Common use of Regulatory Transfer Clause in Contracts

Regulatory Transfer. On a Development-Ready Licensed Product-by-Development-Ready Licensed Product basis, promptly following the JSC’s approval of such Licensed Product as Development-Ready in accordance with Section 2.3, Hookipa shall, and hereby does, assign and transfer to Gilead (or Gilead’s designee) all of Hookipa’s right, title, and interest in and to all Regulatory Approvals, Regulatory Filings, and related submissions, if any, owned by Hookipa or its Affiliates that relate to such Development-Ready Licensed Product, including any IND filed by Hookipa with respect to such Development-Ready Licensed Product, as well as copies of all results generated by or on behalf of Hookipa during its performance of the applicable Program relating to such Development-Ready Licensed Product. Gilead shall reimburse Hookipa and its Affiliates for their reasonable Out-of-Pocket Costs attributable to such assignment and transfer. Hookipa’s obligation to disclose and transfer such Development and regulatory data is limited to the disclosure of the data, information, and reports in the form, format, and quality as reasonably available to Hookipa; in no event shall Hookipa be obliged to translate, summarize, re-arrange, re-format, compile, correct, enhance, evaluate, interpret, or otherwise undertake secondary review of any such Development or regulatory data and any such activities, if CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[***]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. required for the Development, Manufacture, or Commercialization of Licensed Products in the Field in the Territory, shall be the sole responsibility of Gilead. If Hookipa, upon request of Gilead, agrees to perform such activities, Hookipa shall be reimbursed for the internal costs thereof by Gilead at the FTE Rate.

Regulatory Transfer. On a Development-Ready Licensed Product-by-Development-Ready 4.2.1 [*] Merus shall assign and transfer, and hereby assigns and transfers, to Company all of its right, title and interest in all Regulatory Documentations and Regulatory Approvals then Controlled by Merus and held in its name with respect to the Licensed Product basisto the extent that are necessary or reasonably useful for the Development, promptly manufacture and Commercialization of the Licensed Product in the Field and in the Territory, [*] (the “Regulatory Transfer”). Merus shall use Commercially Reasonable Efforts to complete the Regulatory Transfer described above within [*] following the JSCEffective Date, subject to the FDA’s approval of such Licensed Product as Development-Ready in accordance with Section 2.3, Hookipa shallRegulatory Transfer within such time period, and for which Company shall accept such Regulatory Transfer in writing. During the Transition Period and until such Regulatory Transfer becomes effective, Merus hereby doesgrants to Company a right of reference to all such Regulatory Documentations and Regulatory Approvals to the extent necessary for Company to prepare, assign submit, obtain and transfer maintain Regulatory Approvals for the Licensed Products or as otherwise necessary to Gilead (exercise its rights or Gileadperform its obligations under this License Agreement or to comply with Applicable Law. In addition, during the Transition Period and until such Regulatory Transfer becomes effective, Merus will continue to make any required updates or submissions on behalf of Company, subject to the Initial Merus Assistance Cap for the first [*] and the Merus Assistance Cap for the Transition Period. 4.2.2 The Parties will do all things reasonably necessary to give effect to Section 4.2.1, including executing and delivering to the relevant Regulatory Authority any ancillary documents and commitments. If applicable, upon Company’s designee) all of Hookipa’s rightrequest, titleMerus will execute and deliver, or will cause to be executed and delivered, to Company such assignments, and interest other documents as may be reasonably necessary to effect the Regulatory Transfer, including submitting to the applicable Regulatory Authority in the Territory a letter or other necessary documentation notifying such Regulatory Authority of the transfer of ownership of such Regulatory Documentation and Company shall accept such transfer of ownership required to execute the Regulatory Transfer. 4.2.3 Company hereby grants to Merus a non-exclusive, sublicensable right of reference to all Regulatory Approvals, Documentations and Regulatory Filings, and related submissions, if any, owned by Hookipa or its Affiliates that relate to such Development-Ready Licensed Product, including any IND filed by Hookipa Approvals with respect to such Development-Ready the Licensed Product, as well as copies Product that are Controlled by Company or any of all results generated its Affiliates or Sublicensees to the extent necessary or reasonably useful in connection with any activities (including any clinical Development activities) conducted by or on behalf of Hookipa during its performance of the applicable Program relating to such Development-Ready Licensed Product. Gilead shall reimburse Hookipa and Merus (or its Affiliates for their reasonable Out-of-Pocket Costs attributable to such assignment and transfer. Hookipa’s obligation to disclose and transfer such Development and regulatory data is limited to the disclosure of the data, information, and reports or (sub)licensees) in the form, format, and quality as reasonably available to Hookipa; in no event shall Hookipa be obliged to translate, summarize, re-arrange, re-format, compile, correct, enhance, evaluate, interpret, or otherwise undertake secondary review of any such Development or regulatory data and any such activities, if CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[***]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. required for connection with the Development, Manufacture, or manufacture and Commercialization of the Licensed Compound and Licensed Products (a) in the Field in outside the Territory, shall be and (b) outside the sole responsibility of Gilead. If Hookipa, upon request of Gilead, agrees to perform such activities, Hookipa shall be reimbursed for Field (whether in or outside the internal costs thereof by Gilead at the FTE RateTerritory).

Regulatory Transfer. On a Development(a) As soon as possible but in no event later than forty-Ready Licensed Product-by-Development-Ready Licensed Product basisfive (45) calendar days after the Effective Date, promptly following the JSC’s approval of such Licensed Product as Development-Ready in accordance with Section 2.3ALLERGAN, Hookipa shallat its own cost and expense, will use Commercially Reasonable Efforts to take all steps permitted under Applicable Law, and hereby doescause ALLERGAN's Affiliates and/or distributors in the Territory to take all steps permitted under Applicable Law, assign and to do the following: (i) prepare for the transfer to Gilead (of any or Gilead’s designee) all of Hookipa’s right, title, and interest in and to all Regulatory Approvals, Regulatory FilingsApproval Applications (but excluding the Import Drug License (IDL)) and related information to GSK or GSK's Affiliates or distributors; (ii) deliver, or cause its Affiliates and/or distributors to deliver, to GSK or GSK's Affiliates or distributors copies of each Regulatory Approval and Regulatory Approval Application held by ALLERGAN, its Affiliates and/or distributors/agents relating specifically to Product in the Field of Use in the Territory (including, without limitation, the Import Drug License (IDL)), and related submissions, if any, owned by Hookipa or its Affiliates that relate to such Development-Ready Licensed Product, including any IND filed by Hookipa with respect to such Development-Ready Licensed Product, as well as copies of all results generated by or on behalf of Hookipa during its performance of the applicable Program pricing information relating to such Development-Ready Licensed Product. Gilead shall reimburse Hookipa and its Affiliates for their reasonable Out-of-Pocket Costs attributable to such assignment and transfer. Hookipa’s obligation to disclose and transfer such Development and regulatory data is limited to the disclosure of the data, information, and reports Product in the formTerritory; and (iii) certify in writing that the copies of such Regulatory Approvals, format, Regulatory Approval Applications and quality Product pricing information are true and complete copies thereof. As soon as reasonably available to Hookipa; possible but in no event shall Hookipa be obliged later than thirty (30) calendar days after the Effective Date, ALLERGAN, at its own cost and expense, will use Commercially Reasonable Efforts to translatetake all steps permitted under Applicable Law, summarizeand cause ALLERGAN's Affiliates and/or distributors in the Territory to take all steps permitted under Applicable Law, re-arrange, re-format, compile, correct, enhance, evaluate, interpretto deliver, or otherwise undertake secondary review cause its Affiliates and/or distributors to deliver, to GSK or GSK's Affiliates or distributors copies of any such Development the Product pricing dossier. (b) GSK or regulatory data its Affiliate together with ALLERGAN will prepare a joint legal statement and any such activities, if CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[letter for submission to the SFDA regarding GSK's rights to the Product in ***]”* Certain confidential information contained in this document, marked with 3 asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Act of 1934, as amended. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. required for the Development, Manufacture, or Commercialization of Licensed Products in the Field Territory as provided herein and confirming GSK's authority to manage all regulatory matters relating to Product in the Territory. Such joint legal statement and letter will be reviewed by ALLERGAN within fourteen (14) calendar days after receipt of a copy thereof from GSK or its Affiliate. GSK will in good faith consider, shall but will not be the sole responsibility of Gileadobligated to include, any comments from ALLERGAN in such joint legal statement and letter. If HookipaGSK does not receive any comment from ALLERGAN on the joint legal statement and letter within such seven (7) calendar day period, upon request ALLERGAN will be deemed to have no comments on the copy received from GSK and ALLERGAN will countersign or will cause its Affiliate in the Territory to countersign such joint legal statement and letter within five (5) calendar days, which joint legal statement and letter GSK or its Affiliate will be free to also countersign and submit to the SFDA. (c) ALLERGAN will use Commercially Reasonable Efforts during the Term to do all other things as permitted pursuant to any Applicable Law in the Territory to ensure that the Regulatory Approvals and Regulatory Approval Applications (but excluding the Import Drug License (IDL)) are duly transferred into the name of GileadGSK or its nominee in a timely manner, agrees allowing GSK or its nominee to perform such activitieshave the authority to manage all regulatory matters relating to the Product, Hookipa shall be reimbursed for including, without limitation, within the internal costs thereof by Gilead first ninety (90) days after the Effective Date, participating, or causing its Affiliates or distributors of Product in the Territory to participate, in at least one (1) face-to-face meeting in the FTE RateTerritory with the SFDA and GSK or its Affiliate or nominee regarding any of the activities set forth in this Section 4.1.

Regulatory Transfer. On a Development-Ready Licensed Product-by-Development-Ready Licensed Product basis, promptly following the JSC’s approval of such HBV Licensed Product as Development-Ready in accordance with Section 2.32.3 or, as the case may be, Gilead’s exercise of the Option with respect to HIV Licensed Products in accordance with Section 2.4(a), Hookipa shall, and hereby does, assign and transfer to Gilead (or Gilead’s designee) all of Hookipa’s right, title, and interest in and to all Regulatory Approvals, Regulatory Filings, and related submissions, if any, owned by Hookipa or its Affiliates that relate to such Development-Ready Licensed Product, including any IND filed by Hookipa with respect to such Development-Ready Licensed Product, as well as copies of all results generated by or on behalf of Hookipa during its performance of the applicable Program relating to such Development-Ready Licensed ProductProduct and not already provided under Section 5.1(b). Gilead shall reimburse Hookipa and its Affiliates for their reasonable Out-of-Pocket Costs attributable to such assignment and transfer. Hookipa’s obligation to disclose and transfer such Development and regulatory data pursuant to this Section 5.4 is limited to the disclosure of the data, information, and reports in the form, format, and quality as reasonably available to Hookipa; in no event shall Hookipa be obliged to translate, summarize, re-arrange, re-format, compile, correct, enhance, evaluate, interpret, or otherwise undertake secondary review of any such Development or regulatory data and any such activities, if CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[***]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. required for the Development, Manufacture, or Commercialization of Licensed Products in the Field in the Territory, shall be the sole responsibility of Gilead. If HookipaH▇▇▇▇▇▇, upon request of Gilead, agrees to perform such activities, Hookipa H▇▇▇▇▇▇ shall be reimbursed for the internal costs thereof by Gilead at the FTE Rate.

Regulatory Transfer. On a Development-Ready Licensed Product-by-Development-Ready Licensed Product basis, promptly following the JSC’s approval of such Licensed Product as Development-Ready in accordance with Section 2.3, Hookipa shall, and hereby does, assign and transfer to Gilead (or Gilead’s designee) all of Hookipa’s right, title, and interest in and to all Regulatory Approvals, Regulatory Filings, and related submissions, if any, owned by Hookipa or its Affiliates that relate to such Development-Ready Licensed Product, including any IND filed by Hookipa with respect to such Development-Ready Licensed Product, as well as copies of all results generated by or on behalf of Hookipa during its performance of the applicable Program relating to such Development-Ready Licensed Product. Gilead shall reimburse Hookipa and its Affiliates for their reasonable Out-of-Pocket Costs attributable to such assignment and transfer. Hookipa’s obligation to disclose and transfer such Development and regulatory data is limited to the disclosure of the data, information, and reports in the form, format, and quality as reasonably available to Hookipa; in no event shall Hookipa be obliged to translate, summarize, re-arrange, re-format, compile, correct, enhance, evaluate, interpret, or otherwise undertake secondary review of any such Development or regulatory data and any such activities, if required for the Development, Manufacture, or Commercialization of Licensed Products in the Field in the Territory, shall be the sole responsibility of Gilead. If Hookipa, upon request of Gilead, agrees to perform such activities, Hookipa shall be reimbursed for the internal costs thereof by Gilead at the FTE Rate. CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[***]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. required for the Development, Manufacture, or Commercialization of Licensed Products in the Field in the Territory, shall be the sole responsibility of Gilead. If Hookipa, upon request of Gilead, agrees to perform such activities, Hookipa shall be reimbursed for the internal costs thereof by Gilead at the FTE Rate.

Regulatory Transfer. On a Development-Ready Licensed Product-by-Development-Ready Licensed Product basis, promptly following the JSC’s approval of such Licensed Product as Development-Ready in accordance with Section 2.3, Hookipa shall, and hereby does, assign and transfer to Gilead (or Gilead’s designee) all of Hookipa’s right, title, and interest in and to all Regulatory Approvals, Regulatory Filings, and related submissions, if any, owned by Hookipa or its Affiliates that relate to such Development-Ready Licensed Product, including any IND filed by Hookipa with respect to such Development-Ready Licensed Product, as well as copies of all results generated by or on behalf of Hookipa during its performance of the applicable Program relating to such Development-Ready Licensed Product. Gilead shall reimburse Hookipa and its Affiliates for their reasonable Out-of-Pocket Costs attributable to such assignment and transfer. Hookipa’s obligation to disclose and transfer such Development and regulatory data is limited to the disclosure of the data, information, and reports in the form, format, and quality as reasonably available to Hookipa; in no event shall Hookipa be obliged to translate, summarize, re-arrange, re-format, compile, correct, enhance, evaluate, interpret, or otherwise undertake secondary review of any such Development or regulatory data and any such activities, if required for the Development, Manufacture, or Commercialization of Licensed Products in the Field in the Territory, shall be the sole responsibility of Gilead. If Hookipa, upon request of Gilead, agrees to perform such activities, Hookipa shall be reimbursed for the internal costs thereof by Gilead at the FTE Rate. ​ CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[***]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. required for the Development, Manufacture, or Commercialization of Licensed Products in the Field in the Territory, shall be the sole responsibility of Gilead. If Hookipa, upon request of Gilead, agrees to perform such activities, Hookipa shall be reimbursed for the internal costs thereof by Gilead at the FTE Rate.