reasonable or necessary for protecting NVCR’s interest as licensor of INDs, BLAs and other material regulatory filings related to the Licensed Product or holder of Products for the Regulatory Submission or Regulatory Approval Indications in the Territory. In additionField of Use, each Party shall promptly notify the other Party of any including all applications for Regulatory Submissions and any comments or other correspondences related thereto submitted to or received from any Regulatory Authority in the Territory and shall provide the other Party with copies thereof as soon as reasonably practicable. If any such Regulatory Submission, comment or correspondence is not in English, Zai shall also promptly provide NVCR with a written English summary of any comments or other correspondences received from a Regulatory Authority with respect to a Regulatory Submission. (c) Each Party shall promptly provide the other Party with notice after receiving notice of any meeting or discussion with any Regulatory Authority in the Territory related to any Licensed Product in the Field. Zai shall lead any such meeting or discussionApproval, provided, however, that, Licensee shall notify Penn in writing of any such application for Regulatory Approval reasonably in advance of filing to allow for Penn to request and, upon any such request, review such application. Promptly following any such review request from Penn, Licensee shall provide Penn with a copy of such application for Regulatory Approval; provided, however, that NVCR Licensee shall not be obligated to provide any particular application for Regulatory Approval more than once (unless Licensee materially changes such application other than to incorporate any comments provided by Penn). As between the Parties, Licensee will own any and all applications for Regulatory Approvals (including INDs), Regulatory Approvals, and other regulatory filings related to the Licensed Products for the Indications in the Field of Use which will be held in the name of Licensee (or its designee designees). 1.1.2 At Licensee’s reasonable request and expense, Penn (through Xx. Xxxxxx and other Xxxxxx Lab personnel) shall have reasonably cooperate with and assist Licensee (or its designee) in connection with interactions with Regulatory Authorities relating to Licensed Products for the rightIndications in the Field of Use. In addition, Licensee will keep Penn reasonably informed of the progress of such regulatory interactions and, upon request but not more than twice per Calendar Year, Licensee will provide to Xx. Xxxxxx (or another designated Xxxxxx Lab personnel), on a confidential basis, a copy of any material regulatory filings or correspondence to or from the obligation, FDA or EMA with respect to attend and participate in a Licensed Product for an Indication. Licensee will consider any reasonable comments provided on a timely basis by Xx. Xxxxxx (or such meeting or discussion. If NVCR elects not Xxxxxx Lab personnel) with respect to attend such meeting or discussion, Zai shall provide NVCR with a written summary thereof in English promptly following such meeting or discussionregulatory interactions.

Regulatory. 6.1 Holder of Regulatory Approvals and Regulatory Submissions. NVCR shall initially be the holder of Regulatory Approvals and Regulatory Submission for Licensed Products in the Territory. At Zai’s request during the Term, (a) the JSC will discuss in good faith whether to transfer manufacturing responsibilities for Licensed Products for the Territory to Zai, and (b) the Parties will discuss in good faith whether to enable Zai to hold Regulatory Approvals and Regulatory Submissions in the Territory, including any pricing or reimbursement approvals, whether by transfer to Zai of such Regulatory Approvals and Regulatory Submissions or through the submission of a new application for Regulatory THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 21 Approval in the Territory submitted by Zai, in each case ((a) or (b)), to the extent permitted by Applicable Law and in accordance therewith. If agreed by the Parties, NVCR shall reasonably cooperate with Zai, at Zai’s expense, to enable Zai to hold any or all such Regulatory Approvals and Regulatory Submissions. 6.2 Zai’s Responsibilities. (a) Zai shall be responsible [***] for all regulatory activities leading up to and including the obtaining of Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products from Regulatory Authorities in the Field and in the Territory, provided that, Zai shall conduct such regulatory activities (and any and all regulatory activities delegated to Zai in this Agreement or by NVCR during the Term in connection with the Development and Commercialization of the Licensed Product in the Territory during such time that NVCR is the holder of Regulatory Approvals and Regulatory Submissions for the Licensed Product in the Territory) as the express, exclusive, and authorized legal agent of record for NVCR in the Territory, and provided further, that such actions shall be taken on behalf of NVCR and for the benefit of Zai in the Territory. Promptly after the Effective Date and from time to time during the Term, the Parties shall conduct such actions and execute such documents as are required for Zai to act as NVCR’s express, exclusive, and authorized legal agent of record in the Territory. Notwithstanding the foregoing, to the extent permitted under Applicable Laws, Zai may file, obtain and maintain (on behalf of NVCR, which will be the holder of) Regulatory Submissions, Regulatory Approvals and any pricing or reimbursement approvals, as applicable, for Licensed Products in the Territory. (b) Zai shall promptly provide to NVCR for review and comment drafts of all Regulatory Submissions prepared by or on behalf of Zai, including English summaries thereof. NVCR shall have the right to review and comment on such Regulatory Submissions and Zai shall consider in good faith any comments received from NVCR and incorporate all comments that are reasonable or necessary for protecting NVCR’s interest as licensor of the Licensed Product or holder of the Regulatory Submission or Regulatory Approval in the Territory. In addition, each Party shall promptly notify the other Party of any Regulatory Submissions and any comments or other correspondences related thereto submitted to or received from any Regulatory Authority in the Territory and shall provide the other Party with copies thereof as soon as reasonably practicable. If any such Regulatory Submission, comment or correspondence is not in English, Zai shall also promptly provide NVCR with a written English summary of any comments or other correspondences received from a Regulatory Authority with respect to a Regulatory Submission. (c) Each Party shall promptly provide the other Party with notice after receiving notice of any meeting or discussion with any Regulatory Authority in the Territory related to any Licensed Product in the Field. Zai shall lead any such meeting or discussion, provided, however, that NVCR or its designee shall have the right, but not the obligation, to attend and participate in such meeting or discussion. If NVCR elects not to attend such meeting or discussion, Zai shall provide NVCR with a written summary thereof in English promptly following such meeting or discussion.. THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 22