Regulatory Matters. The Company’s obligations under this Agreement are subject to the orders, rules and regulations of the federal and state banking regulators as may be in effect from time to time, including without limitation FDIC regulations governing “golden parachute payments” set forth at 12 CFR Part 359. If the Company is prevented from discharging its obligations hereunder as a result of any such orders, rules or regulations, the Company shall be released from its obligations and shall not be deemed to have breached this Agreement, to that extent. The Company shall have no obligation to petition the

Regulatory Matters. No part of the proceeds of any Loan will be used for “purchasing” or “carrying” any “margin stock” within the respective meanings of each of the quoted terms under Regulation U of the Board of Governors of the Federal Reserve System as now and from time to time in effect or for any purpose which violates the provisions of the Regulations of such Board of Governors.

Regulatory Matters. [[Bachem CH:Organization]] shall cooperate with Apellis as reasonably requested and mutually agreed with respect to Regulatory Submissions regarding the Drug Substance. Without limiting the foregoing, [[Bachem CH:Organization]] shall use reasonable efforts to address any questions or requests of Apellis regarding the Batch Records, reports, analysis, and documentation generated in connection with the activities conducted by [[Bachem CH:Organization]] hereunder, which may be subject to an additional cost to Apellis, depending on the extent of work required. Upon Apellis’ request and at Apellis’ cost, [[Bachem CH:Organization]] shall compile Records and other relevant documents reasonably requested by Apellis regarding Drug Substance that may be necessary for preparing Regulatory Submissions or communicating with Regulatory Authorities relating to the Drug Substance.

DAEWOONG and each of its Affiliates is in compliance in all material respects with all applicable laws that relate to the manufacture, development, or Commercialization of Product;

Regulatory Matters. Licensee shall be responsible for obtaining any necessary or customary regulatory approvals to support the Development Plan and the use and commercialization of the Product(s). Licensor shall share any and all applicable data necessary for regulatory purposes with Licensee. Licensee will keep Licensor reasonably informed of communications with regulatory authorities regarding the Development Plan, the Production Strains, or the Product(s), including providing review copies of submissions to regulatory authorities prior to filing. Licensee shall reasonably consider any comments Licensor provides on planned regulatory submissions. Licensee shall allow Licensor to participate in meetings, inspections, and other interactions with regulatory authorities on Licensor’s request to participate.

Regulatory Matters. [[MedImmune:Organization]] shall have the sole right and responsibility for making Regulatory Filings for the [[MedImmune:Organization]] Study Products (including for the use of [[MedImmune:Organization]] Study Products in combination with the Microbiome Oncology Products as provided for under the Research Plan) and shall have the right to control interactions with Regulatory Authorities with respect to Research Plan activities. Seres will provide reasonable support for such Regulatory Filings and interactions with Regulatory Authorities as related to Microbiome Oncology Products that are used for Research Plan activities in combination with the [[MedImmune:Organization]] Study Products. Seres will have the right to attend all ​ meetings and conferences with Regulatory Authorities in which Microbiome Oncology Products will be discussed. Seres grants [[MedImmune:Organization]] a right to reference the drug master files (“DMFs”) for the Microbiome Oncology Products solely as and to the extent needed for [[MedImmune:Organization]] to make Regulatory Filings for the [[MedImmune:Organization]] Study Products ​. In the event that [[MedImmune:Organization]] deems it necessary to make Regulatory Filings in territories that do not support the referencing of DMFs, then Seres and [[MedImmune:Organization]] shall discuss such filings in good faith and agree an alternative arrangement, which may include ​. Additionally, notwithstanding any other provision of this Agreement (including Article 10 hereunder), with respect to all data, results, analyses, and information which result from activities conducted under the Research Plan (“Research Plan Data”), # Seres may use the Research Plan Data in connection with filing, obtaining, and maintaining Regulatory Approvals for Microbiome Products (and for clarity subject to Section 2.2) and # [[MedImmune:Organization]] may use the Research Plan Data in connection with filing, obtaining, and maintaining Regulatory Approvals for [[MedImmune:Organization]] Study Products.

Regulatory Matters. Subject to [Section 3.5.1], Biogen Idec shall file and be the owner of all regulatory filings for Target Selective Compounds and/or Products (including Co-Funded Products) developed pursuant to this Agreement, including all NDAs and Regulatory Approvals, unless otherwise agreed by the Parties. Subject to [Section 3.5.2], Sunesis shall file and be the owner of all regulatory filings for [[Unknown Identifier]] and [[Unknown Identifier]] Products developed pursuant to this Agreement, including all NDAs and Regulatory Approvals, unless otherwise agreed by the Parties.

Subject to Section 4.2(b), Gilead (itself or through its Affiliates or Sublicensees) shall (as between the Parties) control, have the exclusive right, and be solely responsible for, at its expense, filing, obtaining and maintaining all Regulatory Filings (including Marketing Approvals) for development and commercialization of Product for the Field in the Territory. Gilead, directly or through its Affiliates or Sublicensees, shall ​. Notwithstanding the foregoing, Gilead shall provide to [[Durect:Organization]] ​, in each case as soon as reasonably practicable. [[Durect:Organization]] shall provide existing information in the Control of [[Durect:Organization]] and assistance as reasonably requested by Gilead to support Regulatory Filings, including without limitation, responding to inquiries of Regulatory Authorities if requested by Gilead, and inspections of [[Durect:Organization]] records and facilities by Regulatory Authorities if reasonably requested, in each case at ​expense.

The Company has not received any FDA Form 483, notice of adverse filing, warning letter, untitled letter or other correspondence or notice from the FDA, or any other court or arbitrator or federal, state, local, supranational or foreign governmental or regulatory authority, alleging or asserting noncompliance with the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.) (the “FDCA”). The Company and its directors, officers, employees and agents are and have been in compliance with applicable health care laws, including without limitation, the FDCA, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the civil False Claims Act (31 U.S.C. § 3729 et seq.), the criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (42 U.S.C. § 17921 et seq.) the exclusion laws (42 U.S.C. § 1320a-7), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Affordability Reconciliation Act of 2010, including, without limitation, the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), and the regulations promulgated pursuant to such laws, and comparable state laws, and all other local, state, federal, national, supranational, and foreign laws, manual provisions, policies and administrative guidance relating to the regulation of the Company (collectively, “Health Care Laws”). The Company has not, either voluntarily or involuntarily, initiated, conducted or issued or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the knowledge of the Company, no third-party has initiated or conducted any such notice or action. Neither the Company nor any of its officers, directors, employees, or agents has been or is currently excluded from participation in the Medicare and Medicaid programs or any other state or federal health care program.

Regulatory Matters. All studies, tests and preclinical or clinical trials conducted by or on behalf of the Company (the “Company Studies and Trials”) were and, if still pending, are being, conducted in all material respects in accordance with experimental protocols and all applicable laws and regulations, except where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company’s knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any written notice, warning letter or other communication from the U.S. Food and Drug Administration (“FDA”), the U.K. Medicines and Healthcare Products Regulatory Agency (“MHRA”) or any other governmental or regulatory authority, which # requires the termination, suspension or material modification of any Company Studies or Trials, # imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, # enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or # otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations, and in using or disclosing patient information received by the Company, if any, in connection with the Company Studies and Trials, the Company and its Subsidiaries have complied in all material respects with all applicable laws and regulatory rules or requirements. To the Company’s knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA, the MHRA, or a comparable foreign regulatory authority to have engaged in scientific misconduct or violations of good clinical practices. To the Company’s knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, and regulations of the FDA, the MHRA, and comparable foreign governmental or regulatory authorities to which the Company’s products are subject.