Regulatory Responsibilities. Each Work Order shall set forth the respective roles and responsibilities of the parties with respect to regulatory submissions and related activities for the applicable Joint Study, including without limitation the responsibility for preparing and filing the Investigational New Drug application (the “IND”) filed with the United States Food and Drug Administration (the “FDA”). Such designated party shall be responsible for preparing, filing and maintaining all regulatory filings, including submissions and correspondence, and compliance with all requirements for the conduct of the applicable Joint Study.

. As between the Parties, Lilly shall be responsible for the preparation, submission, and maintenance of all Regulatory Filings and obtaining Regulatory Approvals (including the preparation and submission of the IND filing and for seeking IND approval) with respect to Compounds and Products and shall have sole control over all interactions with the applicable Regulatory Authority. [[Merus:Organization]] shall reasonably cooperate with Lilly, at Lilly’s reasonable request and expense, with respect to any regulatory matters related to Compounds or Products related to seeking, obtaining or maintaining Regulatory Approval or Marketing Authorization or with respect to Commercialization in the United States, Japan or E.U., provided that such cooperation relates to the work [[Merus:Organization]] conducted pursuant to the applicable Research Plan, and provided further that nothing in this Section 5.4 shall require [[Merus:Organization]] to generate any additional data or other Know-How. Lilly will own all right, title and interest in and to any and all Regulatory Filings and Regulatory Approvals for Compounds and Products and, as between the Parties, all such Regulatory Filings and Regulatory Approvals will be held in the name of Lilly, and [[Merus:Organization]] shall execute all documents and take all actions as are necessary ​ to vest such title in Lilly.

Regulatory Lead Responsibilities. Subject to Section 5.4, the Regulatory Lead will be solely responsible for all regulatory matters in the Field in the applicable Territory relating to the Licensed Candidates, Licensed Products, ​ Combinations, and Relay Pipeline Combinations for which such Party is the Regulatory Lead. The Regulatory Lead will own all INDs, NDAs, Regulatory Approvals, Regulatory Materials, and related regulatory documents in the Field in the Territory with respect to such Licensed Candidates, Licensed Products, ​ Pipeline Compounds, ​ Combinations, Relay Pipeline Products and Relay Pipeline Combinations including any drug master files maintained by such Regulatory Lead solely with respect thereto in the Territory. Notwithstanding anything herein to the contrary, the Regulatory Lead responsibilities with respect to Relay and Relay Pipeline Combinations apply only to the Relay Pipeline Products contained in a Relay Pipeline Combinations and the Relay Pipeline Combination taken as a whole but not with respect to the Relay Pipeline Combination Eligible Licensed Product contained therein on its own.

Regulatory Responsibilities. Subject to the terms and conditions of this Agreement, as between the Parties, Akebia shall have sole control over and decision-making authority with respect to, at its own expense, preparing, filing, and maintaining all Regulatory Submissions for Licensed Compounds and Products in the Field in all countries and regulatory jurisdictions of the Territory, including preparing all reports required in connection with the submission of any application for Regulatory Approval. All Regulatory Submissions for the Licensed Compounds and the Products in the Field shall be filed in the name of Akebia or one of its Affiliates or Sublicensees, or in the case of an investigator-sponsored trial, in the name of the investigator or institution conducting the study, and, as between the Parties, Akebia shall sole control over and decision-making authority with respect to all communications and other dealings with the Regulatory Authorities relating to the Licensed Compounds and the Products in the Field in the Territory. As between the Parties, following completion of the assignment and transfer contemplated in Section 4.1, Akebia shall be the legal and beneficial owner of all Regulatory Submissions and Regulatory Approvals for the Licensed Compounds and the Products in the Field in all countries and regulatory jurisdictions of the Territory.

Regulatory Responsibilities. Licensor shall transfer to Licensee or its Affiliates all Regulatory Filings and Marketing Approvals for the Product in the Field in the Licensee Territory existing as of the Effective Date and thereafter during the term of this Agreement, as applicable for Shared Clinical Trials, in accordance with the terms of this Agreement and the Transition Plan, subject to subclause # below. Before the transfer of the applicable Marketing Authorization in the Licensee Territory to Licensee, Licensor shall # not take or omit to take any material action or make any material communication with respect to any Regulatory Filings or such Marketing Authorization for the Product in the Licensee Territory without Licensee’s prior written consent and # promptly transmit to Licensee any communication received from or draft of any planned communication or submission to the Regulatory Authorities with respect to any such Marketing Authorization.

Regulatory Responsibilities. Subject to the terms and conditions of this Agreement, including Section 4.3, Anteris shall have the sole and exclusive right and responsibility, at its own expense and discretion, to seek to obtain and maintain Regulatory Approvals for the Licensed Products in the Field in the Territory and to conduct all related regulatory affairs, including communications with any Regulatory Authorities relating to the Licensed Compound and Licensed Products. Upon Anteris’ reasonable request, vTv shall provide reasonable assistance as necessary for Anteris to file any IND for a Licensed Compound or Licensed Product and to obtain and maintain Regulatory Approvals with respect to Licensed Products. vTv will bear all internal and out-of-pocket costs of providing such assistance for up to ​ hours of assistance, and Anteris will reimburse vTv any internal costs (at an hourly rate of ​) and out-of-pocket costs incurred in providing such assistance in excess of ​ hours.

Regulatory Responsibilities. Everest shall be responsible, at its cost and subject to the Retained Rights and except as set forth in this ARTICLE 5, for all regulatory activities necessary to prepare, obtain and maintain Marketing Authorization Applications, Regulatory Filings and other Regulatory Approvals for the Compound and Licensed Products in the Licensed Field in the Territory. Everest shall keep NPLH informed of regulatory developments related to the Compound and Licensed Products in the Licensed Field in the Territory via the JDC.

Subject to the terms and conditions of this Agreement, Apollomics will be responsible, at its sole cost and expense, for the conduct of all regulatory activities required to obtain and maintain Regulatory Approval of Licensed Products in the Field in the Apollomics Territory, including the preparation and submission of all Regulatory Materials and all communications and interactions with Regulatory Authorities, as necessary to obtain Regulatory Approval for Licensed Products in any Region in the Apollomics Territory. Apollomics shall be responsible for filing each MAA in the Apollomics Territory for each Licensed Product in its own name. The Development Plan shall include the regulatory strategy for obtaining Regulatory Approval of Licensed Products in the Apollomics Territory. Apollomics shall use Commercially Reasonable Efforts to carry out its regulatory obligations for Licensed Products pursuant to such strategy.

Regulatory Responsibilities. During the Term, [[FibroGen:Organization]] will have sole responsibility for, and sole decision-making authority over, all regulatory activities and associated costs and expenses for all Licensed Compounds and all Licensed Products in the Field in the Territory.

Regulatory Responsibilities. The Parties will share responsibility for leading regulatory matters relating to the [[Unknown Identifier]] Co-Co Products, as described in this Section 6.9 (each Party, when designated as provided herein to provide such leadership with respect to designated activities is the “Lead Regulatory Party” with respect to such activities). With respect to each [[Unknown Identifier]] Co-Co Product, Acadia shall # lead the overall strategy for obtaining Regulatory Approval of such [[Unknown Identifier]] Co-Co Product (including labeling for such [[Unknown Identifier]] Co-Co Product), including by selecting the jurisdictions within which MAAs will be pursued and [[Person A:Person]] the timing and order in which such approvals will be sought (“Regulatory Strategy”), and will be the Lead Regulatory Party with respect to such strategic activities with respect to such [[Unknown Identifier]] Co-Co Product, # be the Lead Regulatory Party with respect to the submission of any MAA for such [[Unknown Identifier]] Co-Co Product, and # following the first Regulatory Approval of such [[Unknown Identifier]] Co-Co Product, be the Lead Regulatory Party in connection with such [[Unknown Identifier]] Co-Co Product and with respect to Commercialization and regulatory activities (including post-marketing studies). Subject to the foregoing, the JSC shall designate a Party to lead all other pre-Regulatory Approval regulatory matters relating to each [[Unknown Identifier]] Co-Co Product in accordance with the applicable [[Unknown Identifier]] Co-Development Plan (each Party in such capacity will be deemed the Lead Regulatory Party with respect to such activities). The Lead Regulatory Party shall be responsible for # filing for in its name, and owning, all Regulatory Materials relating to regulatory activities with respect to such [[Unknown Identifier]] Co-Co Product in the relevant country, # overseeing, monitoring, and coordinating all regulatory actions, communications and filings with, and submissions to, each Regulatory Authority with respect to such activities; and # interfacing, corresponding, and meeting with each Regulatory Authority with respect to such activities, in each case consistent with the Regulatory Strategy and applicable [[Unknown Identifier]] Co-Development Plan or [[Unknown Identifier]] Co-Commercialization Plan.