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 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 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 HookipaHxxxxxx, upon request of Gilead, agrees to perform such activities, Hookipa Hxxxxxx 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(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.